Dr. Donald Fredrickson 
page two 
secret those it fears are more controversial. In areas of 
toxic chemical regulation, industry has systematically failed 
to report significant health risks to the appropriate regulatory 
authority. This failure has prompted introduction of legisla- 
tion establishing criminal penalties for failing to report 
potential significant health hazards. 
On the basis of its experience in toxic chemical regu- 
lation, EDF is firmly convinced that voluntary compliance pro- 
grams have never worked and never will. The burden of proof 
is clearly on the proponents of such programs to demonstrate 
how this case will be any different from the many that have 
gone before. To ask that industry first be given time to 
implement a voluntary program before mandatory controls are 
deemed necessary is to be blind to the regulatory history of 
the past decade. 
EDF does not believe that NIH refusal to approve industrial 
experiments will in any way delay the development of beneficial 
recombinant DNA products. If industry feels it needs NIH 
approval in order to proceed, let it forcefully make that case 
to Congress. 
For these reasons EDF opposes NIH approval of industrial 
recombinant DNA research and development projects. If NIH 
feels that industry should comply with the guidelines, we 
urge NIH to make these feelings known to the press and to 
Congress and to use every means at its disposal to press for 
a legislative broadening of its authority. As you are aware, 
RAC did vote at its last meeting to recommend mandatory 
industry compliance. 
EDF also objects to any consideration by RAC of exceptions 
to the large volume prohibition on a case-by-case basis before 
adequate procedural mechanisms for such review are in place. 
RAC is currently debating such provisions, and no individual 
requests for exceptions should be approved outside of whatever 
review mechanism is established. 
EDF does support NIH guidelines for membership on IBC's 
not presently covered by the guidelines. Again we do not see 
the need for NIH approval. Interested citizens and companies, 
armed with the NIH guidelines, can make these determinations 
themselves. We do suggest that the guidelines for industry 
IBC membership be changed from those proposed in 44 Federal 
Register 45868. At the very least, two worker representatives 
should be mandated. It is the workers who are potentially 
at the highest risk for recombinant DNA related health effects. 
They should have a voice in reviewing such proposals. We 
further suggest that the number of non-af filiated members be 
raised to three. We feel that this increase is required to 
overcome the greater insularity and secrecy of industrial 
versus academic institutions. 
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