- Approval of a Person to be a Responsible Official at Only One Entity
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.
- BSL-3/ABSL-3 Verification
This policy statement provides clarification for terms related to BSL-3/ABSL-3 verification as they are used in the select agent regulations.
- Chemical inactivation of whole tissue or homogenized tissue
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.
- Conclusion of Patient Care
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.
- Entity Annual Internal Inspections Required by Section 9(a)(6) of the Select Agent Regulations
This statement provides the policy that addresses requirements for entity annual internal inspections.
- Inactivated Bacillus anthracis
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.
- Inactivation Certificate
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.
- Laboratory Work with Regulated Full-Length Genomes
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.
- Live Bird Lethality Testing Requirements for Pathogenicity Testing of Reverse Genetically Derived Viruses for Avian Influenza Viruses
This AgSAS statement provides guidance on alternatives to the live bird lethality testing required for reassortant virus exclusion requests.
- Meaning of the phrase: “a deviation from a validated inactivation
procedure or a viable select agent removal method”
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.
- Non-Exclusion of Study-Related Activities Involving Naturally Infected Animals
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.
- Registration and Inspection of an Effluent Decontamination System
This policy statement describes requirements for registration and inspection of an effluent decontamination system.
- Requests for Transfers of Select Agents and Toxins
This policy statement provides clarification for filling out the APHIC/CDC Form 2 for the transfer of select agents or toxins.
- “Restricted Person” Access to Select Agents and 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.
- Select agent contained in formalin-fixed paraffin-embedded tissue
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.
- Validated Inactivation Procedure
This policy statement defines “validated inactivation procedure” and clarifies that in-house validation must be completed prior to the use of the procedure.