PUBLIC AND SCIENTIFIC AFFAIRS BOARD 
1913 I Street, N.W. 
AMERICAN SOCIETY FOR MICROBIOLOGY Washington, D.C. 20006 
Telephone: (202 ) 822-9229 
January 29, 1987 
Dr. William Gartland 
Director, Office of Recombinant DNA Activities 
Bldg. 31, Roan 3 BIO 
National Institutes of Health 
Bethesda, MD 20892 
Dear Dr. Gartland: 
On behalf of the American Society for Microbiology (ASM), 
we are submitting the following comments in response to the proposed actions 
involving the National Institutes of Health (NIH) Guidelines for Recombinant 
DtA Research, published in the Federal Register of December 19, 1986 
(51:244). Hie A£J1 is the largest single biological life science 
organization in the world with an active membership of over 34,000. Hie ASM 
membership includes scientists fran the government, academe and industry, 
who are experienced in molecular biology and genetics, environmental 
microbiology, microbial physiology, agricultural and industrial 
microbiology. 
I. Hie ASM supports adoption of the revisions proposed by Dr. Bernard Talbot 
to amend Sections I-A and 1 1 1- A of the NIH Guidelines. Hi is proposed 
revision is consistent with the policies established by the June 26, 1986 
"Coordinated Framework for Regulation of Biotechnology," and will clarify 
for submitters that recombinant DNA experiments requiring approval under the 
NIH Guidelines need not be reviewed by the NIH Recombinant Advisory 
Committee (RAC) once review and approval has been given by another agency 
with the appropriate jurisdiction. 
II. Hie ASM supports adoption of the revisions, proposed by the RAC Working 
Group on Definitions to Section III-A-2 of the NIH Guidelines , which define 
deliberate release and clarify conditions under which a deliberate release 
experiment would be exempt from review by RAC. We believe these revisions 
represent the proper approach to dealing with the issue of deliberate 
release and will assure proper planning and participation by scientists in 
the decision-making process. 
III. Hie ASM agrees with the motion passed by the RAC Working Group on 
Definitions "that certain types of recombinant DNA experiments which do not 
involve the introduction of foreign DNA need not be subjected to special 
regulation as ' recombinant DNA. ' " We endorse the second option for dealing 
with this problem by further modifying Section III-A-2 of the NIH 
Guidelines. Under this option, deliberate release experiments involving 
genetically engineered organisms created by deletions, single base changes, 
rearrangements and amplification within a single genome would be exempt 
from RAC review. We believe the current definition of recombinant DNA 
should remain unchanged and the RAC should continue its past practice of 
recommending exemptions. 
Recombinant DNA Research, Volume 1 1 
[ 291 ] 
