This fourth volume of the NIH public record contains the revised NIH 
Guide! i nes for Research Invol vi ng Recombi nant DNA Molecules . The open 
process that led from the NIH-proposed revision to this new edition of 
the Guidelines, in effect since January 2, 1979, included a public 
hearing on September 15, 1978; an NIH-staff analysis of more than 170 
letters commenting on the proposed Guidelines; an intensive review of 
this analysis and the letters themselves by the HEW Advisory Committee; 
and several meetings of the committee with groups representing the 
environment, industry, biological sciences, and other interests. As a 
result of this process, the Guidelines were modified in many respects, 
particularly to ensure wide notice and public participation in major 
decisions affecting changes. 
A letter by the Director, NIH, is the first item reproduced here. 
It introduced several of the documents described below. 
A preamble by Secretary Joseph A. Califano, Jr., follows. This is 
substantially the same as a press release issued by HEW on December 17, 
1978, in which the Secretary announced the forthcoming publication of 
the Guidelines in the Federal Register . 
Following the preamble is a "Decision of the Director, National 
Institutes of Health, To Issue Revised Guidelines for Recombinant DNA 
Research." This presents an analysis of all the letters and witness 
statements addressing the NIH-proposed revision. It explains the 
revision in light of the commentators suggestions, elucidating both 
acceptances and rejections. The appendices to the Decision include an 
Environmental Impact Assessment of the final Guidelines, which again 
affirms that activities conducted under the Guidelines pose no signif- 
icant risk to the public health or the environment. Another appendix is 
an exchange of letters between Senators and Secretary Califano. These 
are concerned with the question whether to invoke extant regulatory 
authorities to extend NIH standards to cover all recombinant DNA research 
i n the Nation. 
Next are the revised NIH Guidelines, now in effect. The revisions 
relax the 1976 version in two major respects. They exempt five categories 
of experiments from the Guideline controls and ease restrictions on other 
permissible experiments. On the other hand, they require increased public 
participation at both the local and national levels. These requirements 
concern the composition and responsibilities of institutional biosafety 
committees (IBCs), the disclosure of public records, and an expanded role 
for the Recombinant DNA Advisory Committee (RAC). The Guidelines are now 
much more explicit in respect to implementation. 
Secretary Califano requested FDA and EPA to consider applying their 
authorities to extend the new standards to the private sector. FDA gave 
public notice of intent to propose regulations that would require all 
recombinant DNA research leading to FDA-approved products to have been 
conducted according to the NIH standards. The FDA notice and the Sec- 
retary's letter to EPA are included. 
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