Select agents are those that have the potential to be highly pathogenic and toxic. They are often the focus of "bio-terrorism" discussions. This is covered by Department of Health and Human Services, 42 CFR Part 72 | RIN 0905-AE70, Additional Requirements for Facilities Transferring or Receiving Select Agents
Complete information on this regulation can be obtained on the internet at http://www.cdc.gov/od/sap/index.htm
In June, 2002, this legislation was added to by the signing of Public Law 107-188, "Public Health Security and Bioterrorism Preparedness and Response Act of 2002."
THESE AGENTS MAY NOT BE PROCURED OR USED AT ST. LAWRENCE UNIVERSITY. For live organisms, DNA or genetic material of any type is also prohibited as are vaccines containing live material.
The following agents are defined as "select":
Appendix A to Part 72-Select Agents
1. Crimean-Congo hemorrhagic fever virus
2. Eastern Equine Encephalitis virus
3. Ebola viruses
4. Equine Morbillivirus
5. Lassa fever virus
6. Marburg virus
7. Rift Valley fever virus
8. South American Hemorrhagic fever viruses (Junin, Machupo, Sabia, Flexal, Guanarito)
9. Tick-borne encephalitis complex viruses
10. Variola major virus (Smallpox virus)
11. Venezuelan Equine Encephalitis virus
12. Viruses causing hantavirus pulmonary syndrome
13. 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.
1. Bacillus anthracis
2. Brucella abortus, B. melitensis, B. suis
3. Burkholderia (Pseudomonas) mallei
4. Burkholderia (Pseudomonas) pseudomallei
5. Clostridium botulinum
6. Francisella tularensis
7. Yersinia pestis
Exemptions: vaccine strains as described in Title 9 CFR, Part 78.1 are exempt.
1. Coxiella burnetii
2. Rickettsia prowazekii
3. Rickettsia rickettsii
1. Coccidioides immitis
3. Botulinum toxins
4. Clostridium perfringens epsilon toxin
10. Staphylococcal enterotoxins
12. 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.
Recombinant organisms/molecules also restricted:
1.Genetically modified microorganisms or genetic elements from organisms on Appendix A, shown to produce or encode for a factor associated with a disease.
2.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.
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.
1.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.
2.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.
USDA HIGH CONSEQUENCE AGENTS
These agents are not part of the HHS program of select prohibited agents, but they do require a special USDA permit to be possessed and must also be registered through the Bioterrorism act passed by congress in 2002.
These agents may not be used or possessed on the SLU campus and include:
- African horse sickness virus
- African swine sickness virus
- Akabane virus
- Avian influenza virus
- Blue tongue virus
- Bovine spongiform encephalopathy agent
- Camel pox virus
- Classical swine fever virus
- Cowdria ruminantium
- Foot and mouth disease virus
- Goat pox virus
- Japanese encephalitis virus
- Lumpy skin disease virus
- Malignant catarral fever virus
- Menangle virus
- Mycoplasma capricolum (Contagious carpine pleuropneumonia agent)
- Mycoplasma mycoides mycoides (Contagious bovine pleuropneumonia agent)
- NewCastle disease virus
- Nipah virus
- Peste des petitis ruminants virus
- Rinderpest virus
- Sheep pox virus
- Swine vesicular disease virus
- Vesicular stomatitis virus