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​Annual Notification: Possession of Select Agents/Toxins

 

This is the annual reminder that NIH employees cannot receive, possess, or transfer select agents or toxins unless authorized by the CDC Division of Select Agents and Toxins through the NIH Select Agent Program. Noncompliance can result in suspension of research, revocation of NIH's registration, or civil money penalties levied by the HHS Office of the Inspector General against you or against the NIH. For your information, find links to:

1) a current list of select agents and toxins - https://www.selectagents.gov/SelectAgentsandToxinsList.html

2) a list of attenuated forms of some select agents/toxins that are not regulated (i.e., exclusions) - https://www.selectagents.gov/SelectAgentsandToxinsExclusions.html

3) a list showing the aggregate amounts of select toxins that are not regulated - https://www.selectagents.gov/PermissibleToxinAmounts.html

 

Please note: the lists of exclusions and aggregate amounts are very specific and research must still be registered with the NIH Institutional Biosafety Committee. For more information on how to register, visit: https://www.ors.od.nih.gov/sr/dohs/BioSafety/Pages/Registrations.aspx. If you have any questions about what is considered a select agent or toxin, or are interested in acquiring a select agent or toxin to conduct research, please contact the Select Agent Program. Contact information can be found at: https://www.ors.od.nih.gov/sr/dohs/Pages/default.aspx

 

In addition, if a sample is unexpectedly determined to contain a select agent or toxin (via sequencing or some other analysis) or if you discover any select agent or toxin and you are not authorized to possess that agent or toxin, secure the material and notify the Select Agent Program immediately. The Select Agent Program will provide further instructions on the next steps to be completed. The Select Agent Program asks that you report this even if the sample is inactivated so that we can follow up and document disposition of the viable material that gave rise to the inactivated sample and/or notify the sender of the material if it came from a collaborator. This refers to samples that you have no reason to suspect contain a select agent or toxin.

 

If there are any questions or concerns, please contact Dr. Antony Schwartz, Responsible Official (Bethesda) or Ms. Kelly J. Flint, Responsible Official (Frederick) at 301-496-2960.