Select Agent Identification and Destruction Reporting

• Montana Public Health Laboratory (MTPHL) and clinical laboratories use APHIS/CDC Form 4A: Report of the Identification of a Select Agent or Toxin to notify the Federal Select Agent Program (FSAP) of the identification and destruction of a Select Agent.
• Once an agent is confirmed, laboratories are required by federal law to protect original diagnostic specimens and all culture material containing confirmed select agents against theft, loss, or release during the period between identification and destruction.
• The Montana Public Health Laboratory (MTPHL) and clinical laboratories are required to submit their portions of the APHIS/CDC Form 4A to FSAP within seven calendar days.
• APHIS/CDC Form 4A, guidance for completing it, and its submission instructions can be found at https://www.selectagents.gov/forms/form4.htm. Laboratories can submit the form by email (form4@cdc.gov) or fax (404-471-8375). For additional helpful information for filling out an APHIS/CDC Form 4A.
• If your lab submitted all samples and cultures of a suspect organism to MTPHL, that were confirmed to contain a select agent, we will destroy the organism and complete APHIS/CDC Form 4A, sections A & B. Clinical laboratories will complete APHIS/CDC Form 4A, sections C & D. We will provide our sample ID in the event there was an exposure that necessitates the clinical laboratory to fill out and submit an APHIS/CDC Form 3: Report of a Release/Loss/Theft of a Select Agent or Toxin.
• Most pathogens we identify in Montana are designated as Tier 1, which refers to the more serious of the select agents. This list was recently edited and can be found on the FSAP website: https://www.selectagents.gov/forms/form4.htm. Note that Bacillus cereus biovar anthracis has been added to the list, and Brucella spp. have been removed. The MTLSB will continue to confirm Brucella spp. as long as the reagents are available. Bacillus anthracis, Burkholderia mallei, Burkholderia pseudomallei, Francisella tularensis, and Yersinia pestis remain on the list.

• Please don't hesitate to contact the MTLSB with any questions regarding possible Select Agents and their rule-out testing. The laboratory 24/7 number is 800-821-7284. In addition, MTPHL staff will happily assist with regulatory form filings after notification of confirmed select agents. For more information on select agents and/or rule-out testing, call our Laboratory Preparedness Specialist, Kim Newman, at 406-444-3068.