I am writing to you in regard to actions taken at the September 6-7 meeting of the NIH Recombinant DNA Advisory Committee
and Director Fredrickson's recommendations to lower safety standards by exempting some 85% of Recombinant DNA work from
the NIH Guidelines. I testified before Departmental officials a year ago on the proposed Guideline revisions and participated
in a subsequent meeting held with about 10 public interest representatives. I am a member of the IBC here at the University
of Washington, and was nominated for RAC membership by Senator Magnuson.
I am dismayed by the RAC proposals to exempt E. coli K12 host research from the Guidelines and permitting exemptions for the
10-liter limit on culture volume, and I urge you to reject these recommendations.
First of all, as I have stated on several occasions, proper science as well as proper regulatory practice would seem to require
that risk assessment activities be carried out prior to widespread experimentation and especially to widespread unregulated
experimentation. NIH has announced a proposed risk assessment program but has not instituted it yet, not to mention that
there are -- of course -- no results from such a program on which to base exemptions.
I am aware that certain studies funded by NIH may have some utility re: risk assessment; indeed, I have discussed these extensively
with Dr. John Nutter. But these studies are clearly not sufficient, and have already produced results which should lead us
to a more cautious and conservative regulatory approach -- e.g., that supposedly debilitated strains of E. coli can survive
in numbers and duration far in excess of expectations; that naked polyoma DNA can cause infection in mice, etc.
Procedurally also, the operations of the RAC are quite questionable. The RAC does not have clear procedural rules, conducts
important business through rump minority sessions, is chaired by a person of strong biases which become reflected in the way
the Committee does its work and in the materials presented to it, etc.
At the very least, environmental impact statements under the National Environmental Policy Act should be prepared, be made
available for public comment, etc. before such drastic changes in regulatory policy are effectuated. In the past (with the
issuance of the original Guidelines), the NIH has been insufficiently sensitive to NEPA requirements; I urge you to be more
attentive to them now. Any action which Director Fredrickson is contemplating which would seriously alter the Guidelines
ought to be published in the Federal Register for comment as well.