Regulatory Interpretation

Date: April 11, 2017

Subject: Regulatory Interpretation regarding signature by “Principal Investigator” on Inactivation Certificates

This is in response to your request, dated April 4, 2017 for a regulatory interpretation of the requirement for a “Principal Investigator” to sign a certificate for 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 procedure or a procedure for removal of viable select agent.  See, for example, 42 C.F.R. § 73.17 (a)(8)(vii). 

For purposes of the requirement found in 42 C.F.R. § 73.17 (a)(8)(vii), 9 C.F.R. § 121.17(a)(8)(vii), and 7 C.F.R. § 331.17 (a)(8)(vii), the Principal Investigator is the one individual who is designated by the entity to direct a project or program and who is responsible to the entity for the scientific and technical direction of that project or program (including all inactivation procedures or removal procedures associate with that project); or in the absence of that Principal Investigator, the individual designated by that Principal Investigator and approved by the entity Responsible Official to sign the certificate in his or her absence. In order for an individual to be the Principal Investigator’s designee to sign the certificate, a person must be listed on the entity’s registration and have the knowledge and expertise to provide scientific and technical direction regarding the validated inactivation procedure or the procedure for removal of viable select agent to which the certificate refers.