Tab C - Page 7 
association of american 
medical colleges 
One Dupnt Circle, N.W., Washington, D.C. 20036/(202) 828-0400 
May 7, 1985 
Dr. William J. Gartland 
0RDA 
Building 31, Room 3B10 
National Institutes of Health 
Bethesda, MD 20205 
Dear Dr. Gartland: 
The Association of American Medical Colleges (AAMC) is pleased to respond 
to the FEDERAL REGISTER notice of April 15, 1985 (50 FR: 14794-14796) 
concerning the Environmental Assessment, in connection with the application 
of Drs. Steven Lindow and Nickolas Panopoulos of the University of California, 
Berkeley, to field test ice-nucleation-minus bacteria prepared by recombinant 
DNA techniques. 
The Environmental Assessment 
The Environmental Assessment prepared by the NIH in relation to the proposed 
Lindow/Panopoulos experiment is detailed and thorough. The National 
Institutes of Health and the NIH RAC are to be congratulated for establishing 
the procedures necessary to ensure proper review of proposed applications 
to conduct research which involve field testing or deliberate release 
into the environment of genetically engineered organisms. The establishment 
of the Working Group on Environmental Release of the Recombinant DNA Advisory 
Committee and the decision to prepare an Environmental Assessment statement 
on each such proposed experiment for deliberate release are both laudable 
parts of this process. 
The Need for a Programmatic Environmental Impact Statement 
The FEDERAL REGISTER notice solicits opinion about whether a programmatic 
Environmental Impact Statement (EIS) is necessary in the case of this 
experiment. It would certainly seem that the Environmental Assessment 
(EA) statement prepared to accompany the application of Lindow/Panopoulos 
is thorough enough to permit a full judgment of the environmental impact 
of their proposed experiment. Since it concludes that there is no significant 
environmental impact, a further Environmental Impact Statement is not 
also necessary in this case. 
The Association strongly supports the argument advanced by the NIH in the 
FEDERAL REGISTER that a programmatic EIS is neither necessary nor appropriate 
for future research proposals involving field trials of genetically 
engineered microorganisms. A single a priori programmatic EIS cannot 
be made in regard to such experiments. They are not part of a deliberate 
NIH research program but rather unsolicited and as yet unknown proposed 
future experiments. Each experiment will be a unique instance which must 
be evaluated for environmental impact on a case-by-case basis. The 
Environmental Assessment (EA) statement admirably serves this purpose 
[ 272 ] 
