Office of Research Assurances

Biosafety

Select Agents and Toxins


On April 15, 1997 “The Antiterrorism and Effective Death Penalty Act of 1996” (Section 511 of Public Law 104-132) became effective.This law was enacted due to the threat of the illegitimate use of infectious agents and the potential serious adverse consequences for human health and safety. In response to this legislation the Department of Health and Human Services (HHS) published the Select Agents Final Rule (42CFR, Part 72, “Additional Requirements for Facilities Transferring or Receiving Select Agents”) which also became effective on April 15, 1997. This rule created a framework to track the access, use, and transfer select agents. Washington State University (WSU) was registered with the Centers for Disease Control (CDC) to transfer or receive select agents in compliance with the rule (42CFR, Part 72).

On October 26, 2001 the “United and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism of 2001” Act (USA PATRIOT ACT) was signed into law.The law criminalized the possession of select agents that had no legitimate purpose, banned the possession of select agents by “restricted persons”, and required the Secretary of HHS to establish additional standards and procedures to govern the possession, use, and transfer of select agents.

In order to strengthen and enhance the USA PATRIOT ACT of 2001 the “Public Health Security and Bioterrorism Preparedness Act of 2002” (Public Law 107-188) was signed into law on June 12, 2002. This law required that the United States improve its ability to prevent, prepare for, and respond to bioterrorism and other public health emergencies. It necessitates that individuals possessing, using, or transferring agents or toxins deemed a threat to public, animal or plant health, or to animal or plant products, notify either the Secretary of the Department of Health and Human Services (HHS) or the Secretary of the Department of Agriculture (USDA).

In order to meet the requirements of the “Public Health Security and Bioterrorism Preparedness Act of 2002” the HHS authorized the Centers for Disease Control (CDC) to develop and administer rules governing the possession, use, and transfer select agents and toxins and the USDA authorized the Animal and Plant Health Inspection Service (APHIS) to develop and administer rules governing the possession, use, and transfer biological agents and toxins. Because there are some agents and toxins common to both lists (termed “overlap agents and toxins”) the CDC and APHIS coordinated their efforts while producing three new rules.The CDC (for HHS) has introduced 42CFR Part 73 (“Possession, Use, and Transfer of Select Agents and Toxins”). The APHIS has introduced 7CFR Part 331 and 9 CFR Part 121 (“Possession, Use, and Transfer of Biological Agents and Toxins”). The effective date for all three rules was February 11, 2003.

Office of Research Assurances, P.O. Box 643005, Albrook 205, Washington State University, Pullman WA 99164-3005
Phone: 509-335-7195, Fax: 509-335-6410, ibc@wsu.edu