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Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation
relevant experimental data and publications;
a detailed description of the genotypic differences between the regulated article and the nonmodified recipient organism;
a detailed description of the regulated article’s phenotype, especially regarding known and potential differences from the nonmodified recipient organism that would indicate whether or not the regulated article poses a greater plant pest risk; and
field test reports for trials involving the regulated article conducted under permit or notification.
To provide guidance for petitions, the APHIS user’s guide has a sample application for determination of nonregulatory status representing a suggested format for submission. APHIS has inserted in the left-hand margin of the sample application comments and issues that may need to be addressed by the applicant. The guidance detailed under each heading is directly quoted below from the user’s guide:
I.Rationale for Development of the Product
II.Relevant Biology of the Plant
Description of the biology of the nonmodified recipient organism should include taxonomy, genetics, pollination, evidence of reported weediness (e.g., noting whether the crop or sexually compatible species is listed in the relevant publications of the Weed Society of America), discussion of sexual compatibility with wild and weedy free-living relatives in natural crosses or crosses with human intervention. The applicant should provide source of recipient (cultivar name or accession number) and the weed status of its sexually compatible relatives.
The applicant should explicitly identify the lines that are to be considered in the petition and the cultivars from which they are derived. If there are multiple lines, each line must be given a unique identifier that must be listed in the application.
For virus-resistant plants, applicants should provide in an additional section the following information on the nature of the virus that provided the sequences encoding the resistance phenotype:
the taxonomic name of the virus including family, genus, and strain designation including any synonyms;
the type of nucleic acid contained in the virus;
whether the infection is systemic or tissue specific;
whether the virus is associated with any satellite or helper viruses;