FAQ: Legislature, Regulation, and Guidelines

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 here. 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 here.

On July 2, 2010, President Obama signed Executive Order 13546 entitled “Optimizing the Security of Biological Select Agents and Toxins in the United States” that directed the Department of Health and Human Services (HHS) and the Department of Agriculture (Agriculture) to review, tier, and consider the reduction of their select agent lists; establish personnel reliability standards for those having access to biological select agents and toxins (BSAT); and establish physical security standards for BSAT with the highest risk of misuse. The Executive Order is available at: http://edocket.access.gpo.gov/2010/pdf/2010-16864.pdf .

As a result of Executive Order 13546, the Federal Select Agent Program provided technical advice and administrative support to the Federal Experts Security Advisory Panel (FESAP), an interagency group created by Executive Order 13546 to develop national recommendations for optimizing biosecurity. On October 3, 2011, the Federal Select Agent Program published a Notice of Proposed Rulemaking that solicited comments regarding (1) the appropriateness of the current HHS list of select agents and toxins; (2) whether there are other biological agents or toxins that should be added to the HHS list; (3) whether biological agents or toxins currently on the HHS list should be deleted from the list; (4) whether the HHS select agents and toxins list should be tiered based on the relative bioterrorism risk of each biological agent or toxin; and (5) whether the security requirements for select agents or toxins in the highest tier should be further stratified based on type of use or other factors. The final rule was published on October 5, 2012 and addressed recommendations by FESAP on the designation of Tier 1 agents and toxins, reduction in the number of agents on the Select Agent List, establishment of suitability standards for those having access to Tier 1 select agents and toxins, and establishment of physical security and information security standards for Tier 1 select agents and toxins.

Federal Oversight and Information Sharing: In addition to supporting the work of the FESAP, the Federal Select Agent Program has convened an Interagency Working Group to execute Sections 6(a) and 8 of the Executive Order. This working group, which includes representatives from the Departments of Homeland Security (DHS), Defense (DOD), Justice (DOJ), Energy (DOE), and the Environmental Protection Agency (EPA), is developing procedures and policies to better coordinate Federal inspections, information sharing, and other activities so that effective oversight can be achieved with a minimal disruption of critical biodefense functions.

• Joint inspections: A joint inspection program has been initiated between the Federal Select Agent Program and other federal agencies that fund or own entities where select agent/toxin work is conducted to minimize the number of select agent inspections that these entities undergo per year.
• Information sharing: Memoranda of understanding have been developed among HHS, USDA, DHS, DOD, EPA, DOE, and Veterans Health Administration to share information, primarily inspection data.
• Inspector Training Program: Division of Regulatory Science and Compliance (DRSC) has trained individuals associated with our Federal Partners. The goal of the program is to provide the knowledge, skills and experience to Federal partners outside of the Federal Select Agent Program to enable them to conduct “internal” inspections of registered entities they own and operate or fund, or to conduct joint inspections with the Federal Select Agent Program.

The CDC/NIH publication, “Biosafety in Microbiological and Biomedical Laboratories” (BMBL), currently in its sixth 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.

• A federal regulation has the force and effect of law. The select agent and toxin regulations are 42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331.
• An FSAP regulatory interpretation is a written FSAP statement explaining the meaning of a section of the regulations or a regulatory phrase.  Although a regulatory interpretation is a response to a specific request for clarification of the meaning for a section of the regulations or a regulatory phrase, a regulatory interpretation is binding on FSAP for all entities.  The regulatory phrase being interpreted has the force and effect of law.
• An FSAP policy statement is a written FSAP statement explaining how the program reads (interprets) and will apply (enforce) a select agent and toxin regulation.  The regulation that is the subject of the FSAP policy statement has the force and effect of law.
• An FSAP guidance document (e.g., FSAP’s Annual Inspection Guidance or FSAP’s Biosafety/Biocontainment Plan Guidance) is advice and information provided by FSAP to assist registered entities with achieving regulatory compliance.  It is a way to achieve compliance, not the way to achieve compliance.  A guidance document does not have the force and effect of law.