Select agent

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Under United States law, "Biological Select Agents or Toxins" (BSATs) — or simply Select Agents for short — are bio-agents which since 1997[1] have been declared by the U.S. Department of Health and Human Services (HHS) or by the U.S. Department of Agriculture (USDA) to have the "potential to pose a severe threat to public health and safety". These bio-agents are divided into three broad categories: (1) HHS select agents and toxins (affecting humans); (2) USDA select agents and toxins (affecting agriculture); and (3) Overlap select agents and toxins (affecting both).

The U.S. Centers for Disease Control and Prevention (CDC) administers the Select Agent Program (SAP), which regulates the laboratories which may possess, use, or transfer select agents within the United States. 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.

The active use of BSATs in biomedical research prompts concerns about dual use. The federal government has created the National Science Advisory Board for Biosecurity, a critical component of a set of federal initiatives to promote biosecurity in life science research. This advisory board is composed of government, education and industry experts who provide policy recommendations on ways to minimize the possibility that knowledge and technologies emanating from vitally important biological research will be misused to threaten public health or national security.

List of Select Agents[edit]

Tier 1 BSATs are indicated by an asterisk (*).[2]

HHS select agents and toxins[edit]

Pathogens[edit]

Bacteria[edit]
Viruses[edit]

Toxins[edit]

Overlap select agents and toxins[edit]

Bacteria[edit]

Viruses[edit]

USDA select agents and toxins[edit]

For animals[edit]

Bacteria[edit]
  • Mycoplasma mycoides subspecies mycoides small colony (Mmm SC) (contagious bovine pleuropneumonia)
Viruses[edit]

For plants[edit]

Bacteria[edit]
Fungi or fungus-like pathogens[edit]

List of former Select Agents[edit]

Select agent regulations were revised in October 2012 to remove 19 BSATs from the list (7 Human and Overlap Agents and 12 Animal Agents).[5]

Human and Overlap Agents[edit]

Animal Agents[edit]

See also[edit]

References[edit]

  1. ^ Additional Requirements for Facilities Transferring or Receiving Select Agents, Title 42 CFR Part 72 and Appendix A; 15 April 1997 (DHHS).
  2. ^ Select agent regulations were revised in October 2012 to designate thirteen "Tier 1" agents with a documented risk of causing a high consequence event higher than other BSATs. Criteria for Tier 1 status were (1) Ability to produce a mass casualty event or devastating effects to the economy; (2) Communicability; (3) Low infectious dose; and (4) History of or current interest in weaponization based on threat reporting. In the same revision Chapare virus, Lujo virus, and SARS-associated coronavirus (SARS-CoV) were added to the list of select agents. Department of Health and Human Services (2012), “Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review”, Federal Register / Vol. 77, No. 194 / Friday, October 5, 2012 / Rules and Regulations, pg 61084. Government Printing Office [www.gpo.gov] [FR Doc No: 2012-24389]
  3. ^ U.S. government names SARS a select agent, restricting labs that work on virus
  4. ^ This refers to reconstructed, replication-competent forms of the 1918 flu pandemic virus containing any portion of the coding regions of all eight gene segments.
  5. ^ Criteria for removal from the BSAT list were (1) Low potential for causing mortality; (2) Endemicity in the U.S. (animal agents); and (3) Difficulty in producing quantities necessary for high consequence event.

External links[edit]