HHS, USDA announce new rules on use of 'select agents'

Dec 11, 2002 (CIDRAP News) – Following up on two pieces of antiterrorism legislation, federal agencies have established new rules on the handling of biological agents and toxins that could endanger people, crops, or livestock.

The departments of Health and Human Services (HHS) and Agriculture (USDA) yesterday announced complementary regulations on the possession, use, and transfer of "select agents." The rules require individuals and organizations that handle such agents to register with the appropriate federal agency, and state that officials responsible for the agents are subject to a security check by the attorney general.

The new HHS rule requires facilities to register with the Centers for Disease Control and Prevention (CDC) if they possess a select agent that could threaten human health. Previously, laboratories had to register only if they intended to transfer a select agent somewhere else. The USDA's new rule requires facilities to register with the Animal and Plant Health Inspection Service (APHIS) if they have a select agent that could endanger animal or plant health.

In a joint news release, HHS Secretary Tommy Thompson and USDA Secretary Ann Veneman said the new rules will help protect the nation and its food supply from terrorists while allowing research to continue.

HHS and USDA have separate lists of select agents, but some agents appear on both lists, officials said. To eliminate the need for laboratories to register twice for the same agent, "HHS and USDA have worked together to establish a single unified reporting system that will be used by both agencies," officials said.

The two sets of rules will be published in the Federal Register Dec 13 and will take effect Feb 7, 2003, according to the news release. Each department will take comments on the rules for 60 days, and the comments could lead to changes.

The new regulations were triggered by the USA PATRIOT Act, passed in 2001, and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The PATRIOT Act sets rules for the appropriate use of select agents and bars certain categories of people from working with them, and the bioterrorism law requires facilities to register for possession of such agents.

HHS will hold a public forum on the possession, use, and transfer of select agents on Dec 16 from 9 a.m. to 4 p.m. at the Wilbur J. Cohen Building/Voice of America Building, 330 Independence Ave., SW, Washington, DC.

Announcement of the rules came a few days after the CDC published revised security guidelines for labs that work with select agents. The guidelines, published in the Dec 6 issue of Morbidity and Mortality Weekly Report, were expanded in response to the 2002 bioterrorism law.

See also:

HHS/CDC news release

CDC backgrounder on the Select Agent Rule

CDC Select Agent Program site, with links to the HHS rule and related information

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