Anti-Bioterrorism Legislation

A. USA Patriot Act

Section 817 of the USA Patriot Act http://news.findlaw.com/cnn/docs/terrorism/hr3162.pdf, enacted in October, 2001, amends the anti-bioterrorism provisions of the Federal criminal code, 18 USC c.10, by adding Section 175b, prohibiting “restricted persons” from “shipping or transporting [transferring],” “possessing in or affecting commerce” with, or “receiving” select agents listed and not exempted under the 1996 Anti-Terrorism and Effective Death Penalty Act’s regulations. The obligation to comply falls on the individual, and criminal penalties for violating the prohibition also apply to the individual.

“Restricted person” is a person who?

(I) is under indictment for, OR has been convicted of, a crime punishable by imprisonment for over one year (e.g., felonies); or

(II) is a fugitive from justice; or

(III) is an unlawful user of any controlled substance (e.g., an illegal drug or a drug used illegally); or

(IV) is an illegal alien in the U.S.; or

(V) has been “adjudicated a mental defective” or has been “committed to any mental institution”; or

(VI) is an alien (even a legal alien, but not including a lawful permanent resident of the U.S.) who is a national of Cuba, Iran, North Korea, Iraq, Libya, Sudan or Syria; or

(VII) has been dishonorably discharged from the U.S. armed services.

This section also amends 18 USC c.10 by amending Section 175 and prohibits individuals and institutions from knowingly possessing “any biological agent, toxin or delivery system 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.” It provides for a criminal fine and up to 10 years in prison or both for violations.

B. Public Health Security and Bioterrorism Preparedness and Response Act

On June 12, 2002, a new federal law, the “Public Health Security and Bioterrorism Preparedness and Response Act” was passed to further protect against the use of select biological agents in bioterrorism. The law applies to the institution and to individuals at the institution who possess, use, transfer or have access to certain select biological agents and toxins in the U.S. or receive such agents/ toxins from outside the U.S. Export Control laws and regulations govern the transfer of these listed agents/toxins (as well as others) abroad or to foreigners in the U.S.

The new law requires the Secretaries of Health and Human Services and Agriculture to adopt regulations: (1) formally expanding the existing lists of select agents and toxins, (2) requiring institutions and individuals who possess, use or transfer such agents/toxins to register with the Secretaries and to implement related training, safety and security measures (including requirements for physical segregation and access controls for agent/toxin areas and containers, inventories, record keeping and reporting, and cyber-security), (3) requiring the US Attorney General to perform background checks on such individuals and on anyone who will have access to listed agents, and (4) requiring registered institutions and individuals to deny access to listed agents to anyone who does not pass the background check (including anyone who is a “restricted person” under the USA Patriot Act). The USA Patriot Act’s prohibition against “restricted persons” (defined in the Patriot Act) possessing, shipping, receiving or transporting/transferring covered select agents/toxins continues to apply to individuals. Refer to http://web.mit/edu/environment/programs/bioterrorism.html for more information. Attached is a more detailed description of the new law.

On December 13, 2002, regulations implementing the law were published by the Centers for Disease Control and Prevention, HHS (42 CFR Part 73) covering HHS Secretary-listed agents and toxins (including “overlap” agents/toxins listed by HHS and USDA) and by the Animal Plant Health Inspection Service of USDA (7 CFR Part 331, 9 CFR Part 121) covering USDA Secretary-listed agents and toxins (including “overlap” agents/toxins).

For an outline of the regulatory requirements, see http://web.mit.edu/srcounsel/documents/Phase_In_Periods_Effective_Dates.doc

Last updated 6/25/03