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Page 12 of Attachment H 
Authority of OSHA and FDA 
It is my feeling that the RAC, in its certification of an experiment 
as being free of harmful gene sequence and recommending a level of physical 
containment, has rendered an adequate judgment on safety. As we move to 
pilot plant and commercial scale fermentation of these organisms, I believe 
existing agencies represented on this subcommittee already have adequate 
authority to monitor any additional problems, if they arise. Moreover, it 
is my impression that they are already functioning. Lilly's effort in 
recombinant technology, for example, has already been inspected by a 
subcoirmittee of the RAC, a four-member NIOSH group, including Mr. Pauker, 
and a two-member group from the FDA. A report of the RAC inspection is 
attached. 
j 
i 
OSHA has adequate authority under the Occupational Safety and Health Act 
of 1970, to inspect industrial facilities and conduct investigations 
relating to worker safety. Further, OSHA has promulgated standards for 
safe industrial practices. 
Additionally, the FDA will approve for safety and efficacy any 
pharmaceutical product which results from recombinant DNA research. 
Consequently, both the pharmaceutical manufacturer and its products are 
extensively regulated. 
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