PUBLIC AND SCIENTIFIC AFFAIRS BOARD 
AMERICAN SOCIETY FOR MICROBIOLOGY 
1913 I Street, N.W. 
Washington, D. C. 20006 
Telephone: Code 202, 833-9680 
February 14, 1984 
Dr. William J. Gartland, Jr. 
Office of Recombinant DNA Activities, NIAID 
National Institutes of Health 
Bethesda, MD 20205 
Dear Dr. Gartland: 
In response to Dr. Bernard Talbot's memorandum of December 21, the Public 
and Scientific Affairs Board (PSAB) of the American Society for 
Microbiology (ASM) would like to add to our comments concerning the 
National Institutes of Health (NIH) Guidelines for Research Involving 
Recombinant DNA Molecules. Specifically, we would like to address the four 
questions raised by Dr. Talbot in the January 5, 1984 Federal Register 
notice of the Agenda for the February 6 meeting of the Recombinant DNA 
Advisory Committee (RAC) (49 F.R. 696-700) . 
1 . Should the National Institutes of Health (NIH) guidelines be limited 
strictly to work done in the laboratory ? We say no. We believe that 
the Guidelines should be extended and evolve as they have in the past. 
The Guidelines were initially very specific; in response to addressing 
questions that have arisen with recombinant DNA they have become more 
general. We believe that this is a wise and sound policy. Concerns 
over epidemiology, risk assessment and the extension of recombinant 
techniques to both the animal and plant systems require consideration 
of transmission and exchange outside the research laboratory. These 
are highly appropriate areas for the guidelines to address. 
2. Should NIH accept for review only individual proposals funded by NIH or 
only proposals funded by the Federal government ? As in the past, we 
consistently support the role of NIH to review proposals from both the 
private and public sectors. We initially felt that the NIH was the one 
appropriate agency in the government that had the expertise to deal 
with all proposals on recombinant DNA. NIH was selected because it is 
the one agency in the government that is capable of dealing with the 
basic science component of recombinant DNA. This situation has not 
changed. If this responsibility is not retained within the current RAC 
there will be either a lack of oversight and therefore, of confidence 
in the public sector, or a proliferation of government oversight and 
regulations which will lead to a great deal of confusion. We have long 
expressed our concern that a proliferation of regulations at the state 
and local level will hinder the development of both basic research and 
biotechnology. We believe that the best approach is to retain 
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