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3) Revisions of the Guidelines 
Much of the criticism of the guidelines has concerned NIH procedures 
for revising them. Time and again critics have charged that the Recombinant 
DNA Advisory Committee and the Director have relied on the opinions of a 
selected group of scientists rather than on experimental data in recommend- 
ing the relaxation of containment standards, that important data and 
judgments have not been published in time to permit broad scientific peer 
review, that standards for decisions on containment requirements are vague, 
and that NIH has been reluctant to give the public opportunity to review 
and comment on proposed changes. 
I believe that it is time to lay these criticisms to rest by clarifying 
the standards and specifying the procedures for changes in the guidelines. 
Otherwise, doubts will remain that the guidelines provide adequate pro- 
tection of public health and the environment. This is particularly 
important if, as the Federal Register documents imply, future revisions 
will be largely on a case-by-case basis, that is, by exempting specific 
categories of experiments from any regulation, by reclassifying experiments 
on the basis of new evidence, and by assigning containment levels to 
entirely new experiments. 
In each of these cases, the criteria for recommendations by the RAC 
and decisions by the Director should be consistent, clear, and where possible 
precisely stated. For example, exemptions should be made only on the 
grounds that the experiments pose no significant risks or at least no 
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