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Home > Policies for the Responsible Conduct of Research > Use of Select Biological Agents
Use of Select Biological Agents
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The purpose of Duke University’s policy on the transfer,
receipt, and storage of select agents is to ensure that “select agents” on Duke University campuses are handled safely, secured properly, and properly registered with the
Department of Health and Human Services, Centers for Disease Control and Prevention and/or the United States Department of Agriculture, Animal Plant Health Inspection Service.
Each principal investigator (PI) is held responsible for assuring that they register all possession, transfer, and receipt of Select Agents. They are also responsible for assuring that their laboratories fully comply with all prescribed safety policies and procedures. Consequently, all PIs must work closely with the Director of the Biological Safety Division of the Occupational and Environmental Safety Office (who serves as Duke’s Responsible Official, or “RO”) to assure compliance with this standard.
The following are other duties of the PI:
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The PI must develop a detailed standard operating procedure (SOP) for each Select Agent used in the laboratory. The procedure should address each of the following at a minimum: 1) means of limiting access to the lab, 2) means of securing the agent and the laboratory, 3) types of personal protective equipment and ventilation controls to protect workers from exposure, 4) post-exposure procedures, 5) waste handling and disposal, 6) spill and decontamination procedures, and 7) recordkeeping methods.
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The completed SOP is submitted to the RO for review and approval.
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The PI must provide the RO with a drawing of the laboratory in which the Select Agent is used. The drawing shall include 1) fumehood and/or biosafety cabinet, 2) storage refrigerator and/or freezer, 3) air supplies and exhausts, 4) emergency eyewashes and showers, 5) handwashing sink, and 6) autoclave.
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The PI shall oversee the day-to-day adherence to the SOP.
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The PI shall provide the RO with all records of transfer or receipt (Form EA-101).
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The PI shall insure that all personnel with access to the Select Agents have completed a Security Risk Assessment with the Department of Justice prior to work in the laboratory area.