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Mail-order plague: The beginnings of bioterrorism awareness in the U.S.

In 1995, a microbiologist was arrested for using fraud to obtain a strain of Yersinia pestis, the bacterium that causes plague. How did he get it? By mail order.

At that time, there were no licensing, registration, or safety requirements for laboratories or individuals engaged in transferring disease-causing pathogens or toxins within the United States. There were also no federal requirements to report the transfer of these agents.

What is a select agent or toxin?

Select agents and toxins are biological agents and toxins that could pose a severe threat to public health and plant health, or to animal or plant products. The U.S. lists of Select Agents and Toxins are maintained by the Departments of Health and Human Service and Agriculture, and are found in the Select Agent Regulations (42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331).

Congress acts to deter bioterrorism
CDC Select Agent Program established

A heightened concern regarding the ease with which disease-causing agents could be obtained led Congress to pass Section 511 of the Antiterrorism and Effective Death Penalty Act of 1996 (Public Law 104-132). This Act directed the U.S. Department of Health and Human Services (HHS) to establish a list of biological agents and toxins that could threaten public health and safety, procedures for governing the transfer of those agents, and training requirements for entities working with these "select agents".

HHS delegated the authority to implement this Act to the Centers for Disease Control and Prevention (CDC), which then established the CDC Select Agent Program. The Division of Select Agents and Toxins (DSAT) in the CDC Office of Public Health Preparedness and Response execute this program. The provisions of this Act were implemented by 42 CFR 72.6.

9/11 and increased regulation of select agents

Following the anthrax attacks of 2001, Congress significantly strengthened oversight of select agents by passing the following Acts:

• USA PATRIOT Act (Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001; Public Law 107-56): Restricted access to select agents USA PATRIOT Act(PDF format).
• Bioterrorism Response Act (Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Public Law 107-188): Increased safeguards and security measures as well as oversight of the possession and use of select agents Public Health Security and Bioterrorism Preparedness and Response Act of 2002(PDF format).

Animal and plant agents added to select agent list
Federal Select Agent Program established

In addition to strengthening the regulatory authorities of HHS/CDC, the Bioterrorism Response Act also granted comparable regulatory authorities to the U.S. Department of Agriculture (USDA) over select agents that pose a severe threat to animal and plant health or products. The USDA's Animal and Plant Health Inspection Service (APHIS) then established the Agricultural Select Agent Program. DSAT and Agricultural Select Agent Program constitute the Federal Select Agent Program.

The Federal Select Agent Program published select agent regulations for the possession, use, and transfer of select agents and toxins (42 CFR Part 73, 9 CFR Part 121 and 7 CFR Part 331) in the Federal Register.

The Bioterrorism Response Act requires the HHS and USDA Secretaries to review and republish the list of select agents and toxins on at least a biennial basis (42 CFR Part 73, 9 CFR Part 121 and 7 CFR Part 331).

Increased security measures added

In July of 2010 Executive Order 13546 (Optimizing the Security of Biological Select Agents and Toxins in the United States) directed the HHS and USDA Secretaries to (1) designate a subset of the select agents and toxins list (Tier 1) that presents the greatest risk of deliberate misuse with the most significant potential for mass casualties or devastating effects to the economy, critical infrastructure; or public confidence; (2) explore options for graded protection for these Tier 1 agents and toxins to permit tailored risk management practices based upon relevant contextual factors; and (3) consider reducing the overall number of agents and toxins on the select agents and toxins list.

The Federal Select Agent Program published select agent regulations to incorporate these recommendations (42 CFR Part 73, 9 CFR Part 121 and 7 CFR Part 331).