10 
of the trial. It asks how the test site v\as chosen and designed and how these 
considerations will minimize risk. She said Section V-B-l reads as follows: 
"The test site is of limited size or area and is reasonably isolated 
frcrn potentially adversely affected ecosystems." 
: Dr. Fedoroff suggested this section of the document should ask the investigator 
to defend the choice of site. Dr. Miller suggested the language of Section 
V-B-l should read as follows: 
"Justify the selection of the test site with respect to its size, location, 
isolation, etc." 
j 
Dr. Alan Goldhammer of the Industrial Biotechnology Association (IBA) asked if the 
working group would impose a geographical restriction on test sites. He thought 
EPA documents do not specify this type of restriction. Dr. Rissler said the 
location of the test site will be of concern to EPA. 
i 
Dr. Colwall said the working group would like to knew the location of the test 
; site. Dr. Sharpies said the working group would evaluate how site selection 
i factors contribute to minimizing risk. Dr. Pramer said Section V-B-l should 
ask the investigator how risk management considerations will influence test 
site selection. 
Dr. Pimentel moved that the working group accept Er . Miller's preposed 
language for .Section V-B-l. 
Dr. Fedoroff suggested the abbreviation "etc." be replaced by the words "other 
relevant factors." Dr. Colwell sugggested the "etc." be replaced by the phrase 
"other factors relevant to risk." The working group agreed to the preposed 
language by a vote of nine in favor, none opposed , and two abstentions. 
Dr. Tolin said Section V-B-2 addresses points of particular importance in intro- 
ducing the test material. She felt three important issues ware: (1) the applica- 
tion method; (2) the time of application; and (3) the introduction protocols. 
Section V-B-2 reads as follows: 
"Introduction protocols are designed to decrease any potential non- target 
effects of the modified organism." 
Dr. Fedoroff said this section solicits information on the features of the 
, introduction protocols that would minimize or eliminate adverse effects. 
; Dr. Pimentel thought Section V-B-2 should discuss the design of the introduction 
protocols and request a justification of why the design of the introduction 
j protocols would reduce risk to the environment. 
Dr. Gottesman asked whether Sections V-B-2 and V-B-3 could be combined. 
Dr. Fedoroff did not think Dr. Got teaman' s proposed approach would simplify the 
language of the request. 
[305] 
