Regulatory Interpretation

Date:June 16, 2017

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

This is in response to your request, 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.”

The inactivation certificate is only required when the material is transferred externally (entity to entity). It is recommended that an inactivation certificate accompanies intra-entity transfers of inactivated material internally (PI to PI).  Additionally, regardless of the type of a subsequent transfer, an entity remains responsible for the record keeping requirements found in section 17(a)(8) of the select agents and toxins regulations. 

  • Can a contractor be designated as a PI?