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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 
WASHINGTON, D C. 20460 
MAY 1 1978 
OFFICE OF 
RESEARCH AND DEVELOPMENT 
SUBJECT: 
FROM: 
Proposed Revision to 
“vision to Recombinant DNA Guideli 
, Ph.D. 
nes 
Arthur Saz 
Office of Health and Ecological Infects (RD-683) 
TO: Delbert S. Barth, Ph.D. 
Deputy Assistant Administrator for 
Health and Ecological Effects (RD-683) 
I have reviewed the proposed guidelines and my comnents 
follow: 
o Pages 2-3: Not necessarily relevant to Guidelines. 
o Page 6: It would appear that the discussion on this 
page does not really refute the possibility 
that infectious particles could be produced 
in coli. It may not be necessary that 
viral gene products be formed precisely the 
same way in procaryotic and eucaryotic 
vectors. RNA splicing mechanisms are so 
recently reported that one cannot be certain 
that similar reactions do not occur in 
procaryotic vectors. Certainly endonucleolytic 
activity and ligation occur in procaryotes. 
Further, it has been demonstrated that trans- 
lation can occur without capping. Discussion 
of inaccuracies of the expression of animal 
virus m-RNA in E. coli translation systems 
would appear to at variance with statements 
on page 3 indicating that in the future one 
may obtain large amounts of viral protein by 
gene cloning for use as vaccination agents. 
Here the translation system of the vector 
apparently would work adequately. 
o Page 7: The evaluation of viruses to be adapted to 
replication in eucaryotic cells may not be 
[Appendix A — 299] 
