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Food Safety
By Erik D. Olson
10.1377/hlthaff.2010.1265
HEALTH AFFAIRS 30,
NO. 5 (2011): 915923
2011 Project HOPE
The People-to-People Health
Foundation, Inc.
doi:
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H e a lt h A f fai r s
915
Food Safety
Overview Of The US Food Safety
Regulatory System
Chemicals In Food
Foodborne Illness From Pathogens
Studies have estimated the annual costs of foodborne illness from pathogens at between
$152 billion for health-related costs only19 and
$1.4 trillion for broader societal costs.20
The sources of foodborne microbes are manifold. Some are introduced into food by the inappropriate application of animal manure, or
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used in processing and preservation, or to improve flavor, texture, appearance, or shelf life.
Some of these compounds are benign, but
others might not be. For example, high levels
of added sodium from salt or artificial trans fats
might not be as safe as once thought.47 Other
additives have also raised worries, albeit perhaps
not of the same magnitude. Some scientists have
raised safety concerns, for example, about the
use of certain plastics in containers that can result in the leaching into food of chemicals such as
bisphenol A, commonly known as BPA, or phthalates, substances that make plastics more flexible. The use of these plastics has triggered extensive debate. Some academic and government
scientists question the safety of these substances, and other scientists in government agencies
and the chemical industry maintain that these
chemicals are safe as currently used.1115,3943
Environmental contaminants can also get into
food. For example, mercury is released into the
atmosphere from the burning of coal in power
plants.44 Mercury also comes from chloralkali
chemical plants, which produce chlorine and
caustic soda through a chemical process that
uses large amounts of mercury and can release
mercury vapor or liquid into the environment.45,46 It is also released through other human
activities and natural sources.47,48 The mercury
settles into water, where it tends to become concentrated as it moves up the food chaina process called bioconcentration. This means that
larger predatory fish such as tuna can contain
hundreds or thousands of times higher concentrations of mercury than occur in the water in
which they swim.48,49 For this reason, the Environmental Protection Agency and the FDA have
issued joint advisories warning consumersin
particular, vulnerable populations such as pregnant women and young childrento avoid eating large quantities of certain fish, including
shark, swordfish, and tilefish.50
Another class of chemicals, pesticides, are
often found in food. They can adhere to or be
absorbed by plants and animals through direct
application of the pesticide or from environmental contamination. Surveys have found that
pesticides generally occur at low levels in
food, although their concentrations in domestic and imported food have sometimes raised
concerns.10,51,52
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Numerous studies have documented the apparent risks from pesticides in the food supply, including the landmark 1993 National Research
Council report Pesticides in the Diets of Infants
and Children.9 In the wake of these studies,
Congress overhauled the provisions governing
pesticide residues. Section 408 of the Food Quality Protection Act of 1996 established a strict,
health-based standard of reasonable certainty
of no harm to any infant or child. It required
the Environmental Protection Agency to use this
standard to review the safety of all of the 9,721
pesticide tolerancesthe maximum allowable
level of a pesticide on a foodwithin ten years, a
task that the agency largely completed by the
deadline of August 2006.62
The agency recommended the revocation of
3,200 of these tolerances and the modification
of 1,200 others, based on safety concerns and
voluntary withdrawalssome of which had been
triggered by concerns voiced by the agency.60,63,64
As noted above, the FDA is responsible for
enforcing the tolerances established by the Environmental Protection Agency.
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food.75 Completion of a strong guidance document could be a helpful first step, but, ultimately,
mandatory requirements are needed.
Finally, measures are needed that prevent
tainting of food by environmental contaminants,
such as untreated sewage or manure that enter
waters and pollute crops downstream, and requirements are needed to strengthen controls
on air and water discharges of mercury and other
common pollutants that are widely found in the
food supply. Such measures would help reduce
the risks to the American public. These would
probably require the FDA, Department of Agriculture, and Environmental Protection Agency
to work together, and these agencies may need to
receive strengthened legal authorities and issue
regulations to prevent contamination from occurring before it affects the food supply.
For example, legislation to fund and ensure
stronger sewage treatment has been proposed.76
Also, the Environmental Protection Agency has
taken preliminary steps to reduce manure runoff
from large animal feeding operations77 and to
address mercury contamination from power
plants.78 However, some state officials and many
other experts believe that more vigorous regulatory action, potentially including new legislation, is needed to prevent these types of contamination.71,7981
Although the new 2011 food safety law will
help modernize key aspects of the nations food
safety system at the FDA, important gaps remain.
Potential shortcomings from decades-old laws
regarding meat, poultry, and food additives; serious resource constraints; and fragmented legal
authorities spread across multiple agencies must
be carefully evaluated and addressed. Our food
safety system should accommodate rapidly developing scientific knowledge, escalating demand for scientific capacity and other resources
at the FDA, the need to address emerging health
risks, and the greatly changed food industry.
The time has come to review and update our
mid-twentieth-century food laws and programs
to ensure that they are up to the task of pragmatically overseeing the modern food industry
and preventing twenty-first-century threats to
public health.
dress meat and poultry contamination. For example, court decisions handed down under the
decades-old meat safety law have blocked the
department from closing down meatpacking
plants where repeated tests have found Salmonella contamination.69 There have been proposals to create a single food safety agency that
would cover all food.70 However, Congress has
yet to move forward on proposals to enact such
legislation or to update the meat and poultry
laws. A recent Government Accountability Office
report has reiterated the offices previous recommendation that serious consideration be given to
consolidating or restructuring the fragmented
food safety system, which the office found is
splintered among fifteen federal agencies including the Department of Agriculture and the FDA,
implementing thirty laws.17
In addition, the FDAs science and analysis are
in need of modernization and additional resources. The FDA Science Boards Subcommittee on
Science and Technology found that the agency
suffers from serious scientific deficiencies and
is not positioned to meet current or emerging
regulatory responsibilities because the demands on the agency have soared in recent years,
and the resources have not increased in proportion to the demands.71 The agencys oversight of
food additivesespecially the procedures for
substances that are generally recognized as
safemay be in particular need of updating
and strengthening, as the Government Accountability Office recommended.60 Desirable improvements may include regular reevaluations
of current research on the risks posed by all
substances added to food and establishing a system to evaluate all risks in assessing the safety of
these compounds.
Legislative or administrative actions should be
considered to prevent problematic nontherapeutic uses of antibiotics in animal agriculture, to
reduce the risk of creating and spreading antibiotic-resistant superbugs. Bills to mandate such
reform were introduced in Congress in 2009 and
reintroduced in 2011, but they have not moved
beyond the hearing stage.7274 The FDA has proposed, but not yet finalized, a voluntary guidance document intended to encourage the judicious use of key antibiotics in animals used for
NOTES
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18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
from: http://www.producesafety
project.org/admin/assets/files/
PEW-PSP-Composting-ManureNarrative-v4-2.pdf
Sheridan JJ. Sources of contamination during slaughter and measures
for control. J Food Safety. 1998;
18(4):32139.
Dirty birds: even premium chickens harbor dangerous bacteria.
Consum Rep. 2007;72(1):203.
Department of Agriculture, Food
Safety and Inspection Service. Nationwide federal plant raw ground
beef microbiological survey: August 1993March 1994 [Internet].
Washington (DC): USDA; 1996 Apr
[cited 2010 Nov 29]. Available from:
http://www.fsis.usda.gov/OPHS/
baseline/rwgrbeef.pdf
Department of Agriculture, Food
Safety and Inspection Service. Nationwide raw ground turkey microbiological survey [Internet]. Washington (DC): USDA; 1996 May [cited
2010 Nov 29]. Available from:
http://www.fsis.usda.gov/OPHS/
baseline/rwgrturk.pdf
Department of Agriculture, Food
Safety and Inspection Service.
Foodborne illness: what consumers
need to know [Internet]. Washington (DC): USDA; [last modified
2006 Apr 3; cited 2010 Dec 8]. (Fact
Sheet). Available from: http://
www.fsis.usda.gov/factsheets/Food
borne_Illness_What_Consumers_
Need_to_Know/index.asp
Shea KM, American Academy of
Pediatrics Committee on Environmental Health, American Academy
of Pediatrics Committee on Infectious Diseases. Nontherapeutic use
of antimicrobial agents in animal
agriculture: implications for pediatrics. Pediatrics. 2004;114(3):8628.
Food and Drug Administration,
Center for Veterinary Medicine.
2009 summary report on antimicrobials sold or distributed for use in
food-producing animals [Internet].
Silver Spring (MD): FDA; 2010
[cited 2010 Dec 15]. Available from:
http://www.fda.gov/downloads/
ForIndustry/UserFees/Animal
DrugUserFeeActADUFA/
UCM231851.pdf
Mellon M, Benbrook C,
Lutz Benbrook K. Hogging it:
estimates of antimicrobial abuse in
livestock [Internet]. Cambridge
(MA): Union of Concerned Scientists; 2001 Jan; [cited 2011 Apr 7].
Available from: http://www.ucsusa
.org/assets/documents/food_and_
agriculture/hog_front.pdf
Institute of Medicine. Human health
risks with the subtherapeutic use of
penicillin or tetracyclines in animal
feed. Washington (DC): National
Academies Press; 1989.
Khan A. Testimony before the Subcommittee on Health, Committee on
May 2 011
3 0:5
H e a lt h A f fai r s
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34
36
37
38
39
40
922
H e a lt h A f fai r s
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30:5
197739.htm#studies
41 Polycarbonate/BPA Global Group.
About bisphenol [Internet]. Washington (DC): BPA Global Group;
[cited 2011 Feb 12]. Available from:
http://www.bisphenol-a.org/about/
index.html
42 European Food Safety Authority
[Internet]. Parma (Italy): EFSA;
c2010. Press release, EFSA updates
advice on bisphenol A; 2010 Sep 30
[cited 2011 Feb 15]. Available from:
http://www.efsa.europa.eu/en/
press/news/cef100930.htm
43 American Chemistry Council.
Phthalates information center [Internet]. Washington (DC): The
Council; [cited 2011 Feb 12]. Available from: http://www.american
chemistry.com/s_phthalate/index
.asp
44 Environmental Protection Agency.
Mercury: controlling power plant
emissions: overview [Internet].
Washington (DC): EPA; [last updated 2010 Oct 1; cited 2011 Apr 5].
Available from: http://www.epa
.gov/hg/control_emissions/index
.htm
45 Mahan S, Warner K. Hidden costs:
reduced IQ from chlor-alkali plant
mercury emissions harms the
economy [Internet]. Washington
(DC): Oceana; 2009 May [cited 2011
Apr 5]. Available from: http://na
.oceana.org/sites/default/files/
reports/Hidden_Costs.pdf
46 European Commission. An economic and environmental analysis of
the chlor-alkali production process:
mercury cells and alternative technologies [Internet]. Brussels: EC;
1997 Jun 30 [cited 2011 Apr 5].
Available from: http://www.chem
.unep.ch/mercury/2001-ngo-sub/
eurochlor/sub1ngoatt6.pdf
47 US Geological Survey. Mercury in
the environment [Internet]. Reston
(VA): USGS; 2000 Oct [cited 2010
Dec 8]. (Fact Sheet No. 146-00).
Available from: http://www.usgs
.gov/themes/factsheet/146-00/
48 Selin NE, Sunderland EM, Knightes
CD, Mason RP. Sources of mercury
exposure for US seafood consumers:
implications for policy. Environ
Health Perspect. 2010;118:13743.
49 Hintelmann H. Organomercurials:
their formation and pathways in the
environment. Met Ions Life Sci.
2010;7:365401.
50 Environmental Protection Agency.
Fish consumption advisories [Internet]. Washington (DC): EPA; [cited
2010 Dec 10]. Available from: http://
www.epa.gov/hg/advisories.htm
51 Department of Agriculture. Pesticide
Data Program: annual summary,
calendar year 2008 [Internet].
Washington (DC): USDA; 2009 Dec
[cited 3011 Mar 24]. Available from:
http://www.ams.usda.gov/
AMSv1.0/getfile?dDocName=
STELPRDC5081750
52 Baker BP, Benbrook CM, Groth E
53
54
55
56
57
58
59
60
61
62
63
35
64
65
67
68
69
70
71
72
73
74
75
76
77
.gov/npdes/afo/aforule.cfm
78 Environmental Protection Agency.
Controlling power plant emissions:
chronology [Internet]. Washington
(DC): EPA; [last updated 2010 Oct 1;
cited 2011 Feb 21]. Available from:
http://www.epa.gov/hg/control_
emissions/decision.htm
79 US Senate, Committee on Environment and Public Works. Full committee and Subcommittee on Clean
Air and Nuclear Safety joint hearing
entitled, Legislative Hearing: S.
2995, the Clean Air Act Amendments
of 2010 [Internet]. Washington
(DC): The Committee; 2010 Mar 4
[cited 2011 Mar 25]. Available from:
http://epw.senate.gov/public/index
.cfm?FuseAction=Hearings
.Hearing&Hearing_ID=0780a976802a-23ad-42f3-03e35b75a30a
80 Pew Commission on Industrial Farm
Animal Production. Putting meat on
the table: industrial farm animal
production in America [Internet].
Washington (DC): Pew Charitable
Trusts; 2008. [cited 2011 Feb 21].
Available from: http://www.ncifap
.org/index.html
81 Clean Water Network. Legislative
and administrative H20 priorities
[Internet]. Washington (DC): The
Network; 2009 Jan [cited 2011 Feb
21]. Available from: http://www
.cleanwaternetwork.org/sites/
default/files/CWN_Priorities.pdf
May 2 011
3 0:5
H e a lt h A f fai r s
923
66
.org/NLE/CRS/abstract.cfm?
NLEid=1530
Consumers Union. A report card for
the EPA: successes and failures in
implementing the Food Quality
Protection Act [Internet]. Yonkers
(NY): Consumers Union; 2001 Feb
[cited 2010 Dec 14]. Available from:
http://www.consumersunion.org/
pdf/fqpa/ReportCard_final.pdf
Codex Alimentarius [home page on
the Internet]. Rome: Codex; [cited
2011 Feb 12]. Available from: http://
www.codexalimentarius.net/web/
index_en.jsp
Codex Alimentarius. JECFA: The
Joint FAO/WHO Expert Committee
on Food Additives [home page on
the Internet]. Rome: Codex; [cited
2011 Apr 11]. Available from: http://
www.codexalimentarius.net/web/
jecfa.jsp
Food Safety Enhancement Act, H.R.
2749, 111th Cong., 1st Sess. (2009).
Sundlof SF. Statement before the
Subcommittee on Oversight and Investigations, Committee on Energy
and Commerce, House of Representatives. Washington (DC): The
Subcommittee; 2009 Feb 11 [cited
2011 Mar 24]. Available from:
http://democrats.energycommerce
.house.gov/Press_111/20090211/
testimony_sundlof.pdf
Supreme Beef Processors, Inc. v.
USDA, 275 F.3d 432 (5th Cir. 2001).
Single Food Safety Agency Act of