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POLICY FOR DESTRUCTION OF SELECT AGENTS

by schmidy last modified Jun 06, 2007 01:40 PM

Originator: Department of Environmental Health and Safety
Vice President: Finance and Administration
Issued: March 14, 2003



SUMMARY:


When laboratory staff no longer need a Select Agent they possess, the Agent(s) should be destroyed appropriately and in a timely fashion and the destruction documented. The process must be witnessed and documented by a representative of the Department of Environmental Health and Safety. Failure to comply with this policy may result in sanctions.



SCOPE:


This policy applies to any individual, including a principal investigator, researcher, instructor, laboratory or clinical manager that wishes to dispose of any Select Agent(s). This policy also applies to department chairs that take ownership of Select Agent(s) from a departing or deceased principal investigator, researcher, instructor, laboratory or clinical manager. Investigators are advised that possession of a Select Agent is permissible only if the Department of Environmental Health and Safety approves the possession of the Select Agent.



DEFINITIONS:


Select Agent : Any biological agent or toxin that is designated by the Centers for Disease Control or United States Department of Agriculture as a Select Agent because it could pose a threat to human, animal or plant health and safety. The Centers for Disease Control reviews the list of Select Agents at least biennially and may revise the list of agents periodically. The current list can be found at http://www.louisville.edu/admin/dehs/agents.html.



RESPONSIBILITIES:



Department of Environmental Health and Safety (DEHS)


Witness and assist in the destruction of the Select Agent. DEHS will also execute and maintain documentation of the destruction of the Select Agent and provide a copy of this documentation to the department chair. If required, the designated Responsible Official (RO) for UofL, DEHS Director, will submit official notification to the Centers for Disease Control for Select Agents that are consumed or destroyed via a CDC Form EA-101.



Deans, Directors and Department Heads


Ensure that all principal investigators, researchers, instructors, laboratory or clinical managers or other applicable individuals are aware of and follow the procedures outlined in this policy.



Principal Investigator, Researcher, Instructor, Laboratory or Clinical Manager or Other Applicable Individual


Notify the University’s Environmental Operation & Hazardous Materials Manager of the intention to destroy Select Agents by calling 852-6670. Prior to destruction, the principal investigator, researcher, instructor, laboratory or clinical manager or other applicable individual must call the Environmental Manager at 852-6670 and make arrangements for a Department of Environmental Health and Safety (DEHS) representative to witness the destruction. Until DEHS arrives, the Select Agent must remain securely stored in the laboratory and shall not be moved or transferred without DEHS approval.



Department Chair/ Unit Head


The department chair or unit head is responsible for any Select Agent that is left abandoned by a principal investigator, researcher, instructor, laboratory or clinical manager or other applicable individual. The department/unit is responsible for implementing this policy if the Select Agent is abandoned. The department is also responsible for securely storing the Select Agent and maintaining a copy of the documentation of destruction.



Originator: Department of Environmental Health and Safety. Issued: March 14, 2003


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