USDA and the U.S. Department of Health and Human Services established new safeguards for the possession, use and transfer of select biological agents and toxins that could pose a threat to public, animal and plant health and safety.
The new regulations outline the safety and security requirements for possessing select biological agents and toxins and specify who should be restricted from working with select agents.
The USDA interim select agent rule requires facilities to register with USDA’s Animal and Plant Health Inspection Service if they possess a select agent or agents that pose a potential threat to animal or plant health. The HHS interim rule updates the previous select agent rule by requiring facilities to register with HHS’ Centers for Disease Control and Prevention if they possess a select agent or agents that pose a potential threat to human health. The previous rule only required facilities to register with CDC if they intended to transfer a select agent. To reduce the burden on facilities required to register select agents in their possession that overlap both lists, HHS and USDA have worked together to establish a single unified reporting system that will be used by both agencies, thus eliminating duplication of effort.
The two interim final rules will be published in the Dec. 13 issue of the Federal Register and will take effect on Feb. 7, 2003. Each department will accept public comments on the new rules for 60 days, and those comments could result in regulatory changes in the future.
The new rules are in accordance with the USA PATRIOT Act and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The USA PATRIOT Act sets requirements for the appropriate use of select biological agents. It also specifies those persons who should be restricted from working with select agents, and imposes criminal and civil penalties for the inappropriate use of select agents. The Public Health Security Bioterrorism Preparedness and Response Act of 2002 updated the existing Select Agent Rule by requiring facilities to register if they possess select agents. Previously, only facilities that wished to transfer select agents needed to register with CDC.
In an effort to educate interested parties about its new rule, HHS will host a public forum on Possession, Use, and Transfer of Select Agents and Toxins on Dec. 16, 2002, 9 a.m. to 12 p.m. and 1:30 p.m. to 4 p.m. at the Wilbur J. Cohen Building/Voice of America Building in the Cohen Auditorium, 330 Independence Avenue SW Washington, D.C.