Changes and Highlights
This is a living document subject to ongoing improvement. Feedback or suggestions for improvement from entities registered with the Federal Select Agent Program, as well as the general public, are welcomed. Submit comments directly to the Federal Select Agent Program at:
- March 2017: Revised to accommodate the new regulations.
- April 2017: Revised to add further clarification that the new inactivation regulations do not pertain to select toxins, clarification on the level of surrogates that can be used for viruses, bacteria, and regulated nucleic acids, updates to the section dealing with validation, and updates to the section dealing with the inactivation certificate.
- June 2017: Revised for clarity and to update the certificate section to align with the regulatory interpretation.
- August 2017: Revised for clarity and to update links to other resources.
- September 2018: Added additional information about electronic/digital signature.
The United States Department of Health and Human Services (HHS) and the United States Department of Agriculture (USDA) have established regulatory requirements for the possession, use, and transfer of biological select agents and toxins (BSAT) that have the potential to pose a severe threat to public health and safety, animal and plant health, and animal and plant products. These requirements can be found at 42 CFR Part 73 (HHS), 7 CFR Part 331 (USDA-Plant Protection and Quarantine), and 9 CFR Part 121 (USDA-Veterinary Services). Collectively, they are referred to as the select agent regulations (SAR).
The following are excluded from the requirements of the SAR:
- A select agent or regulated nucleic acid (that can produce infectious forms of any select agent virus) that has been subjected to a validated inactivation procedure and confirmed through a viability testing protocol.
- A select toxin that has been rendered non-toxic.
This guidance does not apply to:
- Products that are, bear, or contain listed select agents or toxins that are cleared, approved, licensed, or registered under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.), section 351 of the Public Health Service Act pertaining to biological products (42 U.S.C. § 262), the Virus-Serum-Toxin Act (21 U.S.C. §§ 151-159), or the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) if their use meets the requirements of these laws. See 7 CFR § 331.5(c), 9 CFR §§ 121.5(c), 121.6(c), 42 CFR §§ 73.5(c), 73.6(c).
- Select agents and toxins excluded as an attenuated strain of a select agent or a select toxin modified to be less potent or toxic.  See 7 CFR §331.3(e), 9 CFR §§121.3(e), 121.4(e), 42 CFR §§73.3(e), 73.4(e).
- Decontamination for waste disposal. For more detailed information, see the Biosafety/Biocontainment Plan Guidance.
- Exempt clinical or diagnostic laboratories that possess or use a select agent or toxin that is contained in a specimen presented for diagnosis or verification. See 7 CFR §331.5(a), 9 CFR §§121.5(a), 121.6(a), 42 CFR §§73.5(a), 73.6(a).
See 7 CFR §331.3(d)(2); 9 CFR §121.3(d)(2) and 9 CFR §121.4(d)(2); 42 CFR §73.3(d)(2) and 42 CFR §73.4(d)(2) for more information.