[Code of Federal Regulations]
[Title 42, Volume 1]
[Revised as of October 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR73.13]
[Page 449]
TITLE 42--PUBLIC HEALTH
CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 73_SELECT AGENTS AND TOXINS--Table of Contents
Sec. 73.13 Restricted experiments.
(a) An individual or entity may not conduct a restricted experiment
with a HHS select agent or toxin unless approved by and conducted in
accordance with any conditions prescribed by the HHS Secretary. 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 HHS
Secretary, after consultation with Administrator.
(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 select toxins lethal for
vertebrates at an LD50 < 100 ng/kg body weight.
(c) The HHS Secretary 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 (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.