9 
market, to an elaborate review process. He suggested organisms currently 
distributed commercially might be models for types of organisms to be 
considered for the exenpt category. 
Dr. Sharpies said the Envi ronmental Protection Agency (EPA) review process 
prior to approval of carmercially available microbial pesticides is much 
more stringent than the process suggested in the RAC working group points to 
consider document. Mr. Fred Betz of the EPA corroborated Dr. Sharpies' 
statement. He said: "EPA registration requirements are ccnprehens ive in 
the area of product identity, human health considerations, environmental 
transport, and ecological effects." Historically, EPA has primarily re- 
viewed large-scale experimental testing but recently has begun to evaluate 
microbial pesticides at the small-scale field testing stage. 
Mr. Jeremy Rifkin of the Foundation on Economic Trends asked whether the 
recent decisibh (tab 1225) of the' United States Court of Appeals for the 
District of Columbia Circuit had beert addressed by the working group in 
developing the' points to consider dbcument. In developing the document did 
the working group address the issue of the adequacy of NTH environmental 
assessments. 
Dr. McGarrity said the points to consider document is not designed to be 
an environmental assessment. In developing the points to consider, the 
working group considered rrany envircrmental concerns . The aocument repre- 
sents the best scientific effort of this group of molecular bioloqists and 
environment cil scientists. 
Dr. Walters moved that RAC accept with thanks the points to consider docu- 
ment developed by the Working Group on Release into the Environment and 
request that in the future the working group submit to RAC ary proposed 
major changes. Dr. We ns ink seconded the motion. 
By a vote of twenty in favor, none opposed, and no abstentions, the RAC 
accepted the motion. 
Mr. Mitchell t harked Dr. McGarrity and the Working Group on Release into 
the Environment for an outstanding job. Dr. McGarrity thanked the EPA and 
the U.S. Department of Agriculture (USDA) for their significant contributions 
to this effort. 
[Executive Secretary's Note: The document "Points to Consider for Environmental 
Testing of Microorganisms" is appended to these minutes as Attachment II. 3 
IV. PROPOSED REVISION OF APPFNDIX C 
Dr. Clowes introduced the proposal (tabs 1220, 1221) of Dr. Jack Manis of 
the Upjchn Company, Kalamazoo, Michigan. Dr. Manis had proposed that cer- 
tain types of experiments involving Streptomyces fradiae and Streptonyces 
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