Policy Statement:
Application of the requirement for a “validated inactivation procedure”

Date: August 10, 2018

Subject: FSAP Policy Statement: Application of the requirement for a “validated inactivation procedure” as used in the select agent regulations

This policy statement replaces the FSAP Policy Statement: “Application of the requirement for a “validated inactivation procedure” as used in the select agent regulations,” dated April 6, 2017.

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, Division of Agricultural Select Agents and Toxins 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:

It is the policy of the FSAP that for purposes of the section 3(d)(4) and section 4(d)(4) exclusion provisions, the “validated inactivation procedure,” whose efficacy is confirmed by data generated from a viability testing protocol, must be performed in-house by the entity when the procedure will be used to inactivate a select agent or nucleic acids that can produce infectious forms of any select agent virus.  In-house validation must be completed prior to the use of the procedure to render a select agent non-viable for future use or to render any nucleic acids that can produce infectious forms of any select agent virus non-infectious for future use.

Validation by an entity of an inactivation procedure may include:

1. Use of the exact conditions of a commonly accepted procedure (such as autoclaving) whose efficacy is confirmed with data generated from a viability testing protocol (validated) in-house by the entity.
2. Use of a published procedure with adherence to the exact published conditions whose efficacy is confirmed with data generated from a viability testing protocol (validated) in-house by the entity.
3. Use of entity-derived procedure with specific conditions whose efficacy is confirmed with data generated from a viability testing protocol (validated) in-house by the entity.

This policy statement is effective August 10, 2018.

Authority:

A “validated inactivation procedure” is defined by the select agent and toxin regulations as “a procedure, whose efficacy is confirmed by data generated from a viability testing protocol, to render a select agent non-viable but allows the select agent to retain characteristics of interest for future use; or to render any nucleic acids that can produce infectious forms of any select agent virus non-infectious for future use.” (See 7 CFR §331.1, 9 CFR §121.1, and 42 CFR §73.1).