Select agent

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". 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)—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.^{[citation needed]}

Violations

In July 2015,^[2] 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 (*).^[3]

HHS select agents and toxins

Bacteria

Botulinum neurotoxin-producing species of Clostridium*
Coxiella burnetii
Burkholderia mallei* (formerly Pseudomonas mallei)
Burkholderia pseudomallei* (formerly Pseudomonas pseudomallei)
Francisella tularensis*
Rickettsia prowazekii
Rickettsia rickettsii
Yersinia pestis*

Viruses

Coronavirus:
- SARS-associated coronavirus (SARS-CoV)^[4]
Encephalitis viruses:
- Eastern equine encephalitis virus (excluding South American genotypes)
- Tick-borne encephalitis-complex viruses (3 subtypes, excluding European ones)
  - Central European tick-borne encephalitis virus
  - Far-Eastern tick-borne encephalitis virus
  - Russian spring and summer encephalitis virus
Influenza viruses:
- Highly Pathogenic Avian Influenza H5N1 virus
- Reconstructed 1918 influenza virus^[5]
Orthopoxviruses:
- Monkeypox virus
- Variola major virus* (smallpox virus)
- Variola minor virus* (Alastrim)
Viral hemorrhagic fever (VHF) viruses:
- African VHF viruses:
- Asian VHF viruses:
  - Kyasanur Forest disease virus
  - Omsk hemorrhagic fever virus
- South American VHF viruses:
  - Chapare virus
  - Guanarito virus (Venezuelan hemorrhagic fever)
  - Junin virus (Argentine hemorrhagic fever)
  - Machupo (Bolivian hemorrhagic fever)
  - Sabiá virus (Brazilian hemorrhagic fever)

Toxins

As of April 2021^[update] these biological agents 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".^[6]

Abrin
Botulinum neurotoxins*
Clostridium perfringens epsilon toxin
Conotoxins
Ricin
Saxitoxin
Staphylococcal enterotoxins
Tetrodotoxin
2 Type A trichothecenes:
- Diacetoxyscirpenol
- T-2 toxin

Overlap select agents and toxins

Bacteria

Bacillus anthracis*
Brucella abortus
Brucella melitensis
Brucella suis
Burkholderia mallei* (formerly Pseudomonas mallei)
Burkholderia pseudomallei* (formerly Pseudomonas pseudomallei)

Viruses

Hendra virus
Nipah virus
Rift Valley fever virus
Venezuelan equine encephalitis virus (excluding enzootic subtypes ID and IE)

USDA select agents and toxins

For animals

Bacteria

Mycoplasma mycoides subspecies mycoides small colony (Mmm SC) (contagious bovine pleuropneumonia)

Viruses

African horse sickness virus
African swine fever virus
Avian influenza virus (highly pathogenic)
Classical swine fever virus
Foot-and-mouth disease virus*
Lumpy skin disease virus
Peste des petits ruminants virus
Rinderpest virus*
Swine vesicular disease virus
Virulent Newcastle disease virus 1

For plants

Bacteria

Ralstonia solanacearum race 3, biovar 2
Rathayibacter toxicus
Xanthomonas oryzae

Fungi or fungus-like pathogens

Peronosclerospora philippinensis (Peronosclerospora sacchari)
Phoma glycinicola (formerly Pyrenochaeta glycines)
Sclerophthora rayssiae var zeae
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).^[7]

References

^ Additional Requirements for Facilities Transferring or Receiving Select Agents, Title 42 CFR Part 72 and Appendix A; 15 April 1997 (DHHS).
^ Roos, Robert (2015), "CDC: DoD anthrax errors involved 575 shipments', CIDRAP News (18 July issue).
^ 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]
^ "U.S. government names SARS a select agent, restricting labs that work on 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.
^ "Select Agents and Toxins List". CDC/USDA Federal Select Agent Program. 26 April 2021. Retrieved 27 April 2021.
^ 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

"Home". Federal Select Agent Program. – 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.
"National Science Advisory Board for Biosecurity (NSABB)". Office of Science Policy. 7 April 2020. A federal advisory committee that addresses issues related to biosecurity and dual use research at the request of the United States Government.