Federal Regulation of Biological ("Select") Agents in Research

In response to the terrorist attacks of September 11, 2001, Congress passed, and President Bush signed into law, three pieces of legislation* that expand restrictions on the possession, use, and access to biological agents and toxins (termed "select agents"). Failure to comply with the requirements and restrictions contained in these new laws expose Principal Investigators to large fines and imprisonment of up to ten years.

Prior to 2001, federal law prohibited the development, production, transfer or possession of any biological agent, toxin, or delivery system for use as a weapon (18 USC Section 175). The post 9/11 legislation greatly expands regulation by now prohibiting possession of a biological agent, or toxin "...of a type or in a quantity that, under the circumstances, is not reasonably justified by a prophylactic, protective, bona fide research, or other peaceful purpose." Thus, researchers must have a reasonable justification for the type and quantity of biological agents, toxins or delivery systems they possess. There is a registration procedure that must be followed with respect to both the laboratory that uses select agents and the individual researchers who work in the laboratory.

The legislation also requires extensive security measures to insure against unauthorized access to laboratories that possess "select agents." These measures include the provision of special secured facilities in which the select agents are stored and used, as well as procedures for monitoring access to the agents themselves.

In addition, the USA Patriot Act creates a class of "restricted persons" who may not possess ship, transport or receive any biological agent or toxin that is listed as a "select agent." Under the terms of the Act "restricted persons", who are now prohibited from having access to select agents, means any individual who:

(A) is under indictment for a crime punishable by imprisonment for a term exceeding 1 year;
(B) has been convicted in any court of a crime punishable by imprisonment for a term exceeding 1 year;
(C) is a fugitive from justice;
(D) is an unlawful user of any controlled substance (as defined in section 102 of the Controlled Substances Act (21 U.S.C. 802));
(E) is an alien illegally or unlawfully in the United States;
(F) has been adjudicated as a mental defective or has been committed to any mental institution;
(G) is an alien (other than an alien lawfully admitted for permanent residence) who is a national of Cuba, Iran, Iraq, Libya, North Korea, Sudan or Syria, or any other country to which the Secretary of State, pursuant to applicable law, has made a determination (that remains in effect) that such country has repeatedly provided support for acts of international terrorism; or
(H) has been discharged from the Armed Services of the United States under dishonorable conditions.

The Centers for Disease Control and Prevention (CDC) oversees the implementation of federal laws pertaining to the use of select agents. For details please consult the National Select Agent Registry.

On the UC Berkeley campus the Office of Environmental, Health & Safety is responsible for administering UC Berkeley's compliance with federal regulations pertaining to "select agents." For more information on select agent regulations, as well as for registration procedures, required forms, and a list of select agents, please consult the Office of Environmental, Health & Safety policies and regulations.


* The USA Patriot Act, the Public Health Security and Bio-Terrorism Preparedness and Response Act, and the Agricultural Bio-terrorism Protection Act.