Department of Biochemistry 
Division of Biological Sciences 
Health Sciences Center 
StonyBrook 
State University of New York at Stony B: 
Stony Brook, New York 1 1794 
telephone: (516) 246 - 5043 
September l4 , 1978 
Dr. Donald S. Fredrickson 
Director 
National Institutes of Health 
Bethesda, Md. 200lU 
Dear Dr. Fredrickson: 
I favor the proposed revisions to the NIH Guidelines on Recombinant DNA 
Research. I believe that the proposed changes provide for more than adequate 
safeguards. At the same time, these safeguards are not so restrictive that 
they significantly hinder research progress or interfere with the direct 
application of new information and technology to problems affecting our 
society. 
My reasons for favoring the revised Guidelines can best be illustrated by 
considering the changes in containment proposed for recombinant DNA studies 
on primates. My own work involves primate species and so I have been 
especially interested in this aspect of the revisions. The Guidelines now 
in existence state that P4+EK2 (or P3+EK3) containment must be used when 
constructing a "library" of recombinant DNA molecules encompassing the whole 
of the genetic material of a primate species. In cases where uncontaminated 
embryonic tissue or germ cell lines can be used as a DNA source P3+EK2 con- 
tainment is allowed. These rather restrictive containment conditions were 
mainly a result of concern that a cryptic virus genome present in the primate 
tissue used as the source of DNA could be accidentally cloned. 
In the Revised Guidelines, recombinant DNA experiments involving primates 
would require P2-EK2 containment regardless of the source of DNA. I believe 
these levels of containment are adequate. This belief is based on new 
assessments of the risk of hazard to individuals and the environment. 
The consensus of scientists at the Ascot workshop about the risk of cloning 
viral genomes or genome fragments provide justification for lowering the 
primate containment levels. The virologists who attended this meeting 
concluded that the risk inherent in viral cloning experiments using E. coli 
K-12 were no more dangerous than working with the virus or nucleic acid 
itself. Thus cloning experiments using primate DNA do not pose any additional 
hazard over that associated with the actual handling of the primate tissue or 
DNA itself. 
The conclusion of the Falmouth workshop that E. coli K-12 could not be converted 
into an epidemic pathogen by laboratory manipulations with DNA inserts, in- 
dicates that biological containment using the appropriate E. coli K-12 host 
vector combination is a significantly greater barrier to individual or environmenta. 
[A-142] 
