Patriot Act

                                                                                                                                                        April 2020

Patriot Act and Select Agent Description

    1. Establish a system of safeguards to be followed when specific agents are transported.
    2. Collect and provide information concerning the location where certain potentially hazardous agents are transferred
    3. Track the acquisition and transfer of these specific agents, and
    4. Establish a process for alerting appropriate authorities if an unauthorized attempt is made to acquire these agents. The directive also places additional shipping and handling requirements on facilities that transfer or receive select infectious agents.



Definitions

Select Agents - A select agent is defined as an agent, virus, bacteria, fungi, rickettsia, 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:
Viruses
1. Crimean-Cong hemorrhagic fever virus
2. Eastern encephalitis virus
3. Ebola virus
4. (Nipah and Hendrah Complex viruses)
5. Lassa fever virus
6. Marburg virus
7. Rift Valley fever virus
8. South American hemorrhagic fever virus (Junin, Machupo, Sabia, Flexal, and Guanarito)
9. Tick-borne encephalitis complex (flavi) viruses (Central European Tick-borne encephalitis, Far Eastern Tick-borne encephalitis, Russhian Spring and Summer encephalitis, Kyasanur Forest disease, Omsk Hemorrhagic Fever)
10. Variola major virus (Smallpox virus)
11. Venezuelan equine encephalitis virus
12. Monkey Pox virus
13. Herpes B virus

Fungi
1. Coccidiodes immitis, C. posadasii

Toxins
1. Abrin
2. Botulinum toxins
3. Clostridium perfringens epsilon toxins
4. Conotoxins
5. Diacetoxyscrirpenol
6. Staphylococcal enterotoxins
7. Ricin
8. Saxitoxin
9. Shigatoxin and Shiga-like toxins
10.Tetrodotoxin
11.T-2 Toxin

Bacteria
1. Bacillus anthracis
2. Brucella abortus, B. melitensis, B. suis
3. Burkholderia mallei
4. Burkholderia pseduomallei
5. Botulinum neurotoxin producing strains of Clostridum
6. Coxiella burnetii
7. Francisella tularensis

8. Rickettsia prowazekii
9. Rickettsia rickettsii
10. Yersinia pestis

Genetic Elements Recombinant Nucleic Acids, and Recombinant Organisms
1. Full length nucleic acids (synthetic or naturally derived) of any of the viruses listen in Appendix A.
2. Nucleic acids (synthetic or naturally derived) of 100 nucleotides or more in length of Variola major virus (small pox).
3. Nucleic acids (synthetic or naturally derived) or bacteria, fungi, or viruses listed in Appendix A that encode for either a functional toxin or virulence factor sufficient to cause disease if the nucleic acid is 1)express in-vivo or in-vitro, 2)in an expression vector or host chromosome, or 3)in a carrier plasmid.
4. Nucleic acids (synthetic or naturally derived) that encode for the functional form of any of the toxins listed in Appendix A if 1)expressed in-vivo or in-vitro, 2)in an expression vector or host chromosome, or 3)in a carrier plasmid.
5. Microorganisms in Appendix A that have been genetically modified.

Amherst College is mandated by federal requirement to identify the Select Agents that we store transport or use (if any).

Compliance with Amherst College for the Use of Select Agents

Register the use in research projects with Amherst College Chemical Hygiene Officer before work can begin. Contact Kristi Ohr at X2736 or by email at kohr@amherst.edu

Amherst College faculty and staff that use, handle, transfer, receive or store these select agents must:

  1. Register the facility with the CDC before transferring the agent to another facility or receiving the select agent in a facility
  2. Secure the select infectious agent under lock and key and notify the Amherst College Campus Police of the secure location and contents.
  3. Keep all doors to the laboratory locked.
  4. Restrict access and allow only authorized individuals.
  5. Ensure that individuals in the laboratory are aware of restrictions and are properly trained on transferring, receiving, storage, and use of select agents.
  6. Maintain accurate and detailed records of select agents and stocks
  7. Destroy unused select agent stocks, if no longer needed
  8. Complete and maintain an annual inventory of select agents 

Imported Select Agents



    1. The importer must be registered with CDC in accordance with 42 CFR Part 72.6 (Additional Requirements for Facilities Transferring or Receiving Select Agents).
    2. A CDC Form EA-101 must be completed for each shipment of select agent under the import permit. Upon receipt of the agent, the receiving Responsible Facility Official (RFO) must complete a CDC Form EA-101, placing the “PHS Permit Number” where a registration number is requested for the transferring facility, and forward the completed Form EA-101 to CDC.

    Select Agents exempt from the standard

    1. The agent is part of a clinical specimen intended for diagnostic reference or verification purposes. 
    2. 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.
    3.  Vaccine strains of bacteria listed as described in Title 9.CFR, Part 78.1  
    4. Toxins used for medical purposes and inactivated for vaccine purposes. 
    5. Toxins used for biomedical research with an LD50 for vertebrates of more than 100 nanograms per kilogram of body weight. 
    6. Clinical Laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, which utilize select agents for diagnostic, reference verification, or proficiency testing purposes.
    7. Products subject to regulation under the Federal Insecticide Fungicide and Rondenticide Act (7 U.S.C 136 et seq). 
    8. Products subject to regulation under the Toxic Substances Control Act (15 U.S.C 2601 et seq) 
    9. Additional exemptions for otherwise covered strains will be considered when CDC reviews and updates the list of select agents in Appendix A
    Doors to laboratories shall be locked when facilities are not occupied and unless permission is granted by the Principle Investogator.

    Training

    (1) Training on the handling, storage, transportation, and use must be provided to all personnel that are authorized and/or have access to the select agents.

    (2) Amherst College faculty performing research or otherwise studying selected agents must have competent training. Documentation of that training including date, name, signature of attendee, instructor, material covered, and class duration must be included on the documentation. Copies should be held on file in the department with a copy to the Chemical Hygiene Officer.

    Additional Resources

    www.cdc.gov/od/ohs/lrsat.htm
    www.cdc.gov/od/ohs/biosfty/imprtper.htm