CD - Form 4

National Select Agent Registry phone numbers for APHIS (301-734-5960) and CDC (404-718-2000).

Last Updated: Monday, May 17, 2010

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 APHIS or CDC 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 APHIS or CDC. 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

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 582K) When submitting a completed APHIS/CDC Form 4 to APHIS or CDC, please submit only the applicable section (e.g., Section 1, Section 2 or Section 3). You do not need to include the Introduction and/or Instruction pages (pages 1 and 2 of APHIS/CDC Form 4) as part of your submission. *Forms* Clinical or diagnostic laboratories, or other entities, that have confirmed the presence of a select agent or toxin in a specimen or sample presented for diagnosis or verification must submit Section 1 of APHIS/CDC Form 4. If more than one laboratory handled the sample prior to providing it to your entity, please complete the "APHIS/CDC Form 4, Section 1C – Sample Provider" Word document below for each clinical/diagnostic or reference laboratory that handled the sample and submit this form with your completed APHIS/CDC Form 4. APHIS/CDC Form 4, Section 1 – Reference Laboratories (PDF 209K) APHIS/CDC Form 4, Section 1C - Sample Provider (WRD 112K) Note: The Word document must be saved to a local drive before the document can be edited. Clinical or diagnostic laboratories, or other entities, that have confirmed the presence of a select agent or toxin contained in a specimen or sample presented for proficiency testing must submit Section 2 of APHIS/CDC Form 4. APHIS/CDC Form 4, Section 2 – Proficiency Testing (PDF 165K) Federal law enforcement agencies that have seized a confirmed select agent or toxin must submit Section 3 of APHIS/CDC Form 4. APHIS/CDC Form 4, Section 3 – Federal Law Enforcement (PDF 149K) All Sections Fillable PDF: APHIS/CDC Form 4 (PDF 190K) (Adobe 6.0 or greater required for all fillable PDFs) Print Only PDF: APHIS/CDC Form 4 (PDF 60K) *Frequently Asked Questions* Frequently asked questions about reporting the identification of select agents and toxins: Q & A's (PDF 32K)

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Animal and Plant Health Inspection Service Agricultural Select Agent Program 4700 River Road Unit 2, Mailstop 22, Cubicle 1A07 Riverdale, MD 20737 FAX: 301-734-3652 E-mail: Agricultural.Select.Agent.Program@aphis.usda.gov and Centers for Disease Control and Prevention Division of Select Agents and Toxins 1600 Clifton Road NE, Mailstop A-46 Atlanta, GA 30333 FAX: 404-718-2096 E-mail: lrsat@cdc.gov