Select Toxin Guidance: Identification of a Select Toxin Requirements (APHIS/CDC Form 4)
Any identification of a select toxin contained in a specimen presented for diagnosis or verification (regardless of whether a laboratory is registered with FSAP) must be reported regardless of the amount of select toxin identified. The identification must be reported within seven calendar days after identification except for Botulinum neurotoxin and/or Staphylococcal enterotoxin (Subtypes A-E)), or within 30 calendar days after identification of Botulinum neurotoxin and/or Staphylococcal enterotoxin (Subtypes A-E), using the APHIS/CDC Form 4 (Reporting the Identification of a Select Agent or Toxin from a Clinical/Diagnostic Specimen) and include the final disposition of the select toxin.
The select toxin (except original sample) must be transferred in accordance with § 73.16external icon or destroyed on-site by a recognized sterilization or inactivation process within seven calendar days after identification of the select agent or toxin (except for BoNT and/or SE (Subtypes A–E)), or within 30 calendar days after identification of BoNT and/or SE (Subtypes A–E). The 30 day time frame only applies to the 1) transfer, 2) destruction, or 3) movement into select agent inventory (for a registered entity) after identification and reporting of BoNT and SE (Subtypes A–E). It does not apply to the APHIS/CDC Form 4 reporting requirement. Note: The remaining original food and clinical samples which had portions removed and identified to contain select toxin are excluded. The transfer, destruction, or movement of select toxin positive samples into inventory (for a registered entity) applies only to the portions removed from the original sample and were subsequently used to perform testing. The remainder of the original food sample or clinical sample that was not subjected to the testing protocol is excluded.
Since a registered or reference laboratory typically confirms the identification of a select toxin for public health and agriculture, clinical and diagnostic laboratories, the registered or reference laboratory must inform the specimen provider of the identification as a condition for the reference laboratory to maintain their exemption. It is important that the specimen provider is aware that they are in possession of the toxin and must meet the requirements outlined in 42 CFR §§ 73.5external icon, 73.6external icon, including but not limited to:
- Must secure the toxin against theft, loss, or release.
- Cannot maintain possession of the select agent or toxin.
- Must destroy or get approval for a transfer.
- Must report a theft, loss, or release regardless of the amount.
More information on the theft, loss, release reporting requirements can be found at: