40 C.F.R. § 174.3
Terms used in this part have the same meaning as in FIFRA. In addition, the following terms have the meaning set forth in this section.
Active ingredient means a pesticidal substance that is intended to be produced and used in a living plant, or in the produce thereof, and the genetic material necessary for the production of such a pesticidal substance.
Administrator means the Administrator of the United States Environmental Protection Agency or his/her delegate.
Bridging crosses between plants means the utilization of an intermediate plant in a cross to produce a viable zygote between the intermediate plant and a first plant, in order to cross the plant resulting from that zygote with a third plant that would not otherwise be able to produce viable zygotes from the fusion of its gametes with those of the first plant. The result of the bridging cross is the mixing of genetic material of the first and third plant through the formation of an intermediate zygote.
Cell fusion means the fusion in vitro of two or more cells or protoplasts.
Conventional breeding of plants means the creation of progeny through either: The union of gametes, i.e., syngamy, brought together through processes such as pollination, including bridging crosses between plants and wide crosses, or vegetative reproduction. It does not include use of any of the following technologies: Recombinant DNA; other techniques wherein the genetic material is extracted from an organism and introduced into the genome of the recipient plant through, for example, micro-injection, macro-injection, micro-encapsulation; or cell fusion.
EPA means the United States Environmental Protection Agency.
Exudate means a substance gradually discharged or secreted across intact cellular membranes or cell walls and present in the intercellular spaces or on the exterior surfaces of the plant.
FFDCA means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.).
FIFRA means the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (7 U.S.C. 136 et seq.).
Food includes articles used for food or drink by humans or other animals.
Food plant means a plant which either in part or in toto, is used as food.
Gene, and other grammatical variants such as "genic," means a unit of heritable genetic material that is comprised of the genetic material necessary for the production of a substance.
Genetic engineering means the modification of the genome of an organism using recombinant, synthesized, or amplified nucleic acids or other techniques excluded from the definition of conventional breeding.
Genetic material necessary for the production means both: Genetic material that encodes a substance or leads to the production of a substance; and regulatory regions. It does not include noncoding, nonexpressed nucleotide sequences.
Genome means the sum of the heritable genetic material in the plant, including genetic material in the nucleus and organelles.
In a living plant means inside the living plant, on the surface of the living plant, or as an exudate from the living plant.
Inert ingredient, means any substance, such as a selectable marker, other than the active ingredient, where the substance is used to confirm or ensure the presence of the active ingredient, and includes the genetic material necessary for the production of the substance, provided that genetic material is intentionally introduced into a living plant in addition to the active ingredient.
Living plant means a plant, plant organ, or plant part that is alive, viable, or dormant. Examples of plant parts include, but are not limited to, seeds, fruits, leaves, roots, stems, flowers, and pollen.
Loss-of-function plant-incorporated protectant means a plant-incorporated protectant in which the genetic material of a native gene is modified to result in a pesticidal effect through the reduction or elimination of the activity of that gene. For purposes of loss-of-function plant-incorporated protectants, the active ingredient and pesticidal substance are one and the same and are defined as the genetic material that has been modified to create the pesticidal trait (i.e., modification of the sequence of nucleic acids). Loss-of-function plant-incorporated protectants do not include instances where the reduction or elimination of the activity of the modified native gene results in the intentional increase of activity of another pesticidal gene.
Native allele means a variant of a native gene that is identified in the genetic diversity of plants sexually compatible with the recipient plant.
Native gene means a gene that is identified in the recipient plant or source plants that are sexually compatible with the recipient plant. It does not include genes introduced through genetic engineering from a source organism that is not sexually compatible with the source plant.
Noncoding, nonexpressed nucleotide sequences means the nucleotide sequences are not transcribed and are not involved in gene expression. Examples of noncoding, nonexpressed nucleotide sequences include, but are not limited to, linkers, adapters, homopolymers, and sequences of restriction enzyme recognition sites.
Nucleic acids means ribosides or deoxyribosides of adenine, thymine, guanine, cytosine, and uracil; polymers of the deoxyribose-5'-monophosphates of thymine, cytosine, guanine, and adenine linked by successive 3'-5' phosphodiester bonds (also known as deoxyribonucleic acid); and polymers of the ribose-5'-monophosphates of uracil, cytosine, guanine, and adenine linked by successive 3'-5' phosphodiester bonds (also known as ribonucleic acid). The term does not apply to nucleic acid analogues (e.g., dideoxycytidine), or polymers containing nucleic acid analogues.
Pesticidal substance, means a substance that is intended to be produced and used in a living plant, or in the produce thereof, for a pesticidal purpose, during any part of a plant's life cyle (e.g., in the embryo, seed, seedling, mature plant).
Plant, for plant-incorporated protectants, means an organism classified using the 5-kingdom classification system of Whittaker in the kingdom Plantae. This includes, but is not limited to, bryophytes such as mosses, pteridophytes such as ferns, gymnosperms such as conifers, and angiosperms such as most major crop plants.
Plant-incorporated protectant means a pesticidal substance that is intended to be produced and used in a living plant, or in the produce thereof, and the genetic material necessary for production of such a pesticidal substance. It also includes any inert ingredient contained in the plant, or produce thereof.
Produce thereof, when used with respect to plants containing plant- incorporated protectants only, means a product of a living plant containing a plant-incorporated protectant, where the pesticidal substance is intended to serve a pesticidal purpose after the product has been separated from the living plant. Examples of such products include, but are not limited to, agricultural produce, grains, and lumber. Products such as raw agricultural commodities bearing pesticide chemical residues are not "produce thereof" when the residues are not intended to serve a pesticidal purpose in the produce.
Recipient plant means the living plant in which the plant-incorporated protectant is intended to be produced and used.
Recombinant DNA means the genetic material has been manipulated in vitro through the use of restriction endonucleases and/or other enzymes that aid in modifying genetic material, and subsequently introduced into the genome of the plant.
Regulatory region means genetic material that controls the expression of the genetic material that encodes a pesticidal substance or leads to the production of a pesticidal substance. Examples of regulatory regions include, but are not limited to, promoters, enhancers, and terminators.
Sexually compatible, when referring to plants, means plants must be capable of forming a viable zygote through the union of two gametes through conventional breeding.
Source means the donor of the genetic material that encodes a pesticidal substance or leads to the production of a pesticidal substance.
Vegetative reproduction means either:
Wide crosses means to facilitate the formation of viable zygotes through the use of surgical alteration of the plant pistil, bud pollination, mentor pollen, immunosuppressants, in vitro fertilization, pre-pollination and post-pollination hormone treatments, manipulation of chromosome numbers, embryo culture, or ovary and ovule cultures.
40 C.F.R. §174.3