CDC Select Agents

DC Rule (42 CFR 72 Final Rule Effective April 15, 1997)


Purdue University Action: Report the possession, use, or transfer of "select agents" (below) to the Institutional Biosafety Committee, Professor Dunn Chairperson, 49-41063, pedunn@sps.purdue.edu.

Summary: Rule promulgated to implement section 511 of Public Law 104-132, "The Antiterrorism and Effective Death Penalty Act of 1996."  Individuals in violation of the the rule are subject to a fine of no more than $250,000 or one year in jail, or both.  Violations by organizations are subject to a fine of no more than $500,000 per event.


SELECT AGENTS

Viruses

  • Crimean-Congo hemorrhagic fever virus
  • Eastern Equine Encephalitis virus
  • Ebola viruses
  • Equine Morbillivirus
  • Lassa fever virus
  • Marburg virus
  • Rift Valley fever virus
  • South American Hemorrhagic fever viruses (Junin, Machupo, Sabia, Flexal, Guanarito)
  • Tick-borne encephalitis complex viruses
  • Variola major virus (Smallpox virus)
  • Venezuelan Equine Encephalitis virus
  • Viruses causing hantavirus pulmonary syndrome
  • Yellow fever virus

Exemptions: Vaccine strains of viral agents (Junin Virus strain candid #1, Rift Valley fever virus strain MP-12, Venezuelan Equine encephalitis virus strain TC-83, Yellow fever virus strain 17-D) are exempt.


Bacteria
  • Bacillus anthracis
  • Brucella abortus, B. melitensis, B. suis
  • Burkholderia (Pseudomonas) mallei
  • Burkholderia (Pseudomonas) pseudomallei
  • Clostridium botulinum
  • Francisella tularensis
  • Yersinia pestis

Exemptions: vaccine strains as described in Title 9 CFR, Part 78.1 are exempt.


Toxins

  • Abrin
  • Aflatoxins
  • Botulinum toxins
  • Clostridium perfringens epsilon toxin
  • Conotoxins
  • Diacetoxyscirpenol
  • Ricin
  • Saxitoxin
  • Shigatoxin
  • Staphylococcal enterotoxins
  • Tetrodotoxin
  • T-2 toxin

Exemptions: Toxins for medical use, inactivated for use as vaccines, or toxin preparations for biomedical research use at an LD50 for vertebrates of more than 100 nanograms per kilogram body weight are exempt. National standard toxins required for biologic potency testing as described in 9 CFR Part 113 are exempt.


Rickettsia

  • Coxiella burnetii
  • Rickettsia prowazekii
  • Rickettsia rickettsii

Fungi

  • Coccidioides immitis

Recombinant Organisms/Molecules

  • Genetically modified microorganisms or genetic elements from organisms on Appendix A, shown to produce or encode for a factor associated with a disease.
  • Genetically modified microorganisms or genetic elements that contain nucleic acid sequences coding for any of the toxins listed in this Appendix, or their toxic subunits.

Other Restrictions

The deliberate transfer of a drug resistance trait to microorganisms listed in this Appendix that are not known to acquire the trait naturally is prohibited by NIH "Guidelines for Research Involving Recombinant DNA Molecules," if such acquisition could compromise the use of the drug to control these disease agents in humans or veterinary medicine.


Additional Exemptions

  • Products subject to regulation under the Federal Insecticide Fungicide and Rodenticide Act (7 U.S.C. § 136 et seq.) and the Toxic Substances Control Act (15 U.S.C. § 2601 et seq.) are exempt.
  • Additional exemptions for otherwise covered strains will be considered when CDC reviews and updates the list of select agents in this Appendix. Individuals seeking an exemption should submit a request to CDC that specifies the agent or strain to be exempted and explains why such an exemption should be granted. Future exemptions will be published in the Federal Register for review and comment prior to inclusion in this Appendix.