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been basic to the revised classifications and procedures. 
It must be recognized that the proposed revisions are a needed step in an 
evolving process. As scientific data continues to be gathered, improved tech- 
nical approaches should be considered and introduced, any problems encountered 
should impact our practices and the goal of safe, and efficient practices, 
clearly defined and well understood should remain before us. 
The revised guidelines are commended for their use of good data on normal 
defense mechanisms and the protection of individuals who are at risk because 
of impairments in their normal defense processes. 
While the revised guidelines recognize that Biological Safety Committees 
are involved in numerous important tasks other than recombinant DNA technology, 
there should be considerable caution in further demands on these committees 
which could distort their efforts out of proportion to the need to instruct, 
advise and assure the proper practice with known biological hazards. 
The guidelines are overly presumptive in mandating a lay representative 
on this particular committee when a University may already have lay overview 
at several levels, including Boards of Regents, Public Visitors Boards, 
University/Community Liaison Committees, etc. In contrast to Human Subjects 
Committees where broad concepts of social and ethical values are necessary 
input, the Biological Safety Committee is an expert committee which needs 
breadth in expertise but which should not be diverted from its responsibility 
of safety. 
Section IV. Roles and Responsibilities should be considered as a sec- 
tion to be evaluated in practice and discussed as a priority matter in 
subsequent revisions in the light of legislation and operational experience. 
Clearly, when an expert panel, such as the Recombinant DNA Advisory Committee, 
proposes exception to the guidelines, the Director should be authorized to 
approve or disapprove that exception. 
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