Person. Any individual, partnership, corporation, company, society, association, or other organized group. gymnosperms, Plant. Any living stage or form of any member of the plant kingdom3 in:cluding, but not limited to, eukaryotic algae, mosses, club mosses, ferns, angiosperms, and lichens (which contain algae) including any parts (e.g. pollen, seeds, cells, tu: bers, stems) thereof, and any cellular components (e.g. plasmids, ribosomes, etc.) thereof. Plant pest. 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. Product. Anything made by or from, or derived from an organism, living or dead. Recipient organism. The organism which receives genetic material from a donor organism. Regulated article. 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 genera or taxa designated in §340.2 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 Administrator, 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 character 3 The taxonomic scheme for the plant kingdom is that found in Synopsis and Classification of Living Organisms by S.P. Parker, McGraw Hill (1984). ized and contains only non-coding regulatory regions. Release into the environment. The use of a regulated article outside the constraints of physical confinement that are found in a laboratory, contained greenhouse, or a fermenter or other contained structure. Responsible person. The person who has control and will maintain control over the introduction of the regulated article and assure that all conditions contained in the permit and requirements in this part are complied with. A responsible person shall be a resident of the United States or designate an agent who is a resident of the United States. Secretary. The Secretary of Agriculture, or any other officer or employee of the Department of Agriculture to whom authority to act in his/her stead has been or may hereafter be delegated. Stably integrated. The cloned genetic material is contiguous with elements of the recipient genome and is replicated exclusively by mechanisms used by recipient genomic DNA. State. Any State, the District of Columbia, American Samoa, Guam, Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States, and any other Territories or Districts of the United States. State regulatory official. State official with responsibilities for plant health, or any other duly designated State official, in the State where the introduction is to take place. United States. All of the States. Vector or vector agent. Organisms or objects used to transfer genetic material from the donor organism to the recipient organism. Well-characterized and contains only non-coding regulatory regions (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 region and any inserted flanking nucleotides; (b) The regulatory region 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. [52 FR 22908, June 16, 1987, as amended at 53 FR 12913, Apr. 20, 1988; 55 FR 53276, Dec. 28, 1990; 58 FR 17056, Mar. 31, 1993; 62 FR 23956, May 2, 1997] $340.2 Groups of organisms which are or contain plant pests and exemptions. (a) Groups of organisms which are or contain plant pests. The organisms that are or contain plant pests are included in the taxa or group of organisms contained in the following list. Within any taxonomic series included on the list, the lowest unit of classification actually listed is the taxon or group which may contain organisms which are regulated. Organisms belonging to all lower taxa contained within the group listed are included as organisms that may be or may contain plant pests, and are regulated if they meet the definition of plant pest in § 340.14 NOTE: Any genetically engineered organism composed of DNA or RNA sequences, organelles, plasmids, parts, copies, and/or analogs, of or from any of the groups of organisms listed below shall be deemed a regulated article if it also meets the definition of plant pest in § 340.1. 4 Any organism belonging to any taxa contained within any listed genera or taxa is only considered to be a plant pest if the organism "can directly or indirectly injure, or cause disease, or damage in any plants or parts thereof, or any processed, manufactured, or other products of plants." Thus a particular unlisted species within a listed genus would be deemed a plant pest for purposes of §340.2, if the scientific literature refers to the organism as a cause of direct or indirect injury, disease, or damage to any plants, plant parts or products of plants. (If there is any question concerning the plant pest status of an organism belonging to any listed genera or taxa, the person proposing to introduce the organism in question should consult with APHIS to determine if the organism is subject to regulation.) GROUP VIROIDS Superkingdom Prokaryotae Kingdom Virus All members of groups containing plant viruses, and all other plant and insect vi ruses Kingdom Monera DIVISION BACTERIA Family Pseudomonadaceae Genus Pseudomonas Genus Xanthomonas Family Rhizobiaceae Genus Rhizobium Genus Bradyrhizobium Family Streptomycetaceae Coryneform group Genus Clavibacter Gram-negative phloem-limited bacteria associated with plant diseases Gram-negative xylem-limited bacteria associated with plant diseases And all other bacteria associated with plant or insect diseases Rickettsiaceae Rickettgial-like organisms associated with insect diseases Class Mollicutes Order Mycoplasmatales Mycoplasma-like organisms associated with plant diseases Mycoplasma-like organisms associated with insect diseases Superkingdom Eukaryotae Kingdom Plantae Genus Cephaleuros Family Curculionidae Genus Helophorus Subfamily Melolonthinae Subfamily Dynastinae Family Scolytidae Family Agromyzidae Family Anthomyiidae Family Cecidomyiidae Family Chloropidae Family Otitidae Genus Euxeta Family Syrphidae Family Tephritidae Family Tipulidae Order Hymenoptera Family Apidae Family Caphidae Family Chalcidae Family Cynipidae Family Eurytomidae Family Formicidae Family Psilidae Family Siricidae Family Tenthredinidae Family Torymidae Unclassified organisms and/or organisms whose classification is unknown. (b) Exemptions. (1) A limited permit for interstate movement shall not be required for genetic material from any plant pest contained in Escherichia coli genotype K-12 (strain K-12 and its derivatives), sterile strains of Saccharomyces cerevisiae, or asporogenic strains of Bacillus subtilis, provided that all the following conditions are met: (i) The microorganisms are shipped in a container that meets the requirements of §340.8(b)(3); (ii) The cloned genetic material is maintained on a nonconjugation proficient plasmid and the host does not contain other conjugation proficient plasmids or generalized transducing phages; (iii) The cloned material does not include the complete infectious genome of a known plant pest; (iv) The cloned genes are not carried on an expression vector if the cloned genes code for: (A) A toxin to plants or plant products, or a toxin to organisms beneficial to plants; or (B) Other factors directly involved in eliciting plant disease (i.e., cell wall degrading enzymes); or (C) Substances acting as, or inhibitory to, plant growth regulators. (2) A limited permit for interstate movement is not required for genetic material from any plant pest contained in the genome of the plant Arabiodopsis thaliana, provided that all of the following conditions are met: (i) The plants or plant materials are shipped in a container that meets the requirements of §340.8(b) (1), (2), and (3); (ii) The cloned genetic material is stably integrated into the plant genome; (iii) The cloned material does not inIclude the complete infectious genome of a known plant pest. [52 FR 22908, June 16, 1987, as amended at 53 FR 12913, Apr. 20, 1988; 55 FR 53276, Dec. 28, 1990; 58 FR 17056, Mar. 31, 1993] 8340.3 Notification for the introduction of certain regulated articles.5 (a) General. Certain regulated articles may be introduced without a permit, provided that the introduction is in compliance with the requirements of this section. Any other introduction of regulated articles require a permit under $340.4, with the exception of introductions that are conditionally exempt from permit requirements under § 340.2(b) of this part. 5 APHIS may issue guidelines regarding scientific procedures, practices, or protocols which it has found acceptable in making various determinations under the regulations. A person may follow an APHIS guideline or follow different procedures, practices, or protocols. When different procedures, practices, or protocols are followed, a person may, but is not required to, discuss the matter in advance with APHIS to help ensure that the procedures, practices, or protocols to be followed will be acceptable to APHIS. |