concerned agencies should meet to review the basis for accepting, rejecting, or 
postponing action on RAC recommendations. Consensus on acceptance of a RAC 
recommendation would be tacit approval or certification to be publicly announced 
by the Office of Recombinant DNA (ORDA). Similarly, the reasons for 
postponement of action or rejection of RAC recommendations should be announced 
by ORDA as soon as possible. This suggestion has three advantages over the 
approval and certification procedures of RAC recommendations described in the 
proposed revised guidelines: 1) Each agency can fulfill its own responsibilities 
while N1H coordinates the evolution of a single set of standards, criteria and 
principles for guiding recombinant DNA research in the U.S.; (2) Implementation of 
RAC recommendations will be accomplished in a timely and orderly manner; and (3) 
Scientific considerations will be clearly separated from other considerations. 
Specific matters that any agency wished RAC to consider can be directed to the 
committee via ORDA. 
As you know, NSF accepts Sections I, II, and III of the current guidelines but has 
developed its own Section IV, substituting NSF roles and responsibilities for those 
of NIH. In the proposed revised guidelines, the roles and responsibilities ascribed to 
NIH are found in all of the sections in the documents under review. Presentation of 
the proposed guidelines in this manner does not permit other agencies to adopt the 
revisions for their purposes simply, and would inevitably lead to confusion when 
NSF-supported researchers and IBC's try to distinguish NSF and NIH requirements 
and procedures. We urge that every effort be made to avoid this confusion. 
The NSF endorses the proposal to enhance IBC power by including approval of 
Memoranda of Understanding and Agreement (MUA) and lowering of containment in 
specified instances. Granting agencies will review IBC approval actions, but will 
not review decisions of disapproval or decisions of nonaction, i.e., postponements. 
Since it is possible that some committees may have misconceptions about some 
parts of the guidelines, researchers should have recourse to alternative decision 
processes. Accordingly, we recommend provision for the establishment of a formal 
appeals mechanism so that contested decisions may be presented to RAC for 
arbitration. 
Other specific potential problem areas we wish to call to your attention are the 
following: 
I-C General applicability - We support the principles of compliance with uniform 
national guidelines, but it is not clear by what authority these guidelines can be 
made applicable in certain institutions to recombinant DNA research not supported 
by Federal funds. Conversely is it intended to exclude federally supported research 
not carried out at or affiliated with such institutions such as small businesses? 
Ill- A-3-b— ( 1 ) Characterized Clones - Is it intended that IBC's will notify ORDA of 
the approval of lower containment rather than the agency supporting the research? 
With regard to the exceptions, is it intended that prior NIH approval is required for 
projects supported by agencies other than NIH? 
III-C Experiments with eukaryotic host vectors - What role in evaluating new 
case-by-case situations will the supporting agency play for research not supported 
by NIH? 
[A-395] 
