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.).
Nontoxic HHS toxins, Section 73.3 (d)(2)
Botulinum neurotoxins
Conotoxins
Staphylococcal Enterotoxins (SE)
Excluded Toxins Modified to be Less Potent or Toxic, Section 73.3 (e)
Tetrodotoxin
Excluded Attenuated Strains of HHS Select Agents, Section 73.3 (e)
Botulinum neurotoxin producing species of
Clostridium
Coxiella burnetii
Eastern Equine Encephalitis virus
Ebola virus
Francisella tularensis
Junin virus
Lassa fever virus
Mpox virus
SARS-Coronavirus
Yersinia pestis
Excluded Attenuated Strains of Overlap Select Agents, Section 73.4 (e) and 121.4 (e)
Bacillus anthracis
Brucella abortus
Brucella melitensis
Burkholderia mallei
Burkholderia pseudomallei
Rift Valley Fever Virus
Venezuelan Equine Encephalitis virus
Attenuated Strains of USDA-only Select Agents Excluded, Section 121.3 (e)
African swine fever viruses
Avian influenza virus (low pathogenic)
Avian influenza virus (highly pathogenic)
Foot-and-mouth disease virus
Centers for Disease Control and Prevention
Division of Regulatory Science and Compliance
1600 Clifton Road, NE, Mailstop H21-4
Atlanta, GA 30329
Telephone:
404-718-2000
404-488-7100 (after hours)
Fax:
404-718-2096
Email:
[email protected]
Animal and Plant Health Inspection Service
Division of Agricultural Select Agents and Toxins
4700 River Road, Unit 2, Mailstop 22, Cubicle 1A07
Riverdale, MD 20737
Telephone:
301-851-2070
Fax:
301-734-3652
Email:
[email protected]
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