Policy Statement: Inactivation Certificate

Date: August 3, 2018

Subject: FSAP Policy Statement: Inactivation Certificate

The Federal Select Agent Program (FSAP) is a collaboration between the Centers for Disease Control and Prevention, Division of Select Agents and Toxins and the Animal and Plant Health Inspection Service,  Agriculture Select Agent Services to regulate the possession, use, and transfer of biological agents and toxins listed in 7 C.F.R. Part 331, 9 C.F.R. Part 121, and 42 C.F.R. Part 73 (select agents and toxins).  The FSAP administers the select agent and toxin regulations in close coordination with the Federal Bureau of Investigation’s Criminal Justice Information Services Division (CJIS).

Policy Statement:

The purpose of the certificate required by section 17(a)(8)(vii) of the select agent and toxin regulations is for the Principal Investigator, or designee, responsible for subjecting a select agent or material containing a select agent or regulated nucleic acids that can produce infectious forms of any select agent virus to a validated inactivation procedure or a procedure for removal of viable select agent to certify that the information contained on the certificate is correct.  It is therefore the FSAP policy that the signature of the Principal Investigator, or designee, on such certificate will certify that the information listed on that certificate is true, complete, and accurate.  FSAP notes that knowingly and willfully making any materially false, fictitious, or fraudulent statement or representation on such certificate may be a violation of 18 U.S.C. 1001.

The select agent and toxin regulations allow to be excluded from the requirements of the regulations a select agent or regulated nucleic acids that can produce infectious forms of any select agent virus that has been subjected to a validated inactivation procedure that is confirmed through a viability testing protocol.  Section 17(a)(8) of the select agent and toxin regulations also requires that a certificate be created to document the inactivation or removal process which allows the select agent or regulated nucleic acids to be excluded from the requirements of the select agent and toxin regulations.  It is therefore the FSAP policy that the certificate must be signed by the appropriate Principal Investigator, or designee, before the “inactivated material” is removed from registered space or the biocontainment level required for that material.

This policy statement is effective August 3, 2018.

Authority:

Section 17(a)(8)(vii) of the select agent and toxin regulations requires that an individual or entity required to register under this part must maintain complete records relating to the activities covered by this part. Such records must include for select agents or material 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, a certificate, signed by the Principal Investigator, that includes the date of inactivation or viable select agent removal, the validated inactivation or viable select agent removal method used, and the name of the Principal Investigator.

Page last reviewed: August 25, 2020, 01:00 PM