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
African swine fever virus
Avian influenza virus (highly pathogenic)
Bacillus anthracis
Botulinum neurotoxins
Bovine spongiform encephalopathy agent
Brucella melitensis
Classical swine fever virus
Ebola virus
Foot-and-mouth disease virus
Francisella tularensis
Hendra virus
Lassa fever virus
Marburg virus
Nipah virus
Peronosclerospora philippinensis (Peronosclerospora sacchari)
Phoma glycinicola (formerly Pyrenochaeta glycines)
Ralstonia solanacearum race 3, biovar 2
Rathayibacter toxicus
Rift Valley fever virus
Rinderpest virus
Sclerophthora rayssiae var zeae
South American Haemorrhagic Fever viruses (Junin, Machupo, Sabia, Flexal, Guanarito)
Swine vesicular disease virus
Synchytrium endobioticum
Variola major virus (Smallpox virus)
Variola minor (Alastrim)
Venezuelan equine encephalitis virus
Virulent Newcastle disease virus
Xanthomonas oryzae
Xylella fastidiosa (citrus variegated chlorosis strain)
Yersinia pestis