- If I have questions regarding the Federal Select Agent Program or select agents and toxins, where can I go to get help?
- What are the select agent regulations?
- What is the Federal Select Agent Program?
- What is an entity?
- What is a select agent or toxin?
- What is a Tier 1 Select Agent or Toxin?
- How is the select agent list determined?
- What is the Intragovernmental Select Agents and Toxins Technical Advisory Committee?
- Why do I need to register with the Federal Select Agent Program for select agents or toxins that I possess, use, or transfer?
- Where can I obtain any forms to submit requests or reports associated with the select agent regulations?
- What are the penalties for not being in compliance with the regulations?
- What is the Performance Improvement Plan program?
- Under what conditions could a certificate of registration be withdrawn, revoked, or suspended?
- Is there a restriction on the publication of select agent information?
- How can I report suspicious activity that may be criminal in nature concerning a registered entity, its personnel, or its select agents or toxins?
- Is it possible for me to report a safety or security issue related to a select agent or toxin without identifying myself?
- Should the plans (i.e., biosafety, incident response, and security) developed to comply with the select agent regulations be available to only those individuals that have access approvals from the Federal Select Agent Program?
- When should the entity submit a request to perform a restricted experiment (e.g., prior to writing a grant proposal)?
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For specific questions that aren't addressed at http://www.selectagents.gov/, please submit an email directly to the Federal Select Agent Program at:
CDC: LRSAT@cdc.gov
APHIS: ASAP@aphis.usda.gov
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The select agent regulations can be found at 42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331. The select agent regulations implement the Subtitle A and Subtitle B (also known as the Agricultural Bioterrorism Protection Act of 2002) of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, setting forth the requirements for the possession, use, and transfer of select agents and toxins.
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The Centers for Disease Control and Preventions’ (CDC) Division of Select Agents and Toxins (DSAT) and the Animal and Plant Health Inspection Services’ (APHIS) Agricultural Select Agent Program (ASAP) jointly constitute the Federal Select Agent Program.
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An entity is any government agency (Federal, State, or local) academic institution, corporation, company, partnership, society, association, firm, sole proprietorship, or other legal entity. See section 1 of the select agent regulations.
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Pursuant to 42 USC 262a and 7 USC 8401, select agents and toxins are a subset of biological agents and toxins that the Departments of Health and Human Services (HHS) and Agriculture (USDA) have determined to have the potential to pose a severe threat to public health and safety, to animal or plant health, or to animal or plant products. The current list of select agents and toxins can be found at 42 CFR §§ 73.3, 73.4, 9 CFR §§ 121.3, 121.4, and 7 CFR § 331.3.
A current list of select agents and toxins can also be found at: http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20List.html.
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A subset of select agents and toxins have been designated as Tier 1 because these biological agents and toxins present the greatest risk of deliberate misuse with significant potential for mass casualties or devastating effect to the economy, critical infrastructure, or public confidence, and pose a severe threat to public health and safety:
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Tier 1 Select Agents and Toxins
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HHS Agents and Toxins
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Overlap Agents
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USDA Agents
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Botulinum neurotoxins
Botulinum neurotoxin producing species
of Clostridium
Ebola virus
Francisella tularensis
Marburg virus
Variola major virus (Smallpox virus)
Variola minor virus (Alastrim)
Yersinia pestis
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Bacillus anthracis
Burkholderia mallei
Burkholderia pseudomallei
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Foot-And-Mouth
Disease virus
Rinderpest virus
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Entities that possess, use, or transfer Tier 1 select agents and toxins must adhere to the additional requirements detailed within the Select Agent Regulations: http://www.selectagents.gov/Regulations.html.
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In determining whether to include an agent or toxin on the HHS select agent list, the "Public Health Security and Bioterrorism Preparedness and Response Act" requires that the following criteria be considered:
- The effect on human health of exposure to the agent or toxin;
- The degree of contagiousness of the agent or toxin and the methods by which the agent or toxin is transferred to humans;
- The availability and effectiveness of pharmacotherapies and immunizations to treat and prevent any illness resulting from infection by the agent or toxin; and
- Any other criteria, including the needs of children and other vulnerable populations, that the Secretary considers appropriate.
In determining whether to include an agent or toxin on the USDA list, the "Agricultural Bioterrorism Protection Act of 2002" requires that the following criteria be considered:
- The effect of exposure to the agent or the toxin on animal and plant health, and on the production and marketability of animal or plant products;
- The pathogenicity of the agent or the toxin and the methods by which the agent or toxin is transferred to animals or plants;
- The availability and effectiveness of pharmacotherapies and prophylaxis to treat and prevent any illness or disease caused by the agent or toxin; and
- Any other criteria that the Secretary considers appropriate to protect animal or plant health, or animal or plant products.
The lists are required to be reviewed and republished every 2 years, or revised as necessary.
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The Intragovernmental Select Agents and Toxins Technical Advisory Committee (ISATTAC) is an inter-agency workgroup of subject matter experts from Federal government Departments and Agencies constituted by the CDC Director to provide recommendations to the DSAT in the following three technical areas: (1) review of requests for the exclusion of attenuated strains, (2) review of requests to conduct restricted experiments, and (3) review of the select agents and toxins listed in Part 73.
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Registration of individuals or entities possessing, using, or transferring these select agents and toxins, unless the agent or toxin is specifically excluded by the select agent regulations or the individual or entity has been specifically exempted by the Federal Select Agent Program, is required pursuant to the select agent regulations. Anyone violating the provisions of 42 CFR Part 73, 7 CFR Part 331, or 9 CFR Part 121 may be subject to civil and/or criminal penalties including imprisonment for not more than 5 years.
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Forms are available at http://www.selectagents.gov/Forms.html.
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- Administrative:
- The Federal Select Agent Program has the authority to deny, suspend, or revoke registration to use, possess, or transfer select agents and toxins. See section 8 of the select agent regulations.
- The Federal Select Agent Program has the authority to deny an individual access to select agents and toxins to protect public health and safety. See section 10 of the select agent regulations.
- Civil:
- In addition to any other penalties that may apply under law, any person who violates any provision of select agent regulations shall be subject to the United States for a civil money penalty in an amount not exceeding $250,000 in the case of an individual and $500,000 in the case of any entity.
- Criminal: Violations of 18 USC 175b
- A "restricted person" that possesses a select agent or toxin, or transfers select agent or toxin in interstate or foreign commerce, (and is not excluded or exempted under select agent regulations) is subject to a criminal fine, imprisoned not more than 10 years, or both.
- Whoever transfers a select agent or toxin to a person who the transferor knows or has reasonable cause to believe is not registered with the Federal Select Agent Program in accordance with the select agent regulations is subject to a criminal fine or imprisoned for not more than 5 years, or both.
- Whoever knowingly possesses a select agent or toxin when that person is not registered with the Federal Select Agent Program in accordance with the select agent regulations is subject to a criminal fine and/or imprisoned for not more than 5 years.
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In March 2008, the Federal Select Agent Program established the Performance Improvement Plan (PIP) program to assist entities, identified by Federal Select Agent Program as having systemic biosafety and security deficiencies, to come into compliance with the select agent regulations. After being given the opportunity to participate, an entity begins by submitting a detailed plan, including target completion dates, addressing the specifics of how the entity will address and correct regulatory deficiencies identified by Federal Select Agent Program. An entity’s participation in a PIP allows Federal Select Agent Program to both provide technical assistance as well as monitor an entity’s progress in correcting security or safety shortcomings.
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The Federal Select Agent Program will withdraw a certificate of registration upon the written request of the entity , if the entity no longer possesses or uses any select agents or toxins and no longer wishes to be registered.
A certificate of registration may be revoked or suspended if:
- The individual or entity, the Responsible Official, or an individual who owns or controls the entity is a restricted person (within any of the categories described in 18 U.S.C 175b).
- The individual or entity, the Responsible Official, or an individual who owns or controls the entity is reasonably suspected by any Federal law enforcement or intelligence agency of:
- Committing a crime specified in 18 U.S.C. 2332b(g)(5);
- Knowing involvement with an organization that engages in domestic or international terrorism (as defined in 18 U.S.C. 2331) or with any other organization that engages in international crimes of violence; or
- Being an agent of a foreign power (as defined in 50 U.S.C 1801).
- The individual or entity does not meet the requirements of select agent regulations.
- It is determined that such action is necessary to protect agricultural or public health and safety.
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The select agent regulations place no specific restrictions on the publication of research related to select agents or toxins. However, any records or information systems that could allow an individual to gain access to the select agents or toxins should be safeguarded to prevent unauthorized access, theft, loss, or release of these materials. The Federal Select Agent Program strongly encourages entities to refrain from publishing detailed information about locations of select agents and toxins, quantities on site, or researchers.
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You can notify a Federal Bureau of Investigation Weapons of Mass Destruction Coordinator of any suspicious activity that you believe may be criminal in nature concerning an entity, its personnel, or its select agents or toxins. To locate your Federal Bureau of Investigation Weapons of Mass Destruction Coordinator, refer to http://www.fbi.gov/contact-us/field.
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The Federal Select Agent Program has established a confidential means for reporting safety and security issues associated with the possession, use and transfer of select agents and toxins. The Department of Health & Human Services, Office of Inspector General (OIG) maintains a hotline that allows individuals to anonymously report fraud, waste and abuse in all departmental programs. This hotline is now available to anonymously report safety or security issues related to select agents and toxins. When reporting these issues to OIG, please ensure that you indicate it is a "Select Agent Program" issue.
OIG Hotline contact information:
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1-800-HHS-TIPS (800-447-8477) |
Fax: |
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1-800-223-8164 |
Web: |
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http://oig.hhs.gov/fraud/hotline |
Mail: |
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Office of Inspector General
Department of Health & Human Services
Attn: Hotline
P.O. Box 23489
Washington, DC 20026 |
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The select agent regulations place no specific restrictions on the biosafety, incident response, or security plan being made publically available to individuals (e.g., first responders, maintenance workers) that don’t have access approvals from the Federal Select Agent Program. However, any records or information systems that could allow an individual to gain access to the select agents or toxins should be safeguarded to prevent unauthorized access, theft, loss, or release of these materials. The Federal Select Agent Program strongly encourages entities to refrain from publishing detailed information about locations or quantities of select agents and toxins on site.
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Normally, the Federal Select Agent Program needs at least sixty days to review a request for restricted experiment. Delays in the process may occur if the entity fails to provide relevant information regarding the experiment. This information includes:
- A cover letter (on official entity letterhead) requesting to conduct the experiment along with the following relevant information:
- Synopsis of the proposed experiment(s) and the intended objective(s).
- Description of the nucleic acid insert (complete sequence information is not required) and the predicted biological characteristics of the recombinant product.
- Description of the cloning/expression vector.
- Identification and characteristics of the host organism used for molecular cloning.
- Description of the methods used for selection (e.g., recombinant or passive selection) to include all potential drug resistant traits (including intermediate variants).
- Address whether there are alternative antimicrobial marker genes that could be used, i.e., to avoid the acquisition of drug resistance that could compromise the use of the drug to control disease agents in humans, veterinary medicine, or agriculture (if applicable). Provide an explanation as to why these alternative marker genes are not being considered.
- Description of biosafety level including facility containment, equipment and special practices to be utilized for the proposed experiment(s).
- Description of the mechanism and specificity of the antimicrobial resistance (antibiotic, antifungal and antiviral resistance) being conferred to include any cross-resistance to other therapeutically useful antimicrobials (if applicable).
- Estimated amount of toxin (recombinant or synthetic) to be produced (if applicable).
- Synopsis of any planned animal or plant experiments (if applicable) or other relevant animal or plant work.
- Scientific references or supporting documentation, particularly with respect to the biosafety aspects of the proposed experimental product.
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