Select agent


Under United States law, Biological select agents or toxins — or simply select agents for short — are bio-agents which have been declared by the U.S. Department of Health and Human Services or by the U.S. Department of Agriculture to have the "potential to pose a severe threat to public health and safety". The agents are divided into HHS select agents and toxins affecting humans; USDA select agents and toxins affecting agriculture; and overlap select agents and toxins affecting both.
The U.S. Centers for Disease Control and Prevention regulates the laboratories which may possess, use, or transfer select agents within the United States in its Select Agent Program — also called the Federal Select Agent Program — since 2001. The SAP was established to satisfy requirements of the USA PATRIOT Act of 2001 and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which were enacted in the wake of the September 11, 2001 attacks and the subsequent 2001 anthrax attacks.
Using BSATs in biomedical research prompts concerns about dual use. The federal government created the National Science Advisory Board for Biosecurity which promotes biosecurity in life science research. It is composed of government, education and industry experts who provide policy recommendations on ways to minimize the possibility that knowledge and technologies emanating from biological research will be misused to threaten public health or national security.

Regulation

The CDC has regulated the laboratories which may possess, use, or transfer select agents within the United States under the SAP since 2001. The SAP was established to satisfy requirements of the USA PATRIOT Act of 2001 and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which were enacted in the wake of the September 11, 2001 attacks and the subsequent 2001 anthrax attacks.
Using select agents in biomedical research prompts concerns about dual use. The federal government created the National Science Advisory Board for Biosecurity to promote biosecurity in life science research. It is composed of government, education and industry experts who provide policy recommendations on ways to minimize the possibility that knowledge and technologies emanating from biological research will be misused to threaten public health or national security.

Violations

In July 2015, Gregory E. Demske, chief counsel to the inspector general in the HHS Office of Inspector General, testified that 30 civil violations of the SAP rules had been identified in the past 13 years, and that violators had paid about $2.4 million in fines. He explained that when the CDC's Division of Select Agents and Toxins detects possible SAP misconduct by an HHS worker, it coordinates with the OIG to gather facts; if it concludes that a civil violation might have occurred, it turns the case over to the OIG for possible enforcement. But if it suspects a crime, it pursues the matter with the FBI. Since passage of the Bioterrorism Act of 2002, the OIG had received 68 referrals from the CDC for possible Select Agent enforcement and found violations in 30 of those cases. Notices of violation were sent to 5 federal entities, 3 universities, and 2 other private organizations, all unnamed in his testimony. Demske remarked that no federal agencies had been fined for SAP violations.

List of select agents

HHS select agents and toxins

Bacteria

Bacteria

''For animals''

Bacteria
Bacteria
Select agent regulations were revised in October 2012 to remove 19 BSATs from the list.

Human and overlap agents