2 
The Locus of Regulation 
The Committee agreed unanimously that the regulatory authority for 
recombinant DNA research should reside in DHEW. Dr. Richardson, Center 
for Disease Control, informed the Committee that the Center would consider 
assuming this regulatory function in the Department in light of its respon- 
sibility for regulating clinical laboratories. Dr. Koslov, Department of 
Defense, noted that the FDA will have responsibilities when the use of 
recombinant DNA molecules enters into a production process for new drugs, 
for example. Dr. Fredrickson explained that the suggested legislation would 
grant the Secretary the discretion to determine when the regulatory function 
should pass from one agency to another so that a duplicative regulatory 
process will not be created in the original regulatory agency as the activity 
passed through the stages of research, pilot production, and manufacture. 
The Committee agreed that the Secretary must have the authority for regulation 
of research, pilot production and manufacture but that he should consult with 
appropriate regulatory bodies and should defer to a regulatory body he deter- 
mines is better empowered and equipped to deal with it. 
Definitions 
The Committee agreed that the definition of recombinant DNA molecules for 
purposes of legislation be that found in the NIH Guidelines. Dr. Fredrickson 
noted that this definition may be changed by the Recombinant DNA Molecule 
Program Advisory Committee, after public and scientific review and with 
the approval of the Secretary. 
Dr. Lewis, USDA, then requested clarification of whether the language 
"health and environment" in the suggested legislation includes plant and 
animal life. Dr. Fredrickson assured him that it does. 
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