13 
Dr. Tolin pointed out that Appendix L-II-D succinctly states the appropriate 
conditions for field testing plants under Appendix L. Dr. Gottesman agreed. 
Dr. McGarrity suggested that the language of Appendix L-II-D be restated in 
the guidance document. 
Dr. Pirone questioned whether a specification requiring a description of plot 
design should be included in item C-2-c. He thought a study section would 
review this information as part of the scientific review and, thus, the working 
group would not need to review such information. Dr. Scandalios said this 
assumption does not always hold true. He pointed out that the study section 
reviewing the proposal involving field testing of modified com plants did 
not consider the conditions under which the com would be grown, although the 
experimental design was critical to the outcome of the test. If the field design 
was not reviewed when it was pertinent to the outcome, he doubted it would 
be reviewed in other cases. He felt the RAC guidance document should require 
information on the experimental design. Dr. Tolin felt such inforrration should 
be requested. She said proposals had to be sutmitted to RAC for a second 
review at the June 1, 1984, meeting because the original proposals did not 
contain an adequate design for generating and assessing field plot data. 
Dr. Gottesman agreed and suggested that item C-2 should consist of the language 
of Appendix L-II-D and the language included in items C-2-a through C-2-f. The 
working group agreed. 
Dr. Tolin thought the word “planting" should be deleted frcm item C-2-c. 
Dr. Vidaver suggested the "etc." be deleted from item C-2-c, and that an "e.g. " 
be included. 
Dr. Arntzen suggested that item C-2-d was redundant and should be deleted. 
The working group agreed this item was redundant. Dr. Arntzen suggested the 
words "nature of" be added to modify the phrase "border rcws" in item C-2-c. 
He also suggested the term "abnormalities such as" be deleted from item C-2-e. 
He reiterated his opinion that the guidance document should not emphasize the 
concept of "abnormality." Dr. Scandalios agreed. 
Dr. Arntzen suggested that the requirement for "types of data to be sought, 
such as yield, resistance to stress, lodging, etc." should be deleted frcm 
item C-2-c as this concern is addressed elsevhere . 
Dr. Rissler pointed out that the document being generated by the working group 
only requires data on field testing in "average" conditions. No data will be 
generated on plants grown in "extreme" ecological conditions, and it will not 
be known whether the engineered plants might survive and grow under conditions 
in which the nonengineered parent plant might not grow. Dr. Gottesman said 
Appendix L only applies to testing in a specified field plot. Data generated 
by other testing procedures would be required for review and approval for 
testing and use in other locations. 
Dr. Fedoroff called the working group's attention to the fact that while the 
concept of controls is implicit in the guidance document, this consideration 
is not explicitly stated. She felt the document should explicitly state a 
[437] 
