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United 3^tes Senate 
WASHINGTON. DC 205 10 
August 30 , 1985 
Hon. Margaret M. Heckler 
Secretary 
Department of Health & Human Services 
200 Independence Ave. , S.W. 
Washington, D.C. 20201 
Dear Secretary Heckler: 
I am writing to express ray concern over the current effort by 
the Food and Drug Administration and the proposed Biotechnology 
Science Board to usurp the role of the National Institutes of Health 
Recombinant DNA Advisory Committee In overseeing human gene therapy 
experiments. I am opposed to this effort, and I call upon you to end 
It Immediately. 
It Is ray understanding that plans are now being made within the 
Administration to make the RAC's authority to review proposals for 
gene therapy experiments secondary to that of the BSB Itself. I am 
greatly disturbed by this development, for I do not believe that the 
BSB, as presently conceived, Is a proper forum for the discussion of 
the questions raised by human gene therapy. 
As you are well aware, the Biotechnology Science Board was 
proposed as the result of the Increasing attention that Is being given 
to the rapid development of biotechnology In thl6 country and Its 
Implications. Particularly, the BSB resulted from concern over the 
potential consequences of the deliberate release of genetically 
engineered organisms Into the environment and the role the federal 
government should play In regulating releases. 
As Chairman of the House Science and Technology Subcommittee on 
Investigations and Oversight, I chaired the first congressional 
hearing on the deliberate release Issue in June 1983. Subsequent to 
chat hearing my subcommittee Issued a report calling for the creation 
of an Interagency group to review proposals for deliberate releases. 
The basis for that recommendation was the fact, underscored by 
witnesses at the hearing, that no single agency has both the needed 
expertise, experience, and authority to address the deliberate release 
problem adequately. This sane conclusion was reached by other groups, 
Including two ocher congressional committees, that later examined the 
Issue. 
The Biotechnology Science Board was proposed to correct this 
deficiency and to provide a mechanism for the evaluation of deliberate 
release proposals In a detailed and comprehensive fashion. The Board 
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