APHIS/CDC Form 4
Report of the Identification of a Select Agent or Toxin
Expired forms available on this website can be used because the revision application package is currently under review by Office of Management & 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 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 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.
APHIS/CDC Form 4A – Reporting the Identification from a Clinical/Diagnostic Specimen
- Fillable PDF: APHIS/CDC Form 4A(PDF 205KB) (Adobe Reader 6.0 or greater required)
- Print Only PDF: APHIS/CDC Form 4A(PDF 115KB)
APHIS/CDC Form 4B – Reporting the Identification from a Proficiency Test
- Fillable PDF: APHIS/CDC Form 4B (PDF 117KB) (Adobe Reader 6.0 or greater required)
- Print Only PDF: APHIS/CDC Form 4B(PDF 38KB)
APHIS/CDC Form 4C – Federal Law Enforcement Reporting Seizure of Select Agent or Toxin