PREFACE 
This report is the third in a series documenting activities at the 
National Institutes of Health with respect to research involving recom- 
binant DNA. Volume 1 in the series, prepared in August 1976, covers 
events from February 1975--the Asilomar Conference --through June 
1976--the issuance of NTH Guidelines. Volume 2 covers subsequent 
events culminating with those surrounding (but not including) the pub- 
lication of proposed revisions to the Guidelines as recommended in 
September 1977 by the NTH Recombinant DNA Molecule Program 
Advisory Committee, or simply Recombinant Advisory Committee 
(RAC). 
This third volume of the NIH ' public record" on recombinant DNA 
activities is mainly concerned with current proposed revisions to the 
NIH Guidelines. Revision as needed is implicit in NIH's responsibility 
to provide investigators and institutions with an up-to-date, definitive 
guide to the safe manipulation of recombinant DNA molecules. The 
process of revision began early in 1977 with deliberations of the RAC, 
the scientific and technical committee responsible for proposing and 
revising the Guidelines. After several public meetings where revision 
was considered, the Committee proposed revised Guidelines to the 
Director, NIH, on September 1, 1977. These were published in the 
Federal Register on September 27, 1977, for public comment. The 
present volume contains the record beginning with the RAC-proposed 
revised Guidelines and concluding with the NIH-proposed revision pub- 
lished in the Federal Register of July 28, 1978. 
The NIH-proposed Guidelines are accompanied by the NIH Director's 
Decision on the proposed revisions and an Environmental Impact Assess- 
ment of the proposal to revise. All major documents relevant to the two 
proposals--RAC and NIH--are contained here. 
The three main documents are followed by introductory matter from 
a new supplement to the NIH Guidelines- -"Laboratory Safety Monograph, " 
published in July 1978 to replace Appendix D--and Sherwood L. Gorbach's 
summary of the highly significant Falmouth workshop to assess the risk 
of experimentation with E. coli K-12. 
At this point the contents revert to chronological order, beginning 
with the RAC-proposed revisions. The comments thereon are Appendix 
A (under separate cover). Next appears material from the meeting of 
the Director's Advisory Committee (DAC), December 15-16, 1977, held 
to bring forth the views of witnesses, invited and public, on the RAC 
proposal. Included is a summary and a transcript of the proceedings. 
In April 1978 the RAC held an open meeting to consider selected 
issues from the Director, NIH, based on correspondence received and 
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