February 1, 1982 
Dear RAC Member, 
As many of you know, I have been involved with the revision of the NIH 
guidelines as a member of RAC, advisor to RAC, and chairman of the working 
group on revision of the guidelines. I oppose the RAC proposal, as published 
in the Federal Register (Dec. 4, 1981), and have submitted at alternate 
proposal (Federal Register, Dec. 7, 1981, item #7). I am writing to you 
now to explain my reasons for submitting this proposal and to ask you to 
seriously consider my alternative at the February RAC meeting. 
My proposal contrasts with the RAC proposal in two major ways: (1) It 
retains IBCs and the non-voluntary nature of the guidelines and (2) It keeps 
containment levels somewhat higher than those proposed by RAC, and is more 
specific about what the containment levels for given experiments should be. 
My proposal, in common with the RAC proposal, does lower containment and 
procedures significantly from those found in the current guidelines, and simplifies 
the many categories in the current guidelines. 
Why keep the IBCs and mandatory guidelines? In my mind, the relevant 
question at this stage is "Are there scientific grounds for continuing some 
control over the recombinant DNA field?" If, in fact, we believe that there 
is nothing about recombinant DNA experimentation which requires watching, 
the IBCs and mandatory adherance to guidelines become unnecessary. After a 
careful study of the issues ( summarized in the document "Evaluation of the 
Risks Associated with Recombinant DNA Research" , Federal Register, Dec. 4, 1981, 
page 39385...), my own conclusion is that one cannot totally discount the possible 
risks. Apparently, most of the RAC agrees with me that experiments Involving 
the cloning of toxin genes or indiscriminate rearrangements of antibiotic 
resistance genes should not be done without careful consideration and 
oversight, since even the RAC proposal admonishes people not to do these 
experiments . 
Experiments which involve non-defective animal virus recombinants also 
cause concern. We do not yet understand enough about the biology of these 
viruses to always predict what determines host range and virulence. Currently, 
such animal virus recombinant DNA experiments are dealt with by NIH on a 
case-by-case basis, and then referred back to the IBCs for continuing oversight. 
My proposal suggests more general levels of containment, which would eliminate 
the need for investigators to come to NIH with their requests. 
For these classes of experiments, and some others where we have little 
previous experience to guide our expectations, I believe that some expert group 
other than the principal investigator should be involved in assuring that 
appropriate procedures and containment practices are used. For the moment, 
at least, the IBCs seem to serve that role well. In addition, if there is 
a need for oversight, it seems quite fippropriate that government-funded 
research should be expected to use the oversight mechanism, and that we make 
that expectation explicit. I have heard many discussions about the likelihood 
of IBCs remaining intact if the guidelines became voluntary; if we are agreed 
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