Select Agents in Diagnostic and Clinical Labs

Last Revised: February 21, 2018

Clinical or diagnostic laboratories possession, using or transferring select agents or toxins that are contained in specimens presented for diagnosis, verification or proficiency testing only are exempt from most of the requirements of the Select Agent regulations.

Pharmacies and clinical laboratories that contain any of the Select Agents and Toxins that are cleared, approved, licensed, or registered under any of the Acts listed below are exempt from the registration requirement:

  • Federal Food, Drug and Cosmetic Act
  • Section 531 of the Public Health Service Act
  • Virus-Serum-Toxin Act
  • Federal Insectide, Fungicide, and Rodenticide Act

 

There are different requirements for HHS Select Agents and Toxins and USDA Select Agents and Toxins encountered in clinical and diagnostic labs.

The following provisions are applicable to HHS Select Agents and Toxins and Overlap Select Agents and Toxins encountered in diagnostic and clinical laboratories.

  1. Upon the identification of the following select agents as a result of diagnosis or verification, the lab director must immediately contact EHRS:
    Variola major virus (Smallpox virus) and Variola minor (Alastrim), Bacillus anthracis, Yersinia pestis, Botulinum neurotoxins, Francisella tularensis, Ebola viruses, Marburg virus, Lassa fever virus, and South American Haemorrhagic Fever viruses (Junin, Machupo, Sabia, Flexal, Guanarito)
  2. After diagnosis or verification, the lab must transfer the specimens or isolates to a registered facility or destroy them on-site by an appropriate method within 7 days after identification (unless directed otherwise by the FBI or other law enforcement agency after consultation with the HHS Secretary). Select agents used for proficiency testing must be transferred or destroyed within 90 days after receipt.
  3. EHRS and the laboratory must complete a written record of the identification and transfer or destruction of the above listed specimens and isolates (CDC Form 4). The form must be submitted to HHS within 7 days after identification or 90 days after receipt for proficiency testing.
  4. If any other the above provisions are not followed, complete registration of the agent is required.

The following provisions are applicable to USDA Select Agents and Toxins and Overlap Agents and Toxins encountered in diagnostic and clinical laboratories:

  1. Upon the identification of any animal select agents as a result of diagnosis or verification, the lab director must immediately contact EHRS. EHRS will immediately report this identification to APHIS or CDC depending on the agent.
  2. After diagnosis or verification, the lab must transfer the specimens or isolates to a registered facility or destroy them on-site by an appropriate method within 7 days after identification (unless director otherwise by the FBI or other law enforcement agency after consultation with the HHS Secretary). Select agents used for proficiency testing must be transfered or destroyed within 90 days after receipt.
  3. EHRS and the laboratory must complete a written record of the identification and transfer or destruction of the above listed specimens and isolates (APHIS Form 4).
  4. The form must be submitted to APHIS within 7 days after identification or 90 days after receipt for proficiency testing.
  5. If any other the above provisions are not followed, complete registration of the agent is required.

An individual receiving diagnostic reagents and vaccines that are, bear, or contain listed agents or toxins, also knows as high consequence livestock pathogens or toxins, that are produced at USDA diagnostic facilities will be exempt from the requirements of this part.