APHIS/CDC Form 4: Report of the Identification of a Select Agent or Toxin

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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.  Registered entities report the identification of select agents and toxins through eFSAP.

For non-registered clinical or diagnostic laboratories and other entities, Tier 1 select agents and toxins listed below are required to be immediately reported to Federal Select Agent Program and then submit APHIS/CDC Form 4 within 7 calendar days of identifications and within 90 days of receipt of the proficiency sample.

Tier 1 Select Agents and Toxins

HHS Agents and Toxins
  • Bacillus cereus Biovar anthracis
  • Botulinum neurotoxins
  • Botulinum neurotoxin producing species of Clostridium
  • Ebola virus
  • Francisella tularensis
  • Marburg virus
  • Variola major virus (Smallpox virus)
  • Variola minor virus (Alastrim)
  • Yersinia pestis
Overlap Agents
  • Bacillus anthracis
  • Burkholderia mallei
  • Burkholderia pseudomallei
USDA Agents
  • Foot-And-Mouth Disease virus
  • Rinderpest virus

Animal and Plant Health Inspection Service
Division of Agricultural Select Agents and Toxins
4700 River Road, Unit 2, Mailstop 22, Cubicle 1A07
Riverdale, MD 20737
Fax: 301-734-3652
Email: DASAT@usda.gov

Centers for Disease Control and Prevention
Division of Regulatory Science and Compliance
1600 Clifton Road, NE, Mailstop H21-4
Atlanta, GA 30329
Fax: 404-471-8375
Email: CDCForm4@cdc.gov

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.

Please only hand write if using print only form and do not adjust the formatting and text on the form.