Restricted Experiments Guidance: Definition of Restricted Experiments

Section 13 of the HHS and USDA select agent regulations contain the select agent and toxin “restricted experiment” provisions (42 CFR § 73.13external icon, 7 CFR § 331.13external icon, and 9 CFR § 121.13external icon):

1. An individual or entity may not conduct or possess products resulting from the following experiments unless approved by and conducted in accordance with the conditions prescribed by the HHS Secretary or APHIS Administrator:
   1. Experiments that involve the deliberate transfer of, or selection for, a drug (or chemical §331.13) 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.
   2. Experiments involving the deliberate formation of synthetic or recombinant DNA containing genes for the biosynthesis of select toxins lethal for vertebrates at an LD[50] < 100 ng/kg body weight. Note: Currently, only nucleic acids containing genes for the biosynthesis of Botulinum neurotoxin meet the definition of 42 CFR § 73.13(b)(2) (b)(2).
2. The HHS Secretary or APHIS Administrator may revoke approval to conduct any of the experiments in paragraph (a) of this section, or revoke or suspend a certificate of registration, if the individual or entity fails to comply with the requirements of this part.
3. To apply for approval to conduct any of the experiments in paragraph (a) of this section, an individual or entity must submit a written request and supporting scientific information. A written decision granting or denying the request will be issued.