9 
"If microorganisms are used to introduce vectors, the assessment of subse- 
quent absence of the microorganisms should be specified. Indicate the 
means of strain identification and retrieval." 
Dr. Segal questioned whether this language addressed the concept of the effect 
culture homogeneity would have on efforts to assess the subsequent absence of 
the microorganism. Dr. Lacy said the language of item C-l of the guidance 
document includes this concept. 
Dr. Clcwes suggested the word "persistence" be substituted for the word 
"absence" in the first sentence of item B-4. Dr. Sharpies asked if item B-4 
stated that the plants to be field tested should be free of microorganisms if 
these are used to introduced the recombinant DNA. Dr. Tolin asked if the 
working group felt plants containing such microorganisms could be placed in the 
environment. The working group agreed that this document should specify condi- 
tions for field testing of plants, it would not deal with the introduction of 
associated microorganisms to the environment, thus, the sentence as originally 
written is acceptable . Dr . Gottesman suggested the first sentence might read : 
"If microorganisms are used to introduce vectors, describe how the absence 
of the microorganisms was assessed." 
Dr. Pirone elaborated on Dr. Gottesman' s proposed language and suggested the 
first sentence of item B-4 might read: 
"If microorganisms are used to introduce vectors, the absence of these 
microorganisms in plants to be released in the field should be documented." 
He suggested that the second sentence of item B-4 be deleted. 
The working group agreed to these modifications. 
Dr. McGarrity called the attention of the working group to item C-l of Section C, 
"Characteristics and Monitoring of Plants." Item C-l reads as follows: 
"Provide data from greenhouse and/or growth chamber studies under 
simulated field conditions to support prospective field studies. 
Data should include morphological data for at least two generations 
of plants. 
"Specify plant monitoring procedures; frequency; types of data to be 
obtained, including leaf, seed, fruit or root characteristics." 
Dr. Fedoroff pointed out that grcwth chamber conditions do not simulate field 
conditions. She asked vhether conditions could be specified which would 
actually simulate field conditions and questioned the use of the phrase "under 
simulated field conditions." Dr. Scandalios suggested the phrase "simulated 
field conditions" be deleted fran the first paragraph. Dr. Vidaver pointed cut 
that if this phrase were deleted data might be submitted vhich are clearly not 
applicable to field testing. Dr. Gottesman agreed with Dr. Vidaver but thought 
it would be difficult to specify conditions which would create "simulated 
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