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Dr. William J. Gar eland 
Executive Secretary 
Office of Recombinant DNA Activities 
Building 31. Room 4AS2 
National Institutes of Health 
BetHesda, Maryland 20014 
Dear Dr. Gareland: , 
this letter, on behalf of the Duke University Biohazards Committee, is in 
response to your request for comments on the proposed revisions of the Guidelines 
for Research Involving Recombinant DNA Molecules . 
It is hard to reconcile sentence 2 of the introduction defining recombinant 
DNA with Section III-B.l.a. (2) in which containment levels for intra-species re- 
combinant experiments are discussed. In particular, the term "novel recombinant 
DNA 1 ' as cited in the introduction is ambiguous. If we assume chat chp guidelines 
apply to _E. coll X E. coll cloning experiments, then the minimal containment level 
of P2EK1 or P1EK2 are unjustified, and allowing the Institutional Biohazard Committee 
to downgrade containment is going to introduce further confusion inco the interpreta- 
tion of the guidelines. We therefore propose that all experiments involving cloning 
of DNA fragments isolated from the chromosome of E. coli K12F, or one of its well 
characterized viruses or non-conjugative plasmatids utilizing approved EK1 vector 
systems, be subject to containment at the level of PI. It is our feeling that 
this covers the majority of cloning experiments now is progress and would simplify 
interpretation of the guidelines if this were explicitly stated. 
Another area of concern to our committee is the disposition of MUAs submitted 
to NIH in connection with research grant proposals. We feel NIH should acknowledge 
receipt and disposition of the same so that the investigator and biohazard conmittee 
will have some firm basis for proceeding. 
Sincerely, 
Barbara E. Echols 
Secretary 
Duke University Biohazards 
Cosalttee 
eat Dr. D. 1 . Prod ricks oe 
[Appendix A — 26] 
