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U.S. Dept. of Health & Human Services
FSAP Legislature, Regulations, and Guidelines FAQs
Guidance for entities registered with FSAP
Issued by: Centers for Disease Control and Prevention (CDC)
On June 12, 2002, President Bush signed into law the "Public Health Security and Bioterrorism Preparedness and Response Act of 2002" (the Act). The Act is designed to improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies. Section 201(a) of the Act amends the Public Health Service Act by adding section 351A (Enhanced Control of Certain Biological Agent and Toxins) (42 U.S.C. 262a) that requires all persons possessing, using or transferring those biological agents or toxins designated by the Secretary of the U.S. Department of Health and Human Services (HHS Secretary) as having the potential to pose a severe threat to public health and safety (i.e., HHS select agents and toxins) to register with the HHS Secretary and meet biosafety and security standards and procedures established by the HHS Secretary. The Centers for Disease Control and Prevention (CDC) has been designated as the HHS agency responsible for promulgating, implementing, and providing guidance on 42 CFR Part 73. The HHS Select Agent regulations can be found in Part 73 of Title 42 of the Code of Federal Regulations (42 CFR Part 73). Section 212 of the Act (cited as the Agricultural Bioterrorism Protection Act of 2002, 7 USC 8401) requires all persons possessing, using or transferring those biological agents or toxins designated by the Secretary of the U.S. Department of Agriculture (USDA) as having the potential to pose a severe threat to animal or plant health or to animal or plant products (i.e. USDA select agents and toxins) to register with the USDA Secretary and meet biosafety and security standards and procedures established by the USDA Secretary. The USDA Select Agent regulations covering threats to animals and animal products can be found at Part 121 of Title 9 Code of Federal Regulations (9 CFR Part 121). The Animal and Plant Health Inspection Service (APHIS) has been designated as the USDA agency responsible for promulgating, implementing, and providing guidance on 9 CFR Part 121 and 7 CFR Part 331. The USDA Select Agent regulations covering threats to plants and plant products can be found at Part 331 of Title 7 Code of Federal Regulations (7 CFR Part 331). The Act can be found at the Federal Register website http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=107_cong_public_laws&docid=f:publ188.107.
On October 26, 2001, President Bush signed into law the "Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism" (USA PATRIOT) Act. Section 817 of the USA PATRIOT Act prohibits certain persons designated as a "restricted person" from possessing select agents and toxins. See 18 USC 175b. The USA PATRIOT Act also provides criminal penalties for possession of any biological agent or toxin in a quantity that, under the circumstances, is not reasonably justified by a prophylactic, protective, bona fide research, or other peaceful purpose. More information on the USA PATRIOT Act can be found at Department of Justice website http://www.justice.gov/archive/ll/highlights.htm.
On January 9, 2009, President George W. Bush signed Executive Order (EO) 13486 entitled "Strengthening Laboratory Biosecurity in the United States." The Executive Order is available at: http://www.gpo.gov/fdsys/pkg/FR-2009-01-14/pdf/E9-818.pdf . This EO established a Working Group (WG) co-chaired by the Secretary of Defense and the Secretary of Health and Human Services. The scope of WG activities pertained to the policy of the United States that facilities which possess biological select agents and toxins have appropriate security and personnel assurance practices to protect against theft, misuse, or diversion to unlawful activity of such agents and toxins. The WG report is available at: http://orise.orau.gov/emi/scapa/files/biosecurity-report.pdf .
The CDC/NIH publication, "Biosafety in Microbiological and Biomedical Laboratories" (BMBL), currently in its fifth edition, serves as a nationally and internationally recognized source for the standards and special microbiological practices, safety equipment, and facilities to work with a variety of infectious agents in various laboratory settings. The BMBL utilizes 4 biosafety levels (BSL 1 through 4) for work with pathogenic microorganisms based upon a risk assessment. The select agent regulations (42 CFR Part 73, 7 CFR Part 331, and 9 CFR Part 121) require an entity to develop and implement a written biosafety plan that is commensurate with the risk of the agent or toxin, given its intended use (see, for example, 42 CFR 73.12(a)). In developing the biosafety plan, the regulations state that the entity should consider:
(1) BMBL (2) The "NIH Guidelines for Research Involving Recombinant DNA Molecules," (NIH Guidelines) provides risk assessment, physical containment, and biological containment provisions relating to genetic elements, recombinant nucleic acids and recombinant organisms of select agents and toxins.
DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.
Date Published: 6/19/2020
