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CDC Requirements for the Importation of CRITICAL Laboratory Samples into the United States

This document is meant to provide general guidelines and advice to the CDC Laboratories on shipping critical samples only, e.g.,
samples related to an outbreak investigation. These guidelines are not intended to be followed for shipping routine laboratory
samples.
All samples, regardless of their origin (plant, animal, human, etc.) must meet U.S. federal regulatory requirements before entering
the United States. Packages containing laboratory samples that fail to meet U.S. federal requirements for importation are
inadmissible and could be destroyed or re-exported (returned to the country of origin). Because some required documentation
might take several weeks to obtain, it is important that you begin the process of obtaining permits as soon as possible during the
response planning phase and before collecting and shipping samples:
1.

Apply for and Acquire Necessary Permits (see Appendix):


Federal regulatory agencies recognize the importance of public health outbreak investigations and will attempt to facilitate
importations of critical samples wherever possible. However, regulatory requirements for importations provide crucial
protections for U.S. public health, agriculture, and environmental protection and cannot be waived even in an emergency. Being
proactive to obtain necessary import permits is the ounce of prevention that can save a pound of cure at the port of entry.
In most cases where samples are part of a public health outbreak investigation related to a communicable disease, a CDC import
permit will be required. Whenever possible, obtain an investigation-specific import permit and avoid the use of general, catchall import permits in order to minimize problems at the port of entry. If you are unsure whether your shipment needs a CDC
import permit, contact the Division of Select Agents and Toxins desk officer at:
Call: (404) 718-2077
FAX: (404) 471-8333
importpermit@cdc.gov
You might also need to obtain a permit from the U.S. Department of Agriculture (USDA) or U.S. Fish and Wildlife Service (FWS).
Please use the following links to find USDA and FWS import requirements:
USDA Veterinary Services
http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/importexport?1dmy&urile=wcm%3apath%3a%2Faphis_content_lib
rary%2Fsa_our_focus%2Fsa_animal_health%2Fsa_import_into_us%2Fsa_entry_requirements%2Fct_import_animal_produ
cts
USDA Guidelines for Importation of Human and Non-Human Primate Material
http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/importexport?1dmy&urile=wcm%3apath%3a%2Faphis_content_lib
rary%2Fsa_our_focus%2Fsa_animal_health%2Fsa_import_into_us%2Fsa_entry_requirements%2Fct_micros_1101
FWS Permits
http://www.fws.gov/permits/overview/overview.html

2.

Arrange Shipping:
Do: Use cargo shippers that have existing contracts with CDC for shipment of critical samples. CDC EOC has contracts in
place with several of these couriers, as do many programs within CDC. These couriers: 1) excel at maintaining a cold chain;
2) have Customs brokers readily available to ensure that samples have proper documentation before they are moved
forward; and 3) have longstanding working relationships with DGMQ staff. Cargo shippers are able to facilitate an
expedited clearance at the port of entry and movement of samples.
Do NOT: Ship critical samples, particularly those that require cold-chain management, with express consignment couriers
(e.g., FEDEX, DHL, UPS). Using express consignment couriers has resulted in the past in the loss or significant delay of
shipments, inability to clear shipments for entry into the United States and difficulty in maintaining a cold chain. While it is
true that most express consignment couriers will ship packages for considerably less cost than cargo shippers, the cost of
losing irreplaceable samples is immeasurable.

For assistance with identifying a courier service that has a contract with CDC, you may call the EOC at: 770-488-7100. The
EOC will then route the request to the On-Call Logistics Chief. Please do not use a Customs broker or courier service that
is not contracted by CDC.
3.

Consider the route your package will take:


If maintaining a cold chain and receiving the samples in a timely manner are essential, request that the courier ship
through New York (JFK). JFK allows for re-icing and has all of the major couriers/brokers onsite. In addition, JFK has CDC
staff available to help ensure that the samples are cleared into the United States without issue. CBP and other agencies
may place a hold for inspection at many ports; however, the CDC-CBP partnership at JFK usually prevents this from
occurring. If shipping through JFK is impossible, contact DGMQ for advice before finalizing shipment arrangements.

4.

Consider the shipping date:


If sending samples from Africa or Asia and it is not important that the samples arrive at CDC as soon as possible, ship on
Thursday, Friday, or Saturday so that the samples arrive at CDC at the beginning of the following week. If the shortest
possible transit time is important, contact DGMQ for advice on timing shipments.

5.

Package your samples correctly:


Use proper shipping containers and labels. Shipments must be packaged and labeled according to international regulations
for shipping infectious substances. Improper packaging and labeling is one of the most common causes for shipping delays
or loss of critical samples. Shipping instructions for infectious substances can be found at:
http://www.cdc.gov/od/eaipp/docs/e-tool_Intro_Shipping_and_Packaging.pdf
Always allow for at least 5 days transit time when measuring dry ice. Rule of thumb for dry ice packages:

Dry ice dissipates at a rate of 6 to 10 pounds (3-5 kg) of dry ice per 24 hour period.

Dry ice should take up at least the space in the box.

There should still be dry ice inside when the box is opened upon arrival.

The limit per outer shipping box/overpack is 200 kg of dry ice.


Do not place dry ice in a hermetically sealed container.
Shipping supplies are available at no cost to the program from the Division of Scientific Resources, NCEZID. For supplies,
please contact Yvonne Stifel, Team Leader, Shipping and Export, yjs1@cdc.gov . Please provide the following information
when requesting supplies:
Number and size of specimen containers (tubes/vials, etc.)
Whether dry ice or cold packs will be used
Anticipated number of shipments
Supplies are located at the CDC Roybal Campus. If the supplies will not be picked up in person, provide the following
information so that the Shipping and Export Team can ship the supplies:
CDC CAN or FedEx Account Number.
Consignee information for the shipping supplies (i.e., contact name and telephone number and institute name and
complete address).

6.

Notify DGMQ of Shipments prior to shipping CRITICAL samples (not routine samples):
DGMQ staff can assist with any problems or questions that may occur during shipment of critical samples. Please contact
both Sheryl Shapiro and Adam Langer (see below and copy both) prior to shipping products and provide them with the
shipping/tracking information to assist with clearance into the United States.
Sheryl E. Shapiro, Cargo and Partnership Development Activity Lead, Importation and Animal Contact Team (ImpACT),
Division of Global Migration and Quarantine, shs3@cdc.gov 516-361-3302
Dr. Adam Langer, ImpACT Team Lead, akl7@cdc.gov

*****Obtain all necessary documentation before attempting to ship samples to the United States.*****

APPENDIX
CDC Documentation needed for Importation of Animal Origin Laboratory Samples into the United States

ANIMAL MATERIALS,
MICROORGANISMS, AND
MICROBIAL TOXINS
African rodent, Nonhuman
primate, Family Viverridae

Bats and other Vectors of Human


Disease (e.g., mosquitoes, ticks,
fleas, snails)

Bacteria, viruses, fungi, prions,


infectious nucleic acids

Documents needed
CDC/DGMQ Permit; OR
Statement Regarding
Process Used to Render
Item Noninfectious
(taxidermy certificate is
acceptable)
CDC/IPP Permit; OR
Certification Statement*
that includes a Detailed
Description of How the
Material was Rendered
Noninfectious
(taxidermy certificate is
acceptable for bats)
CDC/IPP Permit; OR
Certification Statement
that includes a Detailed
Description of How the
Material was Rendered
Noninfectious

Related Website(s)
http://www.cdc.gov/animalimportation/animalp
roducts.html
http://www.cdc.gov/od/eaipp/docs/etool_Intro_Shipping_and_Packaging.pdf

http://www.cdc.gov/od/eaipp/
http://www.cdc.gov/od/eaipp/docs/eTool.pdf
http://www.cdc.gov/od/eaipp/docs/etool_Intro_Shipping_and_Packaging.pdf

http://www.cdc.gov/od/eaipp/
http://www.cdc.gov/od/eaipp/docs/eTool.pdf
http://www.cdc.gov/od/eaipp/docs/etool_Intro_Shipping_and_Packaging.pdf

CDC Documentation needed for Importation of Human Origin Laboratory Samples into the United States

HUMAN TISSUES AND


PRODUCTS
Human tissues and products (e.g.,
blood, saliva, feces, urine) known
to be infectious

Documents needed
CDC/Import Permit
Program (IPP) Permit

Related Website(s)
http://www.cdc.gov/od/eaipp/
http://www.cdc.gov/od/eaipp/docs/eTool.pdf

Human tissues and products not


known or reasonably expected to
be infectious (or suspected to be
infectious, if being imported as a
diagnostic specimen)

Certification Statement*

Human tissues and products that


have been rendered
noninfectious

Certification Statement
*that includes a Detailed
Description of How the
Material was Rendered
Noninfectious

http://www.cdc.gov/od/eaipp/docs/etool_Intro_Shipping_and_Packaging.pdf
http://www.cdc.gov/od/eaipp/
http://www.cdc.gov/od/eaipp/docs/eTool.pdf
http://www.cdc.gov/od/eaipp/docs/etool_Intro_Shipping_and_Packaging.pdf
http://www.cdc.gov/od/eaipp/
http://www.cdc.gov/od/eaipp/docs/eTool.pdf
http://www.cdc.gov/od/eaipp/docs/etool_Intro_Shipping_and_Packaging.pdf

Human tissues and products that


are assumed to be noninfectious:

Cremated remains

Human hair

No documents required

http://www.cdc.gov/quarantine/humanremains.html

Clean, dry bones and bone


fragments, including skulls

Teeth, fingernails, or toenails


Items intended for transplant
into patients (might be
regulated by FDA)

*The Certification Statement must include:


A detailed description of the material; and
A statement on official letter head signed by the sender or the recipient clearly stating that
(1) the material is not known or suspected to contain an infectious biological agent and
(2) one of the following:
how the person making the certification knows that the specimen does not contain an infectious
biological agent; or
the basis of the belief that there is no reason to suspect that the specimen does not contain an
infectious biological agent; or
a detailed description of how the material was rendered noninfectious.
The shipment must not be leaking. Potentially infectious material is NOT to be hand-carried aboard aircraft.

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