VI(c). Select Agents

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rev 8/2009

The Public Health Security and Bioterrorism Preparedness Act of 2002 and the USA Patriot Act of 2001 require that academic and research institutions collect information regarding "select agents" and register and obtain approval for possession with the federal government. The Department of Health and Human Services (DHHS) and the U.S. Department of Agriculture (USDA) have issued separate but complementary regulations. In order for the College to comply with the DHHS Select Agent Regulations (42 CFR 73) and the USDA Agricultural Bioterrorism Protection Act of 2002 regulations (7CFR 331 and 9CFR 121), you must notify and obtain approval from the Office of Environmental Health and Safety (EH&S) prior to possession of any agent on the list of Select Biological Agents and Toxins, High Consequence Pathogens and Toxins, or Plant Pathogens.

If you are proposing to possess an agent on the list of Select Biological Agents and Toxins, High Consequence Pathogens and Toxins, or Plant Pathogens, the initial step is to file a Select Agent Registration Form with EH&S. Registration with the CDC is required, so you should anticipate a significant delay in obtaining approval due both to security requirements and procedures that will need to be established at the College and to extensive review of the application by the CDC. There may be requests that the College cannot accommodate because of facility restrictions and security requirements. All registration requests trigger a Center for Disease Control (CDC) security risk assessment. The CDC Select Agent Program web site has a set of FAQs where you can learn more.

Links

List of Select Biological Agents and Toxins, High Consequence Pathogens and Toxins, and Plant Pathogens

CDC Select Agent Program FAQs

Public Health Security and Bioterrorism Preparedness Act of 2002

USA Patriot Act

DHHS Select Agent Regulation (42 CFR 73)

Agricultural Bioterrorism Protection Act of 2002 (7 CFR 331 and 9 CFR 121)

Appendix

A: Select Agents Registration Form