C. Restricted Experiments

An individual may not conduct or possess products resulting from a restricted experiment with a select agent or toxin unless approved by and conducted in accordance with any conditions prescribed by the HHS Secretary. 

Restricted experiments are:

  • Experiments that involve the deliberate transfer of,or selection for, a drug resistance trait to select agents that are not known to acquire the trait naturally, if such acquisition could compromise the control of disease agents in humans, veterinary medicine, or agriculture.
  • Experiments involving the deliberate formation of synthetic or recombinant DNA containing genes for the biosynthesis of select toxins lethal for vertebrates at an LD50<100 ng/kg body weight.

An individual must submit a written request and supporting scientific information to CDC to apply for approval to conduct or possess products from a restricted experiment. A written decision granting or denying the request will be issued from the HHS Secretary.