Policy Statements

This FSAP policy statement explains that individuals will not be approved by FSAP to perform the role of Responsible Official (RO) at more than one registered entity, nor will an RO be approved as an Alternate Responsible Official (ARO) at another registered entity. Further conditions apply to individuals performing the role of ARO at more than one registered entity.

This policy statement provides clarification for terms related to BSL-3/ABSL-3 verification as they are used in the select agent regulations.

This policy statement provides clarification for terms related to BSL-4/ABSL-4 verification as they are used in the select agent regulations.

This policy statement describes the requirements when using surrogates to meet the in-house validation/verification of inactivation by chemical inactivation of whole tissue or homogenized tissue.

This policy statement defines and outlines the appropriate applications of the terms “conclusion of patient care” or “delivery of patient care by health care professionals has concluded” as used in the select agent regulations.

This statement provides the policy that addresses requirements for entity annual internal inspections.

This policy statement clarifies requirements regarding inactivation protocols for B. anthracis strains, includingB. anthracis Pasteur and B. cereus Biovar anthracis, that were subject to an inactivation procedure on or after June 2, 2015.

This policy statement describes that the certificate must be signed by the appropriate Principal Investigator, or designee to certify that the information listed on that certificate is accurate and before the “inactivated material” is removed from registered space or the biocontainment level required for that material.

This policy explains FSAP policy regarding laboratory work with the full-length genomes capable of producing infectious virus of regulated Risk Group 3 and 4 (RG3 and RG4) select agents and Veterinary Services (VS) select agents at one containment level lower than the infectious virus without RNA inactivation.

This DASAT statement provides guidance on alternatives to the live bird lethality testing required for reassortant virus exclusion requests.

This policy statement provides clarification for the term “a deviation from a validated inactivation procedure or a viable select agent removal method” as it is used in the select agent regulations.

This FSAP policy statement clarifies the conditions under which study-related activities associated with the possession of an animal which is naturally infected with a select agent, either within its natural environment or having been transported to an artificially established environment, are not excluded from the requirements of the select agent regulations.

This policy statement describes requirements for registration and inspection of an effluent decontamination system.

This policy statement provides clarification for filling out the APHIC/CDC Form 2 for the transfer of select agents or toxins.

This policy statement outlines the acceptable conditions for allowing a “restricted person” access to an area in which select agents or toxins are used or stored.

This policy statement describes when a select agent contained in formalin-fixed paraffin-embedded tissue is excluded from the requirements of the select agent regulations.

This policy statement defines “validated inactivation procedure” and clarifies that in-house validation must be completed prior to the use of the procedure.

DASAT has issued a policy statement regarding personal quarantine for individuals working with, or in proximity to, specific Veterinary Services (VS) select agents.