Select Agents and Toxins Exclusions
The select agent regulations (7 CFR Part 331, 9 CFR Part 121, and 42 CFR Part 73) established a procedure by which an attenuated strain of a select biological agent or toxin that does not pose a severe threat to public health and safety, animal health, or animal products may be excluded from the requirements of the select agent regulations.
Excluded Strains of HHS and USDA Select Agents and Toxins
Based upon consultations with subject matter experts and a review of relevant published studies and information provided by the entities requesting the exclusions, the Federal Select Agent Program has determined that the following attenuated select agent strains or less toxic select toxins are not subject to the requirements of the select agent regulations.
An excluded select agent strain or modified toxin will be subject to the regulations if there is a reintroduction of factor(s) associated with virulence, toxic activity, or other manipulations that modify the attenuation such that virulence or toxic activity is restored or enhanced. In addition, excluded select agent strains or modified toxins are not exempt from the requirements of other applicable regulations or guidelines (e.g., NIH guidelines, USDA/APHIS permits, etc.).
- Coxiella burnetii
- Eastern Equine Encephalitis virus
- Ebola virus
- Francisella tularensis
- Junin virus
- Lassa fever virus
- Monkeypox virus
- Yersinia pestis
- Bacillus anthracis
- Brucella abortus
- Brucella melitensis
- Burkholderia mallei
- Burkholderia pseudomallei
- Rift Valley Fever Virus
- Venezuelan Equine Encephalitis virus
- Avian influenza virus (low pathogenic)
- Avian influenza virus (highly pathogenic)
- Foot-and-mouth disease virus