Corporate Quality Assurance 
Abbott Laboratories 
Abbott Park 
North Chicago, Illinois 60064, U.S.A. 
January 21 , 1987 
Director, Office of Recombinant DNA Activities 
Building 31 , Room 3B10 
National Institutes of Health 
9000 Rockville Pike 
Bethesda, MD 20892 
Dear Sirs: 
We wish to comment upon proposals III and IV, No. 244, p. 45651, as proposed 
actions under the NIH Guidelines for research Involving recombinant DNA 
molecules . 
III. Proposed Revision of Section I-B or Section III-A-2 of the NIH 
Guidelines 
We strongly support the proposal to modify the NIH Guidelines to 
exempt DNA experiments which do not Involve the Introduction of 
foreign DNA. Option 1 is preferable In that It will clarify the 
concept of exempting experiments not Involving foreign DNA, by stating 
a definition of what constitutes recombinant DNA, and will refocus the 
NIH Guidelines to those areas of research which may, by their nature, 
require oversight of the Institutional Biosafety Committee and the RAC 
of the NIH. 
IV. Proposed Revisions of Appendices C-II, C- I II, and C-IV 
As a major member of the fermentation Industry, we applaud the 
proposed action to treat the large-scale fermentation containment 
under appendices C-II, III and IV the same as the fermentation 
containment for the host organism. This Is appropriate given the 
experience of the fermentation Industry and the experience gained 
working with these recombinant organisms. 
We appreciate the opportunity to comment upon these proposals and urge the 
RAC to act positively upon them. 
Sincerely, 
RDNA Biosafety Committee 
[ 268 ] 
Secretary and Biological Safety Officer 
RDNA Biosafety Committee 
Recombinant DNA Research, Volume 1 1 
