ROCHE INSTITUTE OF MOLECULAR BIOLOGY 
N UTLEY, NEW JERSEY 07110 
August 31, 1978 
Dr. Donald Fredrickson 
National Institutes of Health 
Building 1, Room 124 
Bethesda, Md. 20014 
Dear Dr. Fredrickson: 
As you requested, I have reviewed the Proposed Revised NIH Guidelines for 
Recombinant DNA Research (published on July 28, 1978 in The Federal Register) 
and offer the following comments: 
First, I would like to express my appreciation for the thorough and 
objective way in which all of the many questions and issues raised since the 
publication of the first revision have been addressed both in the "Decision" 
section and in the proposed changes. In my capacity as member of a RAC 
working group and as convenor of COGENE's "Working Group on Risk Assesment", 
I have had the opportunity to follow the many recent developments relevant 
to recombinant DNA research. My general impression is that the new Proposed 
Guidelines — although still restrictive — do much to improve administration 
and to adjust experimental guidelines to accommodate the experience and new 
knowledge accumulated over the last three years. Particularly significant 
has been the input from the groups of knowledgeable scientists (at Falmouth 
and Ascot, etc.) who have conducted technical analyses of the possible risks 
associated with recombinant DNA research and have made concrete suggestions 
as a result of their assessments. It is, of course, imperative that such 
analyses be employed where ever possible, so that the number of assumptions 
utilized in constructing the guidelines may be reduced to a minimum. 
However, while I appreciate the tremendous work and effort that must have 
been involved in addressing the range of scientific and public opinion regarding 
recombinant DNA research I must, as a scientist, question the long delay in 
adoption of revisions. The new proposals (PRG-NIH) are undoubtedly more 
appropriate than those drawn up by the RAC a year ago (PRG-RAC) . But even the 
PRG-RAC were a significant improvement over the 1976 version which experimentors 
in the U.S. still are obliged to follow. In comparison with many other 
countries, we have become so out-of-date that reputable scientists at some of 
our leading institutions (Harvard, University of California, Cold Spring Harbor 
Laboratories) have found it necessary to travel to Europe to perform experiments. 
continued . 
[A-68] 
