The following HTML text is provided to enhance online
readability. Many aspects of typography translate only awkwardly to HTML.
Please use the page image
as the authoritative form to ensure accuracy.
Environmental Effects of Transgenic Plants: The Scope and Adequacy of Regulation
“Production of new transformants of the same cultivar as the antecedent organism, or new cultivars of the same plant species or variety that do not differ significantly from the antecedent cultivar in reproductive fitness, obtained via transformation using the same transforming nucleic acid as was used in producing the antecedent organism.”
“Production of new transformants of the same cultivar as the antecedent organism, using a transformation vector that differs from that used to produce the antecedent organism only: in noncoding regulatory sequences used to control expression of any of the introduced genes; or in other vector DNA sequences that were not incorporated into the recipient plant cells, unless the new regulatory sequences cause the expression of any introduced genes in plant tissues in which the introduced genes were not expressed in the antecedent organism.”
“Production of new transformants of the same cultivar as the antecdent organism, in which the genetic material transferred into the recipient plant to produce the antecedent organism is identical to that in the regulated article in question, but in which said material was introduced into the recipient plant using a different transformation vector or technique.”
“Modifications in which the antecedent organism and the regulated article in question contain different donor genes, but the donor gene used in producing the antecedent organism and the donor gene used in producing the regulated article in question encode enzymes catalyzing the same biochemical reaction (i.e., molecules that have the same substrates and products) or encode other proteins performing the same molecular function (i.e., molecules that bind to the same target molecule in vitro and either inhibit its function via the same mechanism, or cause the same biochemical change in the target molecule).”
“Modifications in which the antecedent organism and the regulated article in question differ only in [the] marker genes they contain, which were used in their identification or selection, provided that the new marker genes in the organism in question do not raise any new risk issues, i.e., do not encode substances toxic to plants; do not encode substances with pesticidal properties; do not confer resistance to any antibiotic of significant importance for veterinary or human use; and do not confer resistance to any different herbicide than was conferred by the marker genes in the antecedent organism.”
To provide guidance for extension requests, the APHIS user’s guide provides a sample request, which suggests that certain information be provided by the applicant. Essentially, the request is a streamlined petition that focuses on differences between the regulated article and the antecedent organism. In particular, APHIS focuses first on a “precise description