4 
experiments involving field testing of genetically modified plants. The Plant 
Working Group and USDA representatives prepared a document which was published 
in the March 4, 1983, Federal Register . The document specified that provided 
the experiments met the criteria detailed in the document, the IBC could review 
the proposal; ORDA would be notified of approvals. The RAC considered the 
Plant Working Group proposal at its April 11, 1983, meeting and discussed it 
extensively. The RAC made several modifications in the specific criteria as 
the result of scientific considerations. The RAC also modified the procedural 
aspects of the proposal. It recommended : (1) the language be incorporated 
into the Guidelines as a new Appendix L, and (2) proposals must be reviewed 
and approved by the Plant Working Group and by the IBC before initiation of 
experiments . 
The NIH accepted this recommendation and Appendix L appeared in the June 1, 
1983, Federal Register (48 FR 24549). 
Dr. Tolin noted that any proposal involving plants which does not meet the 
criteria specified in Appendix L must be reviewed and recommended by the full 
RAC on a case-by-case basis. 
Dr. Gartland said the guidance document (Attachment II) the Working Group on 
Release into Environment would consider at the May 31, 1984 meeting was a 
support document to Appendix L. He said this guidance document entitled 
"Proposed Guidelines for Submission Under Appendix L" was originally developed 
by the Plant Working Group to supplement the information found in Appendix L. 
This guidance document was sent to RAC for consideration at the February 6, 
1984, RAC meeting. During the RAC discussion, several comments and recommenda- 
tions were made concerning the document. He said the Working Group on Release 
into Environment at its April 9, 1984, meeting subsequently modified this 
document. He asked the Working Group can Release into Environment to consider 
whether the comments and recommendations made at the February 6 RAC meeting 
had been incorporated into the document. 
Dr. Gartland said the document "Proposed Guidelines for Submissions Under 
Appendix L" would be a source of information and would probably be published 
in the Recombinant DMA Technical Bulletin and sent to IBC chairpecple. It 
would not be incorporated into the Guidelines. 
Dr. Gottesrran felt that the comments and recommendations made by RAC at the 
February 6 meeting had been incorporated into the document. Other working 
group members agreed. Dr. Gottesman suggested, however, that the third para- 
graph of the document be modified. That paragraph reads as follcws: 
"These annotated items were presented for consideration by prospective 
proposal sutmitters to facilitate the process of approval. The Working 
Group has found that the proposals so far submitted for their consideration 
have emitted information that is considered minimal and essential for their 
approval. Basically, the group would like to see detailed objectives, 
materials and methods, including methodology for monitoring the experiments, 
and expected results. At a minimum summary data should be submitted to 
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