Richard M. Hartzman 
A1-ra«f»CV AT I_AW 
aai wist aTTM «TA««rr 
SUIT* 92 
NOW YOUK NEW YORK 10034 
312 ■ •••.•IAS 
September 30, 1977 
Dr. Donald S. Fredericlcson 
Director 
National Institutes of Health 
9000 Rockville Pike 
Bethasda, Maryland 20014 
Dear Dr. Frederickson: 
I am writing to you on behalf of Friends of the Earth in regard to the proposed 
revised NIH guidelines for recombinant DNA research. 
We are deeply disturbed that these revisions have been proposed and published 
in the Federal Register for comment without the NIH having prepared the legally 
required environmental impact statement. The National Environmental Policy Act 
requires that an environmental impact statement ’’shall accompany the proposal 
through the existing agency review processes". Adequate public disclosure of 
the information base and analysis of the environmental impacts of the proposed 
revisions is not possible without a detailed impact statement, and hence in- 
formed and effective public comment is precluded. Nor can there be any assur- 
ance that the issues have been thoroughly considered and that the decisions 
being made are rationally based. The NIH action proposing revised guidelines 
is a continuation of the scientifically and legally defective processes used 
with respect to the entire recombinant DNA program and the promulgation of the 
original guidelines. If the NIH does not take immediate steps to comply fully 
with the law. Friends of the Earth will be constrained to initiate further le- 
gal action. 
In addition, we find the 30-day comment period for the revisions wholly inade- 
quate. Not only are the guidelines themselves highly complex, but the proposed 
revisions are profuse and often subtle. Nor would most interested commentators 
be able to obtain needed information concerning the basis for the revisions be- 
fore the 30-day period had expired. A 60-day period for comment i3 much more 
reasonable for a complex matter such as this. In any c ase, the proposed revi- 
sions should be withheld from further consideration until an environmental im- 
pact statement has been prepared. 
Finally, we are of the opinion that public hearings should be held before any 
final decisions are made on revisions to the guidelines. Merely holding open 
meetings of NIH advisory cormaittees is not sufficient. This has been an issue 
of great public concern that has involved city councils and town meetings, 
state agencies and legislatures, federal agencies (such as the Environmental 
Protection Agency) , and the United States Congress. It would be a serious 
omission if the key mechanism safeguarding recombinant DNA research, the NIH 
[Appendix A — 4] 
