10.6 Exclusions

Select agents or toxins that are excluded from regulation include:

  • Those agents or toxins that are in their naturally occurring environment, provided that it has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source.
  • Non-viable select agent organisms or non-functional toxins.
  • Certain attenuated and vaccine strains of select agents and toxins.  Please check the following link for the Notification of Excluded Attenuated Strains
  • Certain toxins, under the control of an investigator, if the aggregate amount does not at any time exceed a pre-defined amount.  Please check the following link for the Maximum Toxin Amounts Excluded from Regulation. 

For more information on select agents and toxins which are excluded, please see sections 42CFR73.3 through 42CFR73.6 of the regulations.