Select Toxin Guidance:
Proficiency Testing Identification

Any person or entity, including any clinical or diagnostic laboratory, having identified a select agent or toxin contained in a specimen or sample presented for proficiency testing, is required by the select agent regulations (9 CFR Part 121external icon and 42 CFR Part 73external icon) to report this identification by submitting a APHIS/CDC Form 4 to FSAP within 90 calendar days of receipt of samples. This requirement applies regardless of whether the person or entity is registered with FSAP. More information on identification of select agents and toxins requirements can be found at:

• Report or Identification of Select Agent or Toxin FAQs
• Guidance Document for the Completion of APHIS/CDC Form 4 pdf icon[PDF – 192 KB]

For select toxins identified in clinical, diagnostic, or proficiency testing, the select agent or toxin must be secured against theft, loss, or release during the period between identification of the select agent or toxin, and transfer or destruction of such select agent or toxin. Any theft, loss, or release of a select agent or toxin must be reported using the APHIS/CDC Form 3 (Report of Theft, Loss, or Release of Select Agents And Toxins) as required by 42 CFR §73.19external icon.