William J. Gartland, Jr. 
Director 
Office of Recombinant DNA Activities 
National Institute of Health 
Building 31 Room AA52 
Bethesda, MD 20205 
Dear Sir: 
We are writing to register strong disapproval of the Baltimore/ 
Campbell proposal described In the Federal Register of December 4, 
1981. This proposal would convert the NIH Guidelines from mandatory 
to voluntary and modifies the content to further weaken them. 
Over the last six months, we have served as members of the Bio- 
technology Committee of the Massachusetts Public Health Association 
under the chair of Dr. David Ozonoff, writing a model ordinance for 
state and local communities. We have clearly examined the problems 
Involved In assuring safe and long term development of biotechnology. 
We believe this proposal contravenes the last thirty years of experience 
In developing technology for maximal social benefit and minimal harm, 
and will not advance the productive development of recombinant DNA 
technology. 
We support the Gottesman proposals to streamline the Guidelines 
but keep their mandatory character. Furthermore, we believe that 
broader legislation Is needed to guide the rapidly developing 
commercial applications of rDNA technology. 
We briefly summarize other reasons for our position. 
1. Extensive experience In the chemical, manufacturing, and extraction 
Industries reveal that the deleterious side effects to humans and the 
environment are frequently not detected until decades after the Intro- 
duction of the technology Into commercial use. 
Recombinant DNA technology Is only seven years old. It Is only 
Just now being tapped as a large scale production technology. None 
of the public health and epidemiological studies necessary to assess 
the long term side effects have been carried out. Thus, from the point 
of view of occupational and environmental health and ecosystem protection, 
we have no scientific basis for doing away with regulation at this juncture. 
We note that even after they have been discovered, the fundamental 
nature of the deleterious action Is not always understood, as In the case 
of asbestos and lung disease. It Is naive to believe that the biomedical 
community understands the mechanism of disease causation so deeply that 
It can comfortably predict the absense of future problems. 
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