13 
Dr. McGarrity said the guidance document represents a significant develop- 
ment in improving submission of information for experiments involving 
field testing of plants containing reccxribinant DNA. He said the guidance 
document specifies standard information requirements and at the same time 
can be modified as the technology develops and evolves. Dr. McGarrity 
said the proposals submitted in accordance with this guidance will undergo 
a case-by-case review as it would be very difficult if not impossible to 
devise a standard checklist containing every parameter involved in 
environmental release applications. 
Dr. Clowes added that the document developed at the May 31, 1984, meeting 
of the Working Group on Release into the Environment does not differ 
substantively from the document which appeared in the April 24, 1984, 
Federal Register . 
Dr. Gottesman said the guidance document should be a document which is 
modified as circumstances require; it should not be made part of the NIH 
Guidelines . 
Dr. Gottesman felt that although the guidance document referred to experi- 
ments under Appendix L, the types of questions posed in the document would 
be pertinent to the review of releases involving microorganisms or other 
plants. Dr. Lacy agreed. 
Dr. McKinney said formulating concrete inflexible rules is a gross error 
as RAC operates in a dynamic area. 
Dr. Tolin, the U.S. Department of Agriculture (USDA) liaison representative 
to RAC and a member of the Working Group on Release into the Environment, 
said the language of the guidance document is consistent with USDA ' s role 
in the release of plants. She said USDA will continue to work with RAC 
in the evolution of this guidance. 
Dr. Pimentel said the document is very good. He suggested that other animal 
population monitoring also be added to item C-2-d which discusses monitoring 
of insect populations and disease. 
Mr. Mitchell noted that at the last RAC meeting. Dr. Martin Alexander had 
raised seme points; he asked Dr. McGarrity if these points had been discussed 
by the working group. Dr. McGarrity replied that Dr. Alexander's comments 
were discussed both at the April 9 and May 31, 1984, working group meetings. 
Mr. Mitchell recognized Mr. Jeremy Rifkin. Mr. Rifkin said he agreed the 
guidance document was a very good beginning. He said that "there should be 
some minimum standards and methodology and protocol to look over deliberate 
release experiments . " 
Mr. Rifkin said he had learned frem Dr. McGarrity' s presentation the working 
group would broaden its scope to deal with microorganisms. He said: 
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