Research and Development 
I 
SK&F 
«» SmithKIine company 
SMITH KLINE &FRENCH LABORATORIES 
1500 Spring Garden St. . P 0 Box 7929, Philadelphia, PA 19101 • 215-854-4000 cable Smithkline Philadelphia 
iele» 83-«e 
October 15, 1980 
Dr. Donald S. Fredrickson 
Director, National Institutes 
of Health 
Bethesda, MD 20205 
Dear Dr. Fredrickson: 
I would like to £ring to your attention a change in the NIH Guide- 
lines for Research involving recombinant DNA molecules. This change, 
in my opinion, is a major action and should not be approved without 
further consideration. The change to which I refer occurred on 
September 26, 1980 during consideration by the RAC of a proposed 
amendment of appendix E of the guidelines (see item 9 of the Federal 
Register, vol. 45, no. 164, Thursday, August 21, 1980, p. 55928). 
The proposal was amended by Dr. Richard Novick so as to read 
"Streptomyces coelicolor 3 S. aureofaciens 3 S. rimosus , S. grtseus, 
S. cyaneus, and S. venezuelae can be used as hosts for the cloning 
of DNA derived from B. subtilis } E. colt K-12, or from S. aureus 
vectors that have been approved for use in B. subtilis, under P2 con- 
ditions using as vectors any non-coni ugative plasmids indigenous to 
these Streptomyces species or able to replicate in these hosts by 
natural biological mechanisms." The change from the published text, 
initiated by Dr. Novick, is underlined. 
I would like to see this amended proposal published for public 
comment and put to a second vote at the next RAC meeting before you 
approve this action. This amended proposal failed to receive suf- 
ficient consideration of the following points. First of all, in no 
previous actions regarding Streptomyces species was any consideration 
given during the deliberations to establish levels of physical con- 
tainment as to whether the vectors were capable of mediating exchange 
of genetic information. Therefore, this action by the RAC is more 
restrictive than previous actions and, in my opinion, is inconsistent 
with the intent of the RAC. In fact, experiments can be carried out 
at P2 levels of containment in which B. subtilis, E. colt K-12, or 
S. aureus vector DNA is cloned into S. coelicolor hosts using vectors 
capable of self-mediated exchange in accordance with Appendix E of 
the current NIH Guidelines. 
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