Dr. William J. Gartland 
National Institutes of Health 
February 1, 1982 
Page 2 
throughout the world. During this period, the accumulated scientific 
evidence has contributed substantially to our understanding that recombinant 
DNA research is not in fact a hazard to the public ^’.alth or environment. 
Thus, while maintaining a reasonable degree of caution, and without deciding 
that the available evidence is conclusive, it makes sense today as a matter 
of public policy for government to focus on responsible ways to stimulate 
variety and innovation in recombinant DNA research and its applications. 
Identification and removal of unnecessary technical and economic impediments 
should receive a high priority. 
Secondly, we believe that at the present juncture of recombinant DNA's 
evolution, the formal institutional structure of the RAC and IBC is both 
valuable and desirable to advise scientists and industry in decision-making 
concerning a few remaining areas of uncertainty, to serve as a focal point 
for public monitoring of recombinant DNA's continuing development, and to 
consider further guideline revisions. We regard this support, notwithstand- 
ing that it imposes some restrictions, as currently more of an aid for well- 
managed technological growth than an impediment. 
We would note here that the guidelines' formulation and revision process 
has already produced substantial benefit. It has contributed to raising the 
level of sensitivity in the scientific and industrial communities to possible, 
particular hazards that might arise from biotechnology research and application 
— a clearly desirable societal result even if, as it now appears, no credible 
hazards peculiar to recombinant DNA have been found. It has also put into 
place a federal guidance system which, while amenable to improvement, pre- 
sently commands the confidence of the scientific community, since it allows 
guideline changes to occur as new evidence accumulates and safety-related 
judgments evolve; and also commands the confidence of the community beyond 
involved scientists, which can find comfort in an independent level of mon- 
itoring and review reflecting continued sensitivity to societal concerns. 
The existing system is thus balanced in a way that, on the evidence that 
is available to us today, should neither be cast in concrete, nor cast aside 
too abruptly. The combined proposal that we recommend takes a middle ground 
between the Gottesman and RAC approaches, and promotes stability in recom- 
binant DNA development. On the other hand, the Gottesman proposal, while 
recognizing the benefits of some continuing institutional guidance structure, 
is unduly conservative with respect to present expert scientific opinion. 
And the RAC proposal, while generally cogent with respect to scientific judg- 
ments, shows inadequate appreciation for the benefits of some continuing fed- 
eral guidance as well as for a course of more moderate change as accumulated 
experience validates those scientific judgments. 
We recommend consideration of a system that would modify the present 
guidelines with the following features: 
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