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DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 
NATIONAL INSTITUTES OF HEALTH 
BETHESDA. MARYLAND 20014 
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The Honorable Adlai E. Stevenson 
Chairman, Subcomm.ittae on Science, 
Technology, and Space 
Committee on Commerce, Science, 
and Transportation 
United States Senate 
Washington, D.C. 20510 
Dear Senator Stevenson: 
In a letter dated November 30, 1977, you asked me several questions 
concerning the National Institutes of Health (NTH) Guidelines for 
the conduct of Recombinant DNA Research. I am pleased to have the 
opportunity to answer the questions you raised. 
The documents for the Record of the November 8 hearing on recombinant 
DNA issues and the background report that we have provided to your 
Committee are relevant to the present inquiry. The background report 
should be particularly useful in understanding NIK’s efforts concerning 
recombinant DNA research carried out at the University of California at 
San Francisco (UCSF) . We are striving to improve the NIH Guidelines and 
their implementation so that we have a rational and workable system. 
Your questions are divided into four parts. For rhe sake of convenience, 
I will follow your format in answering the questions. 
Part I 
1. "...have [researchers] been informed in detail about the 
process and criteria for certifying vectors?" 
Detailed technical criteria for certifying host-vector systems 
as EK2 are contained in the NIH Guidelines. The Recombinant 
DNA Molecule Pregram Advisory Committee adopted amplif ications 
of those criteria on January 15-16, 1977, for phage systems, 
and on June 23, 1977, for plasmid systems. The criteria plus 
a list of all certified EK.2 systems appear in the Environmental 
Impact Statement in the Guidelines. Tne EIS was sent to all 
Institutional Biohazards Committees (IBC ! s) in November 1977. 
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