August 16, 1979 
Dr. Donald Fredrickson 
Director 
National Institutes of Health 
Bethesda MD 20205 
RE: Proposed Supplement to the 
NIH Guidelines for Recombinant 
DNA Research; 44 Federal Register 
45868-69. 
Dear Dr. Fredrickson: 
While EDF agrees with NIH's desire to maximize voluntary 
compliance with the NIH recombinant DNA guidelines by experi- 
ments not now covered, EDF strongly opposes any procedure 
which results in NIH approval of such experiments. EDF does 
support RAC establishment of containment guidelines for ex- 
periments voluntarily brought to its attention and RAC 
certification of host-vector systems. 
EDF is concerned that, in the absence of statutory 
authority enabling NIH inspection and enforcement of industrial 
experiments and providing for stiff penalties for violations, 
approval is a meaningless exercise. Indeed, its only benefit 
is to the industrial sponsor, who is then free to proclaim 
that its experiments are safe and above public concern. From 
a political standpoint, we fear that a voluntary program, 
no matter how insufficient, will provide a public relations 
weapon to industry and an argument against mandatory controls. 
NIH is totally without authority to insure that approved 
experiments are actually carried out in compliance with the 
guidelines. When violations are uncovered, RAC members will 
be prohibited from speaking out due to the agencies' interpre- 
tation of 18'U.S.C. §1905. NIH has no recourse to administrative 
or judicial compliance orders, no matter how significant or 
imminent the potential risk to health and the environment. 
Unfortunately, publicity and other informal means will not 
insure compliance. NIH is unable to assure the public that all 
recombinant DNA research and development projects undertaken 
by industry will be reported to NIH. Indeed, it is likely 
that a company will gladly report those experiments it expects 
to easily meet likely containment requirements and keep totally 
[302] 
Environmental Defense Fund, 1525 18th Street NW, Washington, DC 20036 (202)833-1484 
OFFICES IN: NEW YORK, NY (NATIONAL HEADQUARTERS); WASHINGTON, DC; BERKELEY, CA; DENVER. CO 
I00°o RECYCLED PAPER 
