The NIH Guidelines for Research Involving Recombinant DNA Research are 
primarily safety standards for laboratory research, designed to keep organisms 
containing recombinant DNA within the laboratory. There is a section of the 
Guidelines, however, which deals with "deliberate release into the environment of 
any organism containing recombinant DNA." (This was Section III-A, 
"Experiments that are not to be performed" in the original Guidelines of July 7, 
1976; it was Section I-D-4 in the Guidelines of December 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 
organism containing recombinant DNA (except for certain plants described in 
Appendix L of the Guidelines), are that experiments in this category cannot be 
initiated without submission of relevant information on the proposed experiment 
to NIH, the publication of information about the proposal in the Federal Register 
for at least 30 days of comment, review by the RAC, and a specific approval by 
the Director, NIH. The standard for approval of such experiments has remained 
the same since the December 1978 revision of the Guidelines; it is that the NIH 
Director "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." 
Most experiments involving deliberate release into the environment of an 
organism containing recombinant DNA require review by the full RAC and final 
approval by the Director, NIH; however Appendix L of the Guidelines specifies 
that field tests of plants meeting certain criteria can be reviewed by the RAC 
Plant Working Group rather than the full RAC, and can be approved by the NIH 
Office of Recombinant DNA Activities rather than the Director, NIH. 
Environmental Assessment 
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