Select agent

From Wikipedia, the free encyclopedia
Jump to: navigation, search

A "Biological Select Agent or Toxin" (BSAT)—or simply Select Agent for short—is a bio-agent and the U.S. federal government’s term for viruses, bacteria and toxins with the potential to be used as bioweapons or posing significant risk to agriculture or public health. The U.S. Department of Health and Human Services (HHS) or the U.S. Department of Agriculture (USDA) since 1997 have declared as having the "potential to pose a severe threat to public health and safety". The agents are divided into (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) regulates the laboratories which may possess, use, or transfer select agents within the United States in its Select Agent Program (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 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.

Definition[edit]

Since 1997 the U.S. Department of Health and Human Services (HHS) or the U.S. Department of Agriculture (USDA) declared bio-agents to have the "potential to pose a severe threat to public health and safety".[1]

Regulation[edit]

The U.S. Centers for Disease Control and Prevention has regulated the laboratories which may possess, use, or transfer select agents within the United States in its Select Agent Program (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.[citation needed] In 2015, it became known that hundreds of accidents in 100 labs have occurred. [2]

HHS select agents and toxins[edit]

List of Select Agents[edit]

Tier 1 BSATs are indicated by an asterisk (*).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.[3] More than 100 labs experimenting with have faced enforcement actions — some repeatedly — since 200.[2]3

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).[6]

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. ^ a b Alison Young (21 July 2915). "CDC to review oversight of bioterror labs after USA TODAY investigation". USA Today.  Check date values in: |date= (help)
  3. ^ 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]
  4. ^ U.S. government names SARS a select agent, restricting labs that work on virus
  5. ^ 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.
  6. ^ 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]