# Select agent > Mediated Wiki article. Canonical URL: https://mediated.wiki/source/Select_agent > Markdown URL: https://mediated.wiki/source/Select_agent.md > Source: https://en.wikipedia.org/wiki/Select_agent > Source revision: 1353735817 > License: Creative Commons Attribution-ShareAlike 4.0 International (https://creativecommons.org/licenses/by-sa/4.0/) Controlled biological agents in the United States Under [United States law](/source/United_States_law), **biological select agents or toxins** (**BSAT**s)—or simply **select agents** for short—are [bio-agents](/source/Bio-agent) which (since 1997[1]) have been declared by the [U.S. Department of Health and Human Services](/source/U.S._Department_of_Health_and_Human_Services) (HHS) or by the [U.S. Department of Agriculture](/source/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](/source/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](/source/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](/source/USA_PATRIOT_Act) of 2001 and the [Public Health Security and Bioterrorism Preparedness and Response Act of 2002](/source/Public_Health_Security_and_Bioterrorism_Preparedness_Response_Act), which were enacted in the wake of the [September 11, 2001 attacks](/source/September_11%2C_2001_attacks) and the subsequent [2001 anthrax attacks](/source/2001_anthrax_attacks). Using BSATs in biomedical research prompts concerns about [dual use](/source/Dual-use_technology). The federal government created the [National Science Advisory Board for Biosecurity](/source/National_Science_Advisory_Board_for_Biosecurity) which promotes biosecurity in [life science](/source/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](/source/USA_PATRIOT_Act) of 2001 and the [Public Health Security and Bioterrorism Preparedness and Response Act of 2002](/source/Public_Health_Security_and_Bioterrorism_Preparedness_Response_Act), which were enacted in the wake of the [September 11, 2001 attacks](/source/September_11%2C_2001_attacks) and the subsequent [2001 anthrax attacks](/source/2001_anthrax_attacks). Using select agents in biomedical research prompts concerns about [dual use](/source/Dual-use_technology). The federal government created the [National Science Advisory Board for Biosecurity](/source/National_Science_Advisory_Board_for_Biosecurity) to promote biosecurity in [life science](/source/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](https://en.wikipedia.org/wiki/Wikipedia:Citation_needed)*] ## Violations In July 2015,[2] Gregory E. Demske, chief counsel to the inspector general in the HHS Office of Inspector General ([OIG](/source/Office_of_Inspector_General_(United_States))), 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](/source/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](/source/Neurotoxin)-producing species of *[Clostridium](/source/Clostridium)** - *[Coxiella burnetii](/source/Coxiella_burnetii)* - *[Burkholderia mallei](/source/Burkholderia_mallei)** (formerly *Pseudomonas mallei*) - *[Burkholderia pseudomallei](/source/Burkholderia_pseudomallei)** (formerly *Pseudomonas pseudomallei*) - *[Francisella tularensis](/source/Francisella_tularensis)** - *[Rickettsia prowazekii](/source/Rickettsia_prowazekii)* - *[Rickettsia rickettsii](/source/Rickettsia_rickettsii)* - *[Yersinia pestis](/source/Yersinia_pestis)** - *[Bacillus anthracis](/source/Bacillus_anthracis)* #### Viruses - Coronavirus: - [SARS-associated coronavirus](/source/SARS-associated_coronavirus) (SARS-CoV)[4] - Encephalitis viruses: - [Eastern equine encephalitis virus](/source/Eastern_equine_encephalitis_virus) (excluding South American genotypes) - [Tick-borne encephalitis](/source/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](/source/Highly_Pathogenic_Avian_Influenza_H5N1_virus) (exempt from 2024-2027)[5] - Reconstructed [1918 influenza virus](/source/1918_influenza_virus)[6] - [Orthopoxviruses](/source/Orthopoxvirus): - [Monkeypox virus](/source/Monkeypox_virus) [Clade I](/source/Monkeypox_virus#Variants_and_clades) - [Variola major virus](/source/Variola_major_virus)* (smallpox virus) - [Variola minor virus](/source/Variola_minor_virus)* (Alastrim) - Viral hemorrhagic fever (VHF) viruses: - African VHF viruses: - [Crimean–Congo hemorrhagic fever virus](/source/Crimean%E2%80%93Congo_hemorrhagic_fever_virus) - [Ebola virus](/source/Ebola_virus)* - [Lassa fever virus](/source/Lassa_fever_virus) - [Lujo virus](/source/Lujo_virus) - [Marburg virus](/source/Marburg_virus)* - Asian VHF viruses: - [Kyasanur Forest disease virus](/source/Kyasanur_Forest_disease_virus) - [Omsk hemorrhagic fever virus](/source/Omsk_hemorrhagic_fever_virus) - South American VHF viruses: - [Chapare virus](/source/Chapare_virus) - [Guanarito virus (Venezuelan hemorrhagic fever)](/source/Venezuelan_hemorrhagic_fever) - [Junin virus](/source/Junin_virus) ([Argentine hemorrhagic fever](/source/Argentine_hemorrhagic_fever)) - [Machupo](/source/Machupo) (Bolivian hemorrhagic fever) - [Sabiá virus (Brazilian hemorrhagic fever)](/source/Brazilian_hemorrhagic_fever) #### Toxins As of April 2025[\[update\]](https://en.wikipedia.org/w/index.php?title=Select_agent&action=edit) these [biological agents](/source/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".[7] - [Abrin](/source/Abrin) - [Botulinum neurotoxins](/source/Botulinum_neurotoxin)* - [Conotoxins](/source/Conotoxin) - [Ricin](/source/Ricin) - [Saxitoxin](/source/Saxitoxin) - [Staphylococcal enterotoxins](/source/Staphylococcal_enterotoxin) - [Tetrodotoxin](/source/Tetrodotoxin) - 2 Type A trichothecenes: - [Diacetoxyscirpenol](/source/Diacetoxyscirpenol) - [T-2 toxin](/source/T-2_toxin) ### Overlap select agents and toxins #### Bacteria - *[Bacillus anthracis](/source/Bacillus_anthracis)** - *[Burkholderia mallei](/source/Burkholderia_mallei)** (formerly *Pseudomonas mallei*) - *[Burkholderia pseudomallei](/source/Burkholderia_pseudomallei)** (formerly *Pseudomonas pseudomallei*) #### Viruses - [Hendra virus](/source/Hendra_virus) - [Nipah virus](/source/Nipah_virus)* - [Rift Valley fever](/source/Rift_Valley_fever) virus - [Venezuelan equine encephalitis](/source/Venezuelan_equine_encephalitis) virus (excluding enzootic subtypes ID and IE) ### USDA select agents and toxins #### *For animals* #### Bacteria - *[Mycoplasma mycoides](/source/Mycoplasma_mycoides)* subspecies *mycoides* small colony (Mmm SC) (contagious bovine pleuropneumonia) - *[Mycoplasma capricolum](/source/Mycoplasma_capricolum)* subspecies *capripneumoniae* (contagious caprine pleuropneumonia) #### Viruses - [African swine fever](/source/African_swine_fever) virus - [Avian influenza](/source/Avian_influenza) virus (highly pathogenic) - Classical [swine fever](/source/Swine_fever) virus - [Foot-and-mouth disease](/source/Foot-and-mouth_disease) virus* - [Goat Pox virus](/source/Goat_Pox_virus) - [Lumpy skin disease virus](/source/Lumpy_skin_disease) - [Peste des petits ruminants virus](/source/Ovine_rinderpest) - [Rinderpest](/source/Rinderpest) virus* - [Sheep Pox virus](/source/Sheep_Pox_virus) - [Swine vesicular disease](/source/Swine_vesicular_disease) virus - Virulent [Newcastle disease](/source/Newcastle_disease) virus 1 #### *For plants* #### Bacteria - *[Ralstonia solanacearum](/source/Ralstonia_solanacearum)* race 3, biovar 2 - *[Rathayibacter toxicus](/source/Rathayibacter_toxicus)* - *[Xanthomonas oryzae](/source/Xanthomonas_oryzae)* #### Fungi or fungus-like pathogens - *[Coniothyrium glycines](/source/Coniothyrium_glycines)* (formerly *Phoma glycinicola* and *Pyrenochaeta glycines*) - *[Sclerophthora rayssiae](/source/Sclerophthora_rayssiae)* var *zeae* - *[Synchytrium endobioticum](/source/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).[8] ### Human and overlap agents - *[Brucella abortus](/source/Brucella_abortus)* - *[Brucella melitensis](/source/Brucella_melitensis)* - *[Brucella suis](/source/Brucella_suis)* - [Cercopithecine herpesvirus 1 (Herpes B virus)](/source/Cercopithecine_herpesvirus_1) - *[Clostridium perfringens](/source/Clostridium_perfringens)* epsilon toxin - *[Coccidioides posadasii](/source/Coccidioides_posadasii)* - *[Coccidioides immitis](/source/Coccidioides_immitis)* - [Eastern equine encephalitis virus](/source/Eastern_Equine_encephalitis_virus), South American genotypes - [Flexal virus](/source/Flexal_virus) - [Tick-borne encephalitis viruses](/source/Tick-borne_encephalitis_viruses), European subtypes - [Venezuelan equine encephalitis virus](/source/Venezuelan_Equine_Encephalitis_virus), enzootic subtypes ID and IE ### Animal agents - [African horse sickness](/source/African_horse_sickness) virus - [Akabane virus](/source/Akabane_virus) - [Bluetongue virus](/source/Bluetongue_virus) - [Bovine spongiform encephalitis](/source/Bovine_Spongiform_Encephalitis) - [Camel Pox virus](https://en.wikipedia.org/w/index.php?title=Camel_Pox_virus&action=edit&redlink=1) - *[Erlichia ruminantium](https://en.wikipedia.org/w/index.php?title=Erlichia_ruminantium&action=edit&redlink=1)* - [Japanese encephalitis virus](/source/Japanese_encephalitis_virus) - [Malignant Catarrhal Fever virus](https://en.wikipedia.org/w/index.php?title=Malignant_Catarrhal_Fever_virus&action=edit&redlink=1) (Alcelaphine herpesvirus type 1) - [Menangle virus](/source/Menangle_virus) - [Vesicular stomatitis](/source/Vesicular_stomatitis) virus (exotic): Indiana subtypes VSV-IN2, VSV-IN3 ### Plant agents - *[Peronosclerospora philippinensis](/source/Peronosclerospora_philippinensis)* (*Peronosclerospora sacchari*) - *[Xylella fastidiosa](/source/Xylella_fastidiosa)* *pauca* ([citrus variegated chlorosis](/source/Citrus_variegated_chlorosis) strain) ## See also - [Biological agent](/source/Biological_agent) - [Biosecurity in the United States](/source/Biosecurity_in_the_United_States) - [U.S. biological defense program](/source/U.S._biological_defense_program) ## References 1. **[^](#cite_ref-1)** *Additional Requirements for Facilities Transferring or Receiving Select Agents*, Title 42 CFR Part 72 and Appendix A; 15 April 1997 (DHHS). 1. **[^](#cite_ref-2)** Roos, Robert (2015), ["CDC: DoD anthrax errors involved 575 shipments'](http://www.cidrap.umn.edu/news-perspective/2015/07/cdc-dod-anthrax-errors-involved-575-shipments), *[CIDRAP](/source/CIDRAP) News* (18 July issue). 1. **[^](#cite_ref-3)** 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](/source/Department_of_Health_and_Human_Services) (2012), [“Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review”](https://www.gpo.gov/fdsys/pkg/FR-2012-10-05/html/2012-24389.htm), *[Federal Register](/source/Federal_Register)* / Vol. 77, No. 194 / Friday, October 5, 2012 / Rules and Regulations, pg 61084. [Government Printing Office](/source/United_States_Government_Publishing_Office) [www.gpo.gov] [FR Doc No: 2012-24389] 1. **[^](#cite_ref-4)** ["U.S. government names SARS a select agent, restricting labs that work on virus"](https://vancouversun.com/health/government+names+SARS+select+agent+restricting+labs+that+work/7348087/story.html).[*[dead link](https://en.wikipedia.org/wiki/Wikipedia:Link_rot)*] 1. **[^](#cite_ref-5)** ["Select Agents and Toxins Exemption: H5 Avian Influenza Virus | Select Agents and Toxins | Federal Select Agent Program"](https://www.selectagents.gov/sat/exemptions/avian-influenza.htm). *www.selectagents.gov*. 2024-06-06. Retrieved 2025-04-18. 1. **[^](#cite_ref-6)** This refers to reconstructed, replication-competent forms of the [1918 flu pandemic](/source/1918_flu_pandemic) virus containing any portion of the coding regions of all eight gene segments. 1. **[^](#cite_ref-7)** ["Select Agents and Toxins List"](https://www.selectagents.gov/sat/list.htm?CDC_AA_refVal=https%3A%2F%2Fwww.selectagents.gov%2FSelectAgentsandToxinsList.html). *CDC/USDA Federal Select Agent Program*. 26 April 2021. Retrieved 27 April 2021. 1. **[^](#cite_ref-8)** 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. ## Further reading - National Research Council (US) Committee on Laboratory Security and Personnel Reliability Assurance Systems for Laboratories Conducting Research on Biological Select Agents and Toxins. (2009). "Chapter 1. Introduction". [*Responsible Research with Biological Select Agents and Toxins*](https://www.ncbi.nlm.nih.gov/books/NBK44953/). Washington DC: National Academies Press. ## External links - ["Home"](https://www.selectagents.gov/). *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)"](https://osp.od.nih.gov/policies/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. v t e United States biological defense program Organizations Federal administrative DHS DHS Chemical and Biological Defense Division DHS Office of Health Affairs (National Biosurvelliance Integration Center, BioWatch) National Biodefense Analysis and Countermeasures Center National Bio and Agro-Defense Facility National Bioforensic Analysis Center DNI National Counterproliferation Center (Advisory Committee on Bioterrorism) DHHS Office of the Assistant Secretary for Preparedness and Response Division of Select Agents and Toxins (CDC) National Science Advisory Board for Biosecurity DoD Assistant Secretary for Nuclear Deterrence, Chemical, and Biological Defense Policy and Programs Defense Threat Reduction Agency Global Emerging Infections Surveillance and Response System Joint Program Executive Office for CBRN Defense (JPEO-CBRND) National Center for Medical Intelligence Federal research Trans- departmental National Interagency Confederation for Biological Research (National Interagency Biodefense Campus, Fort Detrick) Integrated National Biodefense Medical Countermeasures Portfolio (DHHS/DoD) Military U.S. Army Medical Research Institute of Infectious Diseases Defense Advanced Research Projects Agency Edgewood Chemical Biological Center Dugway Proving Ground Civilian Galveston National Laboratory (UTMB/NIAID) Integrated Research Facility (HHS/NIAID) Biomedical Advanced Research and Development Authority (HHS) Homeland Security Research Program (EPA/DHS) Plum Island Animal Disease Center (USDA) Foreign Disease Weed Science Research Unit (USDA) Response Local Local Health Departments State State Health Departments Nebraska Biocontainment Patient Care Unit Federal National Medical Response Team/National Pharmacy Response Team (NDMS, HHS) Chemical Biological Incident Response Force (USMC) Epidemic Intelligence Service (CDC) Aeromedical Biological Containment System (CDC) Bioterror Rapid Response and Advanced Technology Laboratory (CDC) Non- governmental Academic centers and think tanks Johns Hopkins Center for Health Security (formerly Center for Biosecurity) Henry L. Stimson Center Center for Advancing Microbial Risk Assessment Center for Biodefense and Emerging Pathogens (Brown University) Middle-Atlantic Regional Center of Excellence for Biodefense and Emerging Infectious Diseases Research Center for Biodefense Immune Modeling (University of Rochester) Johns Hopkins Center for Civilian Biodefense Strategies National Center for Biodefense and Infectious Diseases (NCBID; George Mason Univ.) Government contractors Battelle Memorial Institute SRI International Idaho Technology Phoenix Air Programs and projects Threat reduction Nunn–Lugar Cooperative Threat Reduction Program, implemented the Defense Threat Reduction Agency and Biological Threat Reduction (DoD) plus Project Bacchus Project Clear Vision Project Jefferson Biosurveillance National Biosurveillance Strategy Laboratory Response Network (CDC) BioWatch (EPA, CDC) Global Bio-Surveillance Technology Initiative (GBTI), Bio-Surveillance Management Office (BMO) (part of JPEO-CBD) ESSENCE (DoD) RODS (Civilian) Biosecurity/Biosurety Select Agent Program (CDC) Personnel Reliability Program (DoD) Medical intelligence National Intelligence Assessments on Infectious Diseases Disaster response National Response Framework of the National Strategy for Homeland Security (DHS; including NIMS and ICS) National Disaster Medical System (DHHS) Strategic National Stockpile (CDC, DHS) Technology and equipment Protection MOPP NBC suit Respirators Detection Cell CANARY Biological Materials MASINT Autonomous Pathogen Detection System Joint Biological Agent Identification and Diagnostic System (JBAIDS) Biocontainment Biosafety level Biosafety cabinet Positive pressure personnel suit Law Treaties Geneva Protocol (1925, 1975) Statement on Chemical and Biological Defense Policies and Programs (1969) Biological Weapons Convention (1972) Legislation Biological Weapons Anti-Terrorism Act of 1989 Soviet Nuclear Threat Reduction Act of 1991 Executive Order 13139 (1999) Patriot Act (2001) Public Health Security and Bioterrorism Preparedness Response Act (2002) Agricultural Bioterrorism Protection Act of 2002 Project Bioshield Act (2004) Biodefense and Pandemic Vaccine and Drug Development Act of 2005 Public Readiness and Emergency Preparedness Act (2005) Pandemic and All-Hazards Preparedness Act (2006) Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 International representation Global Health Security Initiative Global Partnership Against the Spread of Weapons and Materials of Mass Destruction United Nations Security Council Resolution 1540 (2004) History Past biological incidents 1984 Rajneeshee bioterror attack 1989 California medfly attack 2001 anthrax attacks Wood Green ricin plot (2002) 2003 ricin letters 2013 ricin letters Defunct organizations and programs United States Army Medical Unit United States biological weapons program Sunshine Project Aeromedical Isolation Team (DoD) Predict (USAID) Related topics Agro-terrorism Biodefense Biosecurity in the United States Biological agent Biological hazard Biological warfare (BW) Biosurveillance Bioterrorism CBRN defense Decontamination Entomological warfare Isolation (health care) Select agent Smallpox virus retention debate --- Adapted from the Wikipedia article [Select agent](https://en.wikipedia.org/wiki/Select_agent) by Wikipedia contributors ([contributor history](https://en.wikipedia.org/wiki/Select_agent?action=history)). 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