Last Revised: May 10, 2018
SELECT AGENTS OVERVIEW
SELECT AGENT and TOXINS, NEW FEDERAL REGULATION 42 CFR 73
The Office of Environmental Health & Radiation Safety provides the University oversight (Responsible Official) required by federal laws & regulations. Transfers, sending or receiving of any select agent (intramural or extramural) is prohibited without EHRS approval.
On June 12, 2002 President Bush signed the "Public Health Security and Bioterrorism Preparedness and Response Act of 2002" (Public Law 107-188). The Law's purpose is to improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies. The Law requires that all persons possessing select biological agents or toxins deemed a threat to public health, animal or plant health, or animal or plant products register with the appropriate federal agency.
On March 18, 2005, final rules were published in the Federal Register by the Departments of Health and Human Services(HHS) and Agriculture (USDA) governing facilities that possess, use or transfer select biological agents or toxins. These rules became effective on April 18, 2005.
On October 05, 2012, final rules (42 C.F.R. Part 73, 7 C.F.R. Part 331, and 9 C.F.R. Part 121) were published in the Federal Register by the Departments of Health and Human Services (HHS) and Agriculture (USDA) governing facilities that possess, use or transfer select biological agents or toxins. All provisions of the final rules supersede those contained in the previous final rules. Sections: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 13, 16, 17, 18, 19, 20, and 21 became effective on December 4, 2012. Sections: 11, 12, 14, and 15 became effective on April 3, 2013.
If you have any questions, please contact Andrew Maksymowych, Institutional Biosafety Officer, for additional details.