Institutional Laboratory Biosafety Manual

Transcription

1 Appendix B. Select Agents and Toxins The Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS) oversee the possession, use and transfer of select agents and toxins in the Unites States. Select agents and toxins are biological agents and toxins that have the potential to pose a severe threat to public, animal or plant health, or to animal or plant products. Select agents and toxins are listed in Table 1 of this appendix. Select agent regulations require entities to implement many provisions, including without limitation, Department of Justice security risk assessments of all individuals who will access select agents; providing training to all staff with access to ensure safety and security while conducting research involving select agents or toxins; developing biosecurity, biosafety, and incident response plans; and maintaining records, e.g. select agent inventory and access records and training documentation. Certain individuals, referred to as restricted persons, cannot possess or have access to select agents or toxins. Personnel are subject to significant criminal and civil penalties for the inappropriate use, possession, or transfers of select agents and toxins. The attenuated strains of select agents that are excluded from Select Agent Regulations can be found at An excluded attenuated strain will be subject to the regulations if there is any reintroduction of factor(s) associated with virulence or other manipulations that modify the attenuation such that virulence is restored or enhanced. Table 2 of this appendix lists the toxins, which are excluded from select agent regulations when the amount under the control of a principal investigator does not exceed, at any time, the amounts indicated in Table 2 of this appendix. B.1 May 2014

2 For additional information, contact the Responsible Official (RO) or Alternate Responsible Official (ARO) at the Office of Environmental Health & Safety at All select agent and toxin shipments to or from require prior approval from the RO. has designated the Responsible Official the authority and control to ensure compliance with Select Agent Regulations. B.2 May 2014

3 TABLE 1: SELECT AGENT AND TOXIN LIST HHS SELECT AGENTS AND TOXINS Abrin Botulinum neurotoxins * Botulinum neurotoxin producing species of Clostridium * Conotoxins (Short, paralytic alpha conotoxins containing the following amino acid sequence X 1 CCX 2 PACGX 3 X 4 X 5 X 6 CX 7 Coxiella burnetii Crimean-Congo haemorrhagic fever virus Diacetoxyscirpenol Eastern Equine Encephalitis virus Ebola virus * Francisella tularensis * Lassa fever virus Lujo virus Marburg virus * Monkeypox 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) Ricin Rickettsia prowazekii SARS-associate coronavirus (SARS-CoV) Saxitoxin South American Haemorrhagic Fever viruses: Chapare Guanarito Junin Machupo Sabia Staphylococcal enterotoxins A, B, C, D, E subtypes T-2 toxin Tetrodotoxin Tick-borne encephalitis complex (flavi) viruses: Far Eastern subtype Siberian subtype B.3 May 2014

4 Kyasanur Forest disease virus Omsk hemorrhagic fever virus Variola major virus (Smallpox virus) * Variola minor virus (Alastrim) * Yersinia pestis * OVERLAP SELECT AGENTS AND TOXINS Bacillus anthracis * Bacillus anthracis Pasteur strain Brucella abortus Brucella melitensis Brucella suis Burkholderia mallei * Burkholderia psuedomallei * Hendra virus Nipah virus Rift Valley fever virus Venezuelan equine encephalitis virus USDA SELECT AGENTS AND TOXINS African horse sickness virus African swine fever virus Avian influenza virus Classical swine fever virus Foot-and-mouth disease virus * Goat pox virus Lumpy skin disease virus Mycoplasma capricolum Mycoplasma mycoides Newcastle disease virus 1 Peste des petits ruminants virus Rinderpest virus * Sheep pox virus Swine vesicular disease virus USDA PLANT PROTECTION AND QUARANTINE (PPQ) SELECT AGENTS AND TOXINS Peronosclerospora philippinensis (Peronosclerospora sacchari) Phoma glycinicola (formerly Pyrenochaeta glycines) Ralstonia solanacearum Rathayibacter toxicus Sclerophthora rayssiae B.4 May 2014

5 Synchytrium endobioticum Xanthomonas oryzae * Denotes Tier 1 Agent 1 A 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. Table 2. EXCLUDED TOXIN QUANTITIES Toxin Abrin Botulinum neurotoxins Short, paralytic alpha conotoxins Diacetoxyscirpenol (DAS) Ricin Saxitoxin Staphylococcal Enterotoxins (Subtypes A, B, C, D, E) Permissible amount* 0.5 mg 1000 mg 5.0 mg T-2 toxin 1000 mg Tetrodotoxin B.5 May 2014