Environmental 
Defense 
Fund 
1525 18th Street, NW, Washington, D.C. 20036 • 202/833-1484 
January 3, 1978 
Donald Fredrickson, M.D. 
Director 
National Institutes of Health 
Building One 
Bethesda, MD 20014 
Dear Dr. Fredrickson: 
I enjoyed the opportunity to testify before the Advisory 
Committee and feel we have made some progress in addressing the 
failures of the proposed revised guidelines. 
I cannot stress enough the need to realize that problems 
of procedure, access and credibility are central to the dis- 
cussion of NIH regulation of recombinant DNA research and 
product development. The public rightfully perceives that 
regulation is a public policy decision to be made by repre- 
sentatives of the public interest and not a scientific deci- 
sion to be made by representatives of special interests. 
Only when policy makers, in this case NIH through the recombi- 
nant DNA advisory committee, are free of real or perceived 
conflicts of interests will their decisions be accepted by the 
public. In the long run, bringing the public into the decision 
making process will strengthen the public's trust in science 
and insure science's continued support. Similarly, if pro- 
tection of the public health or safety demands regulation or 
"guidelines", these regulations must be constructed in such a 
way as to enable enforcement. The roles and responsibilities 
section of the guidelines and the administrative procedures 
for its implementation do not insure compliance. 
Many of the specific points that I think need attention 
were described in my testimony, which I imagine will be avail- 
able for your inspection in transcript form. I would just 
like to briefly mention a few of them here: 
1. The need for a detailed criteria document to serve 
as factual basis for the experimental guidelines section of the 
guidelines. As presently written, neither the guidelines nor 
the accompanying background booklets give adequate rationale for 
the containment requirements for each particular experiment. 
2. Citizen membership on the DNA Advisory Committee. The 
setting of acceptable risk levels should not be entrusted to a 
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