1525 18th Street, NW, Washington, D.C. 20036 • 202/833-1484 
September 25, 1978 
COMMENTS OF THE ENVIRONMENTAL DEFENSE FUND 
ON THE PROPOSED REVISED NATIONAL INSTITUTES OF HEALTH 
GUIDELINES FOR RECOMBINANT DNA RESEARCH 
( 43 Federal Register 33041-33178 ) 
Introduction 
The Environmental Defense Fund (EDF) is a non-profit organization 
with over 46,000 members. EDF undertakes legislative, judicial and 
administrative actions to minimize human exposure to toxic chemicals. 
EDF has been deeply involved in the national debate on recombinant DNA. 
In 1976, EDF petitioned the Department of Health, Education and Welfare 
(DHEW) to use its authority under §361 of the Public Health Services 
Act to regulate recombinant DNA activities. EDF submitted comments 
on the current National Institutes of Health (NIH) recombinant DNA 
guidelines and has testified before Congress and the Advisory Committee 
to the Director of NIH on this issue. EDF also testified at the DHEW 
September 15, 1978 public hearing on these proposed revised guidelines. 
Scope of the Guidelines 
I -A. NIH should stop calling its proposed procedures for guaran- 
teeing environmentally sound handling of recombinant DNA "Guidelines" 
and instead refer to them as regulations. The distinctions between 
guidelines and regulations are important. Regulations clearly have 
the binding force of law, are subject to the rules of the Administrative 
Procedure Act and convey to the regulated the seriousness of the issue. 
Continued use of the term "Guidelines" implies that the procedures are 
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Prlnltd on 100% Pecydtd Ptptr 
Environmental 
Defense 
Fund 
[A-336] 
