Policy Statement

Date: April 6, 2017

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

The Federal Select Agent Program (FSAP) is a collaboration between the Centers for Disease Control and Prevention (CDC), Division of Select Agents and Toxins (DSAT) and the Animal and Plant Health Inspection Service (APHIS) Agriculture Select Agent Services (AgSAS) 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 agents and toxins regulations in close coordination with the Federal Bureau of Investigation’s Criminal Justice Information Services Division (CJIS).

Authority:

In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (42 U.S.C. 262a), the Secretary of U.S. Department of Health and Human Services (HHS) has established by regulation a list of each biological agent and each toxin that has the potential to pose a severe threat to public health and safety.  The list of HHS select agents and toxins can be found in section 3 (HHS select agents and toxins) and section 4 (Overlap select agents and toxins) of part 73 of Title 42, Code of Federal Regulations (42 CFR §§ 73.3, 73.4).  Section 73.3(d)(4) and section 73.4(d)(4) provide that a select agent or regulated nucleic acids that can produce infectious forms of any select agent virus is excluded from the requirements of the select agents and toxins regulations if it meets the following criteria: it “has been subjected to a validated inactivation procedure that is confirmed through a viability testing protocol.”   

In accordance with the Agricultural Bioterrorism Protection Act of 2002 (7 USC 8401), the Secretary of the U.S. Department of Agriculture (USDA) has established by regulations a list of each biological agent and toxin that has the potential to pose a severe threat to animal or plant health, or to animal or plant products.  The list of USDA select agents of concern for animals and animal products can be found in section 3 (VS select agents and toxins) and section 4 (Overlap select agents and toxins) of part 121 of Title 9, Code of Federal Regulations (9 CFR §§ 121.3, 121.4) This list of USDA select agents of concern for plants and plant products can be found in section 3 (PPQ select agents and toxins).  Section 121.3(d)(4), section 121.4(d)(4), and section 331(d)(4) provide that a select agent or regulated nucleic acids that can produce infectious forms of any select agent virus is excluded from the requirements of the select agents and toxins regulations if it meets the following criteria: it “has been subjected to a validated inactivation procedure that is confirmed through a viability testing protocol.”   

A “validated inactivation procedure” is defined by the select agents and toxins 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).

Policy Statement:

Consistent with the explanation of the intent of the regulatory amendments to the select agents and toxins regulations effective March 21, 2017, (See 82 FR 6278, January 19, 2017 (Final Rule), 82 FR 6197, January 19, 2017 (Final Rule)), 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. 

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 confirming 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 confirming with data generated from a viability testing protocol (validated) in-house by the entity.

This policy statement is effective April 6, 2017.

This policy statement will be provided to the Responsible Official via SA Gram for each registered entity on or before the effective date; and to the Responsible Official for each newly registered entity during the registration process. 

Any questions concerning this policy may be addressed by contacting the Federal Select Agent Program at lrsat@cdc.gov or AgSAS@aphis.usda.gov.