4 
Dr. Levin reported that a document prepared by the EPA Office of Pesticides 
(Attachment X) presented to the Working Group on Release into the Environment 
at the October 5 meeting would appear in the Federal Register in about two 
weeks. This document announces that EPA will require notification prior to 
all small-scale field tests involving certain microbial pesticides in order to 
determine whether experimental use permits are required. Microbial pesticides 
covered by this policy are those vhich involve naturally occurring microorganisms 
for use in environments vhere they are not native (non-indigencus or exotic) 
or microorganisms vhich have been genet ically altered or manipulated by humans. 
Dr. Levin said this is an interim notice which will be in effect until the EPA 
adepts a final approach. 
Mr. Fred Betz of the EPA explained that the document (Attachment X) modifies the 
conditions under which an environmental use permit (EUP) will be required by 
the EPA. Pursuant to section 5 of FIFRA and 40 CFR 172.2, any person wishing 
to accumulate information necessary to register a pesticide may apply for an 
EUP. It is presumed under these statutes that testing will be performed in 
small-scale field studies for the purpose of determining vhether the substance 
has value for pesticide purposes or to determine toxicity or other preperties. 
EPA has not normally required an EUP for terrestrial field testing involving 
ten acres or less of land; however, as microbial pesticides may replicate and 
spread beyond the site of application, small-scale field studies of these 
agents may raise additional concerns . Mr. Betz said the agency has concluded 
on an interim basis that a closer lock should be taken at small-scale field 
tests of certain microbial pesticides. 
Dr. Levin said EPA intends to publish in the near future a large Federal 
Register announcement dealing with general issues under its FIFRA and TSCA 
statutes . 
Dr. McGarrity asked if the EPA notice would deal with genetically altered microbes. 
Mr. Betz said the document would cover non-indigenous microorganisms, including 
organisms modified by recombinant DNA techniques. 
Dr. Miller asked Mr. Betz to define the term "genetically altered." Mr. Betz 
said EPA is actively seeking input on the definition of "genetically altered." 
Dr. Miller asked if mutants created by chemical mutagenesis and naturally 
occurring nut ants would be covered by the definition. Mr. Betz said they would. 
Dr. Amtzen asked if FIFRA statutes extend to insects or microorganisms bene- 
ficial to plants such as nitrogen fixing bacteria. Mr. Betz replied FIFRA 
does not cover these organisms. The TSCA statutes might, however, cover these 
organisms. 
Dr. Gottesrran asked Dr. Gartland to update the working group on the status of 
the lawsuit filed against the Department of Health and Hunan Services (HHS) and 
the National Institutes of Health (NIH) by the Foundation on Economic Trends. 
Dr. Gartland said the NIH to date has approved three proposals involving field 
testing of genetically modified organisms. These are: 
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