Under United States law, biological select agents or toxins ( BSATs)—or simply select agents for short—are which (since 1997[ Additional Requirements for Facilities Transferring or Receiving Select Agents, Title 42 CFR Part 72 and Appendix A; 15 April 1997 (DHHS).]) 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". The agents are divided into (1) HHS select agents and Toxin 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)—also called the Federal Select Agent Program ( FSAP)—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,
[Roos, Robert (2015), "CDC: DoD anthrax errors involved 575 shipments', CIDRAP News (18 July issue).] Gregory E. Demske, chief counsel to the inspector general in the HHS Office of Inspector General (OIG), 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
- 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. 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]
HHS select agents and toxins
Bacteria
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Botulinum neurotoxin-producing species of Clostridium*
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Coxiella burnetii
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Burkholderia mallei* (formerly Pseudomonas mallei)
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Burkholderia pseudomallei* (formerly Pseudomonas pseudomallei)
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Francisella tularensis*
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Rickettsia prowazekii
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Rickettsia rickettsii
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Yersinia pestis*
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Bacillus anthracis
Viruses
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Coronavirus:
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SARS-associated coronavirus (SARS-CoV)
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Encephalitis viruses:
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Eastern equine encephalitis virus (excluding South American genotypes)
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Tick-borne encephalitis-complex viruses (3 subtypes, excluding European ones)
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Central European tick-borne encephalitis virus
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Far-Eastern tick-borne encephalitis virus
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Russian spring and summer encephalitis virus
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Influenza viruses:
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Highly Pathogenic Avian Influenza H5N1 virus (exempt from 2024-2027)
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Reconstructed 1918 influenza virus
[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.]
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Orthopoxvirus:
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Monkeypox virus Clade I
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Variola major virus* (smallpox virus)
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Variola minor virus* (Alastrim)
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Viral hemorrhagic fever (VHF) viruses:
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African VHF viruses:
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Asian VHF viruses:
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Kyasanur Forest disease virus
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Omsk hemorrhagic fever virus
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South American VHF viruses:
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Chapare virus
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Guanarito virus (Venezuelan hemorrhagic fever)
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Junin virus (Argentine hemorrhagic fever)
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Machupo (Bolivian hemorrhagic fever)
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Sabiá virus (Brazilian hemorrhagic fever)
Toxins
these [[biological agents|Biological agent]] and toxins are considered to "have the potential to pose a severe threat to both human and animal health, to plant health, or to animal and plant products".
Overlap select agents and toxins
Bacteria
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Bacillus anthracis*
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Burkholderia mallei* (formerly Pseudomonas mallei)
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Burkholderia pseudomallei* (formerly Pseudomonas pseudomallei)
Viruses
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Hendra virus
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Nipah virus*
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Rift Valley fever virus
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Venezuelan equine encephalitis virus (excluding enzootic subtypes ID and IE)
USDA select agents and toxins
For animals
Bacteria
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Mycoplasma mycoides subspecies mycoides small colony (Mmm SC) (contagious bovine pleuropneumonia)
Viruses
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African swine fever virus
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Avian influenza virus (highly pathogenic)
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Classical swine fever virus
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Foot-and-mouth disease virus*
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Goat Pox virus
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Lumpy skin disease virus
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Mycoplasma capricolum subspecies capripneumoniae (contagious caprine pleuropneumonia)
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Ovine rinderpest
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Rinderpest virus*
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Sheep Pox virus
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Swine vesicular disease virus
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Virulent Newcastle disease virus 1
For plants
Bacteria
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Ralstonia solanacearum race 3, biovar 2
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Rathayibacter toxicus
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Xanthomonas oryzae
Fungi or fungus-like pathogens
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Coniothyrium glycines (formerly Phoma glycinicola and Pyrenochaeta glycines)
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Sclerophthora rayssiae var zeae
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Synchytrium endobioticum
List of former select agents
Select agent regulations were revised in October 2012 to remove 19 BSATs from the list (7 Human and Overlap Agents and 12 Animal Agents).
[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.]
Human and overlap agents
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Brucella abortus
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Brucella melitensis
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Brucella suis
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Cercopithecine herpesvirus 1 (Herpes B virus)
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Clostridium perfringens epsilon toxin
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Coccidioides posadasii
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Coccidioides immitis
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Eastern equine encephalitis virus, South American genotypes
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Flexal virus
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Tick-borne encephalitis viruses, European subtypes
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Venezuelan equine encephalitis virus, enzootic subtypes ID and IE
Animal agents
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African horse sickness virus
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Akabane virus
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Bluetongue virus
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Bovine spongiform encephalitis
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Camel Pox virus
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Erlichia ruminantium
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Japanese encephalitis virus
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Malignant Catarrhal Fever virus (Alcelaphine herpesvirus type 1)
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Menangle virus
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Vesicular stomatitis virus (exotic): Indiana subtypes VSV-IN2, VSV-IN3
Plant agents
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Peronosclerospora philippinensis ( Peronosclerospora sacchari)
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Xylella fastidiosa pauca (citrus variegated chlorosis strain)
See also
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Biological agent
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Biosecurity in the United States
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U.S. biological defense program
Further reading
External links
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– The FSAP is composed jointly of the Centers for Disease Control and Prevention/Division of Select Agents and Toxins and the Animal and Plant Health Inspection Service/Agriculture Select Agent Services, and oversees the possession, use and transfer of biological select agents and toxins.
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A federal advisory committee that addresses issues related to biosecurity and dual use research at the request of the United States Government.
