3 
coordinating Federal research and have considerably improved interagency 
communications. 
Application of the Revised Guidelines to Private-Sector Research 
Dr. Fredrickson opened the discussion by citing the memorandum that 
Secretary Joseph A. Califano, upon the release of the revised Guidelines 
in December, had sent to Donald Kennedy, Commissioner of Food and Drugs, 
directing him to propose that all recombinant DNA research submitted to 
the Food and Drug Administration comply with the NIH Guidelines in order 
to meet regulatory requirements. In response, the FDA published a notice 
of intent to propose regulations for this purpose. The Secretary also 
sent letters to Administrator Douglas M. Costle, Environmental Protection 
Agency, in December 1978, to Secretary of Agriculture Bob Bergland in 
February 1979, and to Secretary of Labor Ray Marshall in July 1979, 
asking them to consider how their regulatory authorities might be used 
to require that recombinant DNA research conducted in the private sector 
comply with the NIH Guidelines. (See letters. Attachment D. ) 
Dr. Fredrickson asked agency representatives to comment on the 
letters. Dr. Rosa Gryder of FDA reported that the agency had received 
13 letters commenting on the notice. In general, the Pharmaceutical 
Manufacturers Association and other private-sector respondents chal- 
lenged FDA's authority to propose such regulations. Dr. Hugo Graumann 
of Agriculture, citing Secretary Bergland 1 s reply to Secretary Califano 
(Attachment D), reported that Agriculture has a regulatory authority 
under certain circumstances but sees no present need to invoke it. 
Dr. Murray from the Environmental Protection Agency noted that EPA has 
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