13 
Dr. Goldhammer said any attempt by the regulatory agencies to adopt the NIH 
Guidelines or to require industrial firms to abide by the NIH Guidelines in the 
laboratory stage of product development would create legal problems; changes in 
statutes or rules would be required. Dr. Goichammer suggested compliance with 
the NIH Guidelines is already being enforced on an ad hoc basis by insurance 
underwriters . 
Dr. Lardy asked vhether the agencies might indicate re/iew would be facilitated 
by adherence to the NIH Guidelines. Dr. Miller said the FDA. does make this 
policy statement but does not mandate or police industry activities. If a 
company were in technical violation of the NIH Guidelines but had attained the 
requisite safety in another way, FLA would be reluctant to prosecute. 
Dr. Levine asked vhether the December 31, 1984, Federal Register indicates 
EPA will attempt to modify its Toxic Substances Control Act (TSCA) statutes to 
regulate research and small-scale field testing of recombinant DNA organisms 
other than pesticides. Dr. Goldhammer felt this Federal Register indicated 
EPA will attenpt to modify its TSCA statutes to regulate field testing. He 
did not think EPA intends to regulate research in laboratories and greenhouses 
since TSCA as currently written gives EPA legal authority only in the commercial 
setting . Dr. Lardy said EPA may also be considering regulating the transfer 
of naturally occurring organises from one ecosystem to another under its TSCA 
statutes. Dr. David Glass of BioTechnica, Inc., suggested EPA intends to 
regulate agricultural releases under its TSCA statutes. 
Mr. Mitchell said seme academic research might irvolve field testing but no 
product. For example, a data base on factors influencing organism dissemination 
might be constructed through field testing . Would EPA statutes extend to this 
situation? Dr. Pirone thought authority would probably be delegated in this 
situation to the NSF; but the Decenber 31, 1984, Federal Register did not clearly 
indicate vhether NIH or NSF would be responsible. 
Dr. Lardy thought an effective oversight schane should permit investigators 
to easily ascertain the appropriate review body at each step in the testing 
procedure; this would facilitate the researcher's task. 
Dr. McGarrity questioned vhether RAC would continue to review laboratory research 
with potential agricultural applications; RAC would then have to maintain agri- 
cultural expertise. Dr. Gottesman thought the laboratory safety considerations 
for agricultural research would be similar to considerations for other applications 
since the basic genetic mechanisms are the same. She did not think RAC review 
of experiments with potential agricultural applications would present a problem. 
Mr. Mitchell said RAC had two primary concerns in evaluating the December 31, 
1984, Federal Register ; the quality of scientific reviews and the propriety 
of the proposed procedures. He wondered vhether the agencies would haw the 
necessary technical expertise to impianent this scheme. 
Dr. McKinney said pressures currently on NIH will be on the other agencies vhen 
this scheme is implemented . He said issues of particular concern are obtaining 
talented expertise and responding quickly. He noted that many individuals 
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