8 
The NIH Guidelines for Recombinant DNA Research were constructed pains- 
takingly in response to insecurity that was generated by potentially powerful 
techniques for changing the genetic makeup of microorganisms. As you know, 
at the time the Guidelines were released, opinions about them ranged widely. 
Some, at one end, considered them barely sufficient, and others, at another 
extreme, found them so excessive as to possibly excite derision in future 
histories on American culture. And I think only one thing was accepted by 
all: that this is an area of science that is fundamental and rapidly 
moving, and that the Guidelines would require steady evolution in the light 
of accruing knowledge. 
The Recombinant Advisory Committee has taken very seriously the task 
of modifying the rules to reflect an increasingly better understanding of 
this subject. NIH has taken equally seriously the duty to preserve due 
process and to provide for full public participation in this first major 
revision of the Guidelines. The RAC began early this year to frame revi- 
sions, and they were formally submitted to me last September 1. During 
that month they were then speedily published for comment in the Federal 
Register , and in the NIH Recombinant DNA Technical Bulletin. 
Subsequently, the current Guidelines were compared with the proposed 
revisions. The comparison and the Committee's rationale for these are 
included in the Green Book, which I think all of you have been provided. 
In addition you have received an Orange Book in two volumes, which is 
a compilation of all letters received by the last week in December on 
the proposed revisions as published in the Technical Bulletin and in the 
Federal Register . Several additional letters have been provided to you 
as well. The members of the Committee have also received the final En- 
vironmental Impact Statement , published in November. That is the Yellow 
Book. And to complete the color code, you have received the Internat ional 
Report of the Federal Interagency Committee as the Blue Book. Additional 
copies of these materials are available in Conference Room 8, should anyone 
desire them. 
Now, in the interim since the publication of the Guidelines, there 
have been some significant, major scientific events, and these will be 
referred to today, for they have given impetus to some of the proposed 
revisions . 
A need for revision also derives from experience with implementing 
and administering the Guidelines. Approximately 110 institutions where 
NIH-supported research is going on have established institutional bio- 
hazards committees, and about 230 projects are now involved. NIH has 
established the Office of Recombinant DNA Activities, called ORDA, which 
is headed by Dr. Gartland, and has set up other means to deal with admin- 
istrative requirements of the Guidelines, their interpretation, and the 
certification of host-vector systems. Development of both the central 
and the local administrative practices has taken time and resources. Im- 
perfections in procedures and communications have been revealed, and the 
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