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- Establish a system of safeguards to be followed when specific agents are transported.
- Collect and provide information concerning the location where certain potentially hazardous agents are transferred
- Track the acquisition and transfer of these specific agents, and
- 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.
Amherst College is mandated by federal requirement to identify the Select Agents that we store transport or use (if any).
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 firstname.lastname@example.org
Amherst College faculty and staff that use, handle, transfer, receive or store these select agents must:
- Register the facility with the CDC before transferring the agent to another facility or receiving the select agent in a facility
- Secure the select infectious agent under lock and key and notify the Amherst College Campus Police of the secure location and contents.
- Keep all doors to the laboratory locked.
- Restrict access and allow only authorized individuals.
- Ensure that individuals in the laboratory are aware of restrictions and are properly trained on transferring, receiving, storage, and use of select agents.
- Maintain accurate and detailed records of select agents and stocks
- Destroy unused select agent stocks, if no longer needed
- Complete and maintain an annual inventory of select agents
- The importer must be registered with CDC in accordance with 42 CFR Part 72.6 (Additional Requirements for Facilities Transferring or Receiving Select Agents).
- 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.
- 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) of 1988, which 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