Information for Clinical/Diagnostic Laboratories, Healthcare Facilities, and Other Entities Not Registered with the Federal Select Agent Program

The Federal Select Agent Program (FSAP) is jointly comprised of the U.S. Department of Health and Human Services (HHS)/Centers for Disease Control and Prevention (CDC)/Division of Regulatory Science and Compliance (DSRC), and the U.S. Department of Agriculture (USDA)/Animal and Plant Health Inspection Service (APHIS)/Division of Agricultural Select Agents and Toxins (DASAT). FSAP oversees the possession, use, and transfer of select agents and toxins — which pose a threat to public, animal or plant health – as outlined in the select agent and toxin regulations (7 CFR Part 331, 9 CFR Part 121, 42 CFR Part 73).

The following summarizes key information that may be of help to clinical/diagnostic laboratories and healthcare facilities that are not registered with FSAP but may encounter select agents or toxins during the course of their daily work.

Diagnostic Specimen Exemption

The regulations provide that, unless otherwise directed, clinical or diagnostic laboratories or other entities that possess, use, or transfer a select agent or toxin contained in a specimen presented for diagnosis or verification are exempt from the requirements of the regulations for such agent or toxin if the entity:

1. Reports the identification of the select agent or toxin to FSAP and other authorities as required by law (see table at the bottom of the page for additional information about the timeline for reporting);
2. Secures the select agent or toxin against theft, loss, or release after identification;
3. Transfers or destroys the material, in accordance with the regulations; and
4. Maintains a copy of the APHIS/CDC Form 4, Report of the Identification of a Select Agent or Toxin, for a period of three years.

This exemption would apply to clinical or diagnostic specimens collected by a healthcare facility from a patient infected with a select agent or toxin if the exemption requirements described above are met.

See 7 CFR 331.5 – 331.6, 9 CFR 121.5 – 121.6, and 42 CFR 73.5-73.6.

Medical Waste Exclusion

Waste that is generated during the delivery of patient care by health care professionals from a patient diagnosed with an illness or condition associated with a select agent is excluded from the select agent and toxin regulations when the waste is decontaminated or transferred for destruction by complying with state and Federal regulations within seven calendar days of the conclusion of patient care (see 7 CFR 331.3(d)(8), 9 CFR 121.3(d)(8), 9 CFR 121.4(d)(8), 42 CFR 73.3(d)(11), and 42 CFR 73.4(d)(8)).

Reporting Requirements

Reporting Requirements

All entities, including non-FSAP registered clinical or diagnostic laboratories and healthcare facilities, must comply with the following requirements:

• Report the Identification of a Select Agent or Toxin: An APHIS/CDC Form 4, Report of the Identification of a Select Agent or Toxin, must be submitted to notify FSAP 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 (7 CFR 331.5 – 331.6, 9 CFR 121.5 – 121.6, and 42 CFR 73.5-73.6). More specific information about the select agent and toxin identification reporting requirements is provided in the tables below.
• Request To Transfer a Select Agent or Toxin: An APHIS/CDC Form 2, Request to Transfer Select Agents and Toxins, must be submitted to and approved by FSAP prior to transferring select agent(s) or toxin(s) (7 CFR 331.16, 9 CFR 121.16, and 42 CFR 73.16).
• Report the Theft, Loss, or Release of a Select Agent or Toxin: The discovery of a theft (unauthorized taking), loss (failure to account for), or a release (causing an occupational exposure or release of an agent or toxin outside of the primary barriers of the biocontainment area) of a select agent or toxin must be immediately reported to FSAP by phone, fax, or email, and a completed APHIS/CDC Form 3, Report of a Release/Loss/Theft, must be submitted to FSAP within seven calendar days (7 CFR 331.19, 9 CFR 121.19, and 42 CFR 73.19).

Select Agent and Toxin Exclusions

An attenuated strain of a select agent or a select toxin modified to be less potent or toxic may be excluded from the regulatory requirements based upon a determination by the HHS and/or USDA Secretaries that the attenuated strain or modified toxin does not pose a severe threat to public health and safety (42 CFR 73.3(e); 42 CFR 73.4(e); 7 CFR 331.3(e); 9 CFR 121.3(e); 9 CFR 121.4(e)). A list of excluded select agents and toxins can be found here.

Reporting the Identification of a Select Agent or Toxin

To report the identification of a select agent or toxin, or if you have questions or comments regarding reporting requirements, please contact FSAP at the following:

Additional Resources

• Select Agent Regulations
• Full List of Regulated Select Agents and Toxins
• APHIS/CDC Form 2: Request to Transfer Select Agents and Toxins: Frequently Asked Questions
• APHIS/CDC Form 3: Report of a Release/Loss/Theft: Frequently Asked Questions
• APHIS/CDC Form 4: Report of the Identification of a Select Agent or Toxin: Frequently Asked Questions
• Outbreaks: Frequently Asked Questions
• Guidance on the Transfer of Select Agents and Toxins: Packaging and Labeling