APHIS/CDC Form 4
Expired forms available on this website can be used because the revision package is currently under review by Office of Management and Budget.
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 regulation (7 CFR Part 331, 9 CFR Part 121, and 42 CFR Part 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.
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 Federal Select Agent Program (e.g., via telephone, fax, or email):
- Bacillus anthracis
- Bacillus cereus Biovar anthracis
- Botulinum neurotoxins
- Botulinum neurotoxin producing species of Clostridium
- Burkholderia mallei
- Burkholderia pseudomallei
- Ebola virus
- Foot-and-mouth disease virus
- Francisella tularensis
- Marburg virus
- Rinderpest virus
- Variola major virus (Smallpox virus)
- Variola minor virus (Alastrim)
- Yersinia pestis
Form 4 Downloads
For assistance in the completion of APHIS/CDC Form 4, please refer to the guidance document below. This guidance document provides detailed information and direction on how to complete all sections of APHIS/CDC Form 4.
- Guidance Document for the Completion of APHIS/CDC Form 4 pdf icon[PDF – 192 KB]
- APHIS/CDC Form 4A – Reporting the Identification from a Clinical/Diagnostic Specimen
- APHIS/CDC Form 4B – Reporting the Identification from a Proficiency Test
- APHIS/CDC Form 4C – Federal Law Enforcement Reporting Seizure of Select Agent or Toxin