Backgrounder

The Select Agent Rule

December 9, 2002

Introduction
Currently the Centers for Disease Control and Prevention (CDC) regulates the transfer of 38 biological agents and toxins (select agents) that have the potential to pose a severe threat to public health and safety. CDC's Select Agent Program oversees these activities. The Select Agent Program requires all laboratory facilities such as those within government agencies, universities, research institutions and commercial laboratories to register with the CDC if they plan to transfer a select agent to another laboratory facility within the United States.

History
The Antiterrorism and Effective Death Penalty Act of 1996 was passed following an incident where an individual inappropriately ordered plague strains from a supplier of biological agents and officials realized they had no legal mechanism to charge this individual with a crime other than mail fraud.

The Act authorized the Secretary of Health and Human Services (HHS) to regulate the transfer of select agents harmful to humans. HHS requested that CDC develop a regulation that would regulate select agents to protect the public without hindering scientific research. In addition, CDC was designated the agency within HHS responsible for enforcing this regulation.

The CDC formed an interagency group and developed a list of select agents that included 38 microorganisms and toxins. After receiving public comment, the Select Agent Rule was finalized and required that affected facilities register with CDC. The Act also required facilities to report all transfers of select agents and to assure the transferee was registered.

Following the events of September 11, 2001, The USA Patriot Act and the Public Health Safety Bioterrorism Preparedness and Response Act of 2002 were passed.

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.

The Act of 2002 also added a one-time notification of possession requirement, incorporated the "restricted persons" provision of the Patriot Act, developed a similar select agent program for the United States Department of Agriculture (USDA) for plant and animal pathogens, and provided for the protection of certain information associated with the registration of these facilities.

Current Situation
The Public Health Safety and Bioterrorism Preparedness and Response Act of 2002 dictated that the interim final select agent rule prepared by HHS be published by December 9, 2002 in the Federal Register as an interim final rule. This Act also mandated issuance of a joint regulation by HHS and USDA that would address "overlap" agents and require database checks by the Department of Justice for persons identified by the facility as having a legitimate need to have access to these agents.

Timeline

• August 6, 2002, HHS published a notice in the Federal Register providing guidance for notification of possession of select agents. HHS mailed forms to individuals and facilities across the country enabling them to comply with a September 10 deadline for "Notification of Possession" established by the legislation.
• August 23, 2002, HHS published a notice in the Federal Register inviting public comment on the proposed revisions to the select agent list on or before September 17, 2002.
• December 9, 2002, interim final rule published in the Federal Register followed by a 60-day comment period.
• December 16, 2002, public forum to discuss the interim final rule in Washington, D.C.

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This page last updated December 10, 2002
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