and Plant Health Inspection Service, USDA § 340.2

definition of plant pest, or is an unclas- Well-characterized and contains only sified organism and/or an organism non-coding regulatory regions (e.g. oper- whose classification is unknown, or ators, promoters, origins of replication, any product which contains such an or- terminators, and ribosome binding re- ganism, or any other organism or prod- gions). The genetic material added to a uct altered or produced through ge- microorganism in which the following netic engineering which the Adminis- can be documented about such genetic trator, determines is a plant pest or material: (a) The exact nucleotide base has reason to believe is a plant pest. sequence of the regulatory region and Excluded are recipient microorganisms any inserted flanking nucleotides; (b) which are not plant pests and which The regulatory region and any inserted have resulted from the addition of ge- flanking nucleotides do not code for netic material from a donor organism protein or peptide; and (c) The regu- where the material is well character- latory region solely controls the activ- ized and contains only non-coding reg- ity of other sequences that code for ulatory regions. protein or peptide molecules or act as Release into the environment. The use recognition sites for the initiation of of a regulated article outside the con- nucleic acid or protein synthesis. straints of physical confinement that are found in a laboratory, contained [52 FR 22908, June 16, 1987, as amended at 53 greenhouse, or a fermenter or other FR 12913, Apr. 20, 1988; 55 FR 53276, Dec. 28, contained structure. 1990; 58 FR 17056, Mar. 31, 1993; 62 FR 23956, Responsible person. The person who May 2, 1997] has control and will maintain control § 340.2 Groups of organisms which are over the introduction of the regulated or contain plant pests and exemp- article and assure that all conditions tions. contained in the permit and require- ments in this part are complied with. A (a) Groups of organisms which are or responsible person shall be a resident contain plant pests. The organisms that of the United States or designate an are or contain plant pests are included agent who is a resident of the United in the taxa or group of organisms con- States. tained in the following list. Within any Secretary. The Secretary of Agri- taxonomic series included on the list, culture, or any other officer or em- the lowest unit of classification actu- ployee of the Department of Agri- ally listed is the taxon or group which culture to whom authority to act in may contain organisms which are regu- his/her stead has been or may hereafter lated. Organisms belonging to all lower be delegated. taxa contained within the group listed Stably integrated. The cloned genetic are included as organisms that may be material is contiguous with elements or may contain plant pests, and are of the recipient genome and is rep- regulated if they meet the definition of licated exclusively by mechanisms plant pest in § 340.1 4 used by recipient genomic DNA. State. Any State, the District of Co- 4 Any organism belonging to any taxa con- lumbia, American Samoa, Guam, tained within any listed genera or taxa is Northern Mariana Islands, Puerto only considered to be a plant pest if the or- Rico, the Virgin Islands of the United ganism ‘‘can directly or indirectly injure, or cause disease, or damage in any plants or States, and any other Territories or parts thereof, or any processed, manufac- Districts of the United States. tured, or other products of plants.’’ Thus a State regulatory official. State official particular unlisted species within a listed with responsibilities for plant health, genus would be deemed a plant pest for pur- or any other duly designated State offi- poses of § 340.2, if the scientific literature re- cial, in the State where the introduc- fers to the organism as a cause of direct or tion is to take place. indirect injury, disease, or damage to any United States. All of the States. plants, plant parts or products of plants. (If there is any question concerning the plant Vector or vector agent. Organisms or pest status of an organism belonging to any objects used to transfer genetic mate- listed genera or taxa, the person proposing rial from the donor organism to the re- to introduce the organism in question should cipient organism. Continued

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NOTE: Any genetically engineered orga- Superkingdom Eukaryotae nism composed of DNA or RNA sequences, organelles, plasmids, parts, copies, and/or Kingdom Plantae analogs, of or from any of the groups of orga- Subkingdom Thallobionta nisms listed below shall be deemed a regu- lated article if it also meets the definition of Division Chlorophyta plant pest in § 340.1. Genus Cephaleuros GROUP Genus Rhodochytrium Genus Phyllosiphon VIROIDS Division Myxomycota Superkingdom Prokaryotae Class Plasmodiophoromycetes Kingdom Virus Division Eumycota All members of groups containing plant vi- ruses, and all other plant and insect vi- Class Chytridiomycetes ruses Order Chytridiales

Kingdom Monera Class Oomycetes

DIVISION BACTERIA Order Lagenidiales Family Lagenidiaceae Family Pseudomonadaceae Family Olpidiopsidaceae Genus Pseudomonas Order Peronosporales Family Albuginaceae Genus Xanthomonas Family Peronosporaceae Family Rhizobiaceae Family Pythiaceae Genus Rhizobium Order Saprolegniales Genus Bradyrhizobium Family Saprolegniaceae Genus Agrobacterium Family Leptolegniellaceae Genus Phyllobacterium Family Enterobacteriaceae Class Zygomycetes Genus Erwinia Order Mucorales Family Streptomycetaceae Family Choanephoraceae Genus Streptomyces Family Mucoraceae Family Actinomycetacease Family Entomophthoraceae Genus Actinomyces Class Hemiascomycetes Coryneform group Family Protomycetaceae Genus Clavibacter Family Taphrinaceae Genus Arthrobacter Class Loculoascomycetes Genus Curtobacterium Genus Corynebacteria Order Myriangiales Gram-negative phloem-limited bacteria asso- Family Elsinoeaceae ciated with plant diseases Family Myriangiaceae Gram-negative xylem-limited bacteria asso- Order Asterinales ciated with plant diseases Order Dothideales And all other bacteria associated with plant Order Chaetothyriales or insect diseases Order Hysteriales Rickettsiaceae Family Parmulariaceae Rickettgial-like organisms associated with Family Phillipsiellaceae insect diseases Family Hysteriaceae Order Pleosporales Class Mollicutes Order Melanommatales Order Mycoplasmatales Class Plectomycetes Family Spiroplasmataceae Order Eurotiales Genus Spiroplasma Family Ophiostomataceae Mycoplasma-like organisms associated with Order Ascophaerales plant diseases Mycoplasma-like organisms associated with Class Pyrenomycetes insect diseases Order Erysiphales Order Meliolales consult with APHIS to determine if the orga- Order Xylariales nism is subject to regulation.) Order Diaporthales

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Order Hypocreales Genus Cordylanthus Order Clavicipitales Genus Dasistoma Genus Euphrasia Class Discomycetes Genus Gerardia Order Phacidiales Genus Harveya Order Helotiales Genus Hyobanche Family Ascocorticiceae Genus Lathraea Family Hemiphacidiaceae Genus Melampyrum Family Dermataceae Genus Melasma Family Sclerotiniaceae Genus Orthantha Order Cytarriales Genus Orthocarpus Order Medeolariales Genus Pedicularis Order Pezziales Genus Rhamphicarpa Family Sarcosomataceae Genus Rhinanthus Family Sarcoscyphaceae Genus Schwalbea Genus Seymeria Class Teliomycetes Genus Siphonostegia Genus Sopubia Class Phragmobasidiomycetes Genus Striga Family Auriculariaceae Genus Tozzia Family Ceratobasidiaceae Family Viscaceae—parasitic species Class Hymenomycetes Kingdom Animalia Order Exobasidiales Subkingdom Protozoa Order Agaricales Family Corticiaceae Genus Phytomonas Family Hymenochaetaceae And all Protozoa associated with insect Family Echinodontiaceae diseases Family Fistulinaceae Family Clavariaceae Subkingdom Eumetazoa Family Polyporaceae Family Tricholomataceae PHYLUM NEMATA Class Hyphomycetes CLASS SECERNENTEA Order Tylenchida Class Coelomycetes Family Anguinidae And all other fungi associated with plant or Family Belonolaimidae insect diseases Family Caloosiidae Family Criconematidae Subkingdom Embryobionta Family Dolichodoridae Family Fergusobiidae NOTE: Organisms listed in the Code of Federal Family Hemicycliophoridae Regulations as noxious weeds are regulated Family Heteroderidae under the Federal Noxious Weed Act Family Hoplolaimidae Family Meloidogynidae Division Magnoliophyta Family Nacobbidae Family Neotylenchidae Family Balanophoraceae—parasitic species Family Cuscutaceae—parasitic species Family Nothotylenchidae Family Hydnoraceae—parasitic species Family Paratylenchidae Family Krameriaceae—parasitic species Family Pratylenchidae Family Lauraceae—parasitic species Family Tylenchidae Genus Cassytha Family Tylenchulidae Family Lennoaceae—parasitic species Order Aphelenchida Family Loranthaceae—parasitic species Family Aphelenchoididae Family Myzodendraceae—parasitic species CLASS ADENOPHOREA Family Olacaceae—parasitic species Family Orobanchaceae—parasitic species Order Dorylaimida Family Rafflesiaceae—parasitic species Family Longidoridae Family Santalaceae—parasitic species Family Trichodoridae Family Scrophulariaceae—parasitic species Genus Alectra PHYLUM MOLLUSCA Genus Bartsia CLASS GASTROPODA Genus Buchnera Genus Buttonia Subclass Pulmonata Genus Castilleja Order Basommatophora Genus Centranthera Superfamily Planorbacea

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Order Stylommatophora Family Brentidae Subfamily Strophocheilacea Family Bruchidae Family Succineidae Family Buprestidae Superfamily Achatinacae Family Byturidae Superfamily Arionacae Family Cantharidae Superfamily Limacacea Family Carabidae Superfamily Helicacea Family Cerambycidae Order Systellommatophora Family Chrysomelidae Superfamily Veronicellacea Family Coccinellidae Subfamily Epilachninae Phylum Arthropoda Family Curculionidae Family Dermestidae Class Arachnida Family Elateridae Order Family Hydrophilidae Suborder Genus Helophorus Superfamily Ascoidea Family Lyctidae Superfamily Dermanyssoidea Family Meloidae Order Family Mordellidae Suborder Family Platypodidae Superfamily Eriophyoidea Family Scarabaeidae Superfamily Tetranychoidea Subfamily Melolonthinae Superfamily Eupodoidea Subfamily Rutelinae Superfamily Tydeoidea Subfamily Cetoniinae Superfamily Erythraenoidea Subfamily Dynastinae Superfamily Trombidioidea Family Scolytidae Superfamily Hydryphantoidea Family Selbytidae Superfamily Tarsonemoidea Family Tenebrionidae Superfamily Pyemotoidea Order Lepidoptera Suborder Astigmata Order Diptera Superfamily Hemisarcoptoidea Family Agromyzidae Superfamily Acaroidea Family Anthomyiidae Family Cecidomyiidae Class Diplopoda Family Chloropidae Family Ephydridae Order Polydesmida Family Lonchaeidae Class Insecta Family Muscidae Genus Atherigona Order Collembola Family Otitidae Family Sminthoridae Genus Euxeta Order Isoptera Family Syrphidae Order Thysanoptera Family Tephritidae Order Orthoptera Family Tipulidae Family Acrididae Order Hymenoptera Family Gryllidae Family Apidae Family Gryllacrididae Family Caphidae Family Gryllotalpidae Family Chalcidae Family Phasmatidae Family Cynipidae Family Ronaleidae Family Eurytomidae Family Tettigoniidae Family Formicidae Family Tetrigidae Family Psilidae Order Hemiptera Family Siricidae Family Thaumastocoridae Family Tenthredinidae Family Aradidae Family Torymidae Superfamily Piesmatoidea Family Xylocopidae Superfamily Lygaeoidea Unclassified organisms and/or organisms Superfamily Idiostoloidea whose classification is unknown. Superfamily Coreoidea Superfamily Pentatomoidea (b) Exemptions. (1) A limited permit Superfamily Pyrrhocoroidea for interstate movement shall not be Superfamily Tingoidea required for genetic material from any Superfamily Miroidea plant pest contained in Escherichia coli Order Homoptera genotype K–12 (strain K–12 and its de- Order Coleoptera Family Anobiidae rivatives), sterile strains of Saccharo- Family Apionidae myces cerevisiae, or asporogenic strains Family Anthribidae of Bacillus subtilis, provided that all the Family Bostrichidae following conditions are met:

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(i) The microorganisms are shipped provided that the introduction is in in a container that meets the require- compliance with the requirements of ments of § 340.8(b)(3); this section. Any other introduction of (ii) The cloned genetic material is regulated articles require a permit maintained on a nonconjugation pro- under § 340.4, with the exception of in- ficient plasmid and the host does not troductions that are conditionally ex- contain other conjugation proficient empt from permit requirements under plasmids or generalized transducing § 340.2(b) of this part. phages; (b) Regulated articles eligible for intro- (iii) The cloned material does not in- duction under the notification procedure. clude the complete infectious genome Regulated articles which meet all of of a known plant pest; the following six requirements and the (iv) The cloned genes are not carried performance standards set forth in on an expression vector if the cloned paragraph (c) of this section are eligi- genes code for: ble for introduction under the notifica- (A) A toxin to plants or plant prod- tion procedure. ucts, or a toxin to organisms beneficial (1) The regulated article is any plant to plants; or species that is not listed as a noxious (B) Other factors directly involved in weed in regulations at 7 CFR part 360 eliciting plant disease (i.e., cell wall de- under the Plant Protection Act (7 grading enzymes); or U.S.C. 7712), and, when being consid- (C) Substances acting as, or inhibi- ered for release into the environment, tory to, plant growth regulators. the regulated article is not considered (2) A limited permit for interstate by the Administrator to be a weed in movement is not required for genetic the area of release into the environ- material from any plant pest contained ment. in the genome of the plant Arabiodopsis (2) The introduced genetic material thaliana, provided that all of the fol- is ‘‘stably integrated’’ in the plant ge- lowing conditions are met: nome, as defined in § 340.1. (i) The plants or plant materials are (3) The function of the introduced ge- shipped in a container that meets the netic material is known and its expres- requirements of § 340.8(b) (1), (2), and sion in the regulated article does not (3); result in plant disease. (ii) The cloned genetic material is (4) The introduced genetic material stably integrated into the plant ge- does not: nome; (i) Cause the production of an infec- (iii) The cloned material does not in- tious entity, or clude the complete infectious genome (ii) Encode substances that are of a known plant pest. known or likely to be toxic to nontar- [52 FR 22908, June 16, 1987, as amended at 53 get organisms known or likely to feed FR 12913, Apr. 20, 1988; 55 FR 53276, Dec. 28, or live on the plant species, or 1990; 58 FR 17056, Mar. 31, 1993] (iii) Encode products intended for pharmaceutical or industrial use. § 340.3 Notification for the introduc- (5) To ensure that the introduced ge- tion of certain regulated articles. 5 netic sequences do not pose a signifi- (a) General. Certain regulated articles cant risk of the creation of any new may be introduced without a permit, plant virus, plant virus-derived se- quences must be: 5 APHIS may issue guidelines regarding (i) Noncoding regulatory sequences of scientific procedures, practices, or protocols known function, or which it has found acceptable in making var- (ii) Sense or antisense genetic con- ious determinations under the regulations. A structs derived from viral genes from person may follow an APHIS guideline or fol- plant viruses that are prevalent and low different procedures, practices, or proto- endemic in the area where the intro- cols. When different procedures, practices, or duction will occur and that infect protocols are followed, a person may, but is not required to, discuss the matter in ad- plants of the same host species, and vance with APHIS to help ensure that the that do not encode a functional procedures, practices, or protocols to be fol- noncapsid gene product responsible for lowed will be acceptable to APHIS. cell-to-cell movement of the virus.

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