organisms can affect their impacts on ecological systems, and what was being discussed were things that have the 
potential to produce quantitative changes. 
Mr. Norse said he agreed with Dr. Miller in one sense, and that is what that RAC does is very important in setting 
precedents for what other organizations do in this field. He voiced concern that if RAC makes this decision, there will 
be pressure for other agencies to follow along. He stated that relaxation of the NTH Guidelines in the case of laboratory 
experiments was "empirical;" as it was discovered problems did not exist, the NIH Guidelines were relaxed However, 
he said that we haven't had those precedents as far as environmental releases of organisms, particularly microorganisms, 
are concerned. Until we get such a body of information, it is premature to make the kind of proposal that Dr. 
Gottesman is making now, which may be entirely appropriate a year or two from now. 
Dr. Pirone said there is no question that genetic changes can result in changes in host range and pathogenicity, but that 
is not the issue. He stated he supported Dr. Gottesman 's proposal as an eminently logical and scientifically sound 
approach because it will exempt events that can and do occur naturally. If Dr. Gottesman's proposal were rejected, an 
"absurd logical" conclusion could be that we should go out into the environment, collect a wide range of naturally 
occurring biotypes of organisms, determine whether they have adverse effects on the environment, and then attempt to 
ban them from nature. 
Dr. Sharpies stated that she did not believe that rejecting Dr. Gottesman's proposal would undermine the RAC's 
scientific credibility since these were the very NIH Guidelines that contributed to the RACs scientific credibility. She 
said that the RAC should also be concerned about its credibility with the lay public, and the public's perception of 
whether this technology is being dealt with safely and responsibly. She was concerned that if this proposal is accepted, 
then certain research applications will go without any review by any agency, and that would not be appropriate. 
Mr. Mitchell mentioned a letter from Dr. John Moore of the EPA (tab 1281). This letter states that EPA is forming a 
Biotechnology Science Advisory Committee (BSAQ and requests that the RAC "consider postponing making a 
recommendation to the Director of the NIH concerning changes in the NIH Guidelines which would affect oversight of 
deliberate releases of microorganisms to the environment," and that "the RAC and the BSAC coordinate their efforts on 
the very difficult technical problems in the area of environmental release." 
Dr. Gottesman stated that the concerns of the EPA were somewhat different from those of the RAC; what the RAC 
recommends does not preclude EPA from doing what it wants. It is important that RAC vote on the proposal. She 
reminded the RAC that it is a body which is advisory to the Director of NIH, and that any recommendations made by 
the RAC on this proposal would be just that and would not constitute final action. She said that the amendment does 
not state that deletions have no effects on organisms and that therefore no one needs to review them, but it is simply 
saying that the NIH Guidelines should not make a special case of deliberate release into the environment of organisms 
which contain deletions merely because these deletions were accomplished by means of recombinant DNA technology. 
Dr. Johnson agreed with Dr. Gottesman. He stated that the RAC is advisory to the Director of NTH, and that it is his 
prerogative then to coordinate with the EPA. Therefore, the RAC should proceed to make a recommendation to the 
NIH Director without awaiting any direction from the EPA. Dr. Clowes agreed that the RAC should take a position 
concerning this amendment so that other committees can have the advantage of knowing the RAC's arguments and the 
outcome of its deliberations. 
Dr. Neiman stated that the deletion of the long arm of chromosome 6 of man, which occurs naturally, is associated with 
the activation of an oncogene which results in a high risk of T-cell lymphomas in individuals who inherit this trait. He 
asked Dr. Gottesman if a clinical experiment containing such a deletion would no longer be reviewed by the RAC under 
the proposed amendment She explained that the proposal covers release into the environment only and does not in any 
way change the NIH Guidelines in regard to recombinant DNA or DNA made from recombinant DNA used in human 
gene therapy. 
Dr. Davis stated that, although he felt coordination w ith the EPA was desirable, RAC should act now. The Director of 
NIH could represent the RAC's position to the BSCC. Dr. Pramer made the suggestion that perhaps some members of 
the EPA BSAC could be invited to participate in future meetings of the RAC working groups. 
Dr. Walters then recommended, to avoid possible misinterpretation on the part of investigators who may look at 
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