[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.