2022 SA Grams

In June 2022, the Federal Select Agent Program (FSAP) shared an updated draft of the Inventory Guidance document with the regulated community for review and input. The updates included adding a labeling guidance appendix and other edits to enhance material accountability. The September update of the Inventory Guidance document has been further revised based on comments received and can now be found here.

Summary of comments and edits:

  • One commenter requested that a note be added about exempting of clinical specimens during the course of clinical care.
    • FSAP agreed with the commenter and added a sentence referencing Section 5(a)(3) under “Regulated select agents and toxins” (page 5).
  • Two commenters requested clarification regarding working stock records.
    • FSAP clarified in the document that the select agent regulations do not require entities to maintain inventory records in accordance with Section 17(a)(1) for working stock. However, FSAP expects entities be able to clearly identify how and why material is classified as working stock.
  • Two commenters requested leeway in reporting toxin losses when the root cause is clearly due to sublimation, age of samples and/or process loss, or below a “permissible limit.”
    • FSAP made no changes based on this comment. An entity is responsible for maintaining an accurate and current inventory of all registered toxins possessed, regardless of the amount in their possession as stated in Section 7(b).
  • One commenter stated that the example of grouping specimen vials with date of storage on the primary and secondary container is not practical or feasible.
    • FSAP clarified that the example provided on page 9 is a suggestion and is not a regulatory requirement, however, entities are required to maintain an accurate and current inventory of all specimens.
  • One commenter suggested that the length of time records be kept should be included.
    • FSAP agreed with commenter and revised document in accordance with Section 17(c).
  • FSAP received multiple comments regarding Appendix 1: Labeling Guidance and whether or not this guidance was required.
    • Please note that Appendix 1: Labeling Guidance is guidance and not a regulatory requirement. For inventory requirements, please reference Section 17(a)(1,2,3).
  • Two commenters were confused about “unique linkage” and asked for a definition or an example of what this meant under Appendix 1: Labeling Guidance.
    • Upon further review, FSAP agreed with the commenter and deleted the bullet.
  • Two commenters asked if secondary containers were required to have the same information as the primary vial regarding the last paragraph in Appendix 1: Labeling Guidance.
    • FSAP agreed with the commenter and revised the last paragraph in Appendix 1: Labeling Guidance.