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Public Health Emergency U.S. Department of Health and Human Services
 

S3 - Science Safety Security

Biosecurity FAQs

What is Laboratory Biosecurity?
The term laboratory biosecurity refers to the protection of hazardous biological agents, including toxins, from loss, theft, diversion, or intentional misuse.


What are Biological Select Agents and Toxins (BSAT)?
Biological Select Agents and Toxins are federally regulated microbial pathogens and toxins that have the potential to pose a severe threat to public, animal, or plant health, or to animal or plant products and whose possession, use, and transfer are regulated by the Select Agent Regulations (7 CFR Part 331, 9 CFR Part 121, and 42 CFR Part 73). The Department of Health and Human Services, Centers for Disease Control and Prevention (HHS/CDC), regulates the domestic possession, use, and transfer of Select Agents and Toxins that have the potential to pose a severe threat to public health and safety. The United States Department of Agriculture, Animal and Plant Health Inspection Service (USDA/APHIS), regulates the domestic possession, use, and transfer of Select Agents and Toxins that have the potential to pose a severe threat to public health and safety, to animal health, to plant health, or to animal or plant products. Select Agents and Toxins that are regulated by both HHS/CDC and USDA/APHIS are referred to as "overlap" Select Agents and Toxins.  The Department of Commerce, Bureau of Industry and Security (DOC/BIS) regulates the export of Select Agents and Toxins, relevant biological materials, and the technology associated with these pathogens and toxins.  The unlawful possession, use, and transfer of Select Agents and Toxins is punishable through criminal and civil penalties.  For more information, see the HHS and USDA List of Select Agents and Toxins.   
 
What are the Select Agent Regulations?
The Select Agent Regulations are the U.S. Department of Health and Human Services and the U.S. Department of Agriculture regulations implementing the Public Health and Bioterrorism Preparedness and Response Act of 2002 and the Agricultural Bioterrorism Protection Act of 2002.  Responsibility for the promulgation of the Select Agent Regulations and the implementation of Select Agent regulatory oversight resides with the Department of Health and Human Services, Centers for Disease Control and Prevention (HHS/CDC), and the United States Department of Agriculture, Animal and Plant Health Inspection Service (USDA/APHIS).  For more information on both agencies’ current regulations, see Select Agents Regulations


What is the Select Agent Program?

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Agricultural Bioterrorism Protection Act of 2002 (the Acts) require entities to register with the Department of Health and Human Services, Centers for Disease Control and Prevention (HHS/CDC), or the United States Department of Agriculture, Animal and Plant Health Inspection Service (USDA/APHIS), if they possess, use, or transfer biological agents or toxins (i.e. select agents and toxins) that could pose a severe threat to public health and safety; to animal or plant health; or animal or plant products. The Acts also require increased safeguards and security measures for these agents, including controlling access, screening entities and personnel (i.e. security risk assessments), and establishing a comprehensive and detailed national database of registered entities.  The Select Agent Program implements the requirements of these Acts through the Select Agent Regulations.   USDA/APHIS and HHS/CDC work closely with Department of Justice's Federal Bureau of Investigation, Criminal Justice Information Service (CJIS) to identify those individuals who are prohibited from access to Select Agents and based on the restrictions identified in the USA PATRIOT Act. 
 
Where can I find more information on Select Agents and Toxins?
The Select Agent Program website is available at www.selectagents.gov. A comprehensive FAQ is available on that website at http://www.selectagents.gov/FAQ.html.