SA-IBC - OLD

SELECT AGENTS

What is a 'select agent'? The Anti-terrorism and Effective Death Penalty Act was passed in 1996 and built upon the Biological Weapons Anti-terrorism Act (1989) and other earlier anti-terrorism legislation. This legislation directed the Department of Health and Human Services to develop and maintain a list of biological agents that could pose a severe threat to the public health and safety, and to regulate the transfer of such agents while maintaining the availability of these agents for research, education, and other legitimate purposes. In response to this legislation, the CDC developed a list of 31 infectious agents and 12 biological toxins with additional provisions for recombinant organisms and drug resistant organisms and exemptions for research quantities and vaccine strains of organisms. This list of organisms provided below is referred to as the select agent list.

In March of 2005, the Department of Health and Human Services (DHHS) / Centers for Disease Control and Prevention (CDC) and the U.S. Department of Argriculture (USDA) published the final rules which establish new stricter regulations for the possession, use and transfer of select biological agents and toxins that could pose a threat to human, animal and plant health and safety.

The CDC has developed regulations on the transfer and transport of these select agents. They also require that facilities receiving these agents be registered with the federal government, that they fulfill the proper biosafety level requirements for handling, containment, and disposal, and that a person at the facility be responsible for the oversight of the transfer of such agents.

Researchers must register the laboratory with the CDC prior to purchasing or receiving any select agent. Contact the Office of Research Services for more information.

New Select Agent Regulation

New Select Agent Regulation 42 CFR 73

HHS NON-OVERLAP SELECT AGENTS AND TOXINS

  • Abrin
  • Bacillus cereus Biovar anthracis*
  • Botulinum neurotoxins*
  • Botulinum neurotoxin producing species of Clostridium
  • Cercopithecine herpesvirus 1 (Herpes B virus)
  • Coccidioides posadasii
  • Conotoxins (Shorta, paralytic alpha conotoxins)
  • Coxiella burnetti
  • Crimean-Congo haemorrhagic fever virus
  • Diacetoxyscirpenol
  • Eastern Equine Encephalitis virus
  • Ebola virus*
  • Francisella tularensis*
  • Lassa fever virus
  • Lujo virus
  • Marburg virus*
  • Monkeypox virus
  • Reconstructed 1918 Influenza virus
  • Ricin
  • Rickettsia prowqzekii
  • SARS-associated coronavirus (SARS-CoV)
  • Saxitoxin
  • Shiga-like ribosome inactivating proteins
  • Shigatoxin
  • South American Haemorrhagic Fever viruses
    • Chapare
    • Guanarito
    • Junin
    • Machupo
    • Sabia
  • Staphyloccocal enterotoxins A, B, C, D, E subtypes
  • T-2 toxin
  • Tetrodotoxin
  • Tick-borne encephalitis (flavi) viruses
    • Far Eastern subtype (formerly known as Russian Spring Summer encephalitis virus, RSSEV
    • Kyasanur Forest disease
    • Omsk Hemorrhagic fever
    • Siberian subtype
  • Variola major virus (Smallpox virus)*
  • Variola minor virus (Alastrim)*
  • Yersinia Pestis*

OVERLAP SLECT AGENTS AND TOXINS

  • Bacillus anthracis*
  • Brucella anthracis Pasteur strain
  • Brucella abortus
  • Brucella melitensis
  • Brucella suis
  • Burkholderia mallei (formerly Pseudomonas mallei)*
  • Burkholderia pseudomallei (formerly Pseudomonas pseudomallei)*
  • Hendra virus
  • Nipah Virus
  • Rift Valley fever virus
  • Venezuela equine encephalitis virus

USDA SELECT AGENTS AND TOXINS

  • African horse sickness virus
  • African swine fever virus
  • Avian influenza virus (highly pathogenic)
  • Classical swine fever virus
  • Blue tongue virus (Exotic)
  • Bovine spongiform encephalopathy agent
  • Camel pox virus
  • Classical swine fever virus
  • Cowdria ruminantium (Heartwater)
  • Foot and mouth disease virus
  • Goat pox virus
  • Lumpy skin disease virus
  • Japanese encephalitis virus
  • Malignant catarrhal fever virus (Exotic)
  • Menangle virus
  • Mycoplasma capricolum/M.F38/M. mycoides capri
  • Mycoplasma mycoides mycoides
  • Newcastle disease virus (VVND)
  • Peste Des Petits Ruminants virus
  • Rinderpest virus
  • Sheep pox virus
  • Swine vesicular disease virus
  • Vesicular stomatitis virus (Exotic)

LISTED PLANT PATHOGENS

  • Liberobacter africanus
  • Liberobacter asiaticus
  • Peronosclerospora philippinensis
  • Phakopsora pachyrhizi
  • Plum Pox Potyvirus
  • Ralstonia solanacearum race 3, biovar 2
  • Schlerophthora rayssiae var zeae
  • Synchytrium endobioticum
  • Xanthomonas oryzae
  • Xylella fastidiosa (citrus variegated chlorosis strain)

*Toxins are regulated based on potency and quantity. Entities that do not at any time have more than the following aggregate amounts (in the purified form or in combinations of pure and impure forms) under the control of a principal investigator are excluded from requirements of the regulation:

  • Abrin 100 mg
  • Botulinum neurotoxin 0.5 mg
  • Clostridium perfrigens epsilon toxin 100 mg
  • Conotoxins 100 mg
  • Diacetoxyscirpenol 1000 mg
  • Ricin 100 mg
  • Saxitoxin 100 mg
  • Shiga-like ribosome inactivating proteins 100 mg
  • Shigatoxin 100 mg
  • Staphylococcal entertoxins 5 mg
  • Tetrodotoxin 100 mg
  • T-2 1000 mg

CDC Select Agent Rule - Laboratory Registration / Select Agent Transfer Program

CDC Select Agent 42CFR73