29 
Dr. Tolin said the USDA bed discussed the four questions posed by 
Dr. Talbot in the January 5, 1984, Federal Register . She said the USDA 
position is that RAC and the NIH should continue to review requests for 
deliberate release. The Guidelines should not be strictly limited to bio- 
medical research. NIH should not restrict review to NIH funded proposals. 
All federally-funded as well as industrially-funded research should be 
reviewed by RAC ard the NIH. She said there is currently no other mechanism 
to conduct a review of these projects. If agencies other than RAC and the 
NIH review proposals, less information may be available to the public. 
She said USDA meetings are not open to the public. 
Dr. Tolin said USDA throu^i the years has supported NIH as the lead agency 
•in the area of recombinant ENA activities. USDA cooperates in this effort 
through interagency representatives and other activities, and USDA interests 
are considered. 
Dr. Miller of the FTA National Center for Drugs ard Biologies said EDA does 
not have an official position on vhether NIH should restrict review to 
biomedical issues $ but recognizes that RAC hats considered the questions 
competently and carefully and has used appropriate expert consultants well. 
RAC has a great deal of credibility even in nonbiamedical areas and has 
been very effective. In addition, RAC has the advantage of being insulated 
frcm political and other non- scientific perturbations. 
Dr. Miller said RAC's direction and guidance for industry has been invalu- 
able and in general has been extraordinarily competent and useful . RAC has 
provided industry with a framework for research and development; it has also 
been of value to EDA in determining the safety of work with recombinant ENA 
containing organisms. 
Dr. Miller said it isn't realistic to expect industry to interact usefully 
and effectively with RAC if RAC is unwilling or unable to consider propri- 
etary information in closed session. He said there cure long-standing prece- 
dents in other agencies, both regulatory and non-r egulatory , for considering 
confidential information; and RAC is best advised to contirue to do so. 
Dr. Lewis of the National Science Foundation (NSF) said NSF's mission is to 
safeguard the health of U.S. science. He said the tbtional Science Board 
has gone on record with other Federal agencies stating that NIH would be 
the lead agency in dealing with recombinant ENA issues. 
Dr. Mazza of the Office of Toxic Substances (OTS) of the E1PA said the EPA 
was beginning to explore its regulatory responsibilities in this area. He 
said many questions concerning EPA's role cure being raised; for example, 
vhat will be covered ty the statutes of the Toxic Substances Control Act 
(TSCA)? In this situation, OTS feels that RAC and the NIH should contirue 
their role at least until the other agencies determine what is their role. 
EPA, USDA, and NIH will discuss these issues so decisions will not be 
reached in a vacuum. Dr. M azza said EPA supports RAC's importance to the 
process. Esr. Mazza cited a February 3 letter from Don Clay, OTS Director, 
vhich states: 
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