BOX 3.1 Key Definitions Used by APHIS

Introduce or introduction (APHIS 1997b) “To move into or through the United States, to release into the environment, to move interstate, or any attempt thereat.”

Plant (APHIS 1987) “Any living stage or form of any member of the plant kingdom including, but not limited to, eukayotic algae, mosses, club mosses, ferns, angiosperms, gymnosperms, and lichens (which contain algae) including any parts (e.g., pollen, seeds, cells, tubers, stems) thereof, and any cellular components (e.g., plasmids, ribosomes, etc.) thereof.”

Plant pest (APHIS 1987) “Any living stage (including active and dormant forms) of insects, mites, nematodes, slugs, snails, protozoa, or other invertebrate animals, bacteria, fungi, other parasitic plants or reproductive parts thereof; viruses; or any organisms similar to or allied with any of the foregoing; or any infectious agents or substances, which can directly or indirectly injure or cause disease or damage in or to any plants or parts thereof, or any processed, manufactured, or other products of plants.”

Regulated article (APHIS 1987) “Any organism which has been altered or produced through genetic engineering, if the donor organism, recipient organism, or vector or vector agent belongs to any genus or taxon designated in a list (7 CFR 340.2) of taxa known to have plant pests, and meets the definition of plant pest, or is an unclassified organism and/or an organism whose classification is unknown, or any product which contains such an organism, or any other organism or product altered or produced through genetic engineering which the Director, BBEP (Biotechnology, Biologics, and Environmental Protection division of APHIS), determines is a plant pest or has reason to believe is a plant pest. Excluded are recipient microorganisms which are not plant pests and which have resulted from the addition of genetic material from a donor organism where the material is well characterized and contains only non-coding regulatory regions.”

Release into the environment (Federal Register 52:22908–9) “The use of a regulated article outside the constraints of physical containment that are found in a laboratory, contained greenhouse, or a fermenter or other contained structure.”

Well-characterized and contains only noncoding regulatory regions (APHIS 1987; e.g., operators, promoters, origins of replication, terminators, and ribosome binding regions) “The genetic material added to a microorganism in which the following can be documented about such genetic material: (a) The exact nucleotide base sequence of the regulatory regions and any inserted flanking nucleotides; (b) The regulatory regions and any inserted flanking nucleotides do not code for protein or peptide; and (c) The regulatory region solely controls the activity of other sequences that code for protein or peptide molecules or act as recognition sites for the initiation of nucleic acid or protein synthesis.”

ring organisms, which might be plant pests. For example, APHIS regulates the movement and release of geographically separated populations of known plant pests because the source population can have characteristics that are absent in the recipient geographic population, which could

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