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Suggested Citation:"Appendix H: HHS and USDA Select Agents and Toxins." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
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Appendix H

HHS and USDA Select Agents and Toxins

7 CFR Part 331, 9 CFR Part 121, and 42 CFR Part 73

HHS SELECT AGENTS AND TOXINS OVERLAP SELECT AGENTS AND TOXINS
Abrin Bacillus anthracis*
Botulinum neurotoxins* Bacillus anthracis Pasteur strain
Botulinum neurotoxin producing species of Clostridium* Brucella abortus
Conotoxins (Short, paralytic alpha conotoxins containing the following amino acid sequence X1CCX2PACGX3X4X5X6CX7)1 Brucella melitensis
Coxiella burnetii Brucella suis
Crimean-Congo haemorrhagic fever virus Burkholderia mallei*
Diacetoxyscirpenol Burkholderia pseudomallei*
Eastern Equine Encephalitis virus3 Hendra virus
Ebola virus* Nipah virus
Francisella tularensis* Rift Valley fever virus
Lassa fever virus Venezuelan equine encephalitis virus3
Lujo virus
Marburg virus* USDA SELECT AGENTS AND TOXINS
Monkeypox virus3 African horse sickness virus
Reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments (Reconstructed 1918 Influenza virus) African swine fever virus
Ricin Avian influenza virus3
Rickettsia prowazekii Classical swine fever virus
SARS-associated coronavirus (SARS-CoV) Foot-and-mouth disease virus*
Suggested Citation:"Appendix H: HHS and USDA Select Agents and Toxins." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
×
Saxitoxin Goat pox virus
South American Haemorrhagic Fever viruses: Lumpy skin disease virus
Chapare Mycoplasma capricolum3
Guanarito Mycoplasma mycoides3
Junin Newcastle disease virus2,3
Machupo Peste des petits ruminants virus
Sabia Rinderpest virus*
Staphylococcal enterotoxins A,B,C,D,E subtypes Sheep pox virus
T-2 toxin Swine vesicular disease virus
Tetrodotoxin
Tick-borne encephalitis complex (flavi) viruses: USDA PLANT PROTECTION AND QUARANTINE (PPQ) SELECT AGENTS AND TOXINS
Far Eastern subtype Peronosclerospora philippinensis
Siberian subtype (Peronosclerospora sacchari)
Kyasanur Forest disease virus Phoma glycinicola (formerly Pyrenochaeta glycines)
Omsk hemorrhagic fever virus Ralstonia solanacearum
Variola major virus (Smallpox virus)* Rathayibacter toxicus
Variola minor virus (Alastrim)* Sclerophthora rayssiae
Yersinia pestis* Synchytrium endobioticum
Xanthomonas oryzae

*Denotes Tier 1 Agent. These agents present the greatest risk of deliberate misuse with significant potential for mass casualties or devastating effect to the economy, critical infrastructure, or public confidence, and pose a severe threat to public health and safety. (See http://www.cdc.gov/vhf/ebola/healthcare-us/laboratories/select-agent-regulations.html).

1C = Cysteine residues are all present as disulfides, with the 1st and 3rd Cysteine, and the 2nd and 4th Cysteine forming specific disulfide bridges; The consensus sequence includes known toxins α-MI and α-GI (shown above) as well as α-GIA, Ac1.1a, α-CnIA, α-CnIB; X1 = any amino acid(s) or Des-X; X2 = Asparagine or Histidine; P = Proline; A = Alanine; G = Glycine; X3 = Arginine or Lysine; X4 = Asparagine, Histidine, Lysine, Arginine, Tyrosine, Phenylalanine or Tryptophan; X5 = Tyrosine, Phenylalanine, or Tryptophan; X6 = Serine, Threonine, Glutamate, Aspartate, Glutamine, or Asparagine; X7 = Any amino acid(s) or Des X and; “Des X” = “an amino acid does not have to be present at this position.” For example if a peptide sequence were XCCHPA then the related peptide CCHPA would be designated as Des-X.

2A virulent Newcastle disease virus (avian paramyxovirus serotype 1) has an intracerebral pathogenicity index in day-old chicks (Gallus gallus) of 0.7 or greater or has an amino acid sequence at the fusion (F) protein cleavage site that is consistent with virulent strains of Newcastle disease virus. A failure to detect a cleavage site that is consistent with virulent strains does not confirm the absence of a virulent virus.

3Select agents that meet any of the following criteria are excluded from the requirements of this part: Any low pathogenic strains of avian influenza virus, South American genotype of eastern equine encephalitis virus, west African clade of Monkeypox viruses, any strain of Newcastle disease virus which does not meet the criteria for virulent Newcastle disease virus, all subspecies Mycoplasma capricolum except subspecies capripneumoniae (contagious

Suggested Citation:"Appendix H: HHS and USDA Select Agents and Toxins." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
×

caprine pleuropneumonia), all subspecies Mycoplasma mycoides except subspecies mycoides small colony (Mmm SC) (contagious bovine pleuropneumonia), and any subtypes of Venezuelan equine encephalitis virus except for Subtypes IAB or IC, provided that the individual or entity can verify that the agent is within the exclusion category. 9/10/13

SOURCE: Federal Select Agent Program, “Select Agents and Toxins List,” available at: http://www.selectagents.gov/SelectAgentsandToxinsList.html.

Suggested Citation:"Appendix H: HHS and USDA Select Agents and Toxins." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
×

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Suggested Citation:"Appendix H: HHS and USDA Select Agents and Toxins." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
×
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Suggested Citation:"Appendix H: HHS and USDA Select Agents and Toxins." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
×
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Suggested Citation:"Appendix H: HHS and USDA Select Agents and Toxins." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
×
Page 257
Suggested Citation:"Appendix H: HHS and USDA Select Agents and Toxins." National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century. Washington, DC: The National Academies Press. doi: 10.17226/21824.
×
Page 258
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Research universities are critical contributors to our national research enterprise. They are the principal source of a world-class labor force and fundamental discoveries that enhance our lives and the lives of others around the world. These institutions help to create an educated citizenry capable of making informed and crucial choices as participants in a democratic society. However many are concerned that the unintended cumulative effect of federal regulations undercuts the productivity of the research enterprise and diminishes the return on the federal investment in research.

Optimizing the Nation's Investment in Academic Research reviews the regulatory framework as it currently exists, considers specific regulations that have placed undue and often unanticipated burdens on the research enterprise, and reassesses the process by which these regulations are created, reviewed, and retired. This review is critical to strengthen the partnership between the federal government and research institutions, to maximize the creation of new knowledge and products, to provide for the effective training and education of the next generation of scholars and workers, and to optimize the return on the federal investment in research for the benefit of the American people.

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