10 
field conditions." The working group agreed to delete the reference to 
"simulated field conditions." 
Dr. Fedoroff suggested the first two words of the second sentence of item C-l 
be deleted. Dr. Segal asked if a request for morphological data would result 
in adequate information being provided for review. Dr. Lacy said he would 
like to know if the construct is stable, and morphological data would not 
provide this information. Dr. Fedoroff thought the document should request 
information on the fate of the reccmbinant DNA. Dr. Amtzen said the document 
should specify a requirement for data dealing with any evidence of changes in 
traits. Dr. Tolin felt the document should not require complete genetic infor- 
rration as this would result in large amounts of data being submitted for review. 
Dr. Clowes thought the working group would be primarily interested in reviewing 
data on the DNA insert and the vector. Dr. Fedoroff said that in certain 
cases the working group might wish to review all available information including 
the complete genetic background of the plant. She thought the investigators 
should provide any available information particularly any existing data on the 
molecular characterization of the plants. 
Dr. Arntzen suggested the second sentence of item C-l might read: 
"Supply existing molecular, physiological, or morphological data as appli- 
cable to the trait (s) under consideration." 
Dr. Tolin asked if Dr. Arntzen 's preposed language would include a statement 
requiring data for at least two generations of plants. Dr. Amtzen questioned 
vhether a statement requiring data over two generations should be specified in 
item C-l. He pointed out that in sane cases it would not be feasible to gener- 
ate such data. He said seme crcp plants such as pine trees have long genera- 
tion cycles; one might begin the experiment as a graduate student and be retired 
before the requisite data had been generated. Dr. Tolin suggested the guidance 
document might require data covering two cell cycles rather than two generations. 
Dr. Lacy felt the specification for data covering at least two generations of 
plants should remain in the document but be qualified by the phrase "when 
applicable." Drs. Arntzen and Pirone thought the phrase "if feasible" preferable 
to the phrase "when applicable." After further discussion the group agreed to 
use the phrase "if feasible." 
Dr. Hollander asked if the language of item C-l would specify that the investi- 
gators examine and report any unexpected results. Dr. Tolin said language 
could be added to item C-l requesting that "strange observations be reported." 
Dr. Pirone suggested the working group could ask the investigators to "show 
how care has been taken to show that no undesirable traits will develop." 
Dr . Gottesman suggested these concerns could be addressed by rewriting the 
second sentence of item C-l as follows: 
"Include morphological data for at least two generations of plants, if 
feasible. Supply any molecular or physiological data, especially 
as applicable to the trait (s) under consideration." 
[434] 
