CENTRAL RESEARCH 
PFIZER INC.. EASTERN POINT ROAD. GROTON.CONNECTICUT 06340 
203-441-4541 
RICHARD L. HINMAN, Ph D. 
Senior Vice President 
Chemical Products Research and Development 
January 21, 1987 
The Di rector 
Office of Recombinant DNA Activities 
Building 31, Room 3B10 
National Institutes of Health 
Bethesda , MD 20892 
Dear Sir: 
Re : 51 FR 45650-52. Notice of Proposed Actions under NIH Guidelines for 
Research Involving Recombinant DNA Molecules - Amendments to Sections 
I-A, III -A , III-A-2, and Appendices C-II, C-III and C-IV 
We welcome the opportunity to comment on the above FR proposal and would like 
to go on record in support of the amendments to Sections I-A, III-A, III-A-2, 
and Appendices C-II, C-III and C-IV. Furthermore, we would like to offer 
additional comments in support of the proposal of the Commissioner of Food 
and Drugs (Dr. Frank R. Young) to amend the subject appendices to the NIH 
Guidelines. 
The NIH Guidelines of June 26, 1986, point out that large-scale containment 
requirements for many low-risk R.DNA derived industrial microorganisms will be 
no greater than those for the parent organisms. Dr. Young's proposed revision 
would explicitly state this principle in the Guidelines. In view of the indus- 
try's exemplary safety record in handling the parent organisms, we endorse the 
Commissioner's proposal. 
The fermentation industry has a long and distinguished history of safe opera- 
tion of processes involving Baci 1 1 us subtil is , Escherichia col i K-12 and 
Saccharomyces cerevisiae at manufacturing scale. Pf i zer ' s incident-free 
experience with Baci 1 1 us subti 1 i s used in the production of detergent enzymes 
on a worldwide basis for many years is a part of this history of safe commer- 
cial operation. 
We believe that the industry in general and Pfizer Inc. in particular has 
demonstrated an exemplary record of safety in handling these organisms through 
methods which are soundly based on good engineering principles of design and 
practice. We believe that the requirement of containment of the exempted 
organisms identified above at the BL1-LS level during large-scale cultivation 
is unwarranted based on the industry's extensive experience and health and 
safe . ecord. 
[ 278 ] 
Recombinant DNA Research, Volume 1 1 
