If the inserted DNA sequence order is complex, as is often the case for plants engineered via direct transformation systems (e.g. electroporation, polyethylene glycol transformation of protoplasts, or particle bombardment techniques), the applicants should summarize the data by providing the following information for the all genes (whether under the direction of plant or bacterial promoters). Is there a complete copy of the gene present in regulated article? Is the protein expressed in the plant? If multiple complete copies of a gene are present, applicants do not have to determine if each copy of the gene is expressed. It is very helpful to provide a table, like the one shown below, that summarizes the results and indicates where specific data is to be found.
Fig. 3, p. 7
Fig. 4, p. 20
Fig. 8, p. 21
Fig. 9, p. 31
Is protein expressed
Is a complete copy present?
Mendelian inheritance data and Chi square analysis for
at least 2 generations are appropriate to demonstrate whether the transgene is stably inserted and inherited in
Mendelian fashion. Such data are generally not necessary for infertile vegetatively propagated crops such
as male-sterile potatoes.
Table 2—Segregation ratios of progeny of the seeds of the primary transformants
Ratio of Herbicide Tolerant to Susceptible Plants
SAMPLE PETITION—Herbicide-Tolerant Plants