Report of the Identification of a Select Agent or Toxin
The APHIS/CDC Form 4, Report of the Identification of a Select Agent or Toxin, is used by clinical or diagnostic laboratories and other entities to notify the Federal Select Agent Program of the identification of a select agent or toxin as the result of diagnosis, verification, or proficiency testing and of the final disposition of that identified agent or toxin.
Clinical or diagnostic laboratories and other entities that have identified select agents or toxins (select agents & toxins list ) contained in a specimen presented for diagnosis or verification are required by regulations (7 CFR 331, 9 CFR 121, and 42 CFR 73) to report the identification within 7 calendar days to the Federal Select Agent Program. In addition, these laboratories or entities are required to report the identification of select agents and toxins from samples received for proficiency testing within 90 days of receipt of the sample. This webpage contains general information on this process and includes a section on “Frequently Asked Questions” and a link to the APHIS/CDC Form 4 (Report of the Identification of a Select Agent or Toxin).
In addition to reporting the identification of a select agent or toxin contained in a specimen presented for diagnosis or verification using the APHIS/CDC Form 4, the following select agents and toxins are required to be immediately (i.e. within 24 hours) reported to APHIS or CDC (e.g., via telephone, fax, or email):
African horse sickness virus
|*Website is being revamped based on Revised Select Agent regulations.
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