121.13—Restricted experiments. 10
Code of Federal Regulations
Footnote(s): 10 For guidance, see the NIH publication, “NIH Guidelines for Research Involving Recombinant DNA Molecules.” This document is available on the Internet at http://www.aphis.usda.gov/programs/ag_selectagent/index.html.
(a)
An individual or entity may not conduct a restricted experiment with a VS select agent or toxin unless approved by and conducted in accordance with any conditions prescribed by the Administrator. In addition, an individual or entity may not conduct a restricted experiment with an overlap select agent or toxin unless approved by and conducted in accordance with any conditions prescribed by the Administrator and the HHS Secretary.
(b) Restricted experiments:
(1)
Experiments utilizing recombinant DNA that involve the deliberate transfer of a drug resistance trait to select agents that are not known to acquire the trait naturally, if such acquisition could compromise the use of the drug to control disease agents in humans, veterinary medicine, or agriculture.
(2)
Experiments involving the deliberate formation of recombinant DNA containing genes for the biosynthesis of toxins lethal for vertebrates at an LD50 <100 ng/kg body weight.
(c)
The Administrator may revoke approval to conduct any of the experiments in paragraph (b) 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.
(d)
To apply for approval to conduct any of the experiments in paragraph (b) 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.