Dr. William J. Gartland, Jr. 
National Institutes of Health 
February 1 , 1984 
Page Two 
RAC's careful oversight of rDNA activities has to date made an 
invaluable contribution to the orderly development of this rapidly changing 
science and technology. From initially stringent controls over laboratory 
experimentation, the NIH Guidelines have been modified as knowledge and 
understanding of risks improved so that today most laboratory experiments 
are carried out with less formal review. Physical containment guidelines 
covering large-scale work have been formally incorporated. The confidence 
which RAC and its involvment have commanded has greatly facilitated a sta- 
bility in rDNA development that clearly promises future scientific growth 
as well as a favorable climate for commercial expression. We believe that 
NIH's general approach has been commendable, and should not be altered at 
this time. 
RAC deserves a substantial measure of credit for today's public 
confidence in rDNA technology. The NIH Guidelines have satisfied many 
states and localities, minimizing restrictive and inconsistent local legis- 
lation. Areas which have adopted formal ordinances have based these on the 
NIH Guidelines, encouraging desirable consistency. 
Over time, RAC's scientific advisory role has changed. Much of the 
oversight of laboratory and large-scale work is now carried out by Institu- 
tional Biosafety Committees or RAC working groups. Although industry has 
voluntarily accepted the Guideline responsibilities, it should be pointed 
out that not all of the responsibility concerning rDNA technology rests 
with NIH. Other agencies have been exercising oversight and this trend 
appears to be growing. For example, FDA has just circulated for comment a 
draft document concerning production of drugs and biologicals by rDNA tech- 
nology. EPA is currently examining how it can effectively regulate organ- 
isms destined for environmental release. The work of these and other 
agencies will insure adequate oversight of the commercialization of this 
technology , and the EPA efforts in the long term should reduce the burden on 
RAC to review the kinds of proposals which appear to have prompted this 
reconsideration. For the time being, however, even the work of formal regu- 
latory bodies is reliant on RAC's scientific expertise and experience. 
These agencies would not likely be helped in developing their own oversight 
programs by any abrupt change in the role of NIH and RAC. 
RAC's withdrawal of oversight for proposals to field test organisms 
constructed by rDNA techniques would, however, send out very undesirable 
signals. Regulatory agencies which have looked to RAC's scientific expert- 
ise might not be prepared to fill the interim gap which would be created. 
Both USDA and EPA have repeatedly pointed to the valuable role RAC plays, 
without suggestion that its current approach is inappropriate or unwanted. 
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