1 
nr. McGarrity, Chair, caller) the October 30, 1984, meeting of the .Working Group 
on Release into the Environment to order at 9:05 a.m. The participants in the 
meet inn identified themselves at Hr. McGarrity s request. 
Or. McGarrity said three items would be considered by the working group: (1) 
the status of teh national conference on release into the environment of 
genetically modified orqanisms to be sponsored by the American Society for 
Microbiology (ASM); (2) the points to consider document for microorganism 
field testinq generated by the Working Group on Release into the Environment 
at the October 5, 1984, meeting (Attachment II); and (3) a request (Attachment 
III^ by Dr. Carl Mazza of the Environmental Protection Agency (EPA) to consider 
the availabilitv and adequacy of guidelines for greenhouse experiments involving 
reccmhinant PNA organisms. 
Report on a National Conference 
Dr. Pramer offered the working group an update on the status of the national 
conference on release of genetically modified organisms into the environment; 
he said he had little information to add beyond that which had been reported 
at the October 25, 1984, meeting of the Working Group on Release into the 
Environment . 
Development of a Points to Consider Document for Microorganisms 
Dr. McGarrity said with the growing recognition that genetically engineered 
microorganisms are being created for testinq in the field the Working Group on 
Release into the Environment is attempting to develop a guidance document 
(Attachment II) for investigators wishing to submit field testing proposals for 
microorganisms for review under the National Institutes of Health (NIH) 
Guidelines for Research Involving Recombinant CNA Molecules. He recounted bo 
the group the history of this document (Attachment II). He said Drs. Lacy, 
Milewski, Pirone, Tolin, and Vidaver developed a preliminary draft document 
entitled Points to Consider for Submissions Involving the Release of Microorganisms 
Containing Recombinant PNA Molecules into the Environment for the October 5, 
1984, meeting of the working group. 
At the October 5, 1984, meeting, the working group constructed a draft document 
based on portions of the subgroup document and the EPA document entitled Points 
to Consider in the Preparation of TSCA Premanufactured Notices for Genetically- 
Engineered Microorganisms vhich the EPA had sent to the working group to elicit 
comment and to provide information. Dr. McGarrity said a preamble written by 
Dr. Gottesman had subsequently been incorporated into the draft document 
developed at the October 5, 1984, meeting. The preamble attenpts to offer a 
rationale for the document. 
Dr. McGarritv said the draft document (Attachment II) had been sent to the 
Recombinant PNA Advisory Committee (RAC) at its October 29, 1984, meeting: 
(1) as part of the report on the progress of the working group in constructing 
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