SA-IBC

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 - 42 CFR 73

 

HHS AND USDA SELECT AGENTS AND TOXINS
7CFR Part 331, 9 CFR Part 121 and 42 CFR Part 73

HHS SELECT AGENTS AND TOXINS

  • Abrin
  • Bacillus cereus Biovar anthracis*
  • Botulinum neurotoxins*
  • Botulinum neurotoxin producing species of Clostridium
  • 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 prowazekii
  • SARS-associated coronavirus (SARS-CoV)
  • Saxitoxin
  • 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
  • Foot and mouth disease virus
  • Goat pox virus
  • Lumpy skin disease virus
  • Mycoplasma capricolum
  • Mycoplasma mycoides
  • Newcastle disease virus (VVND)
  • 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
  • Schlerophthora rayssiae
  • Synchytrium endobioticum
  • Xanthomonas oryzae
*Denotes Tier 1 Agent

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:

HHS Toxins Amount
Abrin 1000mg
Botulinum Neurotoxins 1 mg
Short, paralytic alpha conotoxins 100 mg
Diacetoxyscirpenol (DAS) 10,000 mg
Ricin 1000 mg
Saxitoxin 500 mg
Staphyloccocal Enterotoxins (Subtypes A, B, C, D and E) 100 mg
T-2 toxin 10,000 mg
Tetrodotoxin 500mg

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

Reference: CDC Select Agent 42CFR73