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Annual Notice for Select Agents and Toxins

This is your 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. Non-compliance can result in suspension of research, revocation of our registration, or Civil Money Penalties levied by the HHS Office of the Inspector General against you or against the NIH.

For your information, the following references are available:

  • Federal Select Agent Program
  • Select Agent and Toxin List
  • Exclusions
  • Permissible Toxin Amounts

Please note that exclusions and permissible 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.

Additional Guidance

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.

Individuals who suspect or have concerns regarding the inappropriate storage or handling of select agents or toxins can anonymously report to DOHS here: https://orsweb.od.nih.gov/_layouts/orssafetyreport/report.aspx (NIH access only).

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

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