Biosafety and USA Patriot Act
"Select Agents"
A select agent is defined as an agent, virus, bacteria, fungi, rickettsiae or toxin listed in Appendix A of Federal Register 29327 (42 CFR Part 72) titled, "Additional Requirements for Facilities Transferring or Receiving Select Agents." The term also includes (a) genetically modified microorganisms or (b) genetic elements that contain nucleic acid sequences associated with pathogenicity from organisms listed in Appendix A, (c) genetically modified microorganisms listed in Appendix A, and (d) genetically modified microorganisms or genetic elements that contain nucleic acid sequences coding for any of the toxins in Appendix A, or their toxic subunits.
List of "Select Agents"
- Crimean-Congo haemorrhagic fever virus
- Eastern equine encephalitis virus
- Ebola virus
- Equine morbillivirus
- Lassa fever virus
- Marburg virus
- Rift Valley fever virus
- South American haemorrhagic fever viruses (Junin, Machupo, Sabia, Flexal, and 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 these viral agents as described in the fourth edition of the CDC/NIH ''Biosafety in Microbiological and Biomedical Laboratories'' (available from Becky Northcut, CIP, in OSP) are exempt.
Bacteria
- Bacillus anthracis
- Brucella abortus, B. melitensis, B. suis
- Burkholderia (Pseudomonas) mallei
- Burkholderia (Pseudomonas) pseudomallei
- Clostridium botulinum
- Francisella tularensis
- Yerinia pestis
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 (e.g., micro-bial toxins such as the botulinum toxins, tetanus toxin, diphtheria toxin, and Shigella dysenteriae neurotoxin) are exempt.
Toxins
- Abrin
- Aflatoxins
- Botulinum toxins
- Clostridium perfringens epsilon toxin
- Conotoxins
- Diacetoxyscirpenol
- Staphylococcal enterotoxins
- Ricin
- Saxitoxin
- Shigatoxin
- Tetrodotoxin
- T-2 toxin
Rickettsiae
- Coxiella burnetii
- Rickettsia prowazekii
- Rickettsia rickettsii
Fungi
- Coccidioides immitis
Recombinant organisms/molecules
- Genetically modified microorganisms or genetic elements from agents in these lists that have the potential to encode for a factor associated with disease.
- Genetically modified microorganisms or genetic elements that contain nucleic acid sequences coding for any of the toxins on these lists, or their toxic subunits.
Select Agents that are considered exempt:
* The following list explains exemptions from the standard:
* The agent is part of a clinical specimen intended for diagnostic reference or verification purposes.
* 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 17D) are exempt.
* Vaccine strains of bacteria listed as described in Title 9 CFR, Part 78.1.
* Toxins used for medical purposes and inactivated for vaccine purposes.
* Toxins used for biomedical research with an LD50 for vertebrates of more than 100 nanograms per kilogram of body weight.
* Clinical Laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of1988, that utilize select agents for diagnostic, reference verification, or proficiency testing purposes.
* Products subject to regulation under the Federal Insecticide Fungicide and Rondenticide Act (7 U.S.C. § 136 et seq.).
* Products subject to regulation under the Toxic Substances Control Act (15 U.S.C. § 2601 et seq.).
* Additional exemptions for otherwise covered strains will be considered when CDC reviews and updates the list of select agents in Appendix A of Federal Register 29327 (42 CFR Part 72) titled, Additional Requirements for Facilities Transferring or Receiving Select Agents.