DEPARTMENT OF HEALTH & HUMAN SERVICES 
Public Health Service 
National Institutes of Health 
Bethesda, Maryland 20205 
September 8, 1981 
Dr. William Gartland 
Office of Recombinant DNA Activities 
Bldg. 31, Rm. 4A-52 
Bethesda, MD 20205 
Dear Dr. Gartland: 
Thank you for sending me the proposal of the working group for revision 
of the Guidelines, dated August 21, 1981. Although I realize that there will 
be a formal request for public comment once the RAC adopts a recommendation, 
I would like now to make some comments on the document prepared the working 
group. Please transmit these comments to the RAC as they may wish to consider 
them during their discussions of the proposal. 
I do not believe that the document does a convincing job of supporting the 
recommendations. This is not meant to indicate that I agree or disagree with 
the recommendations, but only to state that the arguments are not put forth as 
clearly as they might be. This results from the lengthy discussion of scarcely 
relevant issues and the very brief description of others. 
To a large extent, the document has the tone of 1976, not 1981. The para- 
graph in the middle of page 5 (A. Basic Assumptions) is a good examples: these 
are not assumption but questions and the wording is not in concordance with sound 
scientific thinking. It never becomes clear why the newly proposed changes now 
make sense, as distinguished from changes previously adopted. For example, most 
experiments with coli K12 systems are already exempt from the Guidelines and 
any questions regarding those that are not exempt, or those involving alternative 
coll systems, turn on properties (such as ability to be established) relevant 
to many host-vector systems and on the nature of the recombinants (e.g. , toxins, 
high expression systems, etc). The lengthy discussion of coli both in the 
text and the appendix seem out of place and do not help to focus on the present 
issues. On the other hand, the document addresses adequately neither the reasons 
for proposing to abandon the prohibitions nor the reasons for maintaining part 
IV essentially unaltered. The document should concentrate on the issues at hand 
and speak specifically to the proposed changes. Note too that the statement on 
the bottom of page 2 describing the recommendations as adopting the containment 
provisions of the Baltimore -Campbell proposal is incorrect: the containment provi- 
sions of the Baltlmore-Campbell proposal did not, according to my copy, eliminate 
the prohibitions and further, they specified the use of biological containment. 
