2e 
Dr. Friedman said the working group's primary concern is that research 
not be overregulated. Many members of the working group had a sense of 
de ja vu in reading the Federal Register proposed and thought the wheel was 
being reinvented. Ten years of experience have permitted RAC to answer 
many of the questions raised in the December 31, 1984, Federal Register . 
Dr. Friedman said many members of the working group were concerned that 
RAC's collective experience be maintained and used. 
Dr. Johnson said a clear contrast exists between the RAC system and the 
complexity of the proposed system. He felt the preposed system is redundant 
and will be inhibitory to the fragile U.S. lead in biotechology. 
Dr. Johnson also thought the Federal Register proposal was written from the 
perception that produces of biotechnology are "different” and that a dif- 
ferent set of rules have to be designed to regulate and evaluate them. He 
did not think biotechnology products differed from products produced by 
other processes. 
Dr. Jchnson said the December 31, 1984, document contains policy statements 
by the FDA, the USDA, and the EPA. The FDA and the US DA essentially state 
that they possess sufficient authority to regulate products on a case-by-case 
basis in their area of jurisdiction. The EPA on the other hand appears to 
be attempting to regulate research. Moreover, they claim jurisdiction 
over products designed by processes that have been completely unregulated 
for many years, e.g., cell fusion, undirected, and site-directed mutagenesis. 
The EPA, thus, raises the spectre of handling research proposals differently 
if the ultimate intent is to commercialize. This is "regulation by intent." 
Dr. Jchnson said the words "laboratory" and "experimental" should be defined 
and used consistently. 
Dr. Pi rone agreed and suggested the concept of laboratory be broadened to 
include all experimental protocols conducted in growth chambers, greenhouses, 
and perhaps even small-scale plots. Dr. Pircne said he was particularly 
concerned about hew basic research in plant and animal sciences would fare 
under the December 31, 1984, Federal Register proposal. The proposal is 
vague about the review process; and research in plant and animal sciences 
might be overseen by USDA, EPA, NIH, or the National Science Foundation 
(NSF) depending on the considered intent of the experiments. 
Dr. Walters said he had two primary concerns about the document published 
in the December 31, 1984, Federal Register . The first concern is a lack 
of emphasis on public discussion and debate at either the level of the 
scientific advisory committees or the oversight board. The Federal 
Register document does not contain a clear commitment to a public process. 
The second concern is that the document views too narrowly the mission of 
the advisory committees and the oversight board. In many cases, the 
advisory committees and the oversight board will be dealing with value 
judgments and not simply the gathering of scientific facts. Dr. Walters 
said these committees should possess not only the best scientific expertise 
available tut also expertise in disciplines such as political science, 
law, and ethics. 
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