V NGTO'N & BURLING 
Donald S. Fredrickson, M.D. 
February 20, 1976 
Page Nine 
First, and most obvious, amendments can be proposed to regulations, 
and can be expedited, on the basis of any new information which 
justifies a change in the existing regulations. This does take 
time, but it is not as difficult a procedure as many believe. 
Second, and perhaps more to the point, the regulations themselves 
can incorporate a procedure for the grant, by the NIH Advisory 
Committee, of variances from the regulations on either an ad hoc 
or a class basis. Two examples of variance procedures presently 
incorporated in Food and Drug Administration regulations may be 
found in 21 C.F.R. 10.5 (temporary permits to vary from a 
standard of identity for food) and 21 C.F.R. 1010.4 (variances 
from performance standards for electronic products) . Such variances 
permit instant flexibility, while at the same time preserving 
adequate public protection. Thus, publication of the guidelines 
as regulations need not in any way interfere with the flexibility 
that is necessary for the rapid advancement of science in this area. 
Adoption of these guidelines as regulations would, in my 
judgment, have a substantial beneficial impact. It is important 
to convince the public in general, and Congress in particular, 
of the legitimacy of the entire mechanism by which NIH and the 
scientific community are pursuing this matter. Subjecting the 
entire process to close public scrutiny through publication in 
the Federal Register would, I believe, accomplish this purpose, 
and perhaps alleviate many of the concerns which have been expressed 
about recombinant DNA molecule experimentation. 
IV 
Adoption of final NIH guidelines does not appear to me 
to end this matter. NIH guidelines, whether or not they are pub- 
lished and adopted in the Federal Register, are enforceable only 
through the NIH grant and contract mechanisms. The guidelines 
may also carry the force of moral suasion for the scientific 
community as a whole, but anyone who is not conducting recombinant 
DNA molecule experimentation with NIH funds would be under no 
legal obligation whatever to follow these guidelines. Thus, 
experimentation funded by charitable foundations, state and local 
agencies, public school systems, private educational institutions, 
industry, and any other private individuals or institutions, would 
be free to conduct whatever experimentation on recombinant DNA 
molecules it may conclude to pursue. 
I believe it extremely unlikely that Congress and the 
American public will be willing to rely solely on the moral suasion 
engendered by these guidelines, and the peer pressure that they 
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