30 
"EPA recognizes that, as biotechnology moves out of the laboratory and 
into commercial phases, the role of... federal agencies [other than NIH] 
will become increasingly important. . . . However, there are several 
jurisdictional, statutory, and organizational issues which need to be 
resolved before EPA can fully assume its responsibilities.... EPA 
urges the RAC to continue in its current role until a clear delineation 
of responsibilities can be developed." 
Dr. Mazza said Congress clearly stated that under TSCA, EPA must respect the 
confidentiality of proprietary information. Dr. Mazza did not anticipate 
that agencies such as EPA would hold open deliberations in reviewing proposals 
from industry. 
Dr. Gottesman said there is no perfect solution, and RAC will never have 
exactly the expertise which would please everyone. A group which one 
individual might consider expert for environmental concerns might be con- 
sidered less than expert in molecular biology. Dr. Gottesman thought 
fragmentation of issues and responsibilities into several organizations 
would create problems. 
Dr. Gottesman thought a major virtue of RAC and the NIH Guidelines has been 
flexibility. She recalled to the committee that the original 1976 Guidelines 
had been inflexible. However, the technology rapidly overcame the Guidelines. 
The NIH in a long revision process subsequently produced Guidelines in 1978 
which had a built-in process for their further modification. These Guidelines 
have worked well; they have been modified frequently based on the evolution 
of the technology. Regulations would not have this degree of flexibility. 
Dr. Gottesman said she would not wish to see RAC shirk oversight responsi- 
bilities in spite of the fact that these responsibilities are uncomfortable. 
She felt particularly uncomfortable with sessions closed to the public, but 
she also felt the voluntary compliance program was an important aspect of 
RAC's function. In summary, she felt RAC should for the moment continue to 
oversee all of the types of experiments involving recombinant ENA. She did 
not see this approach interferring with the activities of the regulatory 
agencies . 
Dr. McKinney said RAC has been deliberative, balanced, flexible, responsive, 
and conservative. He felt RAC could provide sound scientific guidance to 
the biomedical, agricultural, and environmental communities. 
Dr. Friedman argued that although NIH's primary mission is biomedical 
research, its primary responsibility is to the public. As no other agencies 
are prepared at the moment to assume responsibility in the recombinant DNA 
area, NIH should continue to provide a public forum. He said the proper 
interaction between NIH and other agencies will be clarified as these 
agencies assume their responsibilities. Dr. Friedman said RAC and NIH 
possess a body of experience and information which is currently unmatched. 
In addition, RAC and NIH have a degree of flexibility that cannot exist in 
regulatory agencies. 
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