5 
IV. PROPOSED REVISICN OF TOE GUIDELINES 
Mr. Ttomton called the attention of the RAC to the major topic of the 
F^ruary 8-9, 1982, meeting, a discussion of two proposals (tabs 1050, 1056A, 
1056B, 1056C/1, 1056C/7, 1056D, 1056E, 1056F, 1056G) to itodify the the 
current NIH Guidelines for Research Involving Recombinant DM^ Molecules. 
Mr. 'Ihomton said he would take a moment to give his personal perspective 
prior to resuming the role as committee chairman. He said former NIH 
Director, Donald Fredrickson, summarized the purposes of the Guidelines as 
(1) to establish a rapid, complete means of camunication, (2) to assure 
that the Guidelines are conservative yet allow research to proceed, and 
(3) to permit public participation in the formulation of public policy. 
Mr. Ihomton noted the difficulty of establishing and maintaining oommuii- 
cation between public policy decision makers and experts in a scientific 
field. NIH has devised a mechanism v*iich successfully maintains this 
coTinunication, and he would not wish to abandon it. 
Mr. Thornton then described the Guidelines from a lawyer's perspective. 
He noted that the Guidelines are not laws; he thought this is good since 
laws are difficult to formulate and difficult to change. Neither are 
they regulations; regulations are subject to formal revision procedures 
much more rigid than those RAC and the NIH follow in modifying the Guide- 
lines. Neither are the Guidelines simply statements of good practice. 
The RAC and the NIH have been responsive to change, not as quickly perhaps 
as some would have preferred, but quickly enough that the advance of science 
has not been significantly impeded. 
Mr. Thornton then recognized Dr. Baltimore who referred to the December 4, 
1981, proposal vhioh RAC had recommended for publication in the Federal 
Register (46 FR 59368). Dr. Baltimore said that the proposal had elicited 
tremendous response. He said that conversion to a voluntary code of 
standard practice, as described in the December 4, 1981, Federal Register , 
is appropriate. Although the current NIH Guidelines are not formal regu- 
lations, they have instituted an informal regulatory process. He expressed 
hope that the philosophy of voluntary compliance expressed in the December 4, 
1981, proposal would be aocepted. 
Dr. Baltimore suggested that some of the concerns expressed about the 
December 4, 1981, proposal by correspondents could be addressed and met 
by modifications. Some correspondents had expressed concern that the IBCs 
would be dismantled. Dr. Baltimore assumed that with the language of the 
December 4, 1981, proposal, the IBCs would remain in place. He said he had, 
however, prepared an amendment, v^ich might be added during the discussicxi, 
specifying a continuing role for IBCs. 
Dr. Baltimore said that in setting Pi containment conditions, the Decenber 
4, 1981, proposal implies there could not be deliberate release of recom- 
binant organisms into the environment. It is clear from the letters received 
in response to the proposal, hovever, that sane people would prefer an 
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