Regulatory Interpretation

Date: May 17, 2019

Subject: Regulatory Interpretation regarding requirement for inactivation certificates and intra-entity transfers

This is in response to a request (originally dated May 30, 2017) for the following regulatory interpretations:

  • Whether the regulatory requirement for a copy of a Principal Investigator (PI) signed certificate to accompany any transfer of select agents or materials containing select agents or regulated nucleic acids that can produce infectious forms of any select agent virus that have been subjected to a validated inactivation procedures or a procedure for removal of viable select agent applies to “routine inactivation of materials being tested at a lower biocontainment level in the same building.”

Note: The following information updates and replaces the previous response dated June 16, 2017.

A copy of an inactivation certificate must accompany the inactivated material when the inactivated material is transferred externally (from your entity to another entity). It is recommended that an inactivation certificate also accompany the transfer of inactivated material internally (from one PI to another PI at the same registered entity). Additionally, regardless of whether a transfer is made, an entity remains responsible for the record keeping requirements found in section 17(a)(8) of the select agents and toxins regulations. An original certificate must be generated for every sample inactivated regardless of future transfer.

FSAP recommends that entities maintain the certification of inactivation as long as the material is in their possession.

  • Can a contractor be designated as a PI?

Yes.