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HHS, USDA Establish New Regulations for Use of Select Biological Agents

Last updated March 16, 2020

Approved by: Lester Fahrner, MD

The U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA) today established new safeguards for the possession, use, and transfer of select biological agents and toxins (select agents) that could pose a threat to public, animal and plant health and safety.


HHS, USDA Establish New Regulations for Use of Select Biological Agents

The U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA) today established new safeguards for the possession, use, and transfer of select biological agents and toxins (select agents) that could pose a threat to public, animal and plant health and safety.

In complementary regulations announced today, HHS and USDA established new, tighter controls on these potentially dangerous agents. The 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 HHS interim rule updates the previous select agent rule by requiring facilities to register with HHS' Centers for Disease Control and Prevention (CDC) 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.

"Protecting the health of Americans is paramount, and this new rule strengthens our ability to ensure that essential research on these agents continues while making certain they don't fall into the wrong hands," said HHS Secretary Tommy G. Thompson.

Similarly, the USDA interim select agent rule requires facilities to register with USDA's Animal and Plant Health Inspection Service (APHIS) if they possess a select agent or agents that pose a potential threat to animal or plant health.

"This new rule will continue to strengthen programs aimed at protecting the American people from acts of terrorism," said Agriculture Secretary Ann M. Veneman. "These safeguards will help protect the food supply without sacrificing valuable research being done on these agents."

Some of the select agents subject to these regulations appear on both the HHS and the USDA select agent lists. 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 December 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.

The HHS interim rule can be viewed at http://www.cdc.gov and the USDA interim rule can be viewed at http://www.aphis.usda.gov/ppd/rad/webrepor.html.

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Note to Reporters: All HHS press releases, fact sheets and other press materials are available at http://www.hhs.gov/news. USDA news releases, program announcements and media advisories are available on the Internet. Access the APHIS home page by pointing your Web browser to http://www.aphis.usda.gov and clicking on "APHIS Press Releases."

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CDC protects people's health and safety by preventing and controlling diseases and injuries; enhances health decisions by providing credible information on critical health issues; and promotes healthy living through strong partnerships with local, national, and international organizations.

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Reviewed and Approved by a member of the DoveMed Editorial Board
First uploaded: March 16, 2020
Last updated: March 16, 2020