Date 
From 
Subject 
To 
DEPARTMENT OF HEALTH & HL’.M AN SERVICES 
Public Health Service 
National Institutes of Health 
Memorandum 
June 19, 1985 
Dr. Bernard Talbot, Deputy Director, 
National Institute of Allergy and Infectious Diseases 
Analysis of Comments - ACTION 
Dr. James Wyngaarden, Director, 
National Institutes of Health 
I . Structure of This Memorandum 
Section II of this memorandum contains background information. Section 
III analyzes public comments received and gives my recommendations in 
response to these comments. Section IV recapitulates the recommendations 
made in section III and provides a place for you to indicate whether you 
concur or do not concur with each recommendation. Section V discusses 
future action. 
1 1 . Background 
On January 21, 1985, you signed your concurrence with an Environmental 
Assessment (EA) and Finding of No Significant Impact (FONSI) "concerning 
the application to the National Institutes of Health ( N I H ) under the NIH 
Guidelines for Research Involving Recombinant DNA Molecules by Drs. 
Steven Lindow and Nickolas Panopoulos of the University of California, 
Berkeley, to field test ice-nucleation-minus bacteria prepared by 
recombinant DNA techniques for purposes of biological control of frost 
damage to plants." A copy of the January 21, 1985, EA-FONSI is attached 
at Tab A. 
On April 15, 1985, there appeared in the Federal Register (50 FR 14794) 
a notice which you signed: (1) announcing the avai labi 1 i ty for public 
comment of the January 21, 1985, EA-FONSI; and (2) requesting "comments 
on the need for a programmatic Environmental Impact Statement in 
connection with NIH approvals of proposals to release into the 
environment organisms containing recombinant DNA molecules." A copy of 
the April 15, 1985, Federal Register notice is attached at Tab B. 
In response to the April 15, 1985, Federal Register notice, fifteen 
letters were received. One of the letters, from Allan Hirsch, Director, 
Office of Federal Activities, Environmental Protection Agency (EPA), 
indicated that EPA had no comments to make on the EA-FONSI or on the 
need for NIH to prepare a programmatic Environmental Impact Statement 
(EIS). Copies of the other fourteen letters, which did comment on the 
EA-FONSI and/or the need for a programmatic EIS, are attached at Tab C. 
[165] 
