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Federal Select Agent Program (CDC/USDA)
governmentselectagents.gov·selectagents.gov/
Relevant to AI safety discussions around biosecurity governance, dual-use research risks, and regulatory models that could inform oversight of AI-enabled biological capabilities or gain-of-function research.
Metadata
Importance: 42/100guidance documenthomepage
Summary
The Federal Select Agent Program is a joint CDC-USDA regulatory initiative governing the possession, use, and transfer of dangerous biological agents and toxins that could threaten public, animal, or plant health. It provides biosecurity infrastructure including entity inspections, personnel security risk assessments, a national database, and compliance enforcement. The program serves as a key model for biosecurity governance relevant to emerging biotechnology risks.
Key Points
- •Joint CDC-USDA program regulating biological agents and toxins posing threats to public, animal, or plant health.
- •Conducts entity inspections, personnel security risk assessments, and maintains a national registry of select agent holders.
- •Investigates non-compliance incidents and provides anonymous reporting mechanisms for safety and security concerns.
- •Serves as a regulatory framework model potentially applicable to dual-use research oversight in AI-bio convergence contexts.
- •Provides publicly accessible lists of regulated select agents and toxins, informing biosecurity policy discussions.
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Federal Select Agent Program
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2024 Annual Report of the Federal Select Agent Program
Federal Register Notice: Biennial Review of the List of Select Agents and Toxins
Regulating Select Agents
Inspecting Select Agents
Ensuring Security Risk Assessment
Providing Guidance on Compliance
Federal Select Agent Program
Minus
Related Pages
The Federal Select Agent Program is jointly comprised of the Centers for Disease Control and Prevention/Division of Regulatory Science and Compliance and the Animal and Plant Health Inspection Service/Division of Agricultural Select Agents and Toxins. The Federal Select Agent Program oversees the possession, use and transfer of select agents and toxins, which pose a threat to public, animal or plant health. The Program greatly enhances the nation’s oversight of the safety and security of select agents by:
Developing, implementing, and enforcing the Select Agent Regulations
Maintaining a national database
Inspecting entities that possess, use, or transfer select agents
Ensuring that all individuals who work with these agents undergo a security risk assessment performed by the Federal Bureau of Investigation/Criminal Justice Information Service
Providing guidance to regulated entities on achieving compliance to the regulations through the development of guidance documents, conducting workshops and webinars
Investigation of any incidents in which non-compliance may have occurred
If you have any questions or comments about the program, website or forms, contact lrsat@cdc.gov .
eFSAP Resource Center Visit Annual Report View Information for Clinical/Diagnostic Laboratories, Healthcare Facilities, and Other Entities Not Registered with the Federal Select Agent Program
View Anonymous Reporting To report safety, security, or other concerns associated with select agents and toxins, please use the Office of Inspector General (OIG)’s confidential hotline. When reporting these issues to OIG, please ensure that you indicate it is a “Select Agent Complaint” issue.
OIG Hotline contact information
Voice: 1-800-HHS-TIPS (800-447-8477)
Fax: 1-800-223-8164
Web: https://oig.hhs.gov/fraud/report-fraud/index.asp
Mail:
Office of Inspector General
Department of Health & Human Services
Attn: Hotline
P.O. Box 23489
Washington, DC 20026
USDA OIG Hotline contact information
Voice: 1-800-424-9121
Fax: 1-202-690-2474
Web: https://usdaoig.oversight.gov/hotline
Mail:
United States Department of Agriculture
Offic
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