Tab A - Page 63 
The NIH Guidelines for Research Involving Recombinant ONA Research are 
primarily safety standards for laboratory research, designed to keep organisms 
containing recombinant ONA within the laboratory. There Is a section of the 
Guidelines, however, which deals with "deliberate release Into the environment 
of any organisms containing recombinant ONA." (This was Section III -A , 
"Experiments that are not to be performed" In the original Guidelines of July 
7, 1976; It was Section 1-0-4 In the Guidelines of Oecember 22, 1978; and It Is 
Section III-A-2 in the Guidelines of November 23, 1984. The procedures for 
approval of "deliberate release Into the environment" of any microorganism 
containing recombinant ONA, have remained the same since the Oecember 1978 
revision of the Guidelines; they are that "experiments in this category cannot 
be Initiated without submission of relevant information on the proposed 
experiment to NIH, the publication of the proposal in the Federal Register for 
30 days of comment, review by the RAC, and a specific approval by NIH." The 
standard for approval of such "deliberate release into the environment of any 
organisms containing recombinant DNA" has remained the same since the Oecember 
1978 revision of the Guidelines; it Is that the NIH "01 rector or a designee 
shall weigh each proposed action through appropriate analysis and consultation, 
to determine that It complies with the Guidelines and presents no significant 
risk to health or the environment." 
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