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Compliance Req. Assoc. with Biological Materials

The following is intended as an overview of the compliance requirements associated with certain biological materials. For complete and current information, contact the federal agencies referenced below.

CFR Regulations Biological materials are tightly controlled by regulations found in the Code of Federal Regulations (CFR).

  • 42 CFR Part 71 - Foreign Quarantine (specifically Part 71.54 etiologic agents, hosts and vectors) - permit requirements for agents causing disease in humans that are imported into the U.S. and subsequently transported domestically.
  • 9 CFR Part 122 - Organisms and Vectors - permit requirements for zoonotic agents imported into the U.S. and subsequently transported domestically.
  • 15 CFR Parts 730 - 774 - Department of Commerce, Bureau of Industry and Security (BIS); Commerce Control List - items including commodities, software, and technology that are regulated for export control purposes.
  • 49 CFR Parts 171-180 - Department of Transportation, Research and Special Programs Administration, Hazardous Materials Regulations - documentation and packaging requirements for the transport of hazardous materials.

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Compliance Compliance requirements for acquiring and working with agents depend on the type of agent and its potential threat to public health or agriculture. Access to agents will require the recipient to apply for a permit or license. The following permit requirements apply:

  • Human pathogens imported into the U.S. require a Public Health Service permit for importation and subsequent transport within the U.S.
  • Designated animal and plant pathogens require a USDA permit for transfer within the U.S.
  • The exportation of specific agents and toxins may require an export license as regulated by the Department of Commerce.

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Human Etiologic Agents and Vectors Permits are issued by the Office of Health and Safety, Centers for Disease Control & Prevention. CDC permit 0.728 is required for importation and distribution. For information concerning regulations governing permit requirements and shipment of pathogens and vectors of human disease, contact the Office of Health and Safety, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, 1600 Clifton Road, NE, Mailstop E79, Atlanta, GA 30333, Telephone: 404-498-2260; Fax: 404-498-2275. The application form can be found online.

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Animal Pathogens (Zoonotic Agents) Permits are issued by the National Center for Import Export (NCIE). Veterinary Services permit VS16-6 is required for the importation or movement of certain animal pathogens and vectors. For information concerning regulations governing permit and shipment requirements, contact NCIE, Unit 40, 4700 River Road, Riverdale, MD 20737-1231, Telephone: 301-734-3277; Fax: 301-734-8226. Application forms can be found online. Use Veterinary Services permit application forms VS 16-3 (import or transport) and VS 16-7 (cell cultures and their products). For general instructions on filling out VS 16-3, click here. For general instructions on filling out VS 16-7, click here.

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Export of Controlled Items The HIV Reagent Program materials are reviewed against the Department of Commerce's Commerce Control List to identify reasons for control which indicate licensing requirements to certain destinations. Export Licenses are required if:

  1. The material(s) could support a biological warfare proliferation activity in a country of concern.
  2. There are concerns about the parties to the transaction and the end-use of the item.

For more detailed information regarding Export Licensing Requirements, please contact the U.S. Bureau of Industry and Security. 

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For Additional Information 

Centers for Disease Control

USDA - United States Department of Agriculture

US Department of Transportation

US Department of Commerce