3,4,9, 19. Fish and Fishery Products Hazards and Controls Guidance (Manual HACCP Regulasi FDA)

Fish and Fishery Products
Hazards and Controls Guidance

Fourth Edition APRIL 2011
DEPARTMENT OF HEALTH AND HUMAN SERVICES

PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
OFFICE OF FOOD SAFETY
Fish and Fishery Products Hazards and
Controls Guidance
Fourth Edition April 2011
Additional copies may be purchased from:
Florida Sea Grant

IFAS - Extension Bookstore
University of Florida
P.O. Box 110011
Gainesville, FL 32611-0011
(800) 226-1764
Or
www.ifasbooks.com
Or you may download a copy from:
http://www.fda.gov/FoodGuidances
You may submit electronic or written comments

regarding this guidance at any time. Submit
electronic comments to http://www.regulations.
gov. Submit written comments to the Division
of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All comments
should be identified with the docket number
listed in the notice of availability that publishes
in the Federal Register.
U.S. Department of Health and Human Services

Food and Drug Administration
Center for Food Safety and Applied Nutrition
(240) 402-2300
April 2011
Note: This document was corrected on August 3, 2011. The Agency corrected a typographical error appearing in the April
2011 version of this document. The Agency corrected "15%" to "1.5%" so that the sentence in "Chapter 11: Aquaculture Drugs
" now reads "Sodium sulfite Used in a 1.5% solution for 5 to 8 minutes to treat eggs in order to improve their hatchability."
Table of Contents: Fish and Fishery Products Hazards and Controls Guidance
Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance................................ 1
CHAPTER 1: General Information.......................................................................................................19
CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan ..........................................21
CHAPTER 3: Potential Species-Related and Process-Related Hazards..................................................... 29
CHAPTER 4: Pathogens From the Harvest Area ...................................................................................75
CHAPTER 5: Parasites ......................................................................................................................91
CHAPTER 6: Natural Toxins ............................................................................................................ 99
CHAPTER 7: Scombrotoxin (Histamine) Formation ............................................................................. 113
CHAPTER 8: Other Decomposition-Related Hazards .........................................................................153
CHAPTER 9: Environmental Chemical Contaminants and Pesticides......................................................155
CHAPTER 10: Methylmercury .......................................................................................................... 181
CHAPTER 11: Aquaculture Drugs .....................................................................................................183
CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum)
as a Result of Time and Temperature Abuse ................................................................. 209
CHAPTER 13: Clostridium botulinum Toxin Formation......................................................................... 245
CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying .........293
CHAPTER 15: Staphylococcus aureus Toxin Formation in Hydrated Batter Mixes .................................. 309
CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization ..................................... 315
CHAPTER 17: Pathogenic Bacteria Survival Through Processes Designed to Retain
Raw Product Characteristics .......................................................................................331
CHAPTER 18: Introduction of Pathogenic Bacteria After Pasteurization and
Specialized Cooking Processes ................................................................................. 345
CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances
and Prohibited Food and Color Additives ....................................................................355
CHAPTER 20: Metal Inclusion..........................................................................................................385
CHAPTER 21: Glass Inclusion ..........................................................................................................395
APPENDIX 1: Forms....................................................................................................................... 405
APPENDIX 2: Sample Product Flow Diagram ..................................................................................... 411
APPENDIX 3: Critical Control Point Decision Tree ............................................................................... 413
APPENDIX 4: Bacterial Pathogen Growth and Inactivation .................................................................. 417
APPENDIX 5: FDA and EPA Safety Levels in Regulations and Guidance ................................................439
APPENDIX 6: Japanese and Hawaiian Vernacular Names for Fish Eaten Raw ...................................... 443
APPENDIX 7: Bacterial and Viral Pathogens of Greatest Concern in Seafood Processing

Public Health Impacts..................................................................................................451
APPENDIX 8: Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products ... 455
NOTES:
Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance
Fourth Edition
This guidance represents the Food and Drug Administrations (FDAs) current thinking on this topic. It does not create
or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative
approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss
an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the
appropriate FDA staff, call the telephone number listed on the title page of this guidance.
I. INTRODUCTION II. DISCUSSION

This guidance is intended to assist processors
A. Scope and Limitations
of fish and fishery products in the development
of their Hazard Analysis Critical Control Point The control strategies and practices provided in
(HACCP) plans. Processors of fish and fishery this guidance are recommendations to the fish
products will find information in this guidance and fishery products industry unless they are
that will help them identify hazards that are required by regulation or statute. This guidance
associated with their products, and help them provides information that would likely result in a
formulate control strategies. The guidance will HACCP plan that is acceptable to FDA. Processors
help consumers and the public generally to may choose to use other control strategies, as
understand commercial seafood safety in terms long as they comply with the requirements of
of hazards and their controls. The guidance does the applicable food safety laws and regulations.
not specifically address safe handling practices by However, processors that chose to use other
consumers or by retail establishments, although control strategies (e.g., critical limits) should
many of the concepts contained in this guidance scientifically establish their adequacy.
are applicable to both. This guidance is also The information contained in the tables in
intended to serve as a tool to be used by federal Chapter 3 and in Chapters 4 through 21 provide
and state regulatory officials in the evaluation of guidance for determining which hazards are
HACCP plans for fish and fishery products. reasonably likely to occur in particular fish and
fishery products under ordinary circumstances.
FDAs guidance documents, including this
However, the tables should not be used separately
guidance, do not establish legally enforceable
for this purpose. The tables list potential hazards
responsibilities. Instead, guidance describe the
for specific species and finished product types.
Agencys current thinking on a topic and should
This information should be combined with
be viewed only as recommendations, unless
the information in the subsequent chapters to
specific regulatory or statutory requirements are
determine the likelihood of occurrence.
cited. The use of the word should in Agency
guidance means that something is suggested or The guidance is not a substitute for the
recommended, but not required. performance of a hazard analysis by a processor
of fish and fishery products, as required by FDAs
regulations. Hazards not covered by this guidance
may be relevant to certain products under certain
circumstances. In particular, processors should
be alert to new or emerging problems (e.g., the
occurrence of natural toxins in fish not previously
associated with that toxin).
Guidance for the Industry: Fish and Fishery Products Hazards and Controls Guidance Fourth Edition
1
FDA announced its adoption of final regulations This guidance does not cover the sanitation
to ensure the safe and sanitary processing of fish controls required by the Seafood HACCP
and fishery products in the Federal Register of Regulation. However, the maintenance of a
December 18, 1995 (60 FR 65096) (hereinafter sanitation monitoring program is an essential
referred to as the Seafood HACCP Regulation). prerequisite to the development of a HACCP
This guidance, the Seafood HACCP Regulation program. When sanitation controls are necessary
(21 CFR 123),and the Control of Communicable for food safety, but are not included in a
Diseases regulation (21 CFR 1240) apply to sanitation monitoring program, they must be
all aquatic animal life, other than birds and included in the HACCP plan (21 CFR 123.6).
mammals, used as food for human consumption.
This guidance does not describe corrective action
For example, in addition to fresh and saltwater
or verification records, because these records
finfish and crustaceans, this guidance applies
are not required to be listed in the HACCP plan.
to echinoderms such as sea cucumbers and sea
Nonetheless, such records must be maintained,
urchins; reptiles such as alligators and turtles;
where applicable, as required in 123.7 and
amphibians such as frogs; and to all mollusks,
123.8. Additionally, this guidance does not restate
including land snails (escargot). It also applies
the general requirements for records that are set
to extracts and derivatives of fish, such as eggs
out in 123.9(a).
(roe), oil, cartilage, and fish protein concentrate.
In addition, this guidance applies to products This guidance does not cover reassessment of the
that are mixtures of fish and non-fish ingredients, HACCP plan and/or the hazard analysis or review
such as tuna sandwiches and soups. Appendix 8, of consumer complaints, as mandated by 123.8.
123.3, lists the definitions for fish and fishery
This guidance also does not provide specific
product used in the Seafood HACCP Regulation.
guidance to importers of fish and fishery
This guidance covers safety hazards associated products for the development of required
with fish and fishery products only. It does importer verification procedures. However,
not cover most hazards associated with non- the information contained in the text, and, in
fishery ingredients (e.g., Salmonella enteritidis particular, in Appendix 5 (FDA and EPA Safety
in raw eggs). However, where such hazards are Levels in Regulations and Guidance), should
presented by a fishery product that contains non- prove useful for this purpose.
fishery ingredients, control must be included
in the HACCP plan ( 123.6). Processors may
use the principles included in this guidance for
assistance in developing appropriate controls for
these hazards.
This guidance does not cover the hazard
associated with the formation of Clostridium
botulinum (C. botulinum) toxin in low-acid
canned foods (LACFs) or shelf-stable acidified
foods. Mandatory controls for this hazard are
contained in the Thermally Processed Low-
Acid Foods Packaged in Hermetically Sealed
Containers regulation (hereinafter referred to
as the LACF Regulation, 21 CFR 113) and the
Acidified Foods regulation (21 CFR 114). Such
controls may be, but are not required to be,
included in HACCP plans for these products.
2
B. Changes in This Edition Additional information that is broadly
applicable to these tasks, also contained in
Following is a summary of the most significant the companion document to this guidance,
changes in this edition of the guidance HACCP: Hazard Analysis Critical Control
document. In addition to using this summary list, Point Training Curriculum, developed by the
you should carefully review the chapters that are Seafood HACCP Alliance for Training and
applicable to your product and process. Education, is now included.
The information contained throughout this The information in Chapter 3 for identifying
guidance document is changed as follows: potential species-related and process-related
The elements of a control strategy (i.e., critical hazards is changed as follows:
limits, monitoring procedures, corrective action Information is now provided on how illicit
procedures, recordkeeping system, and verification species substitution can impact on the
procedures) are now consolidated for each control identification of potential species-related
strategy. In most cases, an example of a HACCP hazards.
plan follows the discussion of each control strategy;
The information contained in Table 3-2
A bibliography is now located at the end of
(Potential Vertebrate Species-Related
most chapters. References have been added
Hazards) is changed as follows:
and deleted for many of the chapters;
Information on the mechanics of completing There are several scientific name changes to
a HACCP plan, previously repeated in reflect changes in taxonomic conventions;
Chapters 4 through 21, is now contained in Aholehole (Kuhlia spp.) is no longer listed as
Chapter 2; having a potential ciguatera fish poisoning
Information on the potential public health (CFP) hazard;
consequences (i.e., illness or injury) of Amberjack or Yellowtail, Aquacultured
seafood safety hazards is now provided; (Seriola lalandi), is no longer listed as having
Recommendations for specific job positions a potential CFP hazard;
are no longer listed for Who should perform Barramundi (Lates calcarifer) is now listed as
the monitoring? in Chapters 4 through 21; a species that is aquacultured;
Additional information is now provided on Basa or Bocourti (Pangasius bocourti) is now
the performance of accuracy checks and listed as a species in U.S. commerce;
calibration of temperature-indicating devices Bass, Sea (Dicentrarchus labrax) is now
(e.g., thermometers) and temperature- listed as a species that is aquacultured;
recording devices (e.g., recording
Bata (Labeo bata) is now listed as a species
thermometers); and
in U.S. commerce;
Reference is no longer made to the
Bream (Abramis brama) is now listed as a
intended issuance by FDA of guidance on
species that is aquacultured;
the development of Sanitation Standard
Operating Procedures (SSOPs) and sanitation Caparari (Pseudoplatystoma tigrinum) is
monitoring or guidance on the development now listed as a market name for a species
of importer verification procedures. previously referred to as catfish;
Carp (Barbonymus spp., Hypophthalmichthys
The recommendations in Chapter 2 for nobilis, and Carassius carassius) is now
conducting a hazard analysis and developing a listed as a species in U.S. commerce;
HACCP plan are changed as follows:
Carp (Hypophthalmichthys nobilis and
3
Carassius carassius) is now listed as a Goatfish (Mulloidichthys spp., Pseudupeneus
species that is aquacultured; spp., and Upeneichthys lineatus) is no longer
Cascarudo (Callichthys callichthys) is now listed as having a potential CFP hazard;
listed as a market name for a species Goby (Neogobius melanostomus) is now
previously referred to as catfish; listed as a species in U.S. commerce;
Characin (Leporinus obtusidens) is now listed Grouper (Anyperodon spp., Caprodon
as a species in U.S. commerce; schlegelii, and Diplectrum formosum) is
Charal (Chirostoma jordani) is now listed as no longer listed as having a potential CFP
a species in U.S. commerce; hazard;
Chiring (Apocryptes bato) is now listed as a Grouper, or Coral Grouper (Plectropomus
species in U.S. commerce; spp.), is now listed as a species in U.S.
commerce;
Clarias Fish, or Walking Clarias Fish (Clarias
anguillaris and Clarias gariepinus), is Grouper, or Jewfish (Epinephelus itajara), is
now listed as a market name for a species no longer listed as a having a potential CFP
previously referred to as catfish, and is now hazard;
listed as a species that is aquacultured; Herring, or Sea Herring, or Sild (Clupea
Cobia (Rachycentron canadum) is now listed spp.), is no longer listed as having a potential
as a species that is aquacultured; scombrotoxin (histamine) hazard associated
with its roe;
Coroata (Platynematichthys notatus) is
now listed as a market name for a species Hind (Epinephelus drummondhayi) is no
previously referred to as catfish; longer listed as having a potential CFP
hazard;
Curimbata or Guramata (Prochilodus lineatus)
is now listed as a species in U.S. commerce; Jack (Carangoides bartholomaei) is now
listed as having a potential CFP hazard;
Cusk-eel (Brotula clarkae) is now listed as a
species in U.S. commerce; Jack (Selene spp., Urapsis secunda, and
Oligoplites saurus) is no longer listed as
Dace (Rhinichthys spp.) is now listed as a
having a potential CFP hazard;
species that is aquacultured;
Jack or Crevalle (Alectis indicus) is no longer
Eel, Moray (Muraena retifera), is no longer
Jack or Roosterfish (Nematistius pectoralis)
Featherback (Notopterus notopterus) is now
is no longer listed as having a potential CFP
listed as a species in U.S. commerce;
hazard;
Flathead (Platycephalus conatus) is now
Jobfish (Aprion spp.) is now listed, and
Aprion virescens is deleted because it is
Flatwhiskered Fish (Pinirampus pirinampu) included in Aprion spp.;
is now listed as a market name for a species
Jobfish (Aphareus spp., Aprion spp., and
previously referred to as catfish;
Pristipomoides spp.) is no longer listed as
Frog (Rana spp.) is now listed as having a having a potential scombrotoxin (histamine)
parasite hazard; hazard;
Gillbacker, or Gilleybaka (Aspistor parkeri), Kahawai (Arripis spp.) is no longer listed as
is now listed as a market name for a species having a potential CFP hazard;
previously referred to as catfish;
Loach (Somileptus gongota) is now listed as a
Goatfish (Mulloidichthys vanicolenis) is now species in U.S. commerce;
4
Mackerel, narrow-barred Spanish Salmon and roe (wild) (freshwater)
(Scomberomorus commerson), is now listed (Oncorhynchus spp. and Salmo salar) is now
as having a potential CFP hazard; listed as having a potential parasite hazard;
Menhaden (Brevoortia spp. and Ethmidium Scad (Trachurus spp.) is now listed as having
maculatum) is now listed as having a potential scombrotoxin (histamine) hazard;
a potential scombrotoxin (histamine) Scad or Horse Mackerel (Trachurus trachurus)
hazard for products intended for direct is now listed as a market name for a species
human consumption of the muscle and previously referred to as only scad;
for aqueous components, such as fish
Shad (Alosa spp.) is no longer listed as having
protein concentrates, that are to be used
a potential scombrotoxin (histamine) hazard
as food additives. It is also listed as
associated with its roe;
having a potential environmental chemical
contaminant and pesticide hazard when Shad, Hilsa (Tenualosa ilisha), is now listed
the food products are intended for human as a species in U.S. commerce;
consumption, such as oil extracts used as Snapper (Etelis spp. and Pristipomoides spp.)
dietary ingredients; is no longer listed as having a potential CFP
Oreo Dory (Neocyttus spp.)is now listed as a hazard;
species in U.S. commerce; Snapper (Pristipomoides spp.) is no longer
Oreo Dory (Pseudocyttus spp.) is now listed, listed as having a potential scombrotoxin
and Pseudocyttus maculates is deleted (histamine) hazard;
because it is included in Pseudocyttus spp; Snapper (Symphorus nematophorus) is now
Pangasius or Shortbarbel (Pangasius listed as having a potential CFP hazard;
micronemus) is now listed as a market name Sorubim, or Surubi (Pseudoplatystoma
for a species previously referred to as catfish; corruscans), is now listed as a market name
Parrotfish (Bolbometopon spp.) is now listed for a species previously referred to as catfish;
as a species in U.S. commerce; Spearfish (Tetrapturus spp.) is now listed as
Piramutaba or Laulao Fish (Brachyplatystoma having a potential scombrotoxin (histamine)
vaillanti) is now listed as a market name for hazard;
a species previously referred to as catfish; Squirrelfish (Holocentrus spp.) is no longer
Puffer (Fugu spp., now Takifugu spp.) is now listed as having a potential CFP hazard;
listed as an aquacultured species; Sutchi or Swai (Pangasius hypophthalmus)
Puffer (Sphoeroides annulatus, Sphoeroides are now listed as market names for a species
nephelus, Sphoeroides spengleri, and previously referred to as catfish and are now
Sphoeroides testudineus, Tetraodon spp.) is listed as species that are aquacultured;
now listed as a species in U.S. commerce; Tang (Naso spp.) is now listed as a species in
Puffer (Fugu spp., now Takifugu spp.) is now U.S. commerce;
listed as having a potential Paralytic Shellfish Tang (Tenthis spp.) is no longer listed.
Poisoning (PSP) hazard; Tang (Zebrasoma spp.) is no longer listed as
Rita (Rita rita) is now listed as a species in a having a potential CFP hazard;
U.S. commerce; Tigerfish (Datnioides microlepis and
Rohu (Labeo rohita) is now listed as a Datnioides polota) is now listed as a species
species in U.S. commerce; in U.S. commerce;
Sailfish (Istiophorus platypterus) is now listed Tinfoil (Barbonymus altus) is now listed as a
as a species in U.S. commerce; species in U.S. commerce;
5
Trahira (Hoplias malabaricus) is now listed The information contained in Table 3-3
as a species in U.S. commerce; (Potential Invertebrate Species-Related
Triggerfish (Canthidermis sufflamen and Hazards) is changed as follows:
Melichthys niger) is no longer listed as having There are several scientific name changes to
a potential CFP hazard; reflect changes in taxonomic conventions;
Tuna (Thunnus spp.) is now listed as a genus Abalone (Haliotis spp.) is now listed as
that is aquacultured; having a natural toxin hazard;
Turbot (Scophthalmus maximus, now Psetta Conch (Lambis lambis) is now listed as a
maxima) is now listed as a species that is species in U.S. commerce;
aquacultured;
Crab, all species are now listed as having
Turtle (Malaclemys spp., Chelydra spp., a potential environmental chemical
Apalone spp., and Trachemys spp.) is now contaminant and pesticide hazard;
Crab, Blue (Callinectes sapidus), is now listed
Turtle, Aquacultured (Malaclemys spp., as a species that is aquacultured;
Chelydra spp., Apalone spp., and Trachemys
Crab, Japanese Freshwater (Geothelphusa
spp.), is now listed as a species in U.S.
dehaani), is now listed as a species in U.S.
commerce;
commerce;
Unicornfish (Naso unicornis) is now listed as
Crab, Sheep (Loxorhynchus grandis), is now
a species in U.S. commerce;
Weakfish (Cynoscion spp.) is now listed as
Crab, Swamp (Scylla serrata), is now listed as
having a potential environmental chemical
contaminant and pesticide hazard;
Murex, or Merex (Murex brandaris), is now
Weakfish, or Bangamary (Macrodon ancylodon), listed as a species in U.S. commerce;
is now listed as a market name for a species
Oyster (Spondylus spp.) is now listed as a
previously referred to as only weakfish;
species in U.S. commerce;
Whiskered Fish (Arius spp.) is now listed Sea Squirt (Styela spp.) is now listed as a
as a market name for a species previously species in U.S. commerce;
referred to as sea catfish;
Shrimp (Pleoticus muelleri) is now listed as a
Whiskered Fish, or Gafftopsail Fish (Bagre species in U.S. commerce;
marinus), is now listed as a market name for
Snail, Moon (Polinices spp.), is now listed as
a species previously referred to as sea catfish;
Whiskered Fish, or Hardhead Whiskered Whelk (Busycon spp.) is now listed as having
Fish (Ariopsis felis), is now listed as a market a potential natural toxin hazard.
name for a species previously referred to as
sea catfish; The information contained in Table 3-4
Wrasse (Cheilinus undulatus) is now listed as (Potential Process-Related Hazards) is
a species in U.S. commerce; changed as follows:
Yellowtail Amberjack (Seriola lalandi) is now Fish oil is now listed as a food category;
listed as a species that is aquacultured and Changes have been made to be consistent
is no longer listed as having a potential CFP with changes in Chapters 13, 16, and 17.
hazard;
Zander (Sander lucioperca) is now listed as a
species that is aquacultured.
6
The recommendations in Chapter 4 for the The recommendations in Chapter 6 for the
control of pathogens from the harvest area are control of natural toxins are changed as follows:
changed as follows: Azaspiracid Poisoning (AZP) is now
Hydrostatic pressure, individual quick described, and an action level of 0.16 mg/kg
freezing (IQF) with extended storage, is now provided;
and irradiation are now identified as Information regarding potential molluscan
processes that are designed to retain shellfish toxins, pectenotoxins (PTXs)
raw product characteristics and that can and yessotoxins (YTXs), is now provided,
be used to reduce Vibrio vulnificus (V. although FDA has no specific expectations
vulnificus) and Vibrio parahaemolyticus (V. for control of YTXs;
parahaemolyticus) to non-detectable levels; An example of a HACCP plan is now
It is now recognized that a tag on a container provided for control of natural toxins in
of shellstock (in-shell molluscan shellfish) molluscan shellfish;
received from another dealer need not The action level for Diarrhetic Shellfish
identify the harvester; Poisoning (DSP) is now listed as 0.16 ppm
Critical limits relating to control of pathogen total okadaic acid equivalents;
growth prior to receipt of raw molluscan
Action levels for CFP are now listed as 0.01
shellfish by the primary processor are now
ppb for Pacific ciguatoxin and 0.1 ppb for
linked to monitoring the time that the
Caribbean ciguatoxin;
shellfish are exposed to air (i.e., by harvest
or receding tide) rather than to the time that It is now noted that in 2008, FDA advised
the shellfish are harvested; against the consumption of lobster tomalley
because unusually high levels of PSP toxins
Reference is now made to the role of the
were detected in that organ in lobsters
Federal, state, tribal, territorial and foreign
caught in the waters of New England during
government shellfish control authorities
a red tide event;
in determining whether the hazard of V.
parahaemolyticus is reasonably likely to occur in CFP is now described as being associated
raw molluscan shellfish and in the development with consumption of toxin-contaminated fish
of a V. parahaemolyticus control plan that will found in tropical or subtropical areas around
dictate, at least to some extent, the nature of the the world between 35 north latitude and 35
controls for this pathogen in HACCP plans; south latitude, particularly the Caribbean Sea,
The control strategy examples are Pacific Ocean, and Indian Ocean and in the
restructured for improved clarity: one for Flower Garden Banks area in the northern
source controls (e.g., tagging, labeling, Gulf of Mexico;
source waters, harvester licensure, and raw Gempylotoxin is now described as being
consumption advisory) and a second for time associated with orange roughy (Hoplostethus
from harvest to refrigeration controls. atlanticus) and oreo dory (Allocyttus spp.,
Pseudocyttus spp. and Neocyttus spp.)
The recommendations in Chapter 5 for the although in lesser amounts than escolar.
control of parasites are changed as follows:
It is now recognized that the parasite hazard The recommendations in Chapter 7 for the
may be reasonably likely to occur in fish control of scombrotoxin (histamine) formation
raised in freshwater containing larvae of are changed as follows:
pathogenic liver, lung and intestinal flukes Information is now provided about the
because these parasites enter the fish potential for scombrotoxin (histamine)
through the skin rather than in the food.
7
formation in products like tuna salad The lower anterior portion of the loin is
that have been allowed to become now identified as the best place to collect a
recontaminated and then subjected to time sample from large fish for histamine analysis;
and temperature abuse; Fermenting, pickling, smoking, and drying
The recommendations regarding on-board are now identified as likely critical control
chilling of scombrotoxin-forming species of points (CCPs) for this hazard;
fish are now listed as follows: When fish are checked for internal
Fish exposed to air or water temperatures temperature at off-loading, it is now
above 83F (28.3C) should be placed in recommended that:
ice, or in refrigerated seawater, ice slurry,
For fish held iced or refrigerated (not
or brine of 40F (4.4C) or less, as soon frozen) onboard the vessel and off-
as possible during harvest, but not more loaded from the vessel by the processor
than 6 hours from the time of death, or 24 or more hours after death, the internal
temperature should be 40F (4.4C) or
Fish exposed to air and water
below,
temperatures of 83F (28.3C) or less
should be placed in ice, or in refrigerated OR
seawater, ice slurry, or brine of 40F
(4.4C) or less, as soon as possible For fish held iced or refrigerated (not
frozen) onboard the vessel and off-
during harvest, but not more than 9
loaded from the vessel by the processor
hours from the time of death, or
from 15 to less than 24 hours after death,
Fish that are gilled and gutted before the internal temperature should be 50F
chilling should be placed in ice, or (10C) or below,
in refrigerated seawater, ice slurry, or
OR
brine of 40F (4.4C) or less, as soon as
possible during harvest, but not more For fish held iced or refrigerated (not
than 12 hours from the time of death, or frozen) onboard the vessel and off-
loaded from the vessel by the processor
Fish that are harvested under conditions
from 12 to less than 15 hours after death,
that expose dead fish to harvest waters
the internal temperature should be 60F
of 65F (18.3C) or less for 24 hours or
(15.6C) or below;
less should be placed in ice, refrigerated
seawater, ice slurry, or brine of 40F The recommended level at which a lot
(4.4C) or less, as soon as possible after should be rejected based on sensory
harvest, but not more than the time limits examination when 118 fish are examined
listed above, with the time period starting is now corrected to be no more than 2 fish
when the fish leave the 65F (18.3C) or to coincide with the goal of less than 2.5%
less environment; decomposition in the lot;
Cautions are now provided that handling It is now recommended that the number of
practices and processing controls that are fish subjected to sensory examination be
recommended as suitable for preventing increased if there is likely to be greater than
the formation of scombrotoxin may not normal variability in the lot, and that only
be sufficient to prevent fish from suffering one species constitute a lot for sampling
quality or shelf-life degradation (i.e., purposes;
decomposition) in a way that may otherwise When histamine analysis is performed as a
render it adulterated under the Federal Food, corrective action, it is now recommended
Drug, and Cosmetic Act; that any fish found to exceed the internal
8
temperature at receiving critical limit be or internal product temperatures are used
included in the sample; at receipt of fish from another processor, it
When the sensory critical limit has not is now recommended that the number of
been met, it is now recommended that containers examined and the number of
the processor perform histamine analysis containers in the lot be recorded;
of a minimum of 60 fish, collected Control of scombrotoxin (histamine)
representatively from throughout the lot, formation during processing and storage are
including all fish in the lot that show now provided as separate control strategy
evidence of decomposition, and reject the lot examples, and examples of HACCP plans are
if any fish are found with a histamine level now provided for both strategies;
greater than or equal to 50 ppm; The extended exposure times during
Subdividing and retesting for histamine is no processing (more than 12 hours,
longer recommended after an initial failed cumulatively, if any portion of that time is at
histamine test; temperatures above 70F (21.1C); or more
It is now recommended that employees who than 24 hours, cumulatively, as long as no
conduct sensory screening receive adequate portion of that time is at temperatures above
training; 70F (21.1C)) previously recommended for
fish that have been previously frozen are
It is now recommended that for shipments
now also recommended for fish that have
of scombrotoxin-forming species received
been previously heat treated sufficiently
under ice on open-bed trucks be checked for
to destroy scombrotoxin-forming bacteria
both sufficiency of ice and internal product
and are subsequently handled in a
temperature;
manner where there is an opportunity for
It is now recommended that shipments of recontamination with scombrotoxin-forming
scombrotoxin-forming species received under bacteria;
gel packs be checked for both adequacy of
It is now acknowledged that it may be
gel packs and internal product temperature;
possible to control scombrotoxin formation
It is now recommended that if only the during unrefrigerated processing using a
internal temperature of fish is checked at critical limit that is time of exposure only
receipt by a secondary processor because (i.e., no temperature component), if it is
the transit time is no more than 4 hours, developed with an assumption that worst-
calculation of transit time should include case temperatures (e.g., in excess of 70F
all time outside a controlled temperature (21.1C)) may occur;
environment; Chemical coolants (e.g., gel packs) are
It is now recommended that if only the no longer recommended for control of
internal temperature of fish is checked at temperature during in-plant storage;
receipt by a secondary processor because For control of time and temperature during
the transit time is no more than 4 hours, refrigerated storage, it is now noted that
a temperature-indicating device (e.g., a critical limits that specify a cumulative time
thermometer) should be used to determine and temperature of exposure to temperatures
internal product temperatures in a minimum above 40F (4.4C) are not ordinarily suitable
of 12 fish, unless there are fewer than 12 fish because of the difficulty in determining
in a lot, in which case all of the fish should when specific products have entered and
be measured; left the cooler and the time and temperature
When checks of the sufficiency of ice or exposures to which they were subjected.
chemical cooling media, such as gel packs, However, there may be circumstances where
9
this approach is suitable. It is also noted When testing for environmental chemical
that minor variations in cooler temperature contaminants and pesticides is used as the
measurements can be avoided by control measure, it is now recommended
submerging the sensor for the temperature- that the adequacy of the testing methods
recording device in a liquid that mimics the and equipment be verified periodically (e.g.,
characteristics of the product; by comparing results with those obtained
High-temperature alarms are no longer using an Association of Official Analytical
recommended for monitoring temperatures Chemists (AOAC) or equivalent method, or
in coolers or processing areas; by analyzing proficiency samples).
When the adequacy of ice is established as
Chapter 10, which covers the control of
the critical limit for refrigerated storage, it
methylmercury, has been rewritten to
is now recommended that monitoring be
acknowledge that FDA is receiving comments
performed with sufficient frequency to ensure
on a draft quantitative risk assessment
control rather than at least twice per day.
for methylmercury, which may result in a
The recommendations in Chapter 8 related reassessment of its risk management strategies.
to other decomposition-related hazards are
changed as follows: The recommendations in Chapter 11 for the
control of aquaculture drugs are changed as
It is now noted that FDA has received follows:
consumer complaints concerning illnesses
associated with the consumption of The potential for this hazard to occur during
decomposed salmon, attributable to the transportation of live fish is now recognized,
production in the fish of toxins other than and recommended controls are provided;
histamine (e.g., biogenic amines, such as An explanation of extra-label use of drugs is
putrescine and cadaverine); now provided, and a list of drugs prohibited
It is now noted that there are also some for extra-label use is now listed;
indications that chemicals formed when fats FDA high enforcement priority aquaculture
and oils in foods oxidize may contribute to drugs are now listed;
long-term detrimental health effects. Aquaflor Type A Medicated Article
(florfenicol) is now listed as an approved
The recommendations in Chapter 9 for the
drug for catfish and salmonids;
control of environmental chemical contaminants
and pesticides are changed as follows: Aquaflor CA1 is now listed as an approved
drug for catfish or in fingerling to food fish
Toxic element guidance levels for arsenic, as the sole ration for 10 consecutive days.
cadmium, lead, and nickel are no longer listed;
35% PEROX-AID (hydrogen peroxide)
Tolerance levels for endothall and its is now listed as an approved drug for
monomethyl ester in fish and carbaryl in freshwater-reared salmonids and freshwater-
oysters are now listed; reared cool water finfish and channel catfish;
The collection of soil samples from Terramycin 200 for Fish (oxytetracycline
aquaculture production sites is no longer dihydrate) Type C, is now listed as an approved
listed as a preventive measure; drug for catfish, salmonids; and lobster;
An example of a HACCP plan is now OxyMarine, Oxytetracycline HCl Soluble
provided for control of environmental Powder-343, Terramycin-343, TETROXY Aquatic
chemical contaminants in molluscan is now listed as an approved drug for all finfish
shellfish; fry and fingerlings as an aid in identification;
10
Quarterly raw material, in-process, For control of transit conditions at receipt
or finished product testing is now of ready-to-eat fish or fishery products
recommended as a verification step for delivered refrigerated (not frozen), it is now
control strategies involving review of recommended that all lots be accompanied
suppliers certificates at receipt of raw by transportation records that show that
materials, review of records of drug use at the fish were held at or below an ambient
receipt of raw materials, and on-farm visits; or internal temperature of 40F (4.4C)
When testing for aquaculture drugs is throughout transit or, for transit times of 4
used as the control measure, it is now hours or less, that the internal temperature
recommended that the adequacy of the of the fish at time of receipt was at or below
testing methods and equipment be verified 40F (4.4C);
periodically (e.g., by comparing results with For control of time and temperature
those obtained using an AOAC or equivalent during refrigerated storage and refrigerated
method, or by analyzing proficiency processing, it is now noted that critical
samples). limits that specify a cumulative time and
temperature of exposure to temperatures
The recommendations in Chapter 12 for the above 40F (4.4C) are not ordinarily suitable
control of pathogenic bacteria growth and because of the difficulty in determining
toxin formation (other than C. botulinum) as when specific products have entered and
a result of time and temperature abuse are left the cooler and the time and temperature
changed as follows: exposures to which they were subjected.
It is now recognized that V. vulnificus, V. However, there may be circumstances where
parahaemolyticus, and Vibrio cholarae this approach is suitable. It is also noted
non-O1 and non-0139 are generally that minor variations in cooler temperature
associated with marine and estuarine species measurements can be avoided by
of fish and may not be reasonably likely to submerging the sensor for the temperature-
occur in freshwater species or non-fishery recording device in a liquid that mimics the
ingredients, unless they have been cross- characteristics of the product;
contaminated; It is now recommended that if only the
It is now clarified that products that are internal temperature of the fishery product
partially cooked to set the batter or breading is checked at receipt, because the transit
or stabilize the product shape (e.g., fish balls, time is no more than 4 hours, calculation of
shrimp egg rolls, and breaded fish portions) transit time should include all time outside a
are not considered to be ready to eat; controlled temperature environment;
Information is now provided on the It is now recommended that if only the
determination of CCPs for products that are a internal temperature of product is checked
combination of raw, ready-to-eat and cooked, at receipt by a secondary processor because
ready-to-eat fishery ingredients; the transit time is no more than 4 hours,
Control of time and temperature abuse a temperature-indicating device (e.g., a
at receipt, during cooling after cooking, thermometer) should be used to determine
during unrefrigerated processing, and during internal product temperatures in a minimum
refrigerated storage and processing are now of 12 containers (e.g., cartons and totes),
provided as four separate control strategy unless there are fewer than 12 containers
examples. Examples of HACCP plans are in a lot, in which case all of the containers
now provided for all four strategies; should be measured;
11
When checks of the sufficiency of ice or Alternatively, the product is held at
chemical cooling media, such as gel packs, ambient air temperatures below 50F
or internal product temperatures are used (10C) throughout processing;
at receipt of fish from another processor, it
is now recommended that the number of For cooked, ready-to-eat products:
containers examined and the number of
containers in the lot be recorded; If at any time the product is held at
internal temperatures above 80F
Chemical coolants (e.g., gel packs) are (27.2C), exposure time (i.e., time at
no longer recommended for control of internal temperatures above 50F (10C)
temperature during in-plant storage; but below 135F (57.2C)) should be
Recommended cumulative exposure times limited to 1 hour (3 hours if S. aureus is
and temperatures (i.e., critical limits) are now the only pathogen of concern),
listed as follows:
OR
For raw, ready-to-eat products: Alternatively, if at any time the product

is held at internal temperatures above
If at any time the product is held at
80F (26.7C), exposure time (i.e., time at
internal temperatures above 50F (10C)
(21.1C), exposure time (i.e., time
but below 135F (57.2C)) should be
at internal temperatures above 50F
limited to 4 hours, as long as no more
(10C) but below 135F (57.2C))
than 1 of those hours is above 70F
should be limited to 2 hours (3 hours if
(21.1C),
Staphylococcus aureus (S. aureus) is the
only pathogen of concern), OR
OR If at any time the product is held at
Alternatively, exposure time (i.e., time at (21.1C), but never above 80F (26.7C),
internal temperatures above 50F (10C) exposure time at internal temperatures
but below 135F (57.2C)) should be above 50F (10C) should be limited to
limited to 4 hours, as long as no more 2 hours (3 hours if S. aureus is the only
than 2 of those hours are between 70F pathogen of concern),
(21.1C) and 135F (57.2C),
OR
OR
Alternatively, if the product is never held at

If the product is held at internal
internal temperatures above 80F (26.7C),

temperatures above 50F (10C), but never
exposure times at internal temperatures
above 70F (21.1C), exposure time at
above 50F (10C) should be limited to 4
hours, as long as no more than 2 of those
should be limited to 5 hours (12 hours if S.
hours are above 70F (21.1C),
aureus is the only pathogen of concern),
OR
OR
If the product is held at internal

The product is held at internal
temperatures above 50F (10C), but never

temperatures below 50F (10C),
above 70F (21.1C), exposure time at
OR internal temperatures above 50F (10C)
should be limited to 5 hours (12 hours if S.
aureus is the only pathogen of concern),
12
OR
spoilage organisms have been eliminated or
significantly reduced by such processes as
The product is held at internal
high pressure processing and (2) refrigeration

temperatures below 50F (10C),
is the sole barrier to toxin formation. The
OR generally recommended 10,000 cc/m2/24
Alternatively, the product is held at hours at 24C oxygen transmission rates may
ambient air temperatures below 50F not be suitable in this case;
(10C) throughout processing; High-temperature alarms are no longer
High-temperature alarms are no longer recommended for monitoring temperatures
recommended for monitoring temperatures in coolers or processing areas;
in coolers or processing areas; Chemical coolants (e.g., gel packs) are
When the adequacy of ice is established as no longer recommended for control of
the critical limit for refrigerated storage, it temperature during in-plant storage;
is now recommended that monitoring be When the adequacy of ice is established
performed with sufficient frequency to ensure as the critical limit for refrigerated storage,
control rather than at least twice per day; it is now recommended that monitoring
It is now recommended that monitoring be performed with sufficient frequency to
shipments received under gel packs include ensure control rather than at least twice per
both adequacy of gel packs and internal day;
product temperature. It is now recommended that a water phase
salt level of 20% be achieved in shelf-stable,
reduced oxygen packaged products in which
control of C. botulinum toxin formation are
salt is the only barrier to pathogenic bacteria
changed as follows:
growth and toxin formation;
Information is now provided on Time- It is now recommended that monitoring
Temperature Indicator (TTI) performance shipments received under gel packs include
and suitability; both adequacy of gel packs and internal
A control strategy is now provided for product temperature;
application of TTIs on each of the smallest It is now recommended that if only the
package units (i.e., the unit of packaging that internal temperature of the fishery product
will not be distributed any further, usually is checked at receipt, because the transit
consumer or end-user package), where time is no more than 4 hours, calculation of
refrigeration is the sole barrier to prevent transit time should include all time outside a
toxin formation; controlled temperature environment;
It is no longer recommended that It is now recommended that if only the
consideration be given to whether the internal temperature of product is checked
finished product will be stored and at receipt by a secondary processor because
distributed frozen when determining whether the transit time is no more than 4 hours,
the hazard is significant. A control strategy is a temperature-indicating device (e.g., a
now provided to ensure that frozen products thermometer) should be used to determine
are properly labeled when freezing is the internal product temperatures in a minimum
sole barrier to prevent toxin formation; of 12 containers (e.g., cartons and totes),
Processors are now advised to take particular unless there are fewer than 12 containers
care in determining the safety of a packaging in a lot, in which case all of the containers
material for a product in which (1) the should be measured;
13
A control strategy example is now provided The separate chapters that previously
for receipt by a secondary processor of covered pathogen survival through cooking
refrigerated reduced oxygen packaged and pathogen survival through pasteurization
products that may be stored and further are now combined;
distributed or used as an ingredient for Pasteurization is now defined as a heat
further processing; treatment applied to eliminate the most
It is now clarified that brining time should be resistant pathogen of public health concern
monitored during the processing of smoked that is reasonably likely to be present in
fish; food;
It is now recommended that brine be Information is now provided for an option
treated to minimize microbial contamination to monitor End-Point Internal Product
or be periodically replaced as a good Temperature, instead of continuous time
manufacturing practice control. and temperature monitoring during cooking
or pasteurization, when a scientific study
has been conducted to validate that it will
control of pathogenic bacteria growth and
provide a 6D process for the target pathogen;
toxin formation as a result of inadequate
drying are changed as follows: For surimi-based products, soups, or sauces,
the following pasteurization process is now
It is no longer recommended that consideration recommended: a minimum cumulative,
be given to whether the finished product total lethality of F194F (F90C) = 10 minutes,
will be stored and distributed frozen (in the where z = 12.6F (7C) for temperatures less
case of reduced oxygen packaged products) than 194F (90C), and z = 18F (10C) for
or refrigerated (in the case of aerobically temperatures above 194F (90C);
packaged products) when determining whether
For dungeness crabmeat, the following
the hazard is significant. A control strategy
pasteurization process is now recommended:
to ensure that refrigerated dried products are
a minimum cumulative total lethality of F194F
properly labeled when refrigeration is the sole
(F90C) = 57 minutes, where z = 15.5F (8.6C);
barrier to toxin formation is now provided. A
control strategy to ensure that frozen products Information concerning levels of Listeria
are properly labeled when freezing is the sole monocytogenes (L. monocytogenes) in foods
barrier to toxin formation is now provided in is now updated based on the final FDA/U.S.
Chapter 13. Department of Agriculture L. monocytogenes
risk assessment.
control of S. aureus toxin formation in hydrated Chapter 17 is a new chapter that contains
batter mixes are changed as follows: guidance for the control of pathogen survival
through processes designed to retain raw
The number of S. aureus organisms normally product characteristics, including high
needed to produce toxin is now listed as hydrostatic pressure processing, mild heat
500,000 to 1,000,000 per gram; processing, IQF with extended frozen storage,
High-temperature alarms are no longer and irradiation. At present, the chapter applies
recommended for monitoring temperatures exclusively to the processing of molluscan
in processing areas. shellfish products for which there is a desire
to retain raw product characteristics. However,
these technologies may have other applications
control of pathogenic bacteria survival through
as well.
cooking are changed as follows:
14
The recommendations in Chapter 18 for the The use of sulfiting agents in conch meat is
control of the introduction of pathogenic now identified as a reasonably likely hazard.
bacteria after pasteurization and specialized
cooking processes are changed as follows: The recommendations in Chapter 20 for the
control of metal inclusion are changed as
It is no longer recommended that consideration follows:
be given to whether the finished product
will be stored and distributed frozen when Foreign objects less than 0.3 inch (7 mm)
determining whether the hazard is significant. are now identified as having a potential for
A control strategy to ensure that frozen causing trauma or serious injury to persons
products are properly labeled when freezing is in special risk groups, such as infants,
the sole barrier to prevent C. botulinum toxin surgery patients, and the elderly;
formation is now provided in Chapter 13. Additional information on calibration and
validation of electronic metal detectors is
The recommendations in Chapter 19 for the now provided;
control of undeclared food allergens and
Wire mesh baskets are no longer used as
intolerance substances and prohibited food
an example of an unlikely source of metal
and color additives are changed as follows:
fragments;
Additional explanatory material on food The recommended critical limit for the metal
allergens is now included, with information detection or separation control strategy has
on the Food Allergen Labeling and been expanded to read, All product passes
Consumer Protection Act of 2004 and its through an operating metal detection or
impact on preventive controls for allergens; separation device, and No detectable metal
Additional information is now provided on fragments in a product passing through
the factors to be considered in judging when the metal detection or separation device.
the presence of certain food intolerance As a result, the recommended monitoring
substances and prohibited food and color procedures are also expanded so that they
additives is or is not reasonably likely to now are designed to also ensure that the
occur, such as the historical use of the processes are in place and operating;
substance and the expected level of sulfiting It is now recommended that when metal
agent in the formulated finished food; fragments are found in a product by a metal
Additional information is now provided on detector or separated from the product stream
regulatory requirements for food additives. by magnets, screens, or other devices, the
Corrective actions are now expanded to source of the fragment is located and corrected.
include steps that should be taken to regain
control over the operation after a critical limit
control of glass inclusion are changed as follows:
deviation, for consistency with guidance in
the other chapters; This chapter is no longer identified as a draft;
It is now recommended that finished product The use of x-ray detection devices is no
labels be checked at time of labeling rather longer recommended as a reliable method for
than at time of label receiving; controlling glass inclusion;
It is now recommended that finished product The recommended critical limit for the glass
testing be included as a verification step container cleaning and visual inspection
when review of suppliers labeling is used as control strategy has been expanded to read,
a monitoring procedure for the presence of All container pass through an operating
sulfiting agents; glass container inspection or cleaning
15
process, and No detectable glass fragments exposure times for Bacillus cereus are now
in glass containers passing the CCP. As listed as follows: 5 days at temperatures of
a result, the recommended monitoring 39.2 to 43F (4 to 6C); 1 day at temperatures
procedures are also expanded so that they of 44 to 59F (7 to 15C); 6 hours at
now are designed to also ensure that the temperatures of 60 to 70F (16 to 21C); and
processes are in place and operating; 3 hours at temperatures above 70F (21C);
The monitoring procedures for the The maximum cumulative exposure times for
glass container cleaning and visual E. coli, Salmonella, and Shigella spp. are now
inspection control strategy now include a listed as follows: 2 days for temperatures
recommendation that a representative sample from their minimum growth temperature
of the cleaned or inspected containers be 41.4 to 50F (10C); 5 hours for temperatures
examined at the start of processing, every of 51 to 70F (11 to 21C); and 2 hours for
4 hours during processing, at the end of temperatures above 70F (21C);
processing, and after any breakdowns; The maximum cumulative exposure times
It is now recommended that monitoring for for Listeria monocytogenes are now listed
the presence of glass be performed at the as follows: 7 days for temperatures of 31.3
start of each production day and after each to 41F (-0.4 to 5C); 1 day for temperatures
shift change. of 42 to 50F (6 to 10C); 7 hours for
It is now recommended that a temperatures of 51 to 70F (11 to 21C); 3
representative sample of cleaned or hours for temperatures of 71 to 86F (22 to
inspected glass containers be examined 30C); and 1 hour for temperatures above
daily, at the start of processing, every 4 86F (30C);
hours during processing, at the end of The maximum cumulative exposure times
processing, and after any breakdowns. for Vibrio cholerae, V. vulnificus, and V.
parahaemolyticus are now listed as follows:
The Hazard Analysis Worksheet in Appendix
21 days for temperatures from their minimum
1 has been changed for consistency with the
growth temperature to 50F (10C); 6 hours
worksheet in the HACCP: Hazard Analysis
for temperatures of 51 to 70F (11 to 21C);
Critical Control Point Training Curriculum,
2 hours at temperatures of 71 to 80F (22 to
developed by the Seafood HACCP Alliance for
26.7C); and 1 hour at temperatures above
Training and Education.
80F (26.7C), with the last temperature range
The recommendations in Appendix 4 for applying only to cooked, ready-to-eat products.
bacterial pathogen growth and inactivation are The safety levels listed in Appendix 5, Table
changed as follows: A-5, FDA and EPA Safety Levels in Regulations
Recommended summary cumulative and Guidance, are changed as follows:
exposure times and temperatures are now
Toxic element guidance levels for arsenic,
listed as described above for Chapter 12;
cadmium, lead, and nickel are no longer
The maximum water phase salt level for listed;
growth of Campylobacter jejuni is now listed Tolerance levels for endothall and its
as 1.7%; monomethyl ester in fish and carbaryl in
The maximum level of acidity (pH) for oysters are now listed;
growth of pathogenic strains of Escherichia A tolerance level for Florfenicol in channel
coli (E. coli) is now listed as 10; catfish and freshwater-reared salmonids is
The maximum recommended cumulative now listed;
16
The tolerance for oxytetracycline is now
corrected to apply to all finfish and lobster;
The tolerance for sulfamerazine is now
corrected to apply to trout;
A list of drugs prohibited for extra-label use
is now provided;
V. parahaemolyticus and V. vulnificus levels
are now listed for post-harvest processed
molluscan shellfish.
Appendix 6 no longer lists food allergens. It
now contains a table of Japanese and Hawaiian
vernacular names and their corresponding U.S.
market names.
Appendix 7 no longer lists the bibliography. It

now contains information regarding the public
health impacts of bacterial and viral pathogens
of greatest concern in seafood processing.
17
NOTES:
18
CHAPTER 1: General Information
THE GUIDANCE
This is the fourth edition of the Food and Drug Copies of the training document may be
Administrations (FDAs) Fish and Fishery Products purchased from:
Hazards and Controls Guidance. This guidance
Florida Sea Grant
relates to FDAs Fish and Fishery Products
IFAS - Extension Bookstore
regulation (called the Seafood HACCP Regulation,
University of Florida
21 CFR 123, in this guidance document) and the
P.O. Box 110011
Control of Communicable Diseases regulation,
Gainesville, FL 32611-0011
21 CFR 1240, that require processors of fish
(800) 226-1764
and fishery products to develop and implement
HACCP systems for their operations. Those final Or
regulations were published in the Federal Register www.ifasbooks.com
on December 18, 1995, and became effective on
December 18, 1997. The codified portion of the Or you may download a copy from:
regulations is included in Appendix 8. http://www.fda.gov/FoodGuidances
This guidance is being issued as a companion
document to HACCP: Hazard Analysis Critical
Control Point Training Curriculum, which was
developed by the Seafood HACCP Alliance
for Training and Education. The Alliance is an
organization of federal and state regulators,
including FDA, academia, and the seafood
industry. FDA recommends that processors of
fish and fishery products use the two documents
together in the development of a HACCP system.
This guidance document will be maintained on
the FDA.GOV website, which should be consulted
for subsequent updates.
19
NOTES:
20
CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan
THE HACCP PLAN FORM THE HAZARD ANALYSIS WORKSHEET
This guidance document is designed to walk In order to complete the HACCP Plan Form,
you through a series of 18 steps that will yield a you will need to perform a process called
completed Hazard Analysis Critical Control Point hazard analysis. The Seafood HACCP Regulation
(HACCP) plan. A blank HACCP Plan Form is requires that all seafood processors conduct,
contained in Appendix 1. Note that this is a two- or have conducted for them, a hazard analysis
page form, with the second page to be used if to determine whether there are food safety
your process has more critical control points than hazards that are reasonably likely to occur in
can be listed on one page. The Procedures for their product and to the preventive measures that
the Safe and Sanitary Processing and Importing a processor can apply to control those hazards
of Fish and Fishery Products regulation, 21 CFR (21 CFR 123.6(a)). FDA has found that the use
123 (hereinafter, the Seafood HACCP Regulation), of a standardized Hazard Analysis Worksheet
requires that you prepare a HACCP plan for fish assists with this process. A blank Hazard Analysis
and fishery products that you process if there are Worksheet is contained in Appendix 1. Note that
significant food safety hazards associated with the this is also a two-page form, with the second page
products. The regulation does not require that you to be used if your process has more processing
use the form included in Appendix 1. However, steps than can be listed on one page. The Seafood
using this standardized form may help you develop HACCP Regulation does not require that the
an acceptable plan and will expedite regulatory hazard analysis be kept in writing. However,
review. A separate HACCP plan should be FDA expects that a written hazard analysis will
developed for each location where fish and fishery be useful when you perform mandatory HACCP
products are processed and for each kind of fish plan reassessments and when you are asked by
and fishery product processed at that location. You regulators to justify why certain hazards were or
may group products together in a single HACCP were not included in your HACCP plan.
plan if the food safety hazards and controls are the
same for all products in the group.
21
THE STEPS PRELIMINARY STEPS
Following is a list of the steps that this guidance STEP 1: Provide general information.
uses in HACCP plan development:
Record the name and address of your processing
Preliminary Steps facility in the spaces provided on the first page
Provide general information; of both the Hazard Analysis Worksheet and the
Describe the food; HACCP Plan Form (Appendix 1).
Describe the method of distribution and
STEP 2: Describe the food.
storage;
Identify the intended use and consumer;

Identify the market name or Latin name (species)
Develop a flow diagram. of the fishery component(s) of the product.
Hazard Analysis Worksheet Examples:

Set up the Hazard Analysis Worksheet; Tuna (Thunnus albacares);
Shrimp (Pandals spp.);
Identify potential species-related hazards;
Jack mackerel (Trachurus spp.).
Identify potential process-related hazards;
Understand the potential hazard; Fully describe the finished product food.
Determine whether the potential hazard Examples:

is significant;
Individually quick frozen, cooked, peeled
Identify critical control points.
shrimp;
HACCP Plan Form Fresh tuna steaks;

Frozen, surimi-based, imitation king crab
Set up the HACCP Plan Form; legs;
Set critical limits;
Fresh, raw drum, in-the-round;
Establish monitoring procedures:
Raw shrimp, in-shell;
What,
Raw, shucked clams;
How,
Fresh seafood salad, with shrimp and blue
Frequency,
crabmeat;
Frozen, breaded pollock sticks;
Who;
Frozen crab cakes.

Establish corrective action procedures;
Describe the packaging type.

Establish a recordkeeping system;
Examples:
Establish verification procedures.
Vacuum-packaged plastic bag;
Aluminum can;
Bulk, in wax-coated paperboard box;
Plastic container with snap lid.
Record this information in the space provided
on the first page of both the Hazard Analysis
Worksheet and the HACCP Plan Form.
22
STEP 3: Describe the method of distribution STEP 5: Develop a flow diagram.
and storage.
The purpose of the diagram is to provide a
Identify how the product is distributed and stored clear, simple description of the steps involved in
after distribution. the processing of your fishery product and its
associated ingredients as they flow from receipt
Examples:
to distribution. The flow diagram should cover
Stored and distributed frozen; all steps in the process that your firm performs.
Distributed on ice and then stored under Receiving and storage steps for each of the
refrigeration or on ice. ingredients, including non-fishery ingredients,
Record this information in the space provided should be included. The flow diagram should be
on the first page of both the Hazard Analysis verified on-site for accuracy.
Worksheet and the HACCP Plan Form. Figure A-1 (Appendix 2) is an example of a flow
diagram.
STEP 4: Identify the intended use and
consumer. HAZARD ANALYSIS WORKSHEET
Identify how the product will be used by the end
user or consumer. STEP 6: Set up the Hazard Analysis
Examples: Worksheet.
To be heated (but not fully cooked) and Record each of the processing steps (from
served; the flow diagram) in Column 1 of the Hazard
To be eaten with or without further cooking; Analysis Worksheet.
To be eaten raw or lightly cooked;
STEP 7: Identify the potential species-related
To be fully cooked before consumption;
hazards.
To be further processed into a heat and serve
product. Biological, chemical, and physical hazards can
Identify the intended consumer or user of the affect the safety of fishery products. Some food
product. The intended consumer may be the safety hazards are associated with the product
general public or a particular segment of the (e.g., the species of fish, the way in which the
population, such as infants or the elderly. The fish is raised or caught, and the region of the
intended user may also be another processor that world from which the fish originates). These
will further process the product. hazards are introduced outside the processing
plant environment before, during, or after
Examples:
harvest. This guidance refers to these as species
By the general public; related hazards. Other food safety hazards are
By the general public, including some associated with the way in which the product
distribution to hospitals and nursing homes; is processed (e.g., the type of packaging, the
By another processing facility. manufacturing steps, and the kind of storage).
These hazards are introduced within the
Record this information in the space provided
processing plant environment. This guidance
on the first page of both the Hazard Analysis
refers to these as process-related hazards. They
Worksheet and the HACCP Plan Form.
are covered in Step 8.
Find in Table 3-2 (Chapter 3) or Table 3-3
(Chapter 3) the market name (Column 1) or
23
Latin name (Column 2) of the product that you You may need to include potential hazards for
identified in Step 2. Use Table 3-2 for vertebrates more than one finished product food category
(animals with backbones) such as finfish. Use from Table 3-4, which will happen when your
Table 3-3 for invertebrates (animals without product fits more than one description. For
backbones) such as shrimp, oysters, crabs, and example, if you cook shrimp and use it to prepare
lobsters. Determine whether the species has a a finished product salad, you should look at both
potential species-related hazard by looking for the cooked shrimp and the salads prepared
a mark (or one- or three-letter codes for a from ready-to-eat fishery products categories in
natural toxin) in the right-hand columns of the Table 3-4, Column 1. Potential hazards from both
table. If it does, record the potential species- finished product food categories apply to your
related hazard(s) in Column 2 of the Hazard product and should be listed in Column 2 of the
Analysis Worksheet, at every processing step. Hazard Analysis Worksheet.
Tables 3-2 and 3-3 include the best information Table 3-4 includes the best information currently
currently available to FDA concerning hazards that available to FDA concerning hazards that are
are specific to each species of fish. You should use related to specific processing techniques. You
your own expertise, or that of outside experts, as should use your own expertise, or that of outside
necessary, to identify any hazards that may not experts as necessary, to identify any hazards
be included in the table (e.g., those that may be that may not be included in the table (e.g., those
new or unique to your region). You may already that are new or unique to your physical plant,
have effective controls in place for a number of equipment, or process).
these hazards as part of your routine or traditional
handling practices. The presence of such controls STEP 9: Understand the potential hazard.
does not mean that the hazard is not significant.
Consult the hazards and controls chapters of
The likelihood of a hazard occurring should be
this guidance document (Chapters 4 through 7,
judged in the absence of controls. For example, the
9, and 11 through 21) for each of the potential
fact that scombrotoxin (histamine) development
hazards that you entered in Column 2 of the
in a particular species of fish has not been noted
Hazard Analysis Worksheet. These chapters offer
may be the result of (1) the inability of the fish to
guidance for completing your hazard analysis
produce histamine or (2) the existence of controls
and developing your HACCP plan. Each chapter
that are already in place to prevent its development
contains a section, Understand the Potential
(e.g., harvest vessel time and temperature controls).
Hazard, that provides information about the
In the first case, the hazard is not reasonably
significance of the hazard, the conditions under
likely to occur. In the second case, the hazard is
which it may develop in a fishery product, and
reasonably likely to occur, and the controls should
methods available to control the hazard.
be included in the HACCP plan.
STEP 10: Determine whether the potential
STEP 8: Identify potential process-related
hazard is significant.
hazards.
Narrow the list of potential hazards that you
Find in Table 3-4 (Chapter 3) the finished product
entered in Column 2 of the Hazard Analysis
food (Column 1) and package type (Column 2)
Worksheet to those that are significant or, in
that most closely match the information that you
other words, reasonably likely to occur. The
developed in Steps 2 and 3. Record the potential
Seafood HACCP Regulation defines a food safety
hazard(s) listed in the table for that product in
hazard that is reasonably likely to occur as one
Column 2 of the Hazard Analysis Worksheet, at
for which a prudent processor would establish
every processing step.
controls because experience, illness data,
24
scientific reports, or other information provide STEP 11: Identify critical control points.
a basis to conclude that there is a reasonable
possibility that it will occur in the particular type For each processing step where a significant
of fish or fishery product being processed in the hazard is identified in Column 3 of the Hazard
absence of those controls. Analysis Worksheet, determine whether it
is necessary to exercise control at that step
The hazards and controls chapters of this in order to control the hazard. Figure A-2
guidance (Chapters 4 through 7, 9, and 11 (Appendix 3) is a critical control point (CCP)
through 21) each contain a section, Determine decision tree that can be used to aid you in
Whether this Potential Hazard Is Significant, your determination.
that provides information about how to assess
the significance of potential hazards. You should The hazards and controls chapters of this
evaluate the significance of a potential hazard guidance (Chapters 4 through 7, 9, and 11
independently at each processing step. It may through 21) each contain a section, Identify
be significant at one step but not at another. A Critical Control Points (CCPs), which provides
potential hazard is significant at the processing information about where control should be
or handling step if (1) it is reasonably likely that exercised. Each chapter discusses one or more
the hazard can be introduced at an unsafe level control strategy example(s) for how the hazard
at that processing step; or (2) it is reasonably can be controlled, because there are often more
likely that the hazard can increase to an unsafe ways than one to control a hazard. CCP(s) for
level at that processing step; or (3) it is significant one control strategy example often differ from
at another processing or handling step and it those of another example for the same hazard.
can be prevented, eliminated, or reduced to The control strategies contain preventive measure
an acceptable level at the current processing or information. Record the preventive measure(s) in
handling step. When evaluating the significance Column 5 of the Hazard Analysis Worksheet for
of a hazard at a processing step, you should each Yes answer in Column 3.
consider the method of distribution and storage For every significant hazard, there must be at
and the intended use and consumer of the least one CCP where the hazard is controlled
product, which you developed in Steps 3 and 4. (21 CFR 123.6(c)(2)). In some cases, control may
If you determine that a potential hazard is be necessary at more than one CCP for a single
significant at a processing step, you should hazard. In other cases, a processing step may
answer Yes in Column 3 of the Hazard Analysis be a CCP for more than one hazard. CCPs are
Worksheet. If you determine that a potential points in the process (i.e., processing steps)
hazard is not significant at a processing step, you where the HACCP control activities will occur.
should answer No in that column. You should Control activities at a CCP can effectively prevent,
record the reason for your Yes or No answer eliminate, or reduce the hazard to an acceptable
in Column 4. You need not complete Steps 11 level (21 CFR 123.3(b)).
through 18 for a hazard for those processing If you determine that a processing step is a CCP
steps where you have recorded a No. for a significant hazard, you should enter Yes in
It is important to note that identifying a hazard Column 6 of the Hazard Analysis Worksheet. If
as significant at a processing step does not mean you determine that a processing step is not a CCP
that it must be controlled at that processing step. for a significant hazard, you should enter No
Step 11 will help you determine where in the in that column. You need not complete Steps 12
process the critical control point is located. through 18 for a hazard for those processing steps
where you have recorded a No.
25
HACCP PLAN FORM met, but before a critical limit deviation would
require you to take corrective action. You should
set operating limits based on your experience
STEP 12: Set up the HACCP Plan Form. with the variability of your operation and with
Find the processing steps that you have identified the closeness of typical operating values to the
as CCPs in Column 6 of the Hazard Analysis critical limit.
Worksheet. Record the names of these processing Consider that the critical limit should directly
steps in Column 1 of the HACCP Plan Form. relate to the parameter that you will be
Enter the hazard(s) for which these processing monitoring. For example, if you intend to
steps were identified as CCPs in Column 2 of monitor the temperature of the water in the
the HACCP Plan Form. This information can cooker and the speed of the belt that carries the
be found in Column 2 of the Hazard Analysis product through the cooker (because you have
Worksheet. determined that these factors result in the desired
Complete Steps 13 through 18 for each of the internal product temperature for the desired
significant hazards. These steps involve setting time), you should specify water temperature
critical limits, establishing monitoring procedures, and belt speed as critical limits, not the internal
establishing corrective action procedures, temperature of the product.
establishing a recordkeeping system, and Enter the critical limit(s) in Column 3 of the
establishing verification procedures. HACCP Plan Form.
STEP 13: Set critical limits. STEP 14: Establish monitoring procedures.
For each processing step where a significant For each processing step where a significant
hazard is identified on the HACCP Plan Form, hazard is identified on the HACCP Plan Form,
identify the maximum or minimum value to describe monitoring procedures that will ensure
which a parameter of the process must be that critical limits are consistently met (21 CFR
controlled in order to control the hazard. Each 123.6(c)(4)). The hazards and controls chapters
control strategy example provided in the hazards of this guidance document (Chapters 4 through
and controls chapters of this guidance (Chapters 7, 9, and 11 through 21) each contain a section,
4 through 7, 9, and 11 through 21) each contain Establish Monitoring Procedures, that provides
a section, Set Critical Limits, that provides information about appropriate monitoring
information about appropriate critical limits for procedures for each of the control strategy
each of the control strategy example(s) discussed. example(s) discussed.
You should set a critical limit at such a value that To fully describe your monitoring program, you
if it is not met, the safety of the product may be should answer four questions: (1) What will be
questionable. If you set a more restrictive critical monitored? (2) How will monitoring be done? (3)
limit, you could, as a result, be required to take How often will monitoring be done (frequency)?
corrective action when no safety concern actually and (4) Who will do the monitoring?
exists. On the other hand, if you set a critical It is important for you to keep in mind that the
limit that is too loose, you could, as a result, monitoring process should directly measure
allow an unsafe product to reach the consumer. the parameter for which you have established
As a practical matter, it may also be advisable a critical limit. The necessary frequency of
to set an operating limit that is more restrictive monitoring is dependent upon the circumstances.
than the critical limit. In this way, you can adjust Continuous monitoring is always desirable, and
the process when the operating limit is not in some cases necessary. In other cases, it may
not be necessary or practical. You should monitor
26
often enough that the normal variability in the through 21) each contain a section, Establish
values you are measuring will be detected. This Corrective Action Procedures, that provides
is especially true if these values are typically information about appropriate corrective action
close to the critical limit. Additionally, the greater procedures for each of the control strategy
the time span between measurements, the example(s) discussed. An appropriate corrective
more products you are putting at risk should a action procedure must accomplish two goals: (1)
measurement show a deviation from a critical ensure that an unsafe product does not reach
limit has occurred, because you should assume the consumer and (2) correct the problem that
that the critical limit had not been met since caused the critical limit deviation (21 CFR 123.7).
the last good value. Even with continuous If the corrective action involves testing the
monitoring, the paper or electronic record of the finished product, the limitations of the sampling
continuous monitoring should be periodically plan should be understood. Because of these
checked in order to determine whether limitations, microbiological testing is often not a
deviations from the critical limit have occurred. suitable corrective action. The Seafood HACCP
The frequency of that check should be at least Regulation requires that corrective actions be fully
daily, and more frequent if required in order to documented in records (21 CFR 123.7(d)). Note
implement an appropriate corrective action. that if a critical limit deviation occurs repeatedly,
the adequacy of that CCP for controlling the
Enter the What, How, Frequency, and Who
hazard should be reassessed. Remember that
monitoring information in Columns 4, 5, 6, and 7,
deviations from operating limits do not need to
respectively, of the HACCP Plan Form.
result in formal corrective actions.
STEP 15: Establish corrective action Enter the corrective action procedures in Column
procedures. 8 of the HACCP Plan Form.
A corrective action must be taken whenever there STEP 16: Establish a recordkeeping system.
is a deviation from a critical limit at a CCP (21
CFR 123.7((a)). For each processing step where For each processing step where a significant
a significant hazard is identified on the HACCP hazard is identified on the HACCP Plan Form, list
Plan Form, describe the procedures that you the records that will be used to document the
will use when your monitoring indicates that accomplishment of the monitoring procedures
the critical limit has not been met. Note that the discussed in Step 14 (21 CFR 123.9(a)(2)).
Seafood HACCP Regulation does not require The hazards and controls chapters of this
that you predetermine your corrective actions. guidance (Chapters 4 through 7, 9, and 11
You may instead elect to follow the prescribed through 21) each contain a section, Establish
corrective action procedures listed at 21 CFR a Recordkeeping System, that provides
123.7(c). However, a predetermined corrective information about appropriate records for each
action has the following advantages: (1) It of the control strategy example(s) discussed.
provides detailed instructions to the processing Records must document monitoring of the
employee that can be followed in the event of a CCP and shall contain the actual values and
critical limit deviation; (2) it can be prepared at a observations obtained during monitoring (21
time when an emergency situation is not calling CFR 123.6(b)(7)) The Seafood HACCP Regulation
for an immediate decision; and (3) it removes lists specific requirements about the content of
the obligation to reassess the HACCP plan in the records (21 CFR 123.9(a)).
response to a critical limit deviation. Enter the names of the HACCP monitoring
The hazards and controls chapters of this records in Column 9 of the HACCP Plan Form.
guidance (Chapters 4 through 7, 9, and 11
27
STEP 17: Establish verification procedures. that of the most responsible individual on-site at
your processing facility or a higher level official
For each processing step where a significant (21 CFR 123.6(d)(1)). It signifies that the HACCP
hazard is identified on the HACCP Plan Form, plan has been accepted for implementation by
describe the verification procedures that will your firm.
ensure that the HACCP plan is (1) adequate to
address the hazard and (2) consistently being
followed (21 CFR 123.6(c)(6)).
The hazards and controls chapters of this
guidance (Chapters 4 through 7, 9, and 11 through
21) each contain a section, Establish Verification
Procedures, that provides information about
appropriate verification activities for each of
the control strategy example(s) discussed. The
information covers validation of the adequacy
of critical limits (e.g., process establishment);
calibration (including accuracy checks) of CCP
monitoring equipment; performance of periodic
end-product and in-process testing; and review
of monitoring, corrective action, and verification
records. Note that the Seafood HACCP Regulation
does not require product testing (21 CFR
123.8(a)(2)(iii)). However, it can be a useful tool,
especially when coupled with a relatively weak
monitoring procedure, such as reliance upon
suppliers certificates.
When calibration or an accuracy check of a CCP
monitoring instrument shows that the instrument
is not accurate, you should evaluate the monitoring
records since the last instrument calibration to
determine whether the inaccuracy would have
contributed to a critical limit deviation. For this
reason, HACCP plans with infrequent calibration
or accuracy checks can place more products at risk
than those with more frequent checks should a
problem with instrument accuracy occur.
Enter the verification procedures in Column 10 of
the HACCP Plan Form.
STEP 18: Complete the HACCP Plan Form.

When you have finished these steps for all
significant hazards that relate to your product,
you will have completed the HACCP Plan Form.
You should then sign and date the first page of
the HACCP Plan Form. The signature must be
28
CHAPTER 3: Potential Species-Related and Process-Related Hazards
INTRODUCTION It is important to note that the tables provide

lists of potential hazards. You should use
the tables, together with the information
Purpose
provided in Chapters 4 through 21, and your
The purpose of this chapter is to identify own expertise or that of outside experts, to
potential food safety hazards that are species determine whether the hazard is significant
related and process related. It also provides for your particular product and, if so, how it
information on how the illicit substitution of should be controlled.
one species for another can impact on the
identification of species-related hazards. Species substitution
To assist in identifying species-related and Illicit substitution of one species for another
process-related hazards, this chapter contains may constitute economic fraud and/or
three tables: misbranding violations of the Federal Food,
Drug, and Cosmetic Act. Furthermore, species
Table 3-2, Potential Vertebrate
substitution may cause potential food safety
Species-Related Hazards, contains a
hazards to be overlooked or misidentified by
list of potential hazards that are associated
processors or end users, as shown in Table
with specific species of vertebrates
3-1, The Effect of Misbranding Through
(species with backbones). These hazards
Species Substitution on the Identification of
are referred to as species-related hazards;
Potential Species-Related Hazards. These
Table 3-3, Potential Invertebrate examples are based on actual incidents of
Species-Related Hazards, contains a species substitution or misbranding.
list of potential hazards that are associated
with specific species of invertebrates
(species without backbones). These
hazards are also referred to as species-
related hazards;
Table 3-4, Potential Process-Related
Hazards, contains a list of potential
hazards that are associated with specific
finished fishery products, as a result of
the finished product form, the package
type, and the method of distribution and
storage. These hazards are referred to as
process-related hazards.
29
TABLE 3-1
THE EFFECT OF MISBRANDING THROUGH SPECIES SUBSTITUTION ON THE

IDENTIFICATION OF POTENTIAL SPECIES-RELATED HAZARDS
POTENTIAL
POTENTIAL SPECIES-RELATED HAZARDS
SPECIES- RELATED HAZARDS
ACTUAL MARKET NAME PRODUCT THAT WOULD BE IDENTIFIED BASED ON
ASSOCIATED WITH
OF PRODUCT INAPPROPRIATELY LABELED AS INAPPROPRIATE SPECIES LABELING
THE ACTUAL PRODUCT
(FROM TABLE 3-2)
(FROM TABLE 3-2)
Gempylotoxin
Escolar Sea bass Parasites
Histamine
Tetrodotoxin
Puffer fish Monkfish Parasites
Paralytic Shellfish Poisoning
Parasites
Spanish mackerel Histamine Kingfish None
Ciguatera Fish Poisoning
Environmental
Basa Parasites
chemical contaminants Grouper
and pesticides
Parasites
Grouper Cod Parasites
30
TABLE 3-2
POTENTIAL VERTEBRATE SPECIES-RELATED HAZARDS

Note: You should identify pathogens from the harvest area as a potential species-related hazard if you know or have reason
to know that the fish will be consumed without a process sufficient to kill pathogens, or if you represent, label, or intend for the
product to be so consumed. (See Chapter 4 for guidance on controlling pathogens from the harvest area.)
HAZARDS
NATURAL SCOMBROTOXIN ENVIRONMENTAL AQUACULTURE

MARKET NAMES LATIN NAMES PARASITES
TOXINS (HISTAMINE) CHEMICALS DRUGS
CHP 5 CHP 6 CHP 7 CHP 9 CHP 11
Kuhlia spp.
AHOLEHOLE
Alosa pseudoharengus
ALEWIFE OR RIVER
HERRING
Beryx spp.
ALFONSINO
Centroberyx spp.
Alligator
ALLIGATOR mississipiensis
Alligator sinensis
Alligator
ALLIGATOR, mississipiensis
AQUACULTURED
Alligator sinensis
Seriola spp. CFP
AMBERJACK
Seriola lalandi
AMBERJACK
OR YELLOWTAIL
Seriola lalandi
AMBERJACK
OR YELLOWTAIL,
AQUACULTURED
Anchoa spp. ASP5

Anchoviella spp. ASP 5

Cetengraulis ASP 5

ANCHOVY
mysticetus
Engraulis spp. ASP5
Stolephorus spp. ASP5
Holacanthus spp.
ANGELFISH
Pomacanthus spp.
Argentina elongata
ARGENTINE
QUEENFISH
Sphyraena spp. CFP

BARRACUDA S. barracuda CFP
S. jello CFP
Lates calcarifer
BARRAMUNDI
31
TABLE 3-2

HAZARDS

Lates calcarifer
BARRAMUNDI
AQUACULTURED
Pangasius bocourti
BASA OR
BOCOURTI8
Pangasius bocourti
BASA OR
BOCOURTI8,
AQUACULTURED
Ambloplites spp.
Micropterus spp.
BASS Morone spp.
Stereolepis gigas
Synagrops bellus
Morone spp.
BASS,
AQUACULTURED Centropristis spp.
Acanthistius 3
brasilianus
Centropristis spp. 3
Dicentrarchus labrax 3
Lateolabrax japonicus 3
BASS, SEA
Paralabrax spp. 3
Paranthias furcifer 3
Polyprion americanus 3
Polyprion oxygeneios 3
Polyprion yanezi 3
Dicentrarchus labrax 3
BASS, SEA,
AQUACULTURED
Labeo bata
BATA
Priacanthus arenatus
BIGEYE
Pristigenys alta
Pomatomus saltatrix
BLUEFISH
Lepomis macrochirus
BLUEGILL
32
TABLE 3-2

HAZARDS

Hyperoglyphe
BLUENOSE
antarctica
Harpadon nehereus
BOMBAY DUCK
Cybiosarda elegans
Gymnosarda unicolor
BONITO
Orcynopsis unicolor
Sarda spp.
Amia calva
BOWFIN AND ROE
Abramis brama
Acanthopagrus spp.7
Argyrops spp.
Gymnocranius
BREAM
grandoculis7
Monotaxis spp.
Sparus aurata
Wattsia spp.
Abramis brama
BREAM,
AQUACULTURED
Boops boops
BREAM OR BOGUE
Nemipterus japonicus
BREAM, THREADFIN
Ictiobus spp.
BUFFALOFISH
Ameiurus spp.
BULLHEAD
Lota lota
BURBOT
Odax pullus
BUTTERFISH8 Peprilus spp.
Pampus cinereus
Pseudoplatystoma
CAPARARI8
tigrinum
Mallotus villosus 3
CAPELIN AND ROE
33
TABLE 3-2

HAZARDS

Barbonymus spp.
Cyprinus carpio
Hypophthalmichthys
CARP molitrix
Hypophthalmichthys
nobilis
Carassius carassius
Cyprinus carpio
Hypophthalmichthys
CARP, molitrix
AQUACULTURED Hypophthalmichthys
nobilis.
Carassius carassius
Callichthys callichthys
CASCARUDO8
Ameiurus catus
CATFISH Ictalurus spp.
Pylodictis oliveris
Ictalurus spp.
CATFISH,
AQUACULTURED
Salvelinus alpinus
CHAR
Salvelinus alpinus
CHAR,
AQUACULTURED
Leporinus obtusidens
CHARACIN
Chirostoma jordani
CHARAL
Harriota raleighana
CHIMAERA
Hydrolagus spp.
Apocryptes bato
CHIRING
Coregonus kiyi
Kyphosus spp.
CHUB
Semotilus
atromaculatus
34
TABLE 3-2

HAZARDS

Coregonus alpenae
CISCO OR CHUB Coregonus reighardi
Coregonus zenithicus
Coregonus artedi7
CISCO OR TULLIBEE
Clarias spp.
CLARIAS FISH
OR WALKING
CLARIAS FISH8
Clarias anguillaris
CLARIAS FISH Clarias gariepinus

OR WALKING
CLARIAS FISH,
AQUACULTURED8
Rachycentron 3
COBIA
canadum
Rachycentron 3
COBIA,
canadum
AQUACULTURED
Arctogadus spp. 3
Boreogadus saida 3
COD
Eleginus gracilis 3
Gadus spp. 3
Gadus macrocephalus 3
COD OR ALASKA
COD
Lotella rhacina 3
Mora moro 3
COD, MORID
Psendophycis barbata7 3
Pseudophycis spp. 3
Platynematichthys 3
COROATA8
notatus
Cilus gilberti7 3
CORVINA Micropogonias 3
undulates7
Pomoxis spp.
CRAPPIE
35
TABLE 3-2

HAZARDS

Argyrosomus spp.
Bairdiella spp.
Cheilotrema saturnum
Genyonemus lineatus
Micropogonias spp.
Nebris microps
Nibea spp.
Pachypops spp.
CROAKER
Pachyurus spp.
Paralonchurus spp.
Plagioscion spp.
Pseudotolithus spp.
Pterotolithus spp.
Roncador stearnsii 7

Umbrina roncador
Odontoscion dentex
Cynoscion spp.
CROAKER OR
CORVINA
Argyrosomus regius
CROAKER OR
SHADEFISH
Larimichthys polyactis7
CROAKER OR
YELLOWFISH
Prochilodus lineatus
CURIMBATA OR
GURAMATA
Brosme brosme
CUSK
Lepophidium spp.
CUSK-EEL
Brotula clarkae
Aphanopus carbo
CUTLASSFISH Lepidopus caudatus
Trichiurus spp.
Rhinichthys ssp.
DACE
36
TABLE 3-2

HAZARDS

Rhinichthys ssp.
DACE,
AQUACULTURED
Cyttus
novaezealandiae
DORY
Zenopsis spp.
Zeus spp.
Hyperoglyphe spp.
DRIFTFISH
Equetus punctatus
Larimus spp.
Pogonias cromis
DRUM
Stellifer spp.
Totoaba macdonaldi
Umbrina coroides
Pareques umbrosus7
DRUM OR CUBBYU
Aplodinotus grunniens
DRUM, FRESHWATER
Collichthys spp.
DRUM OR LION FISH
Argyrosomus regius7
DRUM OR MEAGRE
Seriphus politus
DRUM OR
QUEENFISH
Sciaenops ocellatus
DRUM OR REDFISH
Sciaenops ocellatus
DRUM OR REDFISH,
AQUACULTURED
Anguilla spp.
EEL
Anguilla Anguilla
EEL, Anguilla australis

AQUACULTURED Anguilla dieffenbachii
Anguilla japonica7
37
TABLE 3-2

HAZARDS

Ariosoma balearicum
Conger spp.
Gnathophis cinctus
EEL, CONGER
Rhynchoconger spp.
Paraconger
caudilimbatus
Anguilla rostrata
EEL, FRESHWATER
Anguilla rostrata
EEL, FRESHWATER,
AQUACULTURED
Gymnothorax funebris CFP

EEL, MORAY Lycodontis javanicus CFP
Muraena retifera
Notacanthus
EEL, SPINY
chemnitzii
Zoarces americanus 3
EELPOUT
Zoarces viviparus 3
Callorhynchus millii
ELEPHANT FISH
Lethrinus spp.
EMPEROR
Lepidocybium G
ESCOLAR OR flavobrunneum
OILFISH
Ruvettus pretiosus G
Notopterus notopterus
FEATHERBACK
Platycephalus conatus
FLATHEAD
Pinirampus
FLATWHISKERED
pirinampu
FISH8
38
TABLE 3-2

HAZARDS

Ancylopsetta dilecta 3 1
Arnoglossus scapha 3
1
Reinhardtius 3 1
evermanni
Bothus spp. 3 1
Chascanopsetta 3 1
crumenalis
Cleisthenes pinetorum 3 1
Colistium spp. 3
1
Cyclopsetta chittendeni 3 1
Hippoglossoides 3 1
robustus
Limanda ferruginea 3 1
Liopsetta glacialis 3
1
Microstomus achne 3 1
FLOUNDER Paralichthys albigutta 3 1
Hippoglossina oblonga 3
1
Paralichthys olivaceus 3 1
Paralichthys 3 1
patagonicus
Paralichthys 3 1
squamilentus
Pelotretis flavilatus 3 1
Peltorhampus 3
1
novaezeelandiae
Platichthys spp. 3 1
Pseudorhombus spp. 3
1
Rhombosolea spp. 3 1
Samariscus 3
1
triocellatus
Scophthalmus spp. 3 1
39
TABLE 3-2

HAZARDS

Ancylopsetta dilecta 3,4

Arnoglossus scapha 3,4

Reinhardtius 3,4

evermanni
Bothus spp. 3,4
Chascanopsetta 3,4
crumenalis
Cleisthenes pinetorum 3,4
Colistium spp. 3,4

Cyclopsetta chittendeni 3,4

Hippoglossoides 3,4
robustus
FLOUNDER,
AQUACULTURED Limanda ferruginea 3,4
Liopsetta glacialis 3,4

Microstomus achne 3,4

Paralichthys spp. 3,4
Pelotretis flavilatus 3,4

Peltorhampus 3,4

novaezeelandiae
Pseudorhombus spp. 3,4
Rhombosolea spp. 3,4
Samariscus 3,4

triocellatus
Scophthalmus spp. 3,4
Limanda limanda 7
3
1
Limanda proboscidea7 3 1
FLOUNDER OR DAB
Limanda 3
1
punctatissima7
Paralichthys dentatus 3 1
Paralichthys 3 1
FLOUNDER OR lethostigma
FLUKE
Paralichthys microps 3 1
Platichthys flesus7 3 1
Reinhardtius 3
FLOUNDER,
hippoglossoides
ARROWTOOTH
40
TABLE 3-2

HAZARDS

Cypselurus spp.
Exocoetus spp.
Fodiator acutus
Hirundichthys spp.
FLYINGFISH
Oxyporhamphus
AND ROE
micropterus
Parexocoetus
brachypterus
Prognichthys
gibbifrons
Rana spp. 3
FROG
Lepisosteus spp.
GAR
Epinnula magistralis
Nesiarchus nasutus
GEMFISH
Lepidocybium G
flavobrunneum
Rexea solandri
GEMFISH OR
BARRACOUTA Thyrsites atun
Thyrsites lepidopoides
GEMFISH OR
CABALLA
Aspistor parkeri
GILLBACKER OR
GILLEYBAKA8
Mulloidichthys spp.
Mulloidichthys
vanicolenis
Mullus auratus
GOATFISH
Parupeneus spp.
Pseudupeneus spp.
Upeneichthys lineatus
Upeneus spp.
Neogobius
GOBY
melanostomus
Thymallus arcticus
GRAYLING
41
TABLE 3-2

HAZARDS

Odax pullus7
GREENBONE
Hexagrammos spp.
GREENLING
Coryphaenoides spp.
Lepidorhynchus
denticulatus
GRENADIER
Macruronus spp7
Nezumia bairdii7
Trachyrhynchus spp.7
Anyperodon spp. 3
Caprodon schlegelii 3
Cephalopholis spp. 3 CFP
C. argus 3 CFP
C. miniata 3
CFP
Diplectrum formosum 3
Epinephelus spp. 3 CFP

GROUPER E. fuscoguttatus 3
CFP
E. lanceolatus 3
CFP
E. morio 3 CFP
Mycteroperca spp. 3
CFP
M. venenosa 3
CFP
M. bonaci 3 CFP
Variola spp. 3
CFP
Variola louti 3 CFP
Plectropomus spp. CFP
GROUPER OR
3
CORAL GROUPER
Mycteroperca 3 CFP
GROUPER OR GAG
microlepis
Epinephelus guttatus 3 CFP
GROUPER OR HIND
Epinephelus itajara 3
GROUPER OR
JEWFISH
Leuresthes tenuis
GRUNION
42
TABLE 3-2

HAZARDS

Anisotremus
interruptus
Conodon nobilis
GRUNT Haemulon spp.
Orthopristis
chrysoptera
Pomadasys crocro
Anisotremus taeniatus
GRUNT OR
CATALINA
Haemulon album
GRUNT OR
MARGATE Anisotremus
surinamensis7
Plectorhinchus spp.
GRUNT OR
SWEETLIPS
Melanogrammus
HADDOCK
aeglefinus
Urophycis spp.
HAKE
Hippoglossus spp. 3
HALIBUT
Hippoglossus spp. 3,4

HALIBUT,
AQUACULTURED
Paralichthys 3
HALIBUT OR
californicus
CALIFORNIA
HALIBUT
Alphestes afer 7
HAMLET, MUTTON
Etrumeus teres 3
Harengula thrissina 3

Ilisha spp. 3

HERRING
Opisthopterus tardoore 3
Pellona ditchela 3

Alosa spp.
Clupea spp. 3
HERRING OR SEA
HERRING OR SILD
43
TABLE 3-2

HAZARDS

Clupea spp. 3
HERRING OR SEA
HERRING OR SILD
ROE
Opisthonema spp.
HERRING, THREAD
Epinephelus guttatus 3 CFP

Epinephelus 3
CFP
HIND adscensionis
Epinephelus 3
drummondhayi
Lachnolaimus 3 CFP
HOGFISH
maximus
Trachurus trachurus 3
HORSE MACKEREL
OR SCAD
Caranx spp. 3 CFP

C. ignobilis 3
CFP
C.melampygus 3 CFP
C.latus 3
CFP
C. lugubris 3
CFP
C. ruber 3 CFP
JACK
Carangoides 3
CFP
bartholomaei
Oligoplites saurus 3
Selene spp. 3

Seriola rivoliana 3 CFP
Urapsis secunda 3
Caranx crysos 3
CFP
JACK OR BLUE
RUNNER
Alectis indicus7 3
JACK OR CREVALLE
Elagatis bipinnulata 3 CFP

JACK OR RAINBOW
RUNNER
Nematistius pectoralis 3
JACK OR
ROOSTERFISH
44
TABLE 3-2

HAZARDS

Aphareus spp. 3 CFP

JOBFISH Aprion spp. 3
CFP
Pristipomoides spp. 3
CFP
Arripis spp. 3
KAHAWAI
Menticirrhus spp.
KINGFISH6
Genypterus spp.
KINGKLIP
Elops spp.
LADYFISH
Molva spp.
LING
Molva
LING,
macrophthalma7
MEDITERRANEAN
Ophiodon elongatus
LINGCOD
Synodus spp.
LIZARDFISH
Somileptus gongota
LOACH
Cyclopterus lumpus
LUMPFISH ROE
Gasterochisma 3
melampus
MACKEREL Grammatorcynus spp. 3

Rastrelliger kanagurta 3

Scomber scombrus 3

Pleurogrammus 3
MACKEREL, ATKA
monopterygius
Scomber spp. 3
MACKEREL, CHUB
Trachurus spp. 3
MACKEREL, JACK
Scomberomorus spp. 3
MACKEREL, SPANISH
45
TABLE 3-2

HAZARDS

Scomberomorus CFP
MACKEREL,
commerson
NARROW-BARRED
SPANISH
Scomberomorus 3 CFP
MACKEREL, SPANISH
cavalla
OR KING
Coryphaena spp.
MAHI-MAHI
Coryphaena spp.
MAHI-MAHI,
AQUACULTURED
Makaira spp.
MARLIN
Tetrapturus spp.
Brevoortia spp. 9 10
MENHADEN Ethmidium 9 10
maculatum
Chanos chanos
MILKFISH
Chanos chanos
MILKFISH,
AQUACULTURED
Lophius spp. 3
MONKFISH
Aplodactylus
arctidens7
MORWONG Cheilodactylus spp.

Goniistius spp.
Nemadactylus spp.
Agonostomus 3
monticola
Aldrichetta forsteri 3
Crenimugil crenilabis 3

MULLET
Mugil spp. 3

Mullus spp. 3
Mugil cephalus 7
3

Mugil thoburni 3

Esox masquinongy
MUSKELLUNGE
46
TABLE 3-2

HAZARDS

Lampris guttatus
OPAH
Girella nigricans
OPALEYE
Allocyttus niger
OREO DORY Neocyttus spp.
Pseudocyttus spp.
Astronotus ocellatus
OSCAR
Astronotus ocellatus
OSCAR,
AQUACULTURED
Myleus pacu
PACU
Polyodon spp.
PADDLEFISH AND
ROE
Polyodon spp.
PADDLEFISH
AND ROE,
AQUACULTURED
Pangasius gigas
PANGASIUS, GIANT8
Pangasius
PANGASIUS
micronemus
SHORTBARBEL8
Scarus spp. CFP2

PARROTFISH
Bolbometopon spp.
Dissostichus 3
PATAGONIAN
eleginoides7
TOOTHFISH OR
CHILEAN SEA BASS
Hermosilla azurea
PERCH
Perca fluviatilis
Perca flavescens
PERCH, LAKE OR
YELLOW
Lates niloticus
PERCH, NILE
Lates niloticus
PERCH, NILE,
AQUACULTURED
47
TABLE 3-2

HAZARDS

Sebastes spp. 3
PERCH, OCEAN
Rhacochilus vacca
PERCH, PILE
Bairdiella chrysoura
PERCH, SILVER
Morone americana
PERCH, WHITE
Spicara maena
PICAREL
Esox spp.
PICKEREL
Esox lucius
PIKE
Sardina pilchardus
PILCHARD
OR SARDINE Sardinops spp.
Brachyplatystoma
PIRAMUTABA OR
vaillantii
LAULAO FISH8
Hippoglossoides 3
platessoides
PLAICE Pleuronectes platessa 3
Pleuronectes 3
quadrituberculatus
Pollachius pollachius 3
POLLOCK
Pollachius virens 3
Theragra 3
POLLOCK OR
chalcogramma
ALASKA POLLOCK
Brama spp.
POMFRET Parastromateus spp.
Taractes rubescens
Alectis ciliaris CFP
POMPANO Parastromateus niger
Trachinotus spp.
Trachinotus kennedyi
POMPANO
OR PERMIT Trachinotus falcatus
48
TABLE 3-2

HAZARDS

Trachinotus rhodopus
POMPANO
OR POMPANITO
Calamus spp.
Chrysophrys auratus
Dentex spp.
Diplodus spp.
PORGY
Lagodon rhomboides
Pagrus spp.
Pterogymnus laniarus
Stenotomus caprinus
Stenotomus chrysops
PORGY OR SCUP
Arothron spp. T, PSP

Lagocephalus spp. T, PSP
Sphoeroides annulatus T, PSP
Sphoeroides nephelus T, PSP
Sphoeroides maculatus T, PSP
PUFFER
Sphoeroides spengleri T, PSP
Sphoeroides T, PSP
testudineus
Takifugu spp.7 T, PSP
Tetraodon spp. T, PSP
Takifugu spp. 7
T, PSP
PUFFER,
AQUACULTURED
Congiopodus
RACEHORSE
leucopaecilus
Rita rita
RITA
Scorpaena papillosus 3
ROCKFISH Scorpaena cardinalis 3
Sebastes spp. 3
Ciliata spp.
ROCKLING
Enchelyopus cimbrius
Labeo rohita
ROHU
49
TABLE 3-2

HAZARDS

Helicolenus
ROSEFISH
dactylopterus
Paratrachichthys trailli
ROUGHY
Hoplostethus
ROUGHY, ORANGE
atlanticus
Hoplostethus
ROUGHY, SILVER mediterraneus
mediterraneus7
Anoplopoma fimbria 3
SABLEFISH
Istiophorus platypterus
SAILFISH
Oncorhynchus spp. 3,4

SALMON AND ROE,
AQUACULTURED Salmo salar 3,4
Oncorhynchus spp. 3
SALMON AND ROE
(WILD)(FRESHWATER) Salmo salar 3

Oncorhynchus spp. 3
SALMON AND ROE,
(WILD) (OCEAN) Salmo salar 3
Citharichthys sordidus
SANDDAB
Mugiloides chilensis
SANDPERCH
Parapercis spp.
Harengula spp.
SARDINE
Sardinella spp.
Atule mate 7
SAUGER
Cololabis saira
SAURY
Scomberesox saurus
Atule mate7 3
Decapterus spp. 3
SCAD Selar 3
crumenophthalmus
Trachurus spp. 3
Trachurus trachurus 3
SCAD OR HORSE
MACKEREL
50
TABLE 3-2

HAZARDS

Hemitripterus
americanus
Myoxocephalus
SCULPIN
polyacanthocephalus
Scorpaenichthys
marmoratus
Archosargus
rhomboidalis
SEA BREAM
Chrysophrys auratus7
Pagellus spp.
Chelidonichthys spp.
Peristedion miniatum
SEAROBIN
Prionotus carolinus
Pterygotrigla picta
Cynoscion spp. 3
SEATROUT
Alosa spp.
SHAD
Alosa spp.
SHAD ROE
Dorosoma spp.
SHAD, GIZZARD
Nematalosa vlaminghi
Tenualosa ilisha
SHAD, HILSA
Carcharhinus spp.
Cetorhinus maximus
Galeocerdo cuvier
Galeorhinus spp.
Hexanchus griseus
Lamna ditropis
SHARK Negaprion brevirostris
Notorynchus
cepedianus
Prionace glauca
Sphyrna spp.
Triaenodon obesus
Triakis semifasciata
51
TABLE 3-2

HAZARDS

Lamna nasus
SHARK OR
PORBEAGLE
Mustelus spp.
SHARK OR
SMOOTHHOUND
Squatina spp.
SHARK, ANGEL
Centrophorus spp.
SHARK, DOGFISH Mustelus spp.

OR CAPE SHARK Scyliorhinus spp.
Squalus spp.
Isurus spp.
SHARK, MAKO
Alopias spp.
SHARK, THRESHER
Semicossyphus pulcher
SHEEPHEAD Archosargus
probatocephalus
Notropis spp.
SHINER
Atherinops spp.
SILVERSIDE Basilichthys australis
Menidia menidia
Bathyraja spp.
SKATE
Raja spp.
Erilepis zonifer
SKILLFISH
Allosmerus elongatus
Argentina spp.
Hypomesus spp.
Osmerus spp.
SMELT Plecoglossus altivelis
altivelis7
Retropinna retropinna
Spirinchus spp.
Thaleichthys pacificus
52
TABLE 3-2

HAZARDS

Channa striata
SNAKEHEAD
Parachanna obscura7
Apsilus dentatus
Etelis spp.
Lutjanus spp. CFP
L. bohar CFP
L. gibbus CFP
L. sebae CFP
L. buccanella CFP
L. cyanopterus CFP
SNAPPER L. jocu CFP
Symphorus CFP
nematophorus
Macolor spp.
Ocyurus chrysurus
Pristipomoides spp. 3
Rhomboplites
aurorubens
Symphorichthys
spilurus
Centropomus spp.
SNOOK
53
TABLE 3-2

HAZARDS

Aseraggodes spp. 3
Austroglossus spp. 3
Buglossidium luteum 3
Clidoderma 3
asperrimum
Embassichthys 3
bathybius
Lyopsetta exilis7 3
Eopsetta jordani 3
Glyptocephalus 3
zachirus7
Glyptocephalus spp. 3
Gymnachirus melas 3
SOLE OR FLOUNDER Hippoglossina spp. 3

Lepidopsetta bilineata 3
Microchirus spp. 3
Microstomus kitt 3
Microstomus pacificus 3
Pseudopleuronectes 3
americanus7
Parophrys vetulus7 3
Psettichthys 3
melanostictus
Solea solea7 3
Brachirus orientalis7 3
Trinectes spp. 3
Xystreurys liolepis 3
54
TABLE 3-2

HAZARDS

Aseraggodes spp. 3,4

Austroglossus spp. 3,4

Buglossidium luteum 3,4

Clidoderma 3,4
asperrimum
Embassichthys 3,4
bathybius
Lyopsetta exilis 7 3,4
Eopsetta jordani 3,4

Glyptocephalus 3,4

zachirus 7
Glyptocephalus spp. 3,4
SOLE OR FLOUNDER, Gymnachirus melas 3,4

AQUACULTURED Hippoglossina spp. 3,4

Lepidopsetta bilineata 3,4

Microchirus spp. 3,4
Pseudopleuronectes 3,4

americanus 7
Parophrys vetulus 7 3,4
Psettichthys 3,4
melanostictus
Solea solea 7 3,4
Brachirusorientalis 7
3,4

Trinectes spp. 3,4

Xystreurys liolepis 3,4

SORUBIM Pseudoplatystoma
OR SURUBI8 corruscans
Chaetodipterus spp.
SPADEFISH
Tetrapturus spp.
SPEARFISH
Leiostomus xanthurus
SPOT
Sprattus spp. 3
SPRAT OR BRISTLING
55
TABLE 3-2

HAZARDS

Holocentrus spp.
SQUIRRELFISH Myripristis spp.
Sargocentron spp.
Acipenser spp.
Huso huso
STURGEON
AND ROE Pseudoscaphirhynchus
spp.
Scaphirhynchus spp.
Acipenser spp.
STURGEON Huso huso

AND ROE, Pseudoscaphirhynchus
AQUACULTURED spp.
Scaphirhynchus spp.
Carpiodes spp.
Catostomus
SUCKER
commersonii
Cycleptus elongatus
Moxostoma
SUCKER OR
macrolepidotum
REDHORSE
Archoplites interruptus
SUNFISH
(NOT MOLA MOLA) Lepomis spp.
Amphistichus spp.
Cymatogaster
aggregata
SURFPERCH Embiotoca spp.
Hyperprosopon
argenteum
Rhacochilus toxotes
Pangasius
SUTCHI OR SWAI8
hypophthalmus
Pangasius
SUTCHI OR SWAI8,
hypophthalmus
AQUACULTURED
Xiphias gladius
SWORDFISH
56
TABLE 3-2

HAZARDS

Acanthurus spp. CFP2

Ctenochaetus spp CFP2
TANG
Naso spp. CFP2
Zebrasoma spp.
Megalops atlanticus
TARPON
Tautoga onitis
TAUTOG
Sebastolobus spp. 3
THORNYHEAD
Eleutheronema
tetradactylum
Galeoides
THREADFIN decadactylus
Gnathanodon spp.
Polydactylus spp.
Polynemus spp.
Datnioides microlepis
TIGERFISH
Datnioides polota
Tilapia spp.
TILAPIA Oreochromis spp.
Sarotherodon spp
Oreochromis spp.
TILAPIA,
Sarotherodon spp.
AQUACULTURED
Tilapia spp.
Caulolatilus spp.
Lopholatilus
TILEFISH chamaeleonticeps
Malacanthus plumieri
Prolatilus jugularis
Barbonymus altus
TINFOIL
Microgadus spp. 3
TOMCOD
Cynoglossus spp. 3
TONGUESOLE
Hoplias malabaricus
TRAHIRA
57
TABLE 3-2

HAZARDS

Caranx spp. 3 CFP

TREVALLY
Balistes spp. CFP

Canthidermis
TRIGGERFISH sufflamen
Melichthys niger
Navodon spp.
Datnioides
TRIPLETAIL quadrifasciatus
Lobotes spp
Oncorhynchus mykiss
aguabonita
Oncorhynchus clarkii
Oncorhynchus gilae
Oncorhynchus mykiss
TROUT,
AQUACULTURED Salmo trutta
Salvelinus fontinalis
Salvelinus malma
Salvelinus namaycush
Stenodus leucichthys
Oncorhynchus mykiss 3
TROUT, RAINBOW
OR STEELHEAD
Latridopis spp.
TRUMPETER
Latris lineata
Allothunnus fallai 3
Auxis spp. 3
TUNA (SMALL) Euthynnus spp. 3

Katsuwonus pelamis 3
Thunnus tonggol 3

Thunnus alalunga
Thunnus albacares
Thunnus atlanticus
TUNA (LARGE)
Thunnus maccoyii
Thunnus obesus
Thunnus thynnus
58
TABLE 3-2

HAZARDS

Thunnus spp. 3,4

TUNA,
AQUACULTURED
Pleuronichthys 3
guttulatus7
Pleuronichthys spp. 3
TURBOT Psettodes spp. 3
Reinhardtius 3
hippoglossoides
Psetta maxima7 3
Psetta maxima
TURBOT,
AQUACULTURED
Malaclemys spp.
Chelydra spp.
TURTLE
Apalone spp.
Trachemys spp.
Malaclemys spp.
TURTLE, Chelydra spp.
AQUACULTURED Apalone spp.
Trachemys spp.
Naso unicornis
UNICORNFISH
Acanthocybium
WAHOO
solandri
Sander spp.7
WALLEYE
Seriolella spp.
WAREHOU
Cynoscion spp.
WEAKFISH
Macrodon ancylodon
WEAKFISH OR
BANGAMARY
Arius spp.
WHISKERED FISH8
Bagre marinus
WHISKERED FISH OR
GAFFTOPSAIL FISH8
Ariopsis felis
WHISKERED FISH OR
HARDHEAD
WHISKERED FISH8
59
TABLE 3-2

HAZARDS

Coregonus spp.
WHITEFISH Prosopium
cylindraceum
Merluccius gayi
WHITING Merluccius hubbsi
Merluccius merluccius
Micromesistius spp.
WHITING, BLUE
Merluccius productus
WHITING OR
PACIFIC WHITING
Macruronus
WHITING,
novaezelandiae
NEW ZEALAND
Cheilinus CFP
WRASSE
undulatus
Anarhichas spp. 3
WOLFFISH
Seriola lalandi
YELLOW TAIL OR
AMBERJACK
Seriola lalandi7
YELLOWTAIL
AMBERJACK,
AQUACULTURED
Sander lucioperca7
ZANDER
Sander lucioperca7
ZANDER,
AQUACULTURED
60
TABLE 3-2

HAZARDS

ASP = Amnesic Shellfish Poisoning; CFP = Ciguatera Fish Poisoning; G = gempylotoxin; PSP = Paralytic Shellfish Poisoning; and T = tetrodotoxin.
1. This hazard does not apply to offshore catch (e.g., areas not subject to shore side contaminant
discharges).
2. Indicates that the ciguatera hazard is associated with this species only in the tropical Pacific Ocean.
3. This hazard applies where the processor has knowledge or has reason to know that the parasite-containing fish or fishery product will be
consumed without a process sufficient to kill the parasites, or where the processor represents, labels, or intends for the product to be so
consumed.
4. This hazard, when caused by consuming infected feed, only applies if fish processing waste, fresh fish, or plankton is used as feed.
5. This hazard only applies if the product is marketed uneviscerated.
6. Amberjack, yellowtail, Spanish mackerel, king mackerel and other scombrotoxin-forming fish are sometimes marketed incorrectly as kingfish.
7. The scientific name for this species has changed since the previous edition of this guidance.
8. The market name for this species has been changed since the previous edition of this guidance.
9. This hazard does not apply to products intended for animal feed or fish oil products, but does apply to products intended for direct human
consumption of the muscle and to aqueous components, such as fish protein concentrates that are to be used as food additives.
10. This hazard only applies to food products for human consumption, such as oil extracts used as dietary ingredients.
61
TABLE 3-3
POTENTIAL INVERTEBRATE SPECIES-RELATED HAZARDS

Note: You should identify pathogens from the harvest area as a potential species-related hazard if you know, or have reason
to know, that the fish will be consumed without a process sufficient to kill pathogens or if you represent, label, or intend for the
HAZARDS
NATURAL ENVIRONMENTAL AQUACULTURE

MARKET NAMES LATIN NAMES PATHOGENS PARASITES
TOXINS CHEMICALS DRUGS
Haliotis spp
Marinauris roei
ABALONE
Haliotis ruber
Haliotis laevigata
Anadara subcrenata
ARKSHELL
Arca spp.
Macoma nasuta
CLAM, BENTNOSE
Saxidomus spp.
CLAM BUTTER
Macrocallista maculata
CLAM, CALICO
Panopea abrupta
CLAM, GEODUCK
Panopea bitruncata
Arctica islandica
CLAM, HARD Meretrix spp.
Venus mortoni
Protothaca thaca
CLAM, HARDSHELL
OR QUAHOG Mercenaria spp.
Protothaca staminea
Protothaca tenerrima
Tapes variegata
CLAM, LITTLENECK Tapes virginea
Venerupis aurea4
Venerupis decussata 4

Venerupis philippinarum
Corbicula japonica
CLAM, MARSH
Tivela stultorum
CLAM, PISMO
Ensis spp.
Siliqua spp.
CLAM, RAZOR
Solen spp.
Tagelus spp.
Sanguinolaria spp.
CLAM, SANGUIN
62
TABLE 3-3

HAZARDS

Mya arenaria
CLAM, SOFTSHELL
Mactrellona alata
Mactromeris spp.
Mactra spp.
CLAM, SURF OR
Mactrotomas spp.
SURFCLAM
Simomactra spp.
Spisula spp.
Tresus spp.
Mactra schalinensis
CLAM, SURF
AQUACULTURED
Chione spp.
CLAM, VENUS Chionista spp.4
Macrocallista nimbosa
Paphies spp.
CLAM, WEDGE
Cardium spp.
Clinocardium spp.
COCKLE
Dinocardium robustum
Serripes groenlandicus
Strombus spp.
CONCH
Lambis lambis
Donax spp.
COQUINA
Iphigenia brasiliana
COQUINA, FALSE

Callinectes sapidus
CRAB, BLUE,
AQUACULTURED
Callinectes sapidus
CRAB, BLUE
Chaceon fenneri4
CRAB, BROWN
Lithodes aequispinus4
CRAB, BROWN
KING
63
TABLE 3-3

HAZARDS

Lithodes antarcticus
CRAB, CENTOLLA
Lithodes murrayi
Paralomis granulosa
CRAB, DEEPSEA
Cancer magister 2
CRAB, DUNGENESS
Geothelphusa dehaani 1
CRAB, JAPANESE
FRESHWATER
Cancer borealis 2
CRAB, JONAH
Paralithodes camtschaticus
CRAB, KING
Paralithodes platypus
Paralithodes brevipes
CRAB, KING OR
HANASAKI
Erimacrus isenbeckii
CRAB, KOREAN OR
KEGANI
Neolithodes brodiei
CRAB, LITHODES
Chaceon quinquedens4
CRAB, RED
Cancer productus 2
CRAB, RED ROCK
Cancer irroratus
CRAB, ROCK
Cancer pagurus
Loxorhynchus grandis
CRAB, SHEEP
Chionoecetes angulatus
Chionoecetes bairdi
CRAB, SNOW
Chionoecetes opilio
Chionoecetes tanneri
Jacquinotia edwardsii
CRAB, SPIDER
Maja squinado
Menippe spp. 4

CRAB, STONE
Scylla serrata
CRAB, SWAMP
64
TABLE 3-3

HAZARDS

Scylla serrata
CRAB, SWAMP,
AQUACULTURED
Callinectes arcuatus
CRAB, SWIMMING Callinectes toxotes
Portunus spp.
Cambarus spp.
Cherax spp.
Euastacus armatus
CRAWFISH OR
Pacifastacus spp.
CRAYFISH
Paranephrops spp.
Procambarus spp.
Astacus spp.
Cambarus spp.
Cherax spp.
Euastacus armatus
CRAWFISH OR
CRAYFISH, Pacifastacus spp.
AQUACULTURED
Paranephrops spp.
Procambarus spp.
Astacus spp.
Sepia spp.
CUTTLEFISH
Rhopilema spp.
JELLYFISH
Euphausia spp.
Meganyctiphanes
KRILL
norvegica
Thysandoessa inermis
Cervimunida johni
LANGOSTINO Munida gregaria
Pleuroncodes spp.
65
TABLE 3-3

HAZARDS

Tectura testudinalis4
Cellana denticulata
Diodora aspera
LIMPET
Fissurella maxima
Lottia gigantea
Patella caerulea
Homarus spp. 3
LOBSTER
Nephrops norvegicus
LOBSTER, NORWAY
Jasus spp.
LOBSTER, ROCK
Palinurus spp.
LOBSTER,
ROCK OR SPINY Panulirus spp.
Ibacus ciliatus
LOBSTER, SLIPPER Scyllarides spp.
Thenus orientalis
Metanephrops spp.
LOBSTERETTE
Nephropsis aculeata
Murex brandaris
MUREX OR MEREX
Modiolus spp.
MUSSEL Mytilus spp.
Perna canaliculus
Eledone spp. 1
OCTOPUS
Octopus spp. 1
Crassostrea spp.
Ostrea spp.
OYSTER
Spondylus spp.
Tiostrea spp.
Atrina pectinata
PEN SHELL
Littorina littorea
PERIWINKLE
66
TABLE 3-3

HAZARDS

Aequipecten spp. 2 2
Amusium spp. 2
2

Argopecten nucleus 2
2

Chlamys spp. 2 2
SCALLOP
Euvola spp. 4
2
2

Patinopecten yessoensis 2
2

Pecten spp. 2 2
Placopectin magellanicus 2
2

Aequipecten spp. 2
2

Amusium spp. 2 2
Argopecten nucleus 2
2

SCALLOP Chlamys spp. 2 2

AQUACULTURED Euvola spp. 4
2
2

Patinopecten yessoensis 2
2

Pecten spp. 2 2
Placopectin magellanicus 2
2

Argopecten irradians 2
2

SCALLOP OR BAY
SCALLOP
Argopecten gibbus 2 2
SCALLOP, CALICO
Patinopecten caurinus 2 2
SCALLOP OR
WEATHERVANE
Cucumaria spp.
Holothuria spp.
SEA CUCUMBER
Parastichopus spp.
Stichopus spp.
Echinus esculentus
Evechinus chloroticus
Heliocidaris spp.
SEA URCHIN ROE Loxechimus spp.
Paracentrotus spp.
Pseudocentrotus spp.
Strongylocentrotus spp.
Xiphopenaeuskroyeri
SEABOB
67
TABLE 3-3

HAZARDS

Styela spp.
SEA SQUIRT
Crangon spp.
Farfantepenaeus spp.4
Fenneropenaeus spp.4
Litopenaeus spp.4
Marsupenaeus spp.4
Melicertus spp.4
SHRIMP Metapenaeus affinis

Palaemon serratus
Palaemonetes vulgaris
Pandalopsis dispar
Pandalus spp.
Penaeus spp.
Pleoticus muelleri
Plesionika martia
Crangon spp.
Exopalaemon styliferus
Farfantepenaeus spp. 4

Fenneropenaeus spp. 4

Litopenaeus spp.4
Marsupenaeus spp. 4

SHRIMP,
AQUACULTURED Macrobrachium spp.
Melicertus spp.4
Metapenaeus spp.
Palaemon serratus
Palaemonetes vulgaris
Pandalopsis dispar
Pandalus spp.
Penaeus spp.
Plesionika martia
Crangon spp.
Macrobrachium spp.
SHRIMP,
FRESHWATER
68
TABLE 3-3

HAZARDS

Macrobrachium spp.
SHRIMP,
FRESHWATER,
AQUACULTURED
Sicyonia brevirostris
SHRIMP, ROCK
Pleoticus robustus
SHRIMP, ROYAL
Pandalus borealis
SHRIMP
OR PINK SHRIMP Pandalus jordani
Hymenopenaeus sibogae
SHRIMP OR PRAWN
Otala spp.
SNAIL
Helix pomatia
OR ESCARGOT
Achatina fulica 1
Polinices spp.
SNAIL, MOON
Berryteuthis magister 1
Dosidicus gigas 1
Illex spp. 1
Loligo spp. 1
Loligo media 4
1
Lolliguncula spp. 1
SQUID
Nototodarus spp. 1
Ommastrephes spp. 1
Rossia macrosoma 1
Sepiola rondeleti 1
Sepioteuthis spp. 1
Todarodes sagittatus 1
Turbo cornutus
TOP SHELL
Monodonta turbinata4
Buccinum spp.
WHELK
Busycon spp.
OR SEA SNAIL
Neptunea spp. 2
69
TABLE 3-3

HAZARDS

1. This hazard applies where the processor has knowledge or has reason to know that the parasite-containing fish or fishery product will be
consumed without a process sufficient to kill the parasites, or where the processor represents, labels, or intends for the product to be so
consumed.
2. This hazard only applies if the product is marketed uneviscerated.
3. This hazard only applies if the lobsters are held in pounds.
4. The scientific name for this species has changed since the last edition of this guidance.
70
TABLE 3-4
POTENTIAL PROCESS-RELATED HAZARDS

HAZARDS
PATHOGENIC BACTERIA SURVIVAL THROUGH
PATHOGENIC BACTERIA CONTAMINATION

AFTER PASTEURIZATION AND SPECIALIZED
RETAIN RAW PRODUCT CHARACTERISTICS
SURVIVAL THROUGH COOKING OR
PATHOGENIC BACTERIA GROWTH -
S. AUREUS TOXIN - DRYING
PROCESSES DESIGNED TO
S. AUREUS TOXIN - BATTER
PATHOGENIC BACTERIA
COOKING PROCESSES
C. BOTULINUM TOXIN
TEMPERATURE ABUSE
GLASS INCLUSION
METAL INCLUSION
PASTEURIZATION
ALLERGENS/
ADDITIVES
FINISHED PACKAGE
PRODUCT FOOD1 TYPE
CHP CHP CHP CHP CHP CHP CHP CHP CHP CHP
12 13 14 15 16 17 18 19 20 21
Cooked shrimp, Reduced oxygen

crab, lobster, packaged (e.g.,
and other fish, mechanical vacuum,
including cooked steam flush, hot
meat, sections, fill, MAP, CAP,
and whole fish, hermetically sealed,
and surimi-based or packed in oil)
analog products
Cooked shrimp, Other than reduced
crab, lobster, oxygen packaged
and other fish,
including cooked
meat, sections,
and whole fish,
and surimi-based
analog products
Pasteurized crab, Reduced oxygen
lobster, and other packaged (e.g.,
fish, including mechanical vacuum,
pasteurized steam flush, hot
surimi-based fill, MAP, CAP
analog products hermetically sealed,
or packed in oil)
Pasteurized crab, Other than reduced
lobster, and other oxygen packaged
fish, including
pasteurized
surimi-based
analog products
Smoked fish Reduced oxygen
packaged (e.g.,
mechanical vacuum,
steam flush, hot
fill, MAP, CAP,
hermetically sealed,
or packed in oil)
71
TABLE 3-4

HAZARDS

PATHOGENIC BACTERIA
COOKING PROCESSES
C. BOTULINUM TOXIN
TEMPERATURE ABUSE
GLASS INCLUSION
METAL INCLUSION
PASTEURIZATION
ALLERGENS/
ADDITIVES
FINISHED PACKAGE
PRODUCT FOOD1 TYPE
12 13 14 15 16 17 18 19 20 21
Smoked fish Other than reduced

oxygen packaged
Salads, Reduced oxygen
sandwiches, packaged (e.g.,
dips, cocktails, mechanical vacuum,
and similar steam flush, hot
seafood products fill, MAP, CAP,
prepared from hermetically sealed,
ready-to-eat or packed in oil)
fishery products
Salads, Other than reduced

sandwiches, oxygen packaged
dips, cocktails,
and similar
seafood products
prepared from
ready-to-eat
fishery products
Battered or All
breaded
(including
surface-browned)
raw shrimp,
finfish, oysters,
clams, squid, and
other fish
Stuffed crab, All
shrimp, finfish,
and other fish
Dried fish All
72
TABLE 3-4

HAZARDS

PATHOGENIC BACTERIA
COOKING PROCESSES
C. BOTULINUM TOXIN
TEMPERATURE ABUSE
GLASS INCLUSION
METAL INCLUSION
PASTEURIZATION
ALLERGENS/
ADDITIVES
FINISHED PACKAGE
PRODUCT FOOD1 TYPE
12 13 14 15 16 17 18 19 20 21
Raw oysters, Reduced oxygen

clams, and packaged (e.g.,
mussels mechanical vacuum,
steam flush, hot
fill, MAP, CAP,
or packed in oil)
Raw oysters, Other than reduced
clams, and oxygen packaged
mussels
Raw fish other Reduced oxygen 2
than oysters, packaged (e.g.
clams, and mechanical vacuum,
mussels (finfish steam flush, hot
and non-finfish) fill, MAP, CAP,
or packed in oil)
Raw fish other Other than reduced 2
than oysters, oxygen packaged
clams, and
mussels (finfish
and non-finfish)
Partially cooked Reduced oxygen
or uncooked packaged (e.g.,
prepared foods mechanical vacuum,
steam flush, hot
fill, MAP, CAP,
or packed in oil)
Partially cooked Other than reduced
or uncooked oxygen packaged
prepared foods
73
TABLE 3-4

HAZARDS

PATHOGENIC BACTERIA
COOKING PROCESSES
C. BOTULINUM TOXIN
TEMPERATURE ABUSE
GLASS INCLUSION
METAL INCLUSION
PASTEURIZATION
ALLERGENS/
ADDITIVES
FINISHED PACKAGE
PRODUCT FOOD1 TYPE
12 13 14 15 16 17 18 19 20 21
Fully cooked Reduced oxygen

prepared foods packaged (e.g.,
mechanical vacuum,
steam flush, hot
fill, MAP, CAP,
or packed in oil)
Fully cooked Other than reduced
prepared foods oxygen
Fermented, All 3
acidified,
pickled, salted,
and LACFs
Fish oil All 4
C. botulinum = Clostridium botulinum; S. aureus = Staphylococcus aureus; MAP = modified atmosphere packaging; CAP = controlled atmosphere
packaging; and LACF = low-acid canned food.
1. You should include potential hazards from more than one finished product food category if your product fits more than one description.
2. This hazard only applies if you have knowledge, or have reason to know, that the fish will be consumed without a process sufficient to kill
pathogens or if you represent, label, or intend for the product to be so consumed.
3. Controls for this hazard need not be included in HACCP plans for shelf-stable acidified and LACFs. See Thermally Processed Low-Acid Foods
Packaged in Hermetically Sealed Containers regulation (21 CFR 113), called the LACF Regulation in this guidance document, and Acidified
Foods regulation (21 CFR 114) for mandatory controls.
4. This hazard does not apply to highly refined fish oil.
74
CHAPTER 4: Pathogens From the Harvest Area
UNDERSTAND THE POTENTIAL HAZARD Managing the amount of time that food is
exposed to temperatures that are favorable
This chapter covers the control of pathogens from for pathogenic bacteria growth and toxin
the harvest area for both molluscan shellfish and production (covered generally in Chapter 12;
fish other than molluscan shellfish. for Clostridium botulinum, in Chapter 13; and
for Staphylococcus aureus in hydrated batter
Strategies for control of pathogens mixes, in Chapter 15);
There are a number of strategies for the control Killing pathogenic bacteria by cooking or
of pathogens in fish and fishery products. They pasteurization (covered in Chapter 16) or
include: retorting (covered by the Thermally Processed
Controlling the source (i.e., harvest waters) Low-Acid Foods Packaged in Hermetically
of molluscan shellfish and the time from Sealed Containers regulation (hereinafter, the
exposure to air (i.e., by harvest or receding Low-Acid Canned Foods (LACF) Regulation),
tide) to refrigeration to control pathogens from 21 CFR 113);
the harvest area (covered in this chapter); Killing pathogenic bacteria by processes that
Controlling the amount of moisture that is retain raw product characteristics (covered in
available for pathogenic bacteria growth Chapter 17).
(water activity) in the product by drying
Molluscan shellfish
(covered in Chapter 14);
Pathogens found in waters from which molluscan
Controlling the amount of moisture that is
shellfish are harvested can cause disease in
available for pathogenic bacterial growth
consumers. For the purposes of this guidance,
(water activity) in the product by formulation
molluscan shellfish include:
Controlling the amount of salt or (1) oysters; (2) clams; (3) mussels; and (4) scallops,
preservatives, such as sodium nitrite, in the except where the final product is the shucked
product (covered in Chapter 13); adductor muscle only. The pathogens of concern
include both bacteria (e.g., Vibrio spp., Salmonella
Controlling the level of acidity (pH) in the
spp., Shigella spp., and Campylobacter jejuni (C.
product (covered by the Acidified Foods
jejuni)) and viruses (e.g., hepatitis A virus and
regulation, 21 CFR 114, for shelf-stable
norovirus). See Appendix 7 for a description of the
acidified products, and by Chapter 13, for
public health impacts of these pathogens.
refrigerated acidified products);
Pathogens from the harvest area are of particular
Controlling the introduction of pathogenic
concern in molluscan shellfish because (1)
bacteria after the pasteurization process
environments in which molluscan shellfish grow
are commonly subject to contamination from
75
sewage, which may contain pathogens, and harvest location, and the date of harvest (21 CFR
contamination from naturally occurring bacteria, 123.28(c)); (2) molluscan shellfish harvesters be
which may also be pathogens; (2) molluscan licensed (note that licensing may not be required
shellfish filter and concentrate pathogens that in all jurisdictions); (3) processors that ship,
may be present in surrounding waters; and (3) reship, shuck, or repack molluscan shellfish be
molluscan shellfish are often consumed whole, certified; and (4) containers of shucked molluscan
either raw or partially cooked. shellfish bear a label with the processors name,
address, and certification number.
Certain pathogens generally originate
from human or animal fecal sources (e.g., The controls listed above serve to minimize the
Vibrio cholerae (V. cholerae) O1 and O139, risk of molluscan shellfish containing pathogens
Salmonella spp., Shigella spp., C. jejuni, Yersinia of human or animal origin, but do not fully
enterocolitica (Y. enterocolitica), hepatitis A virus, eliminate the risk. As a result, consumption
and norovirus). Other pathogens are naturally of raw or undercooked molluscan shellfish
occurring in certain waters (e.g., Vibrio vulnificus may not be safe for individuals with certain
(V. vulnificus), Vibrio parahaemolyticus (V. health conditions, such as liver disease; chronic
parahaemolyticus), and V. cholerae non-O1 and alcohol abuse; diabetes; and stomach, blood,
non-O139), and their presence is not associated and immune disorders. For this reason, shellfish
with human or animal fecal sources. control authorities require that shellstock
intended for raw consumption bear a tag that
See Appendix 7 for a description of the public
instructs retailers to inform their customers that
health impacts of these pathogens.
consuming raw or undercooked shellfish may
Control of pathogens of human or animal origin increase the risk of foodborne illness, especially
To minimize the risk of molluscan shellfish for individuals with certain medical conditions.
containing pathogens of human or animal fecal You can also eliminate the hazard of pathogens
origin (e.g., V. cholerae O1 and O139, Salmonella from the harvest area by properly cooking,
spp., Shigella spp., C. jejuni, hepatitis A virus, pasteurizing, or retorting the product. Guidance
and norovirus), Federal, state, tribal, territorial on cooking and pasteurizing to control
and foreign government agencies, called shellfish pathogenic bacteria is provided in Chapter 16.
control authorities, classify waters in which Mandatory retorting controls are described in
molluscan shellfish are found, based, in part, the LACF Regulation (21 CFR 113). It should be
on an assessment of water quality. As a result noted that neither cooking, nor pasteurizing, nor
of these classifications, molluscan shellfish retorting will eliminate the hazards of natural
harvesting is allowed from some waters, not toxins or environmental chemical contaminants
from others, and only at certain times or under and pesticides that also may be associated with
certain conditions from others. Shellfish control molluscan shellfish. Appropriate control strategies
authorities exercise control over the molluscan for these hazards are provided in Chapters 6 and
shellfish harvesters to ensure that harvesting 9. Additionally, the laws and regulations of states
takes place only when and where it has been that participate in the National Shellfish Sanitation
determined to be safe. Program administered by FDA require that all
molluscan shellfish be harvested from waters
Other significant elements of shellfish control authorized for harvesting by the shellfish control
authorities efforts to control the safety of authority, regardless of how it will be processed.
molluscan shellfish include requirements that
(1) containers of in-shell molluscan shellfish Control of naturally occurring pathogens
(shellstock) bear a tag that identifies the type To minimize the risk of illness from the
and quantity of shellfish, the harvester, the consumption of molluscan shellfish containing
76
naturally occurring pathogens such as V. As with pathogens of sewage origin, the above
vulnificus, V. parahaemolyticus, and V. cholerae controls for naturally occurring pathogens help
non-O1 and non-O139, shellfish control minimize the risk from these pathogens in
authorities place certain controls on the harvest molluscan shellfish but do not fully eliminate
of molluscan shellfish. the risk. For this same reason, shellfish control
authorities require that shellstock intended
Naturally occurring pathogens may be present in
for raw consumption bear a tag containing
relatively low numbers at the time that molluscan
an advisory relative to raw and undercooked
shellfish are harvested but may increase to more
consumption (described above).
hazardous levels if they are exposed to time
and temperature abuse. To minimize the risk of The controls for Vibrio spp. discussed in this
growth of Vibrio spp., shellfish control authorities chapter apply only to molluscan shellfish if they
place limits on the time from exposure to air (i.e., are intended for raw consumption. For example,
by harvest or receding tide) to refrigeration. The they would not be applied to oyster shellstock
length of time is dependent upon the Average if tags on the containers of shellstock indicate
Monthly Maximum Air Temperature (AMMAT) or that they must be shucked before consumption.
the Average Monthly Maximum Water Temperature Vibrio spp. can be eliminated or reduced to non-
(AMMWT) at the time of harvest, which is detectable levels by cooking, pasteurizing, and
determined by the shellfish control authority. retorting. These control mechanisms are widely
used in the processing of fishery products for the
In addition to the above, control for V. control of pathogens. Guidance for these control
parahaemolyticus in oysters involves (1) a risk mechanisms can be found in Chapter 16 (cooking
evaluation by the shellfish control authority to and pasteurization to control pathogenic bacteria)
determine whether the risk of V. parahaemolyticus and the LACF Regulation, 21 CFR 113 (retorting).
illness from the consumption of oysters harvested Other mechanisms for control of Vibrio spp. include
from a growing area(s) in a state is reasonably processes that are designed to retain the raw
likely to occur; and (2) a determination by characteristics of the food, including individual quick
shellfish control authorities about whether a freezing (IQF) with extended storage, mild heat,
growing area(s) in a state has average monthly high hydrostatic pressure, and irradiation. These
daytime water temperatures that exceed 60F control mechanisms are covered in Chapter 17.
for waters bordering the Pacific Ocean or 81F
Appropriate controls to prevent further growth
for waters bordering the Gulf of Mexico and the
of these pathogenic bacteria during processing,
Atlantic Ocean (New Jersey and south) at times
storage, and transportation between processors
during which harvesting occurs. If either of these are discussed in Chapter 12.
conditions is met, the shellfish control authority
develops and implements a V. parahaemolyticus Fish other than molluscan shellfish
control plan intended to reduce the incidence of Pathogens from the harvest area may also be a
V. parahaemolyticus illnesses. As part of the plan, potential hazard for fish other than molluscan
shellfish control authorities may (1) temporarily shellfish. Pathogens may be found on raw
close some waters to the harvesting of oysters; (2) fish as a result of near-shore harvest water
limit the time from exposure to air (i.e., by harvest contamination, poor sanitary practices on the
or receding tide) to refrigeration; (3) temporarily harvest vessel, and poor aquacultural practices.
permit harvesting of oysters for products that will The pathogens of concern include those
be labeled For Shucking Only from some waters; described above for molluscan shellfish, but also
or (4) temporarily permit harvesting of oysters for include Listeria monocytogenes and Escherichia
processes that retain raw product characteristics coli. See Appendix 7 for a description of the
(covered in Chapter 17) only from some waters. public health impacts of these pathogens.
77
Control of pathogens DETERMINE WHETHER THIS POTENTIAL
The processor can control pathogens by proper HAZARD IS SIGNIFICANT.
cooking, pasteurizing, or retorting. Guidance
for these control mechanisms can be found in The following guidance will assist you in
Chapter 16 (cooking and pasteurizing to kill determining whether pathogens from the harvest
pathogenic bacteria) and the LACF Regulation, 21 area are a significant hazard at a processing step:
CFR 113 (retorting). 1. Is it reasonably likely that an unsafe level
For many products (e.g., raw fish fillets), there of pathogens from the harvest area will be
is no cooking, pasteurizing, or retorting step introduced at this processing step (e.g., are
performed by the processor. For most of these pathogens present in the raw material at an
products, cooking is performed by the consumer unsafe level)?
or end user before consumption. FDA is not
Under ordinary circumstances, it would be
aware of any Hazard Analysis Critical Control
reasonably likely that pathogens of human
Point (HACCP) controls that exist internationally
or animal origin from the harvest area could
for the control of pathogens in fish and fishery
enter the process at an unsafe level at the
products that are customarily fully cooked by
receiving step for the following types of fish:
the consumer or end user before consumption
other than a rigorous sanitation regime as part Raw oysters;
of a prerequisite program or as part of HACCP Raw clams;
itself. The Fish and Fishery Products regulation
(21 CFR 123.11, Sanitation control procedures) Raw mussels;
requires such a regime. The proper application Raw scallops (see information
of sanitation controls is essential because of the provided under Intended use).
likelihood that pathogens in seafood products

can be introduced through poor handling In addition:
practices by the aquaculture producer, the Under ordinary circumstances, it would
harvester, or the processor. be reasonably likely that an unsafe level
of V. vulnificus (a naturally occurring
For some products (e.g., raw fish intended for
pathogen) could enter the process
sushi), there is no cooking performed by either the
from oysters harvested from areas that
processor, or the consumer, or the end user. When
have been confirmed as the original
the processor has knowledge or has reason to
source of oysters associated with two
know that the product will be consumed without
or more V. vulnificus illnesses (e.g.,
a process sufficient to kill pathogens of public
states bordering the Gulf of Mexico);
health concern or where the processor represents,
labels, or intends for the product to be so Under ordinary circumstances, it
consumed, the processor should control time and would be reasonably likely that an
temperature exposure of the product to prevent unsafe level of V. parahaemolyticus
growth of bacterial pathogens and formation of could enter the process from oysters
toxins by any bacterial pathogens that may be harvested from an area that meets any
present in the product. Guidance for these controls one of the following conditions:
can be found in Chapter 12 and in Chapter 13 (for The shellfish control authority
those products where the packaging technique has conducted a risk evaluation
creates a reduced oxygen environment). and determined that the risk of V.
Note: The guidance contained in the remainder of this chapter
parahaemolyticus illness from the
applies to receiving controls for molluscan shellfish only. consumption of oysters harvested
78
from that growing area is reasonably Making sure that incoming molluscan
likely to occur. Specific guidance for shellfish are supplied by a licensed
determining risk can be found in the harvester (where licensing is required
National Shellfish Sanitation Program by law) or by a certified dealer;
Guide for the Control of Molluscan Killing pathogenic bacteria by
Shellfish 2007 Revision; cooking or pasteurizing (covered in
The shellfish control authority has Chapter 16) or retorting (covered by
determined that harvesting occurs the LACF Regulation, 21 CFR 113). It
in the growing area at a time when should be noted that neither cooking
average monthly daytime water nor retorting will eliminate the
temperatures exceed 60F for waters hazards of natural toxins or chemical
bordering the Pacific Ocean and contamination that also may be
81F for waters bordering the Gulf of associated with molluscan shellfish;
Mexico and the Atlantic Ocean (New Killing Vibrio spp. by IQF with
Jersey and south), except where a extended storage, mild heat,
more rigorous risk evaluation has irradiation, or high hydrostatic
led the shellfish control authority pressure (covered in Chapter 17);
to conclude that the risk of V.
Minimizing the growth of V.
parahaemolyticus illness from the
cholerae, V. parahaemolyticus, and V.
consumption of oysters harvested
vulnificus by limiting the time from
from that growing area is not
exposure to air (i.e., by harvesting
reasonably likely to occur;
or receding tide) to refrigeration;
The growing area has been confirmed
Including an advisory on tags on
as the original source of oysters
containers of molluscan shellstock
associated with two or more V.
intended for raw consumption or
parahaemolyticus illnesses in the past
on containers of shucked molluscan
3 years.
shellfish that instructs retailers to
2. Can an unsafe level of pathogens from the inform their customers that consuming
harvest area that was introduced at the receiving raw or undercooked shellfish may
step be eliminated or reduced to an acceptable increase the risk of foodborne
level at this processing step? illness, especially for individuals
with certain medical conditions.
Pathogens from the harvest area should
also be considered a significant hazard at Intended use
any processing step where a measure is For most raw molluscan shellfish products,
or can be used to eliminate the pathogens you should assume that the product will be
that had been introduced at a previous step consumed raw. You should, therefore, identify
or is adequate to reduce the likelihood of the hazard as significant if it meets the criteria in
occurrence of the hazard to an acceptable the previous section.
level. Measures to eliminate pathogens or to
Where the product consists of scallop adductor
reduce the likelihood of occurrence of the
muscle only, it may be reasonable to assume that
hazard from the harvest area include:
the product will be cooked before consumption.
Checking incoming molluscan
In this case, you would not need to identify
shellfish to ensure that they are
pathogens from the harvest area as a significant
properly tagged or labeled;
hazard. However, if you have knowledge, or have
79
reason to know, that the scallop adductor muscle Additionally, the laws and regulations
will be consumed without a process sufficient to of states that participate in the National
kill pathogens of public health concern or where Shellfish Sanitation Program require that
the processor represents, labels, or intends for the all molluscan shellfish be harvested from
product to be so consumed, you should control waters authorized for harvesting by the
time and temperature exposure of the product shellfish control authority, regardless of
to prevent growth of bacterial pathogens and how it will be processed.
formation of toxins by any bacterial pathogens that
Example:
may be present in the product. Guidance for these
A canned clam chowder processor
controls can be found in Chapter 12 and in Chapter
should set the CCP for pathogens from
13 (for those products where the packaging
the harvest area at the retorting step,
technique creates a reduced oxygen environment).
and would not identify the receiving
The controls for V. vulnificus and V. step as a CCP for this hazard.
parahaemolyticus that are discussed in this chapter
do not need to be applied to molluscan shellfish b. If the product will not be cooked,
that are not marketed for raw consumption. For pasteurized, or retorted sufficiently to kill
example, they need not be applied to oyster bacterial pathogens during processing
shellstock from the Gulf of Mexico if tags on the in your facility, you should identify the
containers of shellstock indicate that they must be receiving step as a CCP where you can
shucked before consumption. exercise control over the source of the
molluscan shellfish and the time from
IDENTIFY CRITICAL CONTROL POINTS. exposure to air (i.e., by harvest or receding
tide) to refrigeration in order to control
pathogens from the harvest area. If the
The following guidance will assist you in
finished product is shellstock intended for
determining whether a processing step is a
raw consumption, you should also identify
critical control point (CCP) for pathogens from
the labeling step or the label (tag) receiving
the harvest area:
step as a CCP, because you can ensure that
1. Will the product be cooked, pasteurized, or the raw consumption advisory is on the tag.
retorted sufficiently to kill all bacterial pathogens
Example:
of public health concern during processing in your
A processor that shucks raw oysters
facility?
and ships a raw product should
a. If it will be, you should identify the cook check the tags of incoming shellstock
step, pasteurization step, or retorting step (in-shell oysters), the license of the
as the CCP. In this case, you would not harvesters that supply the shellstock,
need to identify the receiving step as a and the length of time between
CCP for the hazard of pathogens from exposure to air (i.e., by harvest or
the harvest area. However, note that receding tide) and refrigeration. The
neither cooking, nor pasteurizing, nor processor should identify the receiving
retorting will eliminate the hazards of step as the CCP for this hazard.
natural toxins or environmental chemical
contaminants and pesticides that also may
be associated with molluscan shellfish.
Chapters 6 and 9 provide appropriate
control strategies for these hazards.
80
Example: characteristics as the CCP for control of
A processor that ships oyster shellstock V. vulnificus. In this case, you would not
should check the tags of incoming need to identify the receiving step as a
shellstock, the license of the harvesters CCP for the control of V. vulnificus.
that supply the shellstock, the
Example:
harvest location, and the length of
A Gulf of Mexico oyster processor
time between exposure to air (i.e.,
should set the CCP for V. vulnificus
by harvest or receding tide) and
at the mild heat processing step and
refrigeration. The processor should
would not identify the receiving step
identify the receiving step as a CCP
as a CCP for that pathogen.
for this hazard. The processor should
also identify the labeling step as a CCP If you choose to follow this approach,
for this hazard and would check for you should refer to Chapter 17 for further
the presence of the raw consumption guidance.
advisory on the label or tag.
b. If the finished product will not be
This control approach includes two subjected to a process that is designed
control strategies referred to in this to retain raw product characteristics and
chapter as Control Strategy Example 1 is sufficient to kill V. vulnificus during
- Source Control and Control Strategy processing in your facility, you should
Example 2 - Shellstock Temperature identify the receiving step as a CCP,
Control. Refer to Control Strategy because you can exercise control over
Example 2 - Shellstock Temperature the time from exposure to air (i.e., by
Control when controls for V. vulnificus
harvest or receding tide) to refrigeration
or V. parahaemolyticus are needed.
in order to control V. vulnificus.
Conditions that warrant control for these
pathogens are described below. Example:
A Gulf of Mexico oyster processor
2. If the finished product is raw oyster shellstock should set the CCP for V. vulnificus at
intended for raw consumption and is harvested the receiving step.
from a state that has been confirmed as the original
source of oysters associated with two or more V. This control strategy is referred to as
vulnificus illnesses (e.g., the Gulf of Mexico), will it be Control Strategy Example 2 - Shellstock
subjected in your plant to a process that is designed Temperature Control Refer to Control
to retain raw product characteristics (e.g., mild Strategy Example 2 - Shellstock
heat processing, IQF with extended storage, high Temperature Control when controls for
hydrostatic pressure processing, or irradiation) and is V. vulnificus are needed. These controls
sufficient to kill V. vulnificus during processing in your should be considered in addition to the
facility (i.e., reduced to a non-detectable level of less controls contained in Control Strategy
than 30 Most Probable Number per gram (herein Example 1 - Source Control. If your
referred to as 30 MPN/gram), as defined in the shellfish control authority has developed
National Shellfish Sanitation Program Guide for the a V. vulnificus control plan, you should
Control of Molluscan Shellfish 2007 Revision)? develop a HACCP plan that is based on
the requirements of that plan. Elements
a. If the finished product will be subjected of the control strategy example provided
to such a process in your facility, you in this chapter and in Chapter 17 may be
should identify the processing step useful for development of such a plan.
that is designed to retain raw product
81
3. If the finished product is raw oyster shellstock b. If the finished product will not be
intended for raw consumption and is harvested subjected in your facility to a process
from an area where: (1) The shellfish control that is designed to retain raw product
authority has conducted a risk evaluation and characteristics and is sufficient to kill V.
determined that the risk of V. parahaemolyticus parahaemolyticus during processing,
illness from the consumption of oysters harvested you should identify the receiving step
from that growing area is reasonably likely as a CCP, because you can exercise
to occur; (2) the shellfish control authority control over the time from exposure
has determined that harvesting occurs in the to air (i.e., by harvest or receding tide)
growing area at a time when average monthly to refrigeration in order to control V.
daytime water temperatures exceed 60F for parahaemolyticus or exercise other
waters bordering the Pacific Ocean and 81F controls as determined by your states V.
for waters bordering the Gulf of Mexico and the parahaemolyticus control plan.
Atlantic Ocean (New Jersey and south); or (3)
Example:
the waters of the state have been confirmed as
An oyster processor should set the
the original source of oysters associated with two
CCP for V. parahaemolyticus at the
or more V. parahaemolyticus illnesses in the past
receiving step.
3 years, will it be subjected in your facility to a
process that is designed to retain raw product This control strategy is referred to as
characteristics (e.g., mild heat processing, IQF Control Strategy Example 2 - Shellstock
with extended storage, high hydrostatic pressure Temperature Control. Refer to Control
processing, or irradiation) and is sufficient to Strategy Example 2 - Shellstock
kill V. parahaemolyticus (i.e., reduced to a non- Temperature Control when controls for
detectable level of less than 30 MPN/gram, V. parahaemolyticus are needed. These
as defined in the National Shellfish Sanitation controls should be considered in addition
Program Guide for the Control of Molluscan to the controls contained in Control
Shellfish 2007 Revision)? Strategy Example 1 - Source Control.
If your shellfish control authority has
a. If the finished product will be subjected to
developed a V. parahaemolyticus control
such a process in your facility, you should
plan, you should develop a HACCP plan
identify the processing step designed to
that is based on the requirements of that
retain raw product characteristics as the
plan. Elements of the control strategy
CCP for the control of V. parahaemolyticus.
examples provided in this chapter
In this case, you would not need to
and in Chapter 17 may be useful for
identify the receiving step as a CCP for the
development of such a plan.
control of V. parahaemolyticus.
Only the primary processor (the processor who
Example:
takes possession of the molluscan shellfish
An oyster processor should set the CCP
from the harvester) should apply the time-to
for V. parahaemolyticus at the mild
refrigeration controls for Vibrio spp. that are
heat processing step and would not
discussed in this chapter, because this processor
identify the receiving step as a CCP
is in the best position to control the time from
for that pathogen.
exposure to air (i.e., by harvest or receding tide)
If you choose to follow this approach, to refrigeration.
you should refer to Chapter 17 for further
guidance.
82
DEVELOP A CONTROL STRATEGY. accompanied by a bill of lading or similar
shipping document that contains the same
The following guidance provides three examples information;
of control strategies for pathogens from the Note: The source controls listed in this critical limit are required under
harvest area. You may select a control strategy 21 CFR 123.28(c).
that is different from those which are suggested, OR

provided it complies with the requirements of the All containers of shellstock received from
applicable food safety laws and regulations, except a processor must bear a tag that discloses
that some parts of Control Strategy Example 1 - the date and place they were harvested
Source Control are specifically required by the (by state and site), the type and quantity of
Procedures for the Safe and Sanitary Processing shellfish, and the certification number of the
and Importing of Fish and Fishery Products processor;
regulation, 21 CFR 123 (called the Seafood HACCP
Regulation in this guidance document). OR
All containers of shucked molluscan shellfish
The following are examples of control strategies
must bear a label that identifies the name,
included in this chapter:
address, and certification number of the
packer or repacker of the product;
MAY APPLY TO MAY APPLY TO
CONTROL STRATEGY PRIMARY SECONDARY AND
PROCESSOR PROCESSOR
All molluscan shellfish must have been
Source control harvested from waters authorized for
Shellstock temperature harvesting by a shellfish control authority.
control

For U.S. federal waters, no molluscan
shellfish may be harvested from waters that
CONTROL STRATEGY EXAMPLE 1- are closed to harvesting by an agency of the
SOURCE CONTROL federal government;
Note: The following controls should be considered in addition to
AND
those in Control Strategy Example 2 - Shellstock Temperature
Control. All molluscan shellfish must be from a
harvester that is licensed as required (note
Set Critical Limits. that licensing may not be required in all
All containers of shellstock (in-shell jurisdictions) or from a processor that is
molluscan shellfish) received from a certified by a shellfish control authority;
harvester must bear a tag that discloses the AND
date and place they were harvested (by
All finished product shellstock intended
state and site), type and quantity of shellfish,
for raw consumption must bear a tag that
and information on the harvester or the
instructs retailers to inform their customers
harvesters vessel (i.e., the identification
that consuming raw or undercooked shellfish
number assigned to the harvester by the
may increase the risk of foodborne illness,
shellfish control authority, where applicable,
especially for individuals with certain
or if such identification numbers are not
medical conditions.
assigned, the name of the harvester or
the name or registration number of the Note: Only the primary processor, the processor that takes possession
of the molluscan shellfish from the harvester, needs to apply controls
harvesters vessel). For bulk shipments relative to the identification of the harvester, the harvesters license, or
of shellstock where the shellstock is not the approval status of the harvest waters.
containerized, the shellstock must be
83
Establish Monitoring Procedures. For checking incoming labels:
What Will Be Monitored? At least three containers randomly

selected from every lot;
Information contained on tags on containers

of incoming shellstock or on the bill AND
of lading or similar shipping document For checking licenses:

accompanying bulk shipments of shellstock; Every delivery;
AND AND
Information on whether the harvest area is For checking the raw consumption advisory
authorized for harvest by a shellfish control on finished product tags or labels:
authority or information on whether federal
harvest waters are closed to harvesting by an
Each container of finished product
shellstock intended for raw consumption
agency of the federal government; or at least three containers randomly
OR selected from every lot of shucked
Information contained on labels on molluscan shellfish.
containers of incoming shucked molluscan Who Will Do the Monitoring?
shellfish;
Any person who has an understanding of the
AND nature of the controls.
The harvesters license, where applicable;
Establish Corrective Action Procedures.
AND
The raw consumption advisory on tags on Take the following corrective action to a product
containers of finished product shellstock involved in a critical limit deviation:
intended for raw consumption or the Reject the lot;
raw consumption advisory on labels on OR
containers of shucked molluscan shellfish.
Relabel finished product shellstock intended
How Will Monitoring Be Done? for raw consumption that does not bear a tag
Perform visual checks; that contains the raw consumption advisory
or relabel shucked molluscan shellfish that
AND does not bear a label that contains the raw
Ask the shellfish control authority of the consumption advisory;
state in which your shellstock are harvested
OR
whether the harvest area is authorized for
harvest. Reject any incoming tags to be used on
finished product shellstock intended for
How Often Will Monitoring Be Done (Frequency)? raw consumption that do not contain the
For checking incoming tags: raw consumption advisory or reject any
incoming labels to be used on shucked
Every container;
molluscan shellfish that do not contain the
OR raw consumption advisory.
For checking the bill of lading or similar
AND
shipping document:
Every delivery;
OR
84
Take the following corrective action to regain control Quantity and type of shellfish;
over the operation after a critical limit deviation:
AND
Discontinue use of the supplier until
evidence is obtained that harvesting, tagging, Name and certification number of the
packer or repacker;
and/or label manufacturing practices have
changed; AND
OR Presence of the raw consumption

advisory.
Modify labeling practices.
Establish Verification Procedures.
Establish a Recordkeeping System.
Review monitoring and corrective action records
For shellstock: within 1 week of preparation to ensure they are
Receiving record that documents: complete and any critical limit deviations that
occurred were appropriately addressed.
Date of harvest;
AND
Location of harvest by state and site;
AND
Quantity and type of shellfish;
AND
Name of the harvester, name or
registration number of the harvesters
vessel, or an identification number issued
to the harvester by the shellfish control
authority (for shellstock received directly
from the harvester only);
AND
Number and date of expiration of the
harvesters license, where applicable;
AND
Certification number of the shipper,
where applicable;
AND
For shellstock intended for raw
consumption, the presence of the raw
consumption advisory, when received
from a certified dealer.
For shucked molluscan shellfish:
Receiving record that documents:
Date of receipt;
AND
85
TABLE 4-1
CONTROL STRATEGY EXAMPLE 1 - SOURCE CONTROL

This table is an example of a portion of a HACCP plan using Control Strategy Example 1 - Source Control. This example illustrates how a primary processor (processor
that takes possession of the oysters from the harvester) of shellstock oysters, that is, the shellstock shipper, can control pathogens from the harvest area. It is provided for
illustrative purposes only. This control strategy should be considered in addition to Control Strategy Example 2 - Shellstock Temperature Control.
Pathogens from the harvest area may be only one of several significant hazards for this product. Refer to Tables 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g.,
natural toxins, environmental chemical contaminants and pesticides, and pathogens during processing).
Example Only
See Text for Full Recommendations
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
MONITORING
CRITICAL CRITICAL LIMITS FOR
SIGNIFICANT
CONTROL EACH PREVENTIVE CORRECTIVE ACTION(S) RECORDS VERIFICATION
HAZARD(S) WHAT HOW FREQUENCY WHO
POINT MEASURE
Receiving Pathogens All incoming Information on Visual Every sack Receiving Reject the lot Receiving Review
shellstock from the shellstock must be incoming shellstock checks employee Discontinue use of the record monitoring and
harvest area tagged with the date tags supplier until evidence corrective action
and place of harvest, is obtained that tagging records within
type and quantity of practices have changed 1 week of
86
shellfish, and name or preparation
registration number of
the harvesters vessel
All shellstock must be Harvest site on tags Visual Every lot Receiving Reject lots from Receiving
from waters approved Ask the shellfish checks employee unapproved waters record
by the state shellfish control authority of Discontinue use of the

control authority the state in which the supplier until evidence is
shellstock are harvested obtained that harvesting
whether the area is practices have changed
authorized for harvest
All shellstock must Harvesters license Visual Every Receiving Reject lots from unlicensed Receiving
be from a licensed checks delivery employee harvesters record
harvester Discontinue use of the
supplier until evidence is
obtained that the harvester
has secured a license
CONTROL STRATEGY EXAMPLE 2 - SHELLSTOCK 12 hours;
TEMPERATURE CONTROL
OR
Note: The following controls should be considered in addition to
those in Control Strategy Example 1 - Source Control. For AMMAT of greater than 80F (greater
than 27C): 10 hours.
Set Critical Limits. Note: AMMAT is determined by the shellfish control authority. The
When controls for neither V. vulnificus nor V. shellfish control authority may implement time to temperature controls
that are more stringent than those described here. Processors should
parahaemolyticus are needed: consult with their shellfish control authority for current requirements.
For AMMAT of less than 66F (less than Note: Only the primary processor, the processor that takes possession
19C): 36 hours;
of the molluscan shellfish from the harvester, should apply controls
for the time from exposure to air (i.e., by harvest or receding tide) to
OR
refrigeration.
For AMMAT of 66 to 80F (19 to 27C):
24 hours; Establish Monitoring Procedures.

OR What Will Be Monitored?
For AMMAT of greater than 80F (greater The time shellfish was exposed to air (i.e., by
than 27C): 20 hours; harvest or receding tide);
Note: AMMAT is determined by the shellfish control authority.
AND
OR The time shellstock was placed under
When controls for V. vulnificus are needed: refrigeration;
For AMMWT of less than 65F (less than
How Will Monitoring Be Done?
18C): 36 hours;
For the time from exposure to air (i.e., by

OR
harvest or receding tide) to refrigeration:
For AMMWT of 65 to 74F (18 to 23C):
Obtain information from the shellfish

14 hours; control authority;
OR OR
For AMMWT of greater than 74 to 84F

Check the harvesters log or tags;
(greater than 23 to 29C): 12 hours;

OR
OR
Note the time of departure from and
For AMMWT of greater than 84F (greater return to dock;
than 29C): 10 hours;

OR
Note: AMMWT is determined by the shellfish control authority. The

shellfish control authority may implement time to temperature controls
that are more stringent than those described here. Processors should
Ask the harvester.
consult with their shellfish control authority for current requirements. How Often Will Monitoring Be Done (Frequency)?
OR Every delivery.
When controls for V. parahaemolyticus are Who Will Do the Monitoring?
needed:
Any person who has an understanding of
For AMMAT of less than 66F (less than the nature of the controls may perform the
19C): 36 hours;
monitoring.
OR
For AMMAT of 66 to 80F (19 to 27C):
87
Take the following corrective action to a product
involved in a critical limit deviation:
Reject lots that do not meet the critical limit;
OR
Subject the shellstock to a cooking,
pasteurization, retorting, or other process
that reduces pathogens of public health
concern to acceptable levels. See Chapters 16
and 17 and LACF Regulation (21 CFR 113) for
further guidance;
OR
Destroy the product;
OR
Divert the product to a non-food use.
AND
Take the following corrective action to regain control
evidence is obtained that harvesting practices
have changed.

Time shellstock is exposed to air (i.e., by
harvest or receding tide);
AND
Time shellstock was placed under
refrigeration;
AND
AMMWT.

Review monitoring and corrective action
records within 1 week of preparation
to ensure they are complete and any
critical limit deviations that occurred were
appropriately addressed.
88
TABLE 4-2
CONTROL STRATEGY EXAMPLE 2 - SHELLSTOCK TEMPERATURE CONTROL

(V. VULNIFICUS MODEL)
This table is an example of a portion of a HACCP plan using Control Strategy Example 2 - Shellstock Temperature Control. This example illustrates how a primary
processor (one that takes possession of the oysters from the harvester) of shellstock oysters, that is, the shellstock shipper, can control the pathogen from the harvest area, V.
vulnificus. It is provided for illustrative purposes only. This control strategy should be considered in addition to Control Strategy Example 1 - Source Control.
Pathogens from the harvest area may be only one of several significant hazards for this product. Refer to Tables 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g.,
natural toxins, environmental chemical contaminants and pesticides, and pathogens during processing).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
CRITICAL MONITORING
CRITICAL LIMITS
SIGNIFICANT CORRECTIVE
CONTROL FOR EACH RECORDS VERIFICATION
HAZARD(S) WHAT HOW FREQUENCY WHO ACTION(S)
POINT PREVENTIVE
MEASURE
Receiving Pathogens from Maximum time Time of Harvesters log Every Receiving Reject lot Receiving Review
shellstock the harvest area from harvest to harvest delivery employee Discontinue use record monitoring and
refrigeration: of the supplier corrective
89
AMMWT < 65F: until action
36 hours evidence is records within
obtained that 1 week of
AMMWT 65 to
harvesting preparation
74F: 14 hours
practices
AMMWT >74 to have changed
84F: 12 hours;

AMMWT >84F:
10 hours
Time Visual checks Every Receiving
placed in delivery employee
refrigeration
AMMWT = Average Monthly Maximum Water Temperature

BIBLIOGRAPHY. U.S. Centers for Disease Control and
Prevention. 2001. Norwalk-like viruses:
We have placed the following references on Public health consequences and outbreak
display in the Division of Dockets Management, management. Morb. Mortal. Wkly. Rep. 50:1-18.
Food and Drug Administration, 5630 Fishers Lane, U.S. Centers for Disease Control and
rm. 1061, Rockville, MD 20852. You may see Prevention. February 2010 Norovirus:
them at that location between 9 a.m. and 4 p.m., Technical Fact Sheet. Atlanta, GA. http://www.
Monday through Friday. As of March 29, 2011, cdc.gov/ncidod/dvrd/revb/gastro/norovirus
FDA had verified the Web site address for the factsheet.htm.
references it makes available as hyperlinks from U.S. Food and Drug Administration. 2007.
the Internet copy of this guidance, but FDA is not National Shellfish Sanitation Program Guide
responsible for any subsequent changes to Non- for the control of molluscan shellfish 2007
FDA Web site references after March 29, 2011. revision. Department of Health and Human
Cook, D. W., J. C. Bowers, and A. DePaola. Services, Public Health Service, Food and
2002. Density of total and pathogenic (tdh+) Drug Administration, Division of Seafood
Vibrio parahaemolyticus in Atlantic and Gulf Safety, College Park, MD. http://www.fda.gov/
Coast molluscan shellfish at harvest. J. Food Food/FoodSafety/Product-SpecificInformation/
Prot. 65:1873-1880. Seafood/FederalStatePrograms/
DePaola, A., L. H. Hopkins, J. T. Peeler, NationalShellfishSanitationProgram/
B. Wentz, and R. M. McPhearson. 1990. ucm046353.htm.
Incidence of Vibrio parahaemolyticus in U.S.
coastal waters and oysters. Appl. Environ.
Microbiol. 56:2299-2302.
Frankhauser, R. L., S. S. Monroe, J. S. Noel,
C. D. Humphrey, J. S. Bresee, U. D. Parashar,
T. Ando, and R. I. Glass. 2002. Epidemiologic
and molecular trends of Norwalk-like
viruses associated with outbreaks of
gastroenteritis in the United States. J. Infect.
Dis. 186:1-7.
Motes, M. L., A. DePaola, D. W. Cook, J. E.
Veazey, J. C. Hunsucker, W. E. Garthright, R.
J. Blodgett, and S. J. Chirtel. 1998. Influence
of water temperature and salinity on Vibrio
vulnificus in northern Gulf and Atlantic
Coast oysters (Crassostrea virginica). Appl.
Environ. Microbiol. 64:1459-1465.
Nishibuchi, M., and A. DePaola. 2005. Vibrio
species, p. 251-271. In P. M. Fratamico, A.
K. Bhunia, and J. L. Smith (ed.), Foodborne
pathogens: microbiology and molecular
biology. Caister Academic Press, Norfolk, UK.
Rippey, S. R. 1994. Infectious diseases
associated with molluscan shellfish
consumption. Clin. Microbiol. Rev. 7:419-425.
90
CHAPTER 5: Parasites
UNDERSTAND THE POTENTIAL HAZARD and other ingredients); green herring (lightly brined
herring); drunken crabs (crabs marinated in wine
Parasites (in the larval stage) consumed in and pepper); cold-smoked fish; and, undercooked
uncooked or undercooked seafood can present grilled fish. A survey of U.S. gastroenterologists
a human health hazard. Among parasites, the confirmed that seafood-borne parasitic infections
nematodes or roundworms (Anisakis spp., occur in the United States with sufficient frequency
Pseudoterranova spp., Eustrongylides spp., and to recommend preventive controls during the
Gnathostoma spp.), cestodes or tapeworms processing of parasite-containing species of fish that
(Diphyllobothrium spp.), and trematodes or flukes are intended for raw consumption.
(Chlonorchis sinensis (C. sinensis), Opisthorchis Controlling parasites
spp., Heterophyes spp., Metagonimus spp.,
The process of heating raw fish sufficiently
Nanophyetes salmincola, and Paragonimus spp.)
to kill bacterial pathogens is also sufficient to
are of most concern in seafood. Most of these
kill parasites. Guidance concerning cooking
parasites cause mild-to-moderate illness, but
and pasteurizing to kill bacterial pathogens is
severe symptoms can occur. Roundworms may
provided in Chapters 13 (hot smoking) and
embed in the intestinal wall and cause nausea,
16 (cooking and pasteurization). Regulatory
vomiting, diarrhea, and severe abdominal pain
requirements for retorting (i.e., thermal processing
and sometimes may penetrate the intestine.
of low acid canned foods) are contained in the
Tapeworms can cause abdominal swelling and
Thermally Processed Low-Acid Foods Packaged
abdominal cramps and may lead to weight loss
in Hermetically Sealed Containers regulation,
and anemia. Intestinal flukes (Heterophyes spp.,
21 CFR 113 (hereinafter, the Low-Acid Canned
Metagonimus spp., and Nanophyetes salmincola)
Foods (LACF) Regulation). This guidance does not
may cause abdominal discomfort and diarrhea.
provide further information on retorting.
Some intestinal flukes may also migrate to and
damage the heart and central nervous system. The effectiveness of freezing to kill parasites
Liver flukes (C. sinensis and Opisthorchis spp.) and depends on several factors, including the
lung flukes (Paragonimus spp.) may migrate to temperature of the freezing process, the length of
the liver and lung and sometimes cause serious time needed to freeze the fish tissue, the length of
problems in other vital organs. time the fish is held frozen, the species and source
of the fish, and the type of parasite present. The
Some products that have been implicated in human
temperature of the freezing process, the length
parasite infection are the following: ceviche (fish and
of time the fish is held frozen, and the type of
spices marinated in lime juice); lomi lomi (salmon
parasite appear to be the most important factors.
marinated in lemon juice, onion, and tomato);
For example, tapeworms are more susceptible to
poisson cru (fish marinated in citrus juice, onion,
freezing than are roundworms. Flukes appear to
tomato, and coconut milk); herring roe; sashimi
be more resistant to freezing than roundworms.
(slices of raw fish); sushi (pieces of raw fish with rice
91
Freezing and storing at an ambient temperature that the fish will be consumed without
of -4F (-20C) or below for 7 days (total time), thorough cooking by the end user or if you
or freezing at an ambient temperature of -31F represent, label, or intend for the product to
(-35C) or below until solid and storing at an be consumed in that manner.
ambient temperature of -31F (-35C) or below for
Species of fish not listed with a parasite
15 hours, or freezing at an ambient temperature of
hazard in Tables 3-2 and 3-3 may have a
-31F (-35C) or below until solid and storing at an
parasite hazard that has not been identified
ambient temperature of -4F (-20C) or below for
if these fish are not customarily consumed
24 hours are sufficient to kill parasites. Note that
raw or undercooked, or if the hazard occurs
these conditions may not be suitable for freezing
in certain localized harvest areas that are not
particularly large fish (e.g., thicker than 6 inches).
known commercial sources of fresh fish for
Brining and pickling may reduce the parasite the U.S. You should consider this possibility
hazard in a fish, but they do not eliminate it, in your hazard analysis.
nor do they minimize it to an acceptable level.
Species that normally have a parasite hazard as
Nematode larvae have been shown to survive
a result of consuming infected prey apparently
28 days in an 80 salinometer brine (21% salt
do not have the same parasite hazard when
by weight).
raised only on pelleted feed in an aquaculture
Fish that contain parasites in their flesh may also operation. You need not consider such
contain parasites within their egg sacs (skeins), but aquacultured fish as having a parasite hazard.
generally not within the eggs themselves. For this On the other hand, aquacultured fish that are
reason, eggs that have been removed from the sac fed processing waste, fresh fish, or plankton
and rinsed are not likely to contain parasites. may have a parasite hazard, even when wild-
caught fish of that species do not normally
Trimming away the belly flaps of fish or
have a parasite hazard. Pellet fed fish that
candling and physically removing parasites are
sometimes depend on wild-caught prey to
effective methods for reducing the numbers
supplement their diet may have a parasite
of parasites. However, they do not completely
hazard. In addition, fish raised in freshwater
eliminate the hazard, nor do they minimize it to
may have a parasite hazard from trematodes
an acceptable level.
because these parasites enter the fish through
the skin rather than in the food. You should
DETERMINE WHETHER THE POTENTIAL
verify the culture methods used by your
HAZARD IS SIGNIFICANT.
aquaculture producers before eliminating
parasites as a significant hazard.
determining whether parasites are a significant If the finished product is fish eggs that have
hazard at a processing step: been removed from the sac (skein) and rinsed,
the fish eggs are not reasonably likely to
1. Is it reasonably likely that parasites will be contain parasites and you need not consider
introduced at the receiving step (e.g., do they such product as having a parasite hazard.
come in with the raw material)? However, unrinsed fish eggs or fish eggs
Tables 3-2 and 3-3 (Chapter 3) list those that remain in the sac ordinarily will have a
species for which FDA has information that parasite hazard if the species is identified in
a potential parasite hazard exists. Ordinarily, Table 3-2 or 3-3 as having a parasite hazard.
you should identify the receiving step for If you receive the fish frozen and have
these species as having a significant parasite documented assurance from your supplier
hazard if you know or have reason to know that the fish are frozen in a way that will
92
kill the parasites (e.g., consistent with the primary processor would not need to identify
guidance in this chapter), you do not need to parasites as a significant hazard.
identify the hazard of parasites as reasonably
likely to occur in your product. IDENTIFY CRITICAL CONTROL POINTS.
It is not reasonably likely that parasites will
enter the process at other processing steps. The following guidance will assist you in
2. Can the parasite hazard that was introduced at critical control point (CCP) for parasites:
an earlier step be eliminated or reduced to an
acceptable level at this processing step? 1. Does the process contain a heating step, such
as retorting, cooking, or pasteurizing that is
Parasites should be considered a significant designed to kill bacterial pathogens?
hazard at any processing step where a
preventive measure is, or can be, used to a. If the process contains a heating step,
eliminate the hazard that was introduced at an you should identify the heating step as
earlier step or to reduce to an acceptable level the CCP and would not need to identify
the likelihood of occurrence of the hazard. receiving as a CCP for this hazard.
Preventive measures for parasites can include:
See Chapters 13 (Clostridium botulinum
Retorting (covered in 21 CFR
toxin formation) and 16 (Pathogen
113, the LACF Regulation);
bacteria survival through cooking or
pasteurization), and the LACF Regulation
Hot smoking (covered in Chapter 13);
(21 CFR 113) for further information on
Cooking and pasteurization
this control strategy.
Example:
Freezing (covered in this chapter). A hot-smoked salmon processor
should set the CCP for parasites at the
Intended use
hot-smoking step and would not need
If the consumer intends to cook the fish to identify the receiving step as a CCP
thoroughly before consumption, then you do for this hazard.
not need to consider the hazard significant, even
if Table 3-2 or 3-3 lists the species as having a b. If the process does not contain a heating
potential parasite hazard. In order to eliminate step, you should identify a freezing
parasites as a significant hazard when you are step as the CCP, and would not need to
unsure of the products intended use, you should identify receiving as a CCP for this hazard.
obtain documented assurance from the subsequent
Example:
processor, restaurateur, or institutional user (e.g.,
A salmon processor that sells the
prison or nursing home) that the fish will be
finished product for raw consumption
processed in a way that will kill the parasites.
should identify a freezing step as the
Example: CCP for parasites. The processor would
A primary processor receives whole salmon not need to identify the receiving step
from the harvest vessel and re-ices the fish as a CCP for this hazard.
for shipment to a second processor. The
This control approach is a control
second processor butchers the fish for sale
strategy referred to in this chapter as
to the sushi market. The primary processor
Control Strategy Example 1 - Freezing.
has documented assurance that the second
processor freezes the fish before sale. The
93
DEVELOP A CONTROL STRATEGY. For 7-day freezing critical limit:
Starting time of freezing and ending
The following guidance provides an example of time of the frozen storage period;
a control strategy for parasites. It is important
OR
to note that you may select a control strategy
that is different from that which is suggested, For 15-hour and 24-hour freezing critical
provided it complies with the requirements of the limits:
applicable food safety laws and regulations. Time when all fish are solid
The following is an example of the control frozen and ending time of
strategy included in this chapter: the frozen storage period.

CONTROL STRATEGY PRIMARY SECONDARY Use a continuous temperature-recording
PROCESSOR PROCESSOR
device (e.g., a recording thermometer);
Freezing
AND
Perform a visual check of time and physical
CONTROL STRATEGY EXAMPLE - FREEZING check of solid frozen condition, as appropriate.
Set the Critical Limits.
How Often Will Monitoring Be Done (Frequency)?
Freezing and storing at an ambient temperature For temperature:
of -4F (-20C) or below for 7 days (total time);
OR
Continuous monitoring, with a visual
check of the recorded data at least once
Freezing at an ambient temperature of -31F during each freezing or storage period,
(-35C) or below until solid and storing at but no less than once per day;
an ambient temperature of -31F (-35C) or AND
below for 15 hours;
For time:
OR
Freezing at an ambient temperature of -31F
Each batch, at the beginning and end
of the freezing or storage period, as
(-35C) or below until solid and storing at an appropriate.
ambient temperature of -4F (-20C) or below
for 24 hours. Who Will Do the Monitoring?
Note: These conditions may not be suitable for freezing particularly The device itself performs the monitoring. Any
large fish (e.g., thicker than 6 inches). It may be necessary for you person who has an understanding of the nature
to conduct a study to determine effective control parameters specific of the controls may perform the visual check of
to your freezing method, fish thickness, fish species, method of
preparation, and target parasites.
the data generated by this device to ensure that
the critical limits have been met consistently.
Establish Monitoring Procedures.
What Will Be Monitored?
Freezer temperature; involved in a critical limit deviation:
AND Refreeze and store the product at an ambient
Length of time fish is held at freezer temperature temperature of -4F (-20C) or below for 7
or held solid frozen, as appropriate: days (total time), or refreeze it at an ambient
temperature of -31F (-35C) or below until solid
94
and store at an ambient temperature of -31F known accurate reference device (e.g.,
(-35C) or below for 15 hours, or refreeze it at an a thermometer traceable to the National
ambient temperature of -31F (-35C) or below Institute of Standards and Technology
until solid and store at an ambient temperature (NIST) standards) under conditions that
of -4F (-20C) or below for 24 hours. Note that are similar to how it will be used (e.g.,
these conditions may not be suitable for freezing product internal temperature) within the
particularly large fish (e.g., thicker than 6 inches); temperature range at which it will be used;
OR AND
Destroy or divert the product to a non-raw or Once in service, check the temperature-
non-food use. recording device daily before the beginning of
operations. Less frequent accuracy checks may
AND
be appropriate if they are recommended by
Take the following corrective action to regain control the instrument manufacturer and the history
over the operation after a critical limit deviation: of use of the instrument in your facility has
Make repairs or adjustments to the freezer; shown that the instrument consistently remains
accurate for a longer period of time. In addition
OR to checking that the device is accurate by one
Move some or all of the product in the of the methods described above, this process
freezer to another freezer. should include a visual examination of the
sensor and any attached wires for damage or
Establish a Recordkeeping System. kinks. The device should be checked to ensure
Record of continuous temperature monitoring; that it is operational and, where applicable, has
sufficient ink and paper;
AND
Record of visual checks of recorded data. AND
Calibrate the temperature-recording device
AND
against a known accurate reference device (e.g.,
Record of notation of the start time and end a NIST-traceable thermometer) at least once a
time of the freezing periods; year or more frequently if recommended by
AND the device manufacturer. Optimal calibration
frequency is dependent upon the type, condition,
Record of notation of the time the fish is
past performance, and conditions of use of the
solid frozen (if appropriate).
device. Consistent temperature variations away
from the actual value (drift) found during checks
Establish Verification Procedures. and/or calibration may show a need for more
Before a temperature-recording device (e.g., frequent calibration or the need to replace the
a recording thermometer) is put into service, device (perhaps with a more durable device).
check the accuracy of the device to verify Calibration should be performed at a minimum
that the factory calibration has not been of two temperatures that bracket the temperature
affected. This check can be accomplished by: range at which it is used;
Immersing the sensor in an ice slurry AND
(32F (0C)) if the device will be used at
Review monitoring, corrective action,
or near refrigeration temperature;
and verification records within 1 week of
OR preparation to ensure they are complete and
Comparing the temperature reading any critical limit deviations that occurred
on the device with the reading on a were appropriately addressed.
95
TABLE 5-1
CONTROL STRATEGY EXAMPLE - FREEZING

This table is an example of a portion of a Hazard Analysis Critical Control Point plan using Control Strategy Example 1 - Freezing. This example illustrates how a proces
sor can control parasites in frozen salmon fillets with pin bones removed, where the finished product will be distributed to other processors for the production of refrigerated
lox. It is provided for illustrative purposes only.
Parasites may be only one of several significant hazards for this product. Refer to Tables 3-2, and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical
contaminants and pesticides, aquaculture drugs, food and color additives, and metal fragments).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
MONITORING
CRITICAL LIMITS
CRITICAL
SIGNIFICANT FOR EACH CORRECTIVE
CONTROL RECORDS VERIFICATION
HAZARD(S) PREVENTIVE WHAT HOW FREQUENCY WHO ACTION(S)
POINT
MEASURE
Freezing Parasites Blast freeze at Temperature of Recorder Continuous, Freezer Adjust or Recorder chart Check the
-31F or below blast thermometers with visual operator repair freezer with notations recorder
96
until solid, and freezer and check of Refreeze for visual thermometer
hold at -4F or storage freezer recorded data product temperature for accuracy
below for 24 at end of each check, time and damage
hours freezing solid frozen, and to ensure
process and time at that it is
end of storage operational
period before putting
into service;
check it daily,
Time when all Visual and Each batch, at
at the
fish are visually physical checks beginning and
beginning of
solid frozen end of storage
operations; and
and time at period
calibrate it once
end of storage
per year
period
Review
monitoring,
corrective
action, and
verification
records within
1 week of
preparation
BIBLIOGRAPHY. Prevalence of larval Anisakis simplex in pen-
reared and wild-caught salmon (Salmonidae)
We have placed the following references on from Puget Sound, Washington. J. Wildl. Dis.
display in the Division of Dockets Management, 25:416-419.
Food and Drug Administration, 5630 Fishers Deardorff, T. L., and R. M. Overstreet. 1990.
Lane, rm. 1061, Rockville, MD 20852. You may Seafood-transmitted zoonoses in the United
see them at that location between 9 a.m. and 4 States: the fish, the dishes and the worms, p.
p.m., Monday through Friday. As of March 29, 211-265. In D. Ward and C. R. Hackney (ed.).
2011, FDA had verified the Web site address for Microbiology of marine food products, Van
the references it makes available as hyperlinks Nostrand Reinhold, New York, NY.
from the Internet copy of this guidance, but FDA Deardorff, T. L., and R. Throm. 1988.
is not responsible for any subsequent changes Commercial blast-freezing of third-stage
to Non-FDA Web site references after March 29, Anisakis simplex larvae encapsulated in
2011. salmon and rockfish. J. Parasitol. 74(4):600
Adams, A. M., K. D. Murrell, and J. H. 603.
Cross. 1997. Parasites of fish and risks to Deardorff, T. L., M. J. Klicks, M. E. Rosenfeld,
public health. Rev. Sci. Tech. Off. Int. Epiz. R. A. Rychlinski, and R. S. Desowitz. 1982.
16(2):652-660. Larval ascaroid nematodes from fishes near
Adams, A. M., M. N. Ton,M.M. Wekell, the Hawaiian Islands, with comments on
A. P. MacKenzie, and F.M. Dong. 2005. pathogenicity experiments. Pac. Sci. 36:187
Survival of Anisakis simplex in arrowtooth 201.
flounder (Atheresthes stomia) during frozen Deardorff, T. L., R. B. Raybourne, and R. S.
storage.J.Food Prot.68(7):1441-1446. Desowitz. 1984. Behavior and viability of
American Gastroenterological Association. third-stage larvae of Terranova sp. (Type
2000. Determination of the incidence of HA) and Anisakis simplex (type I) under
gastrointestinal parasitic infections from the coolant conditions. J. Food Prot. 47(1):49-52.
consumption of raw seafood in the U.S. Edgerton, B. F., L. H. Evans, F. J. Stephens,
[Report under FDA Contract 223-97-2328 and R. M. Overstreet. 2002. Synopsis of
with Life Sciences Research Office, American freshwater crayfish diseases and commensal
Society for Nutritional Sciences]. AGA, organisms. Aquaculture 206:57-135.
Bethesda, MD. Eslami, A., and B. Mokhayer. 1997. Nematode
Berland, B. 1961. Nematodes from some larvae of medical importance found in
Norwegian marine fishes. Sarsia 2:1-50. market fish in Iran. Pahlavi Med. J. 8:345-348.
Bier, J. W. 1988. Anisakiasis. In A. Balows, W. Freeman, R. S., P. F. Stuart, S. J. Cullen,
J. Hausler, Jr., M. Ohashi, and A. Turano (ed.), A. C. Ritchie, A. Mildon, B. J. Fernandes,
Laboratory diagnosis of infectious diseases, and R. Bonin. 1976. Fatal human infection
vol. I. Springler-Verlag, New York, NY. with mesocercariae of the trematode Alaria
Bouree, P., A. Paugam, and J. C. Petithory. americana, Am. J. Trop. Med. Hyg. 25(6):803
1995. Review - Anisakidosis: report of 25 807.
cases and review of the literature. Comp. Gardner, M. A. 1990. Survival of Anisakis in
Immunol. Microbiol. Infect. Dis. 18(2):75-84. cold-smoked salmon. Can. Inst. Food Sci.
Daniel, R. J. 1950. A guide to marketable fish. Technol. J. 23:143-144.
Proc. Lpool. Biol. Soc. 57:App1, 68 pp. Hauck, A. K. 1977. Occurrence and survival
Deardorff, T. L., and M. L. Kent. 1989. of the larval nematode Anisakis sp. in the
97
flesh of fresh, frozen, brined, and smoked Templeman, W., H. J. Squires, and A. M.
Pacific herring, Clupea harengus pallasi, J. Fleming. 1957. Nematodes in the fillets of
Parasitol. 63:515-519. cod and other fishes in Newfoundland and
Jensen, T., K. Andersen, and S. des Clers. neighbouring areas. J. Fish. Res. Bd. Can.
1994. Sealworm (Pseudoterranova decipiens) 14:831-897.
infections in demersal fish from two areas in Verhamme, M. A. M., and C. H. R. Ramboer.
Norway. Can. J. Zool. 72:598-608. 1988. Anisakiasis caused by herring in
Karl, H., and M. Leinemann. 1989. Viability vinegar: a little known medical problem. Gut.
of nematode larvae (Anisakis sp.) in frozen 29:843-847.
herrings. Archiv fur Lebensmittelhygiene. Williamson, H. C. 1910. Nematodes in the
40(1):14-16 (in German). muscle of the cod (Gadus callarias). Rep.
Lile, N. K., O. Halvorsen, and W. Fish. Bd. Scot. 28:61-62.
Hemmingsen. 1994. Zoogeographical Williamson, H. C. 1919. The distribution of
classification of the macroparasite faunas of parasite-infected fish. Ann. App. Biol. 6:48
four flatfish species from the northeastern 52.
Atlantic. Polar Biol. 14(2):137-141. World Health Organization. 1995. Control of
Margolis, L., and J. R. Arthur. 1979. Synopsis foodborne trematode infections: report of
of the parasites of fishes of Canada. Fish. a WHO study group. WHO, Geneva. WHO
Res. Board Can. Bull. Canadian Department Technical Report Series No. 849.
of Fisheries and Oceans. 199:1-269.
McClelland, G., R. K. Misra, and D. J.
Martell. 1990. Larval anisakine nematodes
in various fish species from Sable Island
Bank and vicinity, p. 83-118. In W. D. Bowen
(ed.), Population biology of sealworm
(Pseudoterranova decipiens) in relation to its
intermediate and seal hosts. Can. Bull. Fish.
Aquat. Sci., vol. 222:83-118.
Ogawa, K. 1996. Marine parasitology with
special reference to Japanese fisheries and
mariculture. Vet. Parasitol. 64:95-105.
Polyanskii, Y. 1966. The parasitology of
fish of northern waters of the U.S.S.R.
Parasites of the fish of the Barents Sea, p.
158. Transactions of the Zoological Institute
of the Academy of Sciences of the U.S.S.R.,
vol. 19 (Translated from Russian by the
Israel Program for Scientific Translations,
Jerusalem).
Punt, A. 1941. Recherches sur quelques
nematodes parasites des poissons de la Mer
du Nord. Mem. Mus. Hist. Nat. Belg. 98:1-110.
Sakanari, J. A., and J. H. McKerrow. 1989.
Anisakiasis. Clin. Microbiol. Rev. 2:278-284.
98
CHAPTER 6: Natural Toxins
This guidance represents the Food and Drug Administrations (FDAs) current thinking on this topic. It does not
create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an
alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want
to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot
identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.
UNDERSTAND THE POTENTIAL HAZARD. Paralytic Shellfish Poisoning (saxitoxin) in the

U.S. is generally associated with the consumption
Contamination of fish with natural toxins from the of molluscan shellfish from its northeast and
harvest area can cause consumer illness. Most of northwest coastal regions. PSP in other parts of
these toxins are produced by species of naturally the world has been associated with molluscan
occurring marine algae (phytoplankton). They shellfish from environments ranging from tropical
accumulate in fish when they feed on the algae to temperate waters. Certain gastropods (e.g.,
or on other fish that have fed on the algae. There conch, snails and whelk) are also known to
are also a few natural toxins that are normal accumulate PSP toxins. They may accumulate
constituents of certain species of fish. toxins by feeding on molluscs that are toxic. In
particular, moon snails and whelk are commonly
For fish products in the United States (U.S.) found to contain PSP toxins off the northeast
commerce there are six recognized fish poisoning coast of the U.S. Abalone from South Africa and
syndromes that can occur from the consumption Spain have been reported to contain PSP toxins,
of fish or fishery products contaminated with although there have been no reports of PSP toxins
natural toxins: Paralytic shellfish poisoning in abalone off the coast of the U.S. Similarly,
(PSP), neurotoxic shellfish poisoning (NSP), PSP toxins have been reported in sea cucumbers,
diarrhetic shellfish poisoning (DSP), amnesic octopi and a variety of echinoderms, targeted
shellfish poisoning (ASP), ciguatera fish poisoning for human consumption in sub-tropical regions
(CFP) and azaspiracid shellfish poisoning (AZP). of Australia, but to date no reports have been
Scombrotoxin (histamine) poisoning, that can shown in these species in U.S. waters. In the U.S.,
occur as a result of scombrotoxin formation PSP toxin has been reported from the viscera of
in time and temperature abused fish, is not lobster and crabs are often eaten whole, therefore
considered a natural toxin, and is covered in it is important to include toxin loads contained
Chapter 7. in the viscera and flesh for these animals. The
Species and geographic areas involved levels of PSP toxins found in lobster tomalley and
crab viscera may pose a health hazard if eaten
This section provides information about species of
from a heavily contaminated area. In 2008, FDA
fish and geographic areas that have been linked
advised against the consumption of American
to one of the five fish poisoning syndromes by
lobster tomalley because unusually high levels
historical occurrence of the syndrome. However,
of PSP toxins were detected in that organ in
it is important to note that historical occurrence
lobsters caught in the waters of New England. In
may be an inadequate guide to future occurrence
2002, PSP from the consumption of the flesh of
in the case of natural toxins, because the
puffer fish was first reported in the U.S. All cases
distribution of the source algae may vary over
to date have been due to fish harvested from
time. You should be alert to the potential for
central east coast Florida. PSP toxins have been
emerging problems.
99
confirmed in southern (Sphoeroides nephelus), the first time in several locations along the Texas
checkered (Sphoeroides testudineus), and bandtail Gulf Coast during a large marine algae bloom.
(Sphoeroides spengleri) puffer fish. There is
DSP is characterized by gastrointestinal
currently a ban on the harvesting of all puffer
symptoms, including: nausea, vomiting, diarrhea,
fish in the Florida counties of Volusia, Brevard,
abdominal pain, headache, and fever. Symptoms
Indian River, St. Lucie, and Martin.
develop from 30 minutes to 3 hours after
The effects of PSP are primarily neurological consumption and last for up to 4 days. DSP is
and can include: tingling, burning, numbness, generally not considered life threatening but
drowsiness, incoherent speech, and respiratory complications could occur as a result of severe
paralysis. Respiratory paralysis can result in dehydration in some patients.
death if respiratory support is not provided in a
Amnesic shellfish poisoning (from domoic acid)
timely manner. PSP toxin is an extremely potent
is generally associated with the consumption
toxin with a high mortality rate. The symptoms
of molluscan shellfish from the northeast and
develop from to 2 hours after consumption.
northwest coasts of North America. In these
Neurotoxic shellfish poisoning (from brevetoxin) regions, domoic acid has been identified in
in the U.S. is generally associated with the the viscera of Dungeness (Cancer magister),
consumption of molluscan shellfish from the tanner, and red rock crab. Domoic acid has also
coast of the Gulf of Mexico, and, sporadically, been identified in several fish species including
along the southern Atlantic coast. NSP has also anchovies (Engraulis mordax), Pacific sanddab
been linked to gastropods (whelk) harvested off (Citharichthys sordidus), chub mackerel (Scomber
the Florida Gulf Coast. In addition, there has japonicas), albacore tuna (Thunnas alalunga),
been a significant occurrence of toxins similar jack smelt (Atherinopsis californiensis), and
to NSP in New Zealand and some suggestions of market squid (Loligo opalescens) along the west
occurrence elsewhere. coast of the U.S. It has not yet been a problem
in the Gulf of Mexico, although the planktonic
NSP is characterized by gastrointestinal and
algae that produce the toxin have been reported
neurological symptoms, including: tingling
in coastal waters, and more recently detected in
and numbness of the lips, tongue, and
menhaden (Brevoortia partonus) collected from
throat; muscular aches; dizziness; reversal
Louisiana. Although this planktivorous species is
of sensations of hot and cold; diarrhea; and
not currently commercially harvested for human
vomiting. Symptoms develop from a few
food in the Gulf of Mexico, it is used in dietary
minutes to a few hours after consumption.
supplements, feed products, and occasionally
There are few, if any, after effects and there
caught recreationally and eaten by locals.
have been no reported fatalities.
ASP is characterized by gastrointestinal
Diarrhetic shellfish poisoning (from okadaic acid
symptoms, including: nausea, vomiting,
and dinophysistoxins) is generally associated
abdominal cramps, and diarrhea. These
with the consumption of molluscan shellfish.
symptoms develop within 24 hours of
There have been no documented occurrences
consumption. In severe cases, neurological
of illness to date in the U.S. however reports of
symptoms also appear, including: dizziness,
this illness can be misidentified as a bacterial or
headache, seizures, disorientation, short-term
viral source and is expected to be highly under-
memory loss, respiratory difficulty, and coma.
reported. Outbreaks have been documented
These symptoms usually develop within 48
in Japan, Southeast Asia, Scandinavia, Western
hours of consumption. These marine toxins
Europe, Chile, New Zealand, and eastern Canada.
described above are not ordinarily a problem in
However, in 2008, okadaic acid levels in excess
scallops if only the adductor muscle is consumed.
of the 0.16 ppm guidance level were recorded for
100
However, products such as roe-on scallops and Netherlands, linked to consumption of mussels
whole scallops do present a potential hazard for harvested in Ireland. Since then, several outbreaks
natural toxins. of AZP have been reported in various regions in
Europe. In 2008, two cases of AZP were reported
Ciguatera fish poisoning (from ciguatoxin
in the US, and linked to consumption of an
(CTX)) is associated with consumption of toxin-
imported mussel product from Ireland confirmed
contaminated subtropical and tropical reef fish.
to contain AZP toxins in excess of guidance levels.
The toxin is introduced to the marine food chain
To date, AZP toxins have not been confirmed in
by microscopic algae and moves up the food
any product harvested in the US.
chain as small plant-eating reef fish eat the toxic
algae and are then eaten by larger reef fish. AZP is characterized by severe gastrointestinal
The toxin accumulates in the flesh of certain disorders including abdominal pain, nausea,
predatory reef fish species. Although ciguatera vomiting, and diarrhea. Symptoms develop
hotspots are well recognized, there is not an within minutes to hours after consumption of the
even distribution of toxic fish within a given contaminated shellfish and last for several days.
reef; fish caught side by side may have widely There have been no reported fatalities.
differing contamination levels. Ciguatoxic fish
A number of additional toxins that have been
may be found in tropical or subtropical areas
identified in molluscan shellfish have shown
around the world between 35 north latitude and
toxicity in mouse studies but have not been
35 south latitude and are common in several
linked to human illness. Pectenotoxins (PTX)
areas in the Caribbean Sea, Pacific Ocean, Indian
have been detected in phytoplankton and/
Ocean, and in the Flower Garden Banks area in
or molluscan shellfish in Australia, Italy, Japan,
the northern Gulf of Mexico. Reef fish associated
New Zealand, Norway, Portugal, and Spain.
with CFP include: barracuda (Sphyraenidae),
Yessotoxins (YTX) have been detected in
amberjack (Seriola), grouper (Family: Serranidae),
phytoplankton and/or molluscan shellfish in
snapper (Family: Lutjanidae), poou (Chelinus
Australia, Canada, Italy, Japan, New Zealand,
spp.), jack (Family: Carangidae), travelly (Caranx
Norway, the United Kingdom, and the U.S. Cyclic
spp.), wrasse (Family: Labridae), surgeon fish
imines have been found in phytoplankton and/
(Family: Acanthuridae), moray eel (Family:
or molluscan shellfish in Canada, Denmark, New
Muraenidae), roi (Cephalopholis spp.), and parrot
Zealand, Norway, Scotland, Tunisia, and the
fish (Family: Scaridae).
U.S. PTX and YTX have been found to occur in
CFP is characterized by numbness and tingling shellfish along with the DSP toxins okadaic acid
of the lips and tongue, which may spread to the and dinophysistoxins. At this time, FDA makes
extremities; nausea; vomiting; diarrhea; joint pain; no recommendations in this guidance and has no
muscle pain; headache; reversal of sensation of specific expectations with regard to controls for
hot and cold; acute sensitivity to temperature PTX, YTX and cyclic imines in processors Hazard
extremes; vertigo; muscular weakness; irregular Analysis Critical Control Point (HACCP) plans.
heartbeat, and reduced blood pressure.
Natural toxin detection
Gastrointestinal symptoms may develop within 2
hours following consumption of toxic fish while The FDA has established action levels for natural
neurological and cardiovascular symptoms will toxins as follows:
usually emerge within 6 hours post-ingestion. PSP - 0.8 ppm (80 ug/100 g) saxitoxin
equivalents;
Azaspiracid shellfish poisoning (AZP) is caused
by the consumption of molluscan shellfish NSP - 0.8 ppm (20 mouse units/100 g)
contaminated with azaspiracids (AZA). AZP was brevetoxin-2 equivalents;
first recognized following a 1995 outbreak in the DSP - 0.16 ppm total okadaic acid
101
equivalents (i.e., combined free okadaic acid, and quantity of shellfish, the harvester, harvest
dinophysistoxins, acyl-esters of okadaic acid location, and the date of harvest (21 CFR
and dinophysistoxins); 123.28(c)); (2) molluscan shellfish harvesters be
ASP - 20 ppm domoic acid, except in the licensed (note that licensing may not be required
viscera of dungeness crab, where the action in all jurisdictions); (3) processors that ship,
level is 30 ppm; reship, shuck, or repack molluscan shellfish be
certified; and (4) containers of shucked molluscan
CFP - 0.01 ppb P-CTX-1 equivalents for
shellfish bear a label with the processors name,
Pacific ciguatoxin and 0.1 ppb C-CTX-1
equivalent for Caribbean ciguatoxin;
AZP - 0.16 ppm azaspiracid equivalents. An established water classification system similar
to that in use for the molluscan shellfish system
There are currently no NSSP-accepted rapid test is not in place for controlling CFP in finfish.
methods for NSP, ASP, DSP, CFP or AZP, and only However, some states issue advisories regarding
one rapid test method has been validated (for PSP). reefs that are known to be toxic. In areas where
Natural toxin control there is no such advisory system, fishermen and
processors must depend on their own knowledge
Natural toxins cannot be reliably eliminated by
of local reporting of illnesses associated with
heat. However, severe heating processes, such as
reefs from which they obtain fish.
retorting, may be effective at reducing the levels
of some natural toxins. Where PSP or ASP has become a problem in
finfish or crustaceans, states generally have
To minimize the risk of molluscan shellfish
closed or restricted the appropriate fisheries or
containing natural toxins from the harvest area,
have issued consumption advisories. In addition,
state and foreign government agencies, called
removal and destruction of the viscera will
shellfish control authorities, classify waters in
eliminate the hazard, and this is at times required
which molluscan shellfish are found, based,
by state public health authorities. In 2008, FDA
in part, on the presence of natural toxins in
advised against the consumption of American
shellfish meats. Shellfish control authorities
lobster tomalley, but not the lobster meat itself,
may also use cell counts of the toxin-forming
because unusually high levels of PSP toxins were
algae in the harvest waters to classify shellfish
detected in the lobster tomalley of lobsters caught
harvest areas. As a result of these classifications,
in the waters of New England.
molluscan shellfish harvesting is allowed from
some waters, not from others, and only at certain Escolar, puffer fish, and whelk
times, or under certain conditions, from others. There are naturally occurring toxins in some
Shellfish control authorities then exercise control species that do not involve marine algae. Escolar
over the molluscan shellfish harvesters to ensure or oilfish (i.e., Lepidocybium flavobrunneum or
that harvesting takes place only when and where Ruvettus pretiosus) contains a strong purgative oil
it has been permitted. In this context, molluscan (wax ester), called gempylotoxin, that may cause
shellfish include oysters, clams, mussels, and diarrhea, abdominal cramps, nausea, headache,
scallops, except where the scallop product and vomiting when consumed. FDA advises
contains the shucked adductor muscle only. against importation and interstate marketing
Other significant elements of shellfish control of these fish. Additional deep sea fish species,
authorities efforts to control the harvesting of such as orange roughy (Hoplostethus atlanticus),
molluscan shellfish include requirements that and, oreo dory (Allocyttus spp., Pseudocyttus
(1) containers of in-shell molluscan shellfish spp., Oreosoma spp., and Neocyttus spp.) are
(shellstock) bear a tag that identifies the type known to contain lesser amounts of the same
indigestible wax esters. Sensitive individuals may
102
also experience symptoms from the consumption Tetramine is a toxin that is found in the salivary
of these fish. Improperly handled escolar glands of Neptunia spp., a type of whelk. The
and oilfish also have been associated with hazard can be controlled by removing the glands.
scombrotoxin (histamine) poisoning (Covered in Symptoms of tetramine poisoning include:
Chapter 7). double vision, temporary blindness, difficulty
in focusing, tingling of the fingers, prostration,
Puffer fish (also known as fugu, swellfish, bok,
nausea, vomiting, diarrhea, and loss of muscle
blowfish, globefish, balloonfish, or sea squab)
control. Symptoms usually develop within 1
may contain tetrodotoxin. Poisonings from
hour of consumption.
tetrodotoxin have usually been associated with
the consumption of puffer fish from waters of the FDA makes no recommendations in this guidance
Indo-Pacific Ocean regions. However, several document and has no specific expectations with
reported cases of poisonings, including fatalities, regard to controls for gempylotoxin in processors
involved puffer fish from the Atlantic Ocean, Gulf HACCP plans. Additionally, FDA makes no
of Mexico, and Gulf of California. There have specific recommendation in this guidance for
been no confirmed cases of poisonings from control of tetrodotoxin and tetramine.
northern puffer fish (Sphoeroides maculatus),
which was once harvested and marketed as sea DETERMINE WHETHER THE POTENTIAL
squab on the U.S. east coast, but there is still HAZARD IS SIGNIFICANT.
reason for concern. There is a restriction on
importation of all species of puffer fish and fishery The following guidance will assist you in
products containing puffer fish. See Import determining whether natural toxins are a
Alert #16-20 at the internet location http://www. significant hazard at a processing step:
accessdata.fda.gov/cms_ia/importalert_37.html.
Some puffer fish are also subject to contamination 1. Is it reasonably likely that unsafe levels of natural
with PSP toxins, covered earlier in this chapter. toxins will be introduced at this processing step
(e.g., does the toxin come in on the raw material
Tetrodotoxin has been implicated in illnesses at an unsafe level)?
from the consumption of additional species
besides puffer fish, for example, certain species Tables 3-2 and 3-3 (Chapter 3) identify the
of xanthid crabs, marine gastropods, and goby species of fish for which natural toxins are
fish. Reports of these illnesses have been mainly known to be a potential hazard. Under
limited to Asia, and involve species unlikely to be ordinary circumstances, it would be
imported into the U.S. reasonably likely to expect that, without
proper controls, natural toxins from the
Tetrodotoxin poisoning is characterized by
harvest area could enter the process at
slight numbness of the lips and tongue, tingling
unsafe levels at the receiving step for those
sensation in the face and extremities, headache,
species. There may be circumstances in
abdominal pain, nausea, diarrhea, vomiting,
your geographic area that would allow you
difficulty in walking, paralysis, respiratory
to conclude that it is not reasonably likely for
distress, difficulty in speech, shortness of breath,
a particular natural toxin to occur at unsafe
blue or purplish discoloration of the lips and
levels in fish from your area. You should be
skin, lowering of blood pressure, convulsions,
guided by the information provided above
mental impairment, irregular heartbeat, and death.
and the historical occurrence of the toxin
Symptoms usually develop between 30 minutes
in the fish, at levels above the established
and 3 hours after consumption and may last for
guidance levels, in your geographic area.
20 minutes to 8 hours. If respiratory aid is not
However, you should remain alert to the
provided, death may occur within 4 to 6 hours.
potential for emerging problems. Examples
103
of natural toxin hazards that had not until Intended use
recently been known to exist are PSP in In most cases, it is unlikely that the intended
puffer fish and domoic acid in anchovies. use of the product would determine whether
If you are receiving fish, other than the hazard is significant. One exception is with
molluscan shellfish, from another processor, certain products for which only the muscle tissue
you would not need to identify natural toxins will be consumed. For example, where the
as a significant hazard. This hazard should finished product is only the shucked adductor
have been fully controlled by the primary muscle of the scallop, it is reasonable to assume
(first) processor. that the product as consumed will not contain
natural toxins. In this case, you may not need to
2. Can natural toxins that were introduced at unsafe identify natural toxins as a significant hazard.
levels at an earlier step be eliminated or reduced
to an acceptable level here? IDENTIFY CRITICAL CONTROL POINTS.
Natural toxins should also be considered
a significant hazard at any processing step The following guidance will assist you in
where a preventive measure is, or can be, determining whether a processing step is a
used to eliminate the natural toxin hazard, critical control point (CCP) for natural toxins.
which had been introduced at a previous Where preventive measures, such as those
step, or is adequate to reduce the likelihood described above, are available to you the hazard
of occurrence of the hazard to an acceptable of natural toxins can best be controlled at the
level. Preventive measures for natural toxins receiving step. This control approach consists of
can include: two control strategies referred to in this chapter as
Control Strategy Example 1 - Source Control for
For molluscan shellfish: Molluscan Shellfish and Control Strategy Example
2 - Source Control for Fish Other Than Molluscan
Shellfish (for primary (first) processors only).
DEVELOP A CONTROL STRATEGY.

Making sure that incoming molluscan
shellfish are supplied by a licensed
The following guidance provides two control
harvester (where licensing is required
strategies for natural toxins. You may select a
by law) or by a certified dealer.
control strategy that is different from those which
For finfish other than molluscan shellfish: are suggested, provided it complies with the
Making sure that incoming fish have requirements of the applicable food safety laws
not been caught in an area from which and regulations.
harvesting is prohibited or restricted The following are examples of control strategies
because of a natural toxin problem; included in this chapter:
Making sure that incoming finfish have
not been caught in an area for which MAY APPLY TO MAY APPLY TO
CONTROL STRATEGY PRIMARY SECONDARY
there is a CFP advisory or for which you PROCESSOR PROCESSOR
have knowledge there is a CFP problem. Source control for
molluscan shellfish
These preventive measures are ordinarily
employed at the receiving step. Source control for
fish other than
molluscan shellfish
104
CONTROL STRATEGY EXAMPLE 1 - SOURCE that licensing may not be required in all
CONTROL FOR MOLLUSCAN SHELLFISH jurisdictions) or from a processor that is
certified by a shellfish control authority.
Set Critical Limits.
Note: Only the primary processor, the processor that takes
All containers of shellstock (in-shell molluscan possession of the molluscan shellfish from the harvester, should apply
shellfish) received from a harvester must controls relative to the identification of the harvester, the harvesters
bear a tag that discloses the date and place license, or the approval status of the harvest waters.
they were harvested (by state and site), type

and quantity of shellfish, and information on Establish Monitoring Procedures.
the harvester or the harvesters vessel (i.e.,
the identification number assigned to the What Will Be Monitored?
harvester by the shellfish control authority, Information contained on tags on containers
where applicable, or if such identification of incoming shellstock or on the bill
numbers are not assigned, the name of of lading or similar shipping document
the harvester or the name or registration accompanying bulk shipments of shellstock;
number of the harvesters vessel). For bulk
AND
shipments of shellstock where the shellstock
is not containerized, the shellstock must be Information on whether the harvest area is
accompanied by a bill of lading or similar authorized for harvest by a shellfish control
shipping document that contains the same authority or information on whether federal
information; harvest waters are closed by an agency of
Note: The source controls listed in this critical limit are required
the federal government.
under 21 CFR 123.28(c). OR
OR Information contained on labels on
All containers of shellstock received from a containers of incoming shucked molluscan
processor must bear a tag that discloses the shellfish;
date and place they were harvested (by state AND
and site), type and quantity of shellfish, and
the certification number of the processor; The harvesters license.
OR How Will Monitoring Be Done?

All containers of shucked molluscan shellfish Perform visual checks;
must bear a label that identifies the name, AND
packer or repacker of the product; Ask the shellfish control authorities of the
state or country in which your shellstock
AND are harvested whether the harvest area is
All molluscan shellfish must have been authorized for harvest.
harvested from waters authorized for
harvesting by a shellfish control authority. How Often Will Monitoring Be Done (Frequency)?
For U.S. federal waters, no molluscan For checking incoming tags:
shellfish may be harvested from waters that
are closed to harvesting by an agency of the Every container;
federal government; OR
For checking the bill of lading or similar
AND
shipping document:
All molluscan shellfish must be from a

harvester that is licensed as required (note Every delivery;
105
OR Number and date of expiration of the
For checking incoming labels: harvesters license, where applicable;
At least three containers randomly AND

selected from every lot;

AND
where applicable.
For checking licenses: For shucked molluscan shellfish:
Every delivery. Receiving record that documents:
Who Will Do the Monitoring? Date of receipt;
Any person who has an understanding of the AND
nature of the controls. Quantity and type of shellfish;
AND
Name and certification number of the
packer or repacker.
Reject the lot. Establish Verification Procedures.
AND Review monitoring and corrective action
Take the following corrective action to regain control of
the operation after a critical limit deviation:
Discontinue use of the supplier until appropriately addressed.
evidence is obtained that harvesting and/or
tagging practices have changed.

For shellstock:
Date of harvest;
AND
AND
AND
AND
106
TABLE 6-1
CONTROL STRATEGY EXAMPLE 1 - SOURCE CONTROL FOR MOLLUSCAN SHELLFISH

This table is an example of a portion of a HACCP plan using Control Strategy Example 1 - Source Control for Molluscan Shellfish. This example illustrates how a primary
processor (processor that takes possession of the oysters from the harvester) of shellstock oysters, that is, the shellstock shipper, can control natural toxins from the harvest
area in shellstock oysters received directly from a harvester. It is provided for illustrative purposes only.
Natural toxins may be only one of several significant hazards for this product. Refer to Tables 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g., natural toxins,
environmental chemical contaminants and pesticides, and pathogens during processing). Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
CRITICAL MONITORING
CRITICAL LIMITS
POINT PREVENTIVE
MEASURE
Receiving Natural toxins All incoming Information Visual Every Receiving Reject Receiving Review
shellstock shellstock must on checks sack employee untagged sacks record monitoring
be tagged incoming and corrective
with the date shellstock Discontinue use of the action records
and place of tags supplier until evidence within
107
harvest, type is obtained that tagging 1 week of
and quantity practices have changed preparation
of shellfish,
and name or

registration
number of
the harvesters
vessel
All shellstock Harvest site Visual checks Every Receiving Reject lots from
must be on tags lot employee unapproved waters
from waters Ask the shellfish control
approved authority of the state Discontinue use of the
by the state in which the shellstock supplier until evidence is
shellfish control are harvested whether obtained that harvesting
authority the area is authorized practices have changed
for harvest
All shellstock Harvesters Visual Every Receiving Reject lots from
must be from a license checks delivery employee unlicensed harvesters
licensed
harvester Discontinue use of the
supplier until evidence is
obtained that the harvester
has secured a license
CONTROL STRATEGY EXAMPLE 2 - SOURCE Establish Corrective Action Procedures.
CONTROL FOR FISH OTHER THAN MOLLUSCAN
SHELLFISH
This guidance applies to primary (first)
Reject the lot.
processors only.
AND
No fish may be received that has been the operation after a critical limit deviation:
harvested from:
An area that is closed to fishing by evidence is obtained that harvesting practices
foreign, federal, state, tribal, territorial or have changed.
local authorities (e.g., certain counties in
Florida for puffer fish);
OR Receiving record that documents the location
An area that is the subject of a CFP or and status (e.g., prohibited, restricted, or
ASP consumption advisory; unrestricted) of the harvest area.
OR
An area for which you have knowledge
that there is a CFP problem.
records within 1 week of preparation to
ensure they are complete and any deviations
that occurred were addressed appropriately.
The location and status (e.g., prohibited,
restricted, or unrestricted) of the harvest
area.

Ask the harvesters for the harvest site at the
time of receipt, or obtain the information
from the harvesters catch record, where
applicable.

Every lot.
Who Will Do the Monitoring?

nature of the controls.
108
TABLE 6-2
CONTROL STRATEGY EXAMPLE 2 - SOURCE CONTROL FOR FISH OTHER THAN MOLLUSCAN SHELLFISH
This table is an example of a portion of a HACCP plan using Control Strategy Example 2 - Source Control for Fish Other Than Molluscan Shellfish. This example illustrates
how a fish processor in Hawaii that receives locally harvested barracuda can control natural toxins. It is provided for illustrative purposes only.
Natural toxins may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental
chemical contaminants and pesticides).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
MONITORING
CRITICAL
CRITICAL LIMITS FOR
CONTROL EACH RECORDS VERIFICATION
POINT PREVENTIVE
MEASURE
Receiving fresh Natural No fish may Location Ask the Every lot Receiving Reject lot Receiving Review
fish toxins - CFP be harvested and status of fisherman for employee Discontinue use record monitoring and
from an area the harvest area the harvest of the supplier corrective
109
that is covered location until evidence action records
by a state CFP is obtained within 1 week
advisory or for that harvesting of preparation
which there practices have

is information changed
from a valid
scientific source
that there is
a current CFP
problem
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Health Agriculture, Fisheries and Forestry, and brevitoxin metabolites: a case study from
Canberra, Australia. Florida. Toxicon. 38:981-993.
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Saito, T., T. Kohama, K. Ui, and S. Watabe. Van Egmond, H. P., T. Aune, P. Lassus, G.
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in Zhoushan: a 25-year retrospective analysis.
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112
CHAPTER 7: Scombrotoxin (Histamine) Formation
UNDERSTAND THE POTENTIAL HAZARD. that the methods of control used to inhibit the
bacteria that result in histamine formation will
Scombrotoxin (histamine) formation as a result also inhibit the bacteria that produce other
of time and temperature abuse of certain species biogenic amines.
of fish can cause consumer illness. The illness Symptoms of scombrotoxin poisoning include
is closely linked to the development of histamine tingling or burning in or around the mouth or
in these fish. In most cases, histamine levels in throat; rash or hives on the upper body; drop in
illness-causing fish have been above 200 ppm, blood pressure; headache; dizziness; itching of the
often above 500 ppm. However, there is some skin; nausea; vomiting; diarrhea; asthmatic-like
evidence that other chemicals (e.g., biogenic constriction of the air passage; heart palpitation;
amines such as putrescine and cadaverine) may and respiratory distress. Symptoms usually
also play a role in the illness. The possible role of occur within a few minutes to a few hours of
these chemicals in consumer illness is the subject consumption and last from 12 hours to a few days.
of Chapter 8.
Scombrotoxin (histamine) formation
Seafood-related scombrotoxin poisoning is
Certain bacteria produce the enzyme histidine
primarily associated with the consumption of
decarboxylase during growth. This enzyme reacts
tuna, mahi-mahi, marlin, and bluefish. Table 3-2
with histidine, a naturally occurring amino acid
(Chapter 3) identifies other species that are also
that is present in larger quantities in some fish
capable of developing elevated levels of histamine
than in others. The result is the formation of
when temperature abuse occurs.
scombrotoxin (histamine).
The illness caused by the consumption of fish
Histamine-forming bacteria are capable of growing
in which scombrotoxin has formed is most
and producing histamine over a wide temperature
appropriately referred to as scombrotoxin
range. Growth of histamine is more rapid, however,
poisoning. The illness has historically been
at high-abuse temperatures (e.g., 70F (21.1C)
known by other names. Originally, the illness
or higher) than at moderate-abuse temperatures
was termed scombroid poisoning because of its
(e.g., 45F (7.2C)). Growth is particularly rapid
association with fish in the families Scombridae
at temperatures near 90F (32.2C). Histamine is
and Scomberesocidae. However, other species
more commonly the result of high temperature
of fish are now known to cause the illness. The
spoilage than of long-term, relatively low-
terms histamine poisoning and histamine fish
temperature spoilage, which is commonly associated
poisoning have also been applied to the illness.
with organoleptically detectable decomposition.
However, because biogenic amines other than
Nonetheless, there are a number of opportunities
histamine have been associated with the illness,
for histamine to form under more moderate-abuse
these terms also present difficulties. Nonetheless,
temperature conditions.
this chapter refers to control measures to prevent
the formation of histamine. It is expected
113
Once the enzyme histidine decarboxylase is species that generate heat, resulting in internal
present in the fish, it can continue to produce temperatures that may exceed environmental
histamine in the fish even if the bacteria are not temperatures and increasing the likelihood
active. The enzyme can be active at or near of conditions favorable to growth of enzyme-
refrigeration temperatures. The enzyme remains forming bacteria.
stable while in the frozen state and may be
The potential for histamine formation is increased
reactivated very rapidly after thawing.
when the scombrotoxin-forming fish muscle is in
Freezing may inactivate some of the enzyme- direct contact with the enzyme-forming bacteria.
forming bacteria. Both the enzyme and This direct contact occurs when the fish are
the bacteria can be inactivated by cooking. processed (e.g., butchering or filleting) and can
However, once histamine is produced, it cannot be particularly problematic when the surface-to
be eliminated by heat (including retorting) or volume ratio of the exposed fish muscle is large,
freezing. After cooking, recontamination of such as minced tuna for salads. Even when such
the fish with the enzyme-producing bacteria products are prepared from canned or pouch
is necessary for additional histamine to form. retorted fish, recontamination can occur during
For these reasons, histamine development is salad preparation, especially with the addition of
more likely in raw, unfrozen fish but should raw ingredients. The mixing in of the bacteria
not be discounted in other product forms of throughout the product and the high surface-to
scombrotoxin-forming fish species. volume ratio can result in substantial histamine
formation if time and temperature abuse occurs.
The kinds of bacteria that are associated with
histamine development are commonly present in At least some of the histamine-forming bacteria
the saltwater environment. They naturally exist are halotolerant (salt tolerant) or halophilic (salt
on the gills, on external surfaces, and in the gut loving). Some are more capable of producing
of live, saltwater fish, with no harm to the fish. histamine at elevated acidity (low pH). As a
Upon death, the defense mechanisms of the fish result, histamine formation is possible during
no longer inhibit bacterial growth in the muscle processes such as brining, salting, smoking,
tissue, and histamine-forming bacteria may start drying, fermenting, and pickling until the product
to grow, resulting in the production of histamine. is fully shelf-stable. Refrigeration can be used
Evisceration and removal of the gills may reduce, to inhibit histamine formation during these
but not eliminate, the number of histamine- processes.
forming bacteria. Packing of the visceral cavity
A number of the histamine-forming bacteria are
with ice may aid in chilling large fish in which
facultative anaerobes that can grow in reduced
internal muscle temperatures are not easily
oxygen environments. As a result, reduced
reduced. However, when done improperly, these
oxygen packaging (e.g., vacuum packaging,
steps may accelerate the process of histamine
modified atmosphere packaging, and controlled
development in the edible portions of the fish by
atmosphere packaging) should not be viewed as
spreading the bacteria from the visceral cavity to
inhibitory to histamine formation.
the flesh of the fish.
Histamine is water soluble (dissolves in water)
With some harvesting practices, such as
and would not be expected in significant
longlining and gillnetting, death may occur many
quantity in products such as fish oil that do not
hours before the fish is removed from the water.
have a water component. However, histamine
Under the worst conditions, histamine formation
could be present in products such as fish protein
can already be underway before the fish is
concentrate that are prepared from the muscle or
brought onboard the vessel. This condition
aqueous (water-based) components of fish tissue.
can be further aggravated with certain tuna
114
Controlling scombrotoxin (histamine)
formation
Rapid chilling of scombrotoxin-forming fish
immediately after death is the most important
element in any strategy for preventing the
formation of scombrotoxin (histamine), especially
for fish that are exposed to warm waters or air,
and for tunas which generate heat in their tissues.
Some recommendations follow:
Fish exposed to air or water temperatures
above 83F (28.3C) should be placed in
or brine of 40F (4.4C) or less, as soon as
possible after harvest, but not more than 6
hours from the time of death; or
Fish exposed to air and water temperatures
of 83F (28.3C) or less should be placed
in ice, or in refrigerated seawater, ice slurry,
possible after harvest, but not more than 9
hours from the time of death; or
Fish that are gilled and gutted before chilling
should be placed in ice, or in refrigerated
seawater, ice slurry, or brine of 40F (4.4C)
or less, as soon as possible after harvest, but
not more than 12 hours from the time of
death; or
Fish that are harvested under conditions that
expose dead fish to harvest waters of 65F
(18.3C) or less for 24 hours or less should
be placed in ice, or in refrigerated seawater,
ice slurry, or brine of 40F (4.4C) or less, as
soon as possible after harvest, but not more
than the time limits listed above, with the
time period starting when the fish leave the
65F (18.3C) or less environment.
Note: If the actual time of death is not known, an estimated time
of the first fish death in the set may be used (e.g., the time the
deployment of a longline begins).
115
TABLE 7-1
RECOMMENDED MAXIMUM TIME TO GET SCOMBROTOXIN-FORMING FISH INTO CHILLING MEDIUM ONBOARD HARVEST VESSELS TO PREVENT
SCOMBROTOXIN FORMATION1
THEN, THE MAXIMUM TIME IN HOURS TO GET THE FISH INTO CHILLING MEDIUM ( 40F) FROM
WHEN
THE TIME OF
THE WATER AND THE AIR TEMPERATURE (F) IS DEATH OF THE FISH OR EARLIEST ESTIMATED ONBOARD LANDING IS
TEMPERATURE (F) IS TIME OF DEATH IS
FOR UNEVISCERATED FISH:
> 65 > 83 6 -
> 83 Any 6 -
> 65, but 83 83 9 -
2
65 > 83 - 6
652 83 - 9
FOR FISH EVISCERATED ONBOARD BEFORE CHILLING:
> 65 Any 12 -
116
652 Any - 12
1. This table is a summary of the preceding recommendations. For complete understanding of the recommendations, refer to the text above.
2. Provided exposure of the fish in the water at 65F or less is 24 hours.

The controls listed above for onboard chilling The size of the fish;
will prevent the rapid formation of the enzyme The chilling method:
histidine decarboxylase. Once this enzyme is
formed, control of the hazard is unlikely. It is Ice alone takes longer to chill fish
than does an ice slurry or recirculated
important to recognize that the parameters listed
refrigerated seawater or brine, a
above are intended to control scombrotoxin
consequence of reduced contact area
formation; these criteria may not effectively control
and heat transfer;
the activity of other spoilage organisms, raising
the possibility that fish may become adulterated The quantity of ice or ice slurry and
because of decomposition (not a food safety the capacity of refrigerated seawater or
hazard covered by the Procedures for the Safe and brine systems, as well as the physical
Sanitary Processing and Importing of Fish and arrangement of the fish in the chilling
Fishery Products regulation, 21 CFR 123, called media, should be suitable for the
the Seafood Hazard Analysis Critical Control Point quantity of catch.
(HACCP) Regulation in this guidance document) Once chilled, the scombrotoxin-forming fish
before scombrotoxin (histamine) is formed. should be maintained as close as possible to the
Further chilling toward the freezing point is also freezing point (or held frozen) until it is consumed.
desirable to safeguard against the less common, Exposure to temperatures above 40F (4.4C)
longer term, lower temperature development of should be minimized. The amount of post-harvest
histamine. Additionally, the shelf life and quality time at elevated temperatures (after proper chilling
of the fish are significantly compromised when onboard the harvest vessel) to which a fish can
product temperature is not rapidly dropped to be exposed (e.g., during processing, storage, and
near freezing. distribution) without adverse effects is dependent
primarily upon whether the fish was previously
Although it may be possible for a harvest vessel frozen (e.g., onboard the harvest vessel) or heat
to completely avoid onboard chilling and still processed sufficiently to destroy scombrotoxin
deliver fish to the processor within the time and forming bacteria.
temperature limitations recommended above
for chilling the fish, this practice is discouraged. Extended frozen storage (e.g., 24 weeks) or
Failure to chill onboard may permit bacteria and cooking minimizes the risk of additional
enzymes, including those that form scombrotoxin histamine development by inactivating the
(histamine), to increase unnecessarily. enzyme-forming bacteria and, in the case
of cooking, the enzyme itself. As previously
The time required to lower the internal mentioned, recontamination with enzyme-
temperature of fish after capture will be forming bacteria and significant temperature
dependent upon a number of factors, including: abuse is necessary for histamine formation
The harvest method: following cooking. Such recontamination may
not be likely if the fish is processed under a
Delays in removing fish from the water
conscientious sanitation program. However,
after capture, such as those captured by
a longline, may significantly limit the addition of raw ingredients, employee contact,
amount of time left for chilling and may or poor sanitary conditions could reintroduce
allow some fish to heat up; contamination. Further guidance is provided
below:
Large quantities of fish captured in a
Scombrotoxin-forming fish that have not
single fishing set, such as those captured
on a purse seiner, may exceed a vessels been previously frozen or heat processed
ability to rapidly chill the product; sufficiently to destroy scombrotoxin
forming bacteria should not be exposed to
117
temperatures above 40F (4.4C) for:
More than 4 hours, cumulatively, if any
portion of that time is at temperatures
above 70F (21.1C); or
More than 8 hours, cumulatively, as
long as no portion of that time is at
temperatures above 70F (21.1C).
Scombrotoxin-forming fish that have
been previously frozen, or heat processed
sufficiently to destroy scombrotoxin-forming
bacteria and are subsequently handled in
a manner in which there is an opportunity
for recontamination with scombrotoxin
forming bacteria (e.g., contact with fresh
fish, employees, or introduction of raw
ingredients), should not be exposed to
temperatures above 40F (4.4C) for:
More than 12 hours, cumulatively, if any
portion of that time is at temperatures
above 70F (21.1C); or
More than 24 hours, cumulatively, as
temperatures above 70F (21.1C);
Scombrotoxin-forming fish that have been
heat processed sufficiently to destroy
scombrotoxin-forming bacteria and enzymes
and are not subsequently handled in a
manner in which there is an opportunity for
recontamination with scombrotoxin-forming
bacteria (e.g., no contact with fresh fish,
employees, or raw ingredients) are at low
risk for further scombrotoxin (histamine)
development.
118
TABLE 7-2
RECOMMENDED MAXIMUM HOURS OF EXPOSURE OF SCOMBROTOXIN-FORMING FISH TO AMBIENT TEMPERATURES GREATER THAN
40F TO PREVENT SCOMBROTOXIN FORMATION AFTER PROPER ONBOARD HARVEST VESSEL CHILLING, FOR DIFFERING TEMPERATURE
EXPOSURE AND PREVIOUS PROCESSING CONDITIONS1
WHEN THE AMBIENT TEMPERATURE (F) OF EXPOSURE IS THEN, THE MAXIMUM HOURS OF EXPOSURE TIME FOR
Fresh fish (not heat processed Previously frozen fish, or heat processed fish (that has been
or previously frozen) is exposed to possible recontamination), is
> 70 AT ANY TIME 4 12
70 DURING ENTIRE EXPOSURE 8 24
1. This table is a summary of the preceding recommendations. For complete understanding of the recommendations, refer to the text above.
119
Detection histamine testing is dependent upon the design
Sensory evaluation of the sampling plan. The amount of sampling
required to accommodate such variability of
Sensory evaluation is generally used to screen
distribution is necessarily quite large. The
fish for indicators of spoilage that develop when
method of collection of the fish sample is also
the fish is exposed to time and temperature
critical. In large scombrotoxin-forming fish, the
abuse. Odor in particular is an effective means
lower, anterior (forward) portion of the fish loin
of detecting fish that have been subjected to a
(not the belly flap) is likely to provide the best
variety of abusive conditions. However, odors of
information about the histamine content of the
decomposition that are typical of relatively low
fish. The number of samples (i.e., scombrotoxin
temperature spoilage may not be present if the
forming fish) necessary to make a judgment
fish has undergone high temperature spoilage.
about a lot depends on the anticipated variability,
This condition makes sensory examination
but should not be fewer than 18 samples per lot,
alone an ineffective control for preventing
unless the lot contains less than 18 fish, in which
scombrotoxin (histamine) formation.
case a sample should be collected from each fish.
It is important to recognize that the Federal
Where samples are composited to reduce the
Food, Drug, and Cosmetic Act (the FFD&C Act)
number of analyses needed on a lot, it should
prohibits interstate commerce of adulterated
be done in a manner that ensures meaningful
foods (21 U.S.C. 331). Under the FFD&C
results. No more than three samples should be
Act, a food that is decomposed is considered
composited, in order to minimize masking of
adulterated (21 U.S.C 342). Accordingly, a fish
problematic fish. Furthermore, the analytical
or fishery product that is decomposed in whole
method and instrument used should be capable
or in part is prohibited from entering interstate
of reliably detecting histamine at the lower levels
commerce even if the type of decomposition
that are necessary for composited samples (e.g.,
may not lead to scombrotoxin (histamine)
17 ppm histamine in a three-sample composite,
formation. You should distinguish between
rather than 50 ppm in an uncomposited sample ).
recommendations in this chapter for sensory
screening, as a component of a HACCP control Combining additional indicators of conditions
strategy for scombrotoxin formation, and your that can lead to histamine formation, such as
obligation to avoid otherwise violating the sensory examination and internal temperature
FFD&C Act with regard to the distribution of measurement, with histamine testing can provide
decomposed food. better assurance of product safety. Observation
for the presence of honeycombing (voids in
Chemical testing
the fish flesh) in cooked tuna loins intended
Chemical testing is an effective means of for canning is a valuable means of screening
detecting the presence of histamine in fish flesh. for fish that have been exposed to the kinds of
However, the variability in histamine levels temperature abuse that can lead to histamine
between fish and within an individual fish can be development. Any scombrotoxin-forming fish
large, even in fish from the same harvest vessel. that demonstrate the trait should be destroyed or
For this reason, a guidance level has been set of diverted to a non-food use.
50 ppm histamine in the edible portion of fish.
If 50 ppm is found in one section of a fish or lot,
there is the possibility that other sections may
exceed 500 ppm.
Because histamine is generally not uniformly
distributed in a fish or a lot, the validity of
120
DETERMINE WHETHER THE POTENTIAL a refrigerated (not frozen) raw or cooked
HAZARD IS SIGNIFICANT. product from another processor (see Chapter
12). The in-transit controls for secondary
The following guidance will assist you in processors recommended in Chapter 12 are
determining whether scombrotoxin (histamine) similar to those recommended in this chapter.
formation is a significant hazard at a processing 2. Is it reasonably likely that unsafe levels of
step: histamine will form at this processing step?
1. Is it reasonably likely that unsafe levels of To answer this question, you should consider
histamine will be introduced at this processing step the potential for time and temperature abuse
(do unsafe levels come in with the raw material)? in the absence of controls. You may already
Table 3-2 (Chapter 3) lists those species of have controls in your process that minimize
fish that are generally known to be capable the potential for time and temperature abuse
of producing elevated levels of histamine if that could result in unsafe levels of histamine.
temperature abused. Such species of fish This guidance will help you determine
have this capability because they contain whether those or other controls should be
naturally high levels of histidine. They also included in your HACCP plan.
have this capability because they are marine Time and temperature abuse that occurs
fish that are likely to harbor the kinds of at successive processing and storage steps
bacteria that produce histidine decarboxylase. may be sufficient to result in unsafe levels
It is, therefore, reasonable to assume that of histamine, even when abuse at one
without proper onboard vessel controls, these step alone would not result in such levels.
species of fish will contain unsafe levels of For this reason, you should consider the
histamine upon receipt by the primary (first) cumulative effect of time and temperature
processor. abuse during the entire process. Information
However, if the worst case environmental is provided above to help you assess the
conditions (i.e., air and water temperatures) significance of time and temperature abuse
during the harvest season in a particular that may occur in your process.
region would not permit the formation of 3. Can unsafe levels of histamine formation that are
histamine during the time necessary to reasonably likely to occur be eliminated or reduced
harvest and transport the fish to the primary to an acceptable level at this processing step?
processor, onboard controls may not be
necessary. For example, such conditions Scombrotoxin (histamine) formation should
might exist if the fish are harvested when air also be considered a significant hazard at any
and water temperatures do not exceed 40F processing or storage step where a preventive
(4.4C), as evidenced by supporting data. measure is or can be used to eliminate the
hazard if it is reasonably likely to occur.
It is also reasonable to assume that without Preventive measures for scombrotoxin
proper controls during refrigerated (not (histamine) formation can include:
frozen) transportation between processors,
scombrotoxin-forming species of fish will Examining harvest vessel records
contain unsafe levels of histamine upon to ensure that incoming fish were
receipt by the secondary processor (including properly handled onboard the
warehouses). In addition, you may need harvest vessel, including:
to exercise control to prevent pathogen Rapidly chilling the fish immediately

growth or toxin formation when receiving after death;
121
Controlling onboard refrigeration IDENTIFY CRITICAL CONTROL POINTS.
(other than frozen storage)
temperatures;
Performing proper onboard icing;
Testing incoming fish for
critical control point (CCP) for scombrotoxin
histamine levels;
(histamine) formation:
Ensuring that incoming fish 1. If scombrotoxin (histamine) formation is a

were handled properly during significant hazard at the receiving step, you
refrigerated transportation from the should identify receiving as a CCP for this
previous processor, including: hazard.
Controlling refrigeration temperatures a. If you are the primary processor of the

during transit;
scombrotoxin-forming fish (i.e., if you
Performing proper icing during
receive the fish directly from the harvest
transit; vessel) and have a relationship with the
Checking incoming fish to ensure
operator of the harvest vessel(s) from
that they are not at an elevated
which you purchase fish that enables
temperature at time of receipt;
you to obtain documentation of onboard
practices, you should identify the
Checking incoming fish to ensure
following preventive measures for control
that they are properly iced or
of this hazard:
refrigerated at time of receipt;
Examining harvest vessel records

Performing sensory examination on
to ensure that incoming fish
incoming fish to ensure that they do
were properly handled onboard
not show signs of decomposition;
the harvest vessel, including:
Controlling refrigeration
temperatures in your plant;
Rapidly chilling the fish

immediately after death;
Performing proper icing in your plant; Controlling onboard refrigeration
(other than frozen storage)
Controlling the amount of time that the

temperatures;
product is exposed to temperatures

that would permit histamine Performing proper onboard icing;
formation during processing. Checking incoming fish to ensure

These preventive measures are ordinarily employed that they are not at an elevated
at receiving, processing, and storage steps. temperature at time of receipt; and,
Performing sensory examination of
Intended use
Because of the heat stable nature of histamine, not show signs of decomposition.
the intended use of the product is not likely to
affect the significance of this hazard. Example:
A mahi-mahi processor that regularly
purchases from the same harvest
vessels should require harvest vessel
records as a condition of purchase.
122
The processor should also check you should identify the following
the internal temperatures of preventive measures for control of this
incoming fish and perform sensory hazard:
examination of these fish. The
Ensuring that incoming fish were
processor should then set a CCP for
properly refrigerated during
histamine formation at receiving.
transportation from the previous
This control approach is a control strategy processor, by controlling refrigeration
referred to in this chapter as Control temperatures during transit or,
Strategy Example 1 - Harvest Vessel
Checking incoming fish to
Control.
ensure that they are properly
b. If you are the primary processor of the iced at time of receipt.
scombrotoxin-forming fish (i.e., if you
Example:
receive the fish directly from the harvest
A tuna processor that receives fish
vessel) and do not have a relationship
from another processor should require
with the operator of the harvest vessel(s)
evidence of temperature control
that enables you to obtain documentation
throughout transit as a condition of
of onboard practices, you should identify
receipt. The processor should then
the following preventive measures for
set a CCP for histamine formation at
control of this hazard:
receiving.
Testing incoming fish for
This control approach is a control strategy
histamine levels;
referred to in this chapter as Control
Checking incoming fish to ensure Strategy Example 3 - Transit Control.
that they are not at an elevated This control strategy, in addition to
temperature at time of receipt and, Control Strategy Example 1 - Harvest
Vessel Control or Control Strategy
Performing sensory examination of
Example 2 - Histamine Testing, may
also be applicable if you are a primary
not show signs of decomposition.
processor and transport the fish by truck
Example: from your harvest vessel unloading site to
A canned tuna processor that your processing facility.
purchases from a variety of harvest
2. If scombrotoxin (histamine) formation is a
vessels should subject incoming fish
significant hazard at one or more processing
from each harvest vessel to histamine
steps, you should identify the processing step(s)
testing, internal temperature checks,
as a CCP for this hazard.
and sensory examination. The
processor should then set a CCP for a. The preventive measure for this type of
histamine formation at receiving. control is:
Controlling the amount of time
that the scombrotoxin-forming
Strategy Example 2 - Histamine Testing.
product is exposed to temperatures
c. If you are a secondary processor of the that would permit histamine
scombrotoxin-forming fish (i.e., if you formation during processing.
receive the fish from another processor),
123
Example: Receiving;
A mahi-mahi processor should Processing, such as:
control histamine formation
by limiting exposure time and Thawing;
temperature of the product during Brining and salting;

processing. The processor should Smoking;
then set CCPs for histamine Heading and gutting;
formation at the processing steps.
Manual filleting and steaking;
This control approach is a control strategy Fermenting;
Strategy Example 4 - Processing Control.
Pickling;
This control strategy is intended for Drying;

processing at ambient and air-conditioned Stuffing;
temperatures. Control Strategy Mixing (e.g., salad preparation);
Example 5 - Storage Control may be
Portioning;
more appropriate for processing under
Packaging;
refrigerated conditions.
Final chilling after processing
3. If scombrotoxin (histamine) formation is a

and packaging;
significant hazard at a storage step for raw

material, in-process product, or finished product, Storing raw material, in-process product,
you should identify the storage step(s) as a CCP and finished product under refrigeration.
for this hazard. Note: Rather than identify each processing step as an individual
CCP when the controls are the same at those steps, it may be more
a. The preventive measures for this type of convenient to combine into one CCP those processing steps that
together contribute to a cumulative time and temperature exposure.
control are:
Controlling refrigeration Unlikely CCPs

temperatures in your plant or, Time and temperature controls will usually
not be needed at processing steps that meet
Performing proper icing
the following conditions:
in your plant.
Continuous, mechanical processing
Example:
steps that are brief, such as:
A mahi-mahi processor should control
histamine formation by icing the Mechanical filleting;
product during raw material, in-process Processing steps that are brief and
product, and finished product storage. unlikely to contribute significantly
The processor should then set CCPs for to the cumulative time and
histamine formation at the storage steps. temperature exposure, such as:
This control approach is a control strategy Date code stamping;
Strategy Example 5 - Storage Control.
Case packing;
Processing steps where the product
Likely CCPs is held in a frozen state, such as:
Following is further guidance on processing Assembly of orders for distribution;
steps that are likely to be identified as CCPs
for this hazard:
Frozen product storage;
124
Retorting and post-retorting steps (if the Sensory examination;
product is covered by the Thermally Internal temperature measurements.
Processed Low-Acid Foods Packaged
Harvest vessel records:
in Hermetically Sealed Containers
regulation, 21 CFR 113 (called the All scombrotoxin-forming fish lots received
Low-Acid Canned Foods Regulation are accompanied by harvest vessel records
in this guidance document)); that show:
Fish exposed to air or water temperatures
DEVELOP A CONTROL STRATEGY. above 83F (28.3C) were placed in ice,
or in refrigerated seawater, ice slurry, or
The following guidance provides examples of five brine of 40F (4.4C) or less, as soon
control strategies for scombrotoxin (histamine) as possible after harvest, but not longer
formation. It may be necessary to select more than 6 hours from the time of death;
than one control strategy in order to fully control OR
the hazard, depending upon the nature of your
operation. You may select a control strategy Fish exposed to air and water temperatures
of 83F (28.3C) or less were placed in
that is different from those which are suggested,
provided it complies with the requirements of the
applicable food safety laws and regulations.
possible after harvest, but not longer than 9
The following are examples of control strategies hours from the time of death;
OR
Fish that were gilled and gutted
before chilling were placed in ice, or
CONTROL STRATEGY PRIMARY SECONDARY in refrigerated seawater, ice slurry, or
PROCESSOR PROCESSOR
brine of 40F (4.4C) or less, as soon
Harvest vessel control as possible after harvest, but not longer
Histamine testing than 12 hours from the time of death;
Transit control OR
Processing control Fish that were harvested under
Storage Control conditions that expose dead fish to
harvest waters of 65F (18.3C) or less
for 24 hours or less were placed in ice,
or in refrigerated seawater, ice slurry, or
CONTROL STRATEGY EXAMPLE 1 - HARVEST brine of 40F (4.4C) or less, as soon
VESSEL CONTROL as possible after harvest, but not more
It may be necessary to select more than one than the time limits listed above, with the
control strategy in order to fully control the time period starting when the fish left the
hazard, depending upon the nature of your 65F (18.3) or less environment;
operation.
OR
Set Critical Limits. Other critical limits for onboard handling
(e.g., maximum refrigerated brine or
The critical limits for this control strategy should
seawater temperature, maximum fish
include three components:
size, maximum fish to brine/seawater/
Harvest vessel records; ice ratio, maximum initial temperature of
125
the fish) necessary to achieve a cooling (10C) or below;
rate that will prevent development of

OR
an unsafe level of histamine in the

specific species, as established through a For fish held iced or refrigerated (not frozen)
scientific study. onboard the vessel from 12 to less than 15
hours after death:
Note: If the actual time of death is not known, an estimated time
of the first fish death in the set may be used (e.g., the time the The internal temperature should be 60F
deployment of a longline begins). Table 7-1 provides a summary of (15.6C) or below;
the preceding recommended critical limits.

OR
AND
For fish held iced or refrigerated (not frozen)

For fish held refrigerated (not frozen)
onboard the vessel less than 12 hours after
onboard the vessel: death:
The fish were stored at or below The internal temperature should
40F (4.4C) after cooling; be sufficiently below water and air
OR temperatures to indicate that appropriate
chilling methods were implemented
The fish were stored completely onboard the harvest vessel. Chilling
and continuously surrounded of the fish should begin on the harvest
by ice after cooling; vessel regardless of the time from death
AND until off-loading from the vessel by the
processor unless the environmental
Sensory examination:
conditions (e.g., air and water
Sensory examination of a representative temperatures) are below 40F (4.4C)
sample of scombrotoxin-forming fish shows from the time of death until off-loading
decomposition (persistent and readily from the vessel by the processor;
perceptible) in less than 2.5% of the fish in
OR
the sample. For example, no more than 2
fish in a sample of 118 fish may show signs For fish held iced or refrigerated (not frozen)
of decomposition. Note that the FFD&C onboard the vessel:
Act prohibits interstate commerce of any Elapsed time from death and internal
decomposed fish whether or not the HACCP temperatures at the time of off-loading
critical limit has been exceeded; from the vessel by the processor should
be consistent with cooling curves that
AND
will prevent development of an unsafe
Internal temperature measurements: level of histamine in the specific species,
For fish held iced or refrigerated (not frozen) as established through a scientific study.
onboard the vessel 24 or more hours after
death: Establish Monitoring Procedures.
The internal temperature should be 40F
(4.4C) or below;
Harvest vessel records containing the following

OR
information:
Method of capture*;
onboard the vessel from 15 to less than 24
hours after death: AND
Where applicable to the critical limit, the
126
date and time of landing the fish onboard The presence of ice that completely
the harvest vessel; and continuously surrounds the fish.
AND (*These items may be documented by the primary (first) processor,
on the receiving records, rather than by the harvest vessel operator,
Where applicable to the critical limit, the on the harvest vessel records, provided the primary processor has
estimated earliest date and time of death for direct knowledge about those aspects of the harvesting practices and
has made first-hand observations for each lot received. The vessel
fish brought onboard in the fishing set (e.g.,
operator should document other onboard handling information. The
trawl, gillnet, longline, or purse seine); primary processor should maintain all relevant information.)
AND AND
Sensory examination:
air and water temperatures at the time of
landing the fish onboard the harvest vessel*; Amount of decomposition in the lot;
AND AND
Where applicable to the critical limit, the Internal temperature measurement:
water temperature at the depth where dead For fish held iced or refrigerated (not frozen)
fish may remain until harvest; onboard the vessel:
AND The internal temperature of a
Where applicable to the critical limit, the representative number of the largest
method of cooling* and temperature of the fish in the lot at the time of off-loading
cooling medium; from the harvest vessel, concentrating on
any fish that show signs of having been
AND mishandled (e.g., inadequately iced);

AND
date and time cooling began and/or the date

and time when the last fish in a fishing set Date and time of off-loading.
(e.g., trawl, gillnet, longline, or purse seine) Example:

was placed in the cooling medium; A primary processor receives
AND bluefish from several day-boats
that catch the fish when the air
Where applicable to the critical limit, those
and water temperatures are below
factors of the cooling process that have been
83F (28.3C). The day-boats take
established through a scientific study as critical
on ice at the processors facility
to achieving the cooling rate critical limits (e.g.,
immediately before setting out for the
refrigerated brine or seawater temperature, fish
day and return within 9 hours to the
size, fish to brine/seawater/ice ratio, maximum
processors facility with the iced catch.
initial temperature of the fish);
The processor monitors and records
AND the date and time of departure of
For fish held iced or refrigerated (not frozen) the vessels after they take on ice; the
onboard the vessel: date and time of the return of the
vessels; the ambient water and air
The storage temperature, as evidenced by:
temperatures of the fishing grounds;
The temperature of refrigerated and the adequacy of icing of the
seawater or brine in which catch at the time of off-loading. The
the fish are stored; processor also conducts sensory
OR evaluations and checks the internal
127
temperature of the catch upon arrival. of the fish. Randomly select fish from
The harvest vessel operators perform throughout the lot. Lots that show a high
no monitoring or record keeping. level of temperature variability or lots
of very small fish may require a larger
How Will Monitoring Be Done? sample size;
For harvest vessel records:
AND
Review controls documented in the
records;
Visually determine the date and time of
off-loading.
AND
For sensory examination:

Every lot of scombrotoxin-forming fish
Examine at least 118 fish, collected
received.
representatively throughout each lot (or the
entire lot, for lots smaller than 118 fish). Who Will Do the Monitoring?
Additional fish should be examined if
For sensory examination:
variability in fish-to-fish histamine content
is expected to be high. Lots should Any person who is qualified by
consist of only one species of fish; for experience or training to perform the
vessels delivering multiple species, testing examination;
should generally be done separately on AND
each species. All fish within a lot should For other checks:
have a similar history of harvest. If the
fish are received frozen, this monitoring Any person who has an understanding of
the nature of the controls.
procedure may be performed by a
sensory examination on the warmed flesh
produced by drilling the frozen fish (drill
method). It may also be performed after Take the following corrective actions to a product
thawing, rather than at receipt; involved in a critical limit deviation:
AND In the absence of harvest vessel records or

when one of the harvester-related critical
limits has not been met, or when the internal
onboard the vessel:
temperature critical limit at receiving has not
Use a temperature-indicating device been met:
(e.g., a thermometer) to measure the
internal temperature of a representative Chill and hold the affected lot (i.e.,
fish of common origin) until histamine
number of the largest fish in each
analysis is performed on a minimum
lot, concentrating on any that show
of 60 fish representatively collected
signs of having been mishandled (e.g.,
from throughout the lot, including any
inadequately iced). For example,
fish measured to have temperatures
when receiving 10 tons or more of fish,
that exceeded the critical limit (or the
measure a minimum of one fish per ton,
entire lot for lots smaller than 60 fish).
and when receiving less than 10 tons of
Reject the lot if any fish are found with
fish, measure a minimum of one fish per
histamine greater than or equal to 50
1,000 pounds. Measure a minimum of
ppm. The fish collected for analysis
12 fish, unless there are fewer than 12
may be composited for analysis if the
fish in the lot, in which case measure all
action point is reduced accordingly. For
128
example, a sample of 60 fish may be Establish a Recordkeeping System.
composited into 20 units of 3 fish each, Harvest vessel records containing the
provided the action point is reduced information described above;
from 50 ppm to 17 ppm for each unit;
AND
OR
Receiving records showing the date and time

Reject the lot;
of off-loading;
AND AND
When the sensory examination critical limit Results of sensory examination;
has not been met:
AND
Chill and hold the affected lot (i.e.,
fish of common origin) until histamine
analysis is performed on a minimum onboard the vessel:
of 60 fish representatively collected Internal temperatures of the fish.
from throughout the lot, including all

fish in the lot that show evidence of Establish Verification Procedures.
decomposition (persistent and readily Collect a representative sample of the raw
perceptible odors) (or the entire lot for material, in-process product, or finished
lots smaller than 60 fish), and reject the product, and analyze it for histamine at least
lot if any fish is found with histamine quarterly;
greater than or equal to 50 ppm;
AND
AND
Ensure that new sensory examiners receive
If any fish in the lot are to proceed training to calibrate their ability to identify
into commerce for food use, perform decomposed fish and that all sensory
a sensory examination of all fish in the examiners receive periodic refresher training;
lot to ensure that no decomposed fish
proceed; AND
Where histamine testing is part of a
AND
corrective action plan, periodically verify
Any individual fish found to be the findings (e.g., by comparing results with
decomposed (persistent and readily those obtained using an Association of
perceptible) should be destroyed or Official Analytical Chemists (AOAC) method);
diverted to a non-food use;
AND
OR
Before a temperature-indicating device (e.g.,

Reject the lot.
a thermometer) is put into service, check
AND the accuracy of the device to verify that the
factory calibration has not been affected.
This check can be accomplished by:
Discontinue use of the supplier until Immersing the sensor in an ice slurry
(32F (0C)), if the device will be used at
evidence is obtained that the identified
harvesting and onboard practices and
controls have been improved. OR
Comparing the temperature reading
on the device with the reading on a
129
known accurate reference device (e.g., Review monitoring, corrective action,
a thermometer traceable to the National and verification records within 1 week of
Institute of Standards and Technology preparation to ensure they are complete and
(NIST) standards) under conditions that any critical limit deviations that occurred
are similar to how it will be used (e.g., were appropriately addressed.
product internal temperature) within
the temperature range at which it will
be used;
OR
Following the manufacturers instructions;
AND
Once in service, check the temperature-
indicating device daily before the
beginning of operations. Less frequent
accuracy checks may be appropriate if
they are recommended by the instrument
manufacturer and the history of use of the
instrument in your facility has shown that
the instrument consistently remains accurate
for a longer period of time. In addition
to checking that the device is accurate by
one of the methods described above, this
process should include a visual examination
of the sensor and any attached wires for
damage or kinks. The device should be
checked to ensure that it is operational;
AND
Calibrate the temperature-indicating device
against a known accurate reference device
(e.g., a NIST-traceable thermometer) at
least once a year or more frequently if
recommended by the device manufacturer.
Optimal calibration frequency is dependent
upon the type, condition, past performance,
and conditions of use of the device.
Consistent temperature variations away from
the actual value (drift) found during checks
and/or calibration may show a need for more
frequent calibration or the need to replace
the device (perhaps with a more durable
device). Calibration should be performed at
a minimum of two temperatures that bracket
the temperature range at which it is used;
AND
130
TABLE 7-3
CONTROL STRATEGY EXAMPLE 1 - HARVEST VESSEL CONTROL
This table is an example of a portion of a HACCP plan using Control Strategy Example 1 - Harvest Vessel Control. This example illustrates how a fresh mahi-mahi processor that
receives the fish on ice directly from harvest vessels that use a hook and line technique (fish brought onboard alive) can control scombrotoxin formation. It is provided for illustrative
purposes only. It may be necessary to select more than one control strategy in order to fully control the hazard, depending upon the nature of your operation.
Histamine formation may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., metal fragments).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
CRITICAL MONITORING
CRITICAL LIMITS
POINT PREVENTIVE
MEASURE
Receiving Scombrotoxin All lots received are accompanied Harvest vessel Review of Every Receiving Reject Harvester Perform histamine analysis on
fresh formation by harvest vessel records that show records controls lot supervisor the lot vessel 1 incoming lot every 3 months
mahi documented received records (18 fish per sample)
(1) placement of fish on ice
mahi on in the records Discontinue
within 9 hours of death if the
ice from use of the Review monitoring, corrective
maximum exposure temperature
harvest supplier action, and verification records
does not exceed 83F or within 6
vessels until within 1 week of preparation
hours if the maximum exposure
131
evidence
temperature exceeds 83F;
is obtained
(2) The fish were stored that
completely and continuously harvesting
surrounded by ice after capture and
Less than 2.5% decomposition Amount Sensory Every Quality onboard Receiving Provide sensory training
(persistent and readily perceptible) of examination lot control practices record for new fish examiners and

in the incoming lot decomposition (118 fish per received staff and annual training for all fish
in the incoming lot; or all fish controls examiners
lot in the lot if have been
less than 118 improved Review monitoring, corrective
fish) action, and verification records
within 1 week of preparation
Internal temperatures of all fish Internal Digital Every Receiving Receiving Check the digital thermometer
are to meet the following criteria temperature thermometer lot supervisor record for accuracy and damage and
based on the time since the death of the fish at (1 fish/1,000 received to ensure that it is operational
of the fish: time of pounds; before putting it into operation;
>24 hours g 40 off-loading minimum of perform these same checks
15 to < 24 hours g 50 from vessel; 12 fish per daily, at the beginning of
12 to < 15 hoursg 60 lot) operations; and calibrate it once
< 12 hours g below ambient Date and time per year
air and water temperatures of off-loading
commensurate with size of fish and Review monitoring, corrective
time since death action, and verification records
CONTROL STRATEGY EXAMPLE 2 - HISTAMINE The internal temperature should be 50F
TESTING (10C) or below;
It may be necessary to select more than one OR
control strategy in order to fully control the For fish held iced or refrigerated (not frozen)
hazard, depending upon the nature of your onboard the vessel from 12 to less than 15
operation. hours after death:
Set Critical Limits. The internal temperature should be 60F
(15.6C) or below;
The critical limits for this control strategy should

include three components: OR
Histamine testing; For fish held iced or refrigerated (not frozen)

onboard the vessel less than 12 hours after
Sensory examination;
death:
Internal temperature measurements.
The internal temperature should
Histamine testing: be sufficiently below water and air
Analysis of a representative sample of temperatures to indicate that appropriate
scombrotoxin-forming fish shows less than chilling methods were implemented
50 ppm histamine in all fish in the sample; onboard the harvest vessel. Chilling
of the fish should begin on the harvest
AND
vessel regardless of the time from death
Sensory examination: until off-loading from the vessel by the
Sensory examination of a representative processor, unless the environmental
sample of scombrotoxin-forming fish shows conditions (e.g. air and water
decomposition (persistent and readily temperatures) are below 40F (4.4C)
perceptible) in less than 2.5% of the fish in from the time of death until off-loading
the sample. For example, no more than 2 from the vessel by the processor;
fish in a sample of 118 fish may show signs OR
of decomposition. Note that the FFD&C
Act prohibits interstate commerce of any
onboard the vessel:
decomposed fish whether or not the HACCP
critical limit has been exceeded; Elapsed time from death and internal
temperatures at the time of off-loading
AND from the vessel by the processor should
Internal temperature measurements: be consistent with cooling curves that
will prevent development of an unsafe
level of histamine in the specific species,
onboard the vessel 24 or more hours after
as established through a scientific study.
death:
(4.4C) or below;
OR
For fish held iced or refrigerated (not frozen) Histamine testing:
onboard the vessel from 15 to less than 24 Histamine content in the scombrotoxin
hours after death: forming fish flesh;
AND
132
Sensory examination: For sensory examination:
Amount of decomposition in the Examine at least 118 fish, collected
scombrotoxin-forming fish lot; representatively throughout each lot
(or the entire lot, for lots smaller than
AND
118 fish). Additional fish should be
Internal temperature measurement: examined if variability in fish-to-fish
For scombrotoxin-forming fish held iced or histamine content is expected to be high.
refrigerated (not frozen) onboard the vessel: Lots should consist of only one species
of fish; for vessels delivering multiple
The internal temperature of a
species, testing should generally be
representative number of the largest
fish in the lot at the time of off-loading

done separately on each species. If the
from the harvest vessel by the processor,
fish are received frozen, this monitoring
concentrating on any fish that show
procedure may be performed by a
signs of having been mishandled (e.g.,
sensory examination on the warmed
inadequately iced);
flesh produced by drilling the frozen fish
(drill method). It may also be performed
AND
after thawing, rather than at receipt;
Date and time of off-loading.
AND
How Will Monitoring Be Done? For fish held iced or refrigerated (not frozen)
For histamine analysis: onboard the vessel:
Test a minimum of 18 fish, collected Use a temperature-indicating device

representatively throughout each lot (or (e.g., a thermometer) to measure the
the entire lot when there are fewer than internal temperature of a representative
18 fish in the lot). Additional fish should number of the largest fish in each
be examined if variability in fish-to-fish lot, concentrating on any that show
histamine content is expected to be high. signs of having been mishandled (e.g.,
Lots should consist of only one species inadequately iced). For example,
of fish; for vessels delivering multiple when receiving 10 tons or more of fish,
species, testing should generally be done measure a minimum of one fish per ton,
separately on each species. Reject the and when receiving less than 10 tons of
lot if any fish are found with histamine fish, measure a minimum of one fish per
greater than or equal to 50 ppm. The 1,000 pounds. Measure a minimum of
fish collected for analysis may be 12 fish, unless there are fewer than 12
composited if the critical limit is reduced fish in the lot, in which case measure all
accordingly. For example, a sample of of the fish. Randomly select fish from
18 fish may be composited into 6 units throughout the lot. Lots that show a high
of 3 fish each, provided the critical limit level of temperature variability or lots
is reduced from 50 ppm to 17 ppm for of very small fish may require a larger
each unit; sample size;
AND AND
Visually determine the date and time of
off-loading.
133
How Often Will Monitoring Be Done (Frequency)? OR
Every lot of scombrotoxin-forming fish received. Reject the lot;
Who Will Do the Monitoring? AND
For sensory examination and histamine When the sensory examination critical limit
testing:
has not been met:
Any person who is qualified by
If histamine did not exceed 50 ppm in
experience or training to perform the the initial testing:
work; Chill and hold the affected lot
AND (i.e., fish of common origin) until
For other checks: histamine analysis is performed on a
minimum of 60 fish representatively
collected from throughout the lot,
including all fish in the lot that
show evidence of decomposition
(persistent and readily perceptible
Take the following corrective actions to a product odors) (or the entire lot for lots
involved in a critical limit deviation: smaller than 60 fish). Reject the
When the histamine-level critical limit at the lot if any fish are found with
receiving step has not been met, reject the lot; histamine greater than or equal
to 50 ppm. The fish collected for
AND
analysis may be composited for
When the internal temperature critical limit analysis if the action point is reduced
has not been met: accordingly. For example, a sample
If histamine did not exceed 50 ppm in of 60 fish may be composited into
the initial testing: 20 units of 3 fish each, provided
the action point is reduced from
Chill and hold the affected lot
50 ppm to 17 ppm for each unit;
(i.e., fish of common origin) until
histamine analysis is performed on a AND
minimum of 60 fish representatively
collected from throughout the lot,
If any fish in the lot are to proceed
into commerce for food use, perform
including any fish measured to a sensory examination of all fish in the
have temperatures that exceeded lot to ensure that no decomposed fish
the critical limit (or the entire lot proceed;
for lots smaller than 60 fish). Reject
AND
the lot if any fish are found with
histamine greater than or equal Any individual fish found to be
to 50 ppm. The fish collected for decomposed (persistent and readily
analysis may be composited for perceptible) should be destroyed or
analysis if the action point is reduced diverted to a non-food use;
accordingly. For example, a sample OR
of 60 fish may be composited into

20 units of 3 fish each, provided Reject the lot.
the action point is reduced from AND

50 ppm to 17 ppm for each unit;
134
Take the following corrective action to regain control traceable thermometer) under conditions
over the operation after a critical limit deviation: that are similar to how it will be used (e.g.,
Discontinue use of the supplier until evidence product internal temperature) within the
is obtained that the identified harvesting and temperature range at which it will be used;
onboard practices have been improved. OR
Establish a Recordkeeping System. Following the manufacturers instructions;
AND
Receiving records showing:
Date and time of off-loading;
indicating device daily before the beginning
AND of operations. Less frequent accuracy checks
Results of histamine analysis; may be appropriate if they are recommended
by the instrument manufacturer and the history
AND
of use of the instrument in your facility has
Results of sensory examination; shown that the instrument consistently remains
AND accurate for a longer period of time. In
For fish held iced or refrigerated (not frozen) addition to checking that the device is accurate
onboard the vessel:
by one of the methods described above, this
process should include a visual examination of
Internal temperatures of the fish.
the sensor and any attached wires for damage

or kinks. The device should be checked to
Establish Verification Procedures. ensure that it is operational;
Periodically verify histamine findings (e.g., by
AND
comparing results with those obtained using
an AOAC method or by analyzing proficiency Calibrate the temperature-indicating device
samples); against a known accurate reference device
AND least once a year or more frequently if
Ensure that new sensory examiners receive recommended by the device manufacturer.
training to calibrate their ability to identify Optimal calibration frequency is dependent
decomposed fish and that all sensory upon the type, condition, past performance,
examiners receive periodic refresher training; and conditions of use of the device.
AND Consistent temperature variations away from
a thermometer) is put into service, check
the accuracy of the device to verify that the
factory calibration has not been affected.
Immersing the sensor in an ice slurry the temperature range at which it is used;
or near refrigeration temperature; AND
OR
Comparing the temperature reading on preparation to ensure they are complete and
the device with the reading on a known any critical limit deviations that occurred
accurate reference device (e.g., a NIST- were appropriately addressed.
135
TABLE 7-4
CONTROL STRATEGY EXAMPLE 2 - HISTAMINE TESTING

This table is an example of a portion of a HACCP plan using Control Strategy Example 2 - Histamine Testing. This example illustrates how a canned tuna processor that
receives frozen tuna directly from the harvest vessel can control scombrotoxin formation. It is provided for illustrative purposes only. It may be necessary to select more than
one control strategy in order to fully control the hazard, depending upon the nature of your operation.
Histamine formation may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., Clostridium
botulinum growth and toxin formation).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
CRITICAL MONITORING
CRITICAL LIMITS
SIGNIFICANT
CONTROL FOR EACH CORRECTIVE ACTION(S) RECORDS VERIFICATION
HAZARD(S) WHAT HOW FREQUENCY WHO
POINT PREVENTIVE
MEASURE
Receiving Scombrotoxin Less than Fish flesh for Histamine testing Every lot Quality Reject the lot; Reports of Do a quarterly
frozen formation 50 ppm histamine using the AOAC received assurance histamine comparison of histamine
tuna from histamine in content 977.13 method staff Discontinue use of the supplier analysis test results with AOAC
harvest all fish in the on a minimum until evidence is obtained method
136
vessels sample of 18 fish per that harvesting and onboard
lot (36 fish from practices have been improved Review
vessels with monitoring,
high variability If the initial histamine sample corrective action, and
of histamine was <50 ppm, perform verification records
detected histamine analysis on a within 1 week of
between fish min, of 60 fish, collected preparation

or when 1 of representatively from the lot
the first 18 fish and reject the lot if any fish
exceeds 30 ppm contains 50 ppm histamine;
histamine) and if all fish <50 ppm
Less than 3 Amount of Sensory Every lot Quality Conduct sensory evaluation of Sensory Provide sensory training
decomposed decomposition examination (118 received assurance all fish in the lot, removing and examination for new fish examiners
fish in the fish per lot, or all staff destroying all decomposed fish record and annual training for
(persistent incoming lot fish if lot is less all fish examiners
and readily than 118 fish) Discontinue use of the supplier
perceptible) until evidence is obtained Review monitoring,
in a 118-fish that harvesting and onboard corrective action, and
sample practices have been improved verification records
within 1 week of
preparation
CONTROL STRATEGY EXAMPLE 3 - TRANSIT a controlled temperature environment) of 4
CONTROL hours or less (optional control strategy):
It may be necessary to select more than one Time of transit does not exceed 4 hours;
control strategy in order to fully control the hazard, AND
depending upon the nature of your operation.
Internal temperature of the fish at the
Set Critical Limits. time of delivery does not exceed 40F
(4.4C).
For fish delivered refrigerated (not frozen):
Note: Processors receiving fish with transit times of 4 hours or less may
All lots received are accompanied by elect to use one of the controls described for longer transit times instead.
transportation records that show that the
fish were held at or below an ambient Establish Monitoring Procedures.
or internal temperature of 40F (4.4C)
throughout transit. Note that allowance What Will Be Monitored?
for routine refrigeration defrost cycles may For scombrotoxin-forming fish delivered
be necessary; refrigerated (not frozen):
OR The internal temperature of the fish
For fish delivered under ice: throughout transportation;
Fish are completely surrounded by ice at OR

the time of delivery;
The ambient temperature within the truck

OR
or other carrier throughout transportation;
For fish delivered under ice on an open-bed OR
truck: For scombrotoxin-forming fish delivered under
Fish are stored completely surrounded by ice:
ice;
The adequacy of ice surrounding the
AND product at the time of delivery;
The internal temperature of the fish at the OR
time of delivery is 40F (4.4C) or below; For scombrotoxin-forming fish delivered under
OR ice on an open-bed truck:
For fish delivered under chemical cooling The adequacy of ice surrounding the
media such as gel packs:
product at the time of delivery;
There is an adequate quantity of

AND
cooling media that remain frozen to
have maintained product at an internal
The internal temperature of the fish at
time of delivery;
temperature of 40F (4.4C) or below

throughout transit; OR
For scombrotoxin-forming fish held under

AND
chemical cooling media such as gel packs:
The internal temperature of the fish at the
The quantity and frozen status of cooling
time of delivery is 40F (4.4C) or below;
media at the time of delivery;
OR
AND
For fish delivered refrigerated (not frozen)
with a transit time (including all time outside The internal temperature of the fish at the
time of delivery;
137
OR Make visual observations of the
For scombrotoxin-forming fish delivered adequacy and frozen state of the cooling
refrigerated (not frozen) with a transit time of media in a representative number of
4 hours or less: containers (e.g., cartons and totes) from
throughout the shipment;
The date and time fish were removed

from a controlled temperature AND
environment before shipment and the

date and time delivered;
Use a temperature-indicating device (e.g.,
a thermometer) to determine internal

AND product temperatures in a representative
number of fish from throughout the
The internal temperature of a representative
shipment, at delivery;
number of fish at the time of delivery.
OR
For fish delivered refrigerated (not frozen)
For fish delivered refrigerated (not frozen): with a transit time of 4 hours or less:
Use a continuous temperature-recording
Review carrier records to determine the
device (e.g., a recording thermometer) date and time fish were removed from
for internal product temperature or a controlled temperature environment
ambient air temperature monitoring before shipment and the date and time
during transit; delivered;
OR AND
For fish delivered under ice:

Make visual observations of the adequacy a thermometer) to determine internal

of ice in a representative number of product temperatures in a representative
containers (e.g., cartons and totes) from number of fish randomly selected from
throughout the shipment, at delivery; throughout the shipment, at delivery.
OR Measure a minimum of 12 fish, unless
there are fewer than 12 fish in a lot, in
For fish delivered under ice on an open-bed
which case measure all of the fish. Lots
truck:
that show a high level of temperature

Make visual observations of the
variability or lots of very small fish may
adequacy of ice surrounding the product
require a larger sample size.
in a representative number of containers
(e.g., cartons and totes) from throughout

the shipment, at delivery;
Every scombrotoxin-forming fish lot received.
AND
For continuous temperature-recording
a thermometer) to determine internal devices:
product temperatures in a representative
number of fish from throughout the Monitoring is performed by the device itself.
The visual check of the data generated
shipment, at delivery;
by the device, to ensure that the critical
OR limits have consistently been met, may
For fish delivered under chemical cooling be performed by any person who has an
media such as gel packs: understanding of the nature of the controls;
138
OR The number of containers examined
For other checks: and the sufficiency of ice for each;
Any person who has an understanding of AND

The number of containers in the lot;
Establish Corrective Action Procedures. OR
Take the following corrective action to a product For chemical cooling media checks:
involved in a critical limit deviation: The number of containers

Chill and hold the affected lot until histamine examined and the frozen status
analysis is performed on a minimum of of the cooling media for each;
60 fish representatively collected from AND
throughout the lot, including any with
temperatures that exceeded a critical limit The number of containers in the lot;
and any fish observed to have been exposed AND
to inadequate cooling media (or the entire lot
for lots smaller than 60 fish). Reject the lot if
Results of internal product temperature
monitoring, where applicable, including:
any fish is found with histamine greater than
or equal to 50 ppm. The number of containers
examined and the internal
The fish collected for analysis may be temperatures observed for each;
composited if the action point is reduced
accordingly. For example, a sample of 60 fish AND
may be composited into 20 units of 3 fish The number of containers in the lot;
each, provided the action point is reduced
AND
from 50 ppm to 17 ppm for each unit;
OR Date and time fish were initially
removed from a controlled temperature
Reject the lot. environment and the date and time fish
AND were delivered, when applicable.
Take the following corrective action to regain control Establish Verification Procedures.
Discontinue use of the supplier or carrier a thermometer) is put into service, check
until evidence is obtained that the identified the accuracy of the device to verify that the
transportation-handling practices have been factory calibration has not been affected.
improved. This check can be accomplished by:
Establish a Recordkeeping System. Immersing the sensor in an ice slurry

Receiving records showing: or near refrigeration temperature;
For continuous temperature monitoring:
OR
Printouts, charts, or readings from
temperature-recording devices (e.g., Comparing the temperature reading on
the device with the reading on a known
temperature recorder);
accurate reference device (e.g., a NIST-
OR
traceable thermometer) under conditions
that are similar to how it will be used
For ice checks:
139
(e.g., product internal temperature)
within the temperature range at which it
will be used;
traceable thermometer) under conditions that
are similar to how it will be used (e.g., air
OR
temperature) within the temperature range at

Following the manufacturers instructions;
which it will be used;
AND AND
Once in service, check the temperature- When visual checks of ice are used,
indicating device daily before the beginning periodically measure internal temperatures
of operations. Less frequent accuracy checks of fish to ensure that the ice are sufficient
may be appropriate if they are recommended to maintain product temperatures at 40F
by the instrument manufacturer and the (4.4C) or less;
history of use of the instrument in your
facility has shown that the instrument AND
consistently remains accurate for a longer Review monitoring, corrective action,
period of time. In addition to checking that and verification records within 1 week
the device is accurate by one of the methods of preparation are complete and any
described above, this process should include critical limit deviations that occurred were
a visual examination of the sensor and any appropriately addressed.
attached wires for damage or kinks. The
device should be checked to ensure that it is
operational;
AND
AND
Check the accuracy of temperature-recording
devices that are used for monitoring transit
conditions upon receipt of each lot. The
accuracy of the device can be checked
by comparing the temperature reading on
140
TABLE 7-5
CONTROL STRATEGY EXAMPLE 3 - TRANSIT CONTROL

This table is an example of a portion of a HACCP plan using Control Strategy Example 3 - Transit Control. This example illustrates how a fresh mahi-mahi secondary processor that
receives the product by air under chemical coolant (gel packs) can control scombrotoxin formation. It is provided for illustrative purposes only. It may be necessary to select more than
one control strategy in order to fully control the hazard, depending upon the nature of your operation.
Histamine formation may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., metal fragments).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
MONITORING
CRITICAL
CRITICAL LIMITS
SIGNIFICANT
CONTROL FOR EACH CORRECTIVE ACTION(S) RECORDS VERIFICATION
HAZARD(S)
POINT PREVENTIVE WHAT HOW FREQUENCY WHO
MEASURE
Receiving Scombrotoxin Adequate Quantity Visual observation Every lot Receiving Reject the lot Receiving Check the
formation quantity of and frozen of a minimum of received clerk record thermometer for
frozen gel condition of 25% of shipping Discontinue use of the accuracy and
141
packs to gel packs containers in the supplier or carrier until damage, and to
maintain the lot but not fewer evidence is obtained that ensure that it
product at than 12 containers transportation-handling is operational
40F or less (or all containers if practices have been before putting
throughout lot has less than 12 improved into operation;
transit; and containers) perform these
same checks daily

at the beginning
of operations, and
Internal Internal core Digital thermometer Every lot Receiving Reject the lot Receiving calibrate it once per
temperatures temperature for internal received clerk record year
of all fish at and a temperature of Discontinue use of the
delivery are near-surface one fish in 25% of supplier or carrier until Review
40F or below temperature shipping containers evidence is obtained that monitoring,
of each fish but not fewer than transportation-handling corrective action,
12 containers (or practices have been and verification
all containers if lot improved records within 1
has less than 12 week of preparation
containers)
CONTROL STRATEGY EXAMPLE 4 - PROCESSING The fish are not exposed to ambient
CONTROL temperatures above 40F (4.4C) for
It may be necessary to select more than one more than 12 hours, cumulatively, if any
control strategy in order to fully control the portion of that time is at temperatures
hazard, depending upon the nature of your above 70F (21.1C);
operation. OR
Set Critical Limits. The fish are not exposed to ambient
temperatures above 40F (4.4C) for
During processing (e.g., butchering, more than 24 hours, cumulatively, as
cleaning, brining, salting, smoking, drying, long as no portion of that time is at
fermenting, pickling, mixing, fermenting, temperatures above 70F (21.1C).
stuffing, packing, labeling, and staging) of
Note: Only one of the two limits above should be selected. They
scombrotoxin-forming fish that have not should not be added for a total exposure of 36 hours.
been previously frozen or heat processed
sufficiently to destroy scombrotoxin-forming Establish Monitoring Procedures.
bacteria:
The fish are not exposed to ambient
The length of time the scombrotoxin-forming
temperatures above 40F (4.4C) for
more than 4 hours, cumulatively, if any fish are exposed to unrefrigerated conditions
portion of that time is at temperatures (i.e., above 40F (4.4C));
above 70F (21.1C); AND
OR The ambient temperatures during the
exposure periods.
The fish are not exposed to ambient
temperatures above 40F (4.4C) for Note: If the critical limit is based on an assumption that temperatures
more than 8 hours, cumulatively, as may exceed 70F (21.1C), then only the length of exposure may
need to be monitored.
temperatures above 70F (21.1C). How Will Monitoring Be Done?
Note: Only one of the two limits above should be selected. They Make visual observations of the length of
should not be added for a total exposure of 12 hours.
time of product exposure to unrefrigerated
OR conditions (i.e., above 40F (4.4C));
During processing (e.g., thawing, butchering, AND
cleaning, brining, mixing, fermenting,
Measure ambient air temperature, using:
stuffing, packing, labeling, and staging)
of scombrotoxin-forming fish or fishery A continuous temperature-recording
products that have been (1) previously device (e.g., a recording thermometer)
frozen or (2) heat processed sufficiently to located in the processing area;
destroy scombrotoxin-forming bacteria and OR
are processed in a manner where there is

an opportunity for recontamination with
A temperature-indicating device (e.g., a
thermometer) located in the processing

scombrotoxin-forming bacteria (e.g., contact area.
with fresh fish, employees, or introduction
Note: Where multiple processing locations are combined in a
of raw ingredients), such as in a tuna salad cumulative exposure control strategy, temperature monitoring may be
made from canned tuna with added raw needed in each of the processing locations.
ingredients:
142
Example: Who Will Do the Monitoring?
A fresh tuna processor using raw For a continuous temperature-recording device:
material that was not previously
frozen has identified a series of Monitoring is performed by the device
itself. The visual check of the data
processing steps (i.e., from raw
generated by the device, to ensure that
material cooler to finished product
the critical limits have consistently been
cooler) as CCPs for scombrotoxin
met, may be performed by any person
formation. The processor establishes
who has an understanding of the nature
a critical limit of no more than 4
of the controls;
cumulative hours of exposure to
unrefrigerated temperatures in OR
excess of 40F (4.4C) during these For other checks:
processing steps. The processor uses
a marked product to monitor the
progress of the product through the
processing steps. The time that the Establish Corrective Action Procedures.
marked product is removed from
refrigeration to the time the last of Take the following corrective action to a product
the marked product is placed in the involved in a critical limit deviation:
finished product cooler is monitored Chill and hold the affected product until
visually and recorded. It is not histamine analysis is performed on a
necessary for the processor to measure minimum of 60 fish representatively collected
temperature because the critical limit from throughout the affected lot. Destroy
is based on an assumption that the the lot or divert it to a non-food use if any
product temperature may exceed 70F fish is found with histamine greater than
(21.1C). or equal to 50 ppm. The fish collected for
analysis may be composited if the action
How Often Will Monitoring Be Done (Frequency)? plan is reduced accordingly. For example,
For exposure time: a sample of 60 fish may be composited into
At least every 2 hours; 20 units of 3 fish each, provided the action
point is reduced from 50 ppm to 17 ppm for
AND
each unit;
For temperature measurements:
OR
For a continuous temperature-recording
device:
Continuous monitoring during OR
processing operations is Divert the product to a non-food use.
accomplished by the device itself,
AND
with a visual check of the device
at least once per lot or batch, but Take the following corrective actions to regain control
no less often than once per day; over the operation after a critical limit deviation:
Add ice to the product;
OR
OR
For a temperature-indicating device:
Return the affected product to the cooler;

At least every 2 hours.
AND
143
Modify the process as needed to reduce the by the instrument manufacturer and the
time and temperature exposure. history of use of the instrument in your
facility has shown that the instrument
Establish a Recordkeeping System. consistently remains accurate for a longer
Processing records showing the results period of time. In addition to checking that
of time and temperature exposure the device is accurate by one of the methods
measurements. described above, this process should include
a visual examination of the sensor and any
Establish Verification Procedures. attached wires for damage or kinks. The
operational and has sufficient ink and paper,
a thermometer) or a temperature-recording
where applicable;
device (e.g., a recording thermometer) is
put into service, check the accuracy of the AND
device to verify that the factory calibration Calibrate the temperature-indicating device
has not been affected. This check can be or temperature-recording device against a
accomplished by: known accurate reference device (e.g., a
Immersing the sensor in an ice slurry NIST-traceable thermometer) at least once a
(32F (0C)), if the device will be used at year or more frequently if recommended by
or near refrigeration temperature; the device manufacturer. Optimal calibration
OR frequency is dependent upon the type,
condition, past performance, and conditions
Immersing the sensor in boiling water
of use of the device. Consistent temperature
(212F (100C)) if the device will be used
variations away from the actual value (drift)
at or near the boiling point. Note that
found during checks and/or calibration may
the temperature should be adjusted to
show a need for more frequent calibration
compensate for altitude, when necessary;
or the need to replace the device (perhaps
OR with a more durable device). Calibration
should be performed at a minimum of two
Doing a combination of the above if
the device will be used at or near room temperatures that bracket the temperature
temperature; range at which it is used;
OR AND
Comparing the temperature reading on Review monitoring, corrective action,

the device with the reading on a known and verification records within 1 week of
accurate reference device (e.g., a NIST- preparation to ensure they are complete and
traceable thermometer) under conditions any critical limit deviations that occurred
that are similar to how it will be used (e.g., were appropriately addressed.
air temperature) within the temperature
range at which it will be used;
AND
indicating device or temperature-recording
device daily before the beginning of
operations. Less frequent accuracy checks
may be appropriate if they are recommended
144
TABLE 7-6
CONTROL STRATEGY EXAMPLE 4 - PROCESSING CONTROL

This table is an example of a portion of a HACCP plan using Control Strategy Example 4 - Processing Control. This example illustrates how a fresh bluefish processor
that butchers, cleans, packs, labels, and boxes the fish at ambient temperature can control scombrotoxin formation. It is provided for illustrative purposes only. It may be
necessary to select more than one control strategy in order to fully control the hazard, depending upon the nature of your operation.
Histamine formation may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., metal
fragments).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
CRITICAL MONITORING
CRITICAL LIMITS
POINT PREVENTIVE
MEASURE
Processing Scombrotoxin The product Time of product Visual tracking Every batch of Quality control Ice and hold Processing Review
(butchering, formation is not out of exposure to of time for a fish supervisor the record monitoring,
cleaning, refrigeration unrefrigerated marked batch removed from affected batch corrective
packaging, for more conditions of product to raw material in raw material action, and
145
labeling, and than 4 hours during move from raw cold storage for cooler verification
boxing) cumulatively processing material cold processing records within
operations storage to final Perform 1 week of
product cold histamine preparation
storage analysis on a
minimum of
60 fish in the

affected batch
Destroy the
entire batch
if any fish
exceeds
50 ppm
histamine
Modify the
process, if
necessary, to
reduce delays
CONTROL STRATEGY EXAMPLE 5 - STORAGE Establish Monitoring Procedures.
CONTROL
It may be necessary to select more than one
control strategy in order to fully control the For refrigerated storage of scombrotoxin
hazard, depending upon the nature of your forming fish:
operation. The temperature of the cooler;
Set Critical Limits. OR

For storage under ice of scombrotoxin
For refrigerated (not frozen) storage or
forming fish:
processing of raw material, in-process
product, or finished product: The adequacy of ice surrounding the
product.
The product is held at a cooler
temperature of 40F (4.4C) or How Will Monitoring Be Done?
below. Note that allowance for For refrigerated storage:
routine refrigeration defrost cycles
may be necessary. On the other Measure cooler temperature using a
continuous temperature-recording device
hand, minor variations in cooler
(e.g., a recording thermometer);
temperature measurements can be
avoided by submerging the sensor OR
for the temperature-recording device For storage under ice:
(e.g., temperature-recorder) in a liquid
that mimics the characteristics of the
adequacy of ice in a representative
product. Also note that critical limits number of containers (e.g., cartons and
during refrigerated storage that specify totes) from throughout the cooler.
a cumulative time and temperature
of exposure to temperatures above How Often Will Monitoring Be Done (Frequency)?
40F (4.4C) are not ordinarily suitable For continuous temperature-recording devices:
because of the difficulty in tracking
the specific products and the specific
Continuous monitoring during storage is
accomplished by the device itself, with a
cumulative temperature exposures visual check of the recorded data at least
that those products experience. The once per day;
cumulative exposure for each product
OR
would then need to be determined prior
to shipping. If you chose this approach, For storage under ice:
the critical limit for cumulative exposure Monitoring with sufficient frequency to
to temperatures above 40F (4.4C) ensure control.
should include time during transit,
refrigerated storage, and refrigerated and Who Will Do the Monitoring?
unrefrigerated processing; For continuous temperature-recording devices:
OR Monitoring is performed by the device

For raw material, in-process product, or generated by the device, to ensure that
finished product stored under ice:
The product is completely and
continuously surrounded by ice who has an understanding of the nature
throughout the storage time. of the controls;
146
OR OR
For other checks: Make adjustments to the ice application
operations.
Establish Corrective Action Procedures. For refrigerated storage:
Take the following corrective action to a product Printouts, charts, or readings from
involved in a critical limit deviation: continuous temperature-recording
devices;
Chill and hold the product until it can

be evaluated based on its total time and AND
temperature exposure, including exposures

during prior processing operations.
Record of visual checks of recorded data;
OR
OR
For storage under ice:
Chill and hold the affected product until
histamine analysis is performed on a The number of containers examined and
the sufficiency of ice for each;
minimum of 60 fish collected from throughout
each affected lot. Destroy the lot or divert AND
it to a non-food use if any fish is found The approximate number of containers
with histamine greater than or equal to 50 in the cooler.
ppm. The fish collected for analysis may
be composited if the action point is reduced Establish Verification Procedures.
accordingly. For example, a sample of 60 fish Before a temperature-recording device (e.g.,
may be composited into 20 units of 3 fish a recording thermometer) is put into service,
each, provided the action point is reduced check the accuracy of the device to verify that
from 50 ppm to 17 ppm for each unit; the factory calibration has not been affected.
OR This check can be accomplished by:
Destroy the product; Immersing the sensor in an ice slurry
OR
OR
AND
Comparing the temperature reading on
Take the following corrective actions to regain control the device with the reading on a known
over the operation after a critical limit deviation: accurate reference device (e.g., a NIST-
Prevent further deviation: traceable thermometer) under conditions
that are similar to how it will be used (e.g.,
OR range at which it will be used;
Move some or all of the product in the
AND
malfunctioning cooler to another cooler;
AND recording device daily before the beginning
Address the root cause: of operations. Less frequent accuracy checks
Make repairs or adjustments to the
by the instrument manufacturer and the
malfunctioning cooler;
147
consistently remains accurate for a longer
period of time. In addition to checking that
the device is accurate by one of the methods
described above, this process should include
device should be checked to ensure that it
is operational and, where applicable, has
AND
AND
When visual checks of ice are used,
periodically measure internal temperatures
of fish to ensure that the ice is sufficient
to maintain product temperatures at 40F
(4.4C) or less;
AND
preparation to ensure they are complete and
any critical limit deviations that occurred
were appropriately addressed.
148
TABLE 7-7
CONTROL STRATEGY EXAMPLE 5 - STORAGE CONTROL

This table is an example of a portion of a HACCP plan using Control Strategy Example 5 - Storage Control. This example illustrates how a fresh fish processor can
control scombrotoxin formation. It is provided for illustrative purposes only. It may be necessary to select more than one control strategy in order to fully control the hazard,
depending upon the nature of your operation.
Histamine formation may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., metal
fragments).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
CRITICAL MONITORING
CRITICAL LIMITS
POINT PREVENTIVE
MEASURE
Raw material Scombrotoxin Maximum Cooler Time and Continuous, Production Ice and hold the Data Check the
and finished formation cooler temperature temperature with a visual supervisor affected product logger data logger for
product cold temperature of data logger check of inside the cooler printout accuracy and
storage (shared 40F recorded data damage and to
149
cooler) once per day Check ensure that it
sufficiency of ice is operational
on the product before putting
two times per into operation;
day until cooler perform these
is functioning checks daily, at
reliably the beginning

of operations;
Perform and calibrate it
histamine analysis once per year
on a minimum
of 60 fish Review
representative monitoring,
of the affected corrective
product action, and
verification
Destroy all records within
affected 1 week of
product if any fish preparation
exceeds 50 ppm
histamine
Adjust and repair

cooler as needed
BIBLIOGRAPHY. seafood science). Elsevier, New York, NY.
Fletcher, G. C., G. Summers, and P. W. C.
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associated with fish, cheese, and other foods,
p. 1-47. World Health Organization, VPH/
FOS/85.1. Geneva, Switzerland.
Taylor, S. 1988. Marine toxins of microbial
origin. Food Technol. 42:94-98.
Taylor, S., and S. Summer. 1987. Detection
of histamine, cadaverine, and putrescine,
p. 235-246. In D. Kramer and J. Liston (ed.),
Seafood quality determination (Book 15 of
Developments in seafood science). Elsevier,
New York, NY.
Taylor, S. L., J. Y. Hui, and D. E. Lyons.
1984. Toxicology of scombroid poisoning, p.
417-430. In E. Ragelis (ed.), Seafood toxins.
American Chemical Society, Washington, DC.
van Spreckens, K. 1987. Histamine
production by psychrophilic flora, p.
309-318. In D. Kramer and J. Liston (ed.),
Seafood quality determination (Book 15 of
Developments in seafood science). Elsevier,
New York, NY.
Yongsawatdigul, J., Y. J. Choi, and S.
Udomporn. 2004. Biogenic amines
formation in fish sauce prepared from
fresh and temperature-abused Indian
anchovy (Stolephourus indicus). J. Food Sci.
69(4):312-319.
151
NOTES:
152
CHAPTER 8: Other Decomposition-Related Hazards
Chapter 7 covers scombrotoxin poisoning in

certain species of fish. This poisoning occurs as a
result of the formation of high levels of histamine
during decomposition of the fish at improper
holding temperatures.
There are indications that decomposition
can result in the production of other toxins
(e.g., biogenic amines, such as putrescine and
cadaverine) that have the potential to cause illness,
even in the absence of histamine formation. Such
illnesses have been reported with consumption of
a number of fish species. FDA also has received
a number of consumer complaints concerning
illnesses that are associated with the consumption
of decomposed shrimp and salmon.
There are also some indications that chemicals
formed when fats and oils in foods oxidize may
contribute to long-term detrimental health effects.
153
BIBLIOGRAPHY. Food Microbiol. 58:1-37.
Parrot, J., and G. Nicot. 1986. Absorption
We have placed the following references on de lhistamine par lappareil digestif, p.
display in the Division of Dockets Management, 148-161. In Handbuch der Experimentellen
Food and Drug Administration, 5630 Fishers Pharmakologie, Vol. 18. Springer-Verlag, New
Lane, rm. 1061, Rockville, MD 20852. You may York, NY.
see them at that location between 9 a.m. and 4 Quakenbush, F. W. 1945. Toxicity of rancid
p.m., Monday through Friday. As of March 29, fats. Oil & Soap. 22:336-338.
2011, FDA had verified the Web site address for Stratton, J., and S. Taylor. 1991. Scombroid
the references it makes available as hyperlinks poisoning, p. 331-351. In D. Ward and C.
from the Internet copy of this guidance, but FDA Hackney (ed.), Microbiology of marine food
is not responsible for any subsequent changes products. Van Nostrand Reinhold, New York,
to Non-FDA Web site references after March 29, NY.
2011.
Taylor, S. 1985. Histamine poisoning
Arnold, S. H., and D. W. Brown. 1978. associated with fish, cheese, and other foods,
Histamine toxicity from fish products. Adv. p. 1-47. World Health Organization, VPH/
Food Res. 24:113-154. FOS/85.1. Geneva, Switzerland.
Bjeldanes, L. F., D. E. Schultz, and M. M. Taylor, S. 1988. Marine toxins of microbial
Morris. 1978. On the aetiology of scombroid origin. Food Technol. 42:94-98.
poisoning: cadaverine potentiation of
Taylor, S., and S. Summer. 1987.
histamine toxicity in the guinea pig. Food
Determination of histamine, putrescine, and
Cosmet. Toxicol. 16:157-159.
cadaverine, p. 235-246. In D. Kramer and J.
Concon, J. 1988. Food toxicology. Part A. Liston (ed.), Seafood quality determination
Principles and concepts, p. 626-627. Marcel (Book 15 of Developments in food science).
Dekker, Inc., New York, NY. Elsevier, New York, NY.
Eitenmiller, R., and S. DeSouza. 1984.
Enzymatic mechanisms for amine formation Taylor, S. L., J. Y. Hui, and D. E. Lyons.
in fish, p. 431-442. In Ragelis, E. (ed.), 1984. Toxicology of scombroid poisoning, p.
Seafood toxins. American Chemical Society, 417-430. In E. Ragelis (ed.), Seafood toxins.
Washington, DC. American Chemical Society, Washington, DC.
Farn, G., and C. Sims. 1987. Chemical indices

of decomposition in tuna, p. 175-184. In D.
Kramer and J. Liston (ed.), Seafood quality
determination (Book 15 of Developments in
food science). Elsevier, New York, NY.
Guilln, M. D., and E. Goicoechea. 2008.
Toxic oxygenated alpha, beta-unsaturated
aldehydes and their study in foods: a review.
Crit. Rev. Food Sci. Nutr. 48:119-136.
Kubow, S. 1992. Routes of formation and
toxic consequences of lipid oxidation
products in foods. Free Radic. Biol. Med.
12:63-81.
Lehane, L., and J. Olley. 2000. Review:
histamine fish poisoning revisited. Int. J.
154
CHAPTER 9: Environmental Chemical Contaminants and Pesticides
UNDERSTAND THE POTENTIAL HAZARD. and used according to conditions described on the
label (40 CFR 180 and the Guide to Drug, Vaccine,
Environmental chemical contaminants and and Pesticide Use in Aquaculture, the Federal Joint
pesticides in fish pose a potential human health Subcommittee on Aquaculture (http://aquanic.org/
hazard. Fish can be harvested from waters that jsa/wgqaap/drugguide/drugguide.htm)).
are contaminated by varying amounts of industrial Many contaminants accumulate in the edible fatty
chemicals, including heavy metals and pesticides. tissues of fish. Concentrations of these contaminants
These contaminants may accumulate in fish at can vary considerably in individual fish of the same
levels that can cause human health problems species from the same location, depending on factors
(e.g., carcinogenic and mutagenic effects). The such as their fat content, size, age, and gender.
hazard is most commonly associated with
In the case of components or extracts of whole
exposure over a prolonged period of time (chronic
fish (e.g., dietary supplements, dietary ingredients,
exposure). Illnesses related to a single exposure
and flavors), the component or extract may contain
(one meal) are very rare. Concern for these
higher or lower concentrations of environmental
contaminants primarily focuses on fish harvested
chemical contaminants and pesticides than
from aquaculture ponds, freshwater bodies,
the whole fish from which it was derived. For
estuaries, and near-shore coastal waters (e.g., areas
example, organochlorine contaminants, such as
subject to shoreside contaminant discharges),
PCBs, are oil soluble. When producing fish oil
rather than from the open ocean. Environmental
and fish meal, any PCBs present will become
chemicals and pesticides may also accumulate
more concentrated in the oil fraction and less
in aquacultured fish through contaminated feed
concentrated in the water fraction, as compared
ingredients (e.g., pesticides in oil-containing feed
with the levels in the whole fish.
ingredients derived from near-shore bait fish).
Although some pesticides have not been produced Control of chemical contaminants
or used in the United States for many years (e.g., Federal tolerances and action levels are
dichloro-diphenyl-trichloroethane (DDT) and established for some of the most toxic and
polychlorinated biphenyls (PCBs)), many are very persistent contaminants that can be found in
persistent and tend to accumulate in soil and fish. These levels are listed in Table 9-1. State,
sediments. Once pesticides are introduced into the tribal, local, or foreign authorities may use the
environment, they may travel beyond their point federal tolerances or action levels to decide
of application or discharge. whether to issue local advisories to consumers
recommending limits on consumption of all or
Certain pesticides are applied directly to the water in
certain species of locally harvested fish (some of
aquaculture ponds to control weeds and algae and
which may be commercially important) or to close
to eliminate fish and invertebrates. These products
waters for commercial harvesting of all or certain
can be used legally only if they are registered with
species of fish.
the U.S. Environmental Protection Agency (US EPA)
155
In the case of molluscan shellfish, state, tribal, Tolerance and action levels
territorial and foreign government agencies, Table 9-1, Environmental Chemical Contaminants
called shellfish control authorities, consider the and Pesticides Tolerance and Action Levels,
degree of chemical contamination as part of their lists the tolerance and action levels that have
classification of harvesting waters. As a result of been established for environmental chemical
these classifications, molluscan shellfish harvesting contaminants and pesticides in the edible portion
is allowed from some waters and not from others. of fish (wet weight).
Shellfish control authorities then exercise control
over the molluscan shellfish harvesters to ensure that
harvesting takes place only when and where it has
been permitted. In this context, molluscan shellfish
include oysters, clams, mussels, and scallops.
Other significant elements of shellfish control
authorities efforts to control the harvesting of
molluscan shellfish include requirements that
(1) containers of in-shell molluscan shellfish
(shellstock) bear a tag that identifies the type
and quantity of shellfish, the harvester, harvest
location, and the date of harvest (21 CFR
123.28(c)); (2) molluscan shellfish harvesters be
licensed (note that licensing may not be required
in all jurisdictions); (3) processors that ship,
reship, shuck, or repack molluscan shellfish be
certified; and (4) containers of shucked molluscan
shellfish bear a label with the processors name,
Processors of seafood components and extracts
may choose to control environmental chemical
contaminants and pesticides at receipt (e.g., by
screening raw materials). If contaminants in
the raw material are present at unacceptable
levels, processors may reject the product or
choose to implement refining steps that reduce
the contaminants to acceptable levels in the
finished product. These steps may include
distillation, absorption, and steam deodorization.
You should validate the effectiveness of these
refining steps at reducing environmental and
chemical contaminants to an acceptable level
and include appropriate controls in your Hazard
Analysis Critical Control Point (HACCP) plan. No
further information on these control measures is
provided in this guidance document.
156
TABLE 9-1
ENVIRONMENTAL CHEMICAL CONTAMINANTS AND PESTICIDES TOLERANCE AND ACTION LEVELS
Tolerance Levels
DELETERIOUS LEVEL IN
FOOD COMMODITY REFERENCE
SUBSTANCE EDIBLE TISSUE
PCBs 2 ppm All fish 21 CFR 109.30

Carbaryl 0.25 ppm Oysters 40 CFR 180.169
Diquat 2 ppm Fish 40 CFR 180.226
Diquat 20 ppm Shellfish 40 CFR 180.226
Diuron and its 2 ppm Farm-raised, 40 CFR 180.106
metabolites freshwater finfish
Endothall and 0.1 ppm All fish 40 CFR 180.293
its monomethyl ester
Fluridone 0.5 ppm Finfish and 40 CFR 180.420
crayfish
Glyphosate 0.25 ppm Fish 40 CFR 180.364
Glyphosate 3 ppm Shellfish 40 CFR 180.364
2,4-D 0.1 ppm Fish 40 CFR 180.142
2,4-D 1 ppm Shellfish 40 CFR 180.142
Action Levels
DELETERIOUS LEVEL IN
FOOD COMMODITY REFERENCE
SUBSTANCE EDIBLE TISSUE
Aldrin and 0.3 ppm All fish Compliance Policy Guide, Sec. 575.100
dieldrin1
Benzene 0.3 ppm Frog legs Compliance Policy Guide, Sec. 575.100
hexachloride
Chlordane 0.3 ppm All fish Compliance Policy Guide, Sec. 575.100
Chlordecone 2
0.3 ppm All fish Compliance Policy Guide, Sec. 575.100
Chlordecone2 0.4 ppm Crabmeat Compliance Policy Guide, Sec. 575.100
DDT, TDE, 5 ppm All fish Compliance Policy Guide, Sec. 575.100
and DDE3
Methylmercury4 1 ppm All fish Compliance Policy Guide, Sec. 540.600
Heptachlor and 0.3 ppm All fish Compliance Policy Guide, Sec. 575.100
Heptachlorepoxide5
Mirex 0.1 ppm All fish Compliance Policy Guide, Sec. 575.100
1. The action level for aldrin and dieldrin is for residues of the pesticides individually or in combination. However, in calculating a total, amounts
of aldrin or dieldrin found at below 0.1 ppm are not counted.
2. Previously listed as Kepone, the trade name of chlordecone.
3. The action level for DDT, TDE, and DDE is for residues of the pesticides individually or in combination. However, in calculating a total, amounts
of DDT, TDE, and DDE found below 0.2 ppm are not counted.
4. See Chapter 10 for additional information.
5. The action level for heptachlor and heptachlor epoxide is for the pesticides individually or in combination. However, in calculating a total,
amounts of heptachlor and heptachlor epoxide found below 0.1 ppm are not counted.
157
DETERMINE WHETHER THE POTENTIAL 2. Can unsafe levels of environmental chemical
HAZARD IS SIGNIFICANT. contaminants and pesticides that were introduced
earlier be eliminated or reduced to an acceptable
The following guidance will assist you in level at this processing step?
determining whether environmental chemical Environmental chemical contaminants and
contaminants and pesticides are a significant pesticides should be considered a significant
hazard at a processing step: hazard at any processing step where a
1. Is it reasonably likely that unsafe levels of preventive measure is or can be used
environmental chemical contaminants or to eliminate the hazard or to reduce the
pesticides will be introduced at this processing likelihood of its occurrence to an acceptable
step (e.g., do such contaminants and pesticides level. Preventive measures for environmental
come in on the raw material)? chemical contaminants and pesticides can
include:
Tables 3-2 and 3-3 (Chapter 3) identify the
species of fish for which environmental For wild-caught fish other than molluscan
chemical contaminants and pesticides shellfish:
are a potential hazard. Under ordinary Making sure that incoming fish have
circumstances, it would be reasonably likely not been harvested from waters that are
to expect that, without proper controls, closed to commercial harvest because of
unsafe levels of environmental chemical concentrations of environmental chemical
contaminants and pesticides could enter contaminants or pesticides exceeding
the process at the receiving step from the federal tolerance or action levels;
those species. However, there may be
Making sure that incoming fish have
circumstances that would allow you to
not been harvested (for commercial
conclude that it is not reasonably likely for
purposes) from the same waters that
unsafe levels of environmental chemical
are under a consumption advisory
contaminants and pesticides to occur in
by a state, tribal, territorial, local, or
fish harvested from your area. You should
foreign regulatory authority based
be guided by the historical occurrence of
on a determination by the authority
environmental contaminants and pesticides,
that fish harvested from these waters
at levels above established tolerance and
are reasonably likely to contain
action levels, in fish from the area in which
contaminants above the federal
your fish are caught. This information may be
tolerance or action levels. Note that
available from federal, state, tribal, territorial,
many consumption advisories are not
local, or foreign health or environmental
based on such a determination.
authorities in the area where your fish are
caught. For aquacultured fish other than molluscan
shellfish:
If you are receiving fish, other than molluscan
shellfish, from another processor, you would Reviewing, at time of receipt, the
not need to identify environmental chemical producers lot-by-lot certification that
contaminants and pesticides as a significant harvest is from uncontaminated waters,
hazard. This hazard should have been fully coupled with appropriate verification;
controlled by the primary (first) processor. Reviewing, at time of receipt, test results
of fish tissue samples or production
site water for those contaminants that
158
are reasonably likely to be present, and firm, it may be possible and desirable to
obtaining information on present land exercise preventive measures early in the
use practices in the area immediately process (ideally when the cultivation site is
surrounding the production area (tests selected), rather than at receipt of the fish
and monitoring may be performed by at the processing plant. Such preventive
the aquacultural producer, a state, tribal, measures will not be covered in this
territorial, local, or foreign authority, guidance document.
or a third-party organization);
Intended use
Conducting on-farm visits to the
For environmental chemical contaminants and
aquacultural producer to collect and
pesticides, it is unlikely that the intended use of the
analyze water or fish samples for those
product will affect the significance of the hazard.
environmental chemical contaminants
and pesticides that are reasonably likely
IDENTIFY CRITICAL CONTROL POINTS.
to be present, and to review present land
use practices in the area immediately
surrounding the production area;
Reviewing, at time of receipt, evidence critical control point (CCP) for the hazard of
(e.g., a third-party certificate) that environmental chemical contaminants and
the producer operates under a third pesticides:
party-audited Quality Assurance (QA)
Is the raw material an aquacultured product other than
program for environmental chemical
molluscan shellfish?
contaminants and pesticides (e.g., the
National Aquaculture Associations Fish 1. If the raw material is an aquacultured product
Producers Quality Assurance Program); other than molluscan shellfish, do you have a
Conducting, at time of receipt, relationship with the producer that enables you to
environmental chemical contaminant visit the farm before receipt of the fish?
and pesticide testing of fish tissue
a. If you have such a relationship with
for those contaminants that are
the producer, then you should identify
reasonably likely to be present.
the pre-harvest step as the CCP for
For molluscan shellfish, both aquacultured environmental chemical contaminants
and wild caught: and pesticides. The preventive measure
for this type of control is:
shellfish to ensure that containers Conducting on-farm visits to the
are properly tagged or labeled; aquacultural producer to collect
Screening incoming molluscan shellfish and analyze water or fish samples
to ensure that they are supplied by a for those environmental chemical
licensed harvester (where licensing is contaminants and pesticides that
required by law) or by a certified dealer. are reasonably likely to be present,
and to review present land use
These preventive measures are ordinarily practices in the area immediately
employed either at the receiving step or surrounding the production area.
at the pre-harvest step. In the case of an
integrated operation, where fish cultivation Example:
and processing are performed by the same An aquacultured catfish processor
that regularly purchases from the same
159
producers should visit the producers verification and should set the CCP
before the fish are harvested. The at receiving.
processor should collect and analyze
water or fish samples for those
strategy referred to in this chapter
as Control Strategy Example 2 -
Suppliers Certification.
to be present and should review present
land use at the pond site and in the Reviewing, at time of receipt,
adjacent areas. The processor should test results of water or fish tissue
then set the CCP for environmental samples for those contaminants that
chemical contaminants and pesticides are reasonably likely to be present
at the pre-harvest step. and obtaining information on the
present land use practices in the
area immediately surrounding the
production area (the aquaculture
Control Strategy Example 1 - On-
producer, a state, tribal, territorial,
Farm Visits.
local or foreign authority, or a
b. If no such relationship exists with the third-party organization may
producer, then you should identify perform tests and monitoring).
the receiving step as the CCP for Example:
environmental chemical contaminants A farm-raised catfish processor
and pesticides. At the receiving step, you purchases catfish from producers
should exercise one of the following with which the processor has no
preventive measures: long-term relationship. The processor
Reviewing, at time of receipt, requires all new suppliers to provide
the suppliers lot-by-lot the test results of water samples or
certification of harvesting from fish tissue for those contaminants
uncontaminated waters, coupled that are reasonably likely to be
with appropriate verification. present and reports on present
agricultural and industrial land use
Example: at and near the pond site. The land
An aquacultured shrimp processor use reports are updated annually
that purchases raw material through and whenever information on the
various brokers should receive lot land use change warrants a more
by-lot certificates from the suppliers. frequent update (the aquaculture
The certificates would state that producer, a state, tribal, territorial,
shrimp were not harvested from local or foreign authority, or a third-
contaminated waters that would party organization may perform
cause the levels in shrimp to exceed tests and monitoring). The processor
the established tolerance or action should set the CCP at receiving.
levels. The processor should combine
this monitoring procedure with This control approach is a control
quarterly raw material testing strategy referred to in this chapter
for those environmental chemical as Control Strategy Example 3 -
contaminants and pesticides that are Records of Testing and Monitoring.
reasonably likely to be present for
160
Conducting, at time of receipt, Is the raw material molluscan shellfish (aquacultured or
analysis of fish tissue for wild caught) or wild caught fish other than molluscan
those environmental chemical shellfish?
contaminants and pesticides that are
reasonably likely to be present. 1. If the raw material is molluscan shellfish or wild-
caught fish other than molluscan shellfish, you
Example: should identify the receiving step as the CCP
An aquacultured shrimp processor for environmental chemical contaminants and
that purchases raw material pesticides. At the receiving step, you should
through various brokers should exercise the following preventive measures:
screen all incoming lots of shrimp
for those environmental chemical a. For wild-caught fish other than
contaminants and pesticides that molluscan shellfish:
are reasonably likely to be used in

the production area. The processor Making sure that incoming fish have
should set the CCP at receiving. not been harvested from waters
that are closed to commercial
This control approach is a control harvest because of concentrations of
strategy referred to in this chapter environmental chemical contaminants
or pesticides exceeding the federal
Chemical Contaminant Testing.
tolerance or action levels;
Reviewing, at time of receipt,
Making sure that incoming fish have
evidence (e.g., a continuing or
not been harvested from waters that
lot-by-lot third- party certificate)
are under a consumption advisory
that the producer operates under
by a state, tribal, territorial, local,
a third-party-audited QA program
or foreign regulatory authority
that covers environmental chemical
based on a determination by the
contaminants and pesticides.
authority that fish harvested from
The certificate should outline the
audit steps and summarize the the waters are reasonably likely to
water and/or fish test results. contain contaminants above the
federal tolerance or action levels.
Example:
Example:
An aquacultured trout processor that A processor purchases bluefish directly
regularly purchases raw trout from the from the harvester. The processor
same producer should obtain a third- asks the harvester where the fish were
party certificate, valid for 1 year (i.e., caught. The processor then compares
a continuing certificate), that attests the harvest area location with the areas
that the producer operates under a QA that are closed to commercial fishing by
program that controls environmental
state or local regulatory authorities or
chemical contaminants and pesticides
that are under consumption advisories
or should receive a lot-by-lot certificate
that include bluefish and that are
issued by the third party. The processor
based on the reasonable likelihood that
should set the CCP at receiving.
a contaminant level in fish tissue will
This control approach is a control exceed a federal tolerance or action
strategy referred to in this chapter level. The processor should set the CCP
as Control Strategy Example 5 - QA at receiving.
Program.
161
This control approach is a control MAY APPLY TO MAY APPLY TO
strategy referred to in this chapter as CONTROL STRATEGY PRIMARY SECONDARY
PROCESSOR PROCESSOR
Control Strategy Example 6 - Source
Control for wild caught Fish Other
On-farm visit
Than Molluscan Shellfish. Suppliers certification
Records of testing and
b. For molluscan shellfish: monitoring
Chemical contaminant
Checking incoming molluscan testing
QA program
Source control for wild
Checking incoming molluscan caught fish other than
molluscan shellfish
supplied by a licensed harvester Source control for
molluscan shellfish
(where licensing is required by
law) or by a certified dealer.
Example:
CONTROL STRATEGY EXAMPLE 1 - ON-FARM
A processor purchases oysters directly VISIT
from the harvesters. The processor
should check the harvest location
on the tags attached to the sacks of Environmental chemical contaminants
oysters. The processor should then and pesticides that are reasonably likely
compare the harvest area location to be present in farm water may not be
with information on closed waters at levels so high that they are reasonably
and check the harvesters state likely to result in concentrations in fish
licenses. The processor should set the tissue above the established tolerance or
CCP at receiving. action levels (refer to Table 9-1). Elevated
concentrations of chemical contaminants
in water can be an indication that they are
reasonably likely to be present in the fish
Control Strategy Example 7 - Source
tissue. Note that US EPA has developed water
Control for Molluscan Shellfish.
quality guidance documents that may be
suitable for evaluating water quality in local
DEVELOP A CONTROL STRATEGY. situations (U.S. EPA Water Quality Standards
Handbook, Appendix I);
The following guidance provides seven
control strategies for environmental chemical OR
contaminants and pesticides. It is important to The levels of environmental contaminants
note that you may select a control strategy that and pesticides in fish tissue samples that
is different from those which are suggested, are reasonably likely to be present may not
provided it complies with the requirements of the exceed the established tolerance or action
applicable food safety laws and regulations. levels (refer to Table 9-1);
The following are examples of control strategies AND
included in this chapter: Agricultural and industrial practices in the
area near the production site must not be
reasonably likely to cause contamination
162
of the fish tissue above the established Who Will Do the Monitoring?
tolerance or action levels (refer to Table 9-1). Any person who has an understanding of the
What Will Be Monitored? Establish Corrective Action Procedures.
The levels of environmental chemical Take the following corrective action to a product
contaminant and pesticide residues found in involved in a critical limit deviation:
water or in fish tissue for those contaminants Do not have the product shipped from the
that are reasonably likely to occur; production site for processing.
AND AND
Agricultural and industrial practices in the Take the following corrective action to regain control
area near the production site. over the operation after a critical limit deviation:
How Will Monitoring Be Done? Discontinue use of the supplier until
Collect and analyze water samples or fish evidence is obtained that the cause of the
tissue samples from each production site; chemical contamination has been eliminated.
AND Establish a Recordkeeping System.

Ask questions about and observe agricultural Test results;
and industrial practices in the area near the
production site, such as: AND
On-site audit report.
Which types of crops, if any, are grown
in the area near the production site?
What pesticides, if any, are used on these
crops, how are they applied, and at what
time of year? records within 1 week of preparation
What industrial and urban discharges, if
any, enter the watershed surrounding the
production site?

For testing water:
Before first delivery from each
production site;
OR
For testing fish tissue:

Before each delivery;
AND
For evaluating agricultural and industrial
practices:
At least once per year for each
production site.
163
TABLE 9-2
CONTROL STRATEGY EXAMPLE 1 - ON-FARM VISITS

This table is an example of a portion of a HACCP plan using Control Strategy Example 1 - On-Farm Visits. This example illustrates how an aquacultured catfish processor can
control environmental chemical contaminants and pesticides. It is provided for illustrative purposes only.
Environmental chemical contaminants and pesticides may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential
hazards (e.g., aquaculture drugs, food and color additives, and metal fragments).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
CRITICAL MONITORING
LIMITS
CRITICAL SIGNIFICANT CORRECTIVE
FOR EACH RECORDS VERIFICATION
CONTROL POINT HAZARD(S) WHAT HOW FREQUENCY WHO ACTION(S)
PREVENTIVE
MEASURE
Pre-harvest Environmental Levels of Environmental Collect samples Before each Field agent will Do not have the Test Review
chemical environmental chemical and analyze for harvest submit samples product shipped results monitoring
contaminants chemical contaminant environmental to the contract for processing and correction
and pesticides contaminants and and pesticide chemical laboratory action records
pesticides in fish levels in fish contaminants Discontinue use within 1 week
164
tissue may not tissue for those and pesticides* of the supplier of preparation
exceed established contaminants until evidence
tolerance and action that are is obtained that
levels for those reasonably the cause of
contaminants that likely to be the chemical
are reasonably likely present* contamination has
to be present* been eliminated
Agricultural and Agricultural Ask questions Once per year Field agent Do not have the Field Review
industrial practices and industrial and observe product shipped agent monitoring
in the area near the practices near agricultural for processing report and correction
pond must not be the pond and industrial action records

reasonably likely to practices Discontinue use within 1 week
cause contamination of the supplier of preparation
of the fish until evidence
tissue above is obtained that
the established the cause of
tolerances and the chemical
action levels contamination has
been eliminated
* Note: This plan is for illustrative purposes only. An actual plan should specify (1) in the Critical Limits column: the environmental chemical contaminants and pesticides that are reasonably likely to
be present and the critical limits to be applied to each contaminant; and (2) in the Monitoring columns: the contaminants for which analysis will be conducted, the protocol for sample collection,
and the analytical method to be used for each contaminant.
CONTROL STRATEGY EXAMPLE 2 - SUPPLIERS Establish a Recordkeeping System.
CERTIFICATION Copy of the certificate;
Set Critical Limits. AND
A certificate accompanying all lots received Receiving record showing lots received and
(lot by lot) that indicates that fish were not the presence or absence of a certificate.
harvested from contaminated waters that
could cause the levels in fish tissue to exceed Establish Verification Procedures.
the established federal tolerance and action
Visit all new aquacultured fish producers
levels (refer to Table 9-1).
within the year and all existing fish suppliers
at a predetermined frequency (e.g., 25% per
Establish Monitoring Procedures. year) to collect and analyze water or fish
What Will Be Monitored? tissue samples, as appropriate, for those
Presence of a certificate indicating harvesting
from uncontaminated waters.
to be present, and review agricultural and
How Will Monitoring Be Done? industrial practices in the production area;
Visual check for the presence of a certificate. OR
How Often Will Monitoring Be Done (Frequency)? Collect a representative sample of the raw
material, in-process product, or finished
Each lot received.
product at least quarterly, and analyze it for
Who Will Do the Monitoring? those environmental chemical contaminants
and pesticides that are reasonably likely to
be present;
AND
Establish Corrective Action Procedures. Review monitoring, corrective action,
Take the following corrective action to a product and verification records within 1 week of
involved in a critical limit deviation: preparation to ensure they are complete and
Reject the lot;
OR
Hold the lot until a certificate can be
provided;
OR
Hold and analyze the lot for those environmental
chemical contaminants and pesticides that are
AND
evidence is obtained that the supplier will
comply with the certification controls.
165
TABLE 9-3
CONTROL STRATEGY EXAMPLE 2 - SUPPLIERS CERTIFICATION

This table is an example of a portion of a HACCP plan using Control Strategy Example 2 - Suppliers Certification. This example illustrates how an aquacultured shrimp
processor can control environmental chemical contaminants and pesticides. It is provided for illustrative purposes only.
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
CRITICAL MONITORING
LIMITS
PREVENTIVE
MEASURE
Receiving Environmental Certificate Presence Visual Each lot Receiving dock Reject lot Copy of the Review
chemical accompanying of a check received employee certificate monitoring,
contaminants all lots received certificate Discontinue use corrective
and pesticides indicates that of the supplier Receiving action, and
fish were not until evidence record verification
166
harvested from is obtained that records within
contaminated the supplier 1 week of
waters that will comply preparation
could cause the with the
levels in fish certification Visit all new
tissue to exceed controls aquacultured
the established fish producers
federal within the year
tolerance and and 25% of
action levels existing
suppliers each

year to collect
and analyze
water samples,
and review
agricultural
and industrial
practices in
the area
CONTROL STRATEGY EXAMPLE 3 - RECORDS OF pesticides that are reasonably likely to be
TESTING AND MONITORING present;
Reports of analyses of the water from all Monitoring results for agricultural and
new suppliers that show that levels of those industrial practices.
environmental chemical contaminants How Will Monitoring Be Done?
Visual check of test results and monitoring
to be present are not so high that they are
reports.
reasonably likely to result in levels in the
fish tissue that exceed the established federal How Often Will Monitoring Be Done (Frequency)?
tolerance and action levels (refer to Table 9-1).
For results of water testing:
(The aquaculture producer, a state, tribal,
territorial, local, or foreign authority, or a All new suppliers;
third-party organization may perform tests.) OR
Note that US EPA has developed water quality For results of fish tissue testing:
documents that may be suitable for evaluating
water quality in local situations (U.S. EPA Water Each delivery;
Quality Standards Handbook, Appendix I); AND
OR For reports of evaluation of agricultural and
industrial practices:
Reports of analyses of fish tissue for each

delivery that show that levels of those At least once every year.

to be present are below the established Any person who has an understanding of the
federal tolerance and action levels (the nature of the controls.
aquaculture grower, a state, tribal, territorial,
local, or foreign authority, or a third-party Establish Corrective Action Procedures.
organization may perform tests); Take the following corrective action to a product
AND
Reports from all suppliers that show that Reject the lot.
agricultural and industrial practices in the AND
area near the aquaculture production site are
not reasonably likely to cause contamination
of fish tissue above the established federal
tolerance or action levels (the aquaculture Discontinue use of the supplier until
producer, a state, tribal, territorial, local, evidence is obtained that the supplier will
or foreign authority, or a third-party comply with the testing and evaluation
organization may perform monitoring). controls.
Establish Monitoring Procedures. Establish a Recordkeeping System.

Test results;
AND
Test results of water or fish tissue for those
environmental chemical contaminants and Reports of evaluation of agricultural and
industrial practices.
167
TABLE 9-4
CONTROL STRATEGY EXAMPLE 3 - RECORDS OF TESTING AND MONITORING

This table is an example of a portion of a HACCP plan using Control Strategy Example 3 - Records of Testing and Monitoring. This example illustrates how a farm-raised catfish
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
CRITICAL MONITORING
CRITICAL LIMITS
POINT PREVENTIVE
MEASURE
Receiving Environmental Reports of analyses of Reports of Visual At first Quality Reject the lot Test Review
chemical the water from all new analyses check delivery control staff results monitoring
contaminants suppliers that show that showing levels Discontinue use and
and pesticides levels of environmental of environmental of the supplier corrective
chemical contaminants chemical until evidence action
168
and pesticides that are contaminants is obtained that records
reasonably likely to be and pesticides in the supplier will within 1
present are not so high water samples comply with the week of
that they are likely to for those testing and preparation
result in levels in fish contaminants that evaluation
tissue that exceed the are reasonably controls.
established federal likely to be
tolerance or action levels* present*
Reports from all suppliers Reports of Visual Once per year Quality Reject the lot Reports of Review
that show that agricultural agricultural check control staff agricultural monitoring
and industrial practices and industrial Discontinue use and and

in the area near the practices in the of the supplier industrial corrective
production site are not area near the until evidence practices action
reasonably likely to production site is obtained that records
cause contamination the supplier will within
of fish tissue above the comply with the 1 week of
established tolerance or testing and preparation
action levels evaluation
controls
Establish Verification Procedures. the chemical contamination has been
Review monitoring and corrective action eliminated.
to ensure they are complete and any Establish a Recordkeeping System.
critical limit deviations that occurred were Test results.
CONTROL STRATEGY EXAMPLE 4 - CHEMICAL
Periodically verify the adequacy of the
CONTAMINANT TESTING
testing methods and equipment (e.g., by
Set Critical Limits. comparing results with those obtained
No lot may exceed the federal tolerance using an Association of Official Analytical
or action levels for those environmental Chemists, or equivalent method, or by
chemical contaminants and pesticides that analyzing proficiency samples);
are reasonably likely to be present (refer to AND
Table 9-1). Review monitoring, corrective action and
verification records within 1 week of
Establish Monitoring Procedures. preparation to ensure they are complete and
What Will Be Monitored? any critical limit deviations that occurred
Fish tissue for those environmental chemical
contaminants and pesticides that are

Obtain samples and analyze for
environmental chemical contaminants and
pesticides.

Each lot received.

Any person who is qualified by training or
experience to perform the analyses.

Take the following corrective action to product involved
in a critical limit deviation:
Reject the lot.
AND

evidence is obtained that the cause of
169
TABLE 9-5
CONTROL STRATEGY EXAMPLE 4 - CHEMICAL CONTAMINANT TESTING

This table is an example of a portion of a HACCP plan using Control Strategy Example 4 - Chemical Contaminant Testing. This example illustrates how an aquacultured shrimp
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
CRITICAL MONITORING
LIMITS
CRITICAL CON SIGNIFICANT CORRECTIVE
TROL POINT HAZARD(S) WHAT HOW FREQUENCY WHO ACTION(S)
PREVENTIVE
MEASURE
Receiving Environmental No lot of Chemical Obtain samples Each lot Receiving Reject the lot Test Annual
chemical shrimp may residue levels and received employee will results methods
contaminants exceed the in shrimp analyze for submit sample Discontinue use comparison to
and pesticides established tissue that are environmental to quality of the supplier AOAC methods
tolerance or reasonably chemical control staff until evidence
170
action likely to be contaminants is obtained that Review
levels for present* and pesticides* the cause of monitoring
environmental the chemical and corrective
chemical contamination action records
contaminants has been within 1 week
and pesticides eliminated of
that are preparation
reasonably
likely to be
present*

CONTROL STRATEGY EXAMPLE 5 - QA AND
PROGRAM
Set Critical Limits. over the operation after a critical limit deviation:
A certificate indicating that the producer Discontinue use of the supplier until
operates under a third-party-audited QA evidence is obtained that the supplier will
program that covers environmental chemical comply with the certification controls.
contaminants and pesticides. The certificate
may accompany each lot of incoming Establish a Recordkeeping System.
aquacultured fish or may be issued for each Third-party certificates;
producer of incoming aquacultured fish as a
AND
continuing certification.
Records showing lots received and the
presence or absence of a certificate.
What Will Be Monitored? Establish Verification Procedures.
Certificate indicating operation under a third Review the third-party-audited QA program
party-audited QA program. and results of audits annually;
How Will Monitoring Be Done? AND

Visual check for the presence of a certificate. Review monitoring, corrective action,
How Often Will Monitoring Be Done (Frequency)? preparation to ensure they are complete and
Each lot received is checked for the presence any critical limit deviations that occurred
of a certificate. Certificates may be issued on were appropriately addressed.
continuing (not less often than annually) or
lot-by-lot basis.


Reject the lot;
OR
provided;
OR
Hold and analyze the lot for those
environmental chemical contaminants and
pesticides that are reasonably likely to be
present.
171
TABLE 9-6
CONTROL STRATEGY EXAMPLE 5 - QA PROGRAM

This table is an example of a portion of a HACCP plan using Control Strategy Example 5 - QA Program. This example illustrates how an aquacultured trout processor can
control environmental chemical contaminants and pesticides. It is provided for illustrative purpose only.
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
CRITICAL MONITORING
LIMITS
PREVENTIVE
MEASURE
Receiving Environmental Certificate Presence of a Visual check for Each lot Receiving dock Reject the lot Certificate Review the
chemical indicating that third-party the presence of employee third-party-
contaminants the producer certificate a certificate Discontinue use Receiving audited QA
and pesticides operates under of the supplier record program and
a third-party until evidence results of audits
172
audited QA is obtained that annually
program that the supplier
covers will comply Review
environmental with the monitoring,
chemical certification corrective
contaminants controls action, and
and pesticides verification
records within
1 week of
preparation

CONTROL STRATEGY EXAMPLE 6 - SOURCE Establish Corrective Action Procedures.
CONTROL FOR WILD CAUGHT FISH OTHER THAN
MOLLUSCAN SHELLFISH
Set Critical Limits. Reject the lot;
No fish may be harvested from an area that is OR
closed to commercial harvesting by state, tribal,
For fish harvested from an area under a
territorial, local, or foreign authorities because
consumption advisory based on federal
of concentrations of environmental chemical
tolerance or action levels:
contaminants or pesticides exceeding the
federal tolerance or action levels; Sample the lot and analyze it for the
appropriate environmental chemical
AND contaminant or pesticide. Reject the lot if
No fish may be harvested from an area that the results exceed the federal tolerance
is under a consumption advisory by a, state, or action level.
tribal, territorial, local, or foreign regulatory
AND
authority based on a determination by the
authority that fish harvested from the waters Take the following corrective action to regain control
are reasonably likely to contain contaminants over the operation after a critical limit deviation:
above the federal tolerance or action levels. Discontinue use of the supplier until
Note that many consumption advisories are evidence is obtained that harvesting practices
not based on such a determination. have changed.
Establish Monitoring Procedures. Establish a Recordkeeping System.

What Will Be Monitored? Receiving records that document the location
and whether the harvest area is subject to
Location of harvest and whether the
closure or consumption advisory.
harvest area is subject to closure or
consumption advisory.
How Will Monitoring Be Done? Review monitoring and corrective action
Ask the harvester for the harvest site at time records within 1 week of preparation
of receipt, or obtain the information from the to ensure they are complete and any
harvesters catch record, where applicable; critical limit deviations that occurred were
AND
Ask the state, tribal, territorial, local, or
foreign authorities in which your fish are
harvested whether there are closures or
consumption advisories that apply to the
areas from which your fish are harvested.

Every lot received.

173
TABLE 9-7
CONTROL STRATEGY EXAMPLE 6 - SOURCE CONTROL

FOR WILD CAUGHT FISH OTHER THAN MOLLUSCAN SHELLFISH
This table is an example of a portion of a HACCP plan using Control Strategy Example 6 - Source Control for Wild Caught Fish Other Than Molluscan Shellfish. This example
illustrates how a wild caught bluefish processor can control environmental chemical contaminants and pesticides. It is provided for illustrative purposes only.
Environmental contaminants and pesticides from the harvest area may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other
potential hazards (e.g., scombrotoxin (histamine), metal fragments).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
CRITICAL MONITORING
LIMITS
PREVENTIVE
MEASURE
Receiving Environmental No fish may be harvested Location of Ask the Each lot Receiving Reject the lot Receiving Review
chemical from an area that is closed to harvest and harvester for received dock record monitoring
contaminants commercial harvesting by state, whether the the harvest employee Discontinue and
and pesticides or local authorities because of harvest area location, and use of the corrective
174
concentrations of environmental is subject to ask state supplier action
chemical contaminants or closure or and local until records
pesticides exceeding the federal consumption authorities the evidence within
tolerance or action levels advisory status of the is obtained 1 week of
area that preparation
No fish may be commercially harvesting
harvested from an area that is practices
under a consumption advisory have
by a state, local, or local changed
regulatory authority based on a
determination by the authority

that fish harvested from the
waters are reasonably likely to
contain contaminants above the
federal tolerance or action levels
CONTROL STRATEGY EXAMPLE 7 - SOURCE All molluscan shellfish must be from a
CONTROL FOR MOLLUSCAN SHELLFISH harvester that is licensed as required (note
that licensing may not be required in all
jurisdictions) or from a processor that is
All containers of shellstock (in-shell certified by a shellfish control authority.
molluscan shellfish) received from a Note: Only the primary processor (the processor that receives
harvester must bear a tag that discloses the molluscan shellfish directly from the harvester) needs to apply controls
date and place they were harvested (by state relative to the identification of the harvester, the harvesters license, or
the approval status of the harvest waters.
and site), the type and quantity of shellfish,
and the harvesters or harvesters vessel
information (i.e., the identification number Establish Monitoring Procedures.
assigned to the harvester by the shellfish What Will Be Monitored?
control authority, where applicable, or if
The information contained on tags on
such identification numbers are not assigned,
containers of incoming shellstock or on
the name of the harvester or the name or
the bill of lading or other similar shipping
registration number of the harvesters vessel).
document accompanying bulk shipments of
For bulk shipments of shellstock, where the
shellstock and whether the harvest area is
shellstock is not containerized, the shellstock
authorized for harvest by a shellfish control
must be accompanied by a bill of lading
authority;
or other similar shipping document that
contains the same information; AND
Note: The source controls listed in this critical limit are required under The license of the harvester;
21 CFR 123.28(c).
OR
OR
The information contained on labels on
All containers of shellstock received from containers of incoming shucked molluscan
a processor must bear a tag that discloses shellfish.
the date and place they were harvested
(by state and site), the type and quantity of How Will Monitoring Be Done?
shellfish, and the certification number of the Perform visual checks;
processor;
AND
OR Ask the relevant shellfish control authority
All containers of shucked molluscan shellfish whether the harvest area is authorized for
must bear a label that identifies the name, harvest.
packer or repacker of the product; How Often Will Monitoring Be Done (Frequency)?
For checking tags:
AND
All molluscan shellfish must have been Every container;
harvested from waters authorized for AND
harvesting by a shellfish control authority. For checking harvester licenses:
For U.S. federal waters, no molluscan
shellfish may be harvested from waters that Every delivery;
are closed to harvesting by an agency of the OR

federal government;
AND
175
For checking labels: For shucked molluscan shellfish:
At least three containers randomly Receiving record that documents:

selected from throughout every lot.
Date of receipt;
Any person who has an understanding of the Quantity and type of shellfish;
AND
Establish Corrective Action Procedures. Name and certification number of the

packer or repacker.
involved in a critical limit deviation: Establish Verification Procedures.
Reject the lot. Review monitoring and corrective action
AND records within 1 week of preparation
evidence is obtained that harvesting and/or
tagging practices have changed.

For shellstock:
Date of harvest;
AND
AND
AND
AND
Number and date of expiration of the
harvesters license, where applicable;
AND
where applicable.
176
TABLE 9-8
CONTROL STRATEGY EXAMPLE 7 - SOURCE CONTROL FOR MOLLUSCAN SHELLFISH

This table is an example of a portion of a HACCP plan using Control Strategy Example 7 - Source Control for Molluscan Shellfish. The example illustrates how a processor of
shellstock oysters received directly from a harvester can control environmental chemical contaminants and pesticides. It is provided for illustrative purposes only.
Environmental contaminants and pesticides from the harvest area may be only one of several significant hazards for this product. Refer to Tables 3-3 and 3-4 (Chapter 3) for other
potential hazards (e.g., natural toxins and pathogens from the harvest area).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
CRITICAL MONITORING
LIMITS
PREVENTIVE
MEASURE
Receiving Environmental All shellstock must be Information Visual checks Every sack Receiving Reject Receiving Review
chemical tagged with the date on incoming employee untagged sacks record monitoring
contaminants and place of harvest, shellstock tags and
and pesticides type and quantity of Discontinue use corrective
shellfish, and name or of the supplier action
177
registration number of until evidence records
the harvesters vessel is obtained that within
tagging practices 1 week of
have changed preparation
All shellstock must be Harvest site on Perform Every lot Reject lots from
from waters tags visual checks unapproved waters
approved by the state and ask the
shellfish control shellfish control Discontinue use
authority authority of the supplier
whether until evidence
the area is is obtained that

authorized for harvesting practices
harvest have changed
All shellstock must be License of Perform visual Every Reject lots from
from licensed harvester checks delivery unlicensed
harvesters harvesters
Discontinue use
of the supplier
until evidence
is obtained that
the harvester is
properly licensed
BIBLIOGRAPHY. U.S. Environmental Protection Agency. 1992.
Water quality standards Establishment of
We have placed the following references on numeric criteria for priority toxic pollutants;
display in the Division of Dockets Management, states compliance, p. 60848-60923. In Federal
Food and Drug Administration, 5630 Fishers Lane, Register, vol. 57, no. 246. U.S. Government
rm. 1061, Rockville, MD 20852. You may see Printing Office, Washington, DC.
them at that location between 9 a.m. and 4 p.m., U.S. Environmental Protection Agency. 1994.
Monday through Friday. As of March 29, 2011, Appendix I: list of EPA water quality criteria
FDA had verified the Web site address for the documents. In Water quality standards
references it makes available as hyperlinks from handbook: second edition. http://www.epa.
the Internet copy of this guidance, but FDA is not gov/waterscience/standards/handbook/.
responsible for any subsequent changes to Non- U.S. Environmental Protection Agency. 1995.
FDA Web site references after March 29, 2011. Final water quality guidance for the Great
Catfish Farmers of America. 1993. Catfish Lakes System. In Federal Register, vol. 60,
quality assurance. Cooperative Extension no. 56. U.S. Government Printing Office,
Service Publication 1873. Mississippi State Washington, DC.
University, Mississippi State, MS. U.S. Environmental Protection Agency.
Federal Joint Subcommittee on Aquaculture. Updated February 2011. Residue Analytical
2007. Guide to drug, vaccine, and pesticide Methods (RAM). http://www.epa.gov/
use in aquaculture. http://aquanic.org/jsa/ pesticides/methods/ramindex.htm.
wgqaap/drugguide/drugguide.htm. U.S. Environmental Protection Agency.
Gutenmann, W. H., J. G. Ebel, Jr., H. T. Revised July 2006. Tolerances and exemptions
Kuntz, K. S. Yourstone, and D. J. Lisk. 1992. from tolerances for pesticide chemicals in
Residues of p,p-DDE and mercury in lake or on raw agricultural products. In Code
trout as a function of age. Arch. Environ. of Federal Regulations, 40 CFR 180. U.S.
Contam. Toxicol. 22(4):452-455. Government Printing Office, Washington,
Karl, H., I. Lehmann, and K. Oetjen. 1998. DC. http://www.access.gpo.gov/nara/cfr/
Levels of chlordane compounds in fish waisidx_05/40cfr180_05.html.
muscle, -meal, -oil and -feed. Chemosphere. U.S. Food and Drug Administration.
36(13):2819-2832. Updated July 2009. Pesticide Analytical
Ruus, A., K. I. Ugland, and J. U. Skaare. Manual (PAM). http://www.fda.gov/Food/
2002. Influence of trophic position on ScienceResearch/LaboratoryMethods/
organochlorine concentrations and PesticideAnalysisManualPAM/default.htm.
compositional patterns in a marine food web. U.S. Food and Drug Administration. Updated
Environ. Toxicol. Chem. 21(11):2356-2364. January 2008. Pesticide chemical residues in
Smith, A. G., and S. D. Grangolli. 2002. food - enforcement criteria. In Compliance
Organochlorine chemicals in seafood: policy guides, sect. 575.100. Department of
occurrence and health concerns. Food Chem. Health and Human Services, Public Health
Toxicol. 40:767-779. Service, Food and Drug Administration,
Center for Food Safety and Applied
Striped Bass Growers Association. 1996.
Nutrition, Washington, DC. http://www.fda.
The hybrid striped bass industry from fish
gov/downloads/ICECI/ComplianceManuals/
farmer to consumer. Striped Bass Growers
CompliancePolicyGuidanceManual/
Association, P.O. Box 11280, Columbia, SC.
UCM186872.pdf.
178
U.S. Food and Drug Administration. Revised
April 2009. Fish and fishery products.
In Code of Federal Regulations, 21 CFR
123.3. U.S. Government Printing Office,
Washington, DC. http://www.access.gpo.gov/
nara/cfr/waisidx_06/21cfr123_06.html.
U.S. Food and Drug Administration. Revised
April 2009. Unavoidable contaminants
in food for human consumption and
food-packaging material. In Code of
Federal Regulations, 21 CFR 109. U.S.
Government Printing Office, Washington,
DC. http://www.access.gpo.gov/nara/cfr/
waisidx_06/21cfr109_06.html.
U.S. Trout Farmers Association. 1994. Trout
producers quality assurance program.
USTFA, P.O. Box 220, Charles Town, WV.
179
NOTES:
180
CHAPTER 10: Methylmercury
As with previous editions of the Fish and Fishery

Products Hazards and Controls Guidance, this
fourth edition does not contain advice on Hazard
Analysis Critical Control Point (HACCP) controls
for methylmercury, except where federal, state,
local, or foreign authorities close certain waters to
commercial harvesting as described in Chapter 9.
181
NOTES:
182
CHAPTER 11: Aquaculture Drugs
Note: This document was corrected on August 3, 2011. The Agency corrected a typographical error appearing in the
April 2011 version of this document. The Agency corrected "15%" to "1.5%" so that the sentence in "Chapter 11:
Aquaculture Drugs" now reads "Sodium sulfite Used in a 1.5% solution for 5 to 8 minutes to treat eggs in order to
improve their hatchability."
UNDERSTAND THE POTENTIAL HAZARD. general-purpose chemicals, or approved drugs in a

manner that deviates from the labeled instructions.
Use of unapproved drugs or misuse of approved When a drug is approved by CVM, the conditions
drugs in aquacultured fish poses a potential of the approval are listed on its label or in the
human health hazard. These substances may labeling (21 CFR 514.1). These conditions specify
be toxic, allergenic, or carcinogenic, and/or may the species for which the drug is approved for use;
cause antibiotic resistance in pathogens that indications (disease or other circumstances) for
affect humans. use; dosage regimen; and other limitations, such
To control this hazard, drugs for use in food as route of administration and withdrawal time.
animals, whether they are for direct medication or Labeled withdrawal times must be followed to
for addition to feed, generally must be approved, ensure that no harmful drug residues are present
conditionally approved or index listed by FDA in the edible tissue of the animal when harvested
(Federal Food, Drug, and Cosmetic Act Section for human consumption and offered for sale.
512). Under certain conditions authorized by FDA, Tolerances for some drug residues in the edible
unapproved new animal drugs may be used in tissue have been established (21 CFR 556).
conformance with the terms of an Investigational Only a licensed veterinarian may legally prescribe
New Animal Drug (INAD) application (21 CFR 511 a drug under conditions that are not listed on
and FDAs Center for Veterinary Medicine (CVM) the label (extra-label use). This includes: use in
Guide 1240.3025). Off label use in animals of species not listed on the label; use for indications
approved human or animal drugs is permissible (disease or other conditions) not listed on the
in certain circumstances. Drugs on the Index label; use at dosage levels, frequencies, or routes
of Legally Marketed Unapproved New Animal of administration other than those stated on the
Drugs for Minor Species (the Index) may not be label; and deviation from the labeled withdrawal
used in food animals except in early nonfood life time. A veterinarian is a person licensed by a
stages of food producing minor species in certain state, territory, or foreign government to practice
circumstances. veterinary medicine.
Reasons for the use of drugs in aquaculture The extra-label use restrictions are fully
include the need to (1) treat and prevent disease, explained in 21 CFR 530. Information on the
(2) control parasites, (3) affect reproduction and new animal drug approval process and for
growth, and (4) provide tranquilization (e.g., other information on the laws, regulations
for weighing). Relatively few drugs have been and policies pertaining to drugs can be found
approved for aquaculture. This factor may lead to on FDAs internet website, http://www.fda.gov/
the inappropriate use of unapproved drugs, AnimalVeterinary/DevelopmentApprovalProcess/
Aquaculture/default.htm.
183
Approved aquaculture drugs spp., Costia spp., Scyphidia spp., Epistylis
FDA-approved aquaculture drugs, with their spp., and Trichodina spp.) and monogenetic
approved sponsor, species for which they have trematodes (Cleidodiscus spp., Gyrodactylus
been approved and required withdrawal times spp., and Dactylogyrus spp.); and on the eggs
are listed below. Additional details on conditions of salmon, trout, and esocids for the control
of use (e.g., dosage levels) can be obtained from of fungi of the family Saprolegniaceae (21
the Code of Federal Regulations (CFR) as cited CFR 529.1030). There is no mandatory
below; the labeling for the drug; the FDA CVM withdrawal time prior to harvest and
Website, (http://www.fda.gov/AnimalVeterinary/ no residue tolerance (formalin does not
DevelopmentApprovalProcess/Aquaculture/ bioaccumulate in animals). This drug is
ucm132954.htm). approved as an over-the-counter (OTC)
product, and a prescription is not required.
FDAs determination that these substances are
approved aquaculture drugs does not exempt Parasite-S , Formacide-B and Formalin-F
facilities from complying with other federal, Parasite-S is supplied by Western Chemical,
state, tribal, territorial and local environmental Inc., Ferndale, WA. Formacide-B is
requirements. For example, in the United States, supplied by B.L. Mitchell, Inc., Leland,
facilities using these substances would still be MS. Formalin-F is supplied by Natchez
required to comply with the National Pollutant Animal Supply Company, Natchez, MS.
Discharge Elimination System requirements. Each is approved for use to control external
protozoan parasites (Chilodonella spp., Costia
Chorionic gonadotropin spp., Epistylis spp., Ichthyophthirius spp.,
Chorulon Scyphidia spp., and Trichodina spp.) and
monogenetic trematodes (Cleidodiscus spp.,
Chorulon, supplied by Intervet, Inc., Dactylogyrus spp., and Gyrodactylus spp.)
Roseland, NJ, is approved for use as an aid on all finfish species; external protozoan
in improving spawning function in male parasites (Bodo spp., Epistylis spp., and
and female brood finfish. The drug may be Zoothamnium spp.) on Penaeid shrimp; and
administered for up to three doses. The total fungi of the family Saprolegniaceae on the
dose should not exceed 25,000 I.U. chorionic eggs of all finfish species (21 CFR 529.1030).
gonadotropin in fish intended for human There is no mandatory withdrawal time
consumption. Federal law restricts this prior to food animal harvest and no residue
drug to use by or on the order of a licensed tolerance (formalin does not bioaccumulate in
veterinarian (21 CFR 522.1081). Because animals). These drugs are approved as OTC
residues are expected to be well below the products, and a prescription is not required.
safe concentration in the edible portion of
fish, there is no tolerance level set for residues
Florfenicol
of gonadotropin in fish tissue 21 CFR 556.304).
Aquaflor Type A Medicated Article
Formalin solution Aquaflor Type A is supplied by Intervet,
Paracide-F Inc., Millsboro DE/ Schering-Plough Animal
Health Corporation, Roseland, NJ, and is
Paracide-F, supplied by Argent Laboratories, approved for use in medicated feed for the
Redmond, WA, is approved for use as control of mortality due to enteric septicemia
follows: in salmon, trout, catfish, largemouth of channel catfish (Ictalurus punctatus)
bass, and bluegill for the control of external associated with Edwardsiella ictaluri, control
protozoa (Ichthyophthirius spp., Chilodonella
184
of mortality in freshwater-reared salmonids been recognized as a valuable tool for the
due to coldwater disease associated with proper handling of these animals during
Flavobacterium psychrophilum, and control of manual spawning (fish stripping), weighing,
mortality in freshwater-reared salmonids due measuring, marking, surgical operations, and
to furunculosis associated with Aeromonas transport. Use in fish intended for human
salmonicida. The minimum withdrawal time consumption is restricted to the following
before harvest is 12 days for catfish and 15 families: Ictaluridae (catfish), Salmonidae
days for salmonids (21 CFR 558.261). The (salmon and trout), Esocidae (pike), and
tolerance level for florfenicol amine (the Percidae (perch). There is a mandatory 21
marker residue) in muscle is 1 ppm (21 CFR day withdrawal time before harvest. In other
556.283). The product is restricted to use by non-food, aquatic, cold-blooded animals,
or on the order of a licensed veterinarian (21 the drug should be limited to hatchery or
CFR 558.261). Extra-label use of medicated laboratory use (21 CFR 529.2503). These
feed containing florfenicol is prohibited (21 drugs are approved as OTC products, and
CFR 558.6(a)(4) and (6)). a prescription is not required. There is no
tolerance level set for residues in fish tissue.
Aquaflor CA1
Aquaflor CA1 is supplied by Intervet, Inc./ Oxytetracycline
Schering-Plough Animal Health Corporation,
Roseland, NJ, and is approved for use in Terramycin 200 for Fish (oxytetracycline
medicated feed for the control of mortality in dihydrate) Type A Medicated Article
catfish due to columnaris disease associated Terramycin 200 for Fish (oxytetracycline
with Flavobacterium columnare. The drug dihydrate) Type A Medicated Article
can be used at any stage of production, from is supplied by Phibro Animal Health,
fingerling to food fish, as the sole ration Ridgefield Park, NJ. Terramycin 200 for
for 10 consecutive days. The minimum Fish is approved for use to treat bacterial
withdrawal time before harvest is 12 days. hemorrhagic septicemia caused by
The product is restricted to use by or on Aeromonas liquefaciens and pseudomonas
the order of a licensed veterinarian (21 CFR disease in catfish. For salmonids,
516.1215) . Extra-label use of medicated feed Terramycin 200 for Fish is approved
containing florfenicol is prohibited (21 CFR for use to control ulcer disease caused
558.6(a)(4) and (6)). Because Aquaflor CAI by Hemophilius piscium, furunculosis
is a conditionally approved new animal drug, caused by Aeromonas salmonicida,
it extra-label use is also prohibited by 21 bacterial hemorrhagic septicemia caused
U.S.C. 360ccc(a)(1). by Aeromonas liquefaciens, pseudomonas
disease and for control of mortality due
Tricaine methanesulfonate (MS-222) to coldwater disease associated with
Flavobacterium psychrophilium. This drug is
Finquel and Tricaine-S
also approved for use to mark skeletal tissue.
Finquel is supplied by Argent Laboratories, For lobster, Terramycin 200 for Fish is
Redmond, WA, and Tricaine-S is supplied approved for use to control gaffkemia caused
by Western Chemical, Inc., Ferndale, WA, by Aerococcus viridians. Withdrawal times
Tricaine-S. This drug is approved for vary with indication as follows: for marking
use to temporary immobilization of fish, skeletal tissue in Pacific salmon, 7 days; for
amphibians, and other aquatic cold-blooded disease control in salmonids, 21 days; catfish,
animals. Tricaine methanesulfonate has 21 days; lobster, 30 days (21 CFR 558.450).
185
OxyMarine, Oxytetracycline
Sulfamerazine
HCl Soluble Powder-343,
Sulfamerazine, supplied by Alpharma, Inc.,

Terramycin-343, TETROXY Aquatic
Bridgewater, NJ, is approved for use only in

OxyMarine is supplied by Alpharma, trout (rainbow, brook, and brown) to control
Inc., Fort Lee, NJ. Oxytetracycline HCl furunculosis. It may be used for treatment
Soluble Powder-343 is supplied by Teva not more than 14 days. The withdrawal time
Animal Health, Inc., St. Joseph, MO. is 21 days before harvest for marketing or
Terramycin-343 is supplied by Aquatic stocking in stream open to fishing (21 CFR
Health Resources. TETROXY Aquatic is 558.582). A tolerance of zero is established
supplied by Cross Vetpharm Group Ltd., for residues of sulfamerazine in the edible
Dublin, Ireland. Each of these drugs is flesh (21 CFR 556.660).
administered by immersion, approved for
use to mark skeletal tissue of all finfish fry Sulfadimethoxine/ormetoprim combination
and fingerlings as an aid in identification.
Romet-30
These drugs are approved as OTC products,
and a prescription is not required. A Romet-30, supplied by Pharmaq AS,
tolerance level of 2 ppm in muscle tissue (as Overhalla, Norway, is approved for use only
the sum of tetracycline residues, including in medicated feed only for control of enteric
oxytetracycline, chlortetracycline, and septicemia of catfish caused by Edwardsiella
tetracycline) has been established for all ictaluri and furunculosis in salmonids
finfish and lobster (21 CFR 556.500). (trout and salmon) caused by Aeromonas
salmonicida. Required withdrawal times
Hydrogen peroxide are as follows: salmonids, 42 days; catfish,
3 days (21 CFR 558.575). The withdrawal
35% PEROX-AID
time for catfish is shorter because any
35% PEROX-AID, supplied by Eka residues that might be present in the skin are
Chemicals, Inc., Marietta, GA, is approved removed during processing. The tolerance
for the control mortality in freshwater-reared for Sulfadimethoxine and ormetoprim in
finfish eggs due to saprolegniasis; freshwater- the flesh is 0.1 ppm for each drug (21 CFR
reared salmonids due to bacterial gill disease; 556.490 and 556.640).
and freshwater-reared coolwater finfish and
channel catfish due to external columnaris FDA low regulatory priority aquaculture
drugs
disease. This drug is approved as an OTC
product, and a prescription is not required. CVM has identified a number of unapproved
There are no limitations on acceptable daily aquaculture drugs that are of low regulatory
intake; there is no required withdrawal time; priority when used in food fish. The
and no tolerance has been set for residues in following list identifies these compounds
fish tissue. However, as with all new animal and provides their indicated use and usage
drugs, a licensed veterinarian is required to levels (CVMs Policy and Procedures Manual
prescribe an extra-label use of 35% PEROX Attachment: Enforcement Priorities for Drug
AID to treat diseases or species not listed on use in Aquaculture (Guide 1240.4200) (http://
the product label (21 CFR 529.1150). www.fda.gov/downloads/AnimalVeterinary/
GuidanceComplianceEnforcement/
PoliciesProceduresManual/UCM046931.pdf).
186
The agency does not intend to take enforcement Calcium oxide
action against low regulatory priority substances
Used as an external protozoacide for fingerlings
if the following conditions are met: (1) the
to adult fish at a concentration of 2,000 mg/L for
substances are used for the stated indications;
5 seconds.
(2) the substances are used at the stated levels;
(3) the substances are used according to good
Carbon dioxide gas
management practices; (4) the product is of an
appropriate grade for use in food animals; and Used for anesthetic purposes in fish.
(5) use of these products is not likely to result in
an adverse effect on the environment. Fullers earth
The agencys enforcement position on the use Used to reduce the adhesiveness of fish eggs to
of these substances should not be considered an improve hatchability.
approval, or an affirmation of their safety and
effectiveness. The agency reserves the right to Garlic (whole form)
take a different position on the use of any or all
Used for control of helminth and sea lice
of these substances at some time in the future.
infestations in marine salmonids at all life stages.
FDAs determination that these substances are
new animal drugs of low regulatory priority Ice
does not exempt facilities from complying with
other federal, state, tribal, territorial and local Used to reduce metabolic rate of fish during
environmental requirements. For example, in transport.
the United States, facilities using these substances
would still be required to comply with the Magnesium sulfate
National Pollutant Discharge Elimination System Used to treat external monogenic trematode
requirements. infestations and external crustacean infestations
in freshwater fish species at all life stages. Fish
Acetic acid are immersed in a 30,000 mg MgSO4/L and 7,000
Used in a 1,000 to 2,000 ppm dip for 1 to 10 mg NaCl/L solution for 5 to 10 minutes.
minutes as a parasitide for fish.
Onion (whole form)
Calcium chloride Used to treat external crustacean parasites and to
Used to increase water calcium concentration deter sea lice from infesting the external surface
to ensure proper egg hardening. Dosages used of salmonids at all life stages.
would be those necessary to raise calcium
concentration to 10 to 20 ppm CaCO3. Used up Papain
to 150 ppm indefinitely to increase the hardness Used in a 0.2% solution to remove the gelatinous
of water for holding and transporting fish in matrix of fish egg masses in order to improve
order to enable fish to maintain osmotic balance. hatchability and decrease the incidence of
disease.
187
Potassium chloride FDA high enforcement priority aquaculture
drugs
Used as an aid in osmoregulation; relieves
stress and prevents shock. Dosages used would CVM has identified a number of drugs and
be those necessary to increase chloride ion families of drugs historically used in fish without
concentration to 10 to 2,000 mg/L. FDA approval that are of high enforcement
priority. They should not be used in fish that
Povidone iodine is to be consumed, unless a sponsor obtains
an approval or index listing for them. The
Used in a 100 ppm solution for 10 minutes as an following list identifies these compounds
egg surface disinfectant during and after water (CVM Program Policy and Procedures Manual
hardening. Attachment: Enforcement Priorities for Drug
Use in Aquaculture (Guide 1240.4200) (http://
Sodium bicarbonate www.fda.gov/downloads/AnimalVeterinary/
Used at 142 to 642 ppm for 5 minutes as a means GuidanceComplianceEnforcement/
of introducing carbon dioxide into the water to PoliciesProceduresManual/UCM046931.pdf ):
anesthetize fish. Chloramphenicol;
Nitrofurans;
Sodium chloride Fluoroquinolones and Quinolones;
Used in a 0.5% to 1% solution for an indefinite Malachite Green;
period as an osmoregulatory aid for the relief Steroid Hormones.
of stress and prevention of shock; and in a 3%
solution for 10 to 30 minutes as a parasitide. Drugs prohibited for extra-label use
The following drugs and families of drugs are
Sodium sulfite prohibited for extra-label use in food-producing
Used in a 1.5% solution for 5 to 8 minutes to treat animals (21 CFR 530.41(a)):
eggs in order to improve their hatchability. Chloramphenicol;
Clenbuterol;
Thiamine hydrochloride Diethylstilbestrol (DES);
Used to prevent or treat thiamine deficiency in Dimetridazole, Ipronidazole, and other
salmonids. Eggs are immersed in an aqueous Nitroimidazoles;
solution of up to 100 ppm for up to 4 hours Furazolidone, and Nitrofurazone;
during water hardening. Sac fry are immersed in Fluoroquinolones;
an aqueous solution of up to 1,000 ppm for up to
Glycopeptides.
1 hour.
None of these drugs and families of drugs
Urea and tannic acid has been approved use in fish. Additional
information on aquaculture-related topics can be
Used to denature the adhesive component of
obtained from FDA/CVM at: http://www.fda.gov/
fish eggs at concentrations of 15g urea and
cvm/aqualibtoc.htm.
20g NaCl/5 liters of water for approximately 6
minutes, followed by a separate solution of 0.75
g tannic acid/5 liters of water for an additional 6
minutes. These amounts will treat approximately
400,000 eggs.
188
DETERMINE WHETHER THE POTENTIAL measure is or can be used to eliminate the
HAZARD IS SIGNIFICANT. hazard or to reduce the likelihood of its
occurrence to an acceptable level. Preventive
The following guidance will assist you in measures for the hazard of aquaculture drugs
determining whether aquaculture drugs are a used in aquaculture operations and during
significant hazard at a processing step: live transportation can include:
Conducting on-farm visits to review
1. Is it reasonably likely that unsafe levels of
drug usage (other than INADs) before
aquaculture drugs will be introduced at this
receipt of the product, coupled with
processing step?
a suppliers certificate that any INADs
Under ordinary circumstances, if you used were used in conformance
are a primary (first) processor, it would with the application requirements
be reasonably likely that unsafe levels and appropriate verification;
of aquaculture drugs could enter the
Reviewing, at time of receipt, drug usage
process at the receiving step of any type of
records (other than INADs), coupled
aquacultured fish, including:
with a suppliers certificate that any
Finfish; INADs used were used in conformance
with the application requirements
Crustaceans;
and appropriate verification;
Other aquatic food animals,
Reviewing, at time of receipt, the
such as alligator.
producers lot-by-lot certification
Under ordinary circumstances it would also of proper drug usage, including
be reasonably likely that unsafe levels of INAD usage, coupled with
aquaculture drugs could enter the process appropriate verification;
during aquatic holding (e.g., live lobster in

Conducting, at time of receipt,
pounds) or transport of live fish.

drug residue testing;
Under ordinary circumstances, it would

Reviewing, at time of receipt, evidence
not be reasonably likely to expect that
(e.g., a third-party certificate) that
aquaculture drugs could enter the process
the producer operates under a third
during the receiving of wild-caught fish.
party-audited Quality Assurance (QA)
Currently, FDA is not aware of drug use in
program for aquaculture drug use.
the grow-out of molluscan shellfish.
Note: INAD records are confidential unless an exception is made by
If you are receiving fish (other than live fish) the sponsor of the drug research. Thus, review of INAD drug usage
from another processor, you would not need records by the processor may not be practical in certain situations.
to identify aquaculture drugs as a significant Written certification, on a lot-by-lot basis, from the producer
to the processor stating that INAD usage is in accordance with
hazard. The primary (first) processor should
authorizations from FDA/CVM is a suitable alternative.
have fully controlled this hazard.
2. Can unsafe levels of aquaculture drugs that are These preventive measures are ordinarily
reasonably likely to occur be eliminated or reduced employed at either the receiving step or the
to an acceptable level at this processing step? pre-harvest step.
Aquaculture drugs should be considered Preventive measures for the control of

a significant hazard at any processing step aquaculture drugs used during aquatic
at a primary processor where a preventive holding (e.g. lobster pounds) can include
189
controlled application of animal drugs in a a. If you have such a relationship with the
manner consistent with: grower, then you should identify a pre-
harvest step as the CCP for aquaculture
Established withdrawal times;
drugs. The preventive measure for this
Labeled instructions for use; type of control is:
Conditions for extra-label use of FDA- Conducting on-farm visits to
approved drugs, under a veterinarians review drug usage, coupled with
supervision and in accordance with a suppliers certificate that any
FDA regulations and guidelines; INAD used is used in accordance
Conditions specified in the FDA list of with food use authorization
low regulatory priority aquaculture drugs; and appropriate verification.
Conditions of an INAD application. Example:
A primary processor of aquacultured
These preventive measures are ordinarily
catfish that regularly purchases from
applied at the holding step.
the same grower should visit the
In the case of an integrated operation, where grower before the fish are harvested
fish processing and farming, and perhaps and review drug usage practices and
feed manufacture, are performed by the records. The processor should also
same firm, it may be possible and desirable receive a guarantee that any INAD
to exercise preventive measures early in the used is used in conformance with the
process (ideally, at feed manufacture), rather food use authorization requirements.
than at receipt of the fish at the processing The processor should combine this
plant. Such preventive measures will not be monitoring procedure with quarterly
covered in this guidance document. raw material testing for verification
and should set the CCP at the pre-
Intended use harvest step.
For aquaculture drugs, it is unlikely that the
intended use of the product will affect the
strategy referred to in this document
significance of the hazard.
as Control Strategy Example 1 - On-
Farm Visits.
b. If you have no such relationship with
The following guidance will assist you in the grower, then you should identify the
determining whether a processing step is a receiving step as the CCP for aquaculture
critical control point (CCP) for the hazard of drugs. At the receiving step, you should
aquaculture drugs. exercise one of the following preventive
measures:
Is the hazard the result of the use of aquaculture drugs
during the raising of fish (i.e., aquaculture) or during Reviewing, at time of receipt, the
aquatic holding (e.g., lobster pounds) or transport of live producers lot-by-lot certification
fish? of proper drug usage, coupled
with appropriate verification.
1. If the hazard is the result of aquaculture, do you
have a relationship with the grower that enables Example:
you to visit the farm before receipt of the fish? A primary processor of aquacultured
shrimp that purchases raw material
190
shrimp through various brokers This screening can be performed by
should receive lot-by-lot certificates rapid analytical methods that may
from the producers. The certificates indicate the presence of a family of
should state that all drugs were used drugs, rather than any specific drug.
in conformance with applicable FDA If the rapid screening test indicates
regulations and labeled instructions. that a family of drugs is present,
The processor should combine this further testing and/or follow-up with
monitoring procedure with quarterly the supplier could be necessary.
raw material testing for verification Note: A limited number of drug screening tests for
and should set the CCP at receiving. aquaculture drugs are available. Tests are not available to
assay for all drugs that might be used in all aquacultured
This control approach is a control species. Processors should be cautioned that tests that
strategy referred to in this document have not been validated may be unreliable. These tests
may fail to detect a residue or may give a false positive.
Processors should ensure that the tests that they intend
Suppliers Certification. to use have been validated and are appropriate for the
species and tissue to be tested.
Reviewing, at time of receipt, drug
usage records (other than INADs), Example:
coupled with a suppliers lot-by A primary processor of aquacultured
lot certificate that any INAD used shrimp that purchases raw material
was used in conformance with the shrimp through various brokers
use authorization requirements should screen all incoming lots of
and appropriate verification. shrimp with a series of validated
Example: rapid tests that target the families
A primary processor of aquacultured of drugs that are reasonably likely
shrimp that purchases raw material to be used during grow-out (e.g.,
shrimp through various brokers chloramphenicol, nitrofurans, and
should receive records of drug fluoroquinolones). The processor
usage (other than INADs) from should set the CCP at receiving.
the producers when the product is This control approach is a control
delivered. Additionally, the processor strategy referred to in this document
should receive a lot-by-lot certificate as Control Strategy Example 4 -
stating that any INAD used was Drug Residue Testing.
used in conformance with the food
Reviewing, at time of receipt,
use authorization requirements.
evidence (e.g., continuing or lot
The processor should combine this
by-lot third- party certificate) that
monitoring procedure with quarterly
the producer operates under a
raw material testing for verification
third-party-audited QA program
and should set the CCP at receiving.
that covers aquaculture drug use.
Example:
A primary processor of aquacultured
trout that regularly purchases
Records of Drug Use.
raw material trout from the same
Conducting, at time of receipt, drug grower should obtain a third-party
screening on all lots for the presence certificate, valid for 1 year (i.e.,
of approved or unapproved drugs. continuing certification), that attests
191
that the grower operates under a QA 3. If the hazard is the result of transportation of live
program that covers aquaculture fish, then you should identify the receiving step
drug use. The processor should set the as the CCP for aquaculture drugs. In this case,
CCP at receiving. you should refer to described in Control Strategy
Examples 2 through 5 for guidance. However,
if live transportation is on your own truck, you
should identify the transportation step as the
CCP, and refer to Control Strategy Example 6 for
Quality Assurance Program.
guidance.
2. If the hazard is the result of aquatic holding (e.g.,
lobster pounds), then you should identify the
Example:
holding step as the CCP for aquaculture drugs.
A primary processor that receives
The preventive measure for this type of control is:
live basa from a broker on the
brokers truck should receive lot
Applying animal drugs in a by-lot certificates from the broker.
manner consistent with: The certificates should state that all
drugs were used in conformance
with applicable regulations and
Labeled instructions for use;
labeled instructions. The processor
Conditions for extra-label use
should combine this monitoring
of FDA-approved drugs under a
veterinarians supervision and in procedure with quarterly raw
accordance with FDA regulations and material testing for verification
guidances; and should set the CCP at
Conditions specified in the FDA low receiving.
regulatory priority aquaculture drug
list;
Example:
A primary processor that receives
Conditions of an INAD food use
live catfish from the growers on

authorization.
the processors own truck and uses
Example: drugs to control animal health
A primary processor that uses during transportation (e.g., carbon
oxytetracycline in the holding of live dioxide as an anesthetizing agent
lobster in a lobster pound should at levels appropriate for the purpose)
use the drug as a medicated feed in should control drug use during
accordance with labeled instructions transportation and should set the CCP
and should document the withdrawal at transportation.
time of 30 days before selling. The
processor should set the CCP at
holding.
Control During Holding.
192
DEVELOP A CONTROL STRATEGY. AND
Verified by a certificate from the producer
The following guidance provides six control indicating that any investigational new
strategies for aquaculture drugs. You may select drug used is subject to an investigational
a control strategy that is different from those new animal drug exemption under 21
which are suggested provided it complies with CFR Part 511, that fish intended for human
the requirements of the applicable food safety consumption is subject to a food use
laws and regulations. authorization, and that the INAD is used
in the fish according to the food use
authorization requirements.
CONTROL STRATEGY
MAY APPLY TO
PRIMARY
MAY APPLY TO
SECONDARY
PROCESSOR PROCESSOR
On-farm visit
On-farm drug usage procedures;
Suppliers certification
Records of drug use AND
Drug residue testing Certificate indicating proper INAD usage.
Quality assurance program How Will Monitoring Be Done?
Control during holding Survey farm husbandry procedures, ask
questions, and review drug usage records;
CONTROL STRATEGY EXAMPLE 1 - ON-FARM VISITS AND
Set Critical Limits. Visual check for presence of INAD certificate
of proper use.
Aquaculture drugs are used on food-producing
fish only if they have been: How Often Will Monitoring Be Done (Frequency)?
Approved by FDA or granted a conditional At least once per year for each aquaculture
approval by FDA and used in accordance site.
with all labeled conditions;
OR Any person who has an understanding of the
Approved by FDA and used in an extra-label nature of the controls.
manner under a veterinarians supervision in
accordance with FDA regulations; Establish Corrective Action Procedures.
OR Take the following corrective action to a product
Put on the FDA list of low regulatory priority involved in a critical limit deviation:
aquaculture drugs and used according to the Do not have the product shipped from the
provisions in the list; production site for processing.
OR AND
Used in food fish as an INAD subjected Take the following corrective action to regain control
to an investigational new animal drug over the operation after a critical limit deviation:
exemption under 21 CFR Part 511 and used
according to the requirements of the food
evidence is obtained that drug treatment
use authorization;
193
practices have changed.

On-site audit report;
AND
INAD certificate of proper use.

Collect a representative sample of the raw
product at least quarterly, and analyze for
those drug residues that are reasonably likely
to be present;
AND
Periodically verify the adequacy of the
comparing results with those obtained
using an Association of Official Analytical
Chemists (AOAC) or equivalent method, or
by analyzing proficiency samples);
AND
Review monitoring, verification, and
corrective action records within 1 week of
194
TABLE 11-1
CONTROL STRATEGY EXAMPLE 1 - ON-FARM VISITS

This table is an example of a portion of a Hazard Analysis Critical Control Point (HACCP) plan using Control Strategy Example 1 - On-Farm Visits. This example illustrates how
a primary processor of farm-raised catfish can control aquaculture drugs. It is provided for illustrative purposes only.
Aquaculture drugs may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
MONITORING
CRITICAL
CRITICAL LIMITS
POINT PREVENTIVE
MEASURE
Pre- Aquaculture Aquaculture drugs are used on fish only if On-farm Survey Once Field Reject the On-site Collect a
harvest drugs the drugs have been drug usage farm per year agent product audit representative sample of
approved by FDA or granted conditional procedures husbandry for each report the raw material
approval by FDA and used in accordance procedures, aquaculture Do not quarterly, and
195
with all labeled conditions; ask site have the analyze for those
approved by FDA and used in an extra-label questions, product drug residues that are
manner under a veterinarians supervision in and review shipped reasonably likely to be
accordance with FDA regulations; drug from the present*
put on the list of low regulatory priority records production

aquaculture drugs and used in accordance site for Periodically verify
with the provisions in the list; or use in food processing. the adequacy of the
fish as an INAD subject to an investigational testing methods and
new animal drug exemption under 21 CFR Discontinue equipment (e.g., by
Part 511 and used in accordance with the use of the comparing results with
requirements of the food use authorization supplier those obtained using an
until Association of Official
Certificate from the producer indicating Certificate Visual Once Field evidence Certificate Analytical Chemists
that any investigational new drug used in indicating check per year agent is obtained of INAD (AOAC)
fish intended for human consumption is proper for each that drug usage
subject to an investigational new animal INAD aquaculture treatment Review
drug exemption under 21 CFR Part 511 usage site practices monitoring, verification,
and that the INAD is used according to the have and corrective action
requirements of the food use authorization changed records within 1 week of
preparation
* Note: This plan is for illustrative purposes only. An actual plan should specify in the Verification column: the aquaculture drugs for which analysis will be conducted, the protocol for sample
collection, and the analytical method to be used for each drug
CONTROL STRATEGY EXAMPLE 2 - SUPPLIERS Establish a Recordkeeping System.
CERTIFICATION Copy of certificates;
Certificate proper drug usage accompanying Receiving record showing lots received and
each lot of incoming aquacultured fish. presence or absence of a certificate of proper
use.
Collect a representative sample of the raw
Presence of a certificate indicating proper
drug usage.
product at least quarterly, and analyze for
How Will Monitoring Be Done? those drug residues that are reasonably likely
Visual check for presence of certificate of to be present;
proper use. AND
How Often Will Monitoring Be Done (Frequency)? Periodically verify the adequacy of the
Each lot received.
Who Will Do the Monitoring? using an Association of Official Analytical
Chemists (AOAC) or equivalent method, or
by analyzing proficiency samples);
AND
Establish Corrective Action Procedures. Review monitoring, corrective action,
Take the following corrective action to a product and verification records within 1 week of
involved in a critical limit deviation: preparation to ensure they are complete and
Reject the lot;
OR
provided;
OR
aquaculture drugs that are reasonably likely
to be present.
AND
comply with the certification controls.
196
TABLE 11-2
CONTROL STRATEGY EXAMPLE 2 - SUPPLIERS CERTIFICATION

This table is an example of a portion of a HACCP plan using Control Strategy Example 2 - Suppliers Certification. This example illustrates how a primary processor of pond-
raised shrimp can control aquaculture drugs. It is provided for illustrative purposes only.
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
MONITORING
CRITICAL LIMITS
CRITICAL
POINT
MEASURE
Receiving Aquaculture Certificate Presence of Visual Each lot Receiving Reject the lot Producers drug Collect a
drugs indicating a certificate check received dock usage certificate representative
proper indicating employee Discontinue use sample of the raw
drug usage proper drug of the supplier Receiving material quarterly,
accompanying usage until evidence record and analyze for
197
all lots of is obtained that those drug residues
incoming pond- the supplier that are reasonably
raised shrimp will comply likely to be present*
with the
certification Periodically verify

controls the adequacy of the
testing methods and
equipment (e.g., by
comparing
results with those
obtained using an
Association of
Official Analytical
Chemists (AOAC)
Review monitoring,
corrective action,
and verification
records within 1
week of
preparation
CONTROL STRATEGY EXAMPLE 3 - RECORDS OF Establish Corrective Action Procedures.
DRUG USE
Set Critical Limits. involved in a critical limit deviation:
Drug usage records for each delivery that show Reject the lot.
aquaculture drugs were used on foodproducing AND
fish only if the drugs have been:
Approved by FDA or granted conditional over the operation after a critical limit deviation:
approval by FDA and used in accordance
with all labeled conditions;
OR practices have changed and/or the producer
Approved by FDA and used in an extra-label will comply with the certification controls.
accordance with FDA regulations; Establish a Recordkeeping System.
OR Producers drug records;
Put on the list of low regulatory priority AND
aquaculture drugs and used according to the INAD certificate of proper use;
provisions in the list;
AND
AND
Receiving record showing lots received and
Lot-by-lot certificate from the producer indicating presence or absence of a certificate.
that any investigational new drug used in fish
intended for human consumption is subjected to Establish Verification Procedures.
an investigational new animal drug exemption Collect a representative sample of the raw
under 21 CFR Part 511 and that the INAD is used material, in-process product, or finished
according to the requirements of the food use product at least quarterly, and analyze for
authorization. those drug residues that are reasonably likely
to be present;
AND
What Will Be Monitored? Periodically verify the adequacy of the
Records of on-farm drug use; testing methods and equipment (e.g., by
AND
using an Association of Official Analytical
Certificate indicating proper INAD usage. Chemists (AOAC) or equivalent method, or
How Will Monitoring Be Done? by analyzing proficiency samples);
Visual check of drug use records and INAD AND
certificate of proper use. Review monitoring, verification, and
corrective action records within 1 week of
Each lot received. any critical limit deviations that occurred
Who Will Do the Monitoring? were appropriately addressed.

198
TABLE 11-3
CONTROL STRATEGY EXAMPLE 3 - RECORDS OF DRUG USE

This table is an example of a portion of a HACCP plan using Control Strategy Example 3 - Records of Drug Use. This example illustrates how a pond-raised shrimp processor
can control aquaculture drugs. It is provided for illustrative purposes only.
Aquaculture drugs may be only one of several significant hazards for this product. Refer to Tables 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g., chemical
contaminants).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
MONITORING
CRITICAL LIMITS
CRITICAL
POINT
MEASURE
Receiving Aquaculture Drug usage records for each delivery Records Visual Each lot Production Reject the lot Growers Collect a
drugs that show that drugs were used on of on- check received supervisor drug representative sample of
fish only if the drugs have been farm drug Discontinue use usage the raw material quarterly,
approved by FDA or granted a usage of the supplier records and analyze for those drug
199
conditional approval by FDA and until evidence is residues that are reasonably
used in accordance with all labeled obtained that drug Receiving likely to be present*
conditions; approved by FDA and treatment practices record
used in an extra-label manner under have changed Periodically verify the
a veterinarians supervision in adequacy of the testing
accordance with FDA regulations; or methods and equipment

put on the list of low regulatory (e.g., by comparing results
priority aquaculture drugs and used with those obtained using
according to the provisions on the list an Association of Official
Analytical Chemists (AOAC)
Lot-by-lot certificate from the Certificate Visual Each lot Production Reject the lot Certificate
producer indicating that any indicating check received supervisor of INAD
Review monitoring,
investigational new drug used in fish proper Discontinue use usage
verification, and corrective
intended for human consumption INAD of the supplier
action records within 1
is subject to an investigational new usage until evidence Receiving
week of preparation
animal drug exemption under 21 CFR is obtained that record
Part 511 and that the INAD is used the supplier will
according to the requirements of the comply with
food use authorization the certification
requirements
CONTROL STRATEGY EXAMPLE 4 - DRUG Establish a Recordkeeping System.
RESIDUE TESTING Test results.
No fish may contain a residue of an
unapproved drug (other than for those Periodically verify the adequacy of the
drugs used as an INAD and according to the testing methods and equipment (e.g., by
requirements of the food use authorization comparing results with those obtained
or used in accordance with the criteria using an Association of Official Analytical
specified in the list of low regulatory priority Chemists (AOAC) or equivalent method, or
aquaculture drugs); by analyzing proficiency samples).
AND AND
No fish may contain a residue level of an Review monitoring, corrective action and
approved drug that is above FDA tolerance verification records within 1 week of
for that drug. preparation to ensure they are complete and
Establish Monitoring Procedures. were appropriately addressed;

Fish edible flesh for those drug residues that
are reasonably likely to occur.

Obtain samples and test for drugs using
rapid screening methods or other validated
analytical methods.

Each lot received.

experience to perform the analyses.

Reject the lot.
AND
practices have changed.
200
TABLE 11-4
CONTROL STRATEGY EXAMPLE 4 - DRUG RESIDUE TESTING

This table is an example of a portion of a HACCP plan using Control Strategy Example 4 - Drug Residue Testing. This example illustrates how a primary processor of farm-
raised catfish can control aquaculture drugs. It is provided for illustrative purposes only.
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
CRITICAL LIMITS MONITORING

CRITICAL
POINT
MEASURE
Receiving Aquaculture No fish may Fish edible Obtain samples Each lot Quality Reject the lot Analytical Periodically
drugs contain residues flesh for drug and analyze received assurance results verify the
of unapproved residues* for drugs using personnel Discontinue use adequacy of the
drugs (other than rapid screening of the supplier testing methods
those used as an methods or until evidence and equipment
201
INAD subject to other analytical is obtained (e.g., by
an investigational methods* that drug comparing
new animal drug treatment results with
exemption under practices those obtained
21 CFR Part511 have changed using an

and according Association
to requirements of Official
of the food use Analytical
authorization or Chemists
included on the list (AOAC) or
of low regulatory equivalent
priority aquaculture
drugs)* Review
monitoring,
No fish may verification,
contain a residue and corrective
level of an action records
approved drug within 1 week
that is above FDA of preparation
tolerance for that
drug*
* Note: This plan is for illustrative purposes only. An actual plan should specify: (1) in the Critical Limits column: the aquaculture drugs that are reasonably likely to be present and the critical
limits to be applied to each drug; and (2) in the Verification column: the aquaculture drugs for which analysis will be conducted, the protocol for sample collection, and the analytical method to
be used for each drug.
CONTROL STRATEGY EXAMPLE 5 - QUALITY Take the following corrective action to regain control
ASSURANCE PROGRAM over the operation after a critical limit deviation:
Set Critical Limits. Discontinue use of the supplier until

Certificate indicating that the producer operates comply with the certification controls.
under a third-party-audited quality assurance
(QA) program that controls aquaculture drug Establish a Recordkeeping System.
use. The certificate may accompany each lot of
Third-party certificates;
incoming aquacultured fish or may be issued for
each producer of incoming aquacultured fish as a AND
continuing certification. Receiving record showing lots received and
presence or absence of a certificate.
Review the third-party QA program and
Certificate indicating operation under third
results of audits annually;
party-audited QA program.
AND
How Will Monitoring Be Done? Review monitoring, corrective action,
Visual check for presence of a certificate. and verification records within 1 week of
Each lot received must be checked for the were appropriately addressed.
presence of certificates. Certificates may be
issued on a lot-by-lot (no less than annually)
or continuing basis.


Reject the lot;
OR
provided;
OR
aquaculture drugs that are reasonably likely
to be present.
AND
202
TABLE 11-5
CONTROL STRATEGY EXAMPLE 5 - QUALITY ASSURANCE PROGRAM

This table is an example of a portion of a HACCP plan using Control Strategy Example 5 - Quality Assurance Program. This example illustrates how an aquacultured trout
processor can control aquaculture drugs. It is provided for illustrative purposes only.
chemical contaminants).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

CRITICAL
POINT
MEASURE
Receiving Aquaculture Certificate Presence of a Visual check Each lot Receiving dock Reject the lot Third- party Review
drugs indicating that third-party employee certificate third-party QA
the producer certificate Discontinue use program and
operates until evidence Receiving results of audits
under a third is obtained that record annually
203
party-audited the supplier
QA program will comply Review
that covers with the monitoring,
aquaculture certificate verification,
drug usage requirements and corrective
action records

within 1 week
of preparation
CONTROL STRATEGY EXAMPLE 6 - CONTROL OR
DURING HOLDING
Requirements of the INAD food use
Set Critical Limits. authorization;
AND
Aquaculture drugs are used on fish only if the

drugs have been: Date of distribution of the finished product.
Approved by FDA or granted a conditional How Will Monitoring Be Done?
approval by FDA and used in accordance Visually observe drug use and finished
with all labeled conditions; product distribution.
OR
Approved by FDA and used in an extra-label
Every time aquaculture drugs are used
during holding or transportation;
accordance with FDA regulations;
AND
OR
Every time the finished product is
Put on the FDA list of low regulatory priority
distributed.
aquaculture drugs and used according to the
provisions on the list; Who Will Do the Monitoring?
OR Any person who has an understanding of
Used for use in food fish as an INAD subject the nature of the controls.
to an investigational new animal drug
exemption under 21 CFR Part 511 and used Establish Corrective Action Procedures.
according to the requirements in the food Take the following corrective action to a product
use authorization. involved in a critical limit deviation:
OR
Divert the product to non-food use;
Type of aquaculture drug used;
OR
AND
If the drug is approved for the species in
Date and quantity of drug use; which it was used, hold the product until the
AND mandatory withdrawal period (if applicable)
has been met and until the drug residue
Any other conditions of drug usage that are
level is below the established tolerance.
relevant to:
These corrective actions may be verified by

collecting and analyzing a representative
Labeled instructions; sample of the product, using an appropriate
Extra-label use of an FDA-approved drug analytical method.
used under a veterinarians supervision AND
in accordance with FDA regulations and
guidances; Take the following corrective action to regain control
Conditions specified in the FDA list
Modify drug use practices.
of low regulatory priority aquaculture
drugs;
204
TABLE 11-6
CONTROL STRATEGY EXAMPLE 6 - CONTROL DURING HOLDING

This table is an example of a portion of a HACCP plan using Control Strategy Example 6 - Control During Holding. This example illustrates how a processor that holds live
lobster in a lobster pound can control aquaculture drugs. It is provided for illustrative purposes only.
chemical contaminants, pesticides and natural toxins).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
MONITORING
CRITICAL LIMITS
CRITICAL
POINT
MEASURE
Holding Aquaculture Lobster will be Type of Visual Every time Production Hold the product Drug use Review
drug withheld from aquaculture observation of aquaculture employee record monitoring
oxytetracycline distribution for drug used drug use drugs are used Collect a sample of and corrective
30 days after the finished product action records
205
treatment with and analyze for drug within 1 week
oxytetracycline residues of preparation
in accordance (oxytetracycline)
with the labeled
directions for Release the product

use if the drug residue
level is below the
No other tolerance (2 ppm)
Date and Visual Every time Production Drug use
aquaculture
quantity of drug observation of aquaculture employee record
drugs will be Hold the product if
use drug use drugs are used
used the drug residue level
exceeds the tolerance
and retest
Date of finished Visual check Every time Shipping Destroy the lot when Shipping
product of product finished supervisor unapproved drugs record
distribution distribution product is are used
shipped
Modify drug use
practices
Drug use records;
AND
Records indicating date of distribution of the
finished product.

206
BIBLIOGRAPHY. of Health and Human Services, Food
and Drug Administration, Center for
We have placed the following references on Veterinary Medicine. http://www.fda.
display in the Division of Dockets Management, gov/downloads/AnimalVeterinary/
Food and Drug Administration, 5630 Fishers Lane, GuidanceComplianceEnforcement/
rm. 1061, Rockville, MD 20852. You may see GuidanceforIndustry/ucm052519.pdf.
them at that location between 9 a.m. and 4 p.m., U.S. Food and Administration. April 2010.
Monday through Friday. As of March 29, 2011, Certain other dosage form new animal
FDA had verified the Web site address for the drugs. In Code of Federal Regulations, 21
references it makes available as hyperlinks from CFR 529. U.S. Government Printing Office,
the Internet copy of this guidance, but FDA is not Washington, DC.
responsible for any subsequent changes to Non- U.S. Food and Administration. April 2010.
FDA Web site references after March 29, 2011. Extra label drug use in animals. In Code
Federal Joint Subcommittee on Aquaculture. of Federal Regulations, 21 CFR 530. U.S.
April 2007. Guide to drug, vaccine, and Government Printing Office, Washington, DC.
pesticide use in aquaculture. http://aquanic. U.S. Food and Administration. April 2010.
org/jsa/wgqaap/drugguide/drugguide.htm. Implantation or injectable dosage form
Federal Register. November 21, 2005. new animal drugs. In Code of Federal
Rules and regulations: new animal drugs: Regulations, 21 CFR 522. U.S. Government
florfenicol, vol. 70, no 233. U.S. Government Printing Office, Washington, DC.
Printing Office, Washington, DC. U.S. Food and Administration. April 2010.
Federal Register. February 6, 2007. Rules and New animal drug applications. In Code
regulations: new animal drugs: hydrogen of Federal Regulations, 21 CFR 514. U.S.
peroxide, vol. 72, no. 24. U.S. Government Government Printing Office, Washington, DC.
Printing Office, Washington, DC. U.S. Food and Drug Administration. April
Federal Register. November 26, 2007. 2010. New animal drugs for investigational
Rules and regulations: new animal drugs: use. In Code of Federal Regulations, 21
florfenicol, vol. 72, no. 226. U.S. Government CFR 511. U.S. Government Printing Office,
Printing Office, Washington, DC. Washington, DC.
U.S. Food and Drug Administration. February U.S. Food and Administration. April 2010.
19, 2008. Extralabel use of approved Tolerances for residues of new animal drugs
drugs in aquaculture. In Program policy in food. In Code of Federal Regulations, 21
and procedures manual guide 1240.4210. CFR 556. U.S. Government Printing Office,
Department of Health and Human Services, Washington, DC.
Food and Drug Administration, Center U.S. Food and Drug Administration. April
for Veterinary Medicine. http://www. 26, 2007. Enforcement priorities for drug
fda.gov/downloads/AnimalVeterinary/ use in aquaculture; part B and part C.
GuidanceComplianceEnforcement/ In CVMs policy and procedures manual
PoliciesProceduresManual/ucm046932.pdf. 1240.4200. Department of Health and Human
U.S. Food and Drug Administration. Services, Food and Drug Administration,
October 23, 2003. Evaluating the safety Center for Veterinary Medicine. http://www.
of antimicrobial new animal drugs with fda.gov/downloads/AnimalVeterinary/
regard to their microbiological effects GuidanceComplianceEnforcement/
on bacteria of human health concern. In PoliciesProceduresManual/ucm046931.pdf.
Guidance for industry, no. 152. Department
207
NOTES:
208
CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than
Clostridium botulinum) as a Result of Time and Temperature Abuse
UNDERSTAND THE POTENTIAL HAZARD. Time and temperature abuse occurs when a
product is allowed to remain at temperatures
Pathogenic bacteria growth and toxin formation favorable to pathogenic bacteria growth for
as a result of time and temperature abuse of fish sufficient time to result in unsafe levels of
and fishery products can cause consumer illness. pathogenic bacteria or their toxins in the product.
This hazard is limited to bacterial pathogens since Therefore, management of time and temperature
viral pathogens (viruses) are not able to grow in of product exposure is important to producing
food. Of particular concern in seafood are the a safe product. Table A-1 (Appendix 4) provides
pathogenic forms of Listeria monocytogenes (L. guidance concerning the conditions under which
monocytogenes), Vibrio vulnificus (V. vulnificus), certain pathogenic bacteria can grow. The bacteria
Vibrio parahaemolyticus (V. parahaemolyticus), listed are those of greatest concern in fish and
Vibrio cholera (V. cholera), Escherichia coli (E. fishery products.
coli), Salmonella spp., Shigella spp., Staphylococcus Managing time and temperature of exposure
aureus (S. aureus), Clostridium perfringens
Time and temperature management relies
(C. perfringens), Bacillus cereus (B. cereus),
on identification of time and temperature
Campylobacter jejuni (C. jejuni), and Yersinia
combinations that ensure the safety of your
enterocolitica (Y. enterocolitica). See Appendix 7
product. The following factors should be
for a description of the public health impacts of
considered:
these pathogens.
The types of pathogenic bacteria that are
Pathogenic bacteria can enter the process on raw reasonably likely to be present;
materials. They can also be introduced into foods
Whether those pathogens can grow in the
during processing from the air, unclean hands,
food;
insanitary utensils and equipment, contaminated
water, or sewage and through cross-contamination The infective dose of the pathogenic bacteria;
between raw and cooked product. The primary The expected initial level of the pathogenic
method for control is to reduce levels through bacteria in the food.
cooking or other treatments, when feasible,
Presence of pathogenic bacteria
minimize the potential for recontamination and
to maintain products at temperatures that do not It is reasonable to assume that pathogenic bacteria
support growth of pathogenic bacteria. of various types that are not associated with
specific food sources, including those listed in
Table A-1 (Appendix 4), will be present on raw fish
CHAPTER 12: Pathogenic Bacteria Growth and Toxin Formation (Other Than Clostridium botulinum) as a Result of Time and Temperature Abuse
209
and fishery products and non-fishery ingredients. Table A-1 (Appendix 4) provides guidance
They might be present only at low levels or only on some conditions that limit the growth
sporadically, but even such occurrences warrant of those pathogenic bacteria that are most
consideration because of the potential for growth relevant to fish and fishery products. Table A-1
and toxin production under temperature abuse provides minimum and maximum values of
conditions. However, certain pathogenic bacteria pathogenic bacteria growth. This table can help
are associated with specific food sources, and it you to decide whether particular pathogenic
may not be necessary to assume that they will be bacteria will grow in your food if it is time and
present in other foods unless introduced from a temperature-abused.
contaminated source. For example, V. vulnificus,
Certain pathogenic bacteria grow well in time
V. parahaemolyticus, and V. cholerae non-O1
and temperature-abused raw fish and fishery
and non-O139 are generally associated with
products (e.g., raw molluscan shellfish), and
marine and estuarine species of fish and not with
freshwater species or non-fishery ingredients. others do not. Those that grow well in time
and temperature-abused raw fish include: V.
Pathogenic bacteria can also be introduced vulnificus, V. parahaemolyticus, V. cholerae, and
during processing, even after cooking. Well- L. monocytogenes. Others may grow if the natural
designed sanitation programs will minimize condition of the raw fish is changed, such as
their introduction. However, in most cases, through salting or reduced oxygen packaging.
it is not reasonable to assume that sanitation Those that ordinarily do not grow well, because
programs will fully prevent the introduction of they compete poorly with the normal spoilage
pathogenic bacteria. For this reason, controls bacteria, include: C. jejuni, pathogenic strains of
should be in place to minimize the risk of E. coli, Salmonella spp., Shigella spp., S. aureus,
pathogenic bacteria growth. C. perfringens, B. cereus, and Y. enterocolitica.
Pathogenic bacteria growth Most pathogenic bacteria will grow well in
Fish and fishery products generally provide temperature-abused cooked fish if their growth is
sufficient nutrients for pathogenic bacteria not controlled by means such as drying, salting,
growth. However, chemical and physical or acidification, because competing bacteria are
characteristics of the product and its packaging destroyed by the cooking process.
could limit or enhance pathogenic bacteria
Infective dose
growth and toxin formation. Furthermore,
these characteristics could restrict competing The infective dose or toxic dose is the total
microorganism growth and provide conditions number of a pathogen, or the total amount of a
favorable to pathogenic bacteria growth. toxin, that is necessary to produce human illness.
The dose often varies considerably for a single
Consider:
pathogen based on the health of the consumer
The moisture available to support pathogenic and the virulence (infective capacity) of the
bacteria growth in the product (i.e., water particular strain of the pathogen.
activity);
The typical infectious dose is known or
The amount of salt and preservatives in the
suspected to be very low (i.e., one to several
product (e.g., water phase salt and nitrates);
hundred organisms can cause illness) for
The acidity of the product (i.e., pH); many of the pathogenic bacteria listed in Table
The availability of oxygen in the product A-1 (Appendix 4). These include C. jejuni,
(i.e., aerobic or anaerobic conditions); E. coli, Salmonella spp., Shigella spp., and Y.
The presence of competing spoilage enterocolitica. The typical infectious dose for
organisms in the food. other pathogenic bacteria is considered to be
210
somewhat higher (i.e., several thousand to less pathogenic bacteria that have a relatively high
than 100,000). These include V. vulnificus and infective dose, the initial number of pathogenic
V. parahaemolyticus. In the case of both of bacteria may be a significant consideration.
these categories of pathogens, it is advisable to
Practical considerations for unrefrigerated
prevent any significant growth so that the typical
processing
infective dose is not exceeded. In other words,
product temperatures should be maintained Consider the above described factors to identify
below the minimum growth temperature for the the pathogen(s) that presents the greatest
pathogen or should not be allowed to exceed challenge with respect to managing time and
that temperature for longer than the lag growth temperature exposure in your product. This then
phase (i.e., the slow growth phase during becomes the target pathogen(s) for time and
which a pathogenic bacteria acclimates to its temperature control. Table A-2 (Appendix 4) can
environment before proceeding to rapid growth) then be used to establish safe exposure times
of the pathogenic bacteria at the exposure for the target pathogen(s) at the temperatures at
temperature. which you expect your product to be exposed.
Still other pathogenic bacteria require large As an alternative, you can use predictive
numbers in order to cause disease. The typical microbiology models, such as the U.S.
infectious dose of V. cholerae is suspected to be Department of Agriculture Pathogen Modeling
1,000,000 cells. S. aureus and B. cereus toxin do Program (http://ars.usda.gov/Services/docs.
not normally produce sufficient toxin to cause htm?docid=6786) or ComBase (http://www.
illness until numbers of the pathogen reach combase.cc/default.html) for product-specific
100,000 to 1,000,000/gram. time and temperature exposure calculations.
However, you should validate the reliability of
C. perfringens typically does not produce toxin
predictions from such models for your food.
in the human gut unless at least 100,000,000
bacteria are consumed. Limited growth of these Growth rates of pathogens are highly
pathogens might not compromise the safety of temperature dependent. Ordinarily, pathogenic
the product. However, time and temperature bacteria growth is relatively slow at temperatures
controls must be adequate to prevent growth below 70F (21.1C). In most cases, growth is
before the infectious or toxic dose is reached. very slow below 50F (10C), and 40F (4.4C)
is below the minimum growth temperature of
Levels of pathogenic bacteria
most pathogenic bacteria, although there are
The levels of a pathogen that are likely to be some exceptions. On the other hand, pathogenic
present in a fish or fishery product is dependent bacteria grow relatively fast at temperatures
on factors such as the quality of the harvest above 70F (21.1C). Product temperatures should
water, how the raw material was handled be maintained below the minimum growth
before it was delivered to your plant, and the temperature for the pathogen or should not be
effectiveness of your sanitation control program. allowed to exceed that temperature for longer
than the lag growth phase of the pathogen
As a practical matter, the initial number of low
growth cycle.
to-moderate infectious dose pathogenic bacteria
in a food is usually of limited importance when Consider the following recommendations when
you develop a time and temperature management developing a product monitoring program. Product
strategy because these pathogens should be surface temperature or ambient temperature
controlled by a time and temperature strategy generally should be monitored when the ambient
that does not permit their growth to pass the temperature (e.g., air) is warmer than the product
lag phase. On the other hand, when controlling internal temperature. Internal temperature in the
211
center of the thickest part of the product should acidified products, and by Chapter 13 for
be monitored when the ambient temperature refrigerated acidified products);
(e.g., air, ice, and brine) is cooler than the product Controlling the introduction of pathogenic
internal temperature. Similarly, when selecting a bacteria after the pasteurization process
product for temperature measurement, consider (covered in Chapter 18);
the location of the product selected in relation to
Controlling the source of molluscan shellfish
the environment and select the likely worse case
and the time from exposure to air (e.g., by
product. For example, a product in the center of
harvest or receding tide) to refrigeration to
a pile of products will take longer to cool than a
control pathogens from the harvest area
product at the surface.
(covered in Chapter 4).
Strategies for control of pathogenic bacteria
There are a number of strategies for the control DETERMINE WHETHER THE POTENTIAL
of pathogenic bacteria in fish and fishery HAZARD IS SIGNIFICANT.
products. They include:
Managing the amount of time that food is
determining whether pathogenic bacteria growth
and toxin formation as a result of time and
for pathogen growth and toxin production
temperature abuse is a significant hazard at a
(covered generally in this chapter; for
processing step:
Clostridium botulinum (C. botulinum), in
Chapter 13; and for S. aureus in hydrated 1. Is it reasonably likely that unsafe levels of
batter mixes, in Chapter 15); pathogenic bacteria will be introduced at this
Killing pathogenic bacteria by cooking processing step (do unsafe levels come in with the
or pasteurization (covered in Chapter 16) raw material or will the process introduce them)?
or by retorting (covered by the Thermally
It is reasonable to assume that pathogenic
Processed Low-Acid Foods Packaged in
bacteria of various types that are not
Hermetically Sealed Containers regulation, 21
associated with specific food sources,
CFR 113 (hereinafter, the Low-Acid Canned
including those listed in Table A-1 (Appendix
Foods (LACF) Regulation);
4), will be present on raw fish and fishery
Killing pathogenic bacteria by processes products and non-fishery ingredients.
that retain the raw product characteristics However, certain pathogenic bacteria are
(covered in Chapter 17); associated with specific food sources, and it
Controlling the amount of moisture that is may not be necessary to assume that they
available for pathogen growth (water activity) in will be present in other foods unless they
the product by drying (covered in Chapter 14); have been cross-contaminated. For example,
Controlling the amount of moisture that is V. vulnificus, V. parahaemolyticus, and V.
available for pathogen growth (water activity) cholerae non-O1 and non-O139 are generally
in the product by formulation (covered in associated with marine and estuarine species
Chapter 13); of fish and not with freshwater species or
non-fishery ingredients.
Controlling the amount of salt or
preservatives, such as sodium nitrite, in the Pathogenic bacteria also could be introduced
product (covered in Chapter 13); during processing, even after cooking. Well-
Controlling the level of acidity (pH) in the designed sanitation programs (prerequisite
product (covered by the Acidified Foods programs) will minimize the introduction of
regulation, 21 CFR 114, for shelf-stable pathogenic bacteria. However, in most cases
212
it is not reasonable to assume that they will In summary, under ordinary circumstances
fully prevent the introduction of pathogenic (e.g., without data to the contrary), you
bacteria. Additional information on this should consider that it is reasonably likely
topic is presented in the previous section, that a pathogenic bacteria in Table A-1
Understand the Potential Hazard. (Appendix 4) will grow to an unsafe level or
produce toxin in your product at a particular
2. Is it reasonably likely that pathogenic bacteria
processing step if all of the following
will grow to unsafe levels and/or produce toxin
conditions are met:
at this processing step?
It is reasonably likely to be present;
In order to answer this question, you must
first determine which of those pathogenic Its growth is not prevented by
bacteria that are reasonably likely to be a condition of the food;
present in your product would be able It is reasonably likely that, in the

to grow under time and temperature absence of controls, cumulative time
abuse conditions. Information on this and temperature abuse conditions
topic is presented in the previous section, such as those described in Table A-2
Understand the Potential Hazard. (Appendix 4) could occur during
Time and temperature abuse at one step processing of the product, and the
alone might not result in an unsafe product. processing step could contribute
However, time and temperature abuse significantly to that cumulative abuse.
that occurs at successive processing steps 3. Can unsafe levels of pathogenic bacteria and/
(including storage steps) might be sufficient or toxin production that are reasonably likely to
to result in unsafe levels of pathogenic occur be eliminated or reduced to an acceptable
bacteria or toxins. For this reason, you should level at this processing step?
consider the cumulative effect of time and
temperature abuse during the entire process. Pathogenic bacteria growth and toxin
Table A-2 (Appendix 4) provides guidance formation due to time and temperature abuse
about the kinds of time and temperature should be considered a significant hazard
abuse that might cause a product to be at any processing step where a preventive
unsafe. A study may need to be conducted to measure is, or can be, used to eliminate
determine time and temperature exposure of the hazard (or reduce the likelihood of its
your seafood to temperature abuse for each occurrence to an acceptable level) if it is
process step. reasonably likely to occur. The preventive
measures that can be applied for pathogenic
Remember that you should consider the
bacteria growth and toxin formation due to
potential for time and temperature abuse in
time and temperature abuse include:
the absence of controls. You might already
have controls in your process that minimize Refrigeration of the product and
the potential for time and temperature controlling refrigeration temperatures;
abuse that could result in unsafe levels of Proper icing of the product;
pathogenic bacteria or toxins. This section
and subsequent sections will help you Controlling the amount of time that the
determine whether those or other controls product is exposed to temperatures
should be included in your Hazard Analysis that would permit pathogenic bacteria
Critical Control Point (HACCP) plan. growth or toxin production;
Rapid cooling of the product;
213
Ensuring that incoming fish the processor for culinary purposes (e.g.,
were handled properly during setting the batter or breading, or stabilizing
refrigerated transportation from the the product shape), and are customarily
previous processor, including: fully cooked by the consumer or end user.
Examples include: fish balls, shrimp egg rolls,
Controlling refrigeration temperatures
shrimp and cheese stuffed ravioli, crab cakes,
during transit;
and breaded fish portions. Although the
Proper icing during transit.
exterior of these products may appear cooked,
Intended use the interior fish protein is not coagulated, and
Except as noted, it is unlikely that the the products are not ready-to-eat.
intended use will affect the significance of Other products contain a combination of
the hazard. raw or partially cooked, and fully cooked
FDA is not aware of any HACCP controls ingredients (e.g., seafood mixture of raw
that exist internationally for the control oysters, cooked shrimp, and raw or cooked
of pathogenic bacteria in fish and fishery octopus). Although the protein of some of
products that are customarily fully cooked the fishery ingredients is coagulated, some is
by the consumer or end user before not. As a result, many of these products are
consumption, other than a rigorous sanitation not ready-to-eat. However, these combination
regime as part of a prerequisite program products should be considered ready-to-eat
or as part of HACCP itself. The Fish and if the raw or partially cooked ingredients are
Fishery Products regulation, 21 CFR 123 customarily eaten without cooking by the
(called the Seafood HACCP Regulation in consumer or end user.
this guidance document) requires such a Note that the toxin produced by S. aureus
regime. The proper application of sanitation is not destroyed by cooking or retorting. Its
controls is essential because of the likelihood formation should, therefore, be prevented
that pathogenic bacteria can be introduced in all fish and fishery products. However, as
into fish and fishery products through previously mentioned, S. aureus does not
poor handling practices by the aquaculture grow well in raw fish, unless the growth of
producer, the fisherman, or the processor. competing spoilage organisms is inhibited (e.g.,
FDA is interested in information regarding any by salting or vacuum packaging). B. cereus also
HACCP controls beyond sanitation that could produces a heat-stable toxin and forms heat-
be necessary and practical for the control resistant spores that can survive cooking.
of pathogenic bacteria in fish and fishery
products that are customarily fully cooked
by the consumer or end user. However, the
agency makes no recommendations in this
guidance document and has no specific
expectations with regard to such controls
in processors HACCP plans. The agency
plans to develop Good Manufacturing
Practice guidelines for harvest vessels and
for aquaculture in an effort to minimize the
likelihood that these operations will contribute
pathogens to fish and fishery products.
Some products are partially cooked by
214
IDENTIFY CRITICAL CONTROL POINTS. identify as a CCP each processing step at which
you have identified this hazard as significant. You
The following guidance will assist you in should control cumulative exposure of the product
determining whether a processing step is a to time and temperatures that will permit growth
critical control point (CCP) for pathogenic or toxin formation at these steps.
bacteria growth and toxin formation as a result of Example:
time and temperature abuse: A crabmeat processor identifies a series
1. If there is a cook step, pasteurization step, or of post-cook processing and storage
retorting step later in your manufacturing process, steps (e.g., backing, picking, packing,
you should, in most cases, identify that step as and refrigerated storage) as presenting
the CCP. You would not usually need to identify a reasonable likelihood of pathogenic
processing steps prior to cooking, pasteurization, bacteria growth and toxin formation.
or retorting as CCPs for this hazard. The processor does not subject the product
to a final pasteurization process and
Example: recognizes that it might be consumed
A cooked shrimp processor should set without further cooking. The processor
the critical control point for pathogenic controls the temperature during
bacteria growth and toxin formation as refrigerated storage and the time of
a result of time and temperature abuse exposure to unrefrigerated conditions
at the cook step. The processor would not during the processing steps. The processor
need to identify each of the processing should identify each of the post-cook
steps prior to cooking as CCPs. processing and storage steps as CCPs for
Guidance for this pathogen control strategy this hazard.
is contained in Chapter 16 (for cooking and This chapter provides the following four
pasteurization) and the LACF Regulation, 21 control approaches, or control strategies, each
CFR 113 (for retorting). relating to a separate potential CCP or a set
However, there are two important limitations of CCPs:
to this strategy: Control Strategy Example 1 - Transit
The cooking, pasteurizing, or retorting Control. This control strategy should
process must be sufficient to eliminate be applied to the control of transit at
the most resistant pathogenic bacteria receipt of chilled (i.e., refrigerated,
of public health concern that are iced, or held under chemical cooling
reasonably likely to be present; media, such as gel packs, and not
frozen) ready-to-eat fishery products;
Certain toxins (e.g., S. aureus and B.
cereus toxins) are heat stable. Heat Control Strategy Example 2 -
treatment, including retorting, might not Refrigerated Storage and Refrigerated
eliminate the toxin once it is formed. Processing Control. This control
strategy should be applied to chilled
In either case, time and temperature control (i.e., refrigerated, iced, and not
would be necessary at the processing steps frozen) storage and refrigerated
at which growth and toxin formation could (i.e., <40F (4.4C)) processing;
occur.
Control Strategy Example 3 - Cooling
2. If there is no cook step, pasteurization step, or After Cooking Control. This control
retorting step later in the process, you should strategy should be applied to a cooling
215
step when there is no significant In some cases, refrigerated cooked, ready-
handling during the cooling and to-eat foods (e.g., lobster meat, pasteurized
there is a need to control spore- crabmeat, smoked fish, and surimi-based
forming pathogenic bacteria; analog products) are received by a secondary
processor and held for sale without further
Control Strategy Example 4 -
handling. In other cases, these products
Unrefrigerated Processing Control.
are received by a secondary processor and
This control strategy should be
used as ingredients in a ready-to-eat product
applied to unrefrigerated (i.e.,
that will not be cooked or pasteurized by
40F (4.4C)) processing.
that processor (e.g., seafood salad). In these
Following is further guidance that may help cases, the receiving and storage steps by the
you determine whether these processing secondary processor should be designated
steps should be identified as CCPs for this as CCPs to control the hazard of pathogenic
hazard. The guidance is divided into two bacteria growth. On the other hand, if
types of finished products: cooked ready-to these ready-to-eat foods are received by the
eat and raw ready-to-eat. secondary processor to be used in a product
that will be cooked or pasteurized by that
Cooked, ready-to-eat products
processor, the receiving and storage steps
These products may be cooked by the before the cooking or pasteurization step
processor, received by the processor already might not need to be designated as CCPs,
cooked, or assembled by the processor from unless S. aureus or B. cereus toxin formation
ready-to-eat components. They may appear is a significant hazard. Remember that these
to the consumer or end user to be ready-to toxins are not likely to be inactivated by heat.
eat products and may, therefore, be eaten
without further cooking. Examples include: In still other cases, ready-to-eat foods are
cooked crabmeat, lobster meat, and crayfish received by a secondary processor and
meat; surimi-based analog products; seafood used as ingredients in a non-ready-to-eat
salads; and hot-smoked fish. Note that product (e.g., cooked octopus used by the
smoked fish is also covered in Chapter 13, processor as an ingredient in a seafood mix
and cooking and pasteurization are covered that is customarily eaten after cooking by the
in Chapter 16. consumer or end user). Again, the receiving
and storage steps might not need to be
Cooked, ready-to-eat products, especially designated as CCPs, unless S. aureus or B.
assembled products, might develop pathogen cereus toxin formation is a significant hazard.
hazards as a result of cross-contamination
and growth. Contributing factors to this The need to establish a CCP at cooling after
risk are manual handling steps, multiple cooking or pasteurization depends on:
ingredients, unrefrigerated processing, and The severity of the cooking (including
multiple cooling steps. Cumulative exposure hot smoking) or pasteurization step;
to time and temperature abuse after the
The extent to which the product
cook step should be taken into consideration
is handled between the end of the
when establishing CCPs based on time and
cooking or pasteurization step and
temperature.
the end of the cooling step.
Spore-forming pathogenic bacteria may
survive cooking or pasteurization processes
that target vegetative pathogenic bacteria.
216
For example, in foods that contain meat or Time and temperature controls may be
rice, spores of C. perfringens and B. cereus needed at the following steps (CCPs):
could be present, could survive the cooking
Receiving;
process, and could grow and produce toxin
in the product during cooling and subsequent Thawing;
handling. In fact, the heat from the cooking Cooling after cooking;
process might initiate growth of the surviving
spores. In this case, a CCP may be needed Processing after cooking:
at product cooling. However, some cooking Slicing hot-smoked salmon;
processes might be adequate to kill even the
Mixing seafood salad;
spores of C. perfringens and B. cereus. In this
case, a CCP at product cooling may not be Picking crabmeat;
necessary. Packaging;
When significant handling occurs after In-process and finished product

cooking or pasteurization, there is a risk refrigerated (not frozen) storage.
that the product might be recontaminated Time and temperature controls will usually
with pathogenic bacteria. Because many of not be needed at processing steps that meet
the normally occurring spoilage organisms the following conditions:
may have been eliminated by the cooking
or pasteurization process and are no longer Continuous, mechanical
present to compete with the pathogenic processing steps that are brief:
bacteria, rapid growth and toxin formation Mechanical size grading of cooked
by the pathogenic bacteria are possible. It shrimp;
is advisable to fully cool a product before Mechanical forming of surimi-based
it is further handled, in order to minimize analog products;

pathogenic bacteria growth and toxin
formation. When significant handling occurs
Individual quick freezing;
after the heating process but before the Processing steps that are brief and
completion of the cooling process or when unlikely to contribute significantly to
the cooked product comes into contact with the cumulative time and temperature
equipment that was not heated along with exposure to unrefrigerated conditions:
the product, time and temperature exposure Date code stamping;
controls may need to start at that point. In
Case packing;
some processes, cooling is performed (1)
Processing steps where the product
before any significant handling of the cooked
is held in a frozen state:
product; and (2) in the same container

in which the product was cooked. Under Glazing;
these conditions, cooling after cooking may Assembly of orders for distribution;
not need to be identified as a CCP for this
hazard. However, such a determination is
Frozen product storage;
dependent upon strict adherence to good Processing steps where the

sanitation practices to further minimize the product is held at temperatures
risk of recontamination with pathogenic above 135F (57.2C):
bacteria. Initial stage of cooling;
Hot holding.
217
Raw, ready-to-eat products Time and temperature controls will usually

These products are not heated during not be needed at processing steps that meet
processing to a temperature that destroys the following conditions:
pathogenic bacteria. They are often Continuous, mechanical
consumed without cooking. Examples processing steps that are brief:
include: cold-smoked fish, raw oysters,
clams and mussels, and raw finfish (when Mechanical filleting;
the processor has knowledge or has reason Processing steps that are brief and
to know that the product will be consumed unlikely to contribute significantly to
without a process sufficient to kill pathogens the cumulative time and temperature
of public health concern or where the exposure to unrefrigerated conditions:
processor represents, labels, or intends for
Date code stamping;
the product to be so consumed).
Case packing;
Like cooked, ready-to-eat products, raw Processing steps where the product
ready-to-eat products may contain pathogenic is held in a frozen state:
bacteria as a result of near-shore harvest
water contamination, poor aquaculture Assembly of orders for distribution;
practices, or poor sanitary practices during Frozen storage.
harvesting, transportation, or processing.
Time and temperature profile
For example, oysters, especially those
harvested during the warm weather Preparing a diagram that depicts the
months, might contain V. vulnificus or maximum times and temperatures at which
V. parahaemolyticus. Raw finfish might your product will be exposed at each
contain V. parahaemolyticus, Salmonella processing step may help you determine
spp., or L. monocytogenes. Some of these cumulative product exposure, especially if
pathogenic bacteria (e.g., V. vulnificus, V. your product is cooked, ready-to-eat. This
parahaemolyticus, and L. monocytogenes) are diagram can help you identify CCPs, as
capable of growth in raw fish. well as critical limits, as will be discussed
later. Figures 12-1 and 12-2 are examples
Time and temperature controls may be needed of time and temperature profiles for two
at the following processing steps (CCPs): different crabmeat processes. Although the
Receiving; figures show similar time and temperature
profiles, they demonstrate how differences in
Processing:
processing operations, especially with respect
Thawing;
to when significant handling occurs, can have
Shucking; an impact on the location of CCPs and on the
critical limits at those CCPs.
Portioning;
Packaging; Figure 12-1 shows a time and temperature
profile for a cooked crabmeat processor that
Raw material, in-process product,
significantly handles product before it is
and finished product refrigerated
cooled to 50F (10C). As a result, a CCP is
(not frozen) storage.
likely to be needed at backing, picking, and
packing.
218
Figure 12-2 shows a time and temperature handling occurs. A more restrictive set of
profile for a cooked crabmeat processor that critical limits is also likely for the product
does not significantly handle product before depicted by Figure 12-1 than for that depicted
it is cooled to 50F (10C). As a result, a CCP by Figure 12-2, because the former product is
is not needed until the picking operation, handled while still warm.
which is the first point at which significant
FIGURE 12-1: Internal Temperature Prole Blue Crabmeat Processing
Partial Cooling Only After Cook With Signicant Handling Before Full Cooling
135F (57.2C)
Backing Begins
Place in Cooler Picking Begins Packing Ends
80F (26.7C)
70F (21.1C)
50F (10C)
40F (4.4C)
1 HR. 2 HOURS
MAX. MAX.
1 HR.
MAX.
FIGURE 12-2: Internal Temperature Prole Blue Crabmeat Processing
Cooling After Cook in Original Container With No Signicant Handling During Cooling
135F (57.2C)
Cooling in Original Container
No Signicant Handling
Picking Begins Packing Ends
80F (26.7C)
70F (21.1C)
50F (10C)
40F (4.4C)
5 HOURS
MAX.
219
DEVELOP A CONTROL STRATEGY. OR
For products delivered under ice:
The following guidance provides examples of four
control strategies for pathogenic bacteria growth
Product is completely surrounded by ice
at the time of delivery;
and toxin formation. It may be necessary to select

OR
more than one control strategy in order to fully

control the hazard, depending upon the nature of For products delivered under chemical
your operation. You may select a control strategy cooling media, such as gel packs:
that is different from those which are suggested, There is an adequate quantity of cooling
provided it complies with the requirements of the media that remain frozen to have
applicable food safety laws and regulations. maintained the product at an internal
temperature of 40F (4.4C) or below
throughout transit;
AND
CONTROL STRATEGY
MAY APPLY TO
PRIMARY
MAY APPLY TO
SECONDARY The internal temperature of the product
PROCESSOR PROCESSOR at the time of delivery is 40F (4.4C) or
Transit control below;
Refrigerated storage and OR
refrigerated
processing control For products delivered refrigerated (not
frozen) with a transit time (including all
Cooling after cooking
control time outside a controlled temperature
Unrefrigerated processing environment) of 4 hours or less (optional
control control strategy):
Time of transit does not exceed 4 hours;
CONTROL STRATEGY EXAMPLE 1 - TRANSIT
AND
CONTROL (FOR REFRIGERATED (NOT FROZEN)
COOKED, READY-TO-EAT OR RAW, READY-TO Internal temperature of the product at
EAT FISHERY PRODUCTS TO BE STORED OR the time of delivery does not exceed
PROCESSED WITHOUT FURTHER COOKING) 40F (4.4C).
It may be necessary to select more than one Note: Processors receiving product with transit times of 4 hours or
less may elect to use one of the controls described for longer transit
control strategy in order to fully control the times instead.
hazard, depending upon the nature of your
operation. Establish Monitoring Procedures.
Set Critical Limits. What Will Be Monitored?
For fish or fishery products delivered For products delivered refrigerated (not
refrigerated (not frozen): frozen):
All lots received are accompanied by
The internal temperature of the product
transportation records that show that the throughout transportation;
product was held at or below an ambient
OR
or internal temperature of 40F (4.4C)
throughout transit. Note that allowance The ambient temperature within the
for routine refrigeration defrost cycles truck or other carrier throughout
may be necessary; transportation;
220
OR OR
For products delivered under ice: For products delivered under chemical
cooling media, such as gel packs:

adequacy and frozen state of the cooling
OR
media in a representative number of
For products held under chemical cooling containers (e.g., cartons and totes) from
media, such as gel packs: throughout the shipment at delivery;

AND
media at the time of delivery;

AND Use a temperature-indicating device (e.g.,

The internal temperature of a product temperatures in a representative
representative number of product units at number of product containers from
time of delivery; throughout the shipment at delivery;
OR OR
For products delivered refrigerated (not For products delivered refrigerated (not
frozen) with a transit time of 4 hours or less: frozen) with a transit time of 4 hours or less:
The date and time product was
Review carrier records to determine the
removed from a controlled temperature date and time product was removed from
environment before shipment and the a controlled temperature environment
date and time delivered; before shipment and the date and time
AND delivered;
The internal temperature of a AND
representative number of product

containers (e.g., cartons and totes) at the a thermometer) to determine internal

time of delivery. product temperatures in a representative
number of product containers (e.g.,
cartons and totes) randomly selected
For products delivered refrigerated (not from throughout the shipment, at
frozen): delivery. Measure a minimum of 12
Use a continuous temperature-recording product containers, unless there are
device (e.g., a recording thermometer) fewer than 12 products in a lot, in which
for internal product temperature or case measure all of the containers. Lots
ambient air temperature monitoring that show a high level of temperature
during transit; variability may require a larger sample
OR size.
For products delivered under ice: How Often Will Monitoring Be Done (Frequency)?
Make visual observations of the Every lot received.
number of containers (e.g., cartons and Who Will Do the Monitoring?
totes) from throughout the shipment at For continuous temperature-recording
delivery; devices:
221
Monitoring is performed by the device AND
met, may be performed by any person Discontinue use of the supplier or carrier
who has an understanding of the nature until evidence is obtained that the identified
of the controls; transportation- handling practices have been
improved.
OR
For other checks: Establish a Recordkeeping System.
Any person who has an understanding of Receiving records showing:
The results of continuous temperature
monitoring, including:
Take the following corrective action to a product temperature-recording devices;
AND
Chill and hold the affected product until an
evaluation of the total time and temperature Visual check of recorded data;
exposure is performed (a product with OR
cumulative exposures that exceed the critical

limits recommended in Control Strategy The results of ice checks, including:
Example 4 - Processing Controls should be The number of containers (e.g.,

cooked or diverted to a use in which the cartons and totes) examined and
critical limit is not applicable (e.g., divert the sufficiency of ice for each;
crabmeat to a stuffed flounder operation),
AND
after giving consideration to the fact that
any S. aureus or B. cereus toxin that may be The number of containers (e.g.,
present may not be inactivated by heat, or cartons and totes) in the lot;
destroyed or diverted to a non-food use); OR
OR
The results of chemical media checks,
Cook the product, after giving consideration including:

to the fact that any S. aureus or B. cereus The number of containers (e.g.,
toxin that may be present may not be cartons and totes) examined and the
inactivated by heat; frozen status of the media for each;
OR AND
Divert the product to a use in which the
The number of units in the lot;
critical limit is not applicable (e.g., divert
crabmeat to a stuffed flounder operation), AND/OR
any S. aureus or B. cereus toxin that may be
The results of internal product
temperature monitoring, including:
present may not be inactivated by heat;
The number of containers (e.g.,
OR cartons and totes) examined
Reject the lot. and the internal temperatures
observed for each;
222
AND kinks. The device should be checked to ensure
that it is operational;
The number of containers (e.g.,
cartons and totes) in the lot; AND
AND Calibrate the temperature-indicating device
Date and time product was (e.g., a NIST-traceable thermometer) at
initially removed from a controlled least once a year or more frequently if
temperature environment and recommended by the device manufacturer.
date and time product was Optimal calibration frequency is dependent
delivered, when applicable. upon the type, condition, past performance,
Establish Verification Procedures. Consistent temperature variations away from
Before a temperature-indicating device (e.g., the actual value (drift) found during checks
a thermometer) is put into service, check and/or calibration may show a need for more
the accuracy of the device to verify that the frequent calibration or the need to replace
factory calibration has not been affected. the device (perhaps with a more durable
This check can be accomplished by: device). Calibration should be performed at
Immersing the sensor in an ice slurry
(32F (0C)) if the device will be used at the temperature range at which it is used;
OR Check the accuracy of temperature-recording
the device to the reading on a known conditions upon receipt of each lot. The
accurate reference device (e.g., a accuracy of the device can be checked
thermometer traceable to standards of by comparing the temperature reading on
the National Institute of Standards and the device with the reading on a known
Technology (NIST)) under conditions that accurate reference device (e.g., a NIST-
are similar to how it will be used (e.g., traceable thermometer) under conditions that
product internal temperature) within the are similar to how it will be used (e.g., air
temperature range at which it will be temperature) within the temperature range at
used; which it will be used;
AND AND
Once in service, check the temperature- When visual checks of ice or cooling media
indicating device daily before the beginning of are used, periodically measure internal
operations. Less frequent accuracy checks may temperatures of fish to ensure that the ice
be appropriate if they are recommended by or cooling media are sufficient to maintain
the instrument manufacturer and if the history product temperatures at 40F (4.4C) or less;
of use of the instrument in your facility has AND
shown that the instrument consistently remains
to checking that the device is accurate by one
of the methods described above, this process
should include a visual examination of the
sensor and any attached wires for damage or
223
TABLE 12-1
CONTROL STRATEGY EXAMPLE 1 - TRANSIT CONTROL

This table is an example of a portion of a HACCP plan using Control Strategy Example 1 - Transit Control. This example illustrates how a processor receiving pasteurized
crabmeat can control pathogenic bacteria growth and toxin formation as a result of time and temperature abuse during transit. It is provided for illustrative purposes only. It
may be necessary to select more than one control strategy in order to fully control the hazard, depending upon the nature of your operation.
Pathogenic bacteria growth and toxin formation may be only one of several significant hazards for this product. Refer to Tables 3-3 and 3-4 (Chapter 3) for other potential
hazards (e.g., environmental chemical contaminants and pesticides, pathogen survival through cooking and pasteurization, and metal fragments).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

CRITICAL
POINT
MEASURE
Receiving Pathogenic All lots received Temperature Digital time and Continuous, Receiving Reject the Data Check
pasteurized bacteria growth are of truck temperature with visual employee shipment logger printout accuracy of the
crabmeat and toxin accompanied refrigerated data logger review and temperature
formation by truck compartment evaluation of Discontinue use data logger
224
records that temperature of the upon
show monitoring supplier or receipt of each
temperature records for each carrier until lot
was maintained shipment evidence is
at or below obtained that Review
40F the identified monitoring,
transportation- corrective
handling action, and
practices have verification
been improved records within
1 week of
preparation
CONTROL STRATEGY EXAMPLE 2 - REFRIGERATED For raw material, in-process product, or
STORAGE AND REFRIGERATED PROCESSING finished product stored under ice:
CONTROL
The product is completely and
It may be necessary to select more than one continuously surrounded by ice

control strategy in order to fully control the throughout the storage time.
operation. Establish Monitoring Procedures.
Set Critical Limits. What Will Be Monitored?
For refrigerated (not frozen) storage or For refrigerated storage or processing:
processing of the raw material, in-process The ambient air temperature of the
product, or finished product: cooler or refrigerated processing room;
The product is held at a cooler ambient OR
air temperature of 40F (4.4C) or
For storage under ice:
below. Note that allowance for routine
refrigeration defrost cycles may be The adequacy of ice surrounding the
necessary. On the other hand, minor product.
variations in cooler temperature How Will Monitoring Be Done?
measurements can be avoided
For refrigerated storage or processing:
by submerging the sensor for the
temperature-recording device (e.g., a Use a continuous temperature-recording
recording thermometer) in a liquid that device (e.g., a recording thermometer);
mimics the characteristics of the product. OR
Also note that critical limits during For storage under ice:
refrigerated storage and refrigerated
processing that specify a cumulative Make visual observations of the
time and temperature of exposure to
number of containers (e.g., cartons and
temperatures above 40F (4.4C) are not
totes) from throughout the cooler.
ordinarily suitable to control the hazard
because of the difficulty in tracking How Often Will Monitoring Be Done (Frequency)?
the specific products and the specific
For continuous temperature recording
cumulative temperature exposures
devices:
that those products experience. The
cumulative exposure for each product Continuous monitoring by the device
would need to be determined prior to itself, with a visual check of the recorded
shipping. If you chose this approach, data at least once per day;
the critical limit for cumulative exposure OR
to temperatures above 40F (4.4C) For storage under ice:
should include time during transit,
refrigerated storage, and refrigerated and Sufficient frequency to ensure the critical
limit is met.
unrefrigerated processing;
OR
225
Who Will Do the Monitoring? OR
For continuous temperature-recording Destroy the product;
devices: OR
Monitoring is performed by the device Divert the product to a non-food use.
generated by the device, to ensure that AND
the critical limits have consistently been Take the following corrective actions to regain control
met, may be performed by any person over the operation after a critical limit deviation:
who has an understanding of the nature Prevent further deterioration of the product:
of the controls;
OR
OR
For other checks:
Move some or all of the product in the
Any person who has an understanding of malfunctioning cooler to another cooler;

OR
Establish Corrective Action Procedures. Freeze the product;
Take the following corrective action to a product AND

involved in a critical limit deviation: Address the root cause:
Chill and hold the affected product
until an evaluation of the total time and
temperature exposure is performed. A
product with cumulative exposures that OR
exceed the critical limits recommended in Make adjustments to the ice application
Control Strategy Example 4 - Unrefrigerated operations.
Processing Controls, should be cooked or
diverted to a use in which the critical limit Establish a Recordkeeping System.
is not applicable (e.g., divert crabmeat to For refrigerated storage:
a stuffed flounder operation), after giving
consideration to the fact that any S. aureus Printouts, charts, or readings from
continuous temperature-recording devices;
or B. cereus toxin that may be present may

not be inactivated by heat, or destroyed or AND
diverted to a non-food use;

OR OR
Cook the product, after giving consideration For storage under ice:
to the fact that any S. aureus or B. cereus
toxin that may be present may not be The results of ice checks:
inactivated by heat; The number of containers (e.g.,
cartons and totes) examined and
OR
the sufficiency of ice for each;
critical limit is not applicable (e.g., divert AND
crabmeat to a stuffed flounder operation), The approximate number
after giving consideration to the fact that of containers (e.g., cartons
any S. aureus or B. cereus toxin that may be and totes) in the cooler.
226
Before a temperature-recording device (e.g., the actual value (drift) found during checks
a recording thermometer) is put into service, and/or calibration may show a need for more
check the accuracy of the device to verify frequent calibration or the need to replace
that the factory calibration has not been the device (perhaps with a more durable
affected. This check can be accomplished by: device). Calibration should be performed at
OR When visual checks of ice are used,

Comparing the temperature reading
of fish to ensure that the ice is sufficient to
maintain product temperatures at 40F (4C)
known accurate reference device (e.g.,
or less;
a NIST-traceable thermometer) under
conditions that are similar to how it will AND
be used (e.g., air temperature) within Review monitoring, corrective action,
the temperature range at which it will be and verification records within 1 week of
used; preparation to ensure they are complete and
AND any critical limit deviations that occurred
recording device daily before the beginning
of operations. Less frequent accuracy checks
AND
227
TABLE 12-2
CONTROL STRATEGY EXAMPLE 2 - REFRIGERATED STORAGE

AND REFRIGERATED PROCESSING CONTROL
(ICING MODEL)
This table is an example of a portion of a HACCP plan using Control Strategy Example 2 - Refrigerated Storage and Refrigerated Processing Control (Icing Model). This
example illustrates how a blue crabmeat processor can control pathogenic bacteria growth and toxin formation as a result of time and temperature abuse during icing. It is
provided for illustrative purposes only. It may be necessary to select more than one control strategy in order to fully control the hazard, depending upon the nature of your
operation.
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
MONITORING
CRITICAL LIMITS
CRITICAL
POINT
MEASURE
228
Finished Pathogenic Finished Adequacy of ice Visual Each case Production Re-ice the Ice storage Check internal
product cooler bacteria growth product observation immediately employee product record temperature of
and toxin containers before iced crabmeat
formation completely shipping Hold and weekly
surrounded evaluate
with ice based on Review
total time and monitoring,
temperature corrective
exposure action, and
verification
records within
1 week of
preparation
TABLE 12-3
CONTROL STRATEGY EXAMPLE 2 - REFRIGERATED STORAGE

AND REFRIGERATED PROCESSING CONTROL
(REFRIGERATION MODEL)
This table is an example of a portion of a HACCP plan using Control Strategy Example 2 - Refrigerated Storage and Refrigerated Processing Control (Refrigeration Model).
This example illustrates how a blue crabmeat processor can control pathogenic bacteria growth and toxin formation as a result of time and temperature abuse during
refrigerated storage. It is provided for illustrative purposes only.
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
MONITORING
CRITICAL LIMITS
CRITICAL
POINT
MEASURE
229
Finished Pathogenic Cooler Cooler Digital time and Continuous, Production Move to Data Check the
product cooler bacteria growth maintained temperature temperature with visual employee alternate cooler logger printout data logger for
and toxin at or below data logger check of and/or add ice accuracy and
formation 40F recorded data Record or visual damage and to
once per day Hold and checks ensure that it
evaluate based is operational
on total time before putting
and into operation;
temperature check it
exposure daily, at the
beginning of
operations; and
calibrate it once
per year
Review
monitoring,
corrective
action, and
verification
records within
1 week of
preparation
CONTROL STRATEGY EXAMPLE 3 - COOLING OR
AFTER COOKING CONTROL Use appropriate instruments (e.g., a
It may be necessary to select more than one temperature-indicating device, such as a
control strategy in order to fully control the hazard, thermometer, a continuous temperature-
depending upon the nature of your operation. recording device, such as a time and
temperature data logger, a scale) and/or
Set Critical Limits. visual observations as necessary to measure
The product is cooled from 135F (57.2C) to the critical factors of the process that affect
70F (21.1C) within 2 hours; the rate of cooling, as established by a
cooling rate study.
AND
The product is further cooled from 135F Example:
(57.2C) to 40F (4.4C) within an additional A crayfish processor identifies cooling
4 hours; after the cook step as a CCP for
OR formation. The processor establishes a
The minimum or maximum values for the cooling critical limit of no more than
critical factors of the process that affect the 2 hours from 135F (57.2C) to 70F
rate of cooling, as established by a cooling (21.1C) and no more than 4 more
rate study (e.g., product internal temperature hours from 70F (21.1C) to 40F
at the start of cooling, cooler temperature, (4.4C). The processor uses marked
quantity of ice, quantity or size of the batches of cooked product to monitor
product being cooled, product formulation, the cooling process. The time that the
configuration of the product in the cooler). marked batch is removed from the
cooker is monitored visually, and the
Establish Monitoring Procedures. internal temperature of the product in
that batch 2 hours after cooking and 4
What Will Be Monitored? more hours after cooking is monitored
The length of the cooling cycle and the with a dial thermometer.
internal temperature of the product;
Example:
OR Another crayfish processor has similarly
The critical factors of the process that affect identified cooling after cooking as
the rate of cooling, as established by a a CCP and has established the same
cooling rate study. critical limit. The processor uses a
digital time and temperature data logger
How Will Monitoring Be Done? to monitor the cooling rate of the cooked
Clock; product.
AND Example:
Use a temperature-indicating device (e.g., a Another crayfish processor has similarly
thermometer) and visual check on time of identified cooling after cooking as a CCP.
cooling; This processor has performed a cooling
rate study that determined that a cooling
OR
rate of no more than 2 hours from 135F
Use a continuous temperature-recording device (57.2C) to 70F (21.1C) and no more
(e.g., time and temperature data logger); than 4 more hours from 70F (21.1C) to
40F (4.4C) can be achieved as long as
230
certain conditions are met in the cooling Establish Corrective Action Procedures.
process. The study determined that the
following critical limits must be met: Take the following corrective action to a product
a cooler temperature of no more than involved in a critical limit deviation:
60F (15.6C) during the first 2 hours of Recook the product, after giving
cooling and no more than 40F (4.4C) consideration to the fact that any S. aureus
during the remainder of cooling; and toxin that may be present may not be
no more than 1,000 pounds of crayfish inactivated by heat;
in the cooler. The processor monitors OR
the cooler temperature with a recording
thermometer and monitors the weight of
the product at receiving with a scale.
crabmeat to a stuffed flounder operation),
How Often Will Monitoring Be Done (Frequency)? after giving consideration to the fact that any
For temperature-indicating devices: B. cereus toxin that may be present may not
be inactivated by heat;
At least every 2 hours;
OR
OR
For temperature-recording devices:
OR
At least every 2 hours a device is placed
in the product. It provides continuous Divert the product to a non-food use.
monitoring, which is visually checked at AND
the end of the cooling period;
Take the following corrective actions to regain control
OR over the operation after a critical limit deviation:
For critical aspects of the cooling process: Prevent further deterioration of the product:
As often as necessary to ensure control
of the process.
AND
Who Will Do the Monitoring? Address the root cause:
Monitoring is performed by the device malfunctioning cooler;

OR

the critical limits have consistently been Make adjustments to the ice application
met, may be performed by any person operation.
of the controls; Establish a Recordkeeping System.
For temperature-indicating devices:
OR
For other checks: Cooling records showing the internal
temperature of the product, and the
Any person who has an understanding of length of time between the end of the
the nature of the controls. cooking (or the time that the product
internal temperature falls below
135F (57.2C)), and the time that the
measurement was made;
231
OR (e.g., product internal temperature)
For temperature-recording devices: within the temperature range at which it
will be used;
Record of continuous temperature
monitoring; AND
AND Once in service, check the temperature-
OR operations. Less frequent accuracy checks may
For the critical factors of the process that be appropriate if they are recommended by
affect the rate of cooling, as established by a the instrument manufacturer and the history
cooling rate study: of use of the instrument in your facility has
Appropriate records (e.g., processing
record showing the results of the time
and temperature checks and/or volume to checking that the device is accurate by one
of product in cooler). of the methods described above, this process
should include a visual examination of the
Establish Verification Procedures. sensor and any attached wires for damage or
kinks. The device should be checked to ensure
that it is operational;
a thermometer) or temperature- recording
device (e.g., a time and temperature data AND
logger) is put into service, check the Calibrate the temperature-indicating device
accuracy of the device to verify that the or temperature-recording device against a
factory calibration has not been affected. known accurate reference device (e.g., a
This check can be accomplished by: NIST-traceable thermometer) at least once a
year or more frequently if recommended by
the device manufacturer. Optimal calibration
or near refrigeration temperature; frequency is dependent upon the type,
OR
Immersing the sensor in boiling water variations away from the actual value (drift)
(212F (100C)) if the device will be used found during checks and/or calibration may
at or near the boiling point. Note that show a need for more frequent calibration or
the temperature should be adjusted to the need to replace the device (perhaps with
compensate for altitude, when necessary; a more durable device). Devices subjected to
OR high temperatures for extended periods of
time may require more frequent calibration.
Calibration should be performed at a
the device will be used at or near room
minimum of two temperatures that bracket
temperature;
OR
AND
232
TABLE 12-4
CONTROL STRATEGY EXAMPLE 3 - COOLING AFTER COOKING CONTROL

This table is an example of a portion of a HACCP plan using Control Strategy Example 3 - Cooling After Cooking Control. This example illustrates how a dungeness
crabmeat processor can control pathogenic bacteria growth and toxin formation as a result of time and temperature abuse during cooling after cooking. In this case, the
product is fully cooled, i.e., to 40F (4.4C), after cooking before significant handling. It is provided for illustrative purposes only. It may be necessary to select more than one
control strategy in order to fully control the hazard, depending upon the nature of your operation.
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

CRITICAL
POINT
MEASURE
Cooked crab Pathogenic Crabs cooled Length of Clock Start marked Production Destroy product Production Check the dial
cooler bacteria growth from 135F to cooling cycle batch supervisor record thermometer
and toxin 70F in 2 hours Make for accuracy
formation and 70F to Approximately adjustment and damage
233
40F in 4 more every 2 hours or repairs to and to ensure
hours during cooking cooler that it is
operational
before putting
Cooked Dial
into operation;
crab internal thermometer in
check it
temperature marked batches
daily, at the
of cooked crabs
beginning of
operations; and
calibrate it once
per year
Review
monitoring,
corrective
action, and
verification
records within
1 week of
preparation
Note: Control during unrefrigerated processing is covered under Control Strategy Example 4 - Unrefrigerated Processing Control.
Note: Control is necessary at this step because the processor has not established that the cook step is adequate to kill the spores of C. perfringens or B. cereus
CONTROL STRATEGY EXAMPLE 4 - OR
UNREFRIGERATED PROCESSING CONTROL
CRITICAL LIMIT 3:
control strategy in order to fully control the The product is held at internal
temperatures below 50F (10C)
hazard, depending upon the nature of your throughout processing,
operation.
OR

Alternatively, the product is held at
The following recommended critical limits are ambient air temperatures below 50F
intended to keep the pathogenic bacteria of (10C) throughout processing.
greatest concern in fish and fishery products For cooked, ready-to-eat products:
from reaching the rapid growth phase (i.e., Note: The critical limits for cooked, ready-to-eat products are
keep them in the lag phase) as a result of time intended to begin at the completion of cooling or at the time that the
and temperature exposure during processing. product is first significantly handled after cooking, whichever occurs
You may also wish to reference Table A-2 first.
(Appendix 4), which provides cumulative time CRITICAL LIMIT 1:

and temperature combinations for the pathogenic
bacteria individually. If at any time the product is held at
For raw, ready-to-eat products: (26.7C), exposure time (i.e., time at
CRITICAL LIMIT 1: but below 135F (57.2C)) should be
If at any time the product is held at limited to 1 hour (3 hours if S. aureus is
internal temperatures above 70F the only pathogen of concern),
(21.1C), exposure time (i.e., time at
internal temperatures above 50F (10C) OR
but below 135F (57.2C)) should be Alternatively, if at any time the product
limited to 2 hours (3 hours if S. aureus is is held at internal temperatures above
the only pathogen of concern), 80F (26.7C), exposure time (i.e., time at
OR
but below 135F (57.2C)) should be
Alternatively, exposure time (i.e., time at limited to 4 hours, as long as no more
internal temperatures above 50F (10C) than 1 of those hours is above 70F
but below 135F (57.2C)) should be (21.1C);
limited to 4 hours, as long as no more
than 2 of those hours are between 70F OR
(21.1C) and 135F (57.2C); CRITICAL LIMIT 2:
OR If at any time the product is held at
CRITICAL LIMIT 2: (21.1C) but never above 80F (26.7C),
If at any time the product is held at exposure time at internal temperatures
internal temperatures above 50F (10C) above 50F (10C) should be limited to
but never above 70F (21.1C), exposure 2 hours (3 hours if S. aureus is the only
time at internal temperatures above 50F pathogen of concern),
(10C) should be limited to 5 hours (12
hours if S. aureus is the only pathogen of
concern);
234
OR Example:
A crabmeat processor using a retort process
Alternatively, if the product is never
identifies a series of post-cook processing
held at internal temperatures above
80F (26.7C), exposure times at internal steps (e.g., backing, picking, and packing)
temperatures above 50F (10C) should as CCPs for pathogenic bacteria growth
be limited to 4 hours, as long as no more and toxin formation. Initial cooling takes
than 2 of those hours are above 70F place in the cooking crates and then the
(21.1C); product is first handled at temperatures of
around 120F (48.9C). The processor sets a
OR critical limit of maximum cumulative time
CRITICAL LIMIT 3: of exposure of 4 hours at product internal
temperatures above 50F (10C), no more
If at any time the product is held at than 1 of which is above 70F (21.1). This
but never above 70F (21.1C), exposure critical limit is selected because the crabs
time at internal temperatures above 50F are handled while still warm (e.g., above
(10C) should be limited to 5 hours (12 80F (26.7C)). Cooling that takes place
hours if S. aureus is the only pathogen of after the product is handled is included in
concern); the limit.
OR Example:
Another crabmeat processor using a retort
CRITICAL LIMIT 4: process also identifies a series of post-cook
The product is held at internal processing steps (e.g., backing, picking,
temperatures below 50F (10C)
and packing) as CCPs. However, this
throughout processing,
product is cooled fully before handling,
OR
and ice is used on the product during
processing to control time and temperature
Alternatively, the product is held at
abuse. The processor sets a critical limit of

ambient air temperatures below 50F
a maximum product internal temperature
(10C) throughout processing.
of 50F (10C) at all times. Specifying a
Note: The preceding recommended critical limits do not address time of exposure is not necessary in this
internal product temperatures between 40F (4.4C), the
recommended maximum storage temperature for refrigerated
case, because it is not reasonably likely
fish and fishery products, and 50F (10C). The recommended that the product would be held long
critical limits do not address such temperatures because growth of enough that significant pathogen growth
foodborne pathogenic bacteria is very slow at these temperatures
could occur at this temperature (e.g., 2 to
and the time necessary for significant growth is longer than would be
reasonably likely to occur in most fish and fishery product processing 21 days, depending upon the pathogen).
steps. However, if you have processing steps that occur at these
temperatures that approach the maximum cumulative exposure
times listed in Table A-2 (Appendix 4) for the pathogenic bacteria
of concern in your product, you should consider development of a
critical limit for control at these temperatures. The cumulative time
and temperature critical limits above (other than the last critical limit
for raw, ready-to-eat and cooked, ready-to-eat fish and fishery
products) are depicted in table format below:
235
TABLE 12-5
CUMULATIVE TIME AND TEMPERATURE CRITICAL LIMITS

THEN THE CUMULATIVE EXPOSURE TIME AT INTERNAL
WHEN THE PRODUCT INTERNAL TEMPERATURES ABOVE 50F (10C) IN HOURS IS1
TEMPERATURE RANGE IN F (C) IS
1 2 3 5 12
RAW, READY TO EAT
>50 3
X X2
(>10)
Alternatively,
>50 to 70 X
(>10 to 21.1)
Plus X
>70
(>21.1)
Alternatively, X
>50 to 70
(>10 to 21.1)
Plus X
>70
(>21.1)
>50 to 70 X X2
(>10 to 21.1)
COOKED, READY TO EAT
>50 4
X X2
(>10)
Alternatively, X
>50 to 70
(>10 to 21.1)
Plus X
>704
(>21.1)
>50 to 80 X X2
(>10 to 26.7)
Alternatively, X
>50 to 70
(>10 to 21.1)
Plus X
>70 to <80
(>21.1 to <26.7)
Alternatively, X
>50 to 70
(>10 to 21.1)
Plus X
>70 to <80
(>21.1 to <26.7)
>50 to 70 X X2
(>10 to 21.1)
1. Time at temperatures of 135F (57.2C) and above is not counted.

2. Where S. aureus is the only pathogen of public health significance.
3. Temperature may exceed 70F (21.1C).
4. Temperature may exceed 80F (26.7C).
236
Establish Monitoring Procedures. Make visual observations of length of
exposure to unrefrigerated conditions (i.e.,
What Will Be Monitored? >40F (4.4C)) using a clock.
The length of time of product exposure to

Example:
unrefrigerated conditions (i.e., above 40F
A crabmeat processor identifies a
(4.4C));
series of processing steps (e.g., backing,
The product internal temperature during picking, and packing) as CCPs for
the exposure period; pathogenic bacteria growth. The processor
OR establishes a critical limit of no more
than 1 cumulative hour of exposure to
The ambient temperature of the
unrefrigerated temperature during these
processing area;
processing steps (Critical Limit 1). The

OR
processor uses marked product containers
The length of time only of product exposure to monitor the progress of the product
to unrefrigerated conditions (i.e., >40F through the three processing steps. The
(4.4C)), for critical limit 1 (raw, ready-to-eat time that the marked container is removed
and cooked, ready-to-eat); from and returned to refrigeration is
monitored using a clock.
OR
The internal temperature only of the Example:
product, when internal temperatures are held Another crabmeat processor with identical
below 50F (10C) or above 135F (57.2C) CCPs establishes a more complex set of
throughout processing for critical limit 3 critical limits: no more than 4 cumulative
for raw, ready-to-eat or critical limit 4 for hours with product internal temperatures
cooked, ready-to-eat; above 50F (10C), with no more than
1 of those hours above 70F (21.1C)
OR (Critical Limit 1 Alternative). This
The ambient air temperature only, when processor also uses marked containers
ambient air temperature is held below 50F to monitor the progress of the product
(10C) throughout processing for critical limit through the process. However, in addition
3 for raw, ready-to-eat or critical limit 4 for to monitoring time using a clock, the
cooked, ready-to-eat. processor also monitors product internal
temperature for the marked containers
How Will Monitoring Be Done? using a thermometer. This monitoring
For product internal temperature or ambient technique provides the processor more
air temperature: flexibility in processing but requires more
Use a temperature-indicating device (e.g., monitoring effort.
a thermometer);
Example:
OR
A lobster meat processor identifies the
For ambient air temperature: meat removal process as a CCP for
pathogenic bacteria growth. The operation
is performed under near-refrigeration
conditions (<50F (10C)) (Critical Limit
AND/OR 4 Alternative). The processor monitors
ambient air temperature with a digital
data logger.
237
How Often Will Monitoring Be Done (Frequency)? Divert the product to a use in which the
For continuous temperature-recording critical limit is not applicable (e.g., divert
devices: crabmeat to a stuffed flounder operation),
Continuous monitoring during processing
any S. aureus or B. cereus toxin that may be
is accomplished by the device itself, with
a visual check of the recorded data at
least once per day; OR
OR Destroy the product;
For temperature-indicating devices and OR
clocks:
At least every 2 hours;
AND
OR
Every batch.
Who Will Do the Monitoring? Add ice to the product;

For continuous temperature recording OR
devices: Return the affected product to the cooler;
Monitoring is performed by the device AND
Modify the process as needed to reduce the
time and temperature exposure.
who has an understanding of the nature Establish a Recordkeeping System.
of the controls; Processing records showing the results of time
and/or temperature exposure measurements.
OR
For temperature-indicating devices and Establish Verification Procedures.
clocks:
Any person who has an understanding of a thermometer) or temperature-recording
the nature of the controls. device (e.g., a recording thermometer) is
put into service, check the accuracy of the
Establish Corrective Action Procedures. device to verify that the factory calibration
Take the following corrective action to a product has not been affected. This check can be
involved in a critical limit deviation: accomplished by:
Chill and hold the affected product until an Immersing the sensor in an ice slurry
evaluation of the total time and temperature (32F (0C)) if the device will be used at
exposure is performed; or near refrigeration temperature;
OR OR
Cook the product, after giving consideration Immersing the sensor in boiling water
to the fact that any S. aureus or B. cereus (212F (100C)) if the device will be used
toxin that may be present may not be at or near the boiling point. Note that
inactivated by heat; the temperature should be adjusted to
compensate for altitude, when necessary;
OR
238
OR or the need to replace the device (perhaps
with a more durable device). Calibration
should be performed at a minimum of two
temperature; temperatures that bracket the temperature
range at which it is used;
OR
AND
Where appropriate to the critical limit, by
accurate reference device (e.g., a NIST- using a study that establishes the relationship
traceable thermometer) under conditions between exposure time and product
that are similar to how it will be used temperature;
(e.g., air temperature and product internal AND
temperature) within the temperature
AND preparation to ensure they are complete and
Once in service, check the temperature- any critical limit deviations that occurred
indicating device or temperature-recording were appropriately addressed.
AND
or temperature-recording device against a
known accurate reference device (e.g., a
NIST-traceable thermometer) at least once a
frequency is dependent upon the type,
239
TABLE 12-6
CONTROL STRATEGY EXAMPLE 4 - UNREFRIGERATED PROCESSING CONTROL

This table is an example of a portion of a HACCP plan using Control Strategy Example 4 - Unrefrigerated Processing Control. This example illustrates how a blue crabmeat
processor that handles the crabs at the beginning of backing while still hot can control pathogenic bacteria growth and toxin formation as a result of time and temperature
abuse during unrefrigerated processing. It is provided for illustrative purposes only. It may be necessary to select more than one control strategy in order to fully control the
hazard, depending upon the nature of your operation.
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

CRITICAL
POINT
MEASURE
Backing, Pathogenic Exposure time The length of Visual Start marked Production Immediately Production Check the dial
in-process bacteria growth (i.e., time time of product observation container supervisor ice product or record thermometer for
cooler, picking, and toxin at internal exposure to of marked approximately move to cooler accuracy and
and packing formation temperatures unrefrigerated containers every 2 hours damage and to
240
above 50F conditions (i.e., using a clock during backing, Hold and ensure that it
but below above 40F) in-process evaluate is operational
135F) during cooler, picking, based on before putting
backing, in- and packing total time and into operation;
The product Dial
process cooler, temperature check it daily, at
internal thermometer
picking, and exposure the beginning of
temperature
packing should operations; and
during the
be limited to 4 calibrate it once
exposure
hours, as long per year
period
as no more
than 1 of those Review
hours is above monitoring,
70F verification, and
corrective action
records within
1 week of
preparation
Note: Control during refrigerated storage is covered under Control Strategy Example 2 - Refrigerated Storage and Refrigerated Processing Control.
Note: This critical limit is necessary because the crabs are handled at internal temperatures above 80F during backing
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243
NOTES:
244
CHAPTER 13: Clostridium botulinum Toxin Formation
UNDERSTAND THE POTENTIAL HAZARD. Controlling the amount of moisture that is

available for pathogenic bacteria growth
Clostridium botulinum (C. botulinum) toxin (water activity) in the product by formulation
formation can result in consumer illness and (covered in this chapter);
death. It is the toxin responsible for botulism. Controlling the amount of moisture that is
About 10 outbreaks of foodborne botulism occur available for pathogenic bacteria growth
annually in the United States, from all sources. (water activity) in the product by drying
Symptoms include: weakness, vertigo, double (covered in Chapter 14);
vision, difficulty in speaking, swallowing and Controlling the introduction of pathogenic
breathing, abdominal swelling, constipation, bacteria after the pasteurization process
paralysis, and death. Symptoms start from 18 and after the cooking process performed
hours to 36 hours after consumption. Everyone immediately before reduced oxygen packaging
is susceptible to intoxication by C. botulinum (covered in Chapter 18);
toxin; only a few micrograms of the toxin can Controlling the source of molluscan shellfish
cause illness in a healthy adult. Mortality is high; and the time from exposure to air (e.g., by
without the antitoxin and respiratory support, harvest or receding tide) to refrigeration
death is likely. to control pathogens from the harvest area
This chapter covers the hazard of C. botulinum (covered in Chapter 4);
growth and toxin formation as a result of time and Managing the amount of time that food is
temperature abuse during processing, storage, and exposed to temperatures that are favorable
distribution. for pathogenic bacteria growth and toxin
production (covered generally in Chapter
Strategies for controlling pathogen growth
12; for C. botulinum, in this chapter; and for
There are a number of strategies for the control Staphylococcus aureus (S. aureus) in hydrated
of pathogens in fish and fishery products. They batter mixes, in Chapter 15);
include:
Killing pathogenic bacteria by cooking or
Controlling the level of acidity (pH) in the pasteurization (covered in Chapter 16), or
product (covered by the Acidified Foods retorting (covered by the Thermally Processed
regulation, 21 CFR 114, for shelf-stable Low-Acid Foods Packaged in Hermetically
acidified products, and by this chapter for Sealed Containers regulation, 21 CFR 113
refrigerated acidified products); (hereinafter, the Low-Acid Canned Foods
Controlling the amount of salt or (LACF) Regulation));
preservatives, such as sodium nitrite, in the Killing pathogenic bacteria by processes that
product (covered in this chapter); retain the raw product characteristics (covered
in Chapter 17).
245
Formation of C. botulinum toxin packaging and modified atmosphere packaging)
When C. botulinum grows, it can produce a extend the shelf life of a product by inhibiting
potent toxin, one of the most poisonous naturally the growth of aerobic spoilage bacteria. There
occurring substances known. The toxin can be is a safety concern with these products because
destroyed by heat (e.g., boiling for 10 minutes), there is an increased potential for the formation
but, because of its potency, you should not rely of C. botulinum toxin before spoilage makes the
on this as a means of control. product unacceptable to consumers.
The strains of C. botulinum can be divided C. botulinum forms toxin more rapidly at higher
into two groups, the proteolytic group (i.e., temperatures than at lower temperatures. The
those that break down proteins) and the non minimum temperature for growth and toxin
proteolytic group (i.e., those that do not break formation by C. botulinum type E and non
down proteins). The proteolytic group includes proteolytic types B and F is 38F (3.3C). For
C. botulinum type A and some of types B and F. type A and proteolytic types B and F, the
The non-proteolytic group includes C. botulinum minimum temperature for growth is 50F (10C).
type E and some of types B and F. As the shelf life of refrigerated foods is increased,
more time is available for C. botulinum growth
The vegetative cells of all types of C. botulinum
and toxin formation. As storage temperatures
are easily killed by heat. However, C. botulinum
increase, the time required for toxin formation is
is able to produce spores. In this state, the
significantly shortened. You should expect that at
pathogen is very resistant to heat. The spores
some point during storage, distribution, display,
of the proteolytic group are much more resistant
or consumer handling of refrigerated foods, safe
to heat than are those of the non-proteolytic
refrigeration temperatures will not be maintained
group (i.e., they require a canning process to be
(especially for the non-proteolytic group). Surveys
destroyed). Table A-4 (Appendix 4) provides
of retail display cases indicate that temperatures
guidance about the conditions under which
of 45 to 50F (7 to 10C) are not uncommon.
the spores of the most heat-resistant form
Surveys of home refrigerators indicate that
of non-proteolytic C. botulinum, type B, are
temperatures can exceed 50F (10C).
killed. However, there are some indications
that substances that may be naturally present In reduced oxygen packaged products in which
in some products (e.g., dungeness crabmeat), the spores of non-proteolytic C. botulinum
such as lysozyme, may enable non-proteolytic are inhibited or destroyed (e.g., smoked fish,
C. botulinum to more easily recover after heat pasteurized crabmeat, and pasteurized surimi),
damage, resulting in the need for a considerably a normal refrigeration temperature of 40F
more stringent process to ensure destruction. (4.4C) is appropriate because it will limit
the growth of proteolytic C. botulinum and
C. botulinum is able to produce toxin when
other pathogens that may be present. Even
a product in which it is present is exposed to
in pasteurized products where non-proteolytic
temperatures favorable for growth for sufficient
C. botulinum is the target organism for the
time. Table A-1 (Appendix 4) provides guidance
pasteurization process, and vegetative pathogens,
about the conditions under which C. botulinum
such as Listeria monocytogenes, are not likely
and other pathogenic bacteria are able to grow.
to be present (e.g., pasteurized crabmeat and
Table A-2 (Appendix 4) provides guidance about
pasteurized surimi), a storage temperature of
the time necessary at various temperatures for
40F (4.4C) is still appropriate because of the
toxin formation to occur.
potential for survival through the pasteurization
Packaging conditions that reduce the amount process and recovery of spores of non-proteolytic
of oxygen present in the package (e.g., vacuum C. botulinum, aided by naturally occurring
246
substances, such as lysozyme. In this case, toxin formation in reduced oxygen packaged fish
refrigeration serves as a prudent second barrier. and fishery products.
However, in reduced oxygen packaged products Alternatively, products of this type may be safely
in which refrigeration is the sole barrier to marketed frozen, with appropriate labeling
outgrowth of non-proteolytic C. botulinum and to ensure that it is held frozen throughout
the spores have not been destroyed (e.g., vacuum- distribution. For some reduced oxygen packaged
packaged refrigerated raw fish, vacuum-packaged products, control of C. botulinum can be
refrigerated unpasteurized crayfish meat, and achieved by breaking the vacuum seal before the
reduced oxygen packaged unpasteurized product leaves the processors control.
dungeness crabmeat), the temperature should be
The guidance in this chapter emphasizes
maintained below 38F (3.3C) from packing to
consumption. Ordinarily you, as a processor, can preventive measures for the control of non
ensure that temperatures are maintained below proteolytic strains of C. botulinum in products
38F (3.3C) while the product is in your control. that are contained in reduced oxygen packaging.
However, the current U.S. food distribution As was previously described, this emphasis
system does not ensure the maintenance of these is because such an environment extends the
temperatures after the product leaves your control. shelf life of a refrigerated product in a way that,
under moderate temperature abuse, favors C.
The use of a Time-Temperature Indicator (TTI) on botulinum growth and toxin formation over
each consumer package may be an appropriate aerobic spoilage. It is also possible for both
means of overcoming these problems in the non-proteolytic and proteolytic C. botulinum
distribution system for reduced oxygen packaged to grow and produce toxin in a product that is
products in which refrigeration is the sole barrier not reduced oxygen packaged and is subjected
to outgrowth of non-proteolytic C. botulinum and to severe temperature abuse. This is the case
in which the spores have not been destroyed.
because of the development within the product
A TTI is a device that monitors the time and
of microenvironments that support its growth.
temperature of exposure of the package and
However, this type of severe temperature abuse
alerts the consumer or end user if a safe exposure
of refrigerated products is not reasonably likely
limit has been exceeded. If a TTI is used, it
to occur in the processing environment of most
should be validated to ensure that it is fit for its
fish or fishery products and the Current Good
intended purpose and verified that it is functional
Manufacturing Practice in Manufacturing, Packing,
at the time of use. It should be designed to alert
or Holding Human Food regulation, 21 CFR 110,
the consumer (e.g., a color change) that an unsafe
requires refrigeration of foods that support the
time and temperature exposure has occurred
growth of pathogenic microorganisms.
that may result in C. botulinum toxin formation.
Additionally, the alert should remain perpetually Sources of C. botulinum
visible after it has been triggered, regardless of
C. botulinum can enter the process on raw
environmental conditions that could reasonably
materials. The spores of C. botulinum are very
be expected to occur thereafter. Skinner, G. E.,
common. They have been found in the gills
and J. W. Larkin in Conservative prediction of
and viscera of finfish, crabs, and shellfish. C.
time to Clostridium botulinum toxin formation for
botulinum type E is the most common form found
use with time-temperature indicators to ensure
in freshwater and marine environments. Types
the safety of foods, Journal of Food Protection,
A and B are generally found on land but may
61:1154-1160 (1998), describe a safe time and
temperature exposure curve (Skinner-Larkin also be occasionally found in water. It should be
curve) that may be useful in evaluating the assumed that C. botulinum will be present in any
suitability of a TTI for control of C. botulinum raw fishery product, particularly in the viscera.
247
Because spores are known to be present in the packaging) may be rapidly depleted by the
viscera, any product that will be preserved by activity of spoilage bacteria, resulting in the
salting, drying, pickling, or fermentation should formation of a reduced oxygen environment.
be eviscerated prior to processing (see the
Packaging that provides an oxygen transmission
Compliance Policy Guide, Sec. 540.650). Without
rate (in the final package) of at least 10,000 cc/
evisceration, toxin formation is possible during the
m2/24 hours at 24C can be regarded as an
process, even with strict control of temperature.
oxygen-permeable packaging material for fishery
Evisceration of fish is the careful and complete
products. The oxygen transmission rate of
removal of all internal organs in the body cavity
packaging material is listed in the packaging
without puncturing or cutting them, including
specifications that can be obtained from the
gonads. If even a portion of the viscera or its
packaging manufacturer.
contents is left behind, the risk of toxin formation
by C. botulinum remains. Uneviscerated small An oxygen-permeable package should provide
fish, less than 5 inches in length (e.g., anchovies sufficient exchange of oxygen to allow aerobic
and herring sprats), for which processing eliminates spoilage organisms to grow and spoil the product
preformed toxin, prevents toxin formation during before toxin is produced under moderate abuse
processing and that reach a water phase salt temperatures. Particular care should be taken in
content of 10% in refrigerated finished products, determining the safety of a packaging material for a
or a water activity of below 0.85 in shelf-stable product in which the spoilage organisms have been
finished products, or a pH of 4.6 or less in shelf- eliminated or significantly reduced by processes
stable finished products, are not subject to the such as high pressure processing. The generally
evisceration recommendation. recommended 10,000 cc/m2/24 hours at 24C
Note: The water phase salt content of 10% is based on the control of
transmission rate may not be suitable in this case.
C. botulinum type A and proteolytic types B and F.
Use of an oxygen-permeable package may not
Note: The water activity value of below 0.85 is based on the compensate for the restriction to oxygen exchange
minimum water activity for toxin production of S. aureus.
created by practices such as packing in oil or in
Reduced oxygen packaging deep containers from which the air is expressed
or the use of oxygen scavengers in the packaging.
A number of conditions can result in the creation
of a reduced oxygen environment in packaged Control of C. botulinum
fish and fishery products. They include: There are a number of strategies to prevent C.
Vacuum, modified, or controlled atmosphere botulinum growth and toxin formation during
packaging. These packaging methods processing, storage, and distribution of finished
generally directly reduce the amount of fish and fishery products. They include:
oxygen in the package;
For products that do not require refrigeration
Packaging in hermetically sealed containers (i.e., shelf-stable products):
(e.g., double-seamed cans, glass jars
Heating the finished product in its final
with sealed lids, and heat-sealed plastic
container sufficiently by retorting to destroy
containers), or packing in deep containers
the spores of C. botulinum types A B, E,
from which the air is expressed (e.g., caviar
and F (e.g., canned fish). This strategy is
in large containers), or packing in oil. These
covered by the LACF Regulation, 21 CFR
and similar processing and packaging
113, and these controls are not required to
techniques prevent the entry of oxygen into
be included in your Hazard Analysis Critical
the container. Any oxygen present at the
Control Point (HACCP) plan;
time of packaging (including oxygen that
may be added during modified atmosphere
248
Controlling the level of acidity (pH) in the Controlling the amount of salt in the product
finished product to 4.6 or below, to prevent to 20% water phase salt (wps) or more, to
growth and toxin formation by C. botulinum prevent the growth of C. botulinum types A,
types A, B, E, and F (e.g., shelf-stable B, E, and F and other pathogens that may
acidified products). This strategy is covered be present in the product (e.g., shelf-stable
by the Acidified Foods regulation, 21 CFR salted products). This strategy is covered
114, and these controls are not required to be in this chapter. Water phase salt is the
included in your HACCP plan; concentration of salt in the water-portion of
Controlling the amount of moisture that is the fish flesh and calculated as follows: (%
available in the product (water activity) to NaCl X 100)/(% NaCl + % moisture) = % NaCl
0.85 or below by drying, to prevent growth in water phase. The relationship between
and toxin formation by C. botulinum types percent water phase salt and water activity in
A, B, E, and F and other pathogens that may fish is described in the following graph.
be present in the product (e.g., shelf-stable
dried products). This strategy is covered by
Chapter 14;
Relationship of Water Activity to Water Phase

1
Salt in NaCl/Water Solutions
1.00
0.98
0.96
Water ac tivity
0.94
0.92
0.90
0.88
0.86
0.84
0 2 4 6 8 10 12 14 16 18 20
Percent water phase salt
1. This relationship is generally valid for fish products when salt (sodium chloride) is the primary means of
binding water. The specific food matrix and the use of other salts or water binding agents could affect the
exact relationship. If you intend to use this relationship in your control strategy, you should determine the
exact relationship in your product by conducting a study.
249
For products that require refrigeration: type A and proteolytic types B and F and
Heating the finished product in its final other pathogens that may be present in
container sufficiently by pasteurization to the finished product through refrigerated
destroy the spores of C. botulinum type storage (e.g., refrigerated dried fish). Drying
E and non-proteolytic types B and F, and is covered in Chapter 14, controlling the
then minimizing the risk of recontamination growth of proteolytic C. botulinum through
by controlling seam closures and cooling refrigeration is covered in this chapter, and
water, and next controlling the growth controlling the growth of other pathogenic
of the surviving C. botulinum type A and bacteria through refrigeration is covered in
proteolytic types B and F in the finished Chapter 12;
product with refrigerated storage (e.g.. Controlling the level of pH to 5 or below, salt
pasteurized crabmeat and some pasteurized to 5% wps or more, moisture (water activity)
surimi-based products). Pasteurization to 0.97 or below, or some combination
is covered in Chapter 16, controlling of these barriers, in the finished product
recontamination after pasteurization is sufficiently to prevent the growth of C.
covered in Chapter 18, and controlling the botulinum type E and non-proteolytic
growth of proteolytic C. botulinum through types B and F by formulation, and then
refrigeration is covered in this chapter; controlling the growth of C. botulinum
Heating the product sufficiently to destroy type A and proteolytic types B and F and
the spores of C. botulinum type E and other pathogens that may be present in
non-proteolytic types B and F, and then the finished product with refrigerated
minimizing the risk of recontamination storage (e.g., refrigerated acidified (pickled)
by hot filling the product into the final products). Controlling the growth of non-
container in a sanitary, continuous, closed proteolytic C. botulinum through formulation
filling system and controlling seam closures is covered in this chapter, controlling the
and cooling water, and next controlling growth of proteolytic C. botulinum through
the growth of the surviving C. botulinum refrigeration is covered in this chapter, and
type A and proteolytic types B and F and controlling the growth of other pathogenic
other pathogens that may be present in the bacteria through refrigeration is covered in
finished product with refrigerated storage Chapter 12;
(e.g., vacuum packed soups, chowders, and Controlling the amount of salt and
sauces). Specialized cooking processes preservatives, such as sodium nitrite, in
are covered in Chapter 16, prevention of the finished product, in combination with
recontamination after specialized cooking other barriers, such as smoke, heat damage,
processes is covered in Chapter 18, and competitive bacteria, sufficiently to
controlling the growth of proteolytic C. prevent the growth of C. botulinum type
botulinum through refrigeration is covered E and non-proteolytic types B and F, and
in this chapter, and controlling the growth then controlling the growth of C. botulinum
of other pathogenic bacteria through type A and proteolytic types B and F and
refrigeration is covered in Chapter 12; other pathogens that may be present in the
Controlling the amount of moisture that finished product with refrigerated storage
is available in the product (water activity) (e.g., salted, smoked, or smoke-flavored fish).
to 0.97 or below to inhibit the growth of Controlling the growth of non-proteolytic
C. botulinum type E and non-proteolytic C. botulinum through salting and smoking
types B and F by drying, and then is covered in this chapter, controlling the
controlling the growth of C. botulinum growth of proteolytic C. botulinum through
250
refrigeration is covered in this chapter, and In hot-smoked products, heat damage to
controlling the growth of other pathogenic the spores of C. botulinum type E and non
bacteria through refrigeration is covered in proteolytic types B and F also helps prevent
Chapter 12; toxin formation. In these products, control of
Controlling the amount of salt in the the heating process is critical to the safety of
finished product, in combination with heat the finished product. It is important to note,
damage from pasteurization in the finished however, that this same heating process also
product container, sufficiently to prevent reduces the numbers of naturally occurring
the growth of C. botulinum type E and spoilage organisms. The spoilage organisms
nonproteolytic types B and F, and then would otherwise have competed with, and
controlling the growth of C. botulinum inhibited the growth of, C. botulinum.
type A and proteolytic types B and F and In cold-smoked fish, it is important that
other pathogens that may be present in the product does not receive so much heat
the finished product with refrigerated that the numbers of spoilage organisms
storage (e.g., some pasteurized surimi are significantly reduced. This is important
based products). Controlling the growth because spoilage organisms must be present
of non-proteolytic C. botulinum through to inhibit the growth and toxin formation
a combination of salt and heat damage of C. botulinum type E and non-proteolytic
is covered in this chapter, controlling the types B and F. This inhibition is important
growth of proteolytic C. botulinum through in cold-smoked fish because the heat applied
refrigeration is covered in this chapter, and during this process is not adequate to
controlling the growth of other pathogenic weaken the C. botulinum spores. Control
bacteria through refrigeration is covered in of the temperature during the cold-smoking
Chapter 12. process to ensure survival of the spoilage
Examples of C. botulinum control in specific organisms is, therefore, critical to the safety
products: of the finished product.
The interplay of these inhibitory effects
Refrigerated (not frozen), reduced oxygen
(i.e., salt, temperature, smoke, and nitrite)
packaged smoked and smoke-flavored fish
is complex. Control of the brining or dry
Achieving the proper concentration of salting process is clearly critical to ensure that
salt and nitrite in the flesh of refrigerated, there is sufficient salt in the finished product.
reduced oxygen packaged smoked and However, preventing toxin formation by C.
smoke-flavored fish is necessary to prevent botulinum type E and non-proteolytic types
the formation of toxin by C. botulinum type B and F is made even more complex by the
E and non-proteolytic types B and F during fact that adequate salt levels are not usually
storage and distribution. Salt works along achieved during brining. Proper drying
with smoke and any nitrites that are added during smoking is also critical in order to
to prevent growth and toxin formation by C. achieve the finished product water phase
botulinum type E and non-proteolytic types salt level (i.e., the concentration of salt in
B and F. Note that nitrites should be used the water portion of the fish flesh) needed
only in salmon, sable, shad, chubs, and tuna, to inhibit growth and toxin formation by C.
according to 21 CFR 172.175 and 21 CFR botulinum.
172.177 , and should not exceed a level of
200 ppm in salmon, sable, shad, chubs and This chapter covers the control procedures
10 ppm in tuna. described above.
251
You should ordinarily restrict brining, dry also serves as a prudent second barrier
salting, and smoking loads to single species because of the potential survival through
and to fish portions of approximately the pasteurization process and recovery of
uniform size. This restriction minimizes the spores of non-proteolytic C. botulinum, aided
complexity of controlling the operation. You by naturally occurring substances, such as
should treat brine to minimize microbial lysozyme. Cooking and pasteurization are
contamination or periodically replace it as a covered in Chapter 16, and controlling the
good manufacturing practice control. growth of C. botulinum through refrigeration
is covered in this chapter.
The combination of inhibitory effects that are
present in smoked and smoke-flavored fish In the second category of products, filling
are not adequate to prevent toxin formation the product into the final container while it is
by C. botulinum type A and proteolytic types still hot in a continuous, closed filling system
B and F. Strict refrigeration control (i.e., at (i.e., hot filling) is also critical to the safety of
or below 40F (4.4C)) during storage and the finished product because it minimizes the
distribution should be maintained to prevent risk of recontamination of the product with
growth and toxin formation by C. botulinum pathogens, including C. botulinum type E and
type A and proteolytic types B and F and non-proteolytic types B and F. This control
other pathogens that may be present in strategy applies to products such as soups,
these products. Controlling the growth of chowders, and sauces that are filled directly
proteolytic C. botulinum through refrigeration from the cooking kettle, where the risk of
is covered in this chapter, and controlling the recontamination is minimized. It may not
growth of other pathogenic bacteria through apply to products such as crabmeat, lobster
refrigeration is covered in Chapter 12. meat, or crayfish meat or to other products
that are handled between cooking and filling.
Refrigerated (not frozen), reduced oxygen Control of hot filling is covered in Chapter 18.
packaged, pasteurized fishery products
Chapter 18 also covers other controls that
Refrigerated, reduced oxygen packaged,
may be necessary to prevent recontamination,
pasteurized fishery products fall into two
including controlling container sealing and
categories: (1) those which are pasteurized
controlling contamination of container
in the final container; and (2) those which
cooling water. These controls may be critical
are cooked in a kettle and then hot filled
to the safety of both categories of products.
into the final container in a continuous,
closed filling system (e.g., heat-and-fill Examples of properly pasteurized products
soups, chowders, and sauces). In both follow: fish and fishery products generally
cases, ordinarily the heating process should (e.g., surimi-based products, soups,
be sufficient to destroy the spores of C. or sauces) pasteurized to a minimum
botulinum type E and non-proteolytic types cumulative total lethality of F194F (F90C)
B and F. In neither case is it likely that = 10 minutes, where z = 12.6F (7C) for
the heating process will be sufficient to temperatures less than 194F (90C), and
destroy the spores of C. botulinum type A z = 18F (10C) for temperatures above
and proteolytic types B and F. Therefore, 194F (90C); blue crabmeat pasteurized
strict refrigeration control (i.e., at or below to a minimum cumulative total lethality of
40F (4.4C)) should be maintained during F185F (F85C) = 31 minutes, where z = 16F
storage and distribution to prevent growth (9C); and dungeness crabmeat pasteurized
and toxin formation by C. botulinum type A to a minimum cumulative total lethality of
and proteolytic types B and F. Refrigeration F194F (F90C) = 57 minutes, where z = 15.5F
252
(8.6C). Equivalent processes at different Adding sufficient acid to reduce
temperatures can be calculated using the z the acidity (pH) to 5.0 or below;
values provided.
Reducing the amount of moisture
that is available for growth (water
EXAMPLES OF PROPERLY PASTEURIZED activity) to below 0.97 (e.g., by
PRODUCTS
adding salt or other substances that
PRODUCT
MINIMUM CUMULATIVE
Z VALUE
bind the available water); or
TOTAL LETHALITY
Fish and fishery F194F (F90C) = 10 minutes 12.6F (7C), for Making a combination of salt, pH,
products temperatures and/or water activity adjustments
generally less than 194F
(e.g., surimi (90C) that, when combined, prevents the
based products, 18F (10C) for growth of C. botulinum type E and
soups, or temperatures
sauces) above 194F
non-proteolytic types B and F (to be
(90C) established by a scientific study).
Blue crabmeat F185F (F85C) = 31 minutes 16F (9C)
Much like smoked products, in some of these
Dungeness F194F (F90C) = 57 minutes 15.5F (8.6C)
crabmeat
products the interplay of these inhibitory
effects (i.e., salt, water activity, and pH) can
be complex. Control of the brining, pickling,
In some pasteurized surimi-based
or formulation steps is, therefore, critical to
products, salt, in combination with a milder
ensure that there are sufficient barriers in the
pasteurization process, in the finished product
finished product to prevent the growth and
container works to prevent growth and toxin
toxin formation of C. botulinum type E and
formation by C. botulinum type E and non
non-proteolytic types B and F during storage
proteolytic types B and F. An example of a
and distribution. These control procedures
properly pasteurized surimi-based product
are covered in this chapter.
in which 2.4% wps is present is one that has
been pasteurized at an internal temperature You should ordinarily restrict brining and
of 185F (85C) for at least 15 minutes. This pickling loads to single species and to fish
process may not be suitable for other types of portions of approximately uniform size.
products because of the unique formulation This restriction minimizes the complexity of
and processing involved in the manufacture of controlling the operation. You should treat
surimi-based products. brine to minimize microbial contamination
or periodically replace it as a good
Refrigerated (not frozen), reduced oxygen manufacturing practice control.
packaged pickled fish, salted fish, caviar,
and similar products The controls discussed above are not
sufficient to prevent toxin formation by C.
In pickled fish, salted fish, caviar, and similar
botulinum type A and proteolytic types B
products that have not been preserved
and F. Strict refrigeration control (i.e., at
sufficiently for them to be shelf stable,
or below 40F (4.4C)) during storage and
growth and toxin formation by C. botulinum
distribution should, therefore, be maintained
type E and non-proteolytic types B and F is
to prevent growth and toxin formation by C.
controlled by one of the following:
botulinum type A and proteolytic types B and
Adding sufficient salt to produce F and other pathogens that may be present
a water phase salt level (i.e., the in these products. Controlling the growth of
concentration of salt in the water proteolytic C. botulinum through refrigeration
portion of the fish flesh) of at least 5%; is covered in this chapter, and controlling the
253
growth of other pathogenic bacteria through Frozen, reduced oxygen packaged raw,
refrigeration is covered in Chapter 12. unpreserved fish and unpasteurized, cooked
fishery products
Refrigerated (not frozen), reduced oxygen
For frozen, reduced oxygen packaged raw,
packaged raw, unpreserved fish and
unpreserved fish (e.g., frozen, vacuum-
unpasteurized, cooked fishery products
packaged fish fillets) and frozen, reduced
For refrigerated, reduced oxygen packaged oxygen packaged, unpasteurized, cooked
raw, unpreserved fish (e.g., refrigerated, fishery products (e.g., frozen, vacuum-
vacuum-packaged fish fillets) and refrigerated, packaged, unpasteurized crabmeat, lobster
reduced oxygen packaged, unpasteurized, meat, or crayfish meat), the sole barrier to
cooked fishery products (e.g., refrigerated, toxin formation by C. botulinum type E
vacuum-packaged, unpasteurized crabmeat, and non-proteolytic types B and F during
lobster meat, or crayfish meat), the sole finished product storage and distribution
barrier to toxin formation by C. botulinum is freezing. Because these products may
type E and non-proteolytic types B and appear to the retailer, consumer, or end user
F during finished product storage and to be intended to be refrigerated, rather than
distribution is refrigeration. These types of C. frozen, labeling to ensure that they are held
botulinum will grow at temperatures as low frozen throughout distribution is critical to
as 38F (3.3C). As was previously noted, their safety.
maintenance of temperatures below 38F
(3.3C) after the product leaves your control Controls should be in place to ensure that
and enters the distribution system cannot such products are immediately frozen after
normally be ensured. The use of a TTI on processing, maintained frozen throughout
the smallest unit of packaging (i.e., the unit storage in your facility, and labeled to
of packaging that will not be distributed be held frozen and to be thawed under
any further, usually consumer or end-user refrigeration immediately before use (e.g.,
package) may be an appropriate means of Important, keep frozen until used, thaw
overcoming these problems in the distribution under refrigeration immediately before use).
system. This chapter provides controls for the Frozen, reduced oxygen packaged products
application of TTIs for packaging. that are customarily cooked by the consumer
or end user in the frozen state (e.g., boil-in
If you intend to package these products in bag products and frozen fish sticks) need not
a reduced oxygen package and you do not be labeled to be thawed under refrigeration.
intend to apply a TTI on each consumer For purposes of hazard analysis, other frozen
package, you should evaluate the effectiveness products that do not contain the keep
of other preventive measures, either singularly, frozen statement should be evaluated as if
or in combination, that may be effective in they will be stored refrigerated because the
preventing growth and toxin formation by C. consumer or end user would not have been
botulinum. Such evaluation is customarily warned to keep them frozen.
accomplished by conducting an inoculated
pack study under moderate abuse conditions. Control procedures to ensure that product
A suitable protocol for the performance of is properly labeled with keep frozen
such studies is contained in a 1992 publication instructions are covered in this chapter.
by the National Advisory Committee on
Microbiological Criteria for Foods, Vacuum
or modified atmosphere packaging for
refrigerated, raw fishery products.
254
Control in unrefrigerated (shelf-stable), DETERMINE WHETHER THE POTENTIAL
reduced oxygen packaged fishery products HAZARD IS SIGNIFICANT.
Examples of shelf-stable, reduced oxygen
packaged fishery products are dried fish, The following guidance will assist you in
acidified fish, canned fish, and salted fish. determining whether C. botulinum toxin formation
Because these products are marketed without is a significant hazard at a processing step:
refrigeration, either (1) the spores of C.
botulinum types A, B, E, and F should be 1. Is it reasonably likely that C. botulinum will
destroyed after the product is placed in the grow and produce toxin during finished product
finished product container (covered by the storage and distribution?
LACF Regulation, 21 CFR 113) or (2) a barrier, The factors that make C. botulinum toxin
or combination of barriers, should be in place formation during finished product storage
that will prevent growth and toxin formation and distribution reasonably likely to occur
by C. botulinum types A, B, E, and F, and are those that may result in the formation of
other pathogens that may be present in the a reduced oxygen packaging environment.
product. Suitable barriers include: These are discussed in the section
Adding sufficient salt to produce Understand the potential hazard, under the
a water phase salt level (i.e., the heading, Reduced oxygen packaging.
concentration of salt in the water
2. Can growth and toxin formation by C. botulinum that
portion of the fish flesh) of at least
is reasonably likely to occur be eliminated or reduced
20%. Note that this value is based on
to an acceptable level at this processing step?
the maximum salt level for growth of
S. aureus, covered in this chapter; C. botulinum toxin formation should also
be considered a significant hazard at any
Reducing the amount of moisture
processing step where a preventive measure
that is available for growth (water
is, or can be, used to eliminate the hazard
activity) to below 0.85 (e.g., by adding
(or reduce the likelihood of its occurrence to
salt or other substances that bind the
an acceptable level) if it is reasonably likely
available water). Note that this value
to occur.
is based on the minimum water activity
for growth and toxin formation of S. Preventive measures for C. botulinum toxin
aureus, covered in this chapter; formation during finished product distribution
and storage are discussed in the section,
Adding sufficient acid to reduce the pH
Understand the potential hazard, under the
to 4.6 or below. This barrier is covered
heading, Control of C. botulinum.
by the Acidified Foods regulation, 21 CFR
114, and these controls are not required Intended use
to be included in your HACCP plan;
Because of the extremely toxic nature of
Drying the product sufficiently to C. botulinum toxin, it is unlikely that the
reduce the water activity to 0.85 or significance of the hazard will be affected by the
below. Note that this value is based intended use of your product.
on the minimum water activity for
growth and toxin formation of S.
aureus, covered in Chapter 14.
Note: A heat treatment, addition of chemical additives, or
other treatment may be necessary to inhibit or eliminate
spoilage organisms (e.g., mold) in shelf-stable products.
255
IDENTIFY CRITICAL CONTROL POINTS. Products dried to control the
growth of C. botulinum type E
The following guidance will assist you in and non-proteolytic types B and
determining whether a processing step is a F and refrigerated to control the
critical control point (CCP) for C. botulinum toxin growth of C. botulinum type A and
formation: proteolytic types B and F and other
pathogens that may be present.
1. Is there an acidification step (equilibrium pH
In these cases, you should also identify
of 4.6 or below), a drying step, an in-package
the finished product storage step as
pasteurization step, a combination of cook and
a CCP for the hazard. Control of
hot-fill steps, or a retorting step (commercial
refrigeration is covered in this chapter for
sterility) in the process?
C. botulinum and in Chapter 12 for other
a. If there is, you should in most cases pathogenic bacteria.
identify the acidification step, drying Additionally, some pasteurized surimi
step, pasteurization step, cook and hot- based products rely on a combination of
fill steps, or retorting step as the CCP(s) salt and a relatively mild pasteurization
for this hazard. Other processing steps process in the finished product container
where you have identified C. botulinum for the control of C. botulinum type E
toxin formation as a significant hazard and non-proteolytic types B and F. In
will then not require control and will these products, you should also identify
not need to be identified as CCPs for the formulation step as a CCP for the
the hazard. However, control should hazard. Guidance provided in Control
be provided for time and temperature Strategy Example 4 - Pickling and Salting
exposure during finished product may be useful in developing controls at
storage and distribution of the following this step.
products:
Guidance for the C. botulinum control
Products pasteurized in the final strategies listed above is contained in the
container to kill C. botulinum type following locations:
E and non-proteolytic types B
Control of cooking and hot-filling
and F and refrigerated to control
is covered in Chapters 16 and 18;
the growth of C. botulinum type
A and proteolytic types B and F Control of pasteurization is
and other pathogens that may covered in Chapters 16 and 18;
be present (e.g., pasteurized
Control of drying is covered
crabmeat and pasteurized surimi);
in Chapter 14;
Products cooked to kill C. botulinum
Control of acidification is
type E and non-proteolytic types
covered in the Acidified Foods
B and F, and then hot filled into
regulation, 21 CFR 114;
the final container, and next
refrigerated to control the growth Control of retorting is covered in
of C. botulinum type A and the LACF Regulation, 21 CFR 113.
proteolytic types B and F and other Note: Acidification and retorting controls for C. botulinum
pathogens that may be present; required by 21 CFRs 113 and 114 need not be included
in your HACCP plan.
256
b. If there is no acidification step and the smoking step should be identified as
(equilibrium pH of 4.6 or below), drying a CCP for this hazard. The smoking step for
step, pasteurization step, cooking and hot-smoked fish should be sufficient to damage
hot-filling, or retorting (commercial the spores and make them more susceptible to
sterility) step in the process, then decide inhibition by salt. The smoking step for cold-
which of the following categories best smoked fish should not be so severe that it kills
describes your product and refer to the the natural spoilage bacteria. These bacteria
guidance below: are necessary so that the product will spoil
before toxin production occurs. It is likely
Smoked and smoke-flavored fish;
that they will also produce acid, which will
Fishery products in which further inhibit C. botulinum growth and toxin
refrigeration is the sole barrier formation.
to prevent toxin formation;
Fishery products in which freezing is referred to in this chapter as Control Strategy
the sole barrier to toxin formation; Example 1 - Smoking (1b - Cold Smoking and
1c - Hot Smoking).
Pickled fish and similar products.
3. Is the storage temperature important to the safety
Smoked and smoke-flavored fish
of the product?
1. Is the water phase salt level and, when permitted,
the nitrite level, important to the safety of the Refrigerated (not frozen) finished product
product? storage is critical to the safety of all products
in this category and should be identified as
For all products in this category, the water a CCP. Toxin formation by C. botulinum
phase salt level is critical to the safety of the type A and proteolytic types B and F is not
product, and the brining, dry salting and, inhibited by water phase salt levels below
where applicable, drying steps should be 10%, nor by the combination of inhibitors
identified as CCPs. Nitrite, when permitted, present in most smoked or smoke-flavored
allows a lower level of salt to be used. Salt fish. Bacillus cereus can grow and form
and nitrite are the principal inhibitors to toxin at water phase salt concentrations as
C. botulinum type E and non-proteolytic high as 18%.
types B and F toxin formation in these
products. The water phase salt level needed
referred to in this chapter as Control Strategy
to inhibit toxin formation is partially achieved
Example 1 - Smoking (1d - Refrigerated
during brining or dry salting and is partially
Finished Product Storage).
achieved during drying. Control should be
exercised over both operations. In some cases, salted, smoked, or smoke-
flavored fish are received as ingredients
for assembly into another product, such
as a salmon pat. In other cases, they are
Example 1 - Smoking (1a - Brining, Dry
received simply for storage and further
Salting, and Drying).
distribution (e.g., by a warehouse). In either
2. Is the temperature of the heating or smoking case, the refrigerated (not frozen) storage step
process important to the safety of the product? is critical to the safety of the product and
should be identified as a CCP. Control is the
For both cold-smoked and hot-smoked fish
same as that provided under Control Strategy
products, the temperature of smoking is critical,
Example 1 - Smoking (1d - Refrigerated
257
Finished Product Storage). Additionally, This control approach is a control strategy
receiving of these products should be referred to in this chapter as Control Strategy
identified as a CCP, where control can be Example 2 - Refrigeration With a TTI (2e
exercised over the time and temperature Receipt of Product by Secondary Processor).
during transit.
As previously noted, maintenance of
This control approach is a control strategy temperatures below 38F (3.3C) after the
referred to in this chapter as Control product leaves your control and enters the
Strategy Example 1 - Smoking (1e - Receipt of distribution system cannot normally be
Products by Secondary Processor). ensured. The use of a TTI on the smallest
unit of packaging (i.e., the unit of packaging
Fishery products in which refrigeration is that will not be distributed any further,
the sole barrier to prevent toxin formation
usually consumer or end-user package) may
1. Is the storage temperature important to the safety be an appropriate means of overcoming these
of the product? problems in the distribution system. When
TTIs are used in this manner, their receipt,
Refrigerated finished product storage is
storage, and application and activation should
critical to the safety of all products in this
be identified as CCPs.
category and should be identified as a CCP.
These products contain no barriers (other This control approach is a control strategy
than refrigeration) to toxin formation by C. referred to as Control Strategy Example 2
botulinum type E and non-proteolytic types Refrigeration With TTI (2a - Unactivated TTI
B and F during finished product storage and Receipt, 2b - Unactivated TTI Storage, and 2c
distribution. These types of C. botulinum - Application and Activation of TTI).
will grow at temperatures as low as 38F
Fishery products in which freezing is the
(3.3C), necessitating particularly stringent
sole barrier to toxin formation
temperature control.
1. Is the storage temperature important to the safety
of the product?
Example 2 - Refrigeration With TTI (2d Frozen finished product storage is critical to
Refrigerated Finished Product Storage). the safety of all products in this category.
These products contain no barriers (other
In some cases, these products are received as
than freezing) to toxin formation by C.
ingredients for assembly into another product.
botulinum type E and non-proteolytic types
In other cases, they are received simply for
B and F during finished product storage and
storage and further distribution (e.g., by a
distribution. As previously noted, because
warehouse). In either case, the refrigerated
these products may appear to the retailer,
storage step is critical to the safety of the
consumer, or end user to be intended to be
product and should be identified as a CCP.
refrigerated, rather than frozen, labeling to
Control is the same as that provided under
ensure that they are held frozen throughout
Control Strategy Example 2 - Refrigeration
distribution is critical to their safety and
With a TTI (2d - Refrigerated Finished
should be identified as a CCP.
Product Storage). Additionally, receiving of
these products should be identified as a CCP, This control approach is a control strategy
where control can be exercised over the time referred to in this chapter as Control Strategy
and temperature during transit. Example 3 - Frozen With Labeling.
258
Pickled and salted fish and similar products Salting (4b - Refrigerated Finished Product
1. Is the water phase salt level, water activity, and/ Storage). Additionally, receiving of these
or pH level important to the safety of the product? products should be identified as a CCP,
where control can be exercised over time and
For all products in this category, the water temperature during transit.
phase salt level, water activity, and/or pH
level are critical to the safety of the product
because they are the principal inhibitors to
Example 4 - Pickling and Salting (4c - Receipt
growth and toxin formation by C. botulinum
of Product by Secondary Processor).
type E and non-proteolytic type B and F. The
levels of these inhibitors needed to inhibit
toxin formation are achieved during the DEVELOP A CONTROL STRATEGY.
pickling, brining, or formulation step. Control
should be exercised over the relevant step. The following guidance provides four control
strategies for C. botulinum toxin formation. You
This control approach is a control strategy may select a control strategy that is different from
referred to in this chapter as Control Strategy those which are suggested, provided it complies
Example 4 - Pickling and Salting (4a - with the requirements of the applicable food
Brining, Pickling, Salting, and Formulation). safety laws and regulations. Control strategies
2. Is the storage temperature important to the safety contain several elements that may need to be
of the product? used in combination to result in an effective
control program.
Unless pickling, brining, or formulation results
in a water phase salt level of at least 20%
(note that this value is based on the maximum
salt concentration for growth of S. aureus), a MAY APPLY TO MAY APPLY TO
pH of 4.6 or below, or a water activity of 0.85 CONTROL STRATEGY PRIMARY SECONDARY
PROCESSOR PROCESSOR
or below (note that this value is based on
Smoking
the minimum water activity for growth of S.
aureus), refrigerated finished product storage Refrigeration with TTI
is critical to ensure the safety of the product Frozen with labeling
and should be identified as a CCP. Pickling and salting
referred to in this chapter as Control Strategy CONTROL STRATEGY EXAMPLE 1 - SMOKING
Example 4 - Pickling and Salting (4b This control strategy should include the following
Refrigerated Finished Product Storage). elements, as appropriate:
In some cases, pickled fish or similar a. Brining, dry salting, and drying;
products are received as ingredients
for assembly into another product. In b. Cold smoking;
other cases, they are received simply for
c. Hot smoking;
storage and further distribution (e.g., by a
warehouse). In either case, the refrigerated d. Refrigerated finished product storage;
storage step is critical to the safety of the
product and should be identified as a CCP. e. Receipt of products by secondary
Control is the same as that provided under processor.
Control Strategy Example 4 - Pickling and
259
1A. BRINING, DRY SALTING, AND DRYING Monitor brine temperature at
the start of the brining process
with a temperature- indicating
The minimum or maximum values for the device (e.g., a thermometer),
critical factors of the brining, dry salting, and then monitor ambient air
and/or drying processes established by a temperature using a continuous
scientific study. The critical factors are those temperature-recording device
that are necessary to ensure that the finished (e.g., a recording thermometer);
product has not less than 3.5% wps or, where
AND
permitted, the combination of 3% wps and

not less than 100 ppm nitrite. The critical Monitor the drying time and the input/
factors may include: brine strength; brine to output air temperature (as specified
fish ratio; brining time; brining temperature; by the study) using a continuous
thickness, texture, fat content, quality, and temperature-recording device (e.g., a
species of fish; drying time; input/output air recording thermometer);
temperature, humidity, and velocity; smoke AND
density; and drier loading.
Monitor all other critical factors specified
by the study with equipment appropriate
Establish Monitoring Procedures. for the measurement;
What Will Be Monitored? OR
The critical factors of the established brining, Collect a representative sample of the
dry salting, and/or drying processes. These finished product and conduct water phase
may include: brine strength; brine to fish salt analysis and, when appropriate, nitrite
ratio; brining time; brining temperature; analysis.
thickness, texture, fat content, quality, and
species of fish; drying time; input/output air How Often Will Monitoring Be Done (Frequency)?
temperature, humidity, and velocity; smoke For brine strength:
density; and drier loading;
At least at the start of the brining
OR process;
The water phase salt and, where appropriate, AND
nitrite level of the finished product. For brine time:

How Will Monitoring Be Done? Once per batch;
For monitoring critical factors: AND
Monitor brine strength with a For manual brine temperature monitoring:
salinometer;
At the start of the brining process and at

AND
least every 2 hours thereafter;
Monitor brine time with a clock;

AND
AND
devices:
Monitor brine temperature using:
A temperature-indicating device
Continuous monitoring by the device
itself, with a visual check of the recorded
(e.g., a thermometer); data at least once per batch;
OR
260
AND that is not hermetically sealed, or an LACF,
For brine to fish ratio: or a frozen product);
At the start of the brining process; OR

AND Destroy the product;
For time requirements of the drying process: OR
Each batch; Divert the product to a non-food use.
AND AND
For all other critical factors specified by the Take the following corrective action to regain control
study: over the operation after a critical limit deviation:
As often as necessary to maintain control; Adjust the salt and/or nitrite concentration in
OR the brine;
For water phase salt and, when appropriate, OR
nitrite: Adjust the air velocity or input air
Each lot or batch of finished product. temperature to the drying chamber;

For continuous temperature-recording Extend the drying process to compensate
devices: for a reduced air velocity or temperature or
elevated humidity;
Monitoring is performed by the device
itself. The visual check of the data OR
generated by the device, to ensure Adjust the brine strength or brine to fish ratio;
that the critical limits have been met
consistently, may be performed by any OR
person who has an understanding of the Cool the brine;
nature of the controls; OR
OR Move some or all of the product to another
For other checks: drying chamber;
Any person who has an understanding of OR

the nature of the controls. Make repairs or adjustments to the drying
chamber as necessary.
Take the following corrective action to a product Establish a Recordkeeping System.
involved in a critical limit deviation: Printouts, charts, or readings from continuous
Chill and hold the product until its safety can temperature-recording devices;
be evaluated; AND
OR Record of visual checks of recorded data;
Reprocess the product; AND
OR Appropriate records (e.g., processing record
Divert the product to a use in which the showing the results of the brine strength
critical limit is not applicable (e.g., packaging and temperature, brine to fish ratio, size
261
and species of fish, and time of brining) as applicable, nitrite levels should be
necessary to document the monitoring of taken into consideration in the process
the critical factors of the brining, dry salting, establishment. A record of the process
and/or drying process, as established by a establishment should be maintained;
study;
AND
OR Before a temperature-indicating device (e.g.,
Results of the finished product water phase a thermometer) or temperature-recording
salt determination and, when appropriate, device (e.g., a recording thermometer) is
nitrite determination. put into service, check the accuracy of the
device to verify that the factory calibration
Establish Verification Procedures. has not been affected. This check can be
Process validation study (except where water accomplished by:
phase salt analysis and, where appropriate, Immersing the sensor in an ice slurry
nitrite analysis of the finished product are the (32F (0C)), if the device will be used at
monitoring procedure): or near refrigeration temperature;
The adequacy of the brining, dry OR
salting, and drying processes should
be established by a scientific study. It Immersing the sensor in boiling water
should be designed to consistently at or near the boiling point. Note that
achieve a water phase salt level of the temperature should be adjusted to
3.5% or 3% with not less than 100 ppm compensate for altitude, when necessary;
nitrite. Expert knowledge of salting and/
or drying processes may be required OR
to establish such a process. Such Doing a combination of the above if
knowledge can be obtained by education the device will be used at or near room
or experience, or both. Process temperature;
validation study for establishment of
OR
brining, dry salting, and drying processes
may require access to adequate facilities Comparing the temperature reading
and the application of recognized on the device with the reading on a
methods. The drying equipment should known accurate reference device (e.g.,
be designed, operated, and maintained to a thermometer traceable to National
deliver the established drying process to Institute of Standards and Technology
every unit of product. In some instances, (NIST) standards) under conditions that
brining, dry salting, and/or drying studies are similar to how it will be used (e.g.,
may be required to establish minimum air temperature, brine temperature,
processes. In other instances, existing product internal temperature) within the
literature, which establishes minimum temperature range at which it will be
processes or adequacy of equipment, used;
is available. Characteristics of the AND
process, product, and/or equipment Once in service, check the temperature-
that affect the ability of the established indicating device or temperature-recording
minimum salting, dry salting, and drying device daily before the beginning of
process to deliver the desired finished operations. Less frequent accuracy checks
product water phase salt and, where may be appropriate if they are recommended
262
by the instrument manufacturer and the and verification records within 1 week of
history of use of the instrument in your preparation to ensure they are complete and
facility has shown that the instrument any critical limit deviations that occurred
consistently remains accurate for a longer were appropriately addressed.
1B. COLD SMOKING
described above, this process should include Set Critical Limits.
The smoker temperature must not exceed
90F (32.2C).
AND What Will Be Monitored?
Calibrate the temperature-indicating device The smoker temperature.
or temperature recording device against a How Will Monitoring Be Done?
Measure ambient smoker chamber
temperature using a continuous temperature-
recording device (e.g., a recording
thermometer).
condition, past performance, and conditions How Often Will Monitoring Be Done (Frequency)?
of use of the device. Consistent temperature Continuous monitoring by the device itself,
variations away from the actual value (drift) with a visual check of the recorded data at
found during checks and/or calibration may least once per batch.
show a need for more frequent calibration or
the need to replace the device (perhaps with Who Will Do the Monitoring?
a more durable device). Devices subjected Monitoring is performed by the device itself.
to high temperatures for extended periods of The visual check of the data generated
time may require more frequent calibration. by the device, to ensure that the critical
Calibration should be performed at a limits have been met consistently, may
minimum of two temperatures that bracket be performed by any person who has an
the temperature range at which it is used; understanding of the nature of the controls.
AND
Perform other calibration procedures as
necessary to ensure the accuracy of the Take the following corrective action to a product
monitoring instruments; involved in a critical limit deviation:
AND Chill and hold the product until its safety can
be evaluated;
Do finished product sampling and analysis
to determine water phase salt and, where OR
appropriate, nitrite analysis at least once Divert the product to a use in which the
every 3 months (except where such testing is critical limit is not applicable (e.g., packaging
performed as part of monitoring); that is not hermetically sealed, or an LACF,
AND or a frozen product);
Review monitoring, corrective action, OR
263
Destroy the product; traceable thermometer) under conditions
OR
Divert the product to a non-food use. range at which it will be used;
AND AND
Take the following corrective action to regain control Once in service, check the temperature-
over the operation after a critical limit deviation: recording device daily before the beginning
Make repairs or adjustments to the smoking of operations. Less frequent accuracy checks
chamber; may be appropriate if they are recommended
AND/OR
Move some or all of the product to another facility has shown that the instrument
smoking chamber. consistently remains accurate for a longer
Establish a Recordkeeping System. the device is accurate by one of the methods
Printouts, charts, or readings from continuous described above, this process should include
temperature-recording devices; a visual examination of the sensor and any
AND
Record of visual checks of recorded data. is operational and, where applicable, has
AND
Before a temperature-recording device (e.g.,
a recording thermometer) is put into service, Calibrate the temperature-recording device
check the accuracy of the device to verify that against a known accurate reference device
the factory calibration has not been affected. (e.g., a NIST-traceable thermometer) at
This check can be accomplished by: least once a year or more frequently if
OR Consistent temperature variations away from
(212F (100C)) if the device will be used and/or calibration may show a need for more
at or near the boiling point. Note that frequent calibration or the need to replace
the temperature should be adjusted to the device (perhaps with a more durable
compensate for altitude, when necessary; device). Calibration should be performed at
OR
AND
temperature; Review monitoring, corrective action,
OR
Comparing the temperature reading on any critical limit deviations that occurred
the device with the reading on a known were appropriately addressed.
264
1C. HOT SMOKING OR
Set Critical Limits. Destroy the product;
The internal temperature of the fish must OR

be maintained at or above 145F (62.8C) Divert the product to a non-food use.
throughout the fish for at least 30 minutes. AND
Establish Monitoring Procedures. Take the following corrective action to regain control
What Will Be Monitored? Make repairs or adjustments to the heating
The internal temperature at the thickest chamber;
portion of three of the largest fish in the
OR
smoking chamber.
Move some or all of the product to another
How Will Monitoring Be Done? heating chamber.
device (e.g., a recording thermometer) Establish a Recordkeeping System.
equipped with three temperature-sensing Printouts, charts, or readings from continuous
probes. temperature-recording devices;
How Often Will Monitoring Be Done (Frequency)? AND
Continuous monitoring by the device itself, Record of visual checks of recorded data.
with visual check of the recorded data at
least once per batch. Establish Verification Procedures.
a recording thermometer) is put into service,
Monitoring is performed by the device itself. check the accuracy of the device to verify
The visual check of the data generated that the factory calibration has not been
by the device, to ensure that the critical affected. This check can be accomplished
limits have been met consistently, may by:
be performed by any person who has an
understanding of the nature of the controls. Immersing the sensor in an ice slurry
OR
involved in a critical limit deviation: Immersing the sensor in boiling water
Chill and hold the product until its safety can
at or near the boiling point. Note that
be evaluated;
OR compensate for altitude, when necessary;
Reprocess the product; OR
OR Doing a combination of the above if
Divert the product to a use in which the the device will be used at or near room
critical limit is not applicable (e.g., packaging temperature;
that is not hermetically sealed, or a LACF, or OR
a frozen product);
265
Comparing the temperature reading on preparation to ensure they are complete and
the device with the reading on a known any critical limit deviations that occurred
accurate reference device (e.g., a NIST- were appropriately addressed.
1D. REFRIGERATED FINISHED PRODUCT STORAGE
product internal temperature) within the Set Critical Limits.
temperature range at which it will be used;
For refrigerated (not frozen) finished product
AND storage:
Once in service, check the temperature- The product is held at a cooler
recording device daily before the beginning temperature of 40F (4.4C) or

of operations. Less frequent accuracy checks below. Note that allowance for routine
may be appropriate if they are recommended refrigeration defrost cycles may be
by the instrument manufacturer and the necessary. Also note that you may
history of use of the instrument in your choose to set a critical limit that specifies
facility has shown that the instrument a time and temperature of exposure to
consistently remains accurate for a longer temperatures above 40F (4.4C);
OR
described above, this process should include For finished product stored under ice:
a visual examination of the sensor and any The product is completely and
attached wires for damage or kinks. The continuously surrounded by ice
device should be checked to ensure that it throughout the storage time.
sufficient ink and paper; Establish Monitoring Procedures.
AND What Will Be Monitored?
Calibrate the temperature-recording device For refrigerated finished product storage:
(e.g., a NIST-traceable thermometer) at The temperature of the cooler;
least once a year or more frequently if OR

recommended by the device manufacturer. For finished product storage under ice:
product.
Consistent temperature variations away from How Will Monitoring Be Done?
the actual value (drift) found during checks For refrigerated finished product storage:
frequent calibration or the need to replace Use a continuous temperature-recording
device). Calibration should be performed at OR
a minimum of two temperatures that bracket For finished product storage under ice:
AND adequacy of ice in a representative
totes) from throughout the cooler.
266
How Often Will Monitoring Be Done (Frequency)? OR
For continuous temperature-recording Move some or all of the product in the
devices: malfunctioning cooler to another cooler;
Continuous monitoring by the device OR
itself, with a visual check of the recorded

data at least once per day; Freeze the product;
AND
OR
Address the root cause:
For finished product storage under ice:
Sufficient frequency to ensure control. malfunctioning cooler;
devices:
Make adjustments to the ice application
operations.
itself. The visual check of the data Establish a Recordkeeping System.
generated by the device, to ensure For refrigerated finished product storage:
consistently, may be performed by any Printouts, charts, or readings from
continuous temperature-recording
person who has an understanding of the

devices;
nature of the controls;

AND
OR
For other checks: Record of visual checks of recorded data;
OR
the nature of the controls. For finished product storage under ice:
Results of ice checks:
The number of containers examined
Take the following corrective action to a product and the sufficiency of ice for each;
AND
evaluation of the total time and temperature The approximate number of
exposure is performed; containers in the cooler.
OR Establish Verification Procedures.

Destroy the product; Before a temperature-recording device (e.g.,
OR a recording thermometer) is put into service,
Divert the product to a non-food use. check the accuracy of the device to verify that
the factory calibration has not been affected.
AND This check can be accomplished by:
Take the following corrective actions to regain control Immersing the sensor in an ice slurry
over the operation after a critical limit deviation: (32F (0C)) if the device will be used at
Prevent further deterioration: or near refrigeration temperature;
Add ice to the product; OR
267
Comparing the temperature reading on of fish to ensure that the ice is sufficient
the device with the reading on a known to maintain product temperatures at 40F
accurate reference device (e.g., a NIST- (4.4C) or less;
AND
air temperature) within the temperature Review monitoring, corrective action,
range at which it will be used; and verification records within 1 week of
Once in service, check the temperature- were appropriately addressed.
1E. RECEIPT OF PRODUCTS BY SECONDARY
PROCESSOR
by the instrument manufacturer and the Set Critical Limits.
For fish or fishery products delivered
refrigerated (not frozen):
period of time. In addition to checking that All lots received are accompanied by
the device is accurate by one of the methods transportation records that show that
described above, this process should include the product was held at or below 40F
a visual examination of the sensor and any (4.4C) throughout transit. Note that
attached wires for damage or kinks. The allowance for routine refrigeration
device should be checked to ensure that it defrost cycles may be necessary;
is operational and, where applicable, has OR
sufficient ink and paper; For products delivered under ice:
AND
Product is completely surrounded by ice
Calibrate the temperature-recording device at the time of delivery;
against a known accurate reference device OR

For products delivered under chemical
cooling media, such as gel packs:
Optimal calibration frequency is dependent There is an adequate quantity of cooling
upon the type, condition, past performance, media that remain frozen to have
and conditions of use of the device. maintained product at 40F (4.4C) or
Consistent temperature variations away from below throughout transit;
the actual value (drift) found during checks AND
frequent calibration or the need to replace The internal temperature of the product
at the time of delivery is 40F (4.4C) or
below;
a minimum of two temperatures that bracket OR
the temperature range at which it is used; For products delivered refrigerated (not
AND frozen) with a transit time (including all
time outside a controlled temperature
When visual checks of ice are used,
environment) of 4 hours or less (optional
control strategy):
268
Time of transit does not exceed 4 hours; containers (e.g., cartons and totes) at the
time of delivery.
AND
Temperature of the product at the time How Will Monitoring Be Done?
of delivery does not exceed 40F (4.4C). For products delivered refrigerated (not
Note: Processors receiving product with transit times of 4 hours or less frozen):
may elect to use one of the controls described for longer transit times.
device (e.g., a recording thermometer)
Establish Monitoring Procedures. for internal product temperature or
What Will Be Monitored? ambient air temperature monitoring
during transit;
For products delivered refrigerated (not
frozen): OR
The internal temperature of the product
throughout transportation; Make visual observations of the
OR adequacy of ice in a representative
The temperature within the truck or
totes) from throughout the shipment, at
other carrier throughout transportation;
delivery;
OR
OR
For products delivered under chemical
The adequacy of ice surrounding the cooling media, such as gel packs:

OR
adequacy and frozen state of the cooling
For products held under chemical cooling media in a representative number of
media, such as gel packs: containers (e.g., cartons and totes) from
throughout the shipment, at delivery;
media at the time of delivery; AND
AND Use a temperature-indicating device (e.g.,
product temperatures in a representative
containers (e.g., cartons and totes) at number of product containers from
time of delivery; throughout the shipment, at delivery;
OR OR
For products delivered refrigerated (not For products delivered refrigerated (not
frozen) with a transit time of 4 hours or less: frozen) with a transit time of 4 hours or less:
The date and time fish were removed Review carrier records to determine
from a controlled temperature the date and time the product was
environment before shipment and the removed from a controlled temperature
date and time delivered; environment before shipment and the
date and time delivered;
AND
AND
269
Use a temperature-indicating device (e.g., Discontinue use of the supplier or carrier
a thermometer) to determine internal until evidence is obtained that the identified
product temperatures in a representative transportation-handling practices have been
number of product containers (e.g., improved.
cartons and totes) randomly selected
from throughout the shipment, at Establish a Recordkeeping System.
delivery. Measure a minimum of 12 Receiving records showing:
product containers, unless there are
fewer than 12 product containers in a Results of continuous temperature
monitoring:
lot, in which case measure all of the
containers. Lots that show a high level Printouts, charts, or readings
of temperature variability may require a from continuous temperature-
larger sample size. recording devices;
How Often Will Monitoring Be Done (Frequency)? AND

Each lot received. Visual check of recorded data;
For continuous temperature-recording Results of ice checks, including:
devices: The number of containers examined

and the sufficiency of ice for each;
itself. The visual check of the data AND
generated by the device, to ensure

consistently, may be performed by any OR
person who has an understanding of the Results of the chemical media checks,
nature of the controls; including:

OR The number of containers
For other checks: examined and the frozen status
of the media for each;
the nature of the controls. AND
AND/OR
involved in a critical limit deviation: Results of internal product temperature
monitoring, including:
The number of containers
evaluation of the total time and temperature
examined and the internal
exposure is performed;
temperatures observed for each;
OR
AND
Reject the lot.
AND
AND
Date and time fish were initially
removed from a controlled
270
temperature environment recommended by the device manufacturer.
and date and time fish were Optimal calibration frequency is dependent
delivered, when applicable. upon the type, condition, past performance,
Before a temperature-indicating device (e.g., the actual value (drift) found during checks
a thermometer) is put into service, check and/or calibration may show a need for more
the accuracy of the device to verify that the frequent calibration or the need to replace
factory calibration has not been affected. the device (perhaps with a more durable
This check can be accomplished by: device). Calibration should be performed at
OR Check the accuracy of temperature-recording
Comparing the temperature reading on devices that are used for monitoring transit
the device with the reading on a known conditions, for all new suppliers and at
accurate reference device (e.g., a NIST- least quarterly for each supplier thereafter.
traceable thermometer) under conditions Additional checks may be warranted based
that are similar to how it will be used on observations at receipt (e.g., refrigeration
(e.g., product internal temperature) units appear to be in poor repair or readings
within the temperature range at which it appear to be erroneous). The accuracy of
will be used; the device can be checked by comparing
the temperature reading on the device with
AND
the reading on a known accurate reference
Once in service, check the temperature- device (e.g., a NIST-traceable thermometer)
indicating device daily before the under conditions that are similar to how it
beginning of operations. Less frequent will be used (e.g., air temperature) within the
accuracy checks may be appropriate if temperature range at which it will be used;
they are recommended by the instrument
manufacturer and the history of use of AND
the instrument in your facility has shown When visual checks of ice are used,
that the instrument consistently remains periodically measure internal temperatures
accurate for a longer period of time. In of fish to ensure that the ice or is sufficient
addition to checking that the device is to maintain product temperatures at 40F
accurate by one of the methods described (4.4C) or less;
above, this process should include a AND
visual examination of the sensor and any
device should be checked to ensure that
it is operational;
AND were appropriately addressed.
271
TABLE 13-1
CONTROL STRATEGY EXAMPLE 1 - SMOKING

This table is an example of a portion of a HACCP plan using Control Strategy Example 1 - Smoking. This example illustrates how a processor of vacuum-packaged hot-
smoked salmon can control C. botulinum toxin formation. It is provided for illustrative purposes only.
C. botulinum toxin formation may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g.,
aquaculture drugs, environmental chemical contaminants and pesticides, parasites, growth of other pathogenic bacteria, survival of other pathogenic bacteria through the
cook step, and metal fragments).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

CRITICAL
POINT
MEASURE*
Brining C. botulinum Minimum Start time Clock Every batch Brine Extend the Production Establish
toxin brining time: and end time room brining record a brining and
formation in 6 hours of the brining Dial Every 2 hours employee process drying process
the finished process thermometer
product Maximum brine Hold and evaluate Check the dial thermometer for
272
temperature: 40F Brine the product accuracy and damage and to
temperature Cool the brine ensure that it is operational
before putting into operation;
Minimum salt Salt Salinometer Start of each Brine Add salt Production
check it daily, at the beginning of
concentration of concentration brining room record
operations; and calibrate it once
brine at the start of brine process employee
per year
of brining: 60
salinometer
Monthly calibration of the scale

Minimum ratio of Weight of Visual, to Start of each Brine Add brine Production
brine to fish: brine (as mark on the brining room record Quarterly water phase salt analysis
2:1 determined tank process employee of the finished product
by volume)
Review monitoring, corrective
action, and verification records
Weight of Scale Each batch Remove some fish
fish and reweigh
Maximum fish Fish Caliper Each batch Brine Hold and evaluate Production
thickness 1 in. thickness (10 largest room based on finished record
Note: To produce fish) employee product water
a minimum water phase salt analysis
phase salt level in
the loin muscle of
3.5%
TABLE 13-1
CONTROL STRATEGY EXAMPLE 1 - SMOKING

This table is an example of a portion of a HACCP plan using Control Strategy Example 1 - Smoking. This example illustrates how a processor of vacuum-packaged hot-
smoked salmon can control C. botulinum toxin formation. It is provided for illustrative purposes only.
aquaculture drugs, environmental chemical contaminants and pesticides, parasites, growth of other pathogenic bacteria, survival of other pathogenic bacteria through the
cook step, and metal fragments).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

CRITICAL
POINT
MEASURE*
Smoking C. botulinum Minimum time Time of open Clock Each batch Smoker Extend the drying Production Establish a brining and drying
and toxin open vent: 2 hours vent employee process record process Quarterly water phase salt
drying formation Hold and evaluate analysis of the finished product
in finished based on finished Review monitoring, corrective
product product water action, and verification records
273
phase salt analysis within 1 week of preparation
Heating C. botulinum Internal Internal Digital data Continuous, Smoker Extend the Data Check the data logger for accuracy
toxin temperature of fish temperature logger with with visual employee heating logger and damage and to ensure that
formation in held at or above of fish and three probes check of process printout it is operational before putting
the finished 145F for at least 30 time at that in thickest recorded data Make repairs or into operation; check it daily, at
product minutes temperature fish in cold at the end of adjustments to the the beginning of operations; and
spot of the batch smoking chamber calibrate it once per year
smoking Review monitoring, corrective

chamber Hold and evaluate action, and verification records
the product within 1 week of preparation

Finished C. botulinum Maximum cooler Cooler air Digital data Continuous, Production Adjust or repair Digital Check the data logger for accuracy
product toxin temperature: 40F temperature logger with visual employee the cooler data logger and damage and to ensure that
storage formation (based on growth check of Hold and evaluate printout it is operational before putting
during of vegetative recorded data the product based into operation; check it daily, at
finished pathogens) once per day on time and the beginning of operations; and
product temperature of calibrate it once per year
storage exposure
Review monitoring, corrective
action, and verification records
*Note: The critical limits in this example are for illustrative purposes only and are not related to any recommended process.
CONTROL STRATEGY EXAMPLE 2 - Performance data from the manufacturer;
REFRIGERATION WITH TTI
AND
This control strategy should include the following For transportation conditions:
elements, as appropriate:
The temperature within the truck or
a. Unactivated TTI receipt; other carrier throughout transportation;
b. Unactivated TTI storage; OR
c. Application and activation of TTI;

Other conditions that affect the
functionality of the TTI, where
applicable;
d. Refrigerated finished product storage;
AND
e. Receipt of product by secondary
For functionality at receipt:

processor.
The ability of the TTI to produce an

2A. UNACTIVATED TTI RECEIPT alert indicator, such as a color change of
the device, when exposed to time and
temperature abuse at time of receipt.
The TTI is suitable for use. It should be
designed to perform properly under the How Will Monitoring Be Done?
conditions that it will be used. It should For suitability of use:
also be designed to produce an alert Review performance data;
indicator (e.g., a color change of the device)
AND
at a combination of time and temperature
exposures that will prevent the formation of For transportation conditions:
non-proteolytic C. botulinum toxin formation Use a continuous temperature-recording
(e.g., consistent with the Skinner-Larkin device (e.g., a recording thermometer)
curve); for ambient air temperature monitoring
during transit;
AND
Where transportation conditions (e.g., AND
temperature) could affect the functionality For functionality at receipt:
of the TTI, all lots of TTIs are accompanied
by transportation records that show that they
Activate and then expose a TTI from
the lot to ambient air temperature for
were held at conditions that do not result in sufficient time to determine whether
loss of functionality throughout transit; it is functional (i.e., produces an alert
AND indicator, such as a color change of the
device).
The TTI functions (i.e., produces an
alert indicator, such as a color change of How Often Will Monitoring Be Done (Frequency)?
the device, when exposed to time and For suitability of use:
temperature abuse) at time of receipt.
The first shipment of a TTI model;
Establish Monitoring Procedures. AND
For transportation conditions and
functionality at receipt:
For suitability of use:

Every shipment.
274
Who Will Do the Monitoring? Records of visual checks of recorded
For suitability of use: data;
Anyone with an understanding of TTI AND
validation studies and of the intended For functionality at receipt:

conditions of use;
Results of a TTI challenge test (i.e.,
AND whether the TTI produces an alert
For transportation conditions and indicator, such as a color change of
functionality at receipt: the device, when exposed to time and
temperature abuse).
Anyone with an understanding of the
Establish Corrective Action Procedures. Check the accuracy of temperature-recording
Take the following corrective action to a product conditions, for all new suppliers and at
involved in a critical limit deviation: least quarterly for each supplier thereafter.
Reject or return the shipment. Additional checks may be warranted based
AND on observations at receipt (e.g., refrigeration
units appear to be in poor repair or readings
Take the following corrective actions to regain control appear to be erroneous). The accuracy of
over the operation after a critical limit deviation: the device can be checked by comparing
For suitability of use: the temperature reading on the device with
the reading on a known accurate reference
device (e.g., a NIST-traceable thermometer)
documentation of validation has been
provided; under conditions that are similar to how it
will be used (e.g., air temperature) within the
AND
temperature range at which it will be used;
For transportation conditions and
functionality at receipt: AND
Discontinue use of the supplier or
carrier until evidence is obtained that the
identified production or transportation preparation to ensure they are complete and
practices have been improved. any critical limit deviations that occurred
Establish a Recordkeeping System. 2B. UNACTIVATED TTI STORAGE
For suitability of use: Set Critical Limits.
Manufacturers performance data;
The combination of storage conditions
AND (e.g., temperature) that prevent loss of
For transportation conditions: functionality throughout storage (based
on manufacturers specifications).
continuous temperature-recording
devices;
AND
275
Establish Monitoring Procedures. Establish Corrective Action Procedures.
What Will Be Monitored? Take the following corrective action to a TTI involved in a
critical limit deviation:
Storage air temperature, where temperature
affects functionality of the TTI; Destroy the lot of TTIs.
AND/OR AND
Other storage conditions that affect Take the following corrective action to regain control
functionality of the TTI. over the operation after a critical limit deviation:
For temperature:
AND/OR
Make other repairs or adjustment appropriate
for the condition.
AND/OR
For other conditions: Establish a Recordkeeping System.
Use instruments appropriate for the For refrigerated storage:
purpose.
How Often Will Monitoring Be Done (Frequency)? continuous temperature-recording
devices;
For temperature:
AND
Continuous monitoring by the device

itself, with a visual check of the recorded Record of visual checks of recorded data;
data at least once per day;

AND/OR
AND/OR Storage record showing the results of
For other conditions: monitoring of other conditions.
With sufficient frequency to ensure
control. Establish Verification Procedures.
With continuous temperature-recording check the accuracy of the device to verify that
devices: the factory calibration has not been affected.
Monitoring is performed by the device This check can be accomplished by:
generated by the device, to ensure
that the critical limits have been met or near refrigeration temperature;
consistently, may be performed by any
person who has an understanding of the OR
nature of the controls; Comparing the temperature reading on
AND
For other checks: traceable thermometer) under conditions
Any person who has an understanding of that are similar to how it will be used (e.g.,
the nature of the controls. air temperature) within the temperature
276
AND 2C. APPLICATION AND ACTIVATION OF TTI
Once in service, check the temperature- Set Critical Limits.
of operations. Less frequent accuracy checks Each consumer package has an activated
may be appropriate if they are recommended TTI.
history of use of the instrument in your Establish Monitoring Procedures.
Packages for the presence of an activated
TTI.
described above, this process should include How Will Monitoring Be Done?
Visual examination.
device should be checked to ensure that it How Often Will Monitoring Be Done (Frequency)?
is operational and, where applicable, has Representative number of packages from
sufficient ink and paper; each lot of product.
AND
Optimal calibration frequency is dependent Take the following corrective action to a product
upon the type, condition, past performance, involved in a critical limit deviation:
and conditions of use of the device. Hold the lot below 38F (3.3C) until TTIs
Consistent temperature variations away from are applied and activated.
and/or calibration may show a need for more AND
frequent calibration or the need to replace Take the following corrective action to regain control
the device (perhaps with a more durable over the operation after a critical limit deviation:
device). Calibration should be performed at Identify and correct the cause of the TTI
a minimum of two temperatures that bracket application or activation deficiency.
Perform other instrument calibration, as Packaging control record that shows the
appropriate; results of the TTI checks.
AND
277
2D. REFRIGERATED FINISHED PRODUCT STORAGE
Follow the guidance for Control Strategy
Example 1 - Smoking (1d - Refrigerated Finished
Product Storage), except that the where the
critical limits list 40F (4.4C), they should list
38F (3.3C).
2E. RECEIPT OF PRODUCTS BY SECONDARY

PROCESSOR
Follow the guidance for Control Strategy
Example 1 - Smoking (1e - Receipt of Products
by Secondary Processor), except that the where
the critical limits list 40F (4.4C), they should list
38F (3.3C).
278
TABLE 13-2
CONTROL STRATEGY EXAMPLE 2 - REFRIGERATION WITH TTI

This table is an example of a portion of a HACCP plan using Control Strategy Example 2 - Refrigeration With TTI. This example illustrates how a processor of refrigerated,
vacuum-packaged, raw fish fillets can control C. botulinum toxin formation. It is provided for illustrative purposes only.
C. Botulinum toxin formation may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g.,
aquaculture drugs, environmental chemical contaminants and pesticides, parasites, growth of other pathogenic bacteria, and metal fragments).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

CRITICAL
SIGNIFICANT FOR EACH
CONTROL CORRECTIVE ACTION(S) RECORDS VERIFICATION
HAZARD(S) PREVENTIVE WHAT HOW FREQUENCY WHO
POINT
MEASURE
Receipt of C. botulinum TTI is Performance Review of First Quality Reject the Manufacturers Review
TTI toxin suitable for use data from the performance shipment of a assurance shipment performance monitoring,
formation in manufacturer data TTI model supervisor Discontinue use of the data corrective
the finished supplier until appropriate action records
product validation within 1 week
documentation of preparation
279
is provided
All lots received Truck Digital time and Continuous, Receiving Discontinue use of the Receiving Check the data
are temperature temperature with visual employee supplier or carrier until record logger for all
accompanied data logger review and evidence is obtained new suppliers
by truck evaluation of that the identified and for all
records temperature- transportation- handling suppliers at
that show monitoring practices have been least quarterly
temperature records for each improved thereafter

was maintained shipment
at or below Reject the Review
40F shipment monitoring,
corrective
action records
within 1 week
of preparation
The TTI The ability Expose a TTI Every Quality Discontinue use of the TTI Review
functions of the TTI to from the lot shipment assurance supplier or carrier until challenge monitoring,
at receipt change color to room air staff evidence is obtained that record corrective
when exposed temperature for the identified production action records
to room air sufficient time or transportation- within 1 week
temperature to determine handling practices have of preparation
whether it been improved
changes color
TABLE 13-2

Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

CRITICAL
POINT
MEASURE
TTI C. botulinum Cooler Cooler Digital time and Continuous, Quality Repair or adjust cooler Data Check the
storage toxin maintained temperature temperature with visual assurance logger printout data logger for
formation in below 38F data logger check of staff Destroy the lot of TTIs accuracy and
the finished recorded data damage and to
product once per day ensure that it
is operational
280
before putting
into operation;
check it
daily, at the
beginning of
operations; and
calibrate it once
per year

Review
monitoring,
corrective
action, and
verification
records within
1 week of
preparation
TTI C. botulinum Each Packages for Visual Representative Production Hold lot below 38F, and Packaging Review
attachment toxin package has an the presence examination number of employee apply and activate TTIs control record monitoring,
and formation in activated TTI of an packages from and corrective
activation the finished activated TTI each lot of Identify and correct the action and
product product cause of TTI application verification
deviation records within
1 week of
preparation
TABLE 13-2

Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

CRITICAL
POINT
MEASURE
Finished C. botulinum Maximum Cooler air Digital data Continuous, Production Adjust or repair cooler Digital logger Check the
product toxin cooler temperature logger with visual employee printout data logger for
storage formation temperature check of Hold and accuracy and
during 38F recorded data evaluate the product damage and to
finished once per day based on time and ensure that it
product temperature of exposure is operational
281
storage before putting
into operation;
check it
daily, at the
beginning of
operations; and
calibrate it once
per year

Review
monitoring,
corrective
action, and
verification
records within
1 week of
preparation
CONTROL STRATEGY EXAMPLE 3 - FROZEN WITH Establish Verification Procedures.
LABELING Review monitoring and corrective action
Set Critical Limits. records within 1 week of preparation
All finished product labels must contain a
keep frozen statement (e.g., Important,
keep frozen until used, thaw under
refrigeration immediately before use).

Finished product labels for the presence of a
keep frozen statement.

Visual examination.

Representative number of packages from
each lot of product.


Segregate and relabel any improperly labeled
product.
AND
Segregate and return or destroy any label
stock or pre-labeled packaging stock that
does not contain the proper statement;
AND
Determine and correct the cause of improper
labels.

Record of labeling checks.
282
TABLE 13-3
CONTROL STRATEGY EXAMPLE 3 - FROZEN WITH LABELING

This table is an example of a portion of a HACCP plan using Control Strategy Example 3 - Frozen With Labeling. This example illustrates how a processor of frozen,
environmental chemical contaminants and pesticides, parasites, and metal fragments).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
MONITORING
CRITICAL LIMITS
CRITICAL
POINT
MEASURE
Receipt of C. botulinum All finished Finished Visual Representative Receiving Segregate and Label receiving Review
labeling toxin product labels product examination number of employee relabel any record monitoring and
283
formation must contain a labels for the packages from improperly correction
during keep presence of a each lot of labeled product action records
finished frozen keep frozen product within 1 week
product statement statement Segregate and of preparation
storage destroy any
label stock
that does not
contain the

proper
statement
Determine
and correct
the cause of
improper labels
CONTROL STRATEGY EXAMPLE 4 - PICKLING For unrefrigerated (shelf-stable), reduced oxygen-
AND SALTING packaged products:
This control strategy should include the following A water phase salt level of at least 20%
elements, as appropriate: (based on the maximum salt level for
growth of S. aureus);
a. Brining, pickling, salting, and
formulation;
OR
b. Refrigerated finished product storage;

A pH of 4.6 or below;
OR
c. Receipt of Product by secondary
processor.
A water activity of 0.85 or below (based

on the minimum water activity for
growth and toxin formation of S. aureus).
4A. BRINING, PICKLING, SALTING, AND
FORMULATION A heat treatment, addition of chemical additives,
or other treatment may be necessary to inhibit or
eliminate spoilage organisms (e.g., mold) in shelf-
The minimum or maximum values for stable products.
the critical factors of the brining, pickling,
or formulation process established by a Establish Monitoring Procedures.
scientific study. The critical factors are those
that are necessary to ensure that the finished What Will Be Monitored?
product has: The critical factors of the established
pickling, brining, or formulation process.
For refrigerated, reduced oxygen-packaged
These may include: brine and acid strength;
fishery products:
brine or acid to fish ratio; brining and
A water phase salt level of at least 5%; pickling time; brine and acid temperature;
OR
thickness, texture, fat content, quality, and
species of fish;
A pH of 5.0 or below;
OR
OR
The water phase salt, pH, and/or water
A water activity of below 0.97;
activity of the finished product.

OR
A water phase salt level of at least
2.4% in surimi-based products, when
For brine strength:
combined with a pasteurization process
Use a salinometer;
in the finished product container
AND
of 185F (85C) for 15 minutes
(pasteurization controls are covered in

For acid strength:
Chapter 16);
Use a pH meter or titrate for acid
concentration;
OR
AND
A combination of water phase salt,
pH, and/or water activity that, when For brine/acid temperature:

combined, have been demonstrated to
prevent the growth of C. botulinum type
a thermometer);
E and non-proteolytic types B and F.

AND
284
For all other critical factors specified by the Establish Corrective Action Procedures.
study:
Use equipment appropriate for the
measurement;
Chill and hold the product until it can be

OR
evaluated based on its water phase salt, pH,
For water phase salt, pH, and/or water and/or water activity level;
activity:
OR
Collect a representative sample of the
Reprocess the product (if reprocessing does
finished product, and conduct water
not jeopardize the safety of the product);
phase salt, pH, and/or water activity
analysis, as appropriate. OR
critical limit is not applicable (e.g., packaging
For brine and acid strength: that is not hermetically sealed, or a LACF, or
At the start of each brining, pickling, and a frozen product);
formulation process;
OR
AND
Divert the product to a non-food use;
For brine and acid temperature:
OR
At the start of each brining, pickling, and
Destroy the product.
formulation process and at least every 2
hours thereafter; AND
AND Take the following corrective action to regain control
For brine or acid to fish ratio: over the operation after a critical limit deviation:
Adjust the brine or acid strength or brine or
At the start of each brining, pickling, and
acid to fish ratio;
formulation process;
AND
OR
For other critical factors specified by the study: Extend the brining or pickling time to
compensate for an improper brine or acid
As often as necessary to maintain control;
temperature.
OR
Water phase salt, pH, and/or water activity Establish a Recordkeeping System.
analysis should be determined for each batch Records, as necessary, to document the
of finished product. monitoring of the critical factors of the
brining or pickling process, as established
by a study (e.g., a processing record showing
For water activity: the results of the brine or acid strength
Any person with sufficient training to and temperature, brine or acid to fish ratio,
perform the analysis;
size and species of fish, time of brining or
pickling);
OR
For other checks: OR

Record of determinations of the finished
Any person with an understanding of the
product water phase salt, pH, or water activity.
285
Establish Verification Procedures. and/or product that affect the ability
Process validation study (except where water of the established minimum pickling,
phase salt, pH, or water activity analysis brining, and formulation process
of the finished product is the monitoring should be taken into consideration in
procedure): the process establishment. A record of
the process establishment should be
The adequacy of the pickling, brining,
maintained;
and formulation process steps should
be established by a scientific study. For AND
refrigerated, reduced oxygen-packaged Before a temperature-indicating device (e.g.,
products, it should be designed to a thermometer) is put into service, check
consistently achieve: a water phase salt the accuracy of the device to verify that the
level of at least 5%; a pH of 5.0 or below; factory calibration has not been affected.
a water activity of below 0.97; a water This check can be accomplished by:
phase salt level of at least 2.4% in surimi
based products, when combined with
a pasteurization process in the finished or near refrigeration temperature;
product container of 185F (85C) for
at least 15 minutes; or a combination OR
of salt, pH, and/or water activity that, Immersing the sensor in boiling water
when combined, prevent the growth of (212F (100C)) if the device will be
C. botulinum type E and non-proteolytic used at or near the boiling point. Note
types B and F (established by a scientific that the temperature should be adjusted
study). For unrefrigerated (shelf-stable), to compensate for altitude, when
reduced oxygen-packaged products, necessary);
it should be designed to consistently OR
achieve: a water phase salt level of
at least 20% (based on the maximum Doing a combination of the above if
water phase salt level for the growth of
temperature;
S. aureus); a pH of 4.6 or below; or a
water activity of 0.85 or below (based OR
on the minimum water activity for the
growth of S. aureus). Expert knowledge
of pickling, brining, and formulation accurate reference device (e.g., a NIST-
processes may be required to establish traceable thermometer) under conditions
such a process. Such knowledge can be that are similar to how it will be used
obtained by education or experience, or (e.g., brine temperature) within the
both. Establishment of pickling, brining, temperature range at which it will be
and formulation processes may require used;
access to adequate facilities and the
application of recognized methods. In AND
some instances, pickling, brining, and Once in service, check the temperature-
formulation studies may be required to indicating device daily before the beginning
establish minimum processes. In other of operations. Less frequent accuracy checks
instances, existing literature, which may be appropriate if they are recommended
establishes minimum processes, is by the instrument manufacturer and the
available. Characteristics of the process history of use of the instrument in your
286
facility has shown that the instrument any critical limit deviations that occurred
consistently remains accurate for a longer were appropriately addressed.
4B. REFRIGERATED FINISHED PRODUCT STORAGE
described above, this process should include Follow the guidance for Control Strategy
a visual examination of the sensor and any Example 1 - Smoking (1d - Refrigerated Finished
attached wires for damage or kinks. The Product Storage).
4C. RECEIPT OF PRODUCT BY SECONDARY
operational;
PROCESSOR
AND Follow the guidance for Control Strategy
Calibrate the temperature-indicating device Example 1 - Smoking (1e - Receipt of Product by
against a known accurate reference device Secondary Processor).
AND
Perform daily calibration of pH meters
against standard buffers;
AND
Perform other calibration procedures as
necessary to ensure the accuracy of the
monitoring instruments;
AND
Do finished product sampling and analysis
to determine water phase salt, pH, or water
activity level, as appropriate, at least once
every 3 months (except where such testing is
performed as part of monitoring);
AND
287
TABLE 13-4
CONTROL STRATEGY EXAMPLE 4 - PICKLING AND SALTING

This table is an example of a portion of a HACCP plan using Control Strategy Example 4 - Pickling and Salting. This example illustrates how a pickled herring processor
can control C. botulinum toxin formation. It is provided for illustrative purposes only.
histamine, environmental and chemical contaminants and pesticides, parasites, and metal fragments).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

CRITICAL
POINT
MEASURE
Pickling C. botulinum Maximum Finished Collect a Each Quality Continue the Pickling control Daily calibration of
toxin formation finished product pH in sample of the pickling control pickling process record the pH meter
in the finished product pH in the loin muscle product from tank, each personnel until pH meets Review
product the loin muscle each pickling cycle the critical limit monitoring,
of 5.0 tank at the corrective action,
end of each and verification
288
pickling cycle records within
and analyze for 1 week of
pH using a pH preparation
meter
Finished C. botulinum Maximum Cooler air Time and Continuous, Production Adjust or Data logger Check the data
product storage toxin cooler temperature temperature with visual employee repair cooler printout logger for accuracy
formation temperature: data logger check of and damage and
during 40F recorded Hold and to ensure that

finished (based on data once evaluate the it is operational
product growth of per day product based before putting
storage vegetative on time and into operation;
pathogens) temperature of check it daily, at
exposure the beginning of
operations; and
calibrate it once
per year
Review
monitoring,
corrective action,
and verification
records within 1
week of
preparation
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new-generation refrigerated foods at retail
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Association of Food and Drug Officials. 2005. Prot. 44:935-941.
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10:192-195. F. T. Poysky, J. S. Almond, and M. W. Eklund.
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76.Rhodehamel, E. J., H. M. Solomon, T.
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291
NOTES:
292
CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of

Inadequate Drying
UNDERSTAND THE POTENTIAL HAZARD. expected conditions of storage and distribution.

Additionally, finished product package closures
Pathogenic bacteria growth and toxin formation should be free of gross defects that could expose
in the finished product as a result of inadequate the product to moisture during storage and
drying of fishery products can cause consumer distribution. Chapter 18 provides guidance on
illness. The primary pathogens of concern are control of container closures.
Staphylococcus aureus (S. aureus) and Clostridium Some dried products that are reduced oxygen
botulinum (C. botulinum). See Appendix 7 for a packaged (e.g., vacuum packaged, modified
description of the public health impacts of atmosphere packaged) are dried only enough
these pathogens. to control growth and toxin formation by C.
botulinum type E and non-proteolytic types B
Control by Drying
and F (i.e., types that will not form toxin with
Dried products are usually considered shelf stable a water activity of below 0.97). These dried
and are, therefore, often stored and distributed products are then refrigerated to control growth
unrefrigerated. Examples of shelf-stable dried and toxin formation by C. botulinum type A and
fish products are salmon jerky, octopus chips, proteolytic types B and F and by other pathogenic
dried shrimp, stock fish, and shark cartilage. The bacteria that may be present in the product,
characteristic of dried foods that makes them including S. aureus. The products might have the
shelf stable is their low water activity (Aw). Water appearance of a fully dried product. Therefore,
activity is the measure of the amount of water their packaging should include keep refrigerated
in a food that is available for the growth of labeling to ensure that temperature controls are
microorganisms, including pathogenic bacteria. A applied throughout distribution.
water activity of 0.85 or below will prevent the
growth and toxin production of all pathogenic Distributing partially dried, reduced oxygen
bacteria, including S. aureus and C. botulinum, packaged products frozen also could be used
and is critical for the safety of a shelf-stable dried to control these pathogens. However, labeling
product. S. aureus grows at a lower water activity with keep frozen instructions would then be
than other pathogenic bacteria, and should, important to ensure food safety. More information
therefore, be considered the target pathogen for on C. botulinum and reduced oxygen packaging is
drying for shelf-stable products. contained in Chapter 13.
You should select a packaging material that will This chapter does not cover the growth of
prevent rehydration of the product under the pathogenic bacteria, including S. aureus, which
may occur as a result of time and temperature
CHAPTER 14: Pathogenic Bacteria Growth and Toxin Formation as a Result of Inadequate Drying
293
abuse during processing, including before or of the viscera or its contents is left behind, the
during the drying process. That hazard is risk of toxin formation by C. botulinum remains.
covered in Chapter 12. It also does not cover the Small fish, less than 5 inches in length, that are
control of C. botulinum type A and proteolytic processed in a manner that eliminates preformed
types B and F and that of other pathogenic toxin and prevents toxin formation and that
bacteria that may be present, including S. aureus, reach (1) a water phase salt content of 10%, a
during refrigerated storage of reduced oxygen value based on the control of C. botulinum type
packaged, partially dried products. That hazard A and proteolytic types B and F, in refrigerated
is covered in Chapters 12 and 13, respectively. products; or (2) a water activity of 0.85 or below
(note that this is a value based on the minimum
Controlling pathogenic bacteria growth and toxin
water activity for toxin production by S. aureus,
formation by drying is best accomplished by:
in shelf-stable products); or (3) a pH (acidity)
Scientifically establishing a drying process level of 4.6 or less in shelf-stable products are not
that reduces the water activity to 0.85 or subject to the evisceration recommendation.
below if the product will be stored and
distributed unrefrigerated (shelf stable). Note Strategies for controlling pathogenic
that a heat treatment, addition of chemical bacteria growth
additives, further drying, or other treatment Pathogens can enter the process on raw materials.
may be necessary to inhibit or eliminate They can also be introduced into foods during
spoilage organisms, for example, mold; processing, from the air, unclean hands, insanitary
Scientifically establishing a drying process utensils and equipment, contaminated water, and
that reduces the water activity to below 0.97 sewage. There are a number of strategies for the
if the product will be stored refrigerated (not control of pathogenic bacteria in fish and fishery
frozen) in reduced oxygen packaging; products. They include:
Designing and operating the drying Controlling the amount of moisture that is
equipment so that every unit of a product available for pathogenic bacteria growth
receives at least the established minimum (water activity) in the product by drying
process; (covered in this chapter);
Packaging the finished product in a container Controlling the amount of moisture that is
that will prevent rehydration. available for pathogenic bacteria growth
(water activity) in the product by formulation
The drying operation used in the production of
smoked or smoke-flavored fish is not designed to
result in a finished product water activity of 0.85 Controlling the amount of salt or
or below. The controls for these products are preservatives, such as sodium nitrite, in the
described in Chapter 13. product (covered in Chapter 13);
Controlling the pH in the product (covered
Because spores of C. botulinum are known to be
by the Acidified Foods regulation, 21 CFR
present in the viscera of fish, any product that
114, for shelf-stable acidified products, and
will be preserved by salting, drying, pickling,
by Chapter 13 for refrigerated acidified
or fermentation should be eviscerated prior to
products);
processing (see the Compliance Policy Guide,
Sec. 540.650). Without evisceration, toxin Controlling the source of molluscan shellfish
formation is possible during the process even and the time from exposure to air (e.g., by
with strict control of temperature. Evisceration harvest or receding tide) to refrigeration to
should be thorough and performed to minimize control pathogens from the harvest area
contamination of the fish flesh. If even a portion (covered in Chapter 12);
294
Controlling the introduction of pathogenic if drying is not properly performed. Note
bacteria after the pasteurization process that drying to control toxin formation by S.
(covered in Chapter 18); aureus will also control toxin formation by C.
Managing the amount of time that food is botulinum in these products.
exposed to temperatures that are favorable 2. For shelf-stable, dried products, can S. aureus
for pathogenic bacteria growth and toxin toxin formation that is reasonably likely to occur
production (covered generally in Chapter 12; be eliminated or reduced to an acceptable level
for C. botulinum, in Chapter 13; and for S. at this processing step?
aureus in hydrated batter mixes, in Chapter
15); Pathogenic bacteria growth and toxin
Killing pathogenic bacteria by cooking formation as a result of inadequate drying
or pasteurization (covered in Chapter 16) should also be considered a significant
or by retorting (covered by the Thermally hazard at any processing step where a
Processed Low-Acid Foods Packaged in preventive measure is, or can be, used to
Hermetically Sealed Containers regulation, 21 eliminate the hazard of S. aureus toxin
CFR 113 (called the Low-Acid Canned Foods formation (or reduce the likelihood of its
Regulation in this guidance document)); occurrence to an acceptable level) if it is
reasonably likely to occur. The preventive
Killing pathogenic bacteria by processes that
measure that can be applied for pathogenic
retain raw product characteristics (covered in
bacteria growth and toxin formation as a
Chapter 17).
result of inadequate drying are:
DETERMINE WHETHER THE POTENTIAL Proper design and control of the drying
HAZARD IS SIGNIFICANT. process (covered in this chapter);
3. For refrigerated or frozen, partially dried (i.e.,
The following guidance will assist you in not shelf stable) products, is it reasonably likely
determining whether pathogenic bacteria growth that C. botulinum type E and nonproteolytic types
and toxin formation as a result of inadequate B and F will grow and form toxin in the finished
drying is a significant hazard at a processing step: product if the product is inadequately dried?
1. For shelf-stable, dried products, is it reasonably Table A-1 (Appendix 4) provides information
likely that S. aureus will grow and form toxin in
on the conditions under which C. botulinum
the finished product if the product is inadequately
type E and non-proteolytic types B and F
dried?
will grow. Because of the need to prevent
Table A-1 (Appendix 4) provides information rehydration of dried products, these products
on the conditions under which S. aureus will generally will be contained in a reduced
grow. If your food that is not distributed oxygen package. If your refrigerated (not
refrigerated or frozen and meets these frozen), reduced oxygen packaged food meets
conditions (i.e., in Table A-1) before drying, these conditions (i.e., Table A-1) before drying,
then drying will usually be important to the then drying will usually be important to the
safety of the product, because it provides safety of the product, because it provides
the barrier to S. aureus growth and toxin the barrier to growth and toxin formation
formation. Under ordinary circumstances, it by C. botulinum type E and non-proteolytic
would be reasonably likely that S. aureus will types B and F. Note that refrigeration will
grow and form toxin in such products during control toxin formation by S. aureus and C.
finished product storage and distribution botulinum type A and non-proteolytic types
B and F in these products. Under ordinary
295
circumstances, it would be reasonably likely Proper design and control of the drying
that C. botulinum type E and non-proteolytic process (covered in this chapter);
types B and F will grow and form toxin
Refrigeration (covered in Chapter
in such products during finished product
12) and labeling to ensure that the
storage and distribution if drying is not
product is held refrigerated throughout
properly performed. In addition, controlling
distribution (covered in this chapter);
labeling (e.g., keep refrigerated labeling) to
ensure that the product is held refrigerated Freezing (Chapter 13 provides guidance
throughout distribution may be important to on labeling controls to ensure that a
the safety of the product, because the product frozen product that otherwise supports
may appear to retailers, consumers, and end the growth of non-proteolytic C.
users to be shelf stable. botulinum is distributed frozen).
However, if your dried, reduced oxygen Intended use
packaged product is distributed frozen, then Because of the highly stable nature of S. aureus
freezing may provide the barrier to growth toxin and the extremely toxic nature of C.
and toxin formation by C. botulinum type botulinum toxin, it is unlikely that the intended
E and non-proteolytic types B and F, rather use will affect the significance of the hazard.
than drying. In this case, labeling to ensure
that the product is distributed frozen may IDENTIFY CRITICAL CONTROL POINTS.
be important to the safety of the product.
Chapter 13 provides guidance on labeling
controls to ensure that frozen product that
determining whether a processing step is a critical
supports the growth of non-proteolytic C.
control point (CCP) for pathogenic bacteria growth
botulinum is distributed frozen.
and toxin formation as a result of inadequate drying:
4. For refrigerated or frozen, partially dried, reduced
1. If you identified the hazard of pathogenic
oxygen packaged dried products, can growth
bacteria growth and toxin formation as a result of
and toxin formation by C. botulinum type E and
inadequate drying as significant because drying
non-proteolytic types B and F that are reasonably
(rather than, or in addition to, refrigeration) is
likely to occur be eliminated or reduced to an
important to the safety of the product, you should
acceptable level at this processing step?
identify the drying step as a CCP for this hazard.
Pathogenic bacteria growth and toxin
Example:
formation as a result of inadequate drying
A salmon jerky processor that distributes
should be considered a significant hazard
the product unrefrigerated should set
at any processing step where a preventive
the CCP for controlling the hazard of
measure is, or can be, used to eliminate
the hazard (or reduce the likelihood of its
formation as a result of inadequate drying
occurrence to an acceptable level) if it is
at the drying step. The processor would
reasonably likely to occur. The preventive
not need to identify the processing steps
measures that can be applied for pathogenic
prior to drying as CCPs for that hazard.
bacteria growth and toxin formation as a
However, these steps may be CCPs for
result of inadequate drying for refrigerated
the control of other hazards, such as the
or frozen, partially dried, reduced oxygen
growth of pathogenic bacteria as a result
packaged products are:
of time and temperature abuse during
processing, covered by Chapter 12.
296
This control approach is a control strategy DEVELOP A CONTROL STRATEGY.
Example 1 - Control by Drying. The following guidance provides examples of
2. If you identified the hazard of pathogenic two control strategies for pathogenic bacteria
bacteria growth and toxin formation as a result growth and toxin formation that occurs as a
of inadequate drying as significant because result of inadequate drying. It may be necessary
refrigeration (in addition to drying) is important to select more than one control strategy in order
to the safety of the product, you should identify to fully control the hazard, depending upon
the finished product storage step and the the nature of your operation. It is important
labeling step, where you will ensure that the to note that you may select a control strategy
keep refrigerated labeling is included on every that is different from those that are suggested,
package, as a CCP, for this hazard. provided it complies with the requirements of the
Example:
A partially dried catfish processor that
distributes the product refrigerated and
reduced oxygen packaged should set
the CCPs for controlling the hazard of CONTROL STRATEGY PRIMARY SECONDARY
pathogenic bacteria growth and toxin PROCESSOR PROCESSOR
formation as a result of inadequate Control by drying

drying at the drying step, finished Control by refrigeration
product labeling step, and finished with labeling
product storage step. The processor would
not need to identify the processing steps CONTROL STRATEGY EXAMPLE 1 - CONTROL BY
prior to drying as CCPs for that hazard. DRYING
However, these steps may be CCPs for
the control of other hazards, such as the
control strategy in order to fully control the
growth of pathogenic bacteria as a result
of time and temperature abuse during
operation.
processing, covered by Chapter 12.
The control by drying is covered in Control Set Critical Limits.
Strategy Example 1 - Control by Drying. The minimum or maximum values for the
Control of labeling is referred to in this critical factors established by a scientific
chapter as Control Strategy Example 2 study (i.e., for shelf-stable products, those
Control by Refrigeration With Labeling. It which must be met in order to ensure that
should be used along with Control Strategy the finished product has a water activity of
Example 1 - Control by Drying. Note that 0.85 or below; for refrigerated (not frozen),
control of refrigerated finished product storage reduced oxygen packaged products, those
is covered in Chapter 12. Note also that which must be met in order to ensure that
Chapter 13 provides guidance on labeling the finished product has a water activity of
controls to ensure that a frozen product less than 0.97). These will likely include
that otherwise supports the growth of non drying time, input/output air temperature,
proteolytic C. botulinum is distributed frozen. humidity, and velocity, as well as flesh
thickness. Other critical factors that affect
the rate of drying of the product may also be
established by the study;
297
OR Use a continuous temperature-recording
The minimum percent weight loss device (e.g., a recording thermometer);
established by a scientific study (i.e., for AND
shelf-stable products, that which must be met
For all other critical factors specified by the
in order to ensure that the finished product
study:
has a water activity of 0.85 or below; for
refrigerated (not frozen), reduced oxygen Use equipment appropriate for the
packaged products, that which must be met measurement;
in order to ensure that the finished product OR
has a water activity of less than 0.97); For percent weight loss:
OR Weigh all, or a portion, of the batch
For shelf-stable products: before and after drying;
Maximum finished product water activity OR
of 0.85 or above;
For water activity analysis:
OR
For refrigerated (not frozen), reduced oxygen finished product and conduct water
packaged products: activity analysis.
Maximum finished product water activity For continuous drying equipment:

of less than 0.97. For input/output air temperature:
Note: A heat treatment, addition of chemical additives, further
drying, or other treatment may be necessary to inhibit or eliminate Use a continuous temperature-recording
spoilage organisms (e.g., mold) in shelf-stable products. device (e.g., a recording thermometer);
AND
Establish Monitoring Procedures. For drying time:
What Will Be Monitored? Measure:
Critical factors of the established drying process The revolutions per minute (RPM)
that affect the ability of the process to ensure of the belt drive wheel, using
the desired finished product water activity (i.e., a stopwatch or tachometer;
0.85 or below for shelf-stable products, less
OR
than 0.97 for refrigerated (not frozen), reduced
oxygen packaged products). These may The time necessary for a test unit
include drying time, air temperature, humidity, or belt marking to pass through the
and velocity, as well as flesh thickness; equipment, using a stopwatch;
OR AND
Percent weight loss; For all other critical factors specified by the
study:
OR
Water activity of the finished product. Use equipment appropriate for the
measurement;
How Will Monitoring Be Done? OR
For batch drying equipment: For percent weight loss:

For drying time and input/output air Weigh all, or a portion, of the batch
temperature: before and after drying;
298
OR For water activity:
For water activity: Each lot of finished product.
finished product and conduct water
activity analysis. For continuous temperature-recording
devices:

Monitoring is performed by the
For batch drying equipment: equipment itself. The visual check of

the data generated by this equipment,
For time and temperature:
to ensure that the critical limits have
Continuous monitoring, with a visual consistently been met, may be performed
check of the recorded data at least once by any person who has an understanding
during each batch; of the nature of the controls;
AND AND
For all other critical factors specified by the For all other critical factors specified by the
study: study:
As often as necessary to maintain control;
OR the nature of the controls;
For percent weight loss: OR
Each batch; For percent weight loss:

OR Any person who has an understanding of
For water activity: the nature of the controls;
Each batch. OR
For continuous drying equipment: For water activity:

For temperature: Any person with sufficient training to
perform the analysis.
per day;
AND
For time:
Redry the product (provided that redrying
At least once per day, and whenever any does not present an unacceptable
changes in belt speed are made;
opportunity for pathogenic bacteria growth);
AND
OR
For all other critical factors specified by the Chill and hold the product for an evaluation
study: of the adequacy of the drying process.
As often as necessary to maintain control; The evaluation may involve water activity
OR determination on a representative sample
of the finished product. If the evaluation
For percent weight loss:
shows that the product has not received an
Each lot of finished product; adequate drying process, the product should
OR be destroyed, diverted to a use in which
299
pathogenic bacteria growth in the finished critical factors (e.g., a drying log that indicates
product will be controlled by means other input/output air humidity and/or velocity);
than drying, diverted to a non-food use, or
OR
redried;
Record of weight before and after drying;
OR
OR
critical limit is not applicable because Record of water activity analysis.
pathogenic bacteria growth in the finished For continuous drying equipment:
product will be controlled by means other Record of continuous temperature
than drying (e.g., divert inadequately dried monitoring;
fish to a frozen fish operation);
AND
OR
Divert the product to a non-food use;
AND
OR
Drying log that indicates the RPM of the belt
Destroy the product. drive wheel or the time necessary for a test
unit or belt marking to pass through the drier;
AND
AND
Records that are appropriate for the other
critical factors (e.g., a drying log that indicates
Adjust the air temperature or velocity; input/output air humidity and/or velocity);
OR OR
Adjust the length of the drying cycle to Record of weight before and after drying;
compensate for a temperature or velocity
drop, humidity increase, or inadequate OR
percent weight loss; Record of water activity analysis.
OR
Adjust the belt speed to increase the length
Process validation study (except where a
of the drying cycle.
water activity analysis of the finished product
is the monitoring procedure):
For batch drying equipment:
The adequacy of the drying process
should be established by a scientific
Record of continuous temperature study. For shelf-stable products, the
monitoring; drying process should be designed to
AND ensure the production of a shelf-stable
product with a water activity of 0.85.
For refrigerated (not frozen), reduced
AND oxygen packaged products, it should be
Record of notation of the start time and end designed to ensure a finished product
time of the drying periods; water activity of less than 0.97. Expert
knowledge of drying process calculations
AND and the dynamics of mass transfer in
Records that are appropriate for the other processing equipment may be required
300
to establish such a drying process. Such Doing a combination of the above if
knowledge can be obtained by education the device will be used at or near room
or experience or both. Establishment of temperature;
drying processes may require access to
OR
adequate facilities and the application
of recognized methods. The drying Comparing the temperature reading
equipment should be designed, operated, on the device with the reading on a
and maintained to deliver the established known accurate reference device (e.g.,
drying process to every unit of a product. a thermometer traceable to National
In some instances, drying studies may Institute of Standards and Technology
be required to establish the minimum (NIST) standards) under conditions that
process. In other instances, existing are similar to how it will be used (e.g.,
literature that establishes minimum air temperature) within the temperature
processes or adequacy of equipment is range at which it will be used;
available. Characteristics of the process, AND
product, and/or equipment that affect Once in service, check the temperature-
the ability to achive the established recording device daily before the beginning
minimum drying process should be of operations. Less frequent accuracy checks
taken into consideration in the process may be appropriate if they are recommended
establishment. A record of the process by the instrument manufacturer and the
establishment should be maintained; history of use of the instrument in your
AND facility has shown that the instrument
Finished product sampling and analysis to consistently remains accurate for a longer
determine water activity at least once every period of time. In addition to checking that
3 months (except where such testing is the device is accurate by one of the methods
performed as part of monitoring); described above, this process should include
AND attached wires for damage or kinks. The
Before a temperature-recording device (e.g., device should be checked to ensure that it
a recording thermometer) is put into service, is operational and, where applicable, has
check the accuracy of the device to verify sufficient ink and paper;
that the factory calibration has not been
AND
affected. This check can be accomplished
by: Calibrate the temperature-recording device
OR Optimal calibration frequency is dependent
at or near the boiling point. Note that Consistent temperature variations away from
the temperature should be adjusted to the actual value (drift) found during checks
compensate for altitude, when necessary; and/or calibration may show a need for more
OR the device (perhaps with a more durable
301
device). For example, devices subjected to
high temperatures for extended periods of
time may require more frequent calibration.
AND
Calibrate other instruments as necessary to
ensure their accuracy;
AND
302
TABLE 14-1
CONTROL STRATEGY EXAMPLE 1 - CONTROL BY DRYING

This table is an example of a portion of a Hazard Analysis Critical Control Point (HACCP) plan using Control Strategy Example 1 - Control by Drying. This example illustrates
how a processor of shelf-stable salmon jerky can control pathogenic bacteria growth and toxin formation as a result of inadequate drying. It is provided for illustrative purposes
only. It may be necessary to select more than one control strategy in order to fully control the hazard, depending upon the nature of your operation.
Pathogenic bacteria growth and toxin formation as a result of inadequate drying may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4
(Chapter 3) for other potential hazards (e.g., aquaculture drugs, environmental chemical contaminants and pesticides, parasites, and metal fragments).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

CRITICAL
POINT
MEASURE
Drying Pathogenic Maximum Product Preset slicer to Once per Slicer Re-adjust Processing log Documentation
(forced bacteria growth product thickness just less than day before operator slicer of drying process
convection and toxin thickness: inch operations establishment
oven) formation inch
Check the data
303
logger for accuracy
and damage and
to ensure that
it is operational
before putting
into operation;
check it daily, at
the beginning of
operations; and
calibrate it once
per year
Analyze the
finished product
sample once every
3 months for water
activity
Review of
monitoring,
corrective action
and verification,
records within
1 week of
preparation
TABLE 14-1

Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

CRITICAL
POINT
MEASURE
Drying Pathogenic Minimum Drying time Digital time and Continuous, Oven Continue Data logger Documentation
(forced bacteria growth drying time: 5 temperature with visual operator drying printout of drying process
convection and toxin hours data logger check of establishment
oven) formation recorded data
each batch Check the data
304
logger for accuracy
and damage and
to ensure that it is
operational before
putting into
operation; check it
daily, at the
beginning of
operations; and
calibrate it once
per year
Analyze the
finished product
sample once every
3 months for
water activity
Review of
monitoring,
corrective action
and verification,
records within 1
week of
preparation
TABLE 14-1

Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

CRITICAL
POINT
MEASURE
Drying Pathogenic Minimum oven Oven air input Digital time and Continuous, Oven Extend Data logger Documentation
(forced bacteria growth temperature: temperature temperature with visual operator drying printout of drying process
convection and toxin 140F data logger check of process establishment
oven) formation recorded data
To achieve each batch Segregate the Check the data
305
a final water product and logger for accuracy
activity of 0.85 hold under and damage and
or less refrigeration to ensure that
for it is operational
evaluation before putting
into operation;
Evaluate by check it daily, at
performing the beginning of
water operations; and
activity calibrate it once
analysis on per year
finished
product Analyze the
finished product
Redry if less sample once every
than 0.85 3 months for
water activity
Review of
monitoring,
corrective action
and verification,
records within 1
week of
preparation
CONTROL STRATEGY EXAMPLE 2 - CONTROL BY AND
REFRIGERATION WITH LABELING Determine and correct the cause of improper
It may be necessary to select more than one labels.
control strategy in order to fully control the
hazard, depending upon the nature of your Establish a Recordkeeping System.
operation. Record of labeling checks.
All finished product labels must contain
a keep refrigerated statement (e.g.,
Important, keep refrigerated until used).
Establish Monitoring Procedures. appropriately addressed.
Finished product labels for presence of keep
refrigerated statement.

Visual examination.

Representative number of packages from
each lot of a finished product.


product.
AND
does not contain the proper statement;
306
TABLE 14-2
CONTROL STRATEGY EXAMPLE 2 - CONTROL BY REFRIGERATION WITH LABELING

This table is an example of a portion of a HACCP plan using Control Strategy Example 2 - Control by Refrigeration With Labeling. This example illustrates how a processor of
refrigerated, partially dried catfish can control pathogenic bacteria growth and toxin formation as a result of inadequate drying. It is provided for illustrative purposes only. It may
be necessary to select more than one control strategy in order to fully control the hazard, depending upon the nature of your operation.
(Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides and metal fragments).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
MONITORING
CRITICAL LIMITS
CRITICAL
POINT
MEASURE
Receipt of C. botulinum All finished Finished Visual One label from Receiving Segregate and Label receiving Review
labeling toxin product labels product examination each case of employee re-label any record monitoring and
307
formation must contain a labels for the labels at improperly correction
during keep presence of receipt labeled product action records
finished refrigerated the keep within 1 week
product statement refrigerated Segregate of preparation
storage statement and return or
destroy any
label stock
that does not
contain the
proper
statement
Determine
and correct
the cause of
improper labels
*Note: Chapter 12 covers control of pathogenic bacteria growth at the CCP of finished product storage.
BIBLIOGRAPHY.
We have placed the following references on

display in the Division of Dockets Management,
Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. You may see
them at that location between 9 a.m. and 4 p.m.,
Monday through Friday. As of March 29, 2011,
FDA had verified the Web site address for the
references it makes available as hyperlinks from
the Internet copy of this guidance, but FDA is not
responsible for any subsequent changes to Non-
FDA Web site references after March 29, 2011.
Hilderbrand, K. S. 1992. Fish smoking

procedures for forced convection
smokehouses, Special report 887. Oregon State
University, Extension Service, Corvallis, OR.
Hilderbrand, K. S., Jr. 1996. Personal
communication. Oregon State University,
Extension Service, Corvallis, Oregon.
McClure, P. J., M. B. Cole, and J. P. P. M.
Smelt. 1994. Effects of water activity and pH
on growth of Clostridium botulinum. J. Appl.
Bact. Symp. Suppl. 76:105S-114S.
Tatini, S. R. 1973. Influence of food
environments on growth of Staphylococcus
aureus and production of various enterotoxins.
J. Milk Food Technol. 36:559-563.
308
CHAPTER 15: Staphylococcus aureus Toxin Formation in Hydrated Batter Mixes
UNDERSTAND THE POTENTIAL HAZARD. reach levels that will cause food poisoning until
the numbers of the pathogen reach 500,000
Staphylococcus aureus (S. aureus) toxin formation to 1,000,000 per gram. S. aureus will grow at
in hydrated batter mixes can cause consumer temperatures as low as 44.6F (7C) and at a water
illness. S. aureus is the bacterium responsible activity as low as 0.83 (additional information
for Staphylococcal Food Poisoning (SFP). Ten on conditions favorable to S. aureus growth is
to thirty outbreaks of SFP occur annually in the provided in Table A-1 (Appendix 4)). However,
United States, from all sources. Symptoms include: toxin formation is not likely at temperatures lower
vomiting, diarrhea, abdominal pain, nausea, than 50F (10C) or at water activities below 0.85.
and weakness. Symptoms usually start within 4 For this reason, toxin formation can be controlled
hours of consumption. Everyone is susceptible to by minimizing exposure of hydrated batter mixes
intoxication by S. aureus toxin, with more severe to temperatures above 50F (10C). Exposure
symptoms, including occasionally death, occurring times greater than 12 hours at temperatures
in infants, the elderly, and debilitated persons. between 50F (10C) and 70F (21.1C) could result
Generally, it is a self-limiting illness. in toxin formation. Exposure times greater than
3 hours at temperatures above 70F (21.1C) could
This chapter covers control of S. aureus toxin also result in toxin formation.
formation that occurs as a result of time and
temperature abuse at the hydrated batter mix Strategies for controlling pathogen growth
storage or recirculation step. This toxin in There are a number of strategies for the control
particular is a concern at this step because it is not of pathogens in fish and fishery products. They
likely to be destroyed by subsequent heating steps include:
that the processor or the consumer may perform. Managing the amount of time that food is
Pathogenic bacteria other than S. aureus, such as exposed to temperatures that are favorable
those described in Chapter 12, are less likely to for pathogen growth and toxin production
grow in hydrated batter mixes and/or are likely to (covered in this chapter for S. aureus
be killed by subsequent heating. in hydrated batter mix; Chapter 13 for
Control of S. aureus in batter mixes Clostridium botulinum; and Chapter 12 for
other pathogenic bacteria and conditions);
S. aureus can enter the process on raw materials.
It can also be introduced into foods during Killing pathogenic bacteria by cooking or
processing, from unclean hands and insanitary pasteurizing (covered in Chapter 16), or
utensils and equipment. retorting (covered by the Thermally Processed
Low-Acid Foods Packaged in Hermetically
The hazard develops when a batter mix is Sealed Containers regulation, 21 CFR 113
exposed to temperatures favorable for S. aureus (called the Low-Acid Canned Foods Regulation
growth for sufficient time to permit toxin
in this guidance document));
development. S. aureus toxin does not normally
309
Killing pathogenic bacteria by processes 2. Can the hazard of S. aureus growth and toxin
that retain the raw product characteristics formation that was introduced at an earlier step
(covered in Chapter 17); be eliminated or reduced to an acceptable level
Controlling the amount of moisture that is at this processing step?
available for pathogenic bacteria growth S. aureus toxin formation in hydrated batter
(water activity) in the product by drying mixes should be considered a significant
(covered in Chapter 14); hazard at any processing step where a
Controlling the amount of moisture that is preventive measure is, or can be, used to
available for pathogenic bacteria growth eliminate the hazard (or reduce the likelihood
(water activity) in the product by formulation of its occurrence to an acceptable level) if it
(covered in Chapter 13); is reasonably likely to occur. The preventive
Controlling the amount of salt or measure that can be applied for S. aureus
preservatives, such as sodium nitrite, in the toxin formation in hydrated batter mixes is
product (covered in Chapter 13); controlling the amount of time that hydrated
Controlling the level of acidity (pH) in the batter mixes are exposed to temperatures
product (covered by the Acidified Foods above 50F (10C).
regulation, 21 CFR 114, for shelf-stable Intended use
acidified products, and by Chapter 13 for
Because of the highly heat-stable nature of S.
refrigerated acidified products);
aureus toxin, it is unlikely that the intended use
Controlling the source of molluscan shellfish will affect the significance of the hazard.
and the time from exposure to air (e.g., by
harvest or receding tide) to refrigeration to IDENTIFY CRITICAL CONTROL POINTS.
control pathogens from the harvest area
(covered in Chapter 4); If the hazard of S. aureus toxin formation in
Controlling the introduction of pathogenic hydrated batter mixes is significant, you should
bacteria after the pasteurization process identify the hydrated batter mix storage or
(covered in Chapter 18). recirculation step as the critical control point
(CCP) for this hazard. For hand-battering
DETERMINE WHETHER THE POTENTIAL operations, where hydrated batter mix is stored
HAZARD IS SIGNIFICANT. at each hand-battering station, the hand-battering
stations also should be identified as a CCP.
determining whether S. aureus toxin formation in
hydrated batter mixes is a significant hazard at a
Example - Hydrated Batter Mix Control.
processing step:
Example:
1. Is it reasonably likely that S. aureus will grow A mechanized breaded fish processor should
and form toxin in the hydrated batter mix at the set the CCP for controlling the hazard of
hydrated batter mix storage or recirculation step? S. aureus growth and toxin formation in
The previous section, Understand the Potential hydrated batter mixes at the hydrated batter
Hazard, provides information to help you mix storage or recirculation step. The
decide whether the time and temperature processor would not need to identify other
conditions of your hydrated batter mix storage processing steps as CCPs for that hazard.
or recirculation step are favorable for S. aureus
growth and toxin formation.
310
DEVELOP A CONTROL STRATEGY. How Often Will Monitoring Be Done (Frequency)?
The following guidance provides an example of devices:
a control strategy for S. aureus toxin formation Continuous monitoring, with a visual
in hydrated batter mixes. It is important to check of the recorded data at least once
note that you may select a control strategy per day;
that is different from that which is suggested, OR
provided it complies with the requirements of the For temperature-indicating devices:
At least every 2 hours.
The following is an example of the control
strategy included in this chapter: Who Will Do the Monitoring?
MAY APPLY TO MAY APPLY TO Monitoring is performed by the device
CONTROL STRATEGY PRIMARY SECONDARY itself. The visual check of the data
PROCESSOR PROCESSOR
Hydrated batter mix control the critical limits have consistently been
CONTROL STRATEGY EXAMPLE - HYDRATED who has an understanding of the nature
of the controls;
BATTER MIX CONTROL
OR
For temperature-indicating devices:
Hydrated batter mix should not be held
for more than 12 hours, cumulatively, at Any person who has an understanding of
temperatures between 50F (10C) and 70F
(21.1C); Establish Corrective Action Procedures.
AND Take the following corrective action to a product
Hydrated batter mix should not be held involved in a critical limit deviation:
for more than 3 hours, cumulatively, at Destroy the product and remaining hydrated
temperatures above 70F (21.1C). batter mix;
OR
Establish Monitoring Procedures. Divert the product and remaining hydrated
What Will Be Monitored? batter mix to a non-food use;
The temperature of the hydrated batter mix OR
and the time of exposure at temperatures Hold the product and hydrated batter until it
above 50F (10C) and above 70F (21.1C). can be evaluated based on its total time and
temperature exposure;
OR
Hold the product and hydrated batter
mix until the hydrated batter mix can be
OR sampled and analyzed for the presence of
Use a temperature-indicating device (e.g., staphylococcal enterotoxin.
a thermometer) and observe the time of AND
exposure.
311
Take the following corrective action to regain control known accurate reference device (e.g.,
over the operation after a critical limit deviation: a thermometer traceable to National
Add ice to the hydrated batter mix storage Institute of Standards and Technology
and recirculation tank; (NIST) standards) under conditions that are
similar to how it will be used (e.g., batter
AND/OR temperature) within the temperature range
Make repairs or adjustments to the hydrated at which it will be used;
batter mix refrigeration equipment.
AND
For continuous temperature-recording device daily before the beginning of
devices: operations. Less frequent accuracy checks may
Recorder thermometer charts or digital time be appropriate if they are recommended by
and temperature data logger printouts;
the instrument manufacturer and the history
AND
of use of the instrument in your facility has
accurate for a longer period of time. In

OR addition to checking that the device is accurate
For temperature-indicating devices: by one of the methods described above, this
process should include a visual examination of
Record of visual checks of devices (time
the sensor and any attached wires for damage
and temperature). or kinks. The device should be checked
to ensure that it is operational and, where
Establish Verification Procedures. applicable, has sufficient ink and paper;
AND
a thermometer) or temperature-recording
device (e.g., a recording thermometer) is Calibrate the temperature-indicating device
put into service, check the accuracy of the or temperature-recording device against a
device to verify that the factory calibration known accurate reference device (e.g., a
has not been affected. This check can be NIST-traceable thermometer) at least once a
accomplished by: year or more frequently if recommended by
Immersing the sensor in an ice slurry frequency is dependent upon the type,
OR variations away from the actual value (drift)
at or near the boiling point. Note that or the need to replace the device (perhaps
the temperature should be adjusted to with a more durable device). Calibration
compensate for altitude, when necessary; should be performed at a minimum of two
temperatures that bracket the temperature
OR range at which it is used;
AND
Comparing the temperature reading any critical limit deviations that occurred
on the device with the reading on a were appropriately addressed.
312
TABLE 15-1
CONTROL STRATEGY EXAMPLE - HYDRATED BATTER MIX CONTROL

This table is an example of a portion of a Hazard Analysis Critical Control Point (HACCP) plan using Control Strategy Example - Hydrated Batter Mix Control. This
example illustrates how a breaded fish processor can control S. aureus toxin formation in hydrated batter mixes. It is provided for illustrative purposes only.
S. aureus toxin formation in hydrated batter mixes may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential
hazards (e.g., environmental chemical contaminants and pesticides and metal fragments).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

CRITICAL
POINT
MEASURE
Batter mix S. aureus Hydrated The Recorder Continuous, Production Destroy Recorder Check the
recirculation growth and batter mix temperature thermometer with visual employee hydrated thermometer recorder
tank toxin temperature not of the check once per batter mix and chart thermometer
formation to exceed 50F hydrated day any product for accuracy
313
for more than batter mix and produced and damage
12 hours, the time of during the and to ensure
cumulatively, exposure at period of the that it is
nor 70F for temperatures deviation operational
more than above 50F before putting
3 hours, (10C) and Adjust hydrated into operation;
cumulatively above 70F batter mix check it
(21.1C) refrigeration daily, at the
equipment beginning of
operations; and
calibrate it once
per year

Review
monitoring,
corrective
action, and
verification
records within
1 week of
preparation
BIBLIOGRAPHY. Duran, A. P., B. A. Wentz, J. M. Lanier, F. D.
McClure, A. H. Schwab, A. Swartzentruber,
We have placed the following references on R. J. Barnard, and R. B. Read. 1983.
display in the Division of Dockets Management, Microbiological quality of breaded shrimp
Food and Drug Administration, 5630 Fishers Lane, during processing. J. Food Prot. 46:974-977.
rm. 1061, Rockville, MD 20852. You may see Godwin, G. J., R. M. Grodner, and A. F.
them at that location between 9 a.m. and 4 p.m., Novak. 1977. Twenty-four hour methods
Monday through Friday. As of March 29, 2011, for bacteriological analyses in frozen raw
FDA had verified the Web site address for the breaded shrimp. J. Food Sci. 42:750-754.
references it makes available as hyperlinks from Greenwood, M. H., E. F. C. Coetzee, B.
the Internet copy of this guidance, but FDA is not M. Ford, P. Gill, W. L. Hooper, S. C. W.
responsible for any subsequent changes to Non- Matthews, S. Patrick, J. V. S. Pether, and R.
FDA Web site references after March 29, 2011. J. D. Scott. 1985. The bacteriological quality
Baird-Parker, A. C. 1971. Factors affecting of selected retail, ready-to-eat food products.
the production of bacterial food poisoning III. Cooked crustaceans and mollusks.
toxins. J. Appl. Bact. 34:181-197. Environ. Health 93:236-239.
Beckers, H. J., F. M. van Leusden, and P. Hughes, A., and A. Hurst. 1980. The effect
D. Tips. 1985. Growth and enterotoxin of NaCl on the upper temperature limit for
production of Staphylococcus aureus in growth of and enterotoxin synthesis by
shrimp. J. Hyg., Camb. 95:685-693. Staphylococcus aureus. Can. J. Microbiol.
26:507-510.
Bryan, F. L. 1979. Staphylococcus aureus
in food microbiology: public health and Lotter, L. P., and L. Leistner. 1978. Minimal
spoilage aspects. The Avi Publishing water activity for enterotoxin A production
Company, Inc., Westport, CT. and growth of Staphylococcus aureus. Appl.
Buchanan, R. L. 1991. Microbiological
criteria for cooked, ready-to-eat shrimp and Ostovar, K., and M. J. Bremier. 1975. Effect of
crabmeat. Food Technol. 45:157-160. thawing on growth of Staphylococcus aureus
in frozen convenience food items. J. Milk
Dahl Sawyer, C. A., and J. J. Pestka. 1985.
Food Technol. 38:337-339.
Foodservice systems: presence of injured
bacteria in foods during food product flow. Potter, L., and L. Leistner. 1978. Minimal
Ann. Rev. Microbiol. 39:51-67. water activity for enterotoxin A production
and growth of Staphylococcus aureus. Appl.
Deibel, K. E. 1995. Potential of
Staphylococcus aureus to produce
enterotoxin in fish batter at various Raj, H. D. 1970. Public health bacteriology of
temperatures, p. 33. In Medallion Lab (ed.), processed frozen foods. Lab. Pract. 19:374
Proceedings of the IFT Annual Meeting. 377, 394.
Medallion Lab, Minneapolis, MN. Sutherland, J. P., A. J. Bayliss, and T. A.
Dengremont, E., and J. M. Membre. 1995. Roberts. 1994. Predictive modeling of growth
Statistical approach for comparison of the of Staphylococcus aureus: the effects of
growth rates of five strains of Staphylococcus temperature, pH and sodium chloride. Int. J.
aureus. Appl. Environ. Microbiol. 61:4389 Food Microbiol. 21:217-236.
4395.
314
CHAPTER 16: Pathogenic Bacteria Survival Through Cooking or Pasteurization
UNDERSTAND THE POTENTIAL HAZARD. Pasteurization is a treatment (usually, but not

always, the application of heat) applied to
The survival of pathogenic bacteria through eliminate the most resistant pathogenic bacteria
cooking or pasteurization can cause consumer of public health concern that is reasonably likely
illness. The primary pathogens of concern are to be present in the food for as long as the shelf-
Clostridium botulinum (C. botulinum), Listeria life of the product, when stored under normal
monocytogenes (L. monocytogenes), Campylobacter and moderate abuse conditions. With fishery
jejuni (C. jejuni), pathogenic strains of Escherichia products, pasteurization is usually performed after
coli (E. coli), Salmonella spp., Shigella spp., Yersinia the product is placed in the hermetically sealed
enterocolitica (Y. enterocolitica), Staphylococcus finished product container. It is applied to fishery
aureus (S. aureus), Vibrio cholera (V. cholera), products that are distributed either refrigerated or
Vibrio vulnificus (V. vulnificus), and Vibrio frozen. Examples of pasteurized fishery products
parahaemolyticus (V. parahaemolyticus). See are pasteurized crabmeat, pasteurized surimi-based
Appendix 7 for a description of the public health analog products, and pasteurized lobster meat.
impacts of these pathogens.
In addition to eliminating bacterial pathogens,
It is not practical to target viral pathogens in
cooking and pasteurization also greatly reduce
cooking or pasteurization processes because of
the number of spoilage bacteria present in the
their extreme heat resistance. Viral pathogens
fishery product. These bacteria normally restrict
should be controlled through a rigorous sanitation
the growth of pathogens through competition.
regime as part of a prerequisite program or as
Elimination of spoilage bacteria allows rapid
part of Hazard Analysis Critical Control Point
growth of newly introduced pathogenic bacteria.
(HACCP) itself. The Procedures for the Safe and
Sanitary Processing and Importing of Fish and Pathogenic bacteria that may be introduced after
Fishery Products regulation, 21 CFR 123 (called cooking or pasteurization are, therefore, a concern.
the Seafood HACCP Regulation in this guidance This is especially true for pasteurization, because
document) requires such a regime. that process can significantly extend the shelf-life
of the fishery product, providing more time for
Types of heat processing pathogenic bacteria growth and toxin formation.
Cooking is a heat treatment, usually performed
Retorting is a heat treatment that eliminates all
before the product is placed in the finished product
food-borne pathogens and produces a product
container. It is applied to fishery products that are
that is shelf stable. Mandatory controls for retorting
distributed either refrigerated or frozen. Generally,
are provided in the Thermally Processed Low-Acid
after cooking, fishery products are referred to as
Foods Packaged in Hermetically Sealed Containers
cooked, ready to eat. Examples of cooked, ready-
to-eat fishery products are crabmeat, lobster meat, regulation, 21 CFR 113 (hereinafter, the Low Acid
crayfish meat, cooked shrimp, surimi-based analog Canned Foods (LACF) Regulation), but are not
products, seafood salads, seafood soups and covered in this chapter.
sauces, and hot-smoked fish.
315
Goal of pasteurization (38F (3.3C)) are not uncommon. Therefore,
Selection of the target pathogen is critical to refrigeration alone cannot be relied upon for
the effectiveness of pasteurization. You should control of the C. botulinum hazard. When
consider the potential that C. botulinum type freezing is relied upon to control the growth of
E or non-proteolytic types B and F will survive C. botulinum type E and non-proteolytic types B
the pasteurization process and grow under and F, controls should be in place to ensure that
normal storage conditions or moderate abuse the product is labeled with instructions that it be
conditions. This is of particular concern if the kept frozen throughout distribution.
product is reduced oxygen packaged (e.g., For pasteurization processes that target C.
vacuum packaged or modified atmosphere botulinum type E and non-proteolytic types B and
packaged), does not contain a barrier that is F, generally a reduction of six orders of magnitude
sufficient to prevent growth and toxin formation (six logarithms, e.g., from 103 to 10-3) in the level
by this pathogen, is not equipped with a time of contamination is suitable. This is called a 6D
and temperature integrator, and is stored or process. However, lower degrees of destruction
distributed refrigerated (not frozen). In such may be acceptable if supported by a scientific
products, you should ordinarily select C. study of the normal levels in the food before
botulinum type E and non-proteolytic types pasteurization. It is also possible that higher levels
B and F as the target pathogen. For example, of destruction may be necessary in some foods, if
vacuum-packaged lobster meat that is pasteurized especially high initial levels of the target pathogen
to kill L. monocytogenes, but not C. botulinum are anticipated. Table A-4 (Appendix 4) provides
type E or non-proteolytic types B and F, and 6D process times for a range of pasteurization
is not equipped with a Time-Temperature temperatures, with C. botulinum type B (the
Indicator should be frozen to prevent growth most heat resistant form of non-proteolytic C.
and toxin formation by C. botulinum type E botulinum) as the target pathogen. The lethal rates
and non-proteolytic types B and F, and should and process times provided in the table may not
be labeled to be held frozen and to be thawed be sufficient for the destruction of C. botulinum
under refrigeration immediately before use (e.g., type E and non-proteolytic types B and F in
Important, keep frozen until used, thaw under dungeness crabmeat, because of the potential that
refrigeration immediately before use). naturally occurring substances, such as lysozyme,
If the product is not reduced oxygen packaged, may enable the pathogen to more easily recover
or contains a barrier that is sufficient to prevent after heat damage.
the growth and toxin formation by C. botulinum Examples of properly pasteurized products are
type E or non-proteolytic types B and F, or fish and fishery products generally (e.g., surimi
is equipped with a time and temperature based products, soups, or sauces) pasteurized
integrator, or is distributed frozen, then selection to a minimum cumulative total lethality of F194F
of another target pathogen may be appropriate. (F90C) = 10 minutes, where z = 12.6F (7C) for
L. monocytogenes may be selected as the target temperatures less than 194F (90C) and z = 18F
pathogen for pasteurization of this type of (10C) for temperatures above 194F (90C); blue
product because it is the most resistant bacterial crabmeat pasteurized to a minimum cumulative
pathogen of public health concern that is total lethality of F185F (F85C) = 31 minutes, where z
reasonably likely to be present. = 16F (9C); and dungeness crabmeat pasteurized
Surveys of retail display cases and home to a minimum cumulative total lethality of F194F
refrigerators indicate that temperatures above the (F90C) = 57 minutes, where z = 15.5F (8.6C).
minimum growth temperature of C. botulinum Equivalent processes at different temperatures can
type E and non-proteolytic types B and F be calculated using the z values provided.
316
forming unit (CFU)/g and that approximately 91%
EXAMPLES OF PROPERLY are contaminated at less than 1 CFU/g. Less than
PASTEURIZED PRODUCTS
1% of raw seafood are contaminated at levels
PRODUCT
MINIMUM CUMULATIVE
Z VALUE greater than 103 CFU/g and none at levels greater
TOTAL LETHALITY
than 106 CFU/g. FDAs limit for L. monocytogenes
Fish and F194F (F90C) = 10 minutes 12.6F (7C), for
fishery temperatures in ready-to-eat products, nondetectable,
products less than 194F corresponds to a level of less than 1 CFU/25g.
generally (90C)
(e.g., surimi Table A-3 (Appendix 4) provides 6D process
based 18F (10C) for
products, temperatures times for a range of pasteurization temperatures,
soups, or above 194F (90C) with L. monocytogenes as the target pathogen.
sauces)
Lower degrees of destruction may be acceptable
Blue F185F (F85C) = 31 minutes 16F (9C)
crabmeat
if supported by a scientific study of the normal
levels in the food before pasteurization. It is also
Dungeness F194F (F90C) = 57 minutes 15.5F (8.6C)
crabmeat possible that higher degrees of destruction may
be necessary in some foods if especially high
In some pasteurized surimi-based products, salt, initial levels are anticipated.
in combination with a milder heat pasteurization Products that are pasteurized in the finished
process in the finished product container, works product container are at risk for recontamination
to prevent growth and toxin formation by C. after pasteurization. Controls, such as container
botulinum type E and non-proteolytic types B seal integrity and protection from contaminated
and F. An example of a properly pasteurized cooling water, are critical to the safety of these
surimi-based product in which 2.4% water phase products and are covered in Chapter 18.
salt is present is one that has been pasteurized
at an internal temperature of 185F (85C) for Goal of cooking for most products
at least 15 minutes. This process may not be One reason for cooking products that will not
suitable for other types of products because of be reduced oxygen packaged is to eliminate
the unique formulation and processing involved vegetative cells of pathogenic bacteria (or reduce
in the manufacture of surimi-based products. them to an acceptable level) that may have been
Reduced oxygen-packaged foods that are introduced to the process by raw materials or
pasteurized to control C. botulinum type E by processing that occurs before the cooking
and non-proteolytic types B and F, but not C. step. Selection of the target pathogen is critical
botulinum type A and proteolytic types B and to the effectiveness of cooking. Generally, L.
F, and that do not contain barriers to its growth monocytogenes is selected as the target pathogen
should be refrigerated or frozen to control C. because it is regarded as the most heat-tolerant,
botulinum type A and proteolytic types B and foodborne bacterial pathogen that does not form
F. Control of refrigeration is critical to the safety spores. Cooking processes are not usually designed
of these products. Further information on C. to eliminate spores of bacterial pathogens.
botulinum and reduced oxygen packaging is Determining the degree of destruction of the target
contained in Chapter 13. pathogen is also critical. Generally, a reduction of
six orders of magnitude (six logarithms, e.g., from
In cases where L. monocytogenes is selected 103 to 10-3) in the level of contamination is suitable.
as the target pathogen, a 6D process is also This is called a 6D process.
generally suitable. FDA and U.S. Department of
Agricultures L. monocytogenes risk assessment Table A-3 provides 6D process times for a range of
indicates that approximately 8% of raw seafood cooking temperatures, with L. monocytogenes as
are contaminated with from 1 to 103 colony the target pathogen. Lower degrees of destruction
317
may be acceptable if supported by a scientific properly cooked to eliminate C. botulinum type
study of the normal levels in the food before E and non-proteolytic types B and F is a soup or
pasteurization. It is also possible that higher sauce that is cooked to a minimum cumulative
degrees of destruction may be necessary in some total lethality of F194F (F90C) = 10 minutes, where
foods if especially high initial levels are anticipated. z = 12.6F (7C) for temperatures less than 194F
(90C) and z = 18F (10C) for temperatures
Goal of cooking refrigerated, reduced above 194F (90C).
oxygen-packaged products
Reduced oxygen-packaged soups or sauces that
Cooking is sometimes performed on products
are cooked immediately before packaging to
immediately before placement in reduced oxygen
control C. botulinum type E and non-proteolytic
packaging (e.g., vacuum packaging or modified
types B and F, but not C. botulinum type A and
atmosphere packaging). These products include
proteolytic types B and F, and that do not contain
cooked, hot-filled soups, chowders, or sauces
barriers to its growth should be refrigerated
that are filled directly from the cook kettle using
or frozen to control C. botulinum type A and
sanitary, automated, continuous filling systems
proteolytic types B and F. Control of refrigeration
designed to minimize risk of recontamination.
is critical to the safety of these products. Further
They are often marketed under refrigeration,
information on C. botulinum and reduced oxygen
which is important for the control of C.
packaging is contained in Chapter 13.
botulinum type A and proteolytic types B and F.
Cooking processes that target C. botulinum
The cooking process for these products should
type E and non-proteolytic types B and F have
be sufficient to eliminate the spores of C.
much in common with pasteurization processes.
Like products that are pasteurized in the final
and F. This is the case when the product does
container, products that are cooked and then
not contain other barriers that are sufficient
placed in the final container also are at risk
to prevent growth and toxin formation by
for recontamination after they are placed in
this pathogen. Generally, a 6D process (six
the finished product container. Controls, such
logarithms, e.g., from 103 to 10 -3) is suitable.
as container seal integrity and protection from
However, lower degrees of destruction may
contaminated cooling water, are critical to the
be acceptable if supported by a scientific
safety of these products and are covered in
study of the normal levels in the food before
Chapter 18.
pasteurization. It is also possible that higher
degrees of destruction may be necessary in Additionally, because these products are cooked
some foods if especially high initial levels are before they are packaged, they are at risk of
anticipated. recontamination between cooking and packaging.
The risk of recontamination may be minimized
Table A-4 provides 6D process times for a range
by filling the container in a sanitary, automated,
of cooking temperatures, with C. botulinum type
continuous filling system while the product is
B (the most heat-resistant form of non-proteolytic
still hot (i.e., hot filling). This is another critical
C. botulinum) as the target pathogen. The lethal
step for the safety of these products. This control
rates and process times provided in the table
strategy is suitable for products that are filled
may not be sufficient for the destruction of C.
directly from the cooking kettle, where the risk of
recontamination is minimized. It is not ordinarily
and F in soups or sauces containing dungeness
suitable for products such as crabmeat, lobster
crabmeat because of the potential that naturally
meat, or crayfish meat that are handled between
occurring substances, such as lysozyme, may
cooking and filling. Hot filling is also covered in
enable the pathogen to more easily recover
Chapter 18.
after damage. An example of a product that is
318
Control by cooking or pasteurization cells of L. monocytogenes and destroying them
Controlling pathogenic bacteria survival through requires an EPIPT that could be achieved only
cooking or pasteurization is accomplished by: in a pressurized steam environment, making
Scientifically establishing a cooking or measurement impractical. Additional guidance
pasteurization process that will eliminate on EPIPT monitoring can be found in Food
pathogenic bacteria of public health concern Processors Association guidance document FPA
or reduce their numbers to acceptable levels; Guidance Document: Establishing or Verifying
a Heat Process for Cooked, Ready-to-Eat
Designing and operating the cooking or
Seafood Products, and Heat Process Monitoring
pasteurization equipment so that every unit
Considerations under HACCP, 2nd Edition,
of product receives at least the established
February 2005 and purchased at the Grocery
minimum process;
Manufacturers Association, Washington DC 20005.
Continuously monitoring the critical process
parameters to verify achievement of a Strategies for controlling pathogenic
scientifically established process (e.g., time bacteria growth
and temperature). There are a number of strategies for the control
You may monitor End-Point Internal Product of pathogenic bacteria in fish and fishery
Temperature (EPIPT), a measurement of the products. They include:
temperature of the product as it exits the heat Killing pathogenic bacteria by cooking or
process, instead of performing continuous time pasteurizing (covered in this chapter) or
and temperature monitoring. This approach is retorting (covered by the LACF Regulation, 21
suitable if you have conducted a scientific study CFR 113);
to validate that the EPIPT that you have selected Killing pathogenic bacteria by processes that
will provide an appropriate reduction in the retain the raw characteristics of the products
numbers of the target pathogen (e.g., 6D) in the (covered in Chapter 17);
slowest heating unit or portion of product under Managing the amount of time that food is
the worst set of heating conditions covered by exposed to temperatures that are favorable
the scientific study. You should (1) conduct a for pathogenic bacteria growth and toxin
temperature distribution study within the heating production (covered generally in Chapter
system to identify any cold spots; (2) conduct 12; for C. botulinum, in Chapter 13; and
a heat penetration study that accounts for the for S. aureus in hydrated batter mixes, in
slowest heating product under the worst case Chapter 15);
heating conditions covered by the scientific study;
Controlling the amount of moisture that is
and identify other critical factors of processing
available for pathogenic bacteria growth
and/or packaging that affect the rate of product
(water activity) in the product by drying
heating when scientifically establishing a cooking
or pasteurization process (i.e., process validation).
The EPIPT should be used as a monitoring Controlling the amount of moisture that is
technique only under those conditions that available for pathogenic bacteria growth
were evaluated by the scientific study. Those (water activity) in the product by formulation
conditions may need to be identified as critical (covered in Chapter 13);
limits and monitored as part of the HACCP plan. Controlling the amount of salt or
preservatives, such as sodium nitrite, in the
EPIPT monitoring may not be an option when
product (covered in Chapter 13);
the objective is control of C. botulinum type E
and non-proteolytic types B and F spores. These Controlling the level of acidity (pH) in the
spores are far more heat resistant than vegetative product (covered by the Acidified Foods
319
regulation, 21 CFR 114, for shelf-stable of bacterial pathogens. For this reason, you
acidified products, and by Chapter 13 for should consider it reasonably likely that
refrigerated acidified products); low numbers of pathogenic bacteria will be
Controlling the source of molluscan shellfish present in the product.
and the time from exposure to air (e.g., by 2. Can unsafe levels of pathogenic bacteria that
harvest or receding tide) to refrigeration to were introduced at an earlier processing step be
control pathogens from the harvest area eliminated or reduced to an acceptable level at
(covered in Chapter 4); this processing step?
bacteria after the pasteurization process Pathogenic bacteria survival through cooking
(covered in Chapter 18). or pasteurization should also be considered
a significant hazard at any processing step
DETERMINE WHETHER THE POTENTIAL where a preventive measure is, or can be,
HAZARD IS SIGNIFICANT. used to eliminate the hazard (or reduce the
likelihood of its occurrence to an acceptable
level) if it is reasonably likely to occur. The
preventive measure that can be applied
determining whether pathogenic bacteria
for pathogenic bacteria survival through
survival through cooking and pasteurization is a
cooking and pasteurization is proper design
significant hazard at a processing step.
and control of the cooking or pasteurization
1. Is it reasonably likely that unsafe levels of process.
pathogenic bacteria will be introduced at this
processing step (do unsafe levels of pathogenic Intended use
bacteria come in with the raw material, or will Because cooked or pasteurized products are
the process introduce unsafe levels of pathogenic ready to eat, it is unlikely that the intended use
bacteria)? will affect the significance of the hazard.
It is reasonable to assume that pathogens of IDENTIFY CRITICAL CONTROL POINTS.

various types, including those listed in Table
A-1 (Appendix 4), will be present on raw fish
and fishery products. They may be present
only at low levels or only occasionally, but
critical control point (CCP) for the survival
even such occurrences warrant consideration
of pathogenic bacteria through cooking or
because of the potential for growth and toxin
pasteurization:
production.
Will the finished product be pasteurized in the final
Pathogenic bacteria may also be introduced
container?
during processing, from the air, unclean
hands, insanitary utensils and equipment, 1. If the finished product will be pasteurized in
unsafe water, and sewage. Well-designed the final container, you should identify the
sanitation programs will minimize the pasteurization step as the CCP. In this case, you
introduction of pathogens. Such sanitation would not need to identify the cooking step as
controls need not be part of your HACCP a CCP for the hazard of pathogenic bacteria
plan if they are monitored under your survival through cooking.
sanitation program (prerequisite program).
Example:
In most cases, it is not reasonable to assume
A crabmeat processor cooks, picks,
that they will fully prevent the introduction
packs, and pasteurizes the crabmeat.
320
The processor sets the CCP for pathogenic cook or pasteurization cycle (speed of the
bacteria survival through cooking and belt for a continuous cooker or pasteurizer),
pasteurization at the pasteurization step temperature of the steam or water used
and does not identify the cooking step as for cooking or pasteurization (or visual
a CCP for this hazard. observation of minutes at a boil for cooking),
initial temperature of the product, container
size (e.g., can dimensions, pouch thickness),
and product formulation. Other critical
Example - Cooking and Pasteurization.
factors that affect the rate of heating of the
2. If the product will not be pasteurized, you should product may also be established by the
identify the cooking step as the CCP. study;
This control approach is the same as the OR
one above and is a control strategy also The EPIPT, established by a scientific
referred to in this chapter as Control Strategy study. Other critical factors that affect the
Example - Cooking and Pasteurization. For rate of heating of the product may also be
products in reduced oxygen packaging for established by the study.
which the cooking process does not target Note: EPIPT monitoring may not be an option when the objective
C. botulinum type E and non-proteolytic is control of C. botulinum type E and non-proteolytic types B and F
types B and F, see Chapter 13 for additional spores.
guidance.
The following guidance provides a control The critical factors established by a scientific
strategy for survival of pathogenic bacteria study. These may include length of the cook
through cooking or pasteurization. You may or pasteurization cycle (speed of the belt
select a control strategy that is different from that for a continuous cooker or pasteurizer) and
which is suggested, provided it complies with the temperature of the steam or water used
requirements of the applicable food safety laws for cooking or pasteurization (or visual
and regulations. observation of minutes at a boil for cooking),
initial temperature of the product, container
The following is an example of the control size (e.g., can dimensions, pouch thickness),
strategy included in this chapter: and product formulation;
OR
CONTROL STRATEGY PRIMARY SECONDARY The EPIPT.
PROCESSOR PROCESSOR
Cooking and pasteurization How Will Monitoring Be Done?

For batch cooking or pasteurization equipment:
CONTROL STRATEGY EXAMPLE - COOKING AND For cooking or pasteurization temperature:
PASTEURIZATION
Set Critical Limits. device (e.g., a recording thermometer).
The device should be installed where
The minimum or maximum values for the
it measures the coldest temperature of
critical factors established by a scientific
the cooking equipment (cold spot to be
study. These may include length of the
determined by a study). Where cooking
321
is performed at the boiling point, visual Use equipment appropriate to the critical
observation of minutes at a boil may be factor (e.g., initial temperature with a
an acceptable alternative; temperature-indicating device, (e.g., a
thermometer);
AND
For the start and end of each cooking or OR
pasteurization cycle:
For the EPIPT:
Visual observation;
a thermometer).
AND
For other critical factors: How Often Will Monitoring Be Done (Frequency)?
Use equipment appropriate to the critical For batch cooking or pasteurization equipment:
factor (e.g., initial temperature with a
For cooking or pasteurization temperature:
temperature-indicating device, (e.g., a
thermometer); Continuous monitoring, with a visual
OR per batch;
For the EPIPT:
AND
For the start and end of each cooking or
a thermometer).
pasteurization cycle:
For continuous cooking or pasteurization

equipment:
Each batch;
AND
For cooking or pasteurization temperature:
For other critical factors:
device (e.g., a recording thermometer). With sufficient frequency to achieve
The device should be installed where control;
it measures the coldest temperature of OR
the cooking equipment (cold spot to For the EPIPT:

be determined by a study). Because
of the extended time of operation of Each batch.
such equipment, it is unlikely that For continuous cooking or pasteurization
visual observation of boiling will be an equipment:
acceptable alternative, even if cooking is For cooking or pasteurization temperature:
performed at the boiling point;
AND check of the recorded data at least once
For cooking or pasteurization time, use: per day;
A stopwatch or tachometer to monitor AND

the speed of the belt drive wheel; For cooking or pasteurization time:
OR At least once per day, and whenever any
changes in belt speed are made;
A stopwatch to monitor the time

necessary for a test unit or belt marking AND
to pass through the equipment; For other critical factors:

AND
With sufficient frequency to achieve
For other critical factors: control;
322
OR AND
For the EPIPT: Take the following corrective action to regain control
At least every 30 minutes, and whenever over the operation after a critical limit deviation:
any changes in product-heating critical Adjust the steam supply to increase the
factors occur. processing temperature;
Who Will Perform the Monitoring? OR
For continuous temperature-recording Extend the length of the cooking or
devices: pasteurization cycle to compensate for a
temperature drop, using a process developed
by a process authority;
generated by the device, to ensure that OR
Process at a higher temperature to
compensate for a low initial temperature,
using a process developed by a process
of the controls;
authority;
AND
OR
For other monitoring:
Adjust the belt speed.
the nature of the controls. Establish a Recordkeeping System.
Establish Corrective Action Procedures. For batch cooking or pasteurization equipment:

For temperature monitoring:
involved in a critical limit deviation: Record of continuous temperature
monitoring;
Recook or repasteurize the product;

AND
OR
Chill and hold the product for an evaluation Record of visual checks of recorded data;
of the adequacy of the cooking or OR

pasteurization process. If the product has Cooking log that indicates visual observation
not received an adequate process, it should of boiling, where cooking is performed at
be destroyed, diverted to a non-food use, or the boiling point;
recooked or repasteurized;
AND
OR Record of notation of the start time and end
Divert the product to a use in which the time of the cooking or pasteurization periods;
AND
improperly cooked or pasteurized shrimp to
a shrimp canning operation); Records that are appropriate for the
other critical factors (e.g., a cooking or
OR pasteurization log that indicates the initial
Destroy the product; temperature);
OR OR
Divert the product to a non-food use. Record of EPIPT results.
323
For continuous cooking or pasteurization the spores of C. botulinum type E and non
equipment: proteolytic types B and F. This is the case
Record of continuous temperature monitoring; when the product does not contain other
barriers that are sufficient to prevent growth
AND and toxin formation by this pathogen (e.g.,
Record of visual checks of devices; refrigerated, vacuum packaged hot-filled
AND soups and sauces). Generally, a 6D process
is suitable, regardless of the target bacterial
Cooking or pasteurization log that indicates
pathogen. However, lower degrees of
the RPM of the belt drive wheel or the time
destruction may be acceptable if supported
necessary for a test unit or belt marking to
by a scientific study of the normal levels in
pass through the tank;
the food. Tables A-3 and A-4 provide 6D
AND process times for a range of internal product
Records that are appropriate for the other temperatures, with L. monocytogenes and C.
critical factors (e.g., a cooking or pasteurization botulinum type B (the most heat-resistant
log that indicates the initial temperature); form of non-proteolytic C. botulinum) as
the target pathogens. The values provided
OR
in Table A-4 may not be sufficient for the
Record of EPIPT results. destruction of C. botulinum type E and
non-proteolytic types B and F in products
Establish Verification Procedures. containing dungeness crabmeat because of
For cooking, process validation study (process the potential protective effect of naturally
establishment): occurring substances, such as lysozyme.
The adequacy of the cooking process Expert knowledge of thermal process
should be established by a scientific study. It calculations and the dynamics of heat transfer
should be designed to ensure an appropriate in processing equipment may be required
reduction in the number of pathogenic to establish such a cooking process. Such
bacteria of public health concern. Selecting knowledge can be obtained by education or
the target organism is critical. In most cases, experience, or both. Conducting a validation
it will be a relatively heat-tolerant vegetative study for cooking processes may require
pathogen, such as L. monocytogenes. access to suitable facilities and the application
However, in some cases where outgrowth of recognized methods. The cooking
of spore-forming pathogens, such as equipment should be designed, operated,
Clostridium perfringens and Bacillus cereus, and maintained to deliver the established
during the post-cook cooling step must be process to every unit of the product. In some
prevented by eliminating these pathogens cases, thermal death time, heat penetration,
during the cook step (e.g., because cooling temperature distribution, and inoculated
after cooking is not controlled (see pack studies may be necessary to validate
Chapter 12)), then they will be the target the minimum process. In many cases,
organisms. Additionally, when cooking is establishing the minimum process may be
performed immediately before reduced simplified by repetitively determining the
oxygen packaging (e.g., vacuum packaging process needed to reach an internal product
or modified atmosphere packaging), for temperature that will ensure the inactivation
a product that will be marketed under of all vegetative bacterial pathogens of public
refrigeration, it may be necessary for the health concern under the most difficult
cooking process to be sufficient to eliminate heating conditions likely to be encountered
324
during processing. In other instances, in processing equipment may be required to
existing literature or federal, state, or local determine the target bacterial pathogen and
regulations that establish minimum processes to establish a pasteurization process. Such
or adequacy of equipment are available. knowledge can be obtained by education
Characteristics of the process, product, and/ or experience, or both. Conducting a
or equipment that affect the ability of the validation study for pasteurization processes
established minimum cooking process should may require access to suitable facilities and
be taken into consideration in the validation the application of recognized methods.
of the process. A record of the process The pasteurization equipment should be
validation study should be maintained; designed, operated, and maintained to
deliver the established process to every
OR
unit of the product. In some cases, thermal
For pasteurization, process validation study death time, heat penetration, temperature
(process establishment): distribution, and inoculated pack studies
The adequacy of the pasteurization process may be necessary to validate the minimum
should be established by a scientific study. It process. In other instances, existing literature
should be designed to ensure an appropriate or federal, state, or local regulations that
reduction in the number of target bacterial establish minimum processes or adequacy
pathogens. Selecting the target organism of equipment are available. Characteristics
is critical. In most cases, it will be the of the process, product, and/or equipment
spores of C. botulinum type E and non that affect the adequacy of the established
proteolytic types B and F. In some cases minimum pasteurization process should be
(e.g., products that are distributed frozen taken into consideration in the validation of
or contain other barriers to prevent growth the process. A record of the validation study
and toxin formation by C. botulinum type should be maintained;
E and non-proteolytic types B and F), the AND
process will target another pathogen, such
as L. monocytogenes. Generally, a 6D process
a thermometer) or temperature-recording
is suitable, regardless of the target pathogen.
device (e.g., a recording thermometer) is
However, lower degrees of destruction may
put into service, check the accuracy of the
be acceptable if supported by a scientific
device to verify that the factory calibration
study of the normal levels in the food. Tables
has not been affected. This check can be
A-3 and A-4 provide 6D process times for
accomplished by:
a range of internal product temperatures,
with L. monocytogenes and C. botulinum Immersing the sensor in an ice slurry
type B (the most heat-resistant form of (32F (0C)) if the device will be used at
non-proteolytic C. botulinum) as the target or near refrigeration temperature;
pathogens. The values provided in Table A-4 OR
may not be sufficient for the destruction of C.
botulinum type E and non-proteolytic types Immersing the sensor in boiling water
B and F in products containing dungeness
at or near the boiling point (note that
crabmeat because of the potential protective
effect of naturally occurring substances, such
compensate for altitude, when necessary);
as lysozyme.
OR
Expert knowledge of thermal process
calculations and the dynamics of heat transfer A combination of the above if the
325
device will be used at or near room show a need for more frequent calibration or
temperature; the need to replace the device (perhaps with
a more durable device). Devices subjected to
OR
high temperatures for extended periods of
Comparing the temperature reading time may require more frequent calibration.
on the device with the reading on a Calibration should be performed at a
known accurate reference device (e.g., minimum of two temperatures that bracket
a thermometer traceable to National the temperature range at which it is used;
Institute of Standards and Technology
(NIST) standards) under conditions that AND
are similar to how it will be used (e.g., Calibrate other instruments as necessary to
steam temperature, water temperature, ensure their accuracy;
product internal temperature) within the
AND
temperature range at which it will be
used; Review monitoring, corrective action,
AND preparation to ensure they are complete and
Once in service, check the temperature- any critical limit deviations that occurred
indicating device or temperature-recording were appropriately addressed.
AND
or temperature-recording device against a
326
TABLE 16-1
CONTROL STRATEGY EXAMPLE - COOKING AND PASTEURIZATION

(COOKING MODEL)
This table is an example of a portion of a HACCP plan using Control Strategy Example - Cooking and Pasteurization (Cooking Model). This example illustrates how a
processor of wild-caught cooked shrimp can control cooking using a continuous steam cooker. It is provided for illustrative purposes only.
Pathogenic bacteria survival through cooking and pasteurization may be only one of several significant hazards for this product. Refer to Tables 3-3 and 3-4 (Chapter 3)
for other potential hazards (e.g., environmental chemical contaminants and pesticides, pathogenic bacteria growth and toxin formation during processing, food and color
additives, and metal fragments).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
MONITORING
CRITICAL LIMITS
CRITICAL
POINT
MEASURE*
Cooking Pathogenic Minimum Length of the Belt speed Once per day Cooker Extend process Cooking Scientific study establishing
bacteria cook time: 2.5 cook cycle measurement and after any operator or elevate record the thermal process
327
survival minutes with stopwatch adjustment temperature (process
to compensate validation)
for deviation
from critical Check the
Minimum cook Temperature Digital time and Continuous, Cooker limit, based Data logger data logger for
temperature: of steam in temperature with visual operator on alternate printout accuracy and
210F the cooker data logger check of processes damage and to ensure that
Note: To recorded data provided by it is operational
achieve a 6D once per day the process before putting
reduction of L. authority into operation; check it
monocytogenes daily, at the beginning of
Chill and hold operations; and calibrate it
for evaluation once per year

Calibrate the scale monthly
Maximum Shrimp size Scale Hourly and Grader operator Grading
shrimp size: 40 after every record Review
count/pound raw material monitoring,
lot change corrective action and
or grader verification, records within
adjustment 1 week of
preparation
TABLE 16-2
CONTROL STRATEGY EXAMPLE - COOKING AND PASTEURIZATION

(PASTEURIZATION MODEL)
This table is an example of a portion of a HACCP plan using Control Strategy Example - Cooking and Pasteurization (Pasteurization Model). This example illustrates how
a processor of pasteurized, refrigerated blue crabmeat can control pasteurization. It is provided for illustrative purposes only.
Pathogenic bacteria survival through cooking and pasteurization may be only one of several significant hazards for this product. Refer to Tables 3-3 and 3-4 (Chapter 3) for
other potential hazards (e.g., environmental chemical contaminants and pesticides, pathogenic bacteria growth and toxin formation during processing, recontamination after
pasteurization, and metal fragments).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
MONITORING
CRITICAL LIMITS
CRITICAL
POINT
MEASURE*
Batch Pathogenic Minimum Initial Dial Coldest Pasteurizer Extend the Pasteurization Process
pasteurization bacteria initial temperature thermometer can entering operator process or log establishment
328
survival product each batch elevate the
temperature: temperature Check the
37F to compensate temperature-
for recording device and
Minimum Time up to Temperature- Each batch Pasteurizer deviation Pasteurization dial thermometer for
length of 189F and recording operator from the log accuracy and damage
pasteurization time cycle device critical and to ensure that they
cycle: ends limit are operational before
120 minutes putting into operation;
Segregate check it daily, at the
and hold for beginning of operations;
evaluation and calibrate it once per
year

Review
Minimum Temperature Temperature- Continuously, Recorder Recorder monitoring,
water bath of water bath recording with visual thermometer, thermometer verification, and
temperature: device check at end with visual chart corrective action records
189F of batch check by within 1 week of
pasteurizer preparation
operator
BIBLIOGRAPHY. National Advisory Committee on
We have placed the following references on Recommendations of the National Advisory
display in the Division of Dockets Management, Committee on Microbiological Criteria for
Food and Drug Administration, 5630 Fishers Lane, Foods for Cooked Ready-to-Eat Shrimp and
rm. 1061, Rockville, MD 20852. You may see Cooked Ready-to-Eat Crabmeat. Executive
them at that location between 9 a.m. and 4 p.m., Secretariat, Food Safety and Inspection
Monday through Friday. As of March 29, 2011, Service, U.S. Department of Agriculture,
FDA had verified the Web site address for the Washington, DC.
references it makes available as hyperlinks from National Advisory Committee on
the Internet copy of this guidance, but FDA is not Microbiological Criteria for Foods. 1990.
responsible for any subsequent changes to Non- Recommendations of the National Advisory
FDA Web site references after March 29, 2011. Committee on Microbiological Criteria for
Foods for Refrigerated Foods Containing
Cockey, R. R., and M. C. Tatro. 1974. Survival
Cooked, Uncured Meat or Poultry Products
studies with spores of Clostridium botulinum
that are Packaged for Extended Refrigerated
type E in pasteurized meat of the blue crab
Shelf Life and that are Ready-to-Eat or
Callinectes sapidus. Appl. Microbiol. 27:629-633.
Prepared with Little or No Additional Heat
European Chilled Food Federation. 1997. Treatment. Executive Secretariat, Food Safety
Guidelines for good hygienic practice in the and Inspection Service, U.S. Department of
manufacture of chilled foods. Agriculture, Washington, DC.
Frazier, J. 2005. Establishing or verifying a National Advisory Committee on
heat process for cooked, ready-to-eat seafood Microbiological Criteria for Foods. 1991.
products, and heat process monitoring Listeria monocytogenes: recommendations
considerations under HACCP. 2nd ed. of the National Advisory Committee on
Grocery Manufacturers Association (Food Microbiological Criteria for Foods for
Products Association), Washington, DC. Refrigerated Foods. Intl. J. Food Microbiol.
Hilderbrand, K. S., Jr. 1996. Personal 14:185-246.
communication. Oregon State University, Peterson, M. E., G. A. Pelroy, F. T. Poysky, R.
Extension Service, Corvallis, OR. N. Paranjpye, R. M. Dong, G. M. Pigott, and M.
Lum, K. C. 1996. Personal communication. W. Eklund. 1997. Heat-pasteurization process
National Food Processors Association, for inactivation of nonproteolytic types of
Seattle, WA. Clostridium botulinum in picked dungeness
Lynt, R. K., D. A. Kautter, and H. M. crabmeat. J. Food Prot. 60:928-934.
Solomon. 1982. Differences and similarities Peterson, M. E., R. N. Paranjpye, F. T.
among proteolytic and nonproteolytic strains Poysky, G. A. Pelroy, and M. W. Eklund.
of Clostridium botulinum types A, B, E and 2002. Control of nonproteolytic Clostridium
F: a review. J. Food Prot. 45:466-474. botulinum types B and E in crab analogs
Lynt, R. K., H. M. Solomon, T. Lilly, and by combinations of heat pasteurization and
D. A. Kautter. 1977. Thermal death time of water phase salt. J. Food Prot. 65:130-139.
Clostridium botulinum type E in meat of the Rippen, T., C. Hackney, G. Flick, G. Knobl,
blue crab. J. Food Sci. 42:1022-1025. and D. Ward. 1993. Seafood pasteurization
Mackey, B. M., and N. Bratchell. 1989. The and minimal processing manual. Virginia
heat resistance of Listeria monocytogenes: a Cooperative Extension Publication 600
review. Lett. Appl. Microbiol. 9:89-94. 0061. Virginia Sea Grant Publication VSG
329
93-09. Virginia Seafood Research and
Extension Center Publication VPI-SG-93-01.
Blacksburg, VA.
U.S. Food and Drug Administration and
U.S. Department of Agriculture. 2003.
Quantitative assessment of the relative risk
to public health from foodborne Listeria
monocytogenes among selected categories
of ready-to-eat foods. http://www.fda.
gov/Food/ScienceResearch/ResearchAreas/
RiskAssessmentSafetyAssessment/ucm183966.
htm.
Thermally processed low-acid foods
packaged in hermetically sealed containers.
In Code of Federal Regulations, 21 CFR
113. U.S. Government Printing Office,
Washington, DC.
330
CHAPTER 17: Pathogenic Bacteria Survival Through Processes Designed to Retain
Raw Product Characteristics
UNDERSTAND THE POTENTIAL HAZARD. Mild heat processing;

Irradiation.
The survival of pathogenic bacteria through HPP, IQF with extended frozen storage, mild heat
processes designed to retain raw product processing, and irradiation are processes currently
characteristics can cause consumer illness. used for the treatment of raw molluscan shellfish
The primary pathogens of concern are to reduce the presence of V. vulnificus and V.
Vibrio vulnificus (V. vulnificus) and Vibrio parahaemolyticus to non-detectable levels. V.
parahaemolyticus (V. parahaemolyticus). See vulnificus and V. parahaemolyticus are naturally
Appendix 7 for a description of the public health occurring pathogens (i.e., not associated with
impacts of these pathogens. human or animal sources) that may be present in
Goal of processes designed to retain raw fish and fishery products, and in particular, raw
product characteristics molluscan shellfish. Non-detectable for these
pathogens is defined under the National Shellfish
Some processes are designed to reduce specific
Sanitation Program (NSSP) as less than 30 (MPN)/
pathogens to acceptable levels while retaining
gram. MPN means most probable number and it
the sensory qualities (appearance, taste, and
is an approximation of the bacterial population in
texture) of the raw product. These processes
analyzed product. Shellfish that are processed in
are particularly useful in addressing the hazard
a manner that achieves a non-detectable level for
associated with the target pathogen in raw
one or both of these pathogens may bear added
products such as raw molluscan shellfish (i.e.,
safety labeling. Additionally, they need not meet
oysters, clams, mussels, and whole and roe-on
the time from exposure to air (e.g., by harvest or
scallops) that are intended for the raw ready-
receding tide) to refrigeration recommendations
to-eat market. Because these processes do not
specific to V. vulnificus and V. parahaemolyticus
eliminate all pathogens of public health concern,
described in Chapter 4.
they are not considered cooking or pasteurization
processes. Finished products in which the raw These processes also may have application to
sensory qualities are not maintained are covered pathogens other than Vibrio spp. and to products
in Chapter 16, Pathogenic Bacteria Survival other than raw molluscan shellfish, but such
Through Cooking and Pasteurization. applications are not presently in commercial use
in the U.S. fish and fishery products industry.
Examples of processes designed to retain raw
product characteristics include: Control of pathogenic bacteria growth and toxin
High hydrostatic pressure processing (HPP); formation during storage of these products may be
important to their safety because:
Individual quick freezing (IQF) with extended
frozen storage; Pathogens that are more resistant than the
target pathogen(s) may survive the process;
CHAPTER 17: Pathogenic Bacteria Survival Through Processes Designed to Retain Raw Product Characteristics
331
These processes may reduce the number Mild heat processing
of spoilage bacteria in the food, reducing Mild heat processing involves submerging the
competition for any surviving pathogenic product first in a hot water bath for a prescribed
bacteria. time period followed by dipping it in an ice
Strategies for controlling pathogenic bacteria water bath. This process results in a reduction
growth and toxin formation are included in in the number of heat-sensitive pathogens. Some
Chapter 12 (for pathogens other than Clostridium pathogens are more sensitive to heat than are
botulinum (C. botulinum)) and Chapter 13 (for others. V. parahaemolyticus and V. vulnificus are
C. botulinum). especially sensitive.
High Hydrostatic Pressure Processing (HPP) Irradiation

HPP is the application of hydrostatic compression Ionizing radiation (i.e., irradiation) is used to
in the range of 14,500 to 145,000 pound per eliminate or reduce the numbers of bacterial
square inch (100 to 1,000 megapascal (MPa)). pathogens, parasites, and insects in food. It
These pressures are capable of inactivating can also be used to delay physiological
pressure-sensitive pathogens, especially processes (e.g., ripening) in fruit and vegetables.
vegetative forms. Some pathogens are more Acceptable sources of ionizing radiation in
sensitive to pressure than are others. For the United States include: gamma rays from
example, V. parahaemolyticus and V. vulnificus sealed units of the radionuclides cobalt-60 and
are particularly sensitive. However, HPP appears cesium-137; electrons generated by machine
to have limited effect against bacterial spores sources (at energies not exceeding 10 million
like C. botulinum unless combined with other electron volts); and, x-rays generated by machine
treatments, such as heat and acidity (pH). sources (at energies not exceeding 5 or 7.5
million electron volts, depending on the target
The effectiveness of the process is dependent
material as set forth in 21 CFR 179.26 (a)).
upon the amount of pressure applied, the
process temperature, and the duration of the FDA has approved the use of ionizing radiation
process. However other organoleptic changes, for the control of V. parahaemolyticus and V.
such as texture, viscous liquor and a plumper vulnificus and other foodborne pathogens in
appearance have been reported. Additionally, fresh or frozen molluscan shellfish. Mandatory
the pressure facilitates oyster adductor muscle irradiation controls are described in the
changes; hence, HPP may result in a shucked Irradiation in the Production, Processing and
oyster. Handling of Food regulation (21 CFR 179).
Irradiation of fresh and frozen molluscan
Individual quick freezing (IQF) with shellfish may not exceed an absorbed dose of 5.5
extended frozen storage kilograys (kGy) (21 CFR 179.26(b)).
IQF involves the use of cryogenic or blast
Some pathogens are more sensitive to ionizing
freezing technology to rapidly lower the product
radiation than are others. V. parahaemolyticus
temperature below freezing. This process results
and V. vulnificus are highly sensitive, whereas
in a reduction in the number of freeze-sensitive
Salmonella spp. and Listeria monocytogenes (L.
pathogens. Some pathogens are more sensitive
monocytogenes) are more resistant. Bacterial
to freezing than are others. For example, V.
spores (e.g., C. botulinum) are more resistant to
parahaemolyticus and V. vulnificus are especially
ionizing radiation than are bacterial vegetative
sensitive. To reduce V. parahaemolyticus and/
cells (e.g., L. monocytogenes).
or V. vulnificus to non-detectable levels, the IQF
process is followed by a period of frozen storage, The effectiveness of the process is determined
which may vary depending on organism. by the amount of the ionizing radiation absorbed
332
by the food. The amount of ionizing radiation If added safety labeling is to be used on the
absorbed depends on factors associated with product or if the process is used as a substitute for
the irradiator itself, for example, activity (energy the time from exposure to air (e.g., by harvest or
output) of the source (e.g., x-ray intensity and receding tide) to refrigeration recommendations
electron or photon energy spectrum), source specific to V. vulnificus and V. parahaemolyticus
geometry (configuration or relationship between described in Chapter 4, the ability of a process to
the product and the source), source-to-product reliably achieve the appropriate reduction of the
distance, process path through the irradiator, target pathogen should be validated by a scientific
and beam characteristics. The amount of study approved by the shellfish control authority
absorption also depends on factors associated with concurrence from FDA. A scientific study is
with the specific process, for example, length of conducted to initially validate the efficacy of the
time irradiated, conveyor speed, environmental process and to revalidate it when there has been a
temperature, product temperature, product change in the process. Additional guidance on the
composition and density, packaging size, shape conduct of a validation study can be found in the
and composition, and configuration of the load National Shellfish Sanitation Program Guide for
of product in the irradiator. It is important the Control of Molluscan Shellfish 2007 Revision.
that every part of the product receive the
Strategies for control of pathogens
prescribed absorbed dose within a specified
range. Dosimetry mapping is used to document There are a number of strategies for the control
the distribution of absorbed dose throughout of pathogens in fish and fishery products. They
a process load for a particular set of irradiator include:
parameters. All factors listed above should be Killing pathogenic bacteria by processes
considered in the establishment of the process that retain the raw product characteristics
and its verification. The parameters that could (covered in this chapter);
affect the absorbed dose should be monitored. Killing pathogenic bacteria by cooking
A suitable dosimetry system should be used to or pasteurizing (covered in Chapter 16)
verify the range of absorbed dose delivered to or by retorting (covered by the Thermally
each lot of product. Processed Low-Acid Foods Packaged in
Hermetically Sealed Containers regulation, 21
Control of processes intended to retain raw
CFR 113, called the Low-Acid Canned Foods
product characteristics
Regulation in this guidance document);
Controlling pathogenic bacteria survival through
Managing the amount of time that food is
processes intended to retain raw product
characteristics is accomplished by:
for pathogenic bacteria growth and toxin
Scientifically establishing and validating a production (covered generally in Chapter
process that will reduce the target pathogen(s) 12; for C. botulinum, in Chapter 13; and for
to an acceptable level (the scientific study may Staphylococcus aureus in hydrated batter
be conducted by the processor or obtained mixes, in Chapter 15);
from scientific literature); Controlling the amount of moisture that is
Designing and operating the processing available for pathogenic bacteria growth
equipment so that every unit of the product (water activity) in the product by drying
receives at least the established minimum (covered in Chapter 14);
process; Controlling the amount of moisture that is
Continuously monitoring the critical process available for pathogenic bacteria growth
parameters to verify achievement of a (water activity) in the product by formulation
scientifically established process. (covered in Chapter 13);
333
Controlling the amount of salt or The shellfish control authority
preservatives, such as sodium nitrite, in the has conducted a risk evaluation
product (covered in Chapter 13); and determined that the risk of V.
Controlling the level of pH in the product parahaemolyticus illness from the
(covered by the Acidified Foods regulation, consumption of oysters harvested
21 CFR 114 for shelf-stable acidified products, from that growing area is reasonably
and by Chapter 13 for refrigerated acidified likely to occur. Specific guidance
products); for determining risk can be found
in the National Shellfish Sanitation
Controlling the source of molluscan shellfish
Program Guide for the Control of
and time from exposure to air (e.g., by
Molluscan Shellfish 2007 Revision;
harvest or receding tide) to refrigeration in
order to control pathogens from the harvest The shellfish control authority has
area (covered in Chapter 4); determined that harvesting occurs in the
Controlling the introduction of pathogenic growing area at a time when average
bacteria after the pasteurization process monthly daytime water temperatures
(covered in Chapter 18). exceed 60F for waters bordering the
Pacific Ocean and 81F for waters
DETERMINE WHETHER THE POTENTIAL bordering the Gulf of Mexico and
HAZARD IS SIGNIFICANT. the Atlantic Ocean (New Jersey and
south), except where a more rigorous
The following guidance will assist you in risk evaluation has led the shellfish
determining whether pathogenic bacteria survival control authority to conclude that the
through processes designed to retain raw risk of V. parahaemolyticus illness
product characteristics is a significant hazard at a from the consumption of oysters
processing step: harvested from that growing area
is not reasonably likely to occur;
1. Is it reasonably likely that unsafe levels of
The waters of the state have been
pathogenic bacteria will be introduced at this
confirmed as the original source
processing step (do unsafe levels of pathogenic
of oysters associated with two
bacteria come in with the raw material or will the
or more V. parahaemolyticus
process introduce unsafe levels of pathogens)?
illnesses in the past 3 years.
Under ordinary circumstances, it would be
2. Can unsafe levels of pathogenic bacteria that
reasonably likely that an unsafe level of
were introduced at an earlier processing step be
V. vulnificus could enter the process from
eliminated or reduced to an acceptable level at
oysters harvested from states that have been
this processing step?
confirmed as the original source of oysters
associated with two or more V. vulnificus Pathogenic bacteria survival through processes
illnesses (e.g., states bordering the Gulf of designed to retain raw product characteristics
Mexico). should also be considered a significant hazard
Under ordinary circumstances, it would be at any processing step where a preventive
reasonably likely that an unsafe level of V. measure is, or can be, used to eliminate
parahaemolyticus could enter the process the hazard (or reduce the likelihood of its
from oysters harvested from an area that occurrence to an acceptable level) if it is
meets any one of the following conditions: reasonably likely to occur. The preventive
measure that can be applied for pathogenic
334
bacteria survival through processes designed This control approach includes two
to retain raw product characteristics is proper control strategies referred to in this chapter
design and control of the process. as Control Strategy Example 1 - High
Hydrostatic Pressure Processing, or
Intended use Control Strategy Example 2 - IQF With
The controls for V. vulnificus and V. Extended Frozen Storage. For guidance
parahaemolyticus that are discussed in this on controls for mild heat processing, see
chapter are only intended to be applied to Control Strategy Example 1 - Cooking and
oysters if they are intended for raw consumption. Pasteurization, in Chapter 16; however,
You should assume that most oysters will be guidance on process validation for mild
consumed raw. However, controls need not heat processing is more appropriately
be applied to oyster shellstock if tags on the obtained from Control Strategy Example 1
containers of shellstock indicate that they must - High Hydrostatic Pressure Processing, in
be shucked before consumption. this chapter. No specific guidance is given
on control of irradiation.
b. If the product will not be subjected to a
process in your facility that is designed
to retain raw product characteristics
and is sufficient to reduce V. vulnificus
critical control point (CCP) for pathogenic
or V. parahaemolyticus to acceptable
bacteria survival through processes designed to
levels, you should identify the receiving
retain raw product characteristics:
step as the CCP for V. vulnificus and/
1. If the finished product is raw oyster shellstock or V. parahaemolyticus, as appropriate.
intended for raw consumption, will it be subjected Guidance for development of this control
to a process in your facility that is designed to strategy is provided in Chapter 4.
retain raw product characteristics (e.g., mild
heat processed, IQF with extended frozen DEVELOP A CONTROL STRATEGY.
storage, high hydrostatic pressure processed, or
irradiated) and is sufficient to reduce V. vulnificus The following guidance provides two control
or V. parahaemolyticus to acceptable levels (i.e., strategies for pathogenic bacteria survival
reduced to a non-detectable level, less than 30 through processes designed to retain raw product
MPN/gram)? characteristics. You may select a control strategy
that is different from those which are suggested,
a. If the finished product will be subjected
provided it complies with the requirements of the
to a process designed to retain raw
product characteristics, you should
identify that processing step as the CCP The following are examples of control strategies
for the target pathogen. In this case, you included in this chapter:
would not need to identify the receiving
step as a CCP for the control of the target MAY APPLY TO MAY APPLY TO
pathogen. However, you may need to CONTROL STRATEGY PRIMARY SECONDARY
identify the receiving step as a CCP for PROCESSOR PROCESSOR
control of other non-target pathogens High hydrostatic pressure

processing

(e.g., Salmonella spp. and norovirus), as
described in Chapter 4. IQF with extended frozen
storage
335
CONTROL STRATEGY EXAMPLE 1 - HIGH How Often Will Monitoring Be Done (Frequency)?
HYDROSTATIC PRESSURE PROCESSING For time and pressure:
Set Critical Limits. Continuous monitoring, with a visual
The minimum or maximum values for the
per batch;
critical factors established by conducting a
scientific study to validate the process (e.g., AND
minimum pressure, minimum hold time at For initial temperature of the product:
pressure, and minimum initial temperature of
the product). Each batch;
AND
Establish Monitoring Procedures. For other critical factors:
What Will Be Monitored? With sufficient frequency to achieve

control.
Pressure;
AND
For continuous-recording devices:
Hold time at pressure;
AND Monitoring is performed by the device
Initial temperature of the product; generated by the device, to ensure that
AND the critical limits have consistently been
Other critical factors that affect the
effectiveness of the process, as specified by
of the controls;
the study (e.g., pressurization time (step-up
time), decompression time (step-down time), AND
and treatment temperature). For other checks:
How Will Monitoring Be Done? Any person who has an understanding of
For time and pressure:
Use a continuous pressure-recording Establish Corrective Action Procedures.
device (e.g., a pressure recorder);

AND
For initial temperature of the product: Reprocess the product;
OR
a thermometer);
Chill and hold the product for an evaluation

AND
of the adequacy of the high hydrostatic
For other critical limits: pressure process. If the product has not
Use equipment appropriate to the critical received an adequate high hydrostatic
limit. pressure process, the product should be
destroyed, diverted to a non-food use, or
reprocessed;
OR
336
critical limit is not applicable (e.g., divert the NSSP as less than 30 MPN/gram. If
improperly processed product to a canning added safety labeling is to be used
operation); on the product or if the process is
used as a substitute for the time from
OR
exposure to air (e.g., by harvest or
Destroy the product; receding tide) to refrigeration limitations
OR described in Chapter 4, the ability
Divert the product to a non-food use or a of a post-harvest process to reliably
use without the added safety labeling. achieve the appropriate reduction of
the target pathogen should be validated
AND by a study approved by the shellfish
Take the following corrective action to regain control control authority with concurrence
over the operation after a critical limit deviation: from FDA. A study is used to initially
Adjust or repair the processing equipment; validate the efficacy of the process and
to revalidate it when there has been
AND/OR a change in the process. Additional
Extend the high hydrostatic pressure process guidance on conducting a validation
to compensate for a pressure drop, using a study can be found in the National
process established by a scientific study. Shellfish Sanitation Program Guide for
the Control of Molluscan Shellfish 2007
Establish a Recordkeeping System. Revision (http://www.fda.gov/Food/
Record of continuous pressure monitoring; FoodSafety/Product-SpecificInformation/
Seafood/FederalStatePrograms/
AND NationalShellfishSanitationProgram/
Record of visual checks of recorded data; ucm046353.htm).
AND Expert knowledge of high hydrostatic
Record of visual observations of initial pressure process calculations may be
temperature of product; required to validate a high hydrostatic
pressure process. Such knowledge can
AND
be obtained by education or experience,
Records that are appropriate for other critical or both. Validating high hydrostatic
limit monitoring. pressure processes may require access
to suitable facilities and the application
Establish Verification Procedures. of recognized methods. The equipment
Process validation study: should be designed, operated, and
maintained to deliver the established
The adequacy of the high hydrostatic
process to every unit of the product.
pressure treatment should be validated
by conducting a scientific study. It In some instances, inoculated pack
should be designed to ensure an studies may be necessary to validate the
appropriate reduction in the number minimum process. In other instances,
of the target pathogen(s). In the case existing literature or federal, state, or
of V. vulnificus or V. parahaemolyticus, local regulations that establish minimum
it should be designed to reduce the processes or adequacy of equipment
presence of these pathogens to non- may be available. Characteristics of
detectable levels. Non-detectable for the process, product, and/or equipment
these pathogens is defined under the that affect the adequacy of the
337
established minimum high hydrostatic attached wires for damage or kinks. The
pressure process should be taken into device should be checked to ensure that it is
consideration in the validation of the operational;
process. A record of process validation
AND
studies should be maintained;
Calibrate the temperature-indicating
AND device against a known accurate reference
Before a temperature-indicating device (e.g., device (e.g., NIST-traceable thermometer)
a thermometer) is put into service, check at least once a year or more frequently if
the accuracy of the device to verify that the recommended by the device manufacturer.
factory calibration has not been affected. Optimal calibration frequency is dependent
This check can be accomplished by: upon the type, condition, past performance,
or near refrigeration temperature; the actual value (drift) found during checks
OR frequent calibration or the need to replace
Immersing the sensor in boiling water the device (perhaps with a more durable
(212F (100C)) if the device will be device). Calibration should be performed at
used at or near the boiling point (note a minimum of two temperatures that bracket
that the temperature should be adjusted the temperature range at which it is used;
to compensate for altitude, when
AND
necessary);
Check and calibrate other monitoring
OR instruments as necessary to ensure their
Doing a combination of the above if accuracy;
AND
temperature;
OR and verification records within 1 week of
Comparing the temperature indicated preparation to ensure they are complete and
by the device with the reading on a any critical limit deviations that occurred
known accurate reference device (e.g., were appropriately addressed.
a thermometer traceable to National
Institute of Standards and Technology
(NIST) standards) under conditions that
are similar to how it will be used (e.g.,
product internal temperature) within the
temperature range at which it will be
used;
AND
indicating device daily before the beginning
of operations. In addition to checking that
338
TABLE 17-1
CONTROL STRATEGY EXAMPLE 1 - HIGH HYDROSTATIC PRESSURE PROCESSING

This table is an example of a portion of a Hazard Analysis Critical Control Point (HACCP) plan using Control Strategy Example 1 - High Hydrostatic Pressure Processing.
This example illustrates how a raw oyster processor using a high hydrostatic pressure processor can control pathogen survival through processes designed to retain raw
product characteristics. It is provided for illustrative purposes only.
Pathogen survival through processes designed to retain raw product characteristics may be only one of several significant hazards for this product. Refer to Tables 3-3 and
3-4 (Chapter 3) for other potential hazards (e.g., pathogens from the harvest area, environmental chemical contaminants, natural toxins, pathogenic bacteria growth and
toxin formation during processing, food and color additives, and metal fragments).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
MONITORING
CRITICAL LIMITS
CRITICAL SIG
FOR EACH CORRECTIVE
CONTROL NIFICANT RECORDS VERIFICATION
PREVENTIVE WHAT HOW FREQUENCY WHO ACTION(S)
POINT HAZARD(S)
MEASURE*
High V. vulnificus Minimum hold Hold time at Pressure- Continuous, Pressure Chill and hold Pressure Process validation
hydrostatic survival time: 250 seconds pressure recording with visual equipment for evaluation recording
339
pressure device check of the operator device Check the dial thermometer
processing recorded data Adjust or repair printout for accuracy and damage
once per batch equipment as and to ensure that it is
needed operational before putting
Minimum pressure: Pressure Pressure- Continuous, Pressure Pressure- into operation; check it
350 MPa during the recording with visual equipment recording daily, at the beginning of
holding device check of the operator device operations; and calibrate it
period recorded data printout once per year
once per batch
Review monitoring,
corrective action, and
Minimum initial Initial Dial Each batch Pressure Initial
verification records within
temperature of temperature thermometer equipment temperature
1 week of preparation
product: 60F of product operator log
CONTROL STRATEGY EXAMPLE 2 - IQF WITH How Often Will Monitoring Be Done (Frequency)?
EXTENDED FROZEN STORAGE For the IQF freezer:
Set Critical Limits. With sufficient frequency to achieve
control;
There are minimum or maximum values for

the critical factors established by conducting AND
a scientific study to validate the process For frozen storage temperature:

(e.g., amount of time to reach frozen state,
maximum frozen storage temperature and Continuous monitoring, with a visual
minimum time)
per lot;

For length of frozen storage:
IQF freezer and product parameters Each lot, at the beginning and end of a
batch.
critical to ensure that the product internal
temperature is achieved within the time Who Will Do the Monitoring?
established by the scientific study. These For temperature-recording devices:
variables may include, but are not limited
to: initial product temperature, tunnel air Monitoring is performed by the device
temperature, time in tunnel, air velocity, belt
speed, product moisture, product size, and
loading pattern;
AND who has an understanding of the nature
Frozen storage temperature; of the controls;
AND AND
Length of frozen storage. For other monitoring:
How Will Monitoring Be Done? Any person who has an understanding of

For the IQF freezer:
Use equipment appropriate to the critical Establish Corrective Action Procedures.
limit (e.g., initial temperature with a
temperature-indicating device (e.g., a
thermometer));
Refreeze the product;
AND
OR
For frozen storage temperature:
Hold the product for an evaluation of the
adequacy of the freezing process. If the
product has not received an adequate
AND process, it should be destroyed, diverted to
For length of frozen storage: a non-food use or other appropriate use, or
refrozen;
Use a clock.
OR
340
Divert the product to a use in which the Establish Verification Procedures.
critical limit is not applicable (e.g., divert an Process validation study:
improperly frozen product to a cooking or
canning operation); The adequacy of the IQF with extended
frozen storage process should be validated
OR by conducting a scientific study. It should
Destroy the product; be designed to ensure an appropriate
reduction in the number of the target
OR
pathogen(s). In the case of V. vulnificus
Divert the product to a non-food use or a or V. parahaemolyticus, it should be
use without the added safety labeling. designed to reduce the presence of
AND these pathogens to non-detectable levels.
Non-detectable for these pathogens is
defined under the NSSP as less than 30
MPN/gram. If added safety labeling
Make repairs or adjustments to the IQF is to be used on the product or if the
freezing equipment; process is used as a substitute for the time
OR from harvest to refrigeration limitations
described in Chapter 4, the ability of a
Make repairs or adjustments to the frozen
post-harvest process to reliably achieve
storage freezer;
the appropriate reduction of the target
OR pathogen should be validated by a study
Move some or all of the product in the approved by the shellfish control authority
frozen storage freezer to a properly with concurrence from FDA. A study is
functioning freezer. performed to initially validate the efficacy
of the process and to revalidate it when
AND/OR
there has been a change in the process.
Extend the freezing cycle or frozen storage Process verification may also be required
time period to compensate for a rise in at predetermined intervals. Additional
temperature, using a process developed by a guidance on conducting a validation study
process authority; can be found in the National Shellfish
Sanitation Program Guide for the Control
Establish a Recordkeeping System. of Molluscan Shellfish 2007 Revision.
For the IQF freezer:
Validating an IQF with extended frozen
Records that are appropriate to the storage process may require access to
monitoring;
suitable facilities and the application of
AND
recognized methods. The equipment
should be designed, operated, and
For frozen storage temperature:
maintained to deliver the established
Record of continuous temperature process to every unit of the product.
monitoring;
In some instances, inoculated pack
AND
studies may be necessary to establish the
For length of frozen storage: minimum process. In other instances,
existing literature or federal, state, or
Freezing log with notation of the start
local regulations that establish minimum
and end of frozen storage periods.
processes or adequacy of equipment
341
may be available. Characteristics of the device is accurate by one of the methods
process, product, and/or equipment that described above, this process should include
affect the adequacy of the established a visual examination of the sensor and any
minimum IQF with extended frozen attached wires for damage or kinks. The
storage process should be taken into device should be checked to ensure that it
consideration in the validation of is operational and has, where applicable,
the process. A record of the process sufficient ink and paper;
validation studies should be maintained;
AND
AND Calibrate the temperature-indicating device
Before a temperature-indicating device (e.g., or temperature-recording device against a
a thermometer) or temperature-recording known accurate reference device (e.g., a
device (e.g., a recording thermometer) is NIST-traceable thermometer) at least once a
put into service, check the accuracy of the year or more frequently if recommended by
device to verify that the factory calibration the device manufacturer. Optimal calibration
has not been affected. This check can be frequency is dependent upon the type,
accomplished by: condition, past performance, and conditions
or near refrigeration temperature; found during checks and/or calibration may
OR or the need to replace the device (perhaps
Immersing the sensor in boiling water with a more durable device). Devices
(212F (100C)) if the device will be used used to determine the core temperature of
at or near the boiling point (note that frozen fish or fishery products may require
the temperature should be adjusted to more frequent calibration. Calibration
compensate for altitude, when necessary); should be performed at a minimum of two
OR temperatures that bracket the temperature
range at which it is used;
the device will be used at or near room AND
OR and verification records within 1 week of
Comparing the temperature indicated by
(e.g., air temperature, product internal
temperature) within the temperature
AND
operations. In addition to checking that the
342
TABLE 17-2
CONTROL STRATEGY EXAMPLE 2 - IQF WITH EXTENDED STORAGE

This table is an example of a portion of a Hazard Analysis Critical Control Point (HACCP) plan using Control Strategy Example 2 - IQF With Extended Storage. This
example illustrates how a raw oyster processor using a continuous cryogenic freezer can control pathogen survival through processes designed to retain raw product
characteristics. It is provided for illustrative purposes only.
Pathogen survival through processes designed to retain raw product characteristics may be only one of several significant hazards for this product. Refer to Tables 3-3 and
3-4 (Chapter 3) for other potential hazards (e.g., pathogens from the harvest area, environmental chemical contaminants and pesticides, natural toxins, pathogenic bacteria
growth and toxin formation during processing, food and color additives, and metal fragments)
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
MONITORING
CRITICAL LIMITS
CRITICAL
POINT
MEASURE*
IQF V. vulnificus The minimum or Critical factors Use With IQF Segregate and hold IQF record Process validation
freezer survival maximum values for that affect the equipment sufficient equipment the product for
343
the critical factors effectiveness appropriate frequency to operator evaluation Check the data logger
established by a of the to the critical achieve control* Adjust or repair for accuracy and
scientific validation process, as limit* equipment as needed damage and to ensure
study* specified by that it
the study* is operational before
putting into operation;
The minimum length Length of Clock Beginning and Frozen storage Frozen
check it daily, at the
of frozen storage frozen end of each lot operator storage
beginning of
established by a storage record
operations; and
scientific validation
calibrate it once per
study*
year
The Temperature Digital time/ Continuous, Frozen storage Data Review

maximum temperature of temperature with visual operator logger monitoring,
of frozen storage frozen data logger check of printout corrective action, and
established by a storage recorded data verification records
scientific validation once per lot within 1 week of
study* preparation
* Note: This plan is for illustrative purposes only. An actual plan should specify the actual critical limits for the IQF freezer, actual minimum frozen storage temperature, and actual minimum length
of frozen storage. Additionally, an actual plan should specify the actual critical factors that will be monitored, the way in which they will be monitored, and the frequency of monitoring.
BIBLIOGRAPHY. U.S. Food and Drug Administration.
Irradiation in the production, processing
We have placed the following references on and handling of food. In Code of Federal
display in the Division of Dockets Management, Regulations, 21 CFR 179. U.S. Government
Food and Drug Administration, 5630 Fishers Lane, Printing Office, Washington, DC.
rm. 1061, Rockville, MD 20852. You may see U.S. Food and Drug Administration. Ionizing
them at that location between 9 a.m. and 4 p.m., radiation for the treatment of food. In Code
Monday through Friday. As of March 29, 2011, of Federal Regulations, 21 CFR 179.26. U.S.
FDA had verified the Web site address for the Government Printing Office, Washington, DC.
references it makes available as hyperlinks from U.S. Food and Drug Administration. 2007.
the Internet copy of this guidance, but FDA is not National Shellfish Sanitation Program,
responsible for any subsequent changes to Non- Guide for the Control of Molluscan Shellfish
FDA Web site references after March 29, 2011. 2007 Revision. Department of Health and
Food Standards Program Codex Alimentarius Human Services, Public Health Service,
Commission. 2003. Codex general standard for Food and Drug Administration, Center
irradiated foods (CODEX STAN 106-1983, rev. for Food Safety and Applied Nutrition,
1-2003). Food and Agriculture Organization and College Park, MD. http://www.fda.gov/Food/
World Health Organization, Rome, Italy. FoodSafety/Product-SpecificInformation/
Food Standards Program Codex Alimentarius
NationalShellfishSanitationProgram/
Commission. 2003. Recommended
ucm046353.htm.
international code of practice for radiation
processing of food (CAC/RCP 19-1979, rev.
2-2003). Food and Agriculture Organization
and World Health Organization, Rome, Italy.
Harewood, R. S. Rippey, and M. Montesalvo.
1994. Effect of gamma irradiation on shelf
life and bacterial and viral loads in hard-
shelled clams (Mercenaria mercenaria).
Appl. Environ. Microbiol. 60: 2666-2670.
Subcommittee E10.01 on Radiation
Processing: Dosimetry and Applications.
2003. Standard guide for irradiation of
finfish and aquatic invertebrates used as
food to control pathogens and spoilage
microorganisms. ASTM International, West
Conshohocken, PA.
Subcommittee E10.01 on Radiation
Processing: Dosimetry and Applications.
2004. Standards on dosimetry for radiation
processing. ASTM International, West
Conshohocken, PA.
344
CHAPTER 18: Introduction of Pathogenic Bacteria After Pasteurization and
Specialized Cooking Processes
UNDERSTAND THE POTENTIAL HAZARD. competition. Rapid growth of pathogenic bacteria

that may be introduced after pasteurization is,
The introduction of pathogenic bacteria after therefore, a concern. This chapter covers control
pasteurization and certain specialized cooking of recontamination after pasteurization.
processes can cause consumer illness. The For some products that are marketed refrigerated,
primary pathogens of concern are Clostridium cooking is performed immediately before reduced
botulinum (C. botulinum), Listeria monocytogenes, oxygen packaging (e.g., vacuum packaging,
Campylobacter jejuni, pathogenic strains of modified atmosphere packaging). For these
Escherichia coli, Salmonella spp., Shigella spp., products, the cooking process is targeted to
Yersinia enterocolitica, Staphylococcus aureus (S. eliminate the spores of C. botulinum type E
aureus), Vibrio cholerae, Vibrio vulnificus, and and non-proteolytic types B and F, particularly
Vibrio parahaemolyticus. See Appendix 7 for a when the product does not contain other
description of the public health impacts of barriers that are sufficient to prevent growth and
these pathogens. toxin formation by this pathogen (e.g., many
refrigerated, vacuum packaged hot-filled soups,
Goal of pasteurization and specialized
chowders, and sauces).
cooking processes
Pasteurization is a heat treatment applied to These specialized cooking processes, which are
eliminate the most resistant pathogenic bacteria discussed in Chapter 16, have much in common
of public health concern that is reasonably likely with pasteurization processes, which are also
to be present in the food. With fishery products, discussed in Chapter 16. For example, control
pasteurization is usually performed after the product of recontamination after the product is placed in
is placed in the hermetically sealed finished product the finished product container is critical to the
container. It is applied to fishery products that are safety of these products. Additionally, because
distributed either refrigerated or frozen. Examples these products are cooked before they are
of pasteurized fishery products follow: pasteurized packaged, they are at risk for recontamination
crabmeat, pasteurized surimi-based analog products, between cooking and packaging. The risk of this
and pasteurized lobster meat. recontamination may be minimized by filling
directly from the cook kettle using a sanitary,
In addition to eliminating pathogenic bacteria, automated, continuous-filling system (designed to
the pasteurization process also greatly reduces minimize the risk of recontamination) while the
the number of spoilage bacteria present in the product is still hot (i.e., hot filling). This control
fishery product. Spoilage bacteria normally strategy may not be suitable for products such as
restrict the growth of pathogenic bacteria through crabmeat, lobster meat, or crayfish meat that are
CHAPTER 18: Introduction of Pathogenic Bacteria After Pasteurization and Specialized Cooking Processes
345
handled between cooking and filling. Hot filling provide limited lethality for any non-proteolytic
is covered in this chapter. C. botulinum spores present on the packaging
material.
Control of pathogenic bacteria introduction
after pasteurization and after specialized It may also be prudent to use packaging that has
cooking processes been manufactured or treated to inactivate spores
of C. botulinum type E and non-proteolytic
There are three primary causes of
types B and F (e.g., gamma irradiation and hot
recontamination after pasteurization and after
extrusion). FDA is also interested in comment on
cooking that is performed immediately before
the utility of such measures.
reduced oxygen packaging:
Defective container closures; Strategies for controlling pathogenic
Contaminated container cooling water; bacteria growth
Recontamination between cooking and There are a number of strategies for the control
reduced oxygen packaging. of pathogenic bacteria in fish and fishery
products. They include:
Poorly formed or defective container closures
can increase the risk of pathogens entering the
bacteria after the pasteurization process
container through container handling that occurs
and after the cooking process performed
after pasteurization or after the cooked product is
immediately before reduced oxygen
filled into the reduced oxygen package. This risk
packaging (covered in this chapter);
is a particular concern during container cooling
performed in a water bath. Contaminated Controlling the amount of moisture that is
cooling water can enter through the container available for pathogenic bacteria growth
closure, especially when the closure is defective. (water activity) in the product by drying
Container closure can be controlled by adherence (covered in Chapter 14);
to seal guidelines that are provided by the Controlling the amount of moisture that is
container or sealing machine manufacturer. available for pathogenic bacteria growth
Control is accomplished through periodic seal (water activity) in the product by formulation
inspection. (covered in Chapter 13);
Contamination of cooling water can be controlled Controlling the amount of salt or
either by ensuring that a measurable residual preservatives, such as sodium nitrite, in the
of chlorine, or other approved water treatment product (covered in Chapter 13);
chemical, is present in the cooling water or by Controlling the level of acidity (pH) in the
ensuring that ultraviolet (UV) treatment systems product (covered by the Acidified Foods
for the cooling water are operating properly, regulation, 21 CFR 114, for shelf-stable
particularly for systems in which the water is acidified products, and by Chapter 13 for
reused or recirculated. refrigerated acidified products);
Recontamination between cooking and reduced Controlling the source of molluscan shellfish
oxygen packaging in continuous filling systems, and the time from exposure to air (e.g., by
where the product is packaged directly from harvest or receding tide) to refrigeration
the kettle, can be controlled by hot filling at to control pathogens from the harvest area
temperatures at or above 185F (85C). FDA (covered in Chapter 4);
is interested in information on the value of Killing pathogenic bacteria by cooking
adding a time component (e.g., 3 minutes) to or pasteurization (covered in Chapter 16)
this hot filling temperature recommendation to or by retorting (covered by the Thermally
346
Processed Low-Acid Foods Packaged in pathogenic bacteria after pasteurization can
Hermetically Sealed Containers regulation, 21 include:
CFR 113, called the Low Acid Canned Foods
Controlling container sealing;
regulation in this guidance document);
Killing pathogens by processes that retain Controlling the residual of chlorine,
the raw product characteristics (covered in or other approved water treatment
Chapter 17); chemical, in container cooling water;
Managing the amount of time that food is Controlling UV light intensity of bulbs
exposed to temperatures that are favorable used for treating container cooling water
for pathogenic bacteria growth and toxin and the flow rate of the cooling water
production (covered generally in Chapter 12; moving through the UV treatment system;
for C. botulinum, in Chapter 13; and for S. Hot filling the product into the final
aureus in hydrated batter mixes, in Chapter 15). container in a continuous filling system.
DETERMINE WHETHER THE POTENTIAL Intended use

HAZARD IS SIGNIFICANT. It is unlikely that the intended use will affect the
significance of this hazard.
determining whether introduction of pathogenic IDENTIFY CRITICAL CONTROL POINTS.
bacteria after pasteurization is a significant
hazard at a processing step: The following guidance will assist you in
1. Is it reasonably likely that pathogenic bacteria
critical control point (CCP) for introduction of
will be introduced at this processing step
pathogenic bacteria after pasteurization.
(consider post-pasteurization and post-cooking
processing steps only)? If you identified the hazard as significant, you
should identify the container sealing step, the
It is reasonable to assume that in the absence
water bath container cooling step, and the hot
of controls, pathogens of various types may
filling step (where applicable) as the CCPs for this
enter the finished product container after
hazard.
pasteurization or after filling the cooked
product into the reduced oxygen package. Example:
This is a particular concern for products that A crabmeat processor that pasteurizes the
are cooled in a water bath. finished product cans after filling and cools
them in a water bath should set the CCPs for
2. Can the introduction of pathogenic bacteria after introduction of pathogenic bacteria after
pasteurization be eliminated or reduced to an pasteurization at the can seaming and water
acceptable level here? bath can cooling steps.
Introduction of pathogenic bacteria after This control approach is a control strategy
pasteurization should also be considered referred to in this chapter as Control Strategy
a significant hazard at any processing step Example - Control of Recontamination.
where a preventive measure is, or can be,
used to eliminate the hazard (or reduce the
likelihood of its occurrence to an acceptable
level) if it is reasonably likely to occur.
Preventive measures for introduction of
347
DEVELOP A CONTROL STRATEGY. For container cooling:
For chemical treatment:
The following guidance provides a strategy to
control the introduction of pathogenic bacteria
Residual chlorine, or other approved
water treatment chemical, in the cooling
into the product after pasteurization. You may water;
select a control strategy that is different from that
OR
which is suggested, provided it complies with the
requirements of the applicable food safety laws For UV treatment:
and regulations. Intensity of UV light;
The following is an example of a control strategy AND

Cooling water flow rate.
For hot filling:

CONTROL STRATEGY PRIMARY SECONDARY Product temperature as the product enters
PROCESSOR PROCESSOR
the final container.
Control of recontamination
CONTROL STRATEGY EXAMPLE - CONTROL OF For container sealing:
RECONTAMINATION
Visual examination of containers (non
Set Critical Limits. destructive):
Recommendations for visual examinations
For container sealing:
that ensure a reliable hermetic seal should
Container or sealing machine manufacturers be obtained from the container or sealing
seal guidelines. machine manufacturer. They should include:
For container cooling:
For double-seamed metal and plastic
Measurable residual of chlorine, or other cans:
approved water treatment chemical, at the The external features of the double
discharge point of the container cooling seam should be examined for
tank; gross closure defects, including:
OR cutovers, seam sharpness, false
Equipment manufacturers UV light intensity seams, deadheading, droop, damage
and flow rate guidelines. to the countersink wall indicating
a broken chuck, cable cuts, and
For hot filling: product overlapping the flange.
Product temperature of 185F (85C) or In addition, visual examination
higher as the product enters the final should include examination of
container. the entire container for product
leakage or other obvious defects;
OR
What Will Be Monitored? For pouches:
For container sealing: Visual examination should be

Container integrity. sufficient to detect gross closure
defects, including: cuts, fractures,
348
non-bonding, malformation, testing (tensile strength), residual
puncture, abrasion, blister, gas testing, electroconductivity
contaminated seal, delamination, seal testing, and dye testing;
creep, wrinkle, flex cracks, crushed
OR
package, or other obvious defects;

OR
For glass containers:
The examination should include cold

For glass containers:
water vacuum testing. Additional

Visual examination should be examinations may include: for
sufficient to detect gross closure lug-type caps, security values (lug
and glass defects, including: cap tension) and for lug-type, twist
tilt, cocked cap, crushed lug, caps, pull-up (lug position).
stripped cap, cut through, and
chipped and cracked glass finish;
AND
Measure residual of chlorine, or other
Detailed examination of containers (destructive): approved water treatment chemical,
Recommendations for seal evaluation at the discharge point of the container
measurements that ensure a reliable hermetic cooling tank;
seal should be obtained from the container OR
or sealing machine manufacturer. They
For UV treatment:
should include:
Use a UV light meter;
For double-seamed metal and plastic
AND
cans:
The examination should include a Use a flow rate meter.
teardown examination of the can. For hot filling:

If the micrometer method is used, Use a continuous temperature-measuring
three measurements, approximately instrument (e.g., a recorder thermometer).
120 apart around the double seam,
should be made. Measurements How Often Will Monitoring Be Done (Frequency)?
should include: cover hook, For container sealing:
body hook, width, tightness, and

thickness. If the optical method Visual examination of containers:
(seamscope or projector) is used, At least one container from each sealing

cuts should be made at at least two head at least every 30 minutes of sealing
different locations, excluding the machine operation. At a minimum, visual
side seam juncture. Measurements examinations should include those made
should include body hook, at the beginning of the production day,
overlap, tightness, and thickness; and immediately after a jam in the sealing
machine, or after machine adjustment, repair,
OR
or prolonged shutdown;
For pouches:
AND
The examination should include
burst, vacuum or bubble testing. It
may also include: drop testing, peel
349
Detailed examination of containers: Establish Corrective Action Procedures.
At least one container from each sealing Take the following corrective action to a product
head at least every 4 hours of sealing involved in a critical limit deviation:
machine operation. At a minimum, visual
examinations should include those made For container sealing:
at the beginning of the production day, Repack and recook or repasteurize the
and immediately after a jam in the sealing affected product;
machine, or after machine adjustment, repair,
OR
or prolonged shutdown.
Segregate and hold the product to evaluate
For container cooling: the seriousness of the defects, which may
For chemical treatment: include, but is not limited to, 100% visual
inspection of all affected containers to
At least once every 4 hours of use;
remove the defective containers. Any
OR containers that are found to be unsafe should
For UV treatment: be destroyed, diverted to a non-food use, or
At least daily. repacked and recooked;
For hot filling: OR
Continuous monitoring, with a visual check Divert the product to a use in which the
of the instrument at least once per batch of critical limit is not applicable (e.g., divert to a
cooked product. canning operation);

Monitoring may be performed by any person OR
who is trained and qualified to conduct Divert the product to a non-food use.
container examinations. For hot filling:
For container cooling: Recook the product;
Monitoring may be performed by any person OR
who has an understanding of the nature of
Segregate and hold the product for a safety
the controls.
evaluation. If the product is found to be
For hot filling: unsafe, it should be destroyed, diverted to a
For continuous temperature-measuring non-food use, or recooked;
instruments:
OR
Monitoring is performed by the
equipment itself. The visual check of critical limit is not applicable (e.g., divert to a
the data generated by the equipment, canning operation);
to ensure that the critical limits have
consistently been met, may be performed OR
by any person who has an understanding Destroy the product;
of the nature of the controls.
OR
AND
350
Take one or more of the following corrective actions to For hot filling:
regain control over the operation after a critical limit Record of continuous temperature
deviation: monitoring;
For container sealing: AND
Identify and correct the source of the defect. Record of visual checks of recorded data.
If no measurable residual chlorine, or other
approved water treatment chemical, is For container sealing:
detected, add chlorine or adjust the chlorine- Obtain container seal guidelines from
metering system and recheck for chlorine container or sealing machine manufacturer;
residual;
AND
OR
If UV intensity is inadequate, replace or records within 1 week of preparation
clean the bulbs or shields; to ensure they are complete and any
OR critical limit deviations that occurred were
If flow exceeds the critical limit, adjust or
replace the pump. For container cooling:
For hot filling: Obtain UV light intensity and flow rate
guidelines from the UV light manufacturer;
Adjust the cooking equipment to increase the
processing temperature; AND
OR Review monitoring and corrective action
Adjust the post-cook process to minimize
time delays.
For hot filling:
Record of visual examination of containers;
AND check the accuracy of the device to verify that
Record of detailed examination of containers. the factory calibration has not been affected.
Record of residual chlorine, or other at or near the boiling point (note that
approved water treatment chemical; the temperature should be adjusted to
compensate for altitude, when necessary);
OR
OR
For UV treatment:
Record of UV intensity testing; Comparing the temperature reading
AND known accurate reference device (e.g.,
a thermometer traceable to National
Record of flow rate testing.
351
Institute of Standards and Technology Review monitoring, corrective action,
(NIST) standards) under conditions that and verification records within 1 week of
are similar to how it will be used (e.g., preparation to ensure they are complete and
product internal temperature) within the any critical limit deviations that occurred
temperature range at which it will be were appropriately addressed.
used;
AND
AND
Calibrate the temperature-recording
device against a known accurate reference
device (e.g., NIST-traceable thermometer)
at least once a year or more frequently if
Consistent temperature variations away
from the actual value (drift) found during
checks and/or calibration may show a need
for more frequent calibration or the need
to replace the device (perhaps with a more
durable device). Devices subjected to high
temperatures for extended periods of time
may require more frequent calibration.
AND
352
TABLE 18-1
CONTROL STRATEGY EXAMPLE - CONTROL OF RECONTAMINATION

This table is an example of a portion of a Hazard Analysis Critical Control Point plan using Control Strategy Example - Control of Recontamination. This example illustrates
how a processor of pasteurized blue crabmeat, packed in steel cans, can control introduction of pathogenic bacteria after pasteurization. It is provided for illustrative
purposes only.
Pathogenic bacteria recontamination after pasteurization may be only one of several significant hazards for this product. Refer to Tables 3-3 and 3-4 (Chapter 3) for other
potential hazards (e.g., environmental chemical contaminants and pesticides, pathogenic bacteria growth and toxin formation during processing, pathogenic bacteria
survival through cooking and pasteurization, and metal fragments).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

CRITICAL
POINT
MEASURE*
Container Pathogenic No visible cutovers, seam Container Visual seam One can per Seamer Identify and correct Visual seam Obtain
sealing bacteria sharpness, false seams, integrity examination seaming head operator the source of the examination can seam
introduction deadheading, droop, every 30 defect record guidelines
353
damage to the countersink minutes; at startup; from the can
wall indicating a broken and after jams, Evaluate the manufacturer
chuck, cable cuts, product adjustments, seriousness of the
overlapping the flange, repairs, and defect, and hold for Review
product leakage, or other prolonged further evaluation if monitoring
obvious defects shutdowns necessary and corrective
action records
within 1 week
Cover hook: .070 inch Container Double seam One can per Seamer Identify and correct Double of preparation
minimum; integrity teardown seaming head operator the source of the seam
body hook: .072-.088 inch; examination, every 4 hours; at defect teardown
using a startup; and record
width: .125 inch maximum; micrometer at after jams, Evaluate the
thickness .052-.058 inch; 3 points on adjustments, seriousness of the
tightness 80% the seam, 120 repairs, and defect, and
apart prolonged hold for further
shutdowns evaluation if
necessary
Water Pathogenic Measurable Residual Rapid test Every batch Pasteurizer Add chlorine and Residual
bath bacteria residual chlorine chlorine operator recheck for residual chlorine
container introduction in water record
cooling bath
* Note: The critical limits in this example are for illustrative purposes only and are not related to any recommended process
BIBLIOGRAPHY.

Gavin, A., and L. M. Weddig (ed.). 1995.
Canned foods principles of thermal
process control, acidification, and container
closure evaluation. National Food Processors
Institute, Washington, DC.
354
CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance
Causing Substances and Prohibited Food and Color Additives
UNDERSTAND THE POTENTIAL HAZARD. The FFD&C Act requires that the name of the
food source from which a major food allergen is
derived be the same as the name of the major
Food allergens
food allergen itself for the following five foods:
A number of foods contain allergenic proteins, milk; egg; wheat; peanuts; and soybeans (e.g.,
which are natural constituents of the food that can milk must be listed as milk). The name of the
pose a health risk to certain sensitive individuals. food source that must be listed on the label for
The symptoms of food allergies can include a tree nuts must be the specific type of tree nut
tingling sensation in the mouth, swelling of the (e.g., almonds, pecans, or walnuts). Likewise, the
tongue and throat, difficulty in breathing, hives, name of the food source that must be listed on the
vomiting, abdominal cramps, diarrhea, drop in label for fish or crustacean shellfish must be the
blood pressure, loss of consciousness, and, in specific type of fish (e.g., bass, cod, or flounder) or
severe cases, death. crustacean shellfish (e.g., crab, lobster, or shrimp)
The Food Allergen Labeling and Consumer (21 CFR U.S.C. 343(w)(2)). The market names
Protection Act of 2004 amended the Federal Food, of species of fish and crustacean shellfish should
Drug, and Cosmetic Act (FFD&C Act). The FFD&C be used to identify the food source of these two
Act now requires that all foods that are not raw major food allergens. The market names are
agricultural commodities and that contain a major found in the document Guidance for Industry:
food allergen be labeled to clearly identify the The Seafood List: FDAs Guide to Acceptable
name of the food source from which the allergen is Market Names for Seafood Sold in Interstate
derived (21 CFR U.S.C. 343(w)(1)). The Act defines Commerce revised 2009 ((http://www.fda.gov/
the following eight foods and any ingredients that Food/GuidanceComplianceRegulatoryInformation/
contain protein derived from these eight foods GuidanceDocuments/Seafood/ucm113260.htm).
(with certain exemptions noted in section 201(qq) You may add the term fish to the market name
(2) of the Act) as major food allergens: on the label if you believe that the market name
Milk; may not otherwise be recognized to be fish by the
consumer (e.g., gar fish).
Eggs;
Fish (e.g., bass, cod, or flounder); To meet the requirements of the FFD&C Act, the
Crustacean shellfish (e.g., crab, lobster, or food labels of packaged fish and fishery products
shrimp); that are or contain a major food allergen must
declare the name of the food source for the
Tree nuts (e.g., almonds, pecans, or walnuts);
allergen, either:
Peanuts;
(1) Within the list of ingredients, in parentheses
Wheat; and
immediately after the common or usual
Soybeans.
CHAPTER 19: Undeclared Major Food Allergens and Certain Food Intolerance Causing Substances and Prohibited Food and Color Additives
355
name of the ingredient that is a major food of rework material). Unintentional introduction of
allergen, (e.g., whey (milk)) when its food allergenic proteins should be controlled through
source name: rigorous process controls, either as part of a
prerequisite program or as part of the Hazard
(a) is not already included as part of that Analysis Critical Control Point (HACCP) program
ingredients common or usual name (e.g., the itself. The Fish and Fishery Products regulation,
food source name milk is included in the 21 CFR 123 (called the Seafood HACCP
name of the ingredient non-fat dried milk); Regulation in this guidance document), requires
or such a regime.
(b) does not appear elsewhere in the Food and color additives
ingredient list (e.g., if the food contains both
Certain food and color additives can cause
casein and whey and the label lists whey
hypersensitivity reactions, or food intolerances,
(milk), the term (milk) need not follow the
in some consumers. Although in most cases
term casein); or
there are no known allergic mechanisms,
(2) In a separate Contains statement symptoms may be similar to those caused
immediately after or adjacent to the list by food allergens and can include a tingling
of ingredients in a print size no smaller sensation in the mouth, swelling of the tongue
than that used for the ingredient list (e.g., and throat, difficulty in breathing (e.g. asthma),
Contains shrimp and eggs). If a Contains hives, vomiting, abdominal cramps, and diarrhea.
statement is included on the label, it must Examples of such food and color additives that
identify the food source names of all are used in fish and fishery products include
major food allergens present as ingredients sulfiting agents and FD&C Yellow No. 5 (Yellow
whether or not those food source names No. 5) described below.
were previously mentioned within the list of Sulfiting agents are mostly used during on
ingredients (21 CFR U.S.C. 343(w)(1)). board handling of shrimp and lobster to
prevent the formation of black spot. They
This chapter contains guidance on the kinds of are sometimes used by cooked octopus
preventive controls that may be suitable to ensure processors as an antioxidant, to retain the
proper labeling if your fish or fishery product is red color of the octopus skin. They are
made in whole or in part of a food that is a major also sometimes used by conch processors
food allergen. As a practical matter, this guidance to prevent discoloration or are used as
covers all finfish and crustacean shellfish and all stabilizers in some breading meals added to
other fishery products (e.g., molluscan shellfish) fish. People sensitive to sulfiting agents can
that contain one or more of the other major food experience symptoms that can range from
allergens. mild severity to life-threatening reactions.
Labeling controls that are designed to ensure that Yellow No. 5 is sometimes added to smoked
any major food allergen that is present in a food fish to impart color. To help protect people
is declared on the label are the most effective who are sensitive to Yellow No. 5, FDAs
means of controlling this hazard. However, regulation for Yellow No. 5 states that any
such controls are not suitable to prevent the food for human use that contains Yellow
unintentional introduction of allergenic proteins No. 5 must specifically declare the presence
from foods that contain these allergens into foods of the color additive by listing it as an
that are not intended to contain them, through ingredient (21 CFR 74.705(d)(2)). If Yellow
cross-contact (e.g., use of common equipment, No. 5 is added to smoked fish but is not
improper production scheduling, or improper use declared, the product not only is misbranded
356
under section 403 of the FFD&C Act, but the food injurious to health (21 U.S.C. 342(a)
also is adulterated under section 402(c). (21 (1)). It is important to note that there is no GRAS
U.S.C. 343(m) and 342(c)). People sensitive to status for color additives.
Yellow No. 5 can experience symptoms that
In addition to the statutory requirements that
can range from mild to moderate severity.
ensure the safety of substances added to food,
Under the FFD&C Act, a use or intended use there are labeling requirements that apply to
of a food or additives is deemed unsafe unless ingredients in food. Under the FFD&C Act,
the use or intended use either conforms with a a food is deemed misbranded unless the
regulation prescribing the conditions for safe use label bears the common or usual name of
or the terms of an exemption for investigational each ingredient with the exception of spices,
use. A food additive that is a food contact flavorings, and color additives not subject to
substance also may be used in accordance certification by FDA (21 U.S.C. 343(i)). This list
with an effective notification (21 U.S.C. 348 of ingredients on the food label is especially
and 21 U.S.C. 379e). Any food that contains an important for people who need to avoid certain
unsafe food additive or color additive is deemed ingredients for health reasons.
adulterated under sections 402(a)(2)(C)(i) and
If a substance is an incidental additive and has
402(c) of the FFD&C Act, respectively (21 U.S.C
no functional or technical effect in the finished
342(a)(2)(C)(i) and 342(c)).
product, then it need not be declared on the
The FFD&C Act excludes from the definition label. Incidental additives are usually either
of food additive substances that are generally processing aids present in the finished food
recognized among experts qualified by or substances that have migrated to the food
scientific training and experience to evaluate from packaging or equipment. Sulfiting agents,
their safety as having been adequately shown which are added to food as preservatives, are
through scientific procedures (or, in the case considered to be incidental only if they have
of a substance used in food prior to January no technical effect in the food and are present
1, 1958, through either scientific procedures or at less than 10 parts per million (ppm) (21 CFR
experience based on common use in food) to 101.100(a)(4)).
be safe under the conditions of their intended
Currently, there are six sulfiting agents allowed
use (21 U.S.C. 321 (s)). A substance (other than a
in processed food. The names by which they are
food contact substance) added to food for a use
listed on food labels are:
that is not generally recognized as safe (GRAS)
under the conditions of its intended use and is sulfur dioxide (21 CFR 182.3862);
not otherwise excluded from the food additive sodium sulfite (21 CFR 182.3798);
definition in section 201(s) of the FFD&C Act, sodium bisulfite (21 CFR 182.3739);
must be used in accordance with a food additive sodium metabisulfite (21 CFR 182.3766);
regulation permitting that specific use (21 CFR
potassium bisulfite (21 CFR 182.3616); and
348). Otherwise, the use of that substance in
food makes the food adulterated under section potassium metabisulfite (21 CFR 182.3637).
402(a)(2)(C) of the FFD&C Act. Additionally, The amount of any one or a combination of any
food may be deemed adulterated if it contains of the six sulfiting agents that may be added to
a poisonous or deleterious substance that may a processed food is restricted by Current Good
render the food injurious to health, but if the Manufacturing Practices (CGMP) (See 21 CFR
substance is not an added substance, the food is part 182, Subpart D). Under CGMPs, the quantity
not considered adulterated if the quantity of the of sulfiting agents added to food should not
substance in the food does not ordinarily render exceed the amount necessary to achieve the
357
technical effect. If the total amount of sulfiting Certain other food and color additives are
agent added to food results in a concentration specifically prohibited from use in food because
of 10 ppm or greater, which is the current limit of a determination by FDA that they present a
of analytical detection identified in the Code potential risk to the public health (see 21 CFR
of Federal Regulation 101.100(a)(4), then the part 189 and 21 CFR 81.10). Examples of such
sulfiting agents are not exempt from FFD&C food and color additives are coumarin, safrole,
Act food labeling requirements and must be and FD&C Red No. 4 (Red No. 4).
listed as an ingredient on the product label (21
CFR 101.100(a)(4)). Table 19-1, Rationale for a
Finished Product Sulfiting Agent Declaration,
provides several examples of raw materials
treated with sulfiting agents and the rationale
for deciding whether or not the finished product
requires a sulfiting agent declaration.
Example:
A processor receives frozen, raw, headless,
shell-on shrimp that are labeled with a
sulfiting agents declaration. The shrimp were
treated with sulfiting agents to prevent the
formation of black spot during on-board
handling. The processor thaws, peels, and
deveins the shrimp, and then adds it to a
gumbo in which the processor has determined
that the final sulfiting agents concentration is
less than 10 ppm. Because the sulfiting agents
no longer has a functional effect in the
finished food, and because the concentration
of the sulfiting agents is less than 10 ppm
in the finished product, the processor is
not required to have a sulfiting agents
declaration on the label of the shrimp gumbo.
Example:
A processor receives frozen, raw, headless,
shell-on shrimp that are labeled with a
sulfiting agents declaration. The processor
uses the shrimp to prepare a shell-on,
deveined, easy-peel shrimp, which is
packaged and refrozen. Because the sulfiting
agents continue to have a functional
(ongoing technical) effect in the finished
product, the processor is required to have a
sulfiting agents declaration on the finished
product label, regardless of the concentration
of sulfiting agents in the finished product.
358
TABLE 19-1
RATIONALE FOR A FINISHED PRODUCT SULFITING AGENT DECLARATION
Is a Sulfiting Agent Declaration Required?
SULFITING AGENT LEVEL IN FINISHED FOOD

EXAMPLES OF SULFITING AGENT USE EXAMPLES OF FINISHED FOOD
<10 PPM 10 PPM
Raw, shell-on shrimp or lobster treated with Raw, shell-on shrimp or lobster
sulfiting agents to prevent black spot YES1 YES1
Cooked octopus
Sulfiting agents added to cooked octopus as
an antioxidant to retain the red skin color Conch meat
of the octopus
Sulfiting agents added to conch meat to

prevent discoloration
Raw, shell-on shrimp or lobster treated with Raw, peeled shrimp or lobster meat
sulfiting agents to prevent black spot NO2 YES2
359
Food containing raw, peeled shrimp or
Raw, shell-on shrimp or lobster treated with lobster meat as an ingredient (e.g., seafood
sulfiting agents to prevent black spot casserole)
1. The sulfiting agents have an ongoing technical or functional effect on/in the finished food and must be declared regardless of the level in the finished food
2. The sulfiting agents have no technical or functional effect in the finished food and do not have to be declared unless the level in the finished food is either 10 ppm or the sulfiting agents were
added to the finished food at any level. To further clarify, if a sulfiting agent or a combination of sulfiting agents is added to finished food such that their collective concentration in/on the finished
food is 10 ppm , then you must declare each by its approved label name (listed above)(21CFR101.100).
DETERMINE WHETHER THE POTENTIAL variation in formulation to establish that
HAZARD IS SIGNIFICANT. sulfiting agents will not be present at 10
ppm or greater in the finished product;
The following guidance will assist you in Product formulation step, if your
determining whether undeclared major food finished product contains one or
allergens, certain food intolerance causing more of the major food allergens
substances, and prohibited food and color (including non-fishery allergens)
additives are a significant hazard at a processing listed in the previous section,
step: Understand the Potential Hazard.;
1. Is it reasonably likely that an undeclared major Product formulation step, if you have
food allergen, undeclared food intolerance an ingredient that is or contains one
causing substance (e.g., sulfiting agents or Yellow or more of the major food allergens
No. 5), or prohibited food or color additive (including non-fishery allergens) or food
(e.g., coumarin, safrole, or Red No. 4) will be intolerance causing substances in your
introduced at each processing step (e.g., does it facility or use such an ingredient in the
come in with the raw material or will the process formulation of any of your products;
introduce it)?
Product formulation step, if your finished
Under ordinary circumstances, you should product is cooked octopus or conch
consider whether undeclared major food meat, because of the potential presence
allergens, certain food intolerance causing of sulfiting agents. However, you may not
substances, and prohibited food and color need to identify the hazard as significant
additives are a significant hazard at the: if you do not have sulfiting agents in
your facility and do not use it in the
Receiving step, if your finished product is
formulation of any of your products;
or contains finfish or crustacean shellfish,
because they are major food allergens; Product formulation step, if your finished
product is a formulated fishery product
Receiving step, if your finished product
(i.e., a product in which two or more
contains either shrimp or lobster,
ingredients are combined) because of
because there is a potential for sulfiting
the potential presence of Yellow No.
agents to be present. However, there
5 or sulfiting agents. However, you
may be circumstances that would allow
may not need to identify the hazard as
you to conclude that the hazard is not
significant if you do not have Yellow No.
reasonably likely to occur. For example,
5 in your facility and do not use it in the
sulfiting agents may not be used in
formulation of any of your products; and
aquacultured shrimp from some regions.
You should be guided by information Ingredient receiving step, if you receive
about the historical use of sulfiting ingredients in which you have reason
agents in your region. Also, in some to believe prohibited food or color
formulated finished products that contain additives (e.g., coumarin, safrole, or
shrimp or lobster, the sulfiting agent may Red No. 4) may be present, based, for
not have a functional effect and may example, on an historic occurrence
not be present at 10 ppm or greater. of the additive in that ingredient.
You should conduct a study that tests
2. Can the hazard of undeclared major food
the range of concentration of sulfiting
allergens, and certain food intolerance causing
agents in the raw material and possible
substances, and prohibited food and color
360
additives that were introduced at an earlier step ingredients in which you have reason
be eliminated or reduced to an acceptable level to believe the additive may be present
at this processing step? (with appropriate verification).
Undeclared major food allergens, food Intended use
intolerance causing substances and prohibited In the case of undeclared major food allergens
food and color additives should also be and certain food intolerance causing substances
considered a significant hazard at a processing and prohibited food and color additives, it is not
step if a preventive measure is or can be likely that the significance of the hazard will be
used to prevent or eliminate the hazard or affected by the intended use of the product.
to reduce the likelihood of its occurrence
to an acceptable level. Preventive measures IDENTIFY CRITICAL CONTROL POINTS.
for undeclared major food allergens, food
intolerance causing substances and prohibited
food and color additives include:
Reviewing finished product labels critical control point (CCP) for undeclared major
to ensure that the presence of food allergens, certain food intolerance causing
certain food intolerance causing substances and prohibited food and color
substances (e.g., sulfiting agents additives:
or Yellow No. 5) is declared;
1. In the case of shrimp or lobster for which you
Testing incoming shrimp or lobster have identified sulfiting agents as a significant
for residues of sulfiting agents; hazard, will the finished product label declare the
Reviewing a suppliers certification presence of sulfiting agents?
of the lack of sulfiting agent use on
a. If the finished product label will declare
incoming lots of shrimp or lobster
the presence of sulfiting agents, you
(with appropriate verification);
should identify the finished product
Reviewing the labeling (or labeling step as the CCP and review the
accompanying documents, in the case labels at that step. You would not need
of unlabeled product) on shipments to identify the shrimp or lobster receiving
of shrimp or lobster received from step as a CCP for this hazard.
another processor for the presence
Example:
of a sulfiting agent declaration;
A frozen shrimp processor labels all of
Reviewing finished product labels the finished product with a sulfiting
to ensure that the presence of the agent declaration. The processor
major food allergens, listed in the should set the CCP for sulfiting agents
previous section, Understand the at the finished product labeling step,
Potential Hazard is declared; where labels would be reviewed for
Testing incoming lots of ingredients the presence of the declaration. The
for the presence of prohibited food processor would not need to have a
and color additives that you have CCP for this hazard at the shrimp
reason to believe may be present; receiving step.
Reviewing a suppliers certification This control approach is a control

of the lack of prohibited food and strategy referred to in this chapter
color additive use in incoming lots of as Control Strategy Example 1
361
- Finished Product Labeling for declaration. The processor should
Control of Food Intolerance Causing set the CCP for sulfiting agents at
Substances from Raw Materials. the raw material receiving step and
obtain certificates from the harvest
b. If the finished product labeling will not
vessels that sulfiting agents were not
declare the presence of sulfiting agents,
used on the shrimp. The processor
you should identify the raw material
should verify the effectiveness of the
receiving step as the CCP, where you
monitoring procedures by collecting
could screen incoming lots for the
quarterly samples of all incoming
presence of sulfiting agents. Preventive
shrimp and samples of incoming
measures that can be applied here
shrimp from all new suppliers and
include:
analyzing for the presence of sulfiting
Testing incoming shrimp or agents. The processor would not need
lobster for residues of sulfiting to have a CCP for this hazard at
agents at or above 10 ppm. finished product labeling.
Example: This control approach is a control
A frozen shrimp processor receives strategy referred to in this chapter
shrimp directly from the harvest as Control Strategy Example 3 -
vessel and does not label the finished Review of Suppliers Certificates for
product with a sulfiting agent Control of Food Intolerance Causing
declaration. The processor should Substances and Prohibited Food and
set the CCP for sulfiting agents at Color Additives from Raw Materials.
the raw material receiving step and Reviewing the labeling (or
test incoming lots of shrimp for the accompanying documents, in the
presence of sulfiting agents. The case of an unlabeled product)
processor would not need to have on shipments of shrimp or
a CCP for this hazard at finished lobster received from another
product labeling. processor for the presence of a
This control approach is a control sulfiting agent declaration (with
strategy referred to in this chapter as appropriate verification).
Control Strategy Example 2 - Raw Example:
Material Testing for Control of Food A frozen shrimp processor receives
Intolerance Causing Substances and shrimp from another processor and
Prohibited Food and Color Additives does not label the finished product
From Raw Materials. with a sulfiting agent declaration.
Receiving a suppliers certification The processor should set the CCP for
of the lack of sulfiting agent use on sulfiting agents at the raw material
incoming lots of shrimp or lobster receiving step and reject incoming
(with appropriate verification). lots that are identified as having
been treated with a sulfiting agent
Example:
(e.g., identified on the label or,
A frozen shrimp processor receives
in the case of unlabeled product,
shrimp directly from the harvest
on documents accompanying the
vessel and does not label the finished
shipment). The processor should verify
product with a sulfiting agent
the effectiveness of the monitoring
362
procedures by collecting quarterly that the appropriate label is being
samples of all incoming shrimp and applied based on the results of the
samples of incoming shrimp from raw material testing. The processor
all new suppliers and analyzing for would not need to have a CCP for this
the presence of sulfiting agents. The hazard at the raw material receiving
processor would not need to have step, although controls would be
a CCP for this hazard at finished exercised there by performing raw
product labeling. material testing at the receiving step.
This control approach is a control This control approach is a control
strategy referred to in this chapter as strategy referred to in this chapter
Control Strategy Example 4 - Review as Control Strategy Example 5 -
of Suppliers Labeling for Control of Finished Product Labeling Based on
Food Intolerance Causing Substances Raw Material Testing for Control of
from Raw Materials. Food Intolerance Causing Substances
from Raw Materials.
c. If the finished product label will declare
the presence of sulfiting agents only Receiving a suppliers certification
when it is present in the raw material, of the lack of sulfiting agent use on
you should identify the finished product incoming lots of shrimp or lobster
labeling step as the CCP, where you (with appropriate verification) and
can ensure that the appropriate label review of finished product labels.
is placed on the package based on Example:
the results of screening performed at A frozen shrimp processor receives
the receiving step for the presence of shrimp directly from the harvest vessel
sulfiting agents. You would not need to and labels the finished product with
identify the shrimp or lobster receiving a sulfiting agent declaration only
step as a CCP for this hazard, although if a lot of raw material shrimp is
you would be exercising controls by received without a certificate attesting
performing raw material tests. Preventive to the absence of sulfiting agent use.
measures that can be applied here The processor should set the CCP
include: for sulfiting agents at the finished
Testing incoming shrimp or lobster product labeling step and check that
for detectable residues of sulfiting the appropriate label is being applied
agents at or above 10 ppm and based on the presence or absence of a
review of finished product labels. certificate. The processor should verify
Example: procedures by collecting quarterly
A frozen shrimp processor receives samples of incoming shrimp for the
shrimp directly from the harvest vessel presence of sulfiting agents. The
and labels the finished product with processor would not need to have
a sulfiting agent declaration only a CCP for this hazard at the raw
if testing at receiving step identifies material receiving step, although
a residue of a sulfiting agent. The controls for the receipt of a certificate
processor should set the CCP for attesting to the absence of sulfiting
sulfiting agents at the finished agent use would be applied there.
product labeling step and check
363
strategy referred to in this chapter This control approach is a control
as Control Strategy Example 6 - strategy referred to in this chapter
Finished Product Labeling Based on as Control Strategy Example 7 -
Review of Suppliers Certificates for Finished Product Labeling Based on
Control of Food Intolerance Causing Review of Suppliers Labeling for
Substances from Raw Materials. Control of Food Intolerance Causing
Substances from Raw Materials.
Reviewing the labeling (or
accompanying documents, in the 2. In the case of (1) cooked octopus or conch
case of an unlabeled product) on meat for which you have identified sulfiting
incoming shipments of shrimp agents as a significant hazard; (2) products
or lobster received from another for which you have identified Yellow No. 5 as
processor for the presence of a a significant hazard because you use one of
sulfiting agent declaration (with this color additive in the product formulation;
applicable verification), and review and (3) products for which you have identified
of finished product labels. undeclared major food allergens as a significant
Example: hazard, you should identify the finished product
A frozen shrimp processor receives labeling step as the CCP, where you can ensure
shrimp (as raw material) from that the appropriate label is placed on the
another processor and labels the package based on the results of a review of the
finished product with a sulfiting agent product formula for that product. You would not
declaration only if the incoming lot need to identify the product formulation step as
was identified on the labeling (or, a CCP for this hazard, although you may be
in the case of unlabeled product, exercising control at that point.
on documents accompanying the Example:
shipment) as having been treated A smoked sablefish processor treats the
with a sulfiting agent. The processor fish with Yellow No. 5 before smoking.
should set the CCP for sulfiting agents The processor should set the CCP for
at the finished product labeling step Yellow No. 5 at the finished product
and check that the appropriate label labeling step, where the labels would
is being applied based on the raw be examined to ensure that the color
material label review. The processor additive is declared. The processor
should verify the effectiveness of the would not need to have a CCP for
monitoring procedures by collecting this hazard at the treatment (product
quarterly samples of all incoming formulation) step.
shrimp and collect at least one
representative sample for each new Example:
supplier and analyzing for the A cooked octopus processor treats
presence of sulfiting agents. The the fish with a sulfiting agent.
processor would not need to have The processor should set the CCP
a CCP for this hazard at the raw for sulfiting agents at the finished
material receiving step, although product labeling step, where the labels
controls for reviewing the labeling would be examined to ensure that
(or, in the case of unlabeled product, the food additive is declared. The
on documents accompanying the processor would not need to have a
shipment) would be applied there. CCP for this hazard at the treatment
(product formulation) step.
364
Example: Material Testing for Control of Food
A breaded fish processor uses pollock Intolerance Causing Substances and
fillets and a batter mix containing Prohibited Food and Color Additives
egg and wheat for some formulations from Raw Materials.
but not others listing egg, wheat,
Receiving a suppliers certification
and pollock on the label only when
of the lack of prohibited food and
those ingredients are included in the
color additive use in the ingredient
formulation. The processor should
lot (with appropriate verification).
set the CCP for undeclared major
food allergens at the finished product Example:
labeling step, where labels would A shrimp salad processor uses
be reviewed for the presence of an an imported ingredient that has
ingredient declaration that matches historically contained Red 4. The
the current product formula. processor should set the CCP for
prohibited food and color additives
at the ingredient receiving step and
obtain certificates from the supplier
that Red No. 4 was not used in
Finished Product Labeling Controls
the formulation of the ingredient
for Major Food Allergens and
lot. The processor should verify
Added Food Intolerance Causing
Substances.
procedures by collecting quarterly
3. In the case of products for which you have samples of the imported ingredient for
identified prohibited food and color additives the presence of Red No. 4.
(e.g., coumarin, safrole, or Red No. 4) as a This control approach is the same
significant hazard because you have reason to control strategy previously identified
believe that it may be present in an ingredient as Control Strategy Example 3 -
used in the finished product, you should identify Review of Suppliers Certificates for
the raw material receiving step as the CCP, Control of Food Intolerance Causing
where you could screen incoming lots for the Substances and Prohibited Food and
presence of the additive. Preventive measures that Color Additives from Raw Materials.
can be applied here include:
Testing the incoming ingredient
for the additive.
Example:
A shrimp salad processor uses
an imported ingredient that has
historically contained Red No. 4. The
processor should test the ingredient at
receipt for the additive and set the CCP
for prohibited food and color additives
at the ingredient receiving step.
This control approach is the same
control strategy previously identified
as Control Strategy Example 2 - Raw
365
DEVELOP A CONTROL STRATEGY. CONTROL STRATEGY EXAMPLE 1 - FINISHED
PRODUCT LABELING FOR CONTROL OF FOOD
The following guidance provides eight control INTOLERANCE CAUSING SUBSTANCES FROM
strategies for undeclared major food allergens, RAW MATERIALS
certain food intolerance causing substances, and Set Critical Limits.
prohibited food and color additives. You may
select a control strategy that is different from All finished product packages must bear a
those that are suggested, provided it complies label that declares the presence of a sulfiting
with the requirements of the applicable food agent.
safety laws and regulations.
included in this chapter: What Will Be Monitored?
MAY APPLY TO MAY APPLY TO Labels on finished product packages for
CONTROL STRATEGY PRIMARY SECONDARY presence of sulfiting agent.
PROCESSOR PROCESSOR
Finished product labeling for How Will Monitoring Be Done?

control of food intolerance
causing substances from raw Visual examination.
materials
Raw material testing for control
of food intolerance Representative number of packages from
causing substances and
prohibited food and color
each lot of a finished product;
additives from raw materials
Review of suppliers certificates
for control of food Any person who has an understanding of the
intolerance causing substances nature of the controls.
and prohibited
food and color additives from
raw materials Establish Corrective Action Procedures.
Review of suppliers labeling Take the following corrective action to a product
for control of food
intolerance causing substances involved in a critical limit deviation:
from raw materials
Finished product labeling product.
based on raw material testing
for control of food intolerance
causing substances from raw AND
materials
Finished product labeling over the operation after a critical limit deviation:
based on review of suppliers
certificates for control of food Modify labeling procedures, as appropriate;
intolerance causing substances
from raw materials OR
Finished product labeling Make corrections to the label generation
based on review of suppliers
labeling for control of food program or equipment;
intolerance causing substances
from raw materials OR
Finished product labeling Discontinue use of the label supplier until
controls for major food evidence is obtained that the labeling will
allergens and added food
intolerance causing substances contain the appropriate declaration;
366
AND/OR
does not contain the proper declaration.

Record of labeling checks of finished product
packages.

367
TABLE 19-2
CONTROL STRATEGY EXAMPLE 1 - FINISHED PRODUCT LABELING FOR CONTROL OF

FOOD INTOLERANCE CAUSING SUBSTANCES FROM RAW MATERIALS
This table is an example of a portion of a HACCP Plan using Control Strategy Example 1 - Finished Product Labeling for Control of Food Intolerance Causing Substances
from Raw Materials. This example illustrates how a processor of shell-on shrimp can control sulfiting agents that are used on the harvest vessel. It is provided for illustrative
purposes only.
Major food allergens, certain food intolerance causing substances and prohibited food and color additives may be only one of several significant hazards for this product.
Refer to Tables 3-3 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides and metal fragments).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)

CRITICAL
POINT
MEASURE
Finished Undeclared All finished Labels on Visual One label Quality Segregate Record of Review
product sulfiting agents product the finished at the assurance and relabel labeling checks monitoring
labeling packages must product beginning employee improperly of finished and corrective
368
bear labels that for the of the labeled product product action records
contain presence of production of packages within 1 week
sulfiting agent sulfiting agent each lot and Discontinue of preparation
declaration declaration one label every use of the label
hour thereafter supplier until
evidence is
obtained that
labeling will
contain the
sulfiting agent
declaration
CONTROL STRATEGY EXAMPLE 2 - RAW Establish Corrective Action Procedures.
MATERIAL TESTING FOR CONTROL OF FOOD
INTOLERANCE CAUSING SUBSTANCES AND
PROHIBITED FOOD AND COLOR ADDITIVES
FROM RAW MATERIALS Reject the lot.
Incoming lots of shrimp or lobster must not Take the following corrective action to regain control of
contain a detectable level of sulfiting agents the operation after a critical limit deviation:
(Note that <10 ppm sulfiting agents may be Discontinue use of the supplier until
present in finished product shell-off shrimp evidence is obtained that control of sulfiting
and lobster without a sulfiting agent declaration agents and/or prohibited food and color
on the label if the sulfiting agents have no additives, as appropriate, has improved.
functional (ongoing technical) effect in the
finished food. However, if the sulfiting agents Establish a Recordkeeping System.
have a functional (ongoing technical) effect in Test results for sulfiting agents and/or
finished shell-on or shell-off shrimp or lobster prohibited food and color additives, as
product regardless of level, then they must be appropriate.
declared as ingredients on the product label).
AND/OR Establish Verification Procedures.
An incoming lot of raw materials must not Review monitoring and corrective action
contain a detectable level of prohibited food records within 1 week of preparation
or color additive. to ensure they are complete and any
Establish Monitoring Procedures. appropriately addressed.

Each lot at receipt for sulfiting agent residual
analysis and/or prohibited food and color
additive analysis, as appropriate.

Screening test for sulfiting agents and/
or prohibited food and color additives, as
appropriate.

Representative sample from each incoming lot.

experience to perform the screening test
procedure.
369
TABLE 19-3
CONTROL STRATEGY EXAMPLE 2 - RAW MATERIAL TESTING FOR CONTROL OF FOOD INTOLERANCE CAUSING SUBSTANCES AND
PROHIBITED FOOD AND COLOR ADDITIVES FROM RAW MATERIALS
This table is a an example of a portion of a HACCP plan using Control Strategy Example 2 - Raw Material Testing for Control of Food Intolerance Causing Substances
and Prohibited Food and Color Additives from Raw Materials. This example illustrates how a processor of shell-on shrimp can control sulfiting agents that are used on the
harvest vessel. It is provided for illustrative purposes only.
Major food allergens, certain food intolerance causing substances and prohibited food and color additives may be only one of several significant hazards for this product.
Refer to Tables 3-2 and 3-3 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides and metal fragments).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
MONITORING
CRITICAL LIMITS
CRITICAL
POINT
MEASURE
Shrimp Undeclared Incoming Each lot of raw Malachite green Three shrimp Receiving Reject any Test results for Review
receiving sulfiting agents lots of shrimp material shrimp test selected employee incoming lot sulfiting agents monitoring
370
must not for randomly of shrimp and corrective
contain 10 ppm sulfiting agent from each lot that contains action records
or greater residual of incoming a detectable within 1 week
sulfiting agents shrimp level of sulfiting of preparation
agent
Discontinue use
of the supplier
until evidence
is obtained that
control of
sulfiting agents
has improved
CONTROL STRATEGY EXAMPLE 3 - REVIEW OF AND
SUPPLIERS CERTIFICATES FOR CONTROL OF
FOOD INTOLERANCE CAUSING SUBSTANCES
AND PROHIBITED FOOD AND COLOR ADDITIVES
FROM RAW MATERIALS
evidence is obtained that certificates will
Set Critical Limits. accompany future shipments.
Incoming lots of shrimp or lobster must
be accompanied by a suppliers lot-by Establish a Recordkeeping System.
lot certificate that sulfiting agents and/ Suppliers lot-by-lot certificates;
AND
appropriate, were not used.
Receiving records showing lots received
and the presence or absence of suppliers
certificates.
The suppliers lot-by-lot certificate that no Establish Verification Procedures.
sulfiting agents and/or prohibited food and Collect at least one representative sample
color additives, as appropriate, were used on per quarter, randomly selected from each
the lot. supplier, and analyze for sulfiting agents
and/or prohibited food and color additives,
How Will Monitoring Be Done? as appropriate. Additionally, collect at least
Visual examination of certificates. one representative sample from each new
supplier, and analyze for sulfiting agents
Each incoming lot. appropriate;
Any person who has an understanding of the Review monitoring, corrective action,
nature of the controls. and verification records within 1 week of
Establish Corrective Action Procedures. any critical limit deviations that occurred
Reject the lot;
OR
provided;
OR
Test the lot for sulfiting agents and/or
prohibited food and color additives, as
appropriate, and reject the lot if 10 ppm or
greater sulfating agents or a detectable levels of
prohibited food and color additives are found.
371
TABLE 19-4
CONTROL STRATEGY EXAMPLE 3 - REVIEW OF SUPPLIERS CERTIFICATES FOR CONTROL OF FOOD INTOLERANCE CAUSING SUBSTANCES
AND PROHIBITED FOOD AND COLOR ADDITIVES FROM RAW MATERIALS
This table is an example of a portion of a HACCP plan using Control Strategy Example 3 - Review of Suppliers Certificates for Control of Food Intolerance Causing
Substances and Prohibited Food and Color Additives from Raw Materials. This example illustrates how a processor of shell-on shrimp can control sulfiting agents that are
used on the harvest vessel. It is provided for illustrative purposes only.
Major food allergens and certain food intolerance causing substances and prohibited food and color additives may be only one of several significant hazards for this
product. Refer to Tables 3-2 and 3-3 (Chapter 3) for other potential hazards (e.g., environmental chemical contaminants and pesticides and metal fragments).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
MONITORING
CRITICAL LIMITS
CRITICAL
POINT
MEASURE
Shrimp Undeclared All incoming Suppliers Visual Every lot Receiving Test the lot Suppliers Collect at
receiving sulfiting agents lots of shrimp lot-by-lot examination received employee for sulfiting lot-by-lot least one
372
must be certificates agents and certificates representative
accompanied stating that no reject the lot Receiving sample per
by a lot-by sulfiting agents if a detectable records quarter and
lot certificate were used on level of sulfiting showing lots test for sulfiting
stating that the incoming agents is found received and agents; in
sulfiting agents lot the presence addition, test
were not used Discontinue use or absence at least one
of the supplier of suppliers lot from each
until evidence certificates new supplier
is obtained that and analyze for
certificates will sulfiting agents
accompany Review
future monitoring,
shipments corrective
action, and
verification
records within
1 week of
preparation
CONTROL STRATEGY EXAMPLE 4 - REVIEW OF Establish a Recordkeeping System.
SUPPLIERS LABELING FOR CONTROL OF FOOD Record of review of labeling or shipping
INTOLERANCE CAUSING SUBSTANCES FROM documents for raw materials.
RAW MATERIALS
Set Critical Limits. Establish Verification Procedures.

The labeling or shipping documents for Collect at least one representative sample
incoming lots of shrimp or lobster received per quarter, randomly selected from among
from another processor must not contain a your suppliers, and analyze for sulfiting
sulfiting agent declaration. agents. Additionally, collect at least one
representative sample for each new supplier,
Establish Monitoring Procedures. and analyze for sulfiting agents;
AND
Suppliers product labels or shipping
documents for the presence of sulfiting agent
declaration.
How Will Monitoring Be Done? were appropriately addressed.
Visual examination of labels.

Every incoming lot.


Reject the lot;
OR
Test the lot for sulfiting agents and reject the
lot if 10 ppm or greater of sulfiting agents are
found.
AND
the operation after a critical limit deviation:
Discontinue use of supplier until evidence is
obtained that they will no longer provide a
product in which sulfiting agents have been
used.
373
TABLE 19-5
CONTROL STRATEGY EXAMPLE 4 - REVIEW OF SUPPLIERS LABELING FOR CONTROL OF

FOOD INTOLERANCE CAUSING SUBSTANCES FROM RAW MATERIALS
This table is an example of a portion of a HACCP plan using Control Strategy Example 4 - Review of Suppliers Labeling for Control of Food Intolerance Causing Substances
from Raw Materials. This example illustrates how a processor of shell-on shrimp can control sulfiting agents that are used on the harvest vessel. It is provided for illustrative
purposes only.
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
MONITORING
CRITICAL LIMITS
CRITICAL
POINT
MEASURE
Shrimp Undeclared The labeling Suppliers Visual Every lot Receiving Reject Record of Collect at
receiving sulfiting agents of incoming product examination of received employee the lot labeling checks least one
374
lots of shrimp labels for the the labels of raw representative
received presence of Discontinue materials sample per
from another sulfiting agent use of supplier quarter and
processor must declaration until evidence test for
not contain a is provided sulfiting agents;
sulfiting agent that they will in addition, test
declaration not provide at least one
sulfiting agent lot from each
treated shrimp new supplier
and analyze for
sulfiting agents
Review
monitoring,
corrective
action, and
verification
records within
1 week of
preparation
CONTROL STRATEGY EXAMPLE 5 - FINISHED Who Will Do the Monitoring?
PRODUCT LABELING BASED ON RAW MATERIAL For finished product labeling:
TESTING FOR CONTROL OF FOOD INTOLERANCE
CAUSING SUBSTANCES FROM RAW MATERIALS Any person who has an
understanding of the nature of the
Set Critical Limits. controls;
All finished product packages processed from AND
raw materials that contain a detectable level of For raw material testing:
sulfiting agents must bear a label that contains
a sulfiting agent declaration. Note that 10 ppm Any person who is qualified by
training or experience to perform the
sulfiting agent may be present in finished
screening test.
product shell-off shrimp and lobster without
a sulfiting agent declaration on the label.
However, any detectable level of sulfiting
agent in finished product shell-on shrimp Take the following corrective action to a product
or lobster would require a sulfiting agent involved in a critical limit deviation:
declaration on the label, because the sulfiting Segregate and relabel any improperly labeled
agents continue to have a functional effect. product.
AND
What Will Be Monitored? the operation after a critical limit deviation:
Labels on finished product packages for Modify labeling procedures, as appropriate.
presence of sulfiting agent declaration;
A representative sample of each lot of raw Record of labeling checks of finished product
material for the presence of sulfiting agents. packages;
How Will Monitoring Be Done? AND

For labels on finished packages: Record of sulfiting agent test results.
Visual examination of labels;

Establish Verification Procedures
AND Review monitoring and corrective action
For raw material testing: records within 1 week of preparation
Screening test for sulfiting agents. to ensure they are complete and any
How Often Will Monitoring Be Done (Frequency)? appropriately addressed.
For finished product labeling:
A representative number of packages
from each lot of a finished product;
AND
For raw material testing:
Each lot of raw material shrimp
received.
375
TABLE 19-6
CONTROL STRATEGY EXAMPLE 5 - FINISHED PRODUCT LABELING BASED ON RAW MATERIAL TESTING FOR CONTROL OF FOOD
INTOLERANCE CAUSING SUBSTANCES FROM RAW MATERIALS
This table is a an example of a portion of a HACCP plan using Control Strategy Example 5 - Finished Product Labeling Based on Raw Material Testing for Control of Food
Intolerance Causing Substances from Raw Materials. This example illustrates how a processor of shell-on shrimp can control sulfiting agents that are used on the harvest
vessel. It is provided for illustrative purposes only.
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
MONITORING
CRITICAL LIMITS
CRITICAL
POINT
MEASURE
Finished Undeclared All finished Labels on Visual One label at the Quality Segregate and Record of Review
product sulfiting agents product finished examination beginning of control relabel any labeling checks monitoring and
376
labeling packages product of labels the production employee improperly of finished corrective
processed from packages on finished of each lot and labeled product product action records
raw materials for the product one label every packages within 1 week
that contain 10 presence of a packages hour thereafter Modify of preparation
ppm or greater sulfiting agent labeling
sulfiting agents declaration procedures, as
must bear appropriate
a label that
contains a
sulfiting agent
Analysis of Malachite green Three shrimp Quality Analytical
declaration
raw test collected control results
material shrimp randomly from employee
for sulfiting each lot of raw
agent material shrimp
residual
CONTROL STRATEGY EXAMPLE 6 - FINISHED Establish Corrective Action Procedures.
PRODUCT LABELING BASED ON REVIEW OF
SUPPLIERS CERTIFICATES FOR CONTROL OF
FOOD INTOLERANCE CAUSING SUBSTANCES
FROM RAW MATERIALS Segregate and relabel any improperly labeled
product.
AND
All finished product packages must bear
a label that contains a sulfiting agent Take the following corrective action to regain control
declaration unless they are processed over the operation after a critical limit deviation:
from raw material shrimp or lobster that Modify labeling procedures, as appropriate.
are accompanied by a suppliers lot-by-lot
certificate that states that no sulfiting agents Establish a Recordkeeping System.
were used. Record of labeling checks;

Copy of certificates;
AND
Labels on finished product packages for the
presence of a sulfiting agent declaration; Receiving record showing lots received and
the presence or absence of a certificate.
AND
Suppliers lot-by-lot certificates for raw Establish Verification Procedures.
material shrimp or lobster that no sulfiting Collect at least one representative sample per
agent was used on the lot. quarter from lots that are accompanied by
How Will Monitoring Be Done? a certificate, randomly selected from among
your suppliers, and analyze for sulfiting
agents. Additionally, collect at least one
Visual examination of the labels; representative sample for each new supplier
AND and analyze for sulfiting agents;
For suppliers lot-by-lot certificates: AND
Visual examination of the certificates. Review monitoring, corrective action,
How Often Will Monitoring Be Done (Frequency)? preparation to ensure they are complete and
For finished product labeling: any critical limit deviations that occurred
A representative number of packages were appropriately addressed.
from each lot of a finished product;
AND
For suppliers lot-by-lot certificates:
Each incoming lot.

377
TABLE 19-7
CONTROL STRATEGY EXAMPLE 6 - FINISHED PRODUCT LABELING

BASED ON REVIEW OF SUPPLIERS CERTIFICATES FOR
CONTROL OF FOOD INTOLERANCE CAUSING SUBSTANCES FROM RAW MATERIALS
This table is an example of a portion of a HACCP plan using Control Strategy Example 6 - Finished Product Labeling Based on Review of Suppliers Certificates for Control
of Food Intolerance Causing Substances from Raw Materials. This example illustrates how a processor of shell-on shrimp can control sulfiting agents that are used on the
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
MONITORING
CRITICAL LIMITS
CRITICAL
POINT
MEASURE
Finished Undeclared All finished product Labels on Visual One label at the Labeling Segregate and relabel Record of Collect at least one
378
product sulfiting packages must bear a finished examination of beginning of the supervisor any improperly labeled labeling representative sample
labeling agents label that contains a product labels on production of product checks per quarter from lots
sulfiting agent packages finished each lot and one that are accompanied
declaration unless for the product label every hour Modify labeling by a certificate, selected
they are processed presence of a packages thereafter procedure, as randomly from among
from raw material sulfiting agent appropriate the suppliers and analyze
shrimp that are declaration for sulfiting agents;
accompanied by a additionally, collect one
suppliers lot-by-lot representative sample from
Lot-by-lot Visual Each Receiving Record
certificate that states each new supplier and
certificates examination incoming lot employee of raw
that no sulfiting analyze for sulfiting agents
stating that no of lot-by-lot material
agents were used
sulfiting agent certificates receiving
Review monitoring,
was used on
corrective action, and
the lot Lot-by-lot
certificates
CONTROL STRATEGY EXAMPLE 7 - FINISHED Establish Corrective Action Procedures.
PRODUCT LABELING BASED ON REVIEW OF
SUPPLIERS LABELING FOR CONTROL OF FOOD
INTOLERANCE CAUSING SUBSTANCES FROM
RAW MATERIALS Segregate and relabel any improperly labeled
product.
AND
All finished product packages must bear
a label that contains a sulfiting agent Take the following corrective action to regain control of
declaration if they are processed from the operation after a critical limit deviation:
raw material shrimp or lobster that are Modify labeling procedures, as appropriate.
labeled with a sulfiting agent declaration or
accompanied by documents that contain a Establish a Recordkeeping System.
sulfiting agent declaration. Record of labeling checks of finished product
packages;
AND
What Will Be Monitored? Record of review of raw material labeling or
Labels on finished product packages for the shipping documents.
presence of a sulfiting agent declaration;
AND Establish Verification Procedures.
Labeling or shipping documents for each lot Collect at least one representative sample
of raw material shrimp or lobster received per quarter from lots that are not labeled
from another processor for the presence of a with a sulfiting agent declaration or not
sulfiting agent declaration. accompanied by documents with a sulfiting
agent declaration, randomly selected from
How Will Monitoring Be Done? among your suppliers, and analyze for
Visual examination of labels and shipping sulfiting agents. Additionally, collect at least
documents. one representative sample for each new
supplier, and analyze for sulfiting agents;
AND
Review monitoring, corrective action and
A representative number of packages verification records within 1 week of
from each lot of a finished product; preparation to ensure they are complete and
For raw material labeling: were appropriately addressed.
Each incoming lot.

379
TABLE 19-8
CONTROL STRATEGY EXAMPLE 7 - FINISHED PRODUCT LABELING

BASED ON REVIEW OF SUPPLIERS LABELING FOR
CONTROL OF FOOD INTOLERANCE CAUSING SUBSTANCES FROM RAW MATERIALS
This table is an example of a portion of a HACCP plan using Control Strategy Example 7 - Finished Product Labeling Based on Review of Suppliers Labeling for Control
of Food Intolerance Causing Substances from Raw Materials. This example illustrates how a processor of shell-on shrimp can control sulfiting agents that are used on the
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
MONITORING
CRITICAL LIMITS
CRITICAL
POINT
MEASURE
Finished Undeclared All finished product Labels on Visual One label Labeling Segregate and Record of Collect at least one
380
product sulfiting packages must bear a finished examination of at the supervisor relabel any labeling representative sample per
labeling agents label that contains a product labels on beginning improperly checks quarter from lots that
sulfiting agent packages for the finished of the labeled product are not labeled with a
declaration if they presence of a product production of sulfiting agent
are processed from sulfiting agent packages each lot and one Modify labeling declaration, randomly
raw declaration label every hour procedure, as selected from among your
material shrimp that thereafter appropriate suppliers, and analyze
are labeled with a for sulfiting agents;
sulfiting agent additionally, collect at
declaration least one representative
Labeling for Visual Each Receiving Records
or accompanied by sample for each new
each lot of raw examination incoming lot employee of raw
documents that supplier, and analyze for
material shrimp of the raw material
contain a sulfiting sulfiting agents
received from material labeling
agent
another processor labeling checks
declaration Review monitoring,
for the presence of
corrective action and
a sulfiting agent
declaration
CONTROL STRATEGY EXAMPLE 8 - FINISHED Establish a Recordkeeping System.
PRODUCT LABELING CONTROLS FOR MAJOR Record of labeling checks of finished product
FOOD ALLERGENS AND ADDED FOOD packages.
INTOLERANCE CAUSING SUBSTANCES
Set Critical Limits. Establish Verification Procedures.

All finished product labeling must accurately Review monitoring and corrective action
list any major food allergens and added records within 1 week of preparation
sulfiting agents that have an on-going to ensure they are complete and any
functional effect or Yellow No. 5 that are critical limit deviations that occurred were
included in the product formulation. appropriately addressed.

Labels on finished product packages for
comparison with the product formula
(recipe), including the market name of any
finfish or crustacean shellfish contained in
the product.

Visual examination of the finished product
labels and product formula.

A representative number of packages from
each lot of a finished product.


product.
AND
Modify label procedures, as appropriate.
381
TABLE 19-9
CONTROL STRATEGY EXAMPLE 8 - FINISHED PRODUCT LABELING CONTROLS FOR

MAJOR FOOD ALLERGENS AND ADDED FOOD INTOLERANCE CAUSING SUBSTANCES
This table is an example of a portion of a HACCP plan using Control Strategy Example 8 - Finished Product Labeling Controls for Major Food Allergens and Added Food
Intolerance Causing Substances. This example illustrates how a breaded fish processor can control undeclared major food allergens in the production of breaded fish
portions containing egg, wheat, and pollock. It is provided for illustrative purposes only.
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
MONITORING
CRITICAL LIMITS
CRITICAL
POINT
MEASURE
Finished Undeclared Finished Finished Visual One label at the Quality Segregate and Record of Review
product major food product labels product labels examination beginning of assurance staff relabel any review of monitoring and
382
labeling allergens must declare for comparison of the the production incorrectly finished corrective
the presence of with labels on of each lot and labeled product product labels action records
egg, wheat, and product formula finished one label every within 1 week
pollock product hour thereafter Modify of preparation
packages labeling
procedure, as
appropriate
BIBLIOGRAPHY. U.S. Food and Drug Administration. October
2003. Import sample collection assignment
We have placed the following references on for undeclared sulfites - DFP #04-08.
display in the Division of Dockets Management, Department of Health and Human Services,
Food and Drug Administration, 5630 Fishers Lane, Public Health Service, Food and Drug
rm. 1061, Rockville, MD 20852. You may see Administration, Center for Food Safety and
them at that location between 9 a.m. and 4 p.m., Applied Nutrition, College Park, MD.
Monday through Friday. As of March 29, 2011, U.S. Food and Drug Administration.
FDA had verified the Web site address for the Substances prohibited from use in human
references it makes available as hyperlinks from food. In Code of Federal Regulations,
the Internet copy of this guidance, but FDA is not CFR 21 74.1304, 74.2303, 81.10, 81.30. U.S.
responsible for any subsequent changes to Non- Government Printing Office, Washington, DC.
FDA Web site references after March 29, 2011. Wade, A. D. October 2005. Final status report
U.S. Congress. Food Allergen Labeling and on import sample collection assignment
Consumer Protection Act of 2004. Title II of for undeclared sulfites - DFP #04-08.
Public Law 108-282. http://www.fda.gov/Food/ (Memorandum). Department of Health and
LabelingNutrition/FoodAllergensLabeling/ Human Services, Public Health Service, Food
GuidanceComplianceRegulatoryInformation/ and Drug Administration, Center for Food
ucm106187.htm. Safety and Applied Nutrition, College Park, MD.
September 23, 1976. Termination of
provisional listing and certification of FD&C
Red No. 4 for use in maraschino cherries and
ingested drugs. In Federal Register, vol. 41,
no. 186.
U.S. Food and Drug Administration. July 9,
1986. Food labeling: declaration of sulfiting
agents. Final rule, CFR Part 101. In Federal
Register, 25012, vol. 51, no. 131.
U.S. Food and Drug Administration. May 29,
1992. Statement of policy: foods derived from
new plant varieties. In Federal Register, vol.
57, no. 104.
Substances prohibited from use in human
food (cyclamate and its derivatives). In Code
of Federal Regulations, CFR 21 189.135;
100.130. U.S. Government Printing Office,
Washington, DC.
Substances prohibited from use in human
food (safrole). In Code of Federal Regulations,
CFR 21 189.180. U.S. Government Printing
Office, Washington, DC.
383
NOTES:
384
CHAPTER 20: Metal Inclusion
UNDERSTAND THE POTENTIAL HAZARD. Alternatively, metal fragments may be detected

in the finished food by an electronic metal
Ingesting metal fragments can cause injury to detector. The use of electronic metal detectors
the consumer. These injuries may include dental is complex, especially with regard to stainless
damage, laceration of the mouth or throat, or steel, which is difficult to detect. The orientation
laceration or perforation of the intestine. FDAs of the metal object in the food affects the ability
Health Hazard Evaluation Board has supported of the equipment to detect it. For example, if a
regulatory action against products with metal detector is not properly calibrated and is set to
fragments 0.3 inch (7 mm) to 1 inch (25 mm) in detect a sphere 0.08 inch (2 mm) in diameter,
length. The Federal Food, Drug, and Cosmetic it may fail to detect a stainless steel wire that is
Act (the FFD&C Act) prohibits interstate commerce smaller in diameter but up to 0.9 inch (24 mm)
of adulterated foods (21 U.S.C. 331). Under the long, depending on the orientation of the wire as
FFD&C Act, a food containing foreign objects it travels through the detector. Processing factors,
is considered adulterated (21 U.S.C 342). See such as ambient humidity or product acidity,
FDAs Compliance Policy Guide, Sec. 555.425. may affect the conductivity of the product and
In addition, foreign objects that are less than 0.3 create an interference signal that may mask metal
inch (7 mm) may cause trauma or serious injury inclusion unless the detector is properly calibrated.
to persons in special risk groups, such as infants, You should consider these factors when calibrating
surgery patients, and the elderly. and using this equipment.
Metal-to-metal contact (e.g., mechanical cutting Finally, the hazard of metal inclusion may also
or blending operations and can openers) and be controlled by periodically examining the
equipment with metal parts that can break loose processing equipment for damage that can
(e.g., moving wire mesh belts, injection needles, contribute metal fragments to the product. This
screens and portion control equipment, and metal measure will not necessarily prevent metal
ties) are likely sources of metal that may enter fragments from being incorporated into the
food during processing. product, but it will enable you to separate products
that may have been exposed to metal fragments.
Control of metal inclusion Visually inspecting equipment for damaged or
Once introduced into a product, metal fragments missing parts may only be feasible with relatively
may be removed from the product by passing it simple equipment, such as band saws, small orbital
through a screen, magnet, or flotation tank. The blenders, and wire mesh belts. More complex
effectiveness of these measures depends on the equipment that contains many parts, some of
nature of the product. These measures are more which may not be readily visible, may not be
likely to be effective in liquids, powders, and suitable for visual inspection and may require
similar products in which the metal fragment will controls such as metal detection or separation.
not become imbedded.
385
DETERMINE WHETHER THE POTENTIAL 2. Can the hazard of metal inclusion that was
HAZARD IS SIGNIFICANT. introduced at an earlier step be eliminated or
reduced to an acceptable level at this processing
The following guidance will assist you in step?
determining whether metal inclusion is a Metal inclusion should also be considered
significant hazard at a processing step: a significant hazard at any processing step
1. Is it reasonably likely that metal fragments will be where a preventive measure is or can be
introduced at this processing step (e.g., do they used to prevent or eliminate the hazard
come in with the raw material or will the process (or is adequate to reduce the likelihood of
introduce them)? its occurrence to an acceptable level) if it
is reasonably likely to occur. Preventive
For example, under ordinary circumstances, measures for metal inclusion can include:
it would be reasonably likely to expect that
metal fragments could enter the process from Periodically checking equipment
the following sources as a result of worn, for damaged or missing parts;
damaged, or broken equipment parts: Passing the product through metal

Mechanical crabmeat pickers; detection or separation equipment.
Wire-mesh belts used to

Control of metal inclusion
convey products;
In most cases, you should assume that the
Saw blades used to cut
product will be consumed in a way that would
portions or steaks;
not eliminate any metal fragments that may
be introduced during the process. However,
Wire from mechanical mixer blades; in some cases, if you have assurance that the
Blades on mechanical chopping,
product will be run through a metal detector, for
filleting, or blending equipment;
detection of metal fragments, or through screens
or a magnet, for separation of metal fragments,
Rings, washers, nuts, or bolts from by a subsequent processor, you would not need
breading, batter, sauce cooling, liquid to identify metal inclusion as a significant hazard.
dispensing, and portioning equipment;
Example:
Injection needles; A primary processor produces frozen fish
Metal ties used to attach
blocks by mechanically heading, eviscerating,
tags or close bags;
and filleting fish in the round. The primary
processor sells exclusively to breaded fish stick
Can slivers from opening cans.
processors and has been given assurance by
Under ordinary circumstances, it would not these processors that the finished breaded
be reasonably likely to expect that metal product will be subjected to a metal detector.
fragments could enter the food from the The primary processor would not need to
following sources: identify metal inclusion as a significant
Utensils used for manual blending, hazard.
cutting, shucking, or gutting;
Metal processing tables or storage tanks.
386
IDENTIFY CRITICAL CONTROL POINTS. b. If the product will not be run through
such a device, you should have
The following guidance will also assist you procedures to periodically check the
in determining whether a processing step is a processing equipment for damage or lost
critical control point (CCP) for metal inclusion: parts at each processing step where metal
inclusion is identified as a significant
1. Will the product be run through a metal detector hazard. In this case, you should identify
or a separation device, such as a screen, those processing steps as CCPs.
magnet, or flotation tank, on or after the last step
where metal inclusion is identified as a significant Example:
hazard? A processor that cuts tuna steaks from
frozen loins has identified the band
a. If it will be, you should identify final saw cutting step as the only step that
metal detection or separation as the is reasonably likely to introduce metal
CCP. Then processing steps prior to fragments into the product. The processor
metal detection or separation would not should identify the band saw cutting step
require controls and would not need to as the CCP for this hazard and should
be identified as CCPs for the hazard of check the condition of the band saw blade
metal fragments. every 4 hours to ensure that it has not
been damaged.
Example:
A breaded fish processor uses saws, This control approach is a control strategy
breading and batter machines, and referred to in this chapter as Control
wire conveyor belts. The processor Strategy Example 2 - Equipment Checks.
should choose to use a metal detector Visually inspecting equipment for
on the finished product containers and damaged or missing parts may only be
should set the CCP for metal inclusion feasible with relatively simple equipment,
at the metal detection step for packaged such as band saws, small orbital blenders,
products. The processor would not need and wire mesh belts. More complex
to have CCPs for this hazard at each of equipment that contains many parts,
the previous processing steps at which some of which may not be readily visible,
there was a reasonable likelihood that may not be suitable for visual inspection
metal fragments could be introduced. and may require controls such as metal
detection or separation.
Strategy Example 1 - Metal Detection or
Separation.
The following guidance provides two examples
You should recognize that by setting the CCP of control strategies for metal inclusion. It is
at or near the end of the process, rather than important to note that you may select a control
at the point of potential metal fragment entry strategy that is different from those which
into the process, you are likely to have more are suggested, provided it complies with the
labor and materials invested in the product requirements of the applicable food safety laws
before the problem is detected or prevented. and regulations.
387
The following are examples of control strategies Continuous monitoring by the metal
included in this chapter: detection or separation device itself.

CONTROL STRATEGY PRIMARY SECONDARY Monitoring is performed by the metal
PROCESSOR PROCESSOR
detection or separation device itself. Visual
Metal detection or checks to ensure that the device is in place
separation
and operating may be performed by any
Equipment checks
person who has an understanding of the
CONTROL STRATEGY EXAMPLE 1 - METAL
DETECTION OR SEPARATION Establish Corrective Action Procedures.
Set Critical Limits. Take the following corrective action to a product
All of the product passes through an involved in a critical limit deviation:
operating metal detection or separation When processing occurred without an
device; operating metal detector or intact or
operating separation device:
AND
No detectable metal fragments are in the Hold all of the product produced
since controls were last confirmed as
product that passes through the metal
functioning properly until it can be run
detection or separation device.
through a metal detection or separation
device;
OR
The presence of an operating metal detection
Hold all of the product produced
or separation device; functioning properly until an inspection
AND of the processing equipment that could
The product for the presence of metal contribute metal fragments can be
fragments. completed to determine whether there
are any broken or missing parts (may
How Will Monitoring Be Done? be suitable only for relatively simple
Visual examination for the presence of an equipment);
operating electronic metal detector, magnet, OR
intact screen, or flotation tank;
Divert all of the product produced
AND since controls were last confirmed as
Product monitoring is performed by the functioning properly to a use in which it
metal detection or separation device itself. will be run through a properly calibrated
metal detector (e.g., divert fish fillets to a
How Often Will Monitoring Be Done (Frequency)? breading operation that is equipped with
Check that the metal detection or separation a metal detector);
device is in place and operating at the start OR
of each production day;
AND
Destroy all of the product produced
functioning properly;
388
OR Establish Verification Procedures.
Divert all of the product produced For metal detectors:
Develop sensitivity standards that are based
functioning properly to a non-food use.
on whether the potential hazard is ferrous,
AND non-ferrous, or stainless steel, or obtain such
When product is rejected by a metal detector: standards from the equipment manufacturer.
The standards should be designed to ensure
Hold and evaluate the rejected product;
that metal fragments will be detected in
OR the product. Conduct a validation study to
Rework the rejected product to eliminate identify the range of values for each of the
metal fragments;
processing factors over which the equipment
OR
will detect the standards that affect its
operation in your product (e.g., ambient
Destroy the rejected product;
humidity and product acidity), or obtain such

OR a study from the equipment manufacturer.
The study should identify the appropriate
Divert the rejected product to a non-food
equipment settings over the range of each of
use.
the processing factors. The study also should
AND consider the range of orientations in which
Take the following corrective actions to regain control the metal fragments may be present;
AND
Correct operating procedures to ensure Challenge the metal detector using validated
that the product is not processed without sensitivity standards daily, at the start of
an operating metal separation or detection production, every 4 hours during operation,
device; when processing factors (e.g., ambient
OR humidity and product acidity) change, and at
Attempt to locate and correct the source of the end of processing;
the fragments found in the product by the AND
metal detector or separated from the product
For all metal detection and separation devices:
stream by the magnets, screens, or other
devices; Review monitoring, corrective action,
Repair or replace the metal separation any critical limit deviations that occurred
device. were appropriately addressed.

Record documenting that the metal detection
or separation device is in place and
operating.
389
TABLE 20-1
CONTROL STRATEGY EXAMPLE 1 - METAL DETECTION OR SEPARATION

This table is an example of a portion of a Hazard Analysis Critical Control Point (HACCP) plan using Control Strategy Example 1 - Metal Detection or Separation.
This example illustrates how a frozen fish sticks processor can control metal fragment inclusion. It is provided for illustrative purposes only.
Metal inclusion may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., environmental
chemical contaminants and pesticides and Staphylococcus aureus toxin formation in the hydrated batter mix).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
CRITICAL MONITORING
CRITICAL LIMITS
POINT PREVENTIVE
MEASURE
Metal Metal All of the Metal detector Visual Daily, at Production If the product is Metal Conduct a
detection inclusion product present and examination start of employee processed without detector validation study
passes operating operations metal detection, operation to determine
390
through an hold it for metal log appropriate
operating detection settings for the metal
metal detector
detector Correct operating

procedures to Develop metal detector
ensure that the sensitivity standards
product is not
processed without Challenge the metal
No The Electronic Continuous Equipment metal detection detector with sensitivity
detectable product metal itself standards daily,
metal for the detector Rework to remove before start-up, every 4
fragments presence metal fragments hours
are in the of metal from any product during production,
product fragments rejected by the whenever
passing the metal detector processing factors
through the change, and at the end of
metal Identify the processing
detector source of the
metal found in the Review
product and monitoring,
fix the corrective action and
damaged verification records within
equipment 1 week of
preparation
CONTROL STRATEGY EXAMPLE 2 - EQUIPMENT Establish Corrective Action Procedures.
CHECKS
No broken or missing metal parts from Hold all of the product produced since the
equipment. previous satisfactory equipment check until it
can be run through a metal detector;
Establish Monitoring Procedures. OR
What Will be Monitored? Divert all of the product produced since
The presence of broken or missing metal the previous satisfactory equipment check
parts from equipment. to a use in which it will be run through a
properly calibrated metal detector (e.g., divert
How Will Monitoring Be Done? fish fillets to a breading operation that is
Visually check the equipment for broken or equipped with a metal detector);
missing parts. OR
Examples: Destroy all of the product produced since the
previous satisfactory equipment check;
Check saw blades for missing teeth or
sections;
OR
Check that all parts are present and
Divert all of the product produced since the
secure on blending equipment; previous satisfactory equipment check to a
Check for missing links or broken wires non-food use.
on metal belts.
AND
How Often Will Monitoring Be Done? Take the following corrective actions to regain control
Check before starting operations each day; over the operation after a critical limit deviation:
AND Stop production;

Check every 4 hours during operation; AND
AND If necessary, adjust or modify the equipment
to reduce the risk of recurrence.
Check at the end of operations each day;
Check whenever there is an equipment Records of equipment inspections.
malfunction that could increase the
likelihood that metal could be introduced Establish Verification Procedures.
into the food.
Review monitoring and corrective action records
Who Will Do the Monitoring? within 1 week of preparation to ensure they are
Any person who has a thorough complete and any critical limit deviations that
understanding of the proper condition of the occurred were appropriately addressed.
equipment.
391
TABLE 20-2
CONTROL STRATEGY EXAMPLE 2 - EQUIPMENT CHECKS

This table is an example of a portion of a HACCP plan using Control Strategy Example 2 - Equipment Checks. This example illustrates how a frozen tuna steak processor
can control metal fragment inclusion. It is provided for illustrative purposes only.
Metal inclusion may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., scombrotoxin
(histamine) and parasites).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
MONITORING
CRITICAL LIMITS
CRITICAL
POINT
MEASURE
Fish Metal No damage or Check the saw Visual Before Saw Stop production Equipment Review
cutting inclusion missing parts to blade check start-up, operator maintenance monitoring
392
the saw blade every 4 Adjust log and corrective
hours during equipment action records
operation, within 1
at the end of Hold all of the week of
day, and after product since preparation

an equipment the last visual
jam check until
it can be run
through a metal
detector
Destroy rejected
product
BIBLIOGRAPHY.

Olsen, A. R. 1998. Regulatory action criteria
for filth and other extraneous materials. I.
Review of hard or sharp foreign objects as
physical hazards in food. Regul. Toxicol.
Pharmacol. 28:181-189.
Foods - Adulteration involving hard or sharp
foreign objects. In Compliance Policy Guides,
Sec. 555.425. Department of Health and Human
Services, Public Health Service, Food and Drug
Administration, Center for Food Safety and
Applied Nutrition, College Park, MD.
393
NOTES:
394
CHAPTER 21: Glass Inclusion
UNDERSTAND THE POTENTIAL HAZARD. Control of glass inclusion

Once introduced into a product container, the
Ingesting glass fragments can cause injury to the hazard of glass fragments may be controlled
consumer. These injuries may include damage by (1) removing the fragments by cleaning the
to teeth, laceration of the mouth and throat, or containers before filling or (2) detecting the
perforation of the intestine. FDAs Health Hazard fragments by visual inspection before or after
Evaluation Board has supported regulatory action filling. Glass containers may be cleaned using
against products with glass 0.3 inch (7 mm) to 1 water or compressed air and inverted during or
inch (25 mm) in length. The Federal Food, Drug, after cleaning to help with glass removal. This
and Cosmetic Act (the FFD&C Act) prohibits measure may be suited only to processes that do
interstate commerce of adulterated foods (21 U.S.C. not use automated filling systems which include
331). Under the FFD&C Act, a food containing filled container conveyors or capping equipment,
foreign objects is considered adulterated (21 U.S.C because this equipment can result in glass
342). See FDAs Compliance Policy Guide, Sec. breakage after glass container cleaning.
555.425. Foreign objects that are less than 0.3 inch The effectiveness of visual inspection depends
(7 mm) may cause trauma or serious injury to on the nature of the product and the process. For
persons in special risk groups, such as infants, most fishery products, this measure also may be
surgery patients, and the elderly. suited only to processes that do not use automated
Glass inclusion can occur whenever processing filled container conveyors or capping equipment,
involves the use of glass containers. Normal because visual inspection after the glass containers
handling and packaging methods, especially are filled is not practical. However, for clear liquids
mechanized methods, can result in breakage. Most (e.g., some fish sauces), candling may be used to
products packed in glass containers are eaten with visually inspect all filled containers. Candling is a
minimal handling on the part of the consumer visual inspection process in which the container is
providing little opportunity to detect glass inclusion. illuminated from behind.
The purpose of this chapter is to address only the Alternatively, the hazard of glass inclusion
hazard of glass fragments that results from the use may be controlled by periodically checking
of glass containers. Glass fragments originating the processing areas and equipment for glass
from sources such as overhead light fixtures must breakage. This measure will not necessarily
be addressed where applicable in a prerequisite prevent glass fragments from being incorporated
sanitation program. The Procedures for the Safe into the product, but it will enable you to separate
and Sanitary Processing and Importing of Fish and products that may have been exposed to glass
Fishery Products regulation, 21 CFR 123 (called fragments.
the Seafood HACCP Regulation in this guidance
document), requires such a program.
395
DETERMINE WHETHER THE POTENTIAL Periodically monitoring processing
HAZARD IS SIGNIFICANT. lines for evidence of glass breakage;
Visually examining glass
The following guidance will assist you in containers containing transparent
determining whether glass inclusion is a liquid fishery products.
significant hazard at a processing step:

Intended use
1. Is it reasonably likely that glass fragments will be
In most cases, you should assume that the
introduced at this processing step (e.g., do they
product will be consumed in a way that would
come in with the raw material or will the process
not eliminate any glass fragments that may be
introduce them)?
introduced during the process.
For example, under ordinary circumstances,
it would be reasonably likely to expect that IDENTIFY CRITICAL CONTROL POINTS.
glass fragments could enter the process
during the processing of any product that is The following guidance will also assist you
packed in a glass container. These are likely in determining whether a processing step is a
areas of concern for glass containers: critical control point (CCP) for glass inclusion:
Glass container receiving; 1. Will the containers be visually inspected for
Glass container storage, when
detection of glass fragments or be cleaned (water
cases are moved mechanically;
or compressed air) and inverted on or after the
last step where glass inclusion is identified as a
Mechanized glass container cleaning; significant hazard?
Glass container conveyor lines;
a. If they will be, you should identify the
Glass container filling; final visual inspection or cleaning as the
Mechanized capping of glass containers; CCP. For example, you should visually
inspect the containers for broken glass
Pasteurizing product in glass containers. or clean and invert the containers after
2. Can glass fragments that were introduced at the processing steps where breakage is
an earlier step be eliminated or reduced to an reasonably likely to occur.
acceptable level at this processing step? For most fishery products, this method
Glass inclusion should be considered a may be suited only to processes that do
significant hazard at any processing step not use automated filling systems which
where a preventive measure is or can be include filled container conveyors or
used to prevent or eliminate the hazard capping equipment. However, if your
(or is adequate to reduce the likelihood product is a clear liquid, you should
of its occurrence to an acceptable level) if visually inspect all filled containers by
it is reasonably likely to occur. Preventive candling. In this case, the candling step
measures for glass inclusion can include: would be designated as the CCP.
Visually examining the

Example:
empty glass containers;
A processor that manually packs
caviar into glass jars has identified
Cleaning (water or compressed air) and the glass container receiving and
inverting the empty glass containers; storage steps as the only steps that
are reasonably likely to introduce
396
glass fragments into the process. The jams. The processor should identify
processor should visually inspect the finished product candling step as
each jar prior to the filling process. the CCP for this hazard.
The processor should also collect a
representative sample of inspected
glass jars at the start of processing,
every 4 hours during processing, at
Cleaning or Visual Inspection of
the end of processing and after any
Containers.
jams. The processor should identify
the container inspection step as the You should recognize that by setting
CCP for this hazard. the CCP at or near the end of the
process, rather than at the point of
Example:
potential glass fragment entry into
Another processor that manually
the process, you are likely to have
packs caviar has identified the glass
more labor and materials invested
container receiving and storage steps
in the product before the problem is
as the only steps that are reasonably
detected or prevented.
likely to introduce glass fragments
into the process. Just before filling, b. If the containers will not be visually
the empty glass jars are inverted and inspected or cleaned and inverted
cleaned using filtered, compressed on or after the last step, you should
air. The processor should also collect periodically check the processing areas
a representative sample of cleaned and equipment for glass breakage at each
glass jars at the start of processing, processing step where glass inclusion
every 4 hours during processing, at is identified as a significant hazard. In
the end of processing and after any this case, those processing steps should
jams. The processor should identify be CCPs. It would not ordinarily be
the container cleaning and inverting necessary to identify these steps as
step as the CCP for this hazard. CCPs in addition to identifying a final
inspection or cleaning step as a CCP.
Example:
A processor that bottles a transparent Example:
fish sauce has identified glass A processor bottles clam juice and has
container receiving and storage, identified glass container receiving
mechanical conveyor lines, and storage, mechanical conveyor
mechanical filling, and mechanical lines, mechanical filling, and
capping as processing steps that mechanical capping as processing
are reasonably likely to introduce steps reasonably likely to introduce
glass fragments into the process. The glass fragments into the process. The
processor should visually inspect processor should visually inspect
each filled and capped bottle for all processing areas for broken
visible glass fragments by candling. glass at start-up and once every 4
The processor should also collect a hours during processing. If broken
representative sample of inspected glass is observed, the line should be
glass jars at the start of processing, stopped, the glass removed and the
every 4 hours during processing, at product that has moved through
the end of processing and after any that area since the last inspection
397
placed on hold to be filtered or Establish Monitor Procedures.
destroyed. The processor should
identify glass container receiving and What Will Be Monitored?
storage, mechanical conveyor lines, The presence of an operating glass container
mechanical filling, and mechanical cleaning or inspection process;
capping as the CCPs for this hazard.
AND
This control approach is a control Cleaned or inspected containers for the
strategy referred to in this chapter presence of glass fragments.
Equipment Checks. How Will Monitoring Be Done?
Visual examination for the presence of
DEVELOP A CONTROL STRATEGY. equipment and employees for cleaning or
inspecting glass containers;
The following guidance provides examples of AND
two control strategies for glass inclusion. You
Visual examination of a representative
may select a control strategy that is different from
sample of glass containers after cleaning or
those which are suggested, provided it complies
inspecting.
with the requirements of the applicable food
safety laws and regulations. The following are How Often Will Monitoring Be Done?
examples of control strategies included in this Check that the glass container cleaning or
chapter: inspection process is in place and operating
at the start of each production day and after
each shift change;
CONTROL STRATEGY PRIMARY SECONDARY AND
PROCESSOR PROCESSOR
Examine a representative sample of glass
Cleaning or visual containers after cleaning or inspection daily,
inspection of containers
at the start of processing, every 4 hours
Equipment checks
during processing, at the end of processing,
and after any breakdowns.
CONTROL STRATEGY EXAMPLE 1 - CLEANING OR Who Will Do the Monitoring?

VISUAL INSPECTION OF CONTAINERS Any person who has an understanding of the
All containers pass through an operating Establish Corrective Action Procedures.
glass container inspection or cleaning
process;
AND Hold and evaluate all of the product
No detectable glass fragments are in glass processed since controls were last confirmed
containers that pass through the glass as functioning properly;
container inspection or cleaning process.
OR
Destroy all of the product produced since
controls were last confirmed as functioning
properly;
398
OR
Divert all of the product produced since
properly to a non-food use;
OR
Rework all of the product produced since
properly to eliminate glass fragments by
visually examining for the presence of glass
or by running the product through a filter or
screen.
AND
Correct operating procedures to ensure that
the product is not processed without an
operating glass container visual inspection or
cleaning process;
AND/OR
Stop operations and locate and correct the
source of the glass fragments.

Record documenting that the glass container
cleaning or inspection process is in place
and operating;
AND
Record documenting the visual examination
of glass containers after cleaning or
inspection.

399
TABLE 21-1
CONTROL STRATEGY EXAMPLE 1 - CLEANING OR VISUAL INSPECTION OF CONTAINERS

This table is an example of a portion of a HACCP plan using Control Strategy Example 1 - Cleaning or Visual Inspection of Containers. This example illustrates how a pro
cessor of pickled herring in glass jars can control glass inclusion. It is provided for illustrative purposes only.
Glass inclusion may be only one of several significant hazards for this product. Refer to Tables 3-2 and 3-4 (Chapter 3) for other potential hazards (e.g., parasites, scombro
toxin (histamine), environmental chemical contaminants and pesticides, unapproved food and color additives, metal fragments, Clostridium botulinum toxin formation, and
pathogen growth as a result of temperature abuse).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
MONITORING
CRITICAL LIMITS
CRITICAL
POINT
MEASURE
Jar Glass All The Visual check At the start of Quality Hold all of the Glass Review
cleaning and inclusion containers presence of the the control staff product for an inspection monitoring
inversion pass through glass cleaning Visual production and evaluation record and corrective
400
an operating process examination shift changes action records
glass cleaning of a Correct within 1 week
process The representative One dozen jars operating of preparation
presence of sample of glass after cleaning procedures to

No glass glass fragments containers after daily, at the ensure that the
fragments in cleaned cleaning start of product is not
are in glass containers processing, processed
containers every 4 without jar
passing through hours during cleaning
the glass processing,
container at the end of Stop
cleaning processing, operations
process and after any and locate and
breakdowns correct the
source of the
glass fragments
CONTROL STRATEGY EXAMPLE 2 - EQUIPMENT Establish Corrective Action Procedures.
CHECKS
No broken glass on or near equipment. Hold and evaluate all of the product
produced since the previous satisfactory
Establish Monitoring Procedures. equipment check;
What Will Be Monitored? OR
The presence of broken glass on or near Destroy all of the product produced since the
equipment. previous satisfactory equipment check;
How Will Monitoring Be Done? OR
Visually check the glass handling areas for Divert all of the product produced since the
broken glass. previous satisfactory equipment check to a
Examples:
non-food use;
Check pallets and packing cases

OR
for damage, broken jars, and glass Rework the product packaged since the
fragments; previous satisfactory equipment check by
Check mechanical glass cleaning area for visually examining for the presence of glass
broken glass;
or by running the product through a filter or
Check floors around conveyors for broken
screen.
glass;
AND
Check filling and capping equipment and
Take one of the following corrective actions to regain

surrounding floors for broken glass;
control over the operation after a critical limit deviation:
Check glass containers for breakage
Stop production;
after exposure to heat (e.g., after heated
product is added or after pasteurization). AND
How Often Will Monitoring Be Done (Frequency)? If necessary, adjust or modify the materials,
Check before starting operations each day; equipment, and/or processes to reduce the
risk of recurrence;
AND
Check at least every 4 hours during AND
operation; Remove all broken glass from the equipment
and surrounding area.
AND
Check at the end of operations each day;
AND Records of equipment and processing area
Check whenever there is an equipment inspections.
malfunction that could increase the likelihood
that glass containers could be damaged. Establish Verification Procedures.
Who Will Do the Monitoring? Review monitoring and corrective action
Any person who has a thorough records within 1 week of preparation
understanding of the proper condition of the to ensure they are complete and any
equipment and surrounding area. critical limit deviations that occurred were
401
TABLE 21-2
CONTROL STRATEGY EXAMPLE 2 - EQUIPMENT CHECKS

This table is an example of a portion of a HACCP plan using Control Strategy Example 2 - Equipment Checks. This example illustrates how a processor of clam juice in
glass jars can control glass inclusion. It is provided for illustrative purposes only.
Glass inclusion may be only one of several significant hazards for this product. Refer to Tables 3-3 and3-4 (Chapter 3) for other potential hazards (e.g., pathogens from the
harvest area, environmental chemical contaminants and pesticides, natural toxins, unapproved food and color additives, and metal fragments).
Example Only
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
MONITORING
CRITICAL LIMITS
CRITICAL
POINT
MEASURE
Glass bottle Glass No broken glass Broken glass Visual check Before Filler Stop Glass Review
receiving, inclusion on or around on or around start-up, every Operator production inspection monitoring
mechanical processing equipment 4 hours during record and corrective
402
bottle equipment operations, Determine the action records
conveyors, after source of the within 1 week
mechanical equipment broken glass of preparation
filling, and jams, and end

mechanical of day Adjust
capping equipment that
caused the
breakage, if
necessary
Remove broken
glass from the
area
Hold and
evaluate the
product since
the last
satisfactory
check
BIBLIOGRAPHY.

Olsen, A. R. 1998. Regulatory action criteria

for filth and other extraneous materials. I.
Review of hard or sharp foreign objects as
physical hazards in food. Regul. Toxicol.
Pharmacol. 28:181-189.
Foods Adulteration involving hard or sharp
foreign objects. In Compliance Policy Guide,
Sect. 555.425. Department of Health and
Human Services, Public Health Service, Food
and Drug Administration, Center for Food
Safety and Applied Nutrition, College Park, MD.
403
NOTES:
404
APPENDIX 1: Forms
This appendix contains a blank model Hazard

Analysis Critical Control Point (HACCP) Plan Form
and a blank model Hazard Analysis Worksheet.
APPENDIX 1: Forms
405
HACCP PLAN FORM
FIRM NAME: PRODUCT DESCRIPTION:
FIRM ADDRESS: METHOD OF DISTRIBUTION AND STORAGE:
INTENDED USE AND CONSUMER:
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
MONITORING
CRITICAL
CRITICAL LIMITS
406
HAZARD(S) ACTION(S)
MEASURE
APPENDIX 1: Forms
SIGNATURE OF COMPANY OFFICIAL: __________________________________________________________ DATE: _________________________
PAGE 1 OF ______________________________
HACCP PLAN FORM
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
MONITORING
CRITICAL
CRITICAL LIMITS
HAZARD(S) ACTION(S)
MEASURE
407
APPENDIX 1: Forms
SIGNATURE OF COMPANY OFFICIAL: __________________________________________________________ DATE: _________________________
PAGE 1 OF _____________________________
APPENDIX 1: FORMS B
HAZARD ANALYSIS WORKSHEET
FIRM NAME: PRODUCT DESCRIPTION:
FIRM ADDRESS: METHOD OF DISTRIBUTION AND STORAGE:
INTENDED USE AND CONSUMER:
(1) (2) (3) (4) (5) (6)
IDENTIFY POTENTIAL
ARE ANY POTENTIAL
BIOLOGICAL, IS THIS STEP A
FOOD SAFETY WHAT PREVENTIVE
CHEMICAL, AND JUSTIFY YOUR CRITICAL CONTROL
INGREDIENT/PROCESSING HAZARDS SIGNIFICANT MEASURE(S) CAN BE
408
PHYSICAL HAZARDS DECISION FOR POINT?
STEP AT THIS STEP? APPLIED FOR THE
ASSOCIATED WITH THIS COLUMN 3
SIGNIFICANT HAZARDS?
PRODUCT AND (YES/NO)
APPENDIX 1: Forms
(YES/NO)
PROCESS
HAZARD ANALYSIS WORKSHEET
(1) (2) (3) (4) (5) (6)
IDENTIFY POTENTIAL
ARE ANY POTENTIAL
BIOLOGICAL, IS THIS STEP A
FOOD SAFETY WHAT PREVENTIVE
CHEMICAL, AND JUSTIFY YOUR CRITICAL CONTROL
INGREDIENT/PROCESSING HAZARDS SIGNIFI MEASURE(S) CAN BE
PHYSICAL HAZARDS DECISION FOR POINT?
STEP CANT AT THIS STEP? APPLIED FOR THE
ASSOCIATED WITH THIS COLUMN 3
SIGNIFICANT HAZARDS?
PRODUCT AND (YES/NO)
(YES/NO)
PROCESS
409
APPENDIX 1: Forms
PAGE 1 OF _____________________________
NOTES:
APPENDIX 1: Forms
410
APPENDIX 2: Sample Product Flow Diagram
This appendix contains a sample product flow

diagram that can be used as a model when you
develop your own flow diagram.
411
CONTROL STRATEGY
FIGURE A-1
SAMPLE PRODUCT FLOW DIAGRAM (SALMON FILLETS)
RECEIVING
$
FISH PUMP
$
SORT
$
REFRIGERATED STORAGE
$
HEAD
$
GUT
$
WASH
$
FILLET
$
INSPECT
$
FREEZE
$
GLAZE
$
WEIGH/PACKAGE
$
FROZEN STORAGE
$
SHIP
412
APPENDIX 3: Critical Control Point Decision Tree
This appendix contains a decision tree that may

be used to assist you with the identification of
critical control points (CCPs). You should not rely
exclusively on the decision tree, because error
may result.
413
FIGURE A-2: CCP DECISION TREE
DOES THIS STEP INVOLVE A HAZARD OF SUFFICIENT RISK AND SEVERITY TO

Q1.
WARRENT ITS CONTROL?
YES NO NOT A CCP
Q2. DOES CONTROL MEASURE FOR THE HAZARD EXIST AT THIS STEP?
MODIFY
THIS STEP,
YES NO
PROCESS OR
PRODUCT
IS CONTROL AT
THIS STEP
NECESSARY YES
FOR
SAFETY?
NO NOT A CCP STOP*
IS CONTROL AT THIS STEP NECESSARY TO PREVENT, ELIMINATE OR

Q3.
REDUCE THE RISK OF THE HAZARD TO CONSUMERS?
YES NO NOT A CCP STOP*
CCP
This decision tree is derived from one that was developed by the National Advisory Committee on
Microbiological Criteria for Foods.
414
BIBLIOGRAPHY.

National Advisory Committee on
Hazard Analysis and Critical Control Point
System. Intl. J. Food Microbiol. 16:1-23.
415
NOTES:
416
APPENDIX 4: Bacterial Pathogen Growth and Inactivation
This appendix contains information on the growth above 50F (10C) but below 135F (57.2C))
and inactivation of bacterial pathogens. should be limited to 2 hours (3 hours if
Staphylococcus aureus (S. aureus) is the only
Table A-1 contains information on the minimum
pathogen of concern),
water activity (aw), acidity (pH), and temperature;
the maximum, pH, water phase salt, and OR
temperature; and oxygen requirements that will
Alternatively, exposure time (i.e., time at
sustain growth for the bacterial pathogens that are
internal temperatures above 50F (10C) but
of greatest concern in seafood processing. Data
below 135F (57.2C)) should be limited to
shown are the minimum or maximum values,
4 hours, as long as no more than 2 of those
the extreme limits reported among the references
hours are between 70F (21.1C) and 135F
cited. These values may not apply to your
(57.2C);
processing conditions.
OR
Table A-2 contains information on maximum,
cumulative time and internal temperature If at any time the product is held at internal
combinations for exposure of fish and fishery temperatures above 50F (10C) but never
products that, under ordinary circumstances, will above 70F (21.1C), exposure time at internal
be safe for the bacterial pathogens that are of temperatures above 50F (10C) should be
greatest concern in seafood processing. These limited to 5 hours (12 hours if S. aureus is the
maximum, cumulative exposure times are derived only pathogen of concern);
from published scientific information. OR
Because the nature of bacterial growth is The product is held at internal temperatures
logarithmic, linear interpolation using the below 50F (10C) throughout processing,
time and temperature guidance may not be OR
appropriate. Furthermore, the food matrix effects
bacterial growth (e.g., presence of competing Alternatively, the product is held at ambient
microorganisms, available nutrients, growth air temperatures below 50F (10C) throughout
restrictive agents). Consideration of such attributes processing.
is needed when using the information in Tables For cooked, ready-to-eat products:
A-1 and A-2. If at any time the product is held at internal
In summary, Table A-2 indicates that: temperatures above 80F (26.7C), exposure
time (i.e., time at internal temperatures above
For raw, ready-to-eat products:
50F (10C) but below 135F (57.2C)) should
If at any time the product is held at internal be limited to 1 hour (3 hours if S. aureus is
temperatures above 70F (21.1C), exposure the only pathogen of concern),
time (i.e., time at internal temperatures
OR
417
Alternatively, if at any time the product is at these temperatures and the time necessary
held at internal temperatures above 80F for significant growth is longer than would be
(26.7C), exposure time (i.e., time at internal reasonably likely to occur in most fish and fishery
temperatures above 50F (10C) but below product processing steps. However, if you have
135F (57.2C)) should be limited to 4 hours, processing steps that occur at these temperatures
as long as no more than 1 of those hours is that approach the maximum cumulative exposure
above 70F (21.1C); times listed in Table A-2 below for the pathogenic
bacteria of concern in your product, you should
OR
consider development of a critical limit for
If at any time the product is held at internal control at these temperatures.
temperatures above 70F (21.1C) but never
above 80F (26.7C), exposure time at It is not possible to furnish recommendations
internal temperatures above 50F (10C) for each pathogenic bacteria, process, type of
should be limited to 2 hours (3 hours if S. fish and fishery product, and temperature or
aureus is the only pathogen of concern), combination of temperatures. Programmable
models to predict growth rates for certain
OR pathogens associated with various foods under
Alternatively, if the product is never held at differing conditions have been developed by
internal temperatures above 80F (26.7C), the U.S. Department of Agricultures (Pathogen
exposure times at internal temperatures Modeling Program (PMP)) and the United
above 50F (10C) should be limited to 4 Kingdoms (Food MicroModel (FMM) program).
hours, as long as no more than 2 of those These programs can provide growth curves
hours are above 70F (21.1C); for selected pathogens. You indicate the
conditions, such as pH, temperature, and salt
OR
concentration that you are interested in and the
If at any time the product is held at internal models provide pathogen growth predictions
temperatures above 50F (10C) but never (e.g., growth curve, time of doubling, time of
above 70F (21.1C), exposure time at internal lag phase, and generation time). FDA does not
temperatures above 50F (10C) should be endorse or require the use of such modeling
limited to 5 hours (12 hours if S. aureus is programs, but recognizes that the predictive
the only pathogen of concern); growth information they provide may be of
OR assistance to some processors. However, you
The product is held at internal temperatures are cautioned that significant deviations between
below 50F (10C) throughout processing, actual microbiological data in specific products
and the predictions do occur, including those for
OR the lag phase of growth. Therefore, you should
Alternatively, the product is held at ambient validate the time and temperature limits derived
air temperatures below 50F (10C) from such predictive models.
throughout processing. Table A-3 contains information on the
Note that the preceding recommended destruction of Listeria monocytogenes (L.
critical limits do not address internal product monocytogenes). Lethal rate, as used in this
temperatures between 40F (4.4C), the table, is the relative lethality of 1 minute at the
recommended maximum storage temperature designated internal product temperature as
for refrigerated fish and fishery products, compared with the lethality of 1 minute at the
and 50F (10C). That is because growth of reference internal product temperature of 158F
foodborne pathogenic bacteria is very slow (70C) (i.e., z = 13.5F (7.5C)). For example, 1
418
minute at 145F (63C) is 0.117 times as lethal as
1 minute at 158F (70C). The times provided
are the length of time at the designated internal
product temperature necessary to deliver a 6D
process for L. monocytogenes. The length of
time at a particular internal product temperature
needed to accomplish a six logarithm reduction
in the number of L. monocytogenes (6D) is,
in part, dependent upon the food in which it
is being heated. The values in the table are
generally conservative and apply to all foods.
You may be able to establish a shorter process
time for your food by conducting scientific
thermal death time studies. Additionally, lower
degrees of destruction may be acceptable in
your food if supported by a scientific study of
the normal initial levels in the food. It is also
possible that higher levels of destruction may be
necessary in some foods, if especially high initial
levels are anticipated.
Table A-4 contains information on the destruction
of Clostridium botulinum (C. botulinum) type B
(the most heat- resistant form of non-proteolytic
C. botulinum). Lethal rate, as used in this table, is
the relative lethality of 1 minute at the designated
internal product temperature as compared with
the lethality of 1 minute at the reference product
internal temperature of 194F (90C) (i.e., for
temperatures less than 194F (90C), z = 12.6F
(7.0C); for temperatures above 194F (90C),
z = 18F (10C)). The times provided are the
length of time at the designated internal product
temperature necessary to deliver a 6D process
for C. botulinum. The values in the table are
generally conservative. However, these values
may not be sufficient for the destruction of non
proteolytic C. botulinum in dungeness crabmeat
because of the potential protective effect of
lysozyme. You may be able to establish a
shorter process time for your food by conducting
scientific thermal death time studies. Additionally,
lower degrees of destruction may be acceptable
in your food if supported by a scientific study of
the normal innoculum in the food.
419
TABLE A-1
LIMITING CONDITIONS FOR PATHOGEN GROWTH
MIN. AW MIN. MAX. MAX. % WATER OXYGEN
PATHOGEN MIN. TEMP. MAX. TEMP.
(USING SALT) pH pH PHASE SALT REQUIREMENT
BACILLUS CEREUS 0.92 4.3 9.3 10 39.2F 131F1 facultative
4C 55C anaerobe4
CAMPYLOBACTER JEJUNI 0.987 4.9 9.5 1.7 86F 113F micro
30C 45C aerophile2
CLOSTRIDIUM BOTULINUM, 0.935 4.6 9 10 50F 118.4F anaerobe3
TYPE A, AND PROTEOLYTIC 10C 48C
TYPES B AND F
CLOSTRIDIUM BOTULINUM, 0.97 5 9 5 37.9F 113F anaerobe3
TYPE E, AND NON 3.3C 45C
PROTEOLYTIC
TYPES B AND F
CLOSTRIDIUM PERFRINGENS 0.93 5 9 7 50F 125.6F anaerobe3
10C 52C
PATHOGENIC STRAINS OF 0.95 4 10 6.5 43.7F 120.9F facultative
ESCHERICHIA COLI 6.5C 49.4C anaerobe4
LISTERIA 0.92 4.4 9.4 10 31.3F 113F facultative
MONOCYTOGENES -0.4C 45C anaerobe4
SALMONELLA SPP. 0.94 3.7 9.5 8 41.4F 115.2F facultative
420
5.2C 46.2C anaerobe4
SHIGELLA SPP. 0.96 4.8 9.3 5.2 43F 116.8F facultative
6.1C 47.1C anaerobe4
STAPHYLOCOCCUS AUREUS 0.83 4 10 20 44.6F 122F facultative
GROWTH 7C 50C anaerobe4
STAPHYLOCOCCUS AUREUS 0.85 4 9.8 10 50F 118F facultative
TOXIN FORMATION 10C 48C anaerobe4
VIBRIO CHOLERAE 0.97 5 10 6 50F 109.4F facultative

10C 43C anaerobe4
VIBRIO 0.94 4.8 11 10 41F 113.5F facultative
PARAHAEMOLYTICUS 5C 45.3C anaerobe4
VIBRIO VULNIFICUS 0.96 5 10 5 46.4F 109.4F facultative
8C 43C anaerobe4
YERSINIA ENTEROCOLITICA 0.945 4.2 10 7 29.7F 107.6F facultative
-1.3C 42C anaerobe4
1. Has significantly delayed growth (>24 hours) at 131F (55C).
2. Requires limited levels of oxygen.
3. Requires the absence of oxygen.
4. Grows either with or without oxygen.
TABLE A-2
TIME AND TEMPERATURE GUIDANCE FOR
CONTROLLING PATHOGEN GROWTH AND TOXIN FORMATION IN FISH AND FISHERY PRODUCTS
MAXIMUM CUMULATIVE
POTENTIALLY HAZARDOUS CONDITION PRODUCT TEMPERATURE
EXPOSURE TIME
GROWTH AND TOXIN FORMATION 39.2-43F (4-6C) 5 days
BY BACILLUS CEREUS 44-59F (7-15C) 1 day
60-70F (16-21C) 6 hours
Above 70F (21C) 3 hours
GROWTH OF CAMPYLOBACTER JEJUNI 86-93F (30-34C) 48 hours
GERMINATION, GROWTH, AND TOXIN 50-70F (10-21C) 11 hours
FORMATION BY CLOSTRIDIUM BOTULINUM Above 70F (21C) 2 hours
TYPE A, AND PROTEOLYTIC TYPES B AND F
GERMINATION, GROWTH, AND TOXIN 37.9-41F (3.3-5C) 7 days
FORMATION BY CLOSTRIDIUM BOTULINUM 42-50F (6-10C) 2 days
TYPE E, AND NON-PROTEOLYTIC 51-70F (11-21C) 11 hours
TYPES B AND F Above 70F (21C) 6 hours
GROWTH OF CLOSTRIDIUM PERFRINGENS 50-54F (10-12C) 21 days
55-57F (13-14 C) 1 day
58-70F (15-21C) 6 hours1
GROWTH OF PATHOGENIC STRAINS OF 43.7-50F (6.6-10C) 2 days
ESCHERICHIA COLI 51-70F (11-21C) 5 hours
GROWTH OF LISTERIA MONOCYTOGENES 31.3-41F (-0.4-5C) 7 days
42-50F (6-10C) 1 day
51-70F (11-21C) 7 hours
71-86F (22-30C) 3 hours
Above 86F (30C) 1 hour
GROWTH OF SALMONELLA SPECIES 41.4-50F (5.2-10C) 2 days
51-70F (11-21C) 5 hours
GROWTH OF SHIGELLA SPECIES 43-50F (6.1-10C) 2 days
51-70F (11-21C) 5 hours
GROWTH AND TOXIN FORMATION BY 50F (7-10C) 14 days
STAPHYLOCOCCUS AUREUS 51-70F (11-21C) 12 hours1
GROWTH OF VIBRIO CHOLERAE 50F (10C) 21 days
51-70F (11-21C) 6 hours
71-80F (22-27C) 2 hours
Above 80F (27C) 1 hour2
GROWTH OF VIBRIO PARAHAEMOLYTICUS 41-50F (5-10C) 21 days
51-70F (11-21C) 6 hours
71-80F (22-27C) 2 hours
GROWTH OF VIBRIO VULNIFICUS 46.4-50F (8-10C) 21 days
51-70F (11-21C) 6 hours
71-80F (22-27C) 2 hours
GROWTH OF YERSINIA ENTEROCOLITICA 29.7-50F (-1.3-10C) 1 day
51-70F (11-21C) 6 hours
Above 70F (21C) 2.5 hours
1. Additional data needed.
2. Applies to cooked, ready-to-eat foods only.
421
TABLE A-3
INACTIVATION OF LISTERIA MONOCYTOGENES
INTERNAL PRODUCT INTERNAL PRODUCT
LETHAL RATE TIME FOR 6D PROCESS (MINUTES)
TEMPERATURE (F) TEMPERATURE (C)
145 63 0.117 17.0

147 64 0.158 12.7
149 65 0.215 9.3
151 66 0.293 6.8
153 67 0.398 5.0
154 68 0.541 3.7
156 69 0.736 2.7
158 70 1.000 2.0
160 71 1.359 1.5
162 72 1.848 1.0
163 73 2.512 0.8
165 74 3.415 0.6
422
167 75 4.642 0.4
169 76 6.310 0.3
171 77 8.577 0.2
172 78 11.659 0.2
174 79 15.849 0.1
176 80 21.544 0.09

178 81 29.286 0.07
180 82 39.810 0.05
182 83 54.116 0.03
183 84 73.564 0.03
185 85 100.000 0.02
Note: z = 13.5F (7.5C).
TABLE A-4
INACTIVATION OF NON-PROTEOLYTIC CLOSTRIDIUM BOTULINUM TYPE B
INTERNAL PRODUCT INTERNAL PRODUCT
LETHAL RATE* TIME FOR 6D PROCESS (MINUTES)
TEMPERATURE (F) TEMPERATURE (C)
185 85 0.193 51.8
187 86 0.270 37.0
189 87 0.370 27.0
190 88 0.520 19.2
192 89 0.720 13.9
194 90 1.000 10.0
196 91 1.260 7.9
198 92 1.600 6.3
199 93 2.000 5.0
201 94 2.510 4.0
203 95 3.160 3.2
205 96 3.980 2.5
207 97 5.010 2.0
423
208 98 6.310 1.6
210 99 7.940 1.3
212 100 10.000 1.0
Note: For temperatures less than 194F (90C), z = 12.6F (7.0C); for temperatures above 194F (90C), z = 18F (10C).
*Note: These lethal rates and process times may not be sufficient for the destruction of non-proteolytic C. botulinum in dungeness crabmeat because of the potential that substances that may be naturally
present, such as lysozyme, may enable the pathogen to more easily recover from heat damage.

BIBLIOGRAPHY. Augustin, J. C., V. Zuliani, M. Cornu, and
L. Guillier. 2005. Growth rate and growth
We have placed the following references on probability of Listeria monocytogenes
display in the Division of Dockets Management, in dairy, meat and seafood products in
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NOTES:
438
APPENDIX 5: FDA and EPA Safety Levels in Regulations and Guidance
This appendix lists FDA and EPA levels relating

to safety attributes of fish and fishery products
published in regulations and guidance. In many
cases, these levels represent the point at or above
which the agency will take legal action to remove
products from the market. Consequently, the
levels contained in this table may not always be
suitable for critical limits.
439
TABLE A-5
FDA AND EPA SAFETY LEVELS IN REGULATIONS AND GUIDANCE
PRODUCT LEVEL
READY-TO-EAT FISHERY PRODUCTS Listeria monocytogenes - presence of organism in

(MINIMAL COOKING BY CONSUMER) 25 gram sample.
ALL FISH Salmonella spp. - presence of organism in 25 gram sample.
ALL FISH 1. Staphylococcus aureus - positive for staphylococcal enterotoxin;

or
2. Staphylococcus aureus - level equal to or greater than 104/g
(MPN).
READY-TO-EAT FISHERY PRODUCTS Vibrio cholerae - presence of toxigenic O1 or O139 or non-O1
(MINIMAL COOKING BY CONSUMER) and
non-O139 in 25 gram sample.
READY-TO-EAT FISHERY PRODUCTS Vibrio parahaemolyticus - levels equal to or greater than 1 x 104/g
(MINIMAL COOKING BY CONSUMER) (Kanagawa positive or negative).
POST-HARVEST PROCESSED CLAMS, MUSSELS, OYSTERS, Vibrio parahaemolyticus - levels less than 30/g (MPN).
AND WHOLE AND ROE-ON SCALLOPS, FRESH OR FROZEN,
THAT MAKE A LABEL CLAIM OF PROCESSED TO REDUCE
VIBRIO PARAHAEMOLYTICUS TO NON-DETECTABLE LEVELS
COOKED READY-TO-EAT FISHERY PRODUCTS Vibrio vulnificus - presence of organism.
(MINIMAL COOKING BY CONSUMER)
POST-HARVEST PROCESSED CLAMS, MUSSELS, OYSTERS, Vibrio vulnificus - levels less than 30/g (MPN).
AND WHOLE AND ROE-ON SCALLOPS, FRESH OR FROZEN,
THAT MAKE A LABEL CLAIM OF PROCESSED TO REDUCE
VIBRIO VULNIFICUS TO NON-DETECTABLE LEVELS
ALL FISH Clostridium botulinum
1. Presence of viable spores or vegetative cells in products that
will
support their growth; or
2. Presence of toxin.
CLAMS, OYSTERS, MUSSELS, AND WHOLE AND ROE-ON Microbiological
SCALLOPS, FRESH OR FROZEN 1. E. coli or fecal coliform - 1 or more of 5 subs exceeding MPN
of 330/100 g or 2 or more exceeding 230/100 g;
2. APC - 1 or more of 5 subs exceeding 1,500,000/g or 2 or more
exceeding 500,000/g.
TUNA, MAHI-MAHI, AND RELATED FISH Histamine - 500 ppm based on toxicity; 50 ppm defect action
level.
ALL FISH Polychlorinated Biphenyls (PCBs) - 2.0 ppm (edible portion).1
FINFISH AND SHELLFISH Aldrin and dieldrin - 0.3 ppm (edible portion).
FROG LEGS Benzene Hexachloride (BHC) - 0.3 ppm (edible portion).
OYSTERS Carbaryl1 - 0.25 ppm.
ALL FISH Chlordane - 0.3 ppm (edible portion).
ALL FISH Chlordecone - 0.4 ppm crabmeat and 0.3 ppm in other fish
(edible portion).
ALL FISH DDT, TDE, and DDE - 5.0 ppm (edible portion).
FARM-RAISED, FRESHWATER FISH Diuron and its matabolites1 - 2.0 ppm.
ALL FISH Endothall and

its monomethyl ester - 0.1 ppm.1
ALL FISH Heptachlor and heptachlor epoxide - 0.3 ppm (edible portion).
ALL FISH Mirex - 0.1 ppm (edible portion).
ALL FISH Diquat - 0.1 ppm.1
440
TABLE A-5
FDA AND EPA SAFETY LEVELS IN REGULATIONS AND GUIDANCE
PRODUCT LEVEL
FINFISH AND CRAYFISH Fluridone - 0.5 ppm.1
FINFISH Glyphosate - 0.25 ppm.1
SHELLFISH Glyphosate - 3.0 ppm.1
FINFISH Simazine and its metabolites - 12 ppm.1
ALL FISH 2,4-D - 1.0 ppm.1
CHANNEL CATFISH AND FRESHWATER-REARED SALMONIDS Florfenicol - 1.0 ppm (muscle tissue).1
FINFISH AND LOBSTER Oxytetracycline - 2.0 ppm (muscle tissue).1
TROUT Sulfamerazine - no residue permitted.1
SALMONIDS AND CATFISH Sulfadimethoxine/ormetoprim combination - 0.1 ppm for each

drug
(edible tissue).1
ALL FISH Drugs prohibited for extra-label use in animals - no residue per
mitted:
Chloramphenicol;
Clenbuterol;
Diethylstilbestrol (DES);
Dimetridazole, Ipronidazole, and other Nitroimidazoles;
Furazolidone, Nitrofurazone, and other nitrofurans;
Fluoroquinilones;
Glycopeptides.
ALL FISH Methylmercury - 1.0 ppm.2
ALL FISH Paralytic Shellfish Poisoning - 0.8 ppm (80g/100g) saxitoxin

equivalent.
CLAMS, MUSSELS, OYSTERS, AND WHOLE AND ROE-ON Neurotoxic Shellfish Poisoning - 0.8 ppm (20 mouse units/100 g)
SCALLOPS, FRESH, FROZEN, OR CANNED brevetoxin-2 equivalent.
CLAMS, MUSSELS, OYSTERS, AND WHOLE AND ROE-ON Diarrhetic Shellfish Poisoning - 0.2 ppm okadaic acid plus
SCALLOPS, FRESH, FROZEN, OR CANNED 35-methyl okadaic acid (DTX 1).
ALL FISH Amnesic Shellfish Poisoning - 20 ppm domoic acid, except in the
viscera of dungeness crab, where 30 ppm is permitted.
ALL FISH Ciguatera Fish Poisoning - 0.01 ppb CTX equivalent for Pacific
ciguatoxin and 0.1 ppb CTX equivalent for Caribbean ciguatoxin.
ALL FISH Hard or sharp foreign object - generally 0.3 (7 mm) to
1.0 (25 mm) in length.
MPN = Most probable number. CTX = ciguatoxin.
1. These values are tolerances.
2. See Chapter 10, Methylmercury, for additional information.
Note: The term fish refers to fresh or saltwater finfish, crustaceans, other forms of aquatic life other than birds or mammals, and all mollusks,
where such animal life is intended for human consumption , as defined in the Fish and Fishery Products, Definitions, 21 CFR 123.3(d).
441
NOTES:
442
APPENDIX 6: Japanese and Hawaiian Vernacular Names for Fish Eaten Raw
Table A-1 contains a list of Japanese

vernacular names and their corresponding
U.S. market names;
Table A-2 contains a list of Hawaiian
vernacular names and their corresponding
U.S. market names.
443
These tables are not intended to be a complete list of species consumed raw.
TABLE A-1
COMMONLY USED JAPANESE VERNACULAR NAMES FOR FISH EATEN RAW WITH
CORRESPONDING U.S. MARKET NAMES
WHEN THE JAPANESE VERNACULAR NAME IS THE U.S. MARKET NAME IS
AINAME GREENLING
AJI MACKEREL, JACK
AKA-GAI CLAM, ARKSHELL
AKAMANBO OPAH
AKAUO MONKFISH
AKODAI MONKFISH
AKOU-DAI ROCKFISH, RED
AMADAI TILEFISH
AMAEBI PRAWN, SWEET
ANAGO, HAMO CONGER EEL
ANKOU MONKFISH
AOYAGI CLAM, SURF
ASARI CLAM, SHORT NECKED
AWABI ABALONE
AYU SMELT
BAIGAI WHELK
BORA MULLET, GRAY
BURL YELLOWTAIL
DOJYOU LOACH
EBI SHRIMP, FRESHWATER
EBI SHRIMP, PINK
EBODAI BUTTERFISH
ESO LIZARDFISH
EZOBORA WHELK
FUEFUKIDAI EMPEROR
FUGU PUFFER
FUGU GLOBEFISH
FUNA CARP
GARIGANI CRAYFISH
GIN-SAKE SALMON, COHO
HAKKAKU SCULPIN
HAMACHI YELLOWTAIL
HAMAGURI CLAM
HANASAKI KANI CRAB, HANASAKI
HATA GROUPER
HAYA DACE
HAZE GOBY
HIGEDARA LINGCOD
HIRAAJI JACK
HIRAME FLUKE, FLOUNDER
HIUCHIDAI ORANGE ROUGHY
HOSHI-GAREI FLOUNDER
HOTARUIKA SQUID
HOTATE-GAI SCALLOP, GIANT
HOUBOU SEA ROBIN
HOYA SEA SQUIRT
IBODAI BUTTERFISH
IIDAKO OCTOPUS
444
TABLE A-1
IKA SQUID
IKANAGO SAND EEL
IKURA SALMON, ROE
INADA YELLOWTAIL
ISAKI GRUNT
ISAKI GRUNT OR SWEETLIPS
ISEEBI LOBSTER
ISEEBI LOBSTER, NORWAY
ISEEBI LOBSTER, SLIPPER
ISHIDAI, ISHIGAKIDAI KNIFEJAW
ISHIMOCHI GUCHI CROAKER
ITOYORIDAI THREADFIN BREAM
IWANA CHAR
IWASHI SARDINE
JNADA YELLOWTAIL
KAJ I KA SCULPIN
KAMASU BARRACUDA
KAMASUSAWARA WAHOO
KANI CRAB, BROWN
KANI CRAB, DEEP SEA
KANI CRAB, KING
KANI CRAB, SNOW
KAREI FLOUNDER
KASAGO ROCKFISH
KATSUO BONITO
KATSUO SMALL TUNA
KAWAHAGI TRIGGERFISH
KAWAHGI FILEFISH
KEGANI (KANI) CRAB, KEGANI
KIJIHATA GROUPER
KINK THORNEYHEAD
KINME ALFONSINO
KINMEDAI ALFONSINO
KINTOKIDAI BIGEYE
KISU JAPANESE WHITING
KOBUDAI, BUDAI PARROTFISH
KOCHI FLATFISH
KOHADA GIZZARD SHAD
KOHADA SHAD
KOI CARP
KOIKA CUTTLEFISH
KONOSHIRO GIZZARD SHAD
KOSHODAI GRUNT OR SWEETLIPS
KURAGE JELLYFISH
KURODAI PORGY
KURUMA-EBI SHRIMP, TIGER PRAWN
KYABIA CAVIAR
KYURINO SMELT
MA-DAKO TAKO OCTOPUS
MA-IKA CUTTLEFISH
445
TABLE A-1
MADAI SEA BREAM

MAGURO TUNA
MAIWASHI SARDINE
MAKOGAREI FLOUNDER
MANAGA TSUO, ECHIOPIA POMFRET
MANBOH SUNFISH, OCEAN
MANDAI OPAH
MEBARU ROCKFISH
MEDAL BLUENOSE
MEKAJIKI SWORDFISH
MIRU-GAI CLAM, GEODUCK
MIZUDAKO OCTOPUS
MIZUIK SQUID
MONGOIKA CUTTLEFISH
MONGORAKAWAHAGI TRIGGERFISH
NAMAKO SEA CUCUMBER
NIBE CROAKER
NIJI-MASU TROUT, RAINBOW
NISHIN HERRING
OHYOU HALIBUT
ODORI SHRIMP, TIGER PRAWN
OKAMASU BARRACUDA
OKAMSU BARRACUDA
ONAGADAI SNAPPER
SABA MACKEREL
SAIRA SAURY
SAKANA FISH
SAKE SALMON, CHUM
SAME SHARK
SAMMA SAURY
SANMA SAURY
SAWAGANI RIVER CRAB
SAYORI, SAVORI HALFBEAK
SAZAE TOP SHELL
SAZAE TURBOT, SHELL
SHINKO SHAD
SHIIRA MAHI-MAHI
SHIMAAJI JACK
SHISHAMO CAPELIN AND ROE
SHITA-BIRAME SOLE
SHIZU BUTTERFISH
SUJI-KO SALMON, ROE
SUKESODORA POLLOCK AND ROE
SUMIIKA CUTTLEFISH
SURUMEIKA SQUID
SUZUKI SEA BASS
SWARA MACKEREL, SPANISH
TACHIUO CUTTLEFISH
TAI SEA BREAM, RED SNAPPER
TAKO OCTOPUS
446
TABLE A-1
TARA COD AND ROE/MILT

TARUMI FEUDA SNAPPER
TARUMI FEUDAI SNAPPER
TENEGADAKO OCTOPUS
TOBIUO FLYING FISH
TORIGAI COCKLE
TORO TUNA
TSUBUGAI WHELK
UMAZURAHAGI TRIGGERFISH
UNAGI EEL
UNI SEA URCHIN ROE
WAKASAGI SMELT
WARASA YELLOWTAIL
YAMAME SALMON, CHERRY
YARIIKA SQUID
Y ANAGI-GAREI FLOUNDER
ZUWAI-GANI CRAB, SNOW
447
TABLE A-2
COMMONLY USED HAWAIIAN VERNACULAR NAMES FOR FISH EATEN RAW WITH
CORRESPONDING U.S. MARKET NAME
WHEN THE HAWAIIAN VERNACULAR NAME IS THE U.S. MARKET NAME IS
A'AWA HOGFISH
A'U BLUE MARLIN
A'U BLACK MARLIN, SILVER MARLIN
A'U LEPE SAILFISH
A'UKU SWORDFISH
AHA NEEDLEFISH
AHI YELLOWFIN TUNA
AHI PALAHA ALBACORE
AHOLEHOLE AHOLHOLE
AKU SKIPJACK TUNA
AKULE BIGEYE SCAD
ALA'IHI SQUIRRELFISH
AMA'AMA MULLET
API SAILFIN TANG
AUWEKE, MOANA KALI GOLDSADDLE GOATFISH
AWA MILKFISH
AWEOWEO BIGEYE TUNA
DEEPSEA MOI BEARDFISH
EHU SQUIRRELFISH SNAPPER
HAHALALU BIGEYE SCAD
HAPU'UPU'U SEALES GROUPER
HE'E MAULI OCTOPUS
HEBE SHORTNOSE SPEARFISH
HILU BLACK STRIPED WRASSE
IHEIHE HALFBEAK
KAHALA AMBERJACK
KAKU BARRACUDA
KALA UNICORNFISH
KALEKALE VON SIEBOLDS SNAPPER
KAMANU RAINBOW RUNNER
KAWAKAWA KAWAKAWA
KAWELE'A JAPANESE BARRACUDA
KOLE YELLOW-EYED SURGEON
KUMU WHITE SADDLE GOATFISH
KUPIPI GRAY DAMSELFISH
LAI LEATHERBACK
LAINIHI RAZOR WRASSE
MAHIMAHI DOLPHIN FISH
MAHIMAHI SMALL DOLPHIN FISH
MAI'I'I BLACK AND BROWN SURGEON
MAILKO BLUELINED SURGEON
MAKIAWA SARDINE
MAKUA OCEAN SUNFISH
MALOLO FLYING FISH
MAMO SERGEANT MAJOR DAMSEL
MANINI CONVICT TANG
MOANA MANYBAR GOATFISH
MOI THREADFIN
MU PORGY
NA'ENA'A ORANGE SPOT WRASSE
448
TABLE A-2
COMMONLY USED HAWAIIAN VERNACULAR NAMES FOR FISH EATEN RAW WITH
CORRESPONDING U.S. MARKET NAME
WHEN THE HAWAIIAN VERNACULAR NAME IS THE U.S. MARKET NAME IS
NENUE RUDDERFISH
NUNU TRUMPETFISH
O'OPU KAI NOHU LARGE-HEADED SCORPION
OILIPA BLUELINED LEATHER JACKET
OIO BONEFISH
ONO WAHOO
OPAH MOONFISH
OPAKAPAKA PINK SNAPPER
OPELU MACKEREL SCAD
PAKI'I FLOUNDER
PAKU'IKU'I ACHILLES TANG
PALANI DUSSUMIERS SURGEON
PANUUNUHU GAIMARDS PARROTFISH
PAPAIKUALOA KONA CRAB
PO'ONUI BIGEYE TUNA
PO'OPA'A HAWKFISH
PO'OU ROSE-COLORED WRASSE
POMFRET POMFRET
PUALU ELONGATE SURGEONFISH
PUHIUHA WHITE EEL
ROI ARGUS GROUPER
SAMOAN CRAB MANGROVE
SQUID PURPLEBACK FLYING SQUID
STRIPED MARLIN STRIPED MARLIN
TA'APE BLUE-STRIPED SNAPPER
TO'AU BLACK TAIL SNAPPER
U'U SQUIRRELFISH
UHU PARROTFISH
UKIUKI BRIGHAMS SNAPPER
UKU GRAY JOBFISH, SNAPPER
ULA SPINY LOBSTER
ULAPAPA SLIPPER LOBSTER
ULUA THICK-LIPPED TREVALLY
ULUA KIHIKIHI THREADFIN JACK
UOAUOA MULLET
UPAPALU CARDINAL FISH
WALU OILFISH
WHITE WEKE WHITE/SAMOAN GOATFISH
449
BIBLIOGRAPHY.

Organization for Economic Co-operation and

Development. 1995. Multilingual dictionary
of fish and fish products. Fishing News Book.
University Press, Cambridge.
The seafood list. Department of Health and
Human Services, Public Health Service,
Food and Drug Administration, Center
for Food Safety and Applied Nutrition,
GuidanceComplianceRegulatoryInformation/
GuidanceDocuments/Seafood/ucm113260.
Tinker, S. W. 1991. Fishes of Hawaii.
Hawaiian Service, Inc., Honolulu HI.
450
APPENDIX 7: Bacterial and Viral Pathogens of Greatest Concern in Seafood
Processing - Public Health Impacts
Bacillus cereus (B. cereus) is the bacterium poisoning. An estimated 249,000 foodborne cases
responsible for B. cereus food poisoning. An of perfringens food poisoning occur annually in
estimated 27,400 foodborne cases of B. cereus the United States. Symptoms include: abdominal
food poisoning occur annually in the United cramps and diarrhea. Symptoms start from 8
States. There are two forms of the intoxication: hours to 1 day after consumption and last for
one causes diarrhea, starting from 6 to 15 hours about a day.
after consumption, and the other causes vomiting
Everyone is susceptible to perfringens food
and nausea, starting from 30 minutes to 6 hours
poisoning, but it is more common in the young
after consumption. Symptoms in both forms last
and elderly.
about 24 hours. Everyone is susceptible to B.
cereus food poisoning While most Escherichia coli (E. coli) are non
pathogenic, certain strains of the bacterium are
Campylobacter jejuni (C. jejuni) is the bacterium
responsible for four types of illness: gastroenteritis
responsible for campylobacteriosis. An estimated
or infantile diarrhea, caused by enteropathogenic
1,960,000 foodborne cases of campylobacteriosis
E. coli (EPEC); travelers diarrhea, caused by
occur annually in the United States. Symptoms
enterotoxigenic E. coli (ETEC); bacillary dysentery,
include: diarrhea, fever, abdominal pain, nausea,
caused by enteroinvasive E. coli (EIEC); and
headache, and muscle pain. Symptoms start from
hemorrhagic colitis, caused by enterohemorrhagic
2 to 5 days after consumption and last from 7 to
E. coli (EHEC). EHEC is the most severe, with
10 days. Everyone is susceptible to infection by
potential for serious consequences, such as
C. jejuni.
hemolytic uremic syndrome, particularly in young
Clostridium botulinum (C. botulinum) toxin is the children. An estimated 173,000 foodborne cases
toxin responsible for botulism. An estimated 58 from all four types of E. coli occur annually in the
foodborne cases of botulism occur annually in United States. Symptoms vary for the different
the United States. Symptoms include: weakness; forms of illness, but include: abdominal pain,
vertigo; double vision; difficulty in speaking, diarrhea, vomiting, fever, chills, dehydration,
swallowing, and breathing; abdominal swelling; electrolyte imbalance, high body fluid acidity, and
constipation; paralysis; and death. Symptoms start general discomfort. Symptoms start from 8 hours
from 18 to 36 hours after consumption. Everyone to 9 days after consumption and last from 6 hours
is susceptible to intoxication by C. botulinum to 19 days, with both periods varying significantly
toxin; only a few micrograms of the toxin can between the illness types. Everyone is susceptible
cause illness. Mortality is high; without the to all forms of infection from E. coli, but EPEC is
antitoxin and respiratory support, death is likely. most commonly associated with infants, and all
types tend to result in more severe symptoms in
Clostridium perfringens (C. perfringens) is the
the very young and elderly.
bacterium responsible for perfringens food
APPENDIX 7: Bacterial and Viral Pathogens of Greatest Concern in Seafood Processing - Public Health Impacts
451
Hepatitis A virus is responsible for foodborne and other closely related bacterial pathogens, such
hepatitis. An estimated 4,200 foodborne cases as Shigella spp., E. coli, and Yersinia enterocolitica
of hepatitis A occur annually in the United infections can lead to chronic reactive arthritic
States. Symptoms include: fever, malaise, symptoms in pre-disposed individuals.
nausea, anorexia, abdominal discomfort, and
Shigella spp. is the bacterium responsible for
jaundice. Symptoms start from 10 to 50 days
shigellosis. An estimated 89,600 foodborne cases
after consumption and last 1 to 2 weeks. Unless
of shigellosis occur annually in the United States.
previously infected or immunized, everyone is
Symptoms include: abdominal pain; cramps;
susceptible to infection by hepatitis A virus.
diarrhea; fever; vomiting; blood, pus, or mucus
Listeria monocytogenes (L. monocytogenes) in stools; continuous or frequent urges for bowel
is the bacterium responsible for listeriosis. movement; and death. Symptoms start from
An estimated 2,500 foodborne cases of
12 hours to 2 days after consumption and last
listeriosis occur annually in the United
from 1 to 2 weeks. Everyone is susceptible to
States. L. monocytogenes can produce
infection by Shigella spp.
mild flu-like symptoms in all individuals.
However, in susceptible individuals, including Staphylococcus aureus (S. aureus) is the
pregnant women, newborns, and the bacterium responsible for staphylococcal food
immunocompromised, it can result in more poisoning. An estimated 185,000 foodborne
severe symptoms, which include: septicemia, cases of staphylococcal food poisoning occur
meningitis, encephalitis, spontaneous abortion, annually in the United States. Symptoms
and stillbirth. Symptoms start from include: vomiting, diarrhea, abdominal pain,
nausea, and weakness. Symptoms usually
3 days to 3 weeks after consumption. Mortality
start within 4 hours of consumption. Everyone
is high in those that display the more severe
is susceptible to intoxication by S. aureus
symptoms.
toxin, with more severe symptoms, including
Norovirus (also known as Norwalk-like virus) occasional death, occurring in infants, the
is a major cause of viral gastroenteritis. An elderly, and debilitated persons.
estimated 9,200,000 foodborne cases of norovirus
Vibrio cholerae (V. cholerae) O1 and O139 are
the bacteria responsible for Asiatic or epidemic
include: diarrhea, nausea, vomiting, abdominal
cholera. No major outbreaks of this disease
cramps, headache, body ache, and low-grade
have occurred in the United States since 1911,
fever. Symptoms start from 2 to 4 days after
but an estimated 49 sporadic foodborne cases
consumption and generally last 2 days.
occur annually (including V. cholerae non-O1 and
Everyone is susceptible to infection by norovirus.
non-O139). Symptoms include: mild-to-severe
Salmonella spp. is the bacterium responsible for diarrhea, abdominal cramps, nausea, vomiting,
salmonellosis. An estimated 1,340,000 cases dehydration, shock, and death. Symptoms
of foodborne salmonellosis occur annually in start from 6 hours to 5 days after consumption.
the United States. Symptoms include: nausea, Everyone is susceptible to infection by V. cholerae
vomiting, abdominal cramps, diarrhea, fever, O1 and O139, but those with weakened immunity,
and headache. Symptoms start from 6 hours reduced stomach acidity, or malnutrition may
to 2 days after consumption and generally last suffer more severe forms of the illness.
from 1 to 2 days. The most severe form, typhoid
V. cholerae non-O1 and non-O139 are bacteria
fever, is caused by Salmonella typhi. Everyone
that are also responsible for vibriosis. V.
is susceptible to infection by Salmonella spp., but
cholerae non-O1 and non-O139 may also cause
symptoms are most severe in the elderly, infants,
gastroenteritis and, rarely, septicemia. The
and the infirmed. Infections by Salmonella spp.
452
symptoms of gastroenteritis include: diarrhea,
include: fever, abdominal pain, diarrhea,
abdominal cramps, fever, vomiting, and
vomiting, arthritis, and, rarely, septicemia.
nausea. Symptoms start from 6 hours to 3 days
Symptoms start from 3 to 7 days after
after consumption and last from 6 to 7 days.
consumption and last from 1 to 3 days. Everyone
Everyone is susceptible to gastroenteritis from V.
is susceptible to infection by Y. enterocolitica, but
cholerae non-O1 and non-O139, but septicemia
symptoms are more severe in the very young,
usually develops only in those with underlying
debilitated, elderly, and immunocompromised.
chronic disease.
Vibrio parahaemolyticus (V. parahaemolyticus) is
another bacterium that is responsible for vibriosis.
An estimated 3,600 foodborne cases of vibriosis
from V. parahaemolyticus occur annually in the
United States. Vibriosis from V. parahaemolyticus,
as with Vibrio vulnificus, may cause gastroenteritis
and primary septicemia, although primary
septicemia is uncommon with V. parahaemolyticus.
The symptoms of gastroenteritis include: diarrhea;
abdominal cramps, nausea, vomiting, headache,
fever, and chills. Symptoms start from 4 hours to 4
days after consumption and last for about 2 days.
Everyone is susceptible to gastroenteritis from V.
parahaemolyticus, but septicemia usually develops
only in those with underlying chronic disease.
Vibrio vulnificus (V. vulnificus) is another
bacterium that is responsible for vibriosis. An
estimated 47 foodborne cases of vibriosis
caused by V. vulnificus (mostly septicemia)
occur annually in the United States, about half
of those resulting in death. Vibriosis caused
by V. vulnificus can take one of two forms,
gastroenteritis and primary septicemia. The
symptoms of gastroenteritis include: nausea,
chills, and fever. The symptoms of primary
septicemia include: septic shock and death.
Symptoms of gastroenteritis start from 16
hours to 2 days after consumption, and death
from septicemia may occur within 36 hours.
Everyone is susceptible to gastroenteritis from
V. vulnificus, but septicemia usually develops

only in those with underlying chronic disease,
particularly liver disease.
Yersinia enterocolitica (Y. enterocolitica) is
the bacterium responsible for yersiniosis. An
estimated 86,700 foodborne cases of yersiniosis
453
BIBLIOGRAPHY.

Mead, P. S., L. Slutsker, V. Dietz, L. F. McCaig,
J. S. Bresee, C. Shapiro, P. M. Griffin, and
R. V. Tauxe. 1999. Food-related illness and
death in the United States. Emerg. Infect.
Dis. 5:607-625.
Painter, J. 2004. Estimated cases of Vibrio
parahaemolyticus in the United States.
Personal communication.
The bad bug book: foodborne pathogenic
microorganisms and natural toxins
handbook. http://www.cfsan.fda.gov/~mow/
intro.html.
454
APPENDIX 8: Procedures for Safe and Sanitary Processing and Importing of Fish and
Fishery Products
TITLE 21 OF THE CODE OF FEDERAL SUBPART A - GENERAL PROVISIONS

REGULATIONS PART 123 - FISH AND Sec. 123.3 Definitions
FISHERY PRODUCTS
The definitions and interpretations of
terms in section 201 of the Federal Food,
SUBPART A - GENERAL PROVISIONS Drug, and Cosmetic Act (the act) and in
Sec. part 110 of this chapter are applicable to
123.3 Definitions such terms when used in this part, except
123.5 Current good manufacturing practice where they are herein redefined. The
123.6 Hazard analysis and Hazard Analysis following definitions shall also apply:
Critical Control Point (HACCP) plan
a. Certification number means a unique
123.7 Corrective actions
combination of letters and numbers
123.8 Verification
assigned by a shellfish control authority to
123.9 Records
a molluscan shellfish processor.
123.10 Training
123.11 Sanitation control procedures b. Critical control point means a point, step,
123.12 Special requirements for imported or procedure in a food process at which
products control can be applied, and a food safety
SUBPART B - SMOKED AND SMOKE-FLAVORED hazard can as a result be prevented,
FISHERY PRODUCTS
eliminated, or reduced to acceptable
levels.
Sec.
123.15 General c. Critical limit means the maximum or
123.16 Process controls minimum value to which a physical,
biological, or chemical parameter must
SUBPART C - RAW MOLLUSCAN SHELLFISH
be controlled at a critical control point
Sec. to prevent, eliminate, or reduce to an
123.20 General acceptable level the occurrence of the
123.28 Source controls identified food safety hazard.
Authority: Secs. 201, 402, 403, 406, 409, 701,
d. Fish means fresh or saltwater finfish,
704, 721, 801, 903 of the Federal Food, Drug,
crustaceans, other forms of aquatic animal
and Cosmetic Act (21 U.S.C. 321, 342, 343, 346,
life (including, but not limited to, alligator,
348, 371, 374, 379e, 381, 393); secs. 301, 307,
frog, aquatic turtle, jellyfish, sea cucumber,
361 of the Public Health Service Act (42 U.S.C.
and sea urchin and the roe of such
241, 2411, 264). animals) other than birds or mammals,
APPENDIX 8: Procedures for Safe and Sanitary Processing and Importing of Fish and Fishery Products
455
and all mollusks, where such animal life changing into different market forms,
is intended for human consumption. manufacturing, preserving, packing,
labeling, dockside unloading, or
e. Fishery product means any human food holding.
product in which fish is a characterizing
ingredient. (2) The regulations in this part do not
apply to:
f. Food safety hazard means any biological,
chemical, or physical property that may (i) Harvesting or transporting
cause a food to be unsafe for human fish or fishery products,
consumption. without otherwise engaging in
processing.
g. Importer means either the U.S. owner
or consignee at the time of entry into (ii) Practices such as heading,
the United States, or the U.S. agent or eviscerating, or freezing
representative of the foreign owner intended solely to prepare a fish
or consignee at the time of entry into for holding on board a harvest
the United States, who is responsible vessel.
for ensuring that goods being offered
(iii) The operation of a retail
for entry into the United States are in
establishment.
compliance with all laws affecting the
importation. For the purposes of this l. Processor means any person engaged
definition, ordinarily the importer is not in commercial, custom, or institutional
the custom house broker, the freight processing of fish or fishery products,
forwarder, the carrier, or the steamship either in the United States or in a foreign
representative. country. A processor includes any
person engaged in the production of
h. Molluscan shellfish means any edible
foods that are to be used in market or
species of fresh or frozen oysters, clams,
consumer tests.
mussels, or scallops, or edible portions of
such species, except when the product m. Scombroid toxin-forming species means
consists entirely of the shucked adductor tuna, bluefish, mahi mahi, and other
muscle. species, whether or not in the family
Scombridae, in which significant levels
i. Preventive measure means physical,
of histamine may be produced in the fish
chemical, or other factors that can be
flesh by decarboxylation of free histidine
used to control an identified food safety
as a result of exposure of the fish after
hazard.
capture to temperatures that permit the
j. Process-monitoring instrument means an growth of mesophilic bacteria.
instrument or device used to indicate
n. Shall is used to state mandatory
conditions during processing at a critical
requirements.
control point.
o. Shellfish control authority means a Federal,
k. (1) Processing means, with respect to
State, or foreign agency, or sovereign
fish or fishery products: Handling,
tribal government, legally responsible
storing, preparing, heading,
for the administration of a program that
eviscerating, shucking, freezing,
includes activities such as classification
456
of molluscan shellfish growing areas, Sec. 123.6 Hazard Analysis and Hazard
enforcement of molluscan shellfish Analysis Critical Control Point (HACCP)
harvesting controls, and certification of plan
molluscan shellfish processors.
a. Hazard analysis. Every processor
p. Shellstock means raw, in-shell molluscan shall conduct, or have conducted
shellfish. for it, a hazard analysis to determine
whether there are food safety hazards
q. Should is used to state recommended that are reasonably likely to occur for
or advisory procedures or to identify each kind of fish and fishery product
recommended equipment. processed by that processor and to
identify the preventive measures that
r. Shucked shellfish means molluscan
the processor can apply to control
shellfish that have one or both shells
those hazards. Such food safety
removed.
hazards can be introduced both
s. Smoked or smoke-flavored fishery products within and outside the processing
means the finished food prepared by: plant environment, including food
safety hazards that can occur before,
(1) Treating fish with salt (sodium during, and after harvest. A food
chloride), and safety hazard that is reasonably likely
to occur is one for which a prudent
(2) Subjecting it to the direct action processor would establish controls
of smoke from burning wood, because experience, illness data,
sawdust, or similar material and/ scientific reports, or other information
or imparting to it the flavor provide a basis to conclude that there
of smoke by a means such as is a reasonable possibility that it will
immersing it in a solution of occur in the particular type of fish or
wood smoke. fishery product being processed in
t. Tag means a record of harvesting
the absence of those controls.
information attached to a container of b. The HACCP plan. Every processor
shellstock by the harvester or processor. shall have and implement a written
Sec. 123.5 Current good manufacturing HACCP plan whenever a hazard
practice analysis reveals one or more food
safety hazards that are reasonably
a. Part 110 of this chapter applies in likely to occur, as described in
determining whether the facilities, paragraph (a) of this section. A
methods, practices, and controls used HACCP plan shall be specific to:
to process fish and fishery products
are safe, and whether these products (1) Each location where fish and
have been processed under sanitary fishery products are processed by
conditions. that processor; and
b. The purpose of this part is to set (2) Each kind of fish and fishery
forth requirements specific to the product processed by the
processing of fish and fishery processor. The plan may group
products. kinds of fish and fishery products
457
together, or group kinds of process sufficient to kill
production methods together, if the parasites, or where the
the food safety hazards, critical processor represents, labels,
control points, critical limits, or intends for the product
and procedures required to be to be so consumed;
identified and performed in
paragraph (c) of this section are (viii) Unapproved use of direct
identical for all fish and fishery or indirect food or color
products so grouped or for all additives; and
production methods so grouped.
(ix) Physical hazards;
c. The contents of the HACCP plan. The
(2) List the critical control points for
HACCP plan shall, at a minimum:
each of the identified food safety
(1) List the food safety hazards that hazards, including as appropriate:
are reasonably likely to occur,
(x) Critical control points
as identified in accordance with
designed to control
paragraph (a) of this section, and
food safety hazards that
that thus must be controlled for
could be introduced
each fish and fishery product.
in the processing plant
Consideration should be given to
environment; and
whether any food safety hazards
are reasonably likely to occur as (xi) Critical control points
a result of the following: designed to control food
safety hazards introduced
(i) Natural toxins;
outside the processing plant
(ii) Microbiological environment, including food
contamination; safety hazards that occur
before, during, and after
(iii) Chemical contamination; harvest;
(iv) Pesticides; (3) List the critical limits that must be

met at each of the critical control
(v) Drug residues; points;
(vi) Decomposition in (4) List the procedures, and
scombroid toxin-forming frequency thereof, that will be
species or in any other used to monitor each of the
species where a food safety critical control points to ensure
hazard has been associated compliance with the critical
with decomposition; limits;
(vii) Parasites, where the (5) Include any corrective action
processor has knowledge plans that have been developed
or has reason to know that in accordance with Sec. 123.7(b),
the parasite-containing to be followed in response to
fish or fishery product will deviations from critical limits at
be consumed without a critical control points;
458
(6) List the verification procedures, safety hazards that are reasonably
and frequency thereof, that the likely to occur.
processor will use in accordance
with Sec. 123.8(a); f. Sanitation. Sanitation controls may
be included in the HACCP plan.
(7) Provide for a recordkeeping However, to the extent that they are
system that documents the monitored in accordance with Sec.
monitoring of the critical control 123.11(b) they need not be included
points. The records shall in the HACCP plan, and vice versa.
contain the actual values and
observations obtained during g. Legal basis. Failure of a processor
monitoring. to have and implement a HACCP
plan that complies with this
d. Signing and dating the HACCP plan. section whenever a HACCP plan is
necessary, [or] otherwise operate in
(1) The HACCP plan shall be signed accordance with the requirements
and dated, either by the most of this part, shall render the fish or
responsible individual on- fishery products of that processor
site at the processing facility adulterated under section 402(a)
or by a higher level official of (4) of the act. Whether a processors
the processor. This signature actions are consistent with ensuring
shall signify that the HACCP the safety of food will be determined
plan has been accepted for through an evaluation of the
implementation by the firm. processor overall implementation of
its HACCP plan, if one is required.
(2) The HACCP plan shall be dated
and signed: Sec. 123.7 Corrective actions
(i) Upon initial acceptance; a. Whenever a deviation from a critical

limit occurs, a processor shall take
(ii) Upon any modification; and corrective action either by:
(iii) Upon verification of the (1) Following a corrective action
plan in accordance with plan that is appropriate for the
Sec. 123.8(a)(1). particular deviation, or
e. Products subject to other regulations. (2) Following the procedures in
For fish and fishery products that paragraph (c) of this section.
are subject to the requirements of
part 113 or 114 of this chapter, the b. Processors may develop written
HACCP plan need not list the food corrective action plans, which
safety hazard associated with the become part of their HACCP plans
formation of Clostridium botulinum in accordance with Sec. 123.6(c)
toxin in the finished, hermetically (5), by which they predetermine the
sealed container, nor list the controls corrective actions that they will take
to prevent that food safety hazard. A whenever there is a deviation from a
HACCP plan for such fish and fishery critical limit. A corrective action plan
products shall address any other food that is appropriate for a particular
deviation is one that describes
459
the steps to be taken and assigns trained in accordance with Sec.
responsibility for taking those steps, 123.10, to determine whether the
to ensure that: HACCP plan needs to be modified
to reduce the risk of recurrence
(1) No product enters commerce that of the deviation, and modify the
is either injurious to health or is HACCP plan as necessary.
otherwise adulterated as a result
of the deviation; and d. All corrective actions taken in accordance
with this section shall be fully
(2) The cause of the deviation is documented in records that are subject
corrected. to verification in accordance with Sec.
123.8(a)(3)(ii) and the recordkeeping
c. When a deviation from a critical limit
requirements of Sec. 123.9.
occurs and the processor does not
have a corrective action plan that is Sec. 123.8 Verification
appropriate for that deviation, the
processor shall: a. Overall verification. Every processor
shall verify that the HACCP plan
(1) Segregate and hold the affected is adequate to control food safety
product, at least until the hazards that are reasonably likely
requirements of paragraphs (c)(2) to occur, and that the plan is being
and (c)(3) of this section are met; effectively implemented. Verification
shall include, at a minimum:
(2) Perform or obtain a review to
determine the acceptability of the (1) Reassessment of the HACCP plan.
affected product for distribution. A reassessment of the adequacy
The review shall be performed of the HACCP plan whenever any
by an individual or individuals changes occur that could affect
who have adequate training or the hazard analysis or alter the
experience to perform such a HACCP plan in any way or at
review. Adequate training may least annually. Such changes may
or may not include training in include changes in the following:
accordance with Sec. 123.10; Raw materials or source of raw
materials, product formulation,
(3) Take corrective action, when processing methods or systems,
necessary, with respect to the finished product distribution
affected product to ensure that systems, or the intended use
no product enters commerce that or consumers of the finished
is either injurious to health or is product. The reassessment shall
otherwise adulterated as a result be performed by an individual
of the deviation; or individuals who have been
trained in accordance with Sec.
(4) Take corrective action, when
123.10. The HACCP plan shall be
necessary, to correct the cause of
modified immediately whenever a
the deviation;
reassessment reveals that the plan
(5) Perform or obtain timely is no longer adequate to fully
reassessment by an individual meet the requirements of Sec.
or individuals who have been 123.6(c).
460
(2) Ongoing verification activities. corrective actions were
Ongoing verification activities taken in accordance with
including: Sec. 123.7. This review
shall occur within 1 week
(i) A review of any consumer of the day that the records
complaints that have been are made; and
received by the processor
to determine whether they (iii) The calibrating of any
relate to the performance process control instruments
of critical control points used at critical control
or reveal the existence of points and the performing
unidentified critical control of any periodic end-
points; product or in-process
testing that is part of the
(ii) The calibration of process- processors verification
monitoring instruments; activities. The purpose of
and, these reviews shall be, at
a minimum, to ensure that
(iii) At the option of the
the records are complete,
processor, the performing
and that these activities
of periodic end-product or
occurred in accordance
in-process testing.
with the processors
(3) Records review. A review, written procedures. These
including signing and dating, reviews shall occur within
by an individual who has been a reasonable time after the
trained in accordance with records are made.
Sec. 123.10, of the records that
b. Corrective actions. Processors shall
document:
immediately follow the procedures in
(i) The monitoring of critical Sec. 123.7 whenever any verification
control points. The procedure, including the review of
purpose of this review a consumer complaint, reveals the
shall be, at a minimum, to need to take a corrective action.
ensure that the records are
c. Reassessment of the hazard analysis.
complete and to verify that
Whenever a processor does not have
they document values that
a HACCP plan because a hazard
are within the critical limits.
analysis has revealed no food safety
This review shall occur
hazards that are reasonably likely to
within 1 week of the day
occur, the processor shall reassess
that the records are made;
the adequacy of that hazard analysis
(ii) The taking of corrective whenever there are any changes that
actions. The purpose of could reasonably affect whether a
this review shall be, at a food safety hazard now exists. Such
minimum, to ensure that the changes may include, but are not
records are complete and limited to changes in: Raw materials
to verify that appropriate or source of raw materials, product
461
formulation, processing methods or case of refrigerated products and
systems, finished product distribution for at least 2 years after the date
systems, or the intended use or they were prepared in the case of
consumers of the finished product. frozen, preserved, or shelf-stable
The reassessment shall be performed products.
by an individual or individuals who
have been trained in accordance with (2) Records that relate to the
Sec. 123.10. general adequacy of equipment
or processes being used by
d. Recordkeeping. The calibration of a processor, including the
process-monitoring instruments, results of scientific studies and
and the performing of any periodic evaluations, shall be retained
end-product and in-process testing, at the processing facility or the
in accordance with paragraphs (a) importers place of business in
(2)(ii) through (iii) of this section the United States for at least 2
shall be documented in records that years after their applicability to
are subject to the recordkeeping the product being produced at
requirements of Sec. 123.9. the facility.
Sec. 123.9 Records (3) If the processing facility is closed
for a prolonged period between
a. General requirements. All records
seasonal packs, or if record
required by this part shall include:
storage capacity is limited on a
(1) The name and location of the processing vessel or at a remote
processor or importer; processing site, the records may
be transferred to some other
(2) The date and time of the activity reasonably accessible location at
that the record reflects; the end of the seasonal pack but
shall be immediately returned for
(3) The signature or initials of the
official review upon demand.
person performing the operation;
and c. Official review. All records required
by this part and all plans and
(4) Where appropriate, the identity of
procedures required by this part shall
the product and the production
be available for official review and
code, if any. Processing and
copying at reasonable times.
other information shall be entered
on records at the time that it is d. Public disclosure.
observed.
(1) Subject to the limitations in
b. Record retention. paragraph (d)(2) of this section,
all plans and records required
(1) All records required by this
by this part are not available for
part shall be retained at the
public disclosure unless they have
processing facility or importers
been previously disclosed to the
place of business in the United
public as defined in Sec. 20.81
States for at least 1 year after the
of this chapter or they relate to
date they were prepared in the
a product or ingredient that has
462
been abandoned and they no a. Developing a HACCP plan, which
longer represent a trade secret could include adapting a model or
or confidential commercial or generic-type HACCP plan, that is
financial information as defined appropriate for a specific processor,
in Sec. 20.61 of this chapter. in order to meet the requirements of
Sec. 123.6(b);
(2) However, these records and plans
may be subject to disclosure b. Reassessing and modifying the
to the extent that they are HACCP plan in accordance with
otherwise publicly available, the corrective action procedures
or that disclosure could not specified in Sec. 123.7(c)(5), the
reasonably be expected to cause HACCP plan in accordance with the
a competitive hardship, such as verification activities specified in Sec.
generic-type HACCP plans that 123.8(a)(1), and the hazard analysis
reflect standard industry practices. in accordance with the verification
activities specified in Sec. 123.8(c);
e. Tags. Tags as defined in Sec. 123.3(t) and
are not subject to the requirements
of this section unless they are used c. Performing the record review
to fulfill the requirements of Sec. required by Sec. 123.8(a)(3). The
123.28(c). trained individual need not be an
employee of the processor.
f. Records maintained on computers.
The maintenance of records on Sec. 123.11 Sanitation control procedures
computers is acceptable, provided
a. Sanitation SOP. Each processor
that appropriate controls are
should have and implement a
implemented to ensure the integrity
written sanitation standard operating
of the electronic data and signatures.
procedure (herein referred to as
Sec. 123.10 Training SSOP) or similar document that is
specific to each location where fish
At a minimum, the following functions
and fishery products are produced.
shall be performed by an individual who
The SSOP should specify how the
has successfully completed training in
processor will meet those sanitation
the application of HACCP principles to
conditions and practices that are to
fish and fishery product processing at
be monitored in accordance with
least equivalent to that received under
paragraph (b) of this section.
a standardized curriculum recognized
as adequate by the U.S. Food and Drug b. Sanitation monitoring. Each processor
Administration or who is otherwise shall monitor the conditions and
qualified through job experience to practices during processing with
perform these functions. Job experience sufficient frequency to ensure, at a
will qualify an individual to perform minimum, conformance with those
these functions if it has provided conditions and practices specified in
knowledge at least equivalent to that part 110 of this chapter that are both
provided through the standardized appropriate to the plant and the food
curriculum. being processed and relate to the
following:
463
(1) Safety of the water that comes document the monitoring and
into contact with food or food corrections prescribed by paragraph
contact surfaces, or is used in the (b) of this section. These records are
manufacture of ice; subject to the requirements of Sec.
123.9.
(2) Condition and cleanliness of food
contact surfaces, including utensils, d. Relationship to HACCP plan. Sanitation
gloves, and outer garments; controls may be included in the
HACCP plan, required by Sec.
(3) Prevention of cross-contamination 123.6(b). However, to the extent that
from insanitary objects to food, they are monitored in accordance
food packaging material, and with paragraph (b) of this section
other food contact surfaces, they need not be included in the
including utensils, gloves, and HACCP plan, and vice versa.
outer garments, and from raw
product to cooked product; Sec. 123.12 Special requirements for imported
products
(4) Maintenance of hand washing,
This section sets forth specific
hand sanitizing, and toilet
requirements for imported fish and
facilities;
fishery products.
(5) Protection of food, food
a. Importer verification. Every importer of
packaging material, and food
fish or fishery products shall either:
contact surfaces from adulteration
with lubricants, fuel, pesticides, (1) Obtain the fish or fishery product
cleaning compounds, sanitizing from a country that has an active
agents, condensate, and other memorandum of understanding
chemical, physical, and biological (MOU) or similar agreement with
contaminants; the Food and Drug Administration,
that covers the fish or fishery
(6) Proper labeling, storage, and use
product and documents the
of toxic compounds;
equivalency or compliance of the
(7) Control of employee health inspection system of the foreign
conditions that could result in the country with the U.S. system,
microbiological contamination of accurately reflects the current
food, food packaging materials, situation between the signing
and food contact surfaces; and parties, and is functioning and
enforceable in its entirety; or
(8) Exclusion of pests from the food
plant. (2) Have and implement written
verification procedures for
The processor shall correct in a timely ensuring that the fish and fishery
manner, those conditions and practices products that they offer for
that are not met. import into the United States
were processed in accordance
c. Sanitation control records. Each
with the requirements of this
processor shall maintain sanitation
part. The procedures shall list at
control records that, at a minimum,
a minimum:
464
(i) Product specifications that D. Maintaining on file a
are designed to ensure copy, in English, of
that the product is not the foreign processors
adulterated under section HACCP plan, and a
402 of the Federal Food, written guarantee from
Drug, and Cosmetic Act the foreign processor
because it may be injurious that the imported fish
to health or have been or fishery product is
processed under insanitary processed in accordance
conditions, and, with the requirements
of this part;
(ii) Affirmative steps that
may include any of the E. Periodically testing
following: the imported fish or
fishery product, and
A. Obtaining from the maintaining on file a
foreign processor the copy, in English, of a
HACCP and sanitation written guarantee from
monitoring records the foreign processor
required by this part that the imported fish
that relate to the specific or fishery product is
lot of fish or fishery processed in accordance
products being offered with the requirements
for import; of this part or,
B. Obtaining either a F. Other such verification

continuing or lot- by- measures as appropriate
lot certificate from an that provide an
appropriate foreign equivalent level of
government inspection assurance of compliance
authority or competent with the requirements
third party certifying of this part.
that the imported fish b. Competent third party. An importer
or fishery product is may hire a competent third party to
or was processed in assist with or perform any or all of
accordance with the the verification activities specified
requirements of this in paragraph (a)(2) of this section,
part; including writing the importers
verification procedures on the
C. Regularly inspecting
importers behalf.
the foreign processors
facilities to ensure that c. Records. The importer shall maintain
the imported fish or records, in English, that document
fishery product is being the performance and results of
processed in accordance the affirmative steps specified in
with the requirements paragraph (a)(2)(ii) of this section.
of this part;
465
These records shall be subject to the such processing does not include a
applicable provisions of Sec. 123.9. treatment that ensures the destruction
of vegetative cells of microorganisms
d. Determination of compliance. There
of public health concern.
must be evidence that all fish and
fishery products offered for entry Sec. 123.28 Source controls
into the United States have been
a. In order to meet the requirements of
processed under conditions that
subpart A of this part as they apply to
comply with this part. If assurances
microbiological contamination, chemical
do not exist that the imported fish or
contamination, natural toxins, and
fishery product has been processed
related food safety hazards, processors
under conditions that are equivalent
shall include in their HACCP plans
to those required of domestic
how they are controlling the origin of
processors under this part, the
the molluscan shellfish they process to
product will appear to be adulterated
ensure that the conditions of paragraphs
and will be denied entry.
(b), (c), and (d) of this section are met.
SUBPART B - SMOKED AND SMOKE-FLAVORED
b. Processors shall only process molluscan
FISHERY PRODUCTS
shellfish harvested from growing
Sec. 123.15 General waters approved for harvesting by a
This subpart augments subpart A of this shellfish control authority. In the case
part by setting forth specific requirements of molluscan shellfish harvested from
for processing smoked and smoke- U.S. Federal waters, the requirements
flavored fishery products. of this paragraph will be met so long as
the shellfish have not been harvested
Sec. 123.16 Process controls
from waters that have been closed to
In order to meet the requirements of harvesting by an agency of the Federal
subpart A of this part, processors of government.
smoked and smoke-flavored fishery
products, except those subject to the c. To meet the requirements of paragraph
requirements of part 113 or 114 of this (b) of this section, processors who
chapter, shall include in their HACCP receive shellstock shall accept only
plans how they are controlling the shellstock from a harvester that is
food safety hazard associated with in compliance with such licensure
the formation of toxin by Clostridium requirements as may apply to the
botulinum for at least as long as the shelf harvesting of molluscan shellfish or
life of the product under normal and from a processor that is certified by
moderate abuse conditions. a shellfish control authority, and that
has a tag affixed to each container of
SUBPART C - RAW MOLLUSCAN SHELLFISH shellstock. The tag shall bear, at a
minimum, the information required in
Sec. 123.20 General Sec. 1240.60(b) of this chapter. In place
of the tag, bulk shellstock shipments
This subpart augments subpart A may be accompanied by a bill of lading
of this part by setting forth specific or similar shipping document that
requirements for processing fresh or contains the information required in Sec.
frozen molluscan shellfish, where
466
1240.60(b) of this chapter. Processors 2. Section 1240.3 is amended by revising
shall maintain records that document paragraph (r), and by adding new paragraphs
that all shellstock have met the (s), (t), and (u) to read as follows:
requirements of this section. These
Sec. 1240.3 General Definitions
records shall document:
a. Molluscan shellfish. Any edible species of
(1) The date of harvest; fresh or frozen oysters, clams, mussels,
and scallops or edible portions thereof,
(2) The location of harvest by State and
except when the product consists entirely
site;
of the shucked adductor muscle.
(3) The quantity and type of shellfish;
b. Certification number means a unique
(4) The date of receipt by the processor; combination of letters and numbers
and assigned by a shellfish control authority
to a molluscan shellfish processor.
(5) The name of the harvester, the
name or registration number of the c. Shellfish control authority means a Federal,
harvesters vessel, or an identification State, or foreign agency, or sovereign
number issued to the harvester by tribal government, legally responsible
the shellfish control authority. for the administration of a program that
includes activities such as classification
d. To meet the requirements of paragraph of molluscan shellfish growing areas,
(b) of this section, processors who enforcement of molluscan shellfish
receive shucked molluscan shellfish harvesting controls, and certification of
shall accept only containers of shucked molluscan shellfish processors.
molluscan shellfish that bear a label
that complies with Sec. 1240.60(c) of d. Tag means a record of harvesting
this chapter. Processors shall maintain information attached to a container of
records that document that all shucked shellstock by the harvester or processor.
molluscan shellfish have met the
3. Section 1240.60 is amended by revising the
requirements of this section. These
section heading, by redesignating the existing
records shall document:
text as paragraph (a) and adding the word
(1) The date of receipt; molluscan before the word shellfish the
two times that it appears, and by adding new
(2) The quantity and type of shellfish; paragraphs (b), (c), and (d) to read as follows:
and
Sec. 1240.60 Molluscan Shellfish
(3) The name and certification number of
a. All shellstock shall bear a tag that discloses
the packer or repacker of the product.
the date and place they were harvested
PART 1240 - CONTROL OF COMMUNICABLE (by State and site), type and quantity
DISEASES of shellfish, and by whom they were
harvested (i.e., the identification number
1. The authority citation for 21 CFR part 1240
assigned to the harvester by the shellfish
continues to read as follows:
control authority, where applicable or,
Authority: Secs. 215, 311, 361, 368 of the Public if such identification numbers are not
Health Service Act (42 U.S.C. 216, 243, 264, 271). assigned, the name of the harvester
467
or the name or registration number
of the harvesters vessel). In place of
the tag, bulk shellstock shipments may
be accompanied by a bill of lading or
similar shipping document that contains
the same information.
b. All containers of shucked molluscan

shellfish shall bear a label that identifies
the name, address, and certification
number of the packer or repacker of the
molluscan shellfish.
c. Any molluscan shellfish without such

a tag, shipping document, or label, or
with a tag, shipping document, or label
that does not bear all the information
required by paragraphs (b) and (c) of
this section, shall be subject to seizure or
refusal of entry, and destruction.
468

3,4,9, 19. Fish and Fishery Products Hazards and Controls Guidance (Manual HACCP Regulasi FDA)

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3,4,9, 19. Fish and Fishery Products Hazards and Controls Guidance (Manual HACCP Regulasi FDA)

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Fish and Fishery Products

Hazards and Controls Guidance

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Additional copies may be purchased from:

Florida Sea Grant

You may submit electronic or written comments

U.S. Department of Health and Human Services

CHAPTER 1: General Information.......................................................................................................19

CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan ..........................................21

CHAPTER 3: Potential Species-Related and Process-Related Hazards..................................................... 29

CHAPTER 4: Pathogens From the Harvest Area ...................................................................................75

CHAPTER 5: Parasites ......................................................................................................................91

CHAPTER 6: Natural Toxins ............................................................................................................ 99

CHAPTER 7: Scombrotoxin (Histamine) Formation ............................................................................. 113

CHAPTER 8: Other Decomposition-Related Hazards .........................................................................153

CHAPTER 9: Environmental Chemical Contaminants and Pesticides......................................................155

CHAPTER 10: Methylmercury .......................................................................................................... 181

CHAPTER 11: Aquaculture Drugs .....................................................................................................183

as a Result of Time and Temperature Abuse ................................................................. 209

CHAPTER 13: Clostridium botulinum Toxin Formation......................................................................... 245

CHAPTER 17: Pathogenic Bacteria Survival Through Processes Designed to Retain

Raw Product Characteristics .......................................................................................331

CHAPTER 18: Introduction of Pathogenic Bacteria After Pasteurization and

Specialized Cooking Processes ................................................................................. 345

and Prohibited Food and Color Additives ....................................................................355

CHAPTER 20: Metal Inclusion..........................................................................................................385

CHAPTER 21: Glass Inclusion ..........................................................................................................395

APPENDIX 1: Forms....................................................................................................................... 405

APPENDIX 2: Sample Product Flow Diagram ..................................................................................... 411

APPENDIX 3: Critical Control Point Decision Tree ............................................................................... 413

APPENDIX 4: Bacterial Pathogen Growth and Inactivation .................................................................. 417

APPENDIX 7: Bacterial and Viral Pathogens of Greatest Concern in Seafood Processing

I. INTRODUCTION II. DISCUSSION

For raw, ready-to-eat products: Alternatively, if at any time the product

Alternatively, if the product is never held at

internal temperatures above 80F (26.7C),

If the product is held at internal

temperatures above 50F (10C), but never

high pressure processing and (2) refrigeration

Appendix 7 no longer lists the bibliography. It

CHAPTER 1: General Information

CHAPTER 1: General Information

CHAPTER 1: General Information

CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan

THE HACCP PLAN FORM THE HAZARD ANALYSIS WORKSHEET

CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan

Identify the intended use and consumer;

Hazard Analysis Worksheet Examples:

Determine whether the potential hazard Examples:

HACCP Plan Form Fresh tuna steaks;

Frozen crab cakes.

Describe the packaging type.

CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan

CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan

CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan

CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan

CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan

CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan

STEP 18: Complete the HACCP Plan Form.

CHAPTER 2: Conducting a Hazard Analysis and Developing a HACCP Plan

INTRODUCTION It is important to note that the tables provide

CHAPTER 3: Potential Species-Related and Process-Related Hazards

THE EFFECT OF MISBRANDING THROUGH SPECIES SUBSTITUTION ON THE

CHAPTER 3: Potential Species-Related and Process-Related Hazards