31 
Reaister on the NIH, the NIH Guidelines, and the RAC. Mr. Mitchell sug- 
gested perhaps the working group might now review EPA's suggestions in 
greater detail and offer some response. 
Dr. Davis did not think it appropriate at this time for the RAC working 
group to comment further on the December 31, 1984, Federal Register . He 
suggested RAC await the Cabinet Council Working Group response to the 
comments received. 
IX. PROPOSED AMENDMENT OF PART III OF THE GUIDELINES 
Dr. Friedman said this proposal (tab 1205) had been submitted by Dr. Talbot. 
Dr. Friedman said Dr. Talbot noted that under the NIH Guidelines certain 
proposals are received by. NIH for review by RAC and subsequent NIH approval. 
Recently other Federal agencies have taken steps toward assuming new roles 
in review of recombinant ENA proposals. Because of these developments, 
proposals submitted to the NIH for RAC review may also be submitted to 
another agency for review. 
Dr. Friedman said Dr. Talbot suggested it would be advantageous for NIH to 
have the option of deferring to other Federal agencies. In order to give 
NIH this latitude. Dr. Talbot suggested a new sentence would be added at 
the end of Section III-A of the NIH Guidelines just before Section III-A-1 
as follows: 
"If experiments in this category are submitted for review to another 
Federal Agency, the submitter should notify ORDA; ORDA may then determine 
that such review serves the same purpose, and based on that determination, 
notify the submitter that no RAC review will take place, no NIH approval 
is necessary, and the experiment may proceed upon apprcval frcm the 
other Federal agency." 
Dr. Friedman said this proposal is an attempt to reduce paperwork. He 
supported Dr. Talbot's proposal. 
Dr. Johnson felt the proposal did not clearly distinguish between oversight 
of products and oversight of experiments. He said he had no problem with 
Dr. Talbot's proposed if the proposal relates to regulation of products. 
He thought, however, that a single review body for evaluation of scientific 
issues should be in place. 
Dr. Sag i nor asked whether Dr. Talbot’s proposal referred to the review 
system proposed in the December 31, 1984, Federal Register or to the current 
system. Dr. Talbot said his proposal refers to the current system. For 
example, under the current system the Lindow/Pancpoulos proposal involving 
the ice-minus bacteria was reviewed by both the NIH and the EPA. 
Dr. Mills questioned whether other agencies would perform a type of review 
equivalent to RAC review. If review systems equivalent to RAC’s exist. 
Dr. Mills said he would support Dr. Talbot’s proposal. 
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