Compliance Requirements Associated with Biological Materials
The following is intended as an overview of the compliance requirements associated with certain biological materials, including select agents. For complete and current information, contact the federal agencies referenced below.
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.
- 42 CFR Part 73 - Possession, Use and Transfer of Select Agents and Toxins - requirements as established by HHS, as a means to provide protection against the misuse of those agents and toxins that pose a severe threat to public health and safety (including zoonotic agents), to include registration requirements, security risk assessments, safety and security plans, training, transfers, and documentation.
- 7 CFR Part 331/ 9 CFR Part 121 - Possession, Use and Transfer of Biological Agents and Toxins - requirements as established by USDA, Animal and Plant Health Inspection Service (APHIS) to control those agents and toxins that have been determined to pose a severe threat to human, animal, and plant health and includes requirements regarding registration, security risk assessments, biosafety and security plans, training, transfers, and documentation.
- 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 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, and in the case of select agents and toxins, institutions must be registered with the Centers for Disease Control and Prevention (CDC) and/or USDA and be in compliance with pertinent HHS and/or USDA regulations. 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.
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.
Export of Controlled Items
BEI 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:
- The material(s) could support a biological warfare proliferation activity in a country of concern.
- 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.
Select Agents are specific biological agents and toxins regulated by the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA) due to their potential to pose a threat to public health, agriculture, and safety. The current list contains 82 agents, including groups of agents, toxins, and plant pathogens.
Anyone desiring to acquire, possess, use or transfer any agent or toxin on the select agent list must register with the Centers for Disease Control and Prevention (CDC) Select Agent Office and/or the USDA Animal and Plant Health Inspection Service (APHIS). The following registration requirements must be met before an entity or individual can acquire, possess, use, or transfer a select agent or toxin:
- Responsible Official and Alternate Responsible Official must be designated as the institutional representatives to the regulating agencies.
- These designated officials, as well as anyone at the institution granted access to select agents must undergo a security risk assessment, to include fingerprint analysis, conducted by the U.S. Department of Justice.
- The institution must meet all laboratory safety conditions for the agents to be handled.
- The institution must ensure that select agents are secure at all times, and must develop and implement a security plan for review by the federal agencies.
- The institution must undergo a safety and security inspection by either the CDC, USDA, or both, depending on the agents listed in the registration.
- The institution must meet all requirements found in the regulations cited above.
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For Additional Information
Centers for Disease Control -- Select Agent Program
U.S. Department of Agriculture -- Select Agent Program
CDC & USDA -- Select Biological Agents
CDC -- Biosafety in Microbiological and Biomedical Laboratories
U.S. Department of Commerce
U.S. Department of Transportation
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