2 
Dr. McGarrity called the Working Group on Release into the Environment to order 
at 10:10 a.m. , May 31, 1984. He said the working group had three agenda items. 
These are: (1) to review the document "Proposed Guidelines for Submissions 
Under Appendix L" (Attachment II) which the working group had rrodified at their 
April 9, 1984, meeting; (2) to discuss plans for the risk assessment workshop 
to be sponsored by the National Institutes of Health (NIH) and the United States 
Department of Agriculture (USDA); and (3) to begin developing principles which 
could be applied to review of proposals involving field testing of genetically 
engineered microorganisms. 
Dr. McGarrity called the attention of the working group to a document 
(Attachment III) which had been submitted to the working group by the Environ- 
mental Protection Agency (EPA) representative, Dr. John Fcwle. Dr. Fowle of 
the EPA Office of Research and Development (ORD) said the EPA document is to 
provide points for industry to consider in preparing premanufacture notices for 
genetically engineered organisms which may be reviewed under the Toxic Sub- 
stances Control Act (TSCA) . The objective of the document is to develcp general 
guidelines and provide general guidance for evaluating genetically engineered 
organisms preposed for release into the environment and is intended to be 
flexible and evolve over time. Dr. Fcwle said EPA is forwarding the document 
to the Working Group on Release into Environment to solicit comments from the 
working group and to provide information which might be useful to the group. 
Eventually, EPA plans to solicit wide public comment on the document by 
publishing it as technical background to the planned Federal Register notice, 
currently scheduled for publication this fall. 
Dr. Scandalios asked who had developed the EPA document. Dr. Hollander of the 
EPA Office of Toxic Substances (OTS) said OTS and ORD had developed it. The 
document is in a very early stage of development, but EPA feels it is appropri- 
ate to share its thoughts with the working group. She emphasized that the 
document is restricted and not for general distribution. 
REVIEW OF THE "PROPOSED GUIDELINES FOR SUBMISSION UNDER APPENDIX L" 
Dr. McGarrity asked Dr. Tolin to review the history of those documents dealing 
with field testing of plants modified through recombinant DNA techniques. 
Dr. Tolin said the first proposal to field test a genetically modified plant 
was submitted to the Recombinant DNA Advisory Committee (RAC) by Dr. Ronald 
Davis of Stanford University. Dr. Davis requested permission to field test 
com plants ( Zea mays ) which had been transformed by com DNA or modified com 
sequences. The RAC reviewed this proposal at its June 5-6, 1980, meeting and 
recommended approval. However, the Director, NIH, in the Federal Register of 
July 29, 1980, announced that he was deferring action on this recanmendation 
pending receipt of additional information on technical aspects of the 
experiments. Dr. Tolin said the issue was referred to the Department of 
Agriculture, and as the USDA representative to the RAC, she wrote the following 
to the NIH on August 7, 1980: 
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