Introduction of Organisms and Products Altered or Produced through Genetic Engineering which are Plant Pests or which there is reason to believe are Plant Pests (7 CFR 340.0-340.9)

463 Animal and Plant Health Inspection Service, USDA § 340.1 1 Part 340 regulates, among other things, the introduction of organisms and products altered or produced through genetic engi neering that are plant pests or are believed to be plant pests. The introduction into the United States of such articles also may be subject to other regulations promulgated under the Plant Protection Act (7 U.S.C. 7701–7772) and found in 7 CFR parts 319, 330, and 360. For example, under regulations pro mulgated in ‘‘Subpart-Nursery Stock, Plants, Roots, Bulbs, Seeds, and Other Plant Products’’ (7 CFR 319.37–3), a permit is re quired for the importation of certain classes of nursery stock whether such stock is ge netically engineered or not. Accordingly, in dividuals should refer to those regulations before importing any nursery stock. 2 An inspector may hold, seize, quarantine, treat, apply other remedial measures to, de stroy, or otherwise dispose of plants, plant pests, or other articles in accordance with sections 411, 412, 421, and 434 of the Plant Protection Act (7 U.S.C. 7711, 7712, 7731, and 7754). (vi) Actions taken to respond to the release; and (vii) Hazards posed by the release. (2) A completed APHIS/CDC Form 3 must be submitted within 7 calendar days. [70 FR 13278, Mar. 18, 2005, as amended at 77 FR 61077, Oct. 5, 2012] § 331.20 Administrative review. (a) An individual or entity may ap peal a denial, revocation, or suspension of registration under this part. The ap peal must be in writing, state the fac tual basis for the appeal, and be sub mitted to the Administrator within 30 calendar days of the decision. (b) An individual may appeal a de nial, limitation, or revocation of access approval under this part. The appeal must be in writing, state the factual basis for the appeal, and be submitted to the Administrator within 180 cal endar days of the decision. (c) The Administrator’s decision con stitutes final agency action. [77 FR 61077, Oct. 5, 2012] PART 340—INTRODUCTION OF OR GANISMS AND PRODUCTS AL TERED OR PRODUCED THROUGH GENETIC ENGINEERING WHICH ARE PLANT PESTS OR WHICH THERE IS REASON TO BELIEVE ARE PLANT PESTS Sec. 340.0 Restrictions on the introduction of regulated articles. 340.1 Definitions. 340.2 Groups of organisms which are or con tain plant pests and exemptions. 340.3 Notification for the introduction of certain regulated articles. 340.4 Permits for the introduction of a regu lated article. 340.5 Petition to amend the list of orga nisms. 340.6 Petition for determination of nonregu lated status. 340.7 Marking and identity. 340.8 Container requirements for the move ment of regulated articles. 340.9 Cost and charges. AUTHORITY: 7 U.S.C. 7701–7772 and 7781–7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3. SOURCE: 52 FR 22908, June 16, 1987, unless otherwise noted. § 340.0 Restrictions on the introduc tion of regulated articles. (a) No person shall introduce any reg ulated article unless the Administrator is: (1) Notified of the introduction in ac cordance with § 340.3, or such introduc tion is authorized by permit in accord ance with § 340.4, or such introduction is conditionally exempt from permit requirements under § 340.2(b); and (2) Such introduction is in con formity with all other applicable re strictions in this part. 1 (b) Any regulated article introduced not in compliance with the require ments of this part shall be subject to the immediate application of such re medial measures or safeguards as an inspector determines necessary to pre vent the introduction of such plant pests. 2 [52 FR 22908, June 16, 1987, as amended at 58 FR 17056, Mar. 31, 1993; 62 FR 23956, May 2, 1997; 66 FR 21058, Apr. 27, 2001] § 340.1 Definitions. Terms used in the singular form in this part shall be construed as the plu ral, and vice versa, as the case may de mand. The following terms, when used in this part, shall be construed, respec tively, to mean: VerDate Sep<11>2014 09:24 Feb 15, 2018 Jkt 244016 PO 00000 Frm 00473 Fmt 8010 Sfmt 8010 Y:\SGML\244016.XXX 244016ns h a tt u ck o n D S K 9 F 9 S C 4 2 P R O D w ith C F R 464 7 CFR Ch. III (1–1–18 Edition) § 340.1 3 The taxonomic scheme for the plant king dom is that found in Synopsis and Classifica tion of Living Organisms by S.P. Parker, McGraw Hill (1984). Administrator. The Administrator of the Animal and Plant Health Inspec tion Service (APHIS) or any other em ployee of APHIS to whom authority has been or may be delegated to act in the Administrator’s stead. Animal and Plant Health Inspection Service (APHIS). An agency of the United States Department of Agri culture. Antecedent organism. An organism that has already been the subject of a determination of nonregulated status by APHIS under § 340.6, and that is used as a reference for comparison to the regulated article under consideration under these regulations. Courtesy permit. A written permit issued by the Administrator, in accord ance with § 340.4(h). Donor organism. The organism from which genetic material is obtained for transfer to the recipient organism. Environment. All the land, air, and water; and all living organisms in asso ciation with land, air and water. Expression vector. A cloning vector de signed so that a coding sequence in serted at a particular site will be tran scribed and translated into protein. Genetic engineering. The genetic modi fication of organisms by recombinant DNA techniques. Inspector. Any employee of the Ani mal and Plant Health Inspection Serv ice, U.S. Department of Agriculture, or other person, authorized by the Admin istrator, in accordance with law to en force the provisions of this part. Interstate. From any State into or through any other State. Introduce or introduction. To move into or through the United States, to release into the environment, to move interstate, or any attempt thereat. Move (moving, movement). To ship, offer for shipment, offer for entry, im port, receive for transportation, carry, or otherwise transport or move, or allow to be moved into, through, or within the United States. Organism. Any active, infective, or dormant stage or life form of an entity characterized as living, including vertebrate and invertebrate animals, plants, bacteria, fungi, mycoplasmas, mycoplasma-like organisms, as well as entities such as viroids, viruses, or any entity characterized as living, related to the foregoing. Permit. A written permit issued by the Administrator, for the introduction of a regulated article under conditions determined by the Administrator, not to present a risk of plant pest introduc tion. Person. Any individual, partnership, corporation, company, society, associa tion, or other organized group. Plant. Any living stage or form of any member of the plant kingdom 3 in cluding, but not limited to, eukaryotic algae, mosses, club mosses, ferns, angiosperms, gymnosperms, 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 (includ ing active and dormant forms) of in sects, mites, nematodes, slugs, snails, protozoa, or other invertebrate ani mals, 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 proc essed, 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 orga nism, 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 unclas sified organism and/or an organism whose classification is unknown, or VerDate Sep<11>2014 09:24 Feb 15, 2018 Jkt 244016 PO 00000 Frm 00474 Fmt 8010 Sfmt 8010 Y:\SGML\244016.XXX 244016ns h a tt u ck o n D S K 9 F 9 S C 4 2 P R O D w ith C F R 465 Animal and Plant Health Inspection Service, USDA § 340.2 4 Any organism belonging to any taxa con tained within any listed genera or taxa is only considered to be a plant pest if the or ganism ‘‘can directly or indirectly injure, or cause disease, or damage in any plants or parts thereof, or any processed, manufac tured, or other products of plants.’’ Thus a particular unlisted species within a listed genus would be deemed a plant pest for pur poses of § 340.2, if the scientific literature re fers 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 orga nism is subject to regulation.) any product which contains such an or ganism, or any other organism or prod uct altered or produced through ge netic engineering which the Adminis trator, 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 ge netic material from a donor organism where the material is well character ized and contains only non-coding reg ulatory regions. Release into the environment. The use of a regulated article outside the con straints 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 require ments 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 Agri culture, or any other officer or em ployee of the Department of Agri culture 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 rep licated exclusively by mechanisms used by recipient genomic DNA. State. Any State, the District of Co lumbia, 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 offi cial, in the State where the introduc tion is to take place. United States. All of the States. Vector or vector agent. Organisms or objects used to transfer genetic mate rial from the donor organism to the re cipient organism. Well-characterized and contains only non-coding regulatory regions (e.g. oper ators, promoters, origins of replication, terminators, and ribosome binding re gions). 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 regu latory region solely controls the activ ity 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 exemp tions. (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 con tained in the following list. Within any taxonomic series included on the list, the lowest unit of classification actu ally listed is the taxon or group which may contain organisms which are regu lated. 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 § 340.1 4 NOTE: Any genetically engineered orga nism composed of DNA or RNA sequences, organelles, plasmids, parts, copies, and/or VerDate Sep<11>2014 09:24 Feb 15, 2018 Jkt 244016 PO 00000 Frm 00475 Fmt 8010 Sfmt 8010 Y:\SGML\244016.XXX 244016ns h a tt u ck o n D S K 9 F 9 S C 4 2 P R O D w ith C F R 466 7 CFR Ch. III (1–1–18 Edition) § 340.2 analogs, of or from any of the groups of orga nisms listed below shall be deemed a regu lated article if it also meets the definition of plant pest in § 340.1. GROUP VIROIDS Superkingdom Prokaryotae Kingdom Virus All members of groups containing plant vi ruses, and all other plant and insect vi ruses Kingdom Monera DIVISION BACTERIA Family Pseudomonadaceae Genus Pseudomonas Genus Xanthomonas Family Rhizobiaceae Genus Rhizobium Genus Bradyrhizobium Genus Agrobacterium Genus Phyllobacterium Family Enterobacteriaceae Genus Erwinia Family Streptomycetaceae Genus Streptomyces Family Actinomycetacease Genus Actinomyces Coryneform group Genus Clavibacter Genus Arthrobacter Genus Curtobacterium Genus Corynebacteria Gram-negative phloem-limited bacteria asso ciated with plant diseases Gram-negative xylem-limited bacteria asso ciated 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 Family Spiroplasmataceae Genus Spiroplasma Mycoplasma-like organisms associated with plant diseases Mycoplasma-like organisms associated with insect diseases Superkingdom Eukaryotae Kingdom Plantae Subkingdom Thallobionta Division Chlorophyta Genus Cephaleuros Genus Rhodochytrium Genus Phyllosiphon Division Myxomycota Class Plasmodiophoromycetes Division Eumycota Class Chytridiomycetes Order Chytridiales Class Oomycetes Order Lagenidiales Family Lagenidiaceae Family Olpidiopsidaceae Order Peronosporales Family Albuginaceae Family Peronosporaceae Family Pythiaceae Order Saprolegniales Family Saprolegniaceae Family Leptolegniellaceae Class Zygomycetes Order Mucorales Family Choanephoraceae Family Mucoraceae Family Entomophthoraceae Class Hemiascomycetes Family Protomycetaceae Family Taphrinaceae Class Loculoascomycetes Order Myriangiales Family Elsinoeaceae Family Myriangiaceae Order Asterinales Order Dothideales Order Chaetothyriales Order Hysteriales Family Parmulariaceae Family Phillipsiellaceae Family Hysteriaceae Order Pleosporales Order Melanommatales Class Plectomycetes Order Eurotiales Family Ophiostomataceae Order Ascophaerales Class Pyrenomycetes Order Erysiphales Order Meliolales Order Xylariales Order Diaporthales Order Hypocreales Order Clavicipitales Class Discomycetes Order Phacidiales Order Helotiales Family Ascocorticiceae Family Hemiphacidiaceae Family Dermataceae VerDate Sep<11>2014 09:24 Feb 15, 2018 Jkt 244016 PO 00000 Frm 00476 Fmt 8010 Sfmt 8010 Y:\SGML\244016.XXX 244016ns h a tt u ck o n D S K 9 F 9 S C 4 2 P R O D w ith C F R 467 Animal and Plant Health Inspection Service, USDA § 340.2 Family Sclerotiniaceae Order Cytarriales Order Medeolariales Order Pezziales Family Sarcosomataceae Family Sarcoscyphaceae Class Teliomycetes Class Phragmobasidiomycetes Family Auriculariaceae Family Ceratobasidiaceae Class Hymenomycetes Order Exobasidiales Order Agaricales Family Corticiaceae Family Hymenochaetaceae Family Echinodontiaceae Family Fistulinaceae Family Clavariaceae Family Polyporaceae Family Tricholomataceae Class Hyphomycetes Class Coelomycetes And all other fungi associated with plant or insect diseases Subkingdom Embryobionta NOTE: Organisms listed in the Code of Federal Regulations as noxious weeds are regulated under the Federal Noxious Weed Act Division Magnoliophyta Family Balanophoraceae—parasitic species Family Cuscutaceae—parasitic species Family Hydnoraceae—parasitic species Family Krameriaceae—parasitic species Family Lauraceae—parasitic species Genus Cassytha Family Lennoaceae—parasitic species Family Loranthaceae—parasitic species Family Myzodendraceae—parasitic species Family Olacaceae—parasitic species Family Orobanchaceae—parasitic species Family Rafflesiaceae—parasitic species Family Santalaceae—parasitic species Family Scrophulariaceae—parasitic species Genus Alectra Genus Bartsia Genus Buchnera Genus Buttonia Genus Castilleja Genus Centranthera Genus Cordylanthus Genus Dasistoma Genus Euphrasia Genus Gerardia Genus Harveya Genus Hyobanche Genus Lathraea Genus Melampyrum Genus Melasma Genus Orthantha Genus Orthocarpus Genus Pedicularis Genus Rhamphicarpa Genus Rhinanthus Genus Schwalbea Genus Seymeria Genus Siphonostegia Genus Sopubia Genus Striga Genus Tozzia Family Viscaceae—parasitic species Kingdom Animalia Subkingdom Protozoa Genus Phytomonas And all Protozoa associated with insect diseases Subkingdom Eumetazoa PHYLUM NEMATA CLASS SECERNENTEA Order Tylenchida Family Anguinidae Family Belonolaimidae Family Caloosiidae Family Criconematidae Family Dolichodoridae Family Fergusobiidae Family Hemicycliophoridae Family Heteroderidae Family Hoplolaimidae Family Meloidogynidae Family Nacobbidae Family Neotylenchidae Family Nothotylenchidae Family Paratylenchidae Family Pratylenchidae Family Tylenchidae Family Tylenchulidae Order Aphelenchida Family Aphelenchoididae CLASS ADENOPHOREA Order Dorylaimida Family Longidoridae Family Trichodoridae PHYLUM MOLLUSCA CLASS GASTROPODA Subclass Pulmonata Order Basommatophora Superfamily Planorbacea Order Stylommatophora Subfamily Strophocheilacea Family Succineidae Superfamily Achatinacae Superfamily Arionacae Superfamily Limacacea Superfamily Helicacea Order Systellommatophora Superfamily Veronicellacea VerDate Sep<11>2014 09:24 Feb 15, 2018 Jkt 244016 PO 00000 Frm 00477 Fmt 8010 Sfmt 8010 Y:\SGML\244016.XXX 244016ns h a tt u ck o n D S K 9 F 9 S C 4 2 P R O D w ith C F R 468 7 CFR Ch. III (1–1–18 Edition) § 340.2 Phylum Arthropoda Class Arachnida Order Parasitiformes Suborder Mesostigmata Superfamily Ascoidea Superfamily Dermanyssoidea Order Acariformes Suborder Prostigmata Superfamily Eriophyoidea Superfamily Tetranychoidea Superfamily Eupodoidea Superfamily Tydeoidea Superfamily Erythraenoidea Superfamily Trombidioidea Superfamily Hydryphantoidea Superfamily Tarsonemoidea Superfamily Pyemotoidea Suborder Astigmata Superfamily Hemisarcoptoidea Superfamily Acaroidea Class Diplopoda Order Polydesmida Class Insecta Order Collembola Family Sminthoridae Order Isoptera Order Thysanoptera Order Orthoptera Family Acrididae Family Gryllidae Family Gryllacrididae Family Gryllotalpidae Family Phasmatidae Family Ronaleidae Family Tettigoniidae Family Tetrigidae Order Hemiptera Family Thaumastocoridae Family Aradidae Superfamily Piesmatoidea Superfamily Lygaeoidea Superfamily Idiostoloidea Superfamily Coreoidea Superfamily Pentatomoidea Superfamily Pyrrhocoroidea Superfamily Tingoidea Superfamily Miroidea Order Homoptera Order Coleoptera Family Anobiidae Family Apionidae Family Anthribidae Family Bostrichidae Family Brentidae Family Bruchidae Family Buprestidae Family Byturidae Family Cantharidae Family Carabidae Family Cerambycidae Family Chrysomelidae Family Coccinellidae Subfamily Epilachninae Family Curculionidae Family Dermestidae Family Elateridae Family Hydrophilidae Genus Helophorus Family Lyctidae Family Meloidae Family Mordellidae Family Platypodidae Family Scarabaeidae Subfamily Melolonthinae Subfamily Rutelinae Subfamily Cetoniinae Subfamily Dynastinae Family Scolytidae Family Selbytidae Family Tenebrionidae Order Lepidoptera Order Diptera Family Agromyzidae Family Anthomyiidae Family Cecidomyiidae Family Chloropidae Family Ephydridae Family Lonchaeidae Family Muscidae Genus Atherigona 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 Family Xylocopidae 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 de rivatives), sterile strains of Saccharo myces 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 require ments of § 340.8(b)(3); (ii) The cloned genetic material is maintained on a nonconjugation pro ficient plasmid and the host does not contain other conjugation proficient plasmids or generalized transducing phages; VerDate Sep<11>2014 09:24 Feb 15, 2018 Jkt 244016 PO 00000 Frm 00478 Fmt 8010 Sfmt 8010 Y:\SGML\244016.XXX 244016ns h a tt u ck o n D S K 9 F 9 S C 4 2 P R O D w ith C F R 469 Animal and Plant Health Inspection Service, USDA § 340.3 5 APHIS may issue guidelines regarding scientific procedures, practices, or protocols which it has found acceptable in making var ious determinations under the regulations. A person may follow an APHIS guideline or fol low different procedures, practices, or proto cols. When different procedures, practices, or protocols are followed, a person may, but is not required to, discuss the matter in ad vance with APHIS to help ensure that the procedures, practices, or protocols to be fol lowed will be acceptable to APHIS. (iii) The cloned material does not in clude 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 prod ucts, or a toxin to organisms beneficial to plants; or (B) Other factors directly involved in eliciting plant disease (i.e., cell wall de grading enzymes); or (C) Substances acting as, or inhibi tory 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 fol lowing 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 ge nome; (iii) The cloned material does not in clude 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] § 340.3 Notification for the introduc tion 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 in troductions that are conditionally ex empt from permit requirements under § 340.2(b) of this part. (b) Regulated articles eligible for intro duction under the notification procedure. Regulated articles which meet all of the following six requirements and the performance standards set forth in paragraph (c) of this section are eligi ble for introduction under the notifica tion procedure. (1) The regulated article is any plant species that is not listed as a noxious weed in regulations at 7 CFR part 360 under the Plant Protection Act (7 U.S.C. 7712), and, when being consid ered for release into the environment, the regulated article is not considered by the Administrator to be a weed in the area of release into the environ ment. (2) The introduced genetic material is ‘‘stably integrated’’ in the plant ge nome, as defined in § 340.1. (3) The function of the introduced ge netic material is known and its expres sion in the regulated article does not result in plant disease. (4) The introduced genetic material does not: (i) Cause the production of an infec tious entity, or (ii) Encode substances that are known or likely to be toxic to nontar get organisms known or likely to feed or live on the plant species, or (iii) Encode products intended for pharmaceutical or industrial use. (5) To ensure that the introduced ge netic sequences do not pose a signifi cant risk of the creation of any new plant virus, plant virus-derived se quences must be: (i) Noncoding regulatory sequences of known function, or (ii) Sense or antisense genetic con structs derived from viral genes from plant viruses that are prevalent and endemic in the area where the intro duction will occur and that infect plants of the same host species, and that do not encode a functional noncapsid gene product responsible for cell-to-cell movement of the virus. (6) The plant has not been modified to contain the following genetic mate rial from animal or human pathogens: (i) Any nucleic acid sequence derived from an animal or human virus, or (ii) Coding sequences whose products are known or likely causal agents of disease in animals or humans. VerDate Sep<11>2014 09:24 Feb 15, 2018 Jkt 244016 PO 00000 Frm 00479 Fmt 8010 Sfmt 8010 Y:\SGML\244016.XXX 244016ns h a tt u ck o n D S K 9 F 9 S C 4 2 P R O D w ith C F R 470 7 CFR Ch. III (1–1–18 Edition) § 340.3 (c) Performance standards for introduc tions under the notification procedure. The following performance standards must be met for any introductions under the notification procedure. (1) If the plants or plant materials are shipped, they must be shipped in such a way that the viable plant mate rial is unlikely to be disseminated while in transit and must be main tained at the destination facility in such a way that there is no release into the environment. (2) When the introduction is an envi ronmental release, the regulated arti cle must be planted in such a way that they are not inadvertently mixed with non-regulated plant materials of any species which are not part of the envi ronmental release. (3) The plants and plant parts must be maintained in such a way that the identity of all material is known while it is in use, and the plant parts must be contained or devitalized when no longer in use. (4) There must be no viable vector agent associated with the regulated ar ticle. (5) The field trial must be conducted such that: (i) The regulated article will not per sist in the environment, and (ii) No offspring can be produced that could persist in the environment. (6) Upon termination of the field test: (i) No viable material shall remain which is likely to volunteer in subse quent seasons, or (ii) Volunteers shall be managed to prevent persistence in the environ ment. (d) Procedural requirements for noti fying APHIS. The following procedures shall be followed for any introductions under the notification procedure: (1) Notification should be directed to the Animal and Plant Health Inspec tion Service, Plant Protection and Quarantine, Biotechnology and Sci entific Services, Biotechnology Per mits, 4700 River Road, Unit 147, River dale, Maryland 20737–1237. (2) The notification shall include the following: (i) Name, title, address, telephone number, and signature of the respon sible person; (ii) Information necessary to identify the regulated article(s), including: (A) The scientific, common, or trade names, and phenotype of regulated ar ticle, (B) The designations for the genetic loci, the encoded proteins or functions, and donor organisms for all genes from which introduced genetic material was derived, and (C) The method by which the recipi ent was transformed; (iii) The names and locations of the origination and destination facilities for movement or the field site location for the environmental release; and the size of the introduction, (iv) The date and, in the case of envi ronmental release, the expected dura tion of the introduction (release); and (v) A statement that certifies that introduction of the regulated article will be in accordance with the provi sions of this section. (3) Notification must be submitted to APHIS: (i) At least 10 days prior to the day of introduction, if the introduction is interstate movement. (ii) At least 30 days prior to the day of introduction, if the introduction is an importation. (iii) At least 30 days prior to the day of introduction, if the introduction is an environmental release. (4) Field test reports must be sub mitted to APHIS within 6 months after termination of the field test. Field test reports shall include the APHIS ref erence number, methods of observa tion, resulting data, and analysis re garding all deleterious effects on plants, nontarget organisms, or the en vironment. (5) The Administrator, shall be noti fied of any unusual occurrence within the time periods and in the manner specified in § 340.4(f)(10). (6) Access shall be allowed for APHIS and State regulatory officials to in spect facilities and/or the field test site and any records necessary to evaluate compliance with the provisions of para graphs (b) and (c) of this section. (e) Administrative action in response to notification. (1) APHIS will provide cop ies of all notifications to appropriate State regulatory official(s) for review VerDate Sep<11>2014 09:24 Feb 15, 2018 Jkt 244016 PO 00000 Frm 00480 Fmt 8010 Sfmt 8010 Y:\SGML\244016.XXX 244016ns h a tt u ck o n D S K 9 F 9 S C 4 2 P R O D w ith C F R 471 Animal and Plant Health Inspection Service, USDA § 340.4 6 See footnote 5 in § 340.3. 7 The 120 day review period would be ex tended if preparation of an environmental impact statement in addition to an environ mental assessment was necessary. 8 Application forms are available without charge from the Animal and Plant Health In spection Service, Plant Protection and Quar antine, Biotechnology and Scientific Serv ices, Biotechnology Permits, 4700 River Road, Unit 147, Riverdale, Maryland 20737– 1237, or from local offices which are listed in telephone directories. A person should speci fy in requesting the application that the per mit is for the introduction of a regulated ar ticle subject to regulation under part 340. within 5 business days of receipt. Com ments to APHIS from appropriate State regulatory officials in response to notifications for interstate move ment of regulated articles will not be required by APHIS prior to acknowl edgment, although States may provide their reviews to APHIS at their discre tion. (2) The Administrator, will provide acknowledgement within 10 days of re ceipt that the interstate movement is appropriate under notification. (3) The Administrator, will provide acknowledgement within 30 days of re ceipt that the importation is appro priate under notification. (4) APHIS will provide acknowledg ment within 30 days of receipt that the environmental release is appropriate under notification. Such acknowledg ment will apply to field testing for 1 year from the date of introduction, and may be renewed annually by submis sion of an additional notification to APHIS. (5) A person denied permission for in troduction of a regulated article under notification may apply for a permit for introduction of that regulated article without prejudice. [58 FR 17056, Mar. 31, 1993, as amended at 59 FR 67610, Dec. 30, 1994; 62 FR 23956, May 2, 1997; 66 FR 21058, Apr. 27, 2001; 68 FR 46436, Aug. 6, 2003] § 340.4 Permits for the introduction of a regulated article. 6 (a) Application for permit. Two copies of a written application for a permit to introduce a regulated article, which may be obtained from APHIS, shall be submitted by the responsible person to the Animal and Plant Health Inspec tion Service, Plant Protection and Quarantine, Biotechnology and Sci entific Services, Biotechnology Per mits, 4700 River Road, Unit 147, River dale, Maryland 20737–1237. If there are portions of the application deemed to contain trade secret or confidential business information (CBI), each page of the application containing such in formation should be marked ‘‘CBI Copy’’. In addition, those portions of the application which are deemed ‘‘CBI’’ shall be so designated. The sec ond copy shall have all such CBI de leted and shall be marked on each page of the application where CBI was de leted, ‘‘CBI Deleted’’. If an application does not contain CBI then the first page of both copies shall be marked ‘‘No CBI’’. (b) Permit for release into the environ ment. An application for the release into the environment of a regulated ar ticle shall be submitted at least 120 days in advance of the proposed release into the environment. An initial review shall be completed by APHIS within 30 days of the receipt of the application. If the application is complete, the re sponsible individual shall be notified of the date of receipt of the application for purposes of advising the applicant when the 120 day review period com menced. 7 If the application is not com plete, the responsible individual will be advised what additional information must be submitted. APHIS shall com mence the 120 day review period upon receipt of the additional information, assuming the additional information submitted is adequate. When it is de termined that an application is com plete, APHIS shall submit to the State department of agriculture of the State where the release is planned, a copy of the initial review and a copy of the ap plication marked, ‘‘CBI Deleted’’, or ‘‘No CBI’’ for State notification and re view. The application shall include the following information: 8 (1) Name, title, address, telephone number, signature of the responsible person and type of permit requested (for importation, interstate movement, or release into the environment); (2) All scientific, common, and trade names, and all designations necessary VerDate Sep<11>2014 09:24 Feb 15, 2018 Jkt 244016 PO 00000 Frm 00481 Fmt 8010 Sfmt 8010 Y:\SGML\244016.XXX 244016ns h a tt u ck o n D S K 9 F 9 S C 4 2 P R O D w ith C F R 472 7 CFR Ch. III (1–1–18 Edition) § 340.4 to identify the: Donor organism(s); re cipient organism(s); vector or vector agent(s); constituent of each regulated article which is a product; and, regu lated article; (3) Names, addresses, and telephone numbers of the persons who developed and/or supplied the regulated article; (4) A description of the means of movement (e.g., mail, common carrier, baggage, or handcarried (and by whom)); (5) A description of the anticipated or actual expression of the altered genetic material in the regulated article and how that expression differs from the expression in the non-modified paren tal organism (e.g., morphological or structural characteristics, physio logical activities and processes, num ber of copies of inserted genetic mate rial and the physical state of this ma terial inside the recipient organism (integrated or extrachromosomal), products and secretions, growth char acteristics); (6) A detailed description of the mo lecular biology of the system (e.g., donor-recipient-vector) which is or will be used to produce the regulated arti cle; (7) Country and locality where the donor organism, recipient organism, vector or vector agent, and regulated article were collected, developed, and produced; (8) A detailed description of the pur pose for the introduction of the regu lated article including a detailed de scription of the proposed experimental and/or production design; (9) The quantity of the regulated ar ticle to be introduced and proposed schedule and number of introductions; (10) A detailed description of the processes, procedures, and safeguards which have been used or will be used in the country of origin and in the United States to prevent contamination, re lease, and dissemination in the produc tion of the: Donor organism; recipient organism; vector or vector agent; con stituent of each regulated article which is a product; and regulated arti cle; (11) A detailed description of the in tended destination (including final and all intermediate destinations), uses, and/or distribution of the regulated ar ticle (e.g., greenhouses, laboratory, or growth chamber location; field trial lo cation; pilot project location; produc tion, propagation, and manufacture lo cation; proposed sale and distribution location); (12) A detailed description of the pro posed procedures, processes, and safe guards which will be used to prevent escape and dissemination of the regu lated article at each of the intended destinations; (13) A detailed description of any bio logical material (e.g., culture medium, or host material) accompanying the regulated article during movement; and (14) A detailed description of the pro posed method of final disposition of the regulated article. (c) Limited permits for interstate move ment or importation of a regulated article. An application for the interstate move ment or importation of a regulated ar ticle shall be submitted at least 60 days in advance of the first proposed inter state movement and at least 60 days prior to each importation. An initial review shall be completed by APHIS within 15 days of the receipt of the ap plication. If the application is com plete, the responsible person shall be notified of the date of receipt of the ap plication for purposes of advising the applicant when the 60 day review pe riod commenced. If the application is not complete, the responsible person will be advised what additional infor mation must be submitted. APHIS shall commence the 60 day review pe riod upon receipt of the additional in formation, assuming the additional in formation submitted is adequate. When it is determined that an application is complete, APHIS shall submit to the State department of agriculture of the State of destination of the regulated article a copy of the initial review and the application marked, ‘‘CBI De leted’’, or ‘‘No CBI’’ for State notifica tion and review. (1) Limited permit for interstate move ment. The responsible person may apply for a single limited permit for the interstate movement of multiple regu lated articles in lieu of submitting an application for each individual inter state movement. Each limited permit issued shall be numbered and shall be VerDate Sep<11>2014 09:24 Feb 15, 2018 Jkt 244016 PO 00000 Frm 00482 Fmt 8010 Sfmt 8010 Y:\SGML\244016.XXX 244016ns h a tt u ck o n D S K 9 F 9 S C 4 2 P R O D w ith C F R 473 Animal and Plant Health Inspection Service, USDA § 340.4 9 Renewals may receive shorter review. In the case of a renewal for a limited permit for importation that has been issued less than one year earlier, APHIS will notify the re sponsible person within 15 days that either: (1) The renewal permit is approved or (2) that a 60 day review period is necessary because the conditions of the original permit have changed. valid for one year from the date of issuance. If a permit is sought for mul tiple interstate movements between contained facilities the responsible in dividual shall specify in the permit ap plication all the regulated articles to be moved interstate; the origins and destinations of all proposed shipments; a detailed description of all the con tained facilities where regulated arti cles will be utilized at destination; and a description of the containers that will be used to transport the regulated articles. A limited permit for inter state movement of a regulated article shall only be valid for the movement of those regulated articles moving be tween those locations specified in the application. If a person seeks to move regulated articles other than those specified in the application, or to a lo cation other than those listed in the application, a supplemental applica tion shall be submitted to APHIS. No person shall move a regulated article interstate unless the number of the limited permit appears on the outside of the shipping container. The respon sible person shipping a regulated arti cle interstate shall keep records for one year demonstrating that the regu lated article arrived at its intended destination. The responsible person seeking a limited permit for interstate movement shall submit on an applica tion form obtained from APHIS, the data required by paragraphs (b) (1), (2), (4), (6), (7), (9), and (11) through (14) of this section. (2) Limited permit for importation. The responsible person seeking a permit for the importation of a regulated article shall submit an application for a per mit prior to the importation of each shipment of regulated articles. The re sponsible person importing a regulated article shall keep records for one year demonstrating that the regulated arti cle arrived at its intended destination. The responsible person seeking a lim ited permit for importation shall sub mit on an application form obtained from APHIS data required by para graphs (b) (1), (2), (4), (6), (7), (9), and (11) through (14) of this section. 9 (d) Premises inspection. An inspector may inspect the site or facility where regulated articles are proposed, pursu ant to a permit, to be released into the environment or contained after their interstate movement or importation. Failure to allow the inspection of a premises prior to the issuance of a per mit or limited permit shall be grounds for the denial of the permit. (e) Administrative action on applica tions. After receipt and review by APHIS of the application and the data submitted pursuant to paragraph (a) of this section, including any additional information requested by APHIS, a permit shall be granted or denied. If a permit is denied, the applicant shall be promptly informed of the reasons why the permit was denied and given the opportunity to appeal the denial in ac cordance with the provisions of para graph (g) of this section. If a permit is granted, the permit will specify the ap plicable conditions for introduction of the regulated article under this part. (f) Permit conditions. A person who is issued a permit and his/her employees or agents shall comply with the fol lowing conditions, and any supple mental conditions which shall be listed on the permit, as deemed by the Ad ministrator to be necessary to prevent the dissemination and establishment of plant pests: (1) The regulated article shall be maintained and disposed of (when nec essary) in a manner so as to prevent the dissemination and establishment of plant pests. (2) All packing material, shipping containers, and any other material ac companying the regulated article shall be treated or disposed of in such a man ner so as to prevent the dissemination and establishment of plant pests. (3) The regulated article shall be kept separate from other organisms, except as specifically allowed in the permit; (4) The regulated article shall be maintained only in areas and premises specified in the permit; VerDate Sep<11>2014 09:24 Feb 15, 2018 Jkt 244016 PO 00000 Frm 00483 Fmt 8010 Sfmt 8010 Y:\SGML\244016.XXX 244016ns h a tt u ck o n D S K 9 F 9 S C 4 2 P R O D w ith C F R 474 7 CFR Ch. III (1–1–18 Edition) § 340.4 (5) An inspector shall be allowed ac cess, during regular business hours, to the place where the regulated article is located and to any records relating to the introduction of a regulated article; (6) The regulated article shall, when possible, be kept identified with a label showing the name of the regulated ar ticle, and the date of importation; (7) The regulated article shall be sub ject to the application of measures de termined by the Administrator to be necessary to prevent the accidental or unauthorized release of the regulated article; (8) The regulated article shall be sub ject to the application of remedial measures (including disposal) deter mined by the Administrator to be nec essary to prevent the spread of plant pests; (9) A person who has been issued a permit shall submit to APHIS a field test report within 6 months after the termination of the field test. A field test report shall include the APHIS ref erence number, methods of observa tion, resulting data, and analysis re garding all deleterious effects on plants, nontarget organisms, or the en vironment. (10) APHIS shall be notified within the time periods and manner specified below, in the event of the following oc currences: (i) Orally notified immediately upon discovery and notify in writing within 24 hours in the event of any accidental or unauthorized release of the regu lated article; (ii) In writing as soon as possible but not later than within 5 working days if the regulated article or associated host organism is found to have characteris tics substantially different from those listed in the application for a permit or suffers any unusual occurrence (exces sive mortality or morbidity, or unan ticipated effect on non-target orga nisms); (11) A permittee or his/her agent and any person who seeks to import a regu lated article into the United States shall: (i) Import or offer the regulated arti cle for entry only through any USDA plant inspection station listed in § 319.37–14 of this chapter; (ii) Notify APHIS promptly upon ar rival of any regulated article at a port of entry, of its arrival by such means as a manifest, customs entry docu ment, commercial invoice, waybill, a broker’s document, or a notice form provided for such purpose; and (iii) Mark and identify the regulated article in accordance with § 340.5 of this part. (g) Withdrawal or denial of a permit. Any permit which has been issued may be withdrawn by an inspector or the Administrator if he/she determines that the holder thereof has not com plied with one or more of the condi tions listed on the permit. APHIS will confirm the reasons for the withdrawal of the permit in writing within ten (10) days. Any person whose permit has been withdrawn or any person who has been denied a permit may appeal the decision in writing to the Adminis trator within ten (10) days after receiv ing the written notification of the withdrawal or denial. The appeal shall state all of the facts and reasons upon which the person relies to show that the permit was wrongfully withdrawn or denied. The Administrator shall grant or deny the appeal, in writing, stating the reasons for the decision as promptly as circumstances allow. If there is a conflict as to any material fact, a hearing shall be held to resolve such conflict. Rules of practice con cerning such a hearing will be adopted by the Administrator. (h) Courtesy permit—(1) Issuance. The Administrator may issue a courtesy permit for the introduction of orga nisms modified through genetic engi neering which are not subject to regu lation under this part to facilitate movement when the movement might otherwise be impeded because of the similarity of the organism to other or ganisms regulated under this part. (2) Application. A person seeking a courtesy permit shall submit on an ap plication form obtained from APHIS data required by paragraphs (b) (1), (2), and (5) of this section and shall indi cate such data is being submitted as a request for a courtesy permit. A person should also include a statement ex plaining why he or she believes the or ganism or product does not come with in the definition of a regulated article. VerDate Sep<11>2014 09:24 Feb 15, 2018 Jkt 244016 PO 00000 Frm 00484 Fmt 8010 Sfmt 8010 Y:\SGML\244016.XXX 244016ns h a tt u ck o n D S K 9 F 9 S C 4 2 P R O D w ith C F R 475 Animal and Plant Health Inspection Service, USDA § 340.5 10 See footnote 5 in § 340.3. The application shall be submitted at least 60 days prior to the time the courtesy permit is sought. (3) Administrative action. APHIS shall complete an initial review within 15 days of the date of receipt of the appli cation. If the application is complete, the responsible individual shall be no tified of the date of receipt of the ap plication for purposes of advising the applicant when the 60 day review pe riod commenced. If the application is not complete, the responsible indi vidual will be advised what additional information must be submitted, and shall commence the 60 day review pe riod upon receipt of the additional in formation, assuming the additional in formation submitted is adequate. With in 60 days from the date of receipt of a complete application, APHIS will ei ther issue a courtesy permit or advise the responsible individual that a per mit is required under paragraph (b) or (c) of this section. (Approved by the Office of Management and Budget under control number 0579–0216) [52 FR 22908, June 16, 1987. Redesignated at 58 FR 17056, Mar. 31, 1993, as amended at 58 FR 17058, Mar. 31, 1993; 59 FR 67610, Dec. 30, 1994; 62 FR 23956, 23957, May 2, 1997; 68 FR 46436, Aug. 6, 2003; 72 FR 43523, Aug. 6, 2007] § 340.5 Petition to amend the list of or ganisms. 10 (a) General. Any person may submit to the Administrator a petition to amend the list of organisms in § 340.2 of this part by adding or deleting any genus, species, or subspecies. A peti tioner may supplement, amend, or withdraw a petition in writing without prior approval of the Administrator and without prejudice to resubmission at any time until the Administrator rules on the petition. A petition to amend the list of organisms shall be submitted in accordance with the pro cedures and format specified by this section. (b) Submission procedures and format. A person shall submit two copies of a petition to the Animal and Plant Health Inspection Service, Bio technology and Scientific Services, PPQ, Biotechnology Permits, 4700 River Road, Unit 147, Riverdale, Mary land 20737–1237. The petition should be dated, and structured as follows: PETITION TO AMEND 7 CFR 340.2 The undersigned submits this petition under 7 CFR 340.4 to request that the Admin istrator [add the following genus, species, or subspecies to the list of organisms in 7 CFR 340.2] or [to remove the following genus, spe cies, or subspecies from the list of organisms in § 340.2]. A. Statement of Grounds (A person must present a full statement explaining the factual grounds why the genus, species, or subspecies to be added to § 340.2 of this part is a plant pest or why there is reason to believe the genus, species, or subspecies is a plant pest or why the genus, species, or subspecies sought to be re moved is not a plant pest or why there is rea son to believe the genus, species, or sub species is not a plant pest. The petition should include copies of scientific literature which the petitioner is relying upon, copies of unpublished studies, or data from tests performed. The petition should not include trade secret or confidential business informa tion. A person should also include representa tive information known to the petitioner which would be unfavorable to a petition for listing or delisting. (If a person is not aware of any unfavorable information the petition should state, Unfavorable Information: NONE). B. Certification The undersigned certifies, that to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petitioner relies, and that it in cludes representative data and information known to the petitioner which are unfavor able to the petition. (Signature) lllllllllllllllll (Name of petitioner) llllllllllll (Mailing address) llllllllllllll (Telephone number) lllllllllllll (c) Administrative action on a petition. (1) A petition to amend the list of orga nisms which meets the requirements of paragraph (b) of this section will be filed by the APHIS, stamped with the date of filing, and assigned a docket number. The docket number shall iden tify the file established for all submis sions relating to the petition. APHIS, will promptly notify the petitioner in writing of the filing and docket number of a petition. If a petition does not meet the requirements of paragraph (b) of this section, the petitioner shall be VerDate Sep<11>2014 09:24 Feb 15, 2018 Jkt 244016 PO 00000 Frm 00485 Fmt 8010 Sfmt 8010 Y:\SGML\244016.XXX 244016ns h a tt u ck o n D S K 9 F 9 S C 4 2 P R O D w ith C F R 476 7 CFR Ch. III (1–1–18 Edition) § 340.6 11 See footnote 5 in § 340.3. sent a notice indicating how the peti tion is deficient. (2) After the filing of a petition to amend the list of organisms USDA shall publish a proposal in the FEDERAL REGISTER to amend § 340.2 and solicit comments thereon from the public. An interested person may submit written comments to the APHIS on a filed peti tion, which shall become part of the docket file. (3) The Administrator shall furnish a response to each petitioner within 180 days of receipt of the petition. The re sponse will either: (i) Approve the peti tion in whole or in part in which case the Administrator shall concurrently take appropriate action (publication of a document in the FEDERAL REGISTER amending § 340.2 of this part; or (ii) deny the petition in whole or in part. The petitioner shall be notified in writ ing of the Administrator’s decision. The decision shall be placed in the pub lic docket file in the offices of APHIS, and in the form of a notice published in the FEDERAL REGISTER. [52 FR 22908, June 16, 1987. Redesignated at 58 FR 17056, Mar. 31, 1993, as amended at 58 FR 17059, Mar. 31, 1993; 59 FR 67611, Dec. 30, 1994; 62 FR 23957, May 2, 1997] § 340.6 Petition for determination of nonregulated status. 11 (a) General. Any person may submit to the Administrator, a petition to seek a determination that an article should not be regulated under this part. A petitioner may supplement, amend, or withdraw a petition in writ ing without prior approval of the Ad ministrator, and without affecting re submission at any time until the Ad ministrator, rules on the petition. A petition for determination of nonregu lated status shall be submitted in ac cordance with the procedure and for mat specified in this section. (b) Submission procedures and format. A person shall submit two copies of a petition to the Animal and Plant Health Inspection Service, Plant Pro tection and Quarantine, Biotechnology and Scientific Services, Biotechnology Coordination and Technical Assistance, 4700 River Road, Unit 146, Riverdale, Maryland 20737–1237. The petition shall be dated and structured as follows: PETITION FOR DETERMINATION OF NONREGULATED STATUS The undersigned submits this petition under 7 CFR 340.6 to request that the Admin istrator, make a determination that the arti cle should not be regulated under 7 CFR part 340. (Signature) lllllllllllllllll A. Statement of Grounds A person must present a full statement ex plaining the factual grounds why the orga nism should not be regulated under 7 CFR part 340. The petitioner shall include copies of scientific literature, copies of unpublished studies, when available, and data from tests performed upon which to base a determina tion. The petition shall include all informa tion set forth in paragraph (c) of 7 CFR 340.6. If there are portions of the petition deemed to contain trade secret or confidential busi ness information (CBI), each page of the pe tition containing such information should be marked ‘‘CBI Copy’’. In addition, those por tions of the petition which are deemed ‘‘CBI’’ shall be so designated. The second copy shall have all such CBI deleted and shall have marked on each page where the CBI was de leted: ‘‘CBI Deleted.’’ If a petition does not contain CBI, the first page of both copies shall be marked: ‘‘No CBI.’’ A person shall also include information known to the petitioner which would be un favorable to a petition. If a person is not aware of any unfavorable information, the petition should state, ‘‘Unfavorable informa tion: NONE.’’ B. Certification The undersigned certifies, that to the best knowledge and belief of the undersigned, this petition includes all information and views on which to base a determination, and that it includes relevant data and information known to the petitioner which are unfavor able to the petition. (Signature) lllllllllllllllll (Name of Petitioner) llllllllllll (Mailing Address) llllllllllllll (Telephone Number) llllllllllll (c) Required data and information. The petition shall include the following in formation: (1) Description of the biology of the nonmodified recipient plant and infor mation necessary to identify the re cipient plant in the narrowest taxo nomic grouping applicable. (2) Relevant experimental data and publications. VerDate Sep<11>2014 09:24 Feb 15, 2018 Jkt 244016 PO 00000 Frm 00486 Fmt 8010 Sfmt 8010 Y:\SGML\244016.XXX 244016ns h a tt u ck o n D S K 9 F 9 S C 4 2 P R O D w ith C F R 477 Animal and Plant Health Inspection Service, USDA § 340.6 (3) A detailed description of the dif ferences in genotype between the regu lated article and the nonmodified re cipient organism. Include all scientific, common, or trade names, and all des ignations necessary to identify: the donor organism(s), the nature of the transformation system (vector or vec tor agent(s)), the inserted genetic ma terial and its product(s), and the regu lated article. Include country and lo cality where the donor, the recipient, and the vector organisms and the regu lated articles are collected, developed, and produced. (4) A detailed description of the phe notype of the regulated article. De scribe known and potential differences from the unmodified recipient orga nism that would substantiate that the regulated article is unlikely to pose a greater plant pest risk than the un modified organism from which it was derived, including but not limited to: Plant pest risk characteristics, disease and pest susceptibilities, expression of the gene product, new enzymes, or changes to plant metabolism, weediness of the regulated article, im pact on the weediness of any other plant with which it can interbreed, ag ricultural or cultivation practices, ef fects of the regulated article on non target organisms, indirect plant pest effects on other agricultural products, transfer of genetic information to orga nisms with which it cannot interbreed, and any other information which the Administrator believes to be relevant to a determination. Any information known to the petitioner that indicates that a regulated article may pose a greater plant pest risk than the un modified recipient organism shall also be included. (5) Field test reports for all trials conducted under permit or notification procedures, involving the regulated ar ticle, that were submitted prior to sub mission of a petition for determination of nonregulated status or prior to sub mission of a request for extension of a determination of nonregulated status under paragraph (e) of this part. Field test reports shall include the APHIS reference number, methods of observa tion, resulting data, and analysis re garding all deleterious effects on plants, nontarget organisms, or the en vironment. (d) Administrative action on a petition. (1) A petition for determination of non regulated status under this part which meets the requirements of paragraphs (b) and (c) of this section will be filed by the Administrator, stamped with the date of filing, and assigned a peti tion number. The petition number shall identify the file established for all submissions relating to the peti tion. APHIS will promptly notify the petitioner in writing of the filing and the assigned petition number. If a peti tion does not meet the requirements specified in this section, the petitioner shall be sent a notice indicating how the petition is deficient. (2) After the filing of a completed pe tition, APHIS shall publish a notice in the FEDERAL REGISTER. This notice shall specify that comments will be ac cepted from the public on the filed pe tition during a 60 day period com mencing with the date of the notice. During the comment period, any inter ested person may submit to the Admin istrator, written comments, regarding the filed petition, which shall become part of the petition file. (3) The Administrator shall, based upon available information, furnish a response to each petitioner within 180 days of receipt of a completed petition. The response will either: (i) Approve the petition in whole or in part; or (ii) deny the petition. The petitioner shall be notified in writing of the Administrator’s deci sion. The decision shall be placed in the public petition file in the offices of APHIS and notice of availability pub lished in the FEDERAL REGISTER. (e) Extensions to determinations of non regulated status. (1) The Administrator may determine that a regulated article does not pose a potential for plant pest risk, and should therefore not be regu lated under this part, based on the sim ilarity of that organism to an ante cedent organism. (2) A person may request that APHIS extend a determination of nonregu lated status to other organisms. Such a request shall include information to es tablish the similarity of the antecedent VerDate Sep<11>2014 09:24 Feb 15, 2018 Jkt 244016 PO 00000 Frm 00487 Fmt 8010 Sfmt 8010 Y:\SGML\244016.XXX 244016ns h a tt u ck o n D S K 9 F 9 S C 4 2 P R O D w ith C F R 478 7 CFR Ch. III (1–1–18 Edition) § 340.7 12 The requirements of this section are in addition to and not in lieu of any other pack ing requirements such as those for the trans portation of etiologic agents prescribed by the Department of Transportation in Title 49 CFR or any other agency of the Federal gov ernment. organism and the regulated articles in question. (3) APHIS will announce in the FED ERAL REGISTER all preliminary deci sions to extend determinations of non regulated status 30 days before the de cisions become final and effective. If additional information becomes avail able that APHIS believes justifies changing its decision, it will issue a re vised decision. (4) If a request to APHIS to extend a determination of nonregulated status under this part is denied, APHIS will inform the submitter of that request of the reasons for denial. The submitter may submit a modified request or a separate petition for determination of nonregulated status without prejudice. (f) Denial of a petition; appeal. (1) The Administrator’s written notification of denial of a petition shall briefly set forth the reason for such denial. The written notification shall be sent by certified mail. Any person whose peti tion has been denied may appeal the determination in writing to the Admin istrator within 10 days from receipt of the written notification of denial. (2) The appeal shall state all of the facts and reasons upon which the per son relies, including any new informa tion, to show that the petition was wrongfully denied. The Administrator shall grant or deny the appeal, in writ ing, stating the reasons for the deci sion as promptly as circumstances allow. An informal hearing may be held by the Administrator if there is a dis pute of a material fact. Rules of Prac tice concerning such a hearing will be adopted by the Administrator. [58 FR 17057, Mar. 31, 1993, as amended at 59 FR 67611, Dec. 30, 1994; 62 FR 23957, May 2, 1997] § 340.7 Marking and identity. (a) Any regulated article to be im ported other than by mail, shall, at the time of importation into the United States, plainly and correctly bear on the outer container the following infor mation: (1) General nature and quantity of the contents; (2) Country and locality where col lected, developed, manufactured, reared, cultivated or cultured; (3) Name and address of shipper, owner, or person shipping or for warding the organism; (4) Name, address, and telephone number of consignee; (5) Identifying shipper’s mark and number; and (6) Number of written permit author izing the importation. (b) Any regulated article imported by mail, shall be plainly and correctly ad dressed and mailed to APHIS through any USDA plant inspection station listed in § 319.37–14 of this chapter and shall be accompanied by a separate sheet of paper within the package plainly and correctly bearing the name, address, and telephone number of the intended recipient, and shall plainly and correctly bear on the outer container the following information: (1) General nature and quantity of the contents; (2) Country and locality where col lected, developed, manufactured, reared, cultivated, or cured; (3) Name and address of shipper, owner, or person shipping or for warding the regulated article; and (4) Number of permit authorizing the importation; (c) Any regulated article imported into the United States by mail or oth erwise shall, at the time of importation or offer for importation into the United States, be accompanied by an invoice or packing list indicating the contents of the shipment. [52 FR 22908, June 16, 1987. Redesignated at 58 FR 17056, Mar. 31, 1993, as amended at 58 FR 17059, Mar. 31, 1993; 62 FR 23958, May 2, 1997; 72 FR 43523, Aug. 6, 2007] § 340.8 Container requirements for the movement of regulated articles. (a) General requirements. A regulated article shall not be moved unless it complies with the provisions of para graph (b) of this section, unless a vari ance has been granted in accordance with the provisions of paragraph (c) of this section. 12 VerDate Sep<11>2014 09:24 Feb 15, 2018 Jkt 244016 PO 00000 Frm 00488 Fmt 8010 Sfmt 8010 Y:\SGML\244016.XXX 244016ns h a tt u ck o n D S K 9 F 9 S C 4 2 P R O D w ith C F R 479 Animal and Plant Health Inspection Service, USDA § 340.8 (b) Container requirements—(1) Plants and plant parts. All plants or plant parts, except seeds, cells, and subcel lular elements, shall be packed in a sealed plastic bag of at least 5 mil thickness, inside a sturdy, sealed, leak proof, outer shipping container con structed of corrugated fiberboard, corrogated cardboard, wood, or other material of equivalent strength. (2) Seeds. All seeds shall be trans ported in a sealed plastic bag of at least 5 mil thickness, inside a sealed metal container, which shall be placed inside a second sealed metal container. Shock absorbing cushioning material shall be placed between the inner and outer metal containers. Each metal container shall be independently capa ble of protecting the seeds and pre venting spillage or escape. Each set of metal containers shall then be enclosed in a sturdy outer shipping container constructed of corrugated fiberboard, corrugated cardboard, wood, or other material of equivalent strength. (3) Live microorganisms and/or etiologic agents, cells, or subcellular elements. All regulated articles which are live (non inactivated) microorganisms, or etio logic agents, cells, or subcellular ele ments shall be packed as specified below: (i) Volume not exceeding 50 ml. Regu lated articles not exceeding 50 ml shall be placed in a securely closed, water tight container (primary container, test tube, vial, etc.) which shall be en closed in a second, durable watertight container (secondary container). Sev eral primary containers may be en closed in a single secondary container, if the total volume of all the primary containers so enclosed does not exceed 50 ml. The space at the top, bottom, and sides between the primary and sec ondary containers shall contain suffi cient nonparticulate absorbent mate rial (e.g., paper towel) to absorb the en tire contents of the primary con tainer(s) in case of breakage or leak age. Each set of primary and secondary containers shall then be enclosed in an outer shipping container constructed of corrugated fiberboard, corrugated card board, wood, or other material of equivalent strength. (ii) Volume greater than 50 ml. Regu lated articles which exceed a volume of 50 ml. shall comply with requirements specified in paragraph (b)(3)(i) of this section. In addition, a shock absorbing material, in volume at least equal to that of the absorbent material between the primary and secondary containers, shall be placed at the top, bottom, and sides between the secondary container and the outer shipping container. Sin gle primary containers shall not con tain more than 1,000 ml. of material. However, two or more primary con tainers whose combined volumes do not exceed 1,000 ml. may be placed in a sin gle, secondary container. The max imum amount of micro-organisms or etiologic agents, cells, or subcellular elements which may be enclosed within a single outer shipping container shall not exceed 4,000 ml. (iii) Dry ice. If dry ice is used as a re frigerant, it shall be placed outside the secondary container(s). If dry ice is used between the secondary container and the outer shipping container, the shock absorbing material shall be placed so that the secondary container does not become loose inside the outer shipping container as the dry ice sub limates. (4) Insects, mites, and related orga nisms. Insects, mites, and other small arthropods shall be packed for ship ment as specified in this paragraph or in paragraph (b)(3) of this section. In sects (any life stage) shall be placed in an escape-proof primary shipping con tainer (insulated vacuum container, glass, metal, plastic, etc.) and sealed to prevent escape. Such primary con tainer shall be placed securely within a secondary shipping container of crushproof styrofoam or other material of equivalent strength; one or more rigid ice packs may also be placed within the secondary shipping con tainer; and sufficient packing material shall be added around the primary con tainer to prevent movement of the pri mary shipping container. The sec ondary (styrofoam or other) container shall be placed securely within an outer shipping container constructed of corrugated fiberboard, corrugated card board, wood, or other material of equivalent strength. (5) Other macroscopic organisms. Other macroscopic organisms not covered in paragraphs (b) (1), (2), and (4) of this VerDate Sep<11>2014 09:24 Feb 15, 2018 Jkt 244016 PO 00000 Frm 00489 Fmt 8010 Sfmt 8010 Y:\SGML\244016.XXX 244016ns h a tt u ck o n D S K 9 F 9 S C 4 2 P R O D w ith C F R 480 7 CFR Ch. III (1–1–18 Edition) § 340.9 13 The Department’s provisions relating to overtime charges for an inspector’s services are set forth in 7 CFR part 354. section which do not require contin uous access to atmospheric oxygen shall be packaged as specified in para graph (b)(3) or (b)(4) of this section. All macroscopic organisms which are not plants and which require continuous access to atmospheric oxygen shall be placed in primary shipping containers constructed of a sturdy, crush-proof frame of wood, metal, or equivalent strength material, surrounded by es cape-proof mesh or netting of a strength and mesh size sufficient to prevent the escape of the smallest or ganism in the shipment, with edges and seams of the mesh or netting sealed to prevent escape of organisms. Each pri mary shipping container shall be se curely placed within a larger secondary shipping container constructed of wood, metal, or equivalent strength material. The primary and secondary shipping containers shall then be placed securely within an outer ship ping container constructed of cor rugated fiberboard, corrugated card board, wood, or other material of equivalent strength, which outer con tainer may have air holes or spaces in the sides and/or ends of the container, provided that the outer shipping con tainer must retain sufficient strength to prevent crushing of the primary and secondary shipping containers. (c) Request for a variance from con tainer requirements. A responsible per son who believes the container require ments normally applicable to the movement of the person’s regulated ar ticle(s) are inappropriate due to unique circumstances (such as the nature, vol ume, or life stage of the regulated arti cle) may submit in an application for a permit, a request for a variance from the container requirements. The re quest for a variance under this section shall consist of a short statement de scribing why the normally applicable container requirements are inappro priate for the regulated article which the person proposes to move and what container requirements the person would use in lieu of the normally pre scribed container requirements. USDA shall advise the responsible person in writing at the time a permit is granted on the person’s request for a variance. [52 FR 22908, June 16, 1987. Redesignated at 58 FR 17056, Mar. 31, 1993; 62 FR 23956, May 2, 1997] § 340.9 Cost and charges. The services of the inspector during regularly assigned hours of duty and at the usual places of duty shall be fur nished without cost. 13 The U.S. Depart ment of Agriculture will not be respon sible for any costs or charges incident to inspections or compliance with the provisions of this part, other than for the services of the inspector. [52 FR 22908, June 16, 1987. Redesignated at 58 FR 17056, Mar. 31, 1993; 62 FR 23956, May 2, 1997] PART 351—IMPORTATION OF PLANTS OR PLANT PRODUCTS BY MAIL AUTHORITY: 7 U.S.C. 7711–7714, 7721, 7754, and 7755; 7 CFR 2.22, 2.80, and 371.3. Sec. 351.1 Joint treatment generally. 351.2 Location of inspectors. 351.3 Procedure on arrival. 351.4 Records. 351.5 Return or destruction. 351.6 Packages in closed mail dispatches. 351.7 Regulations governing importation by mail of plant material for immediate ex port. CROSS REFERENCE: For customs regulations governing importation of plants and plant products, see 19 CFR part 12. AUTHORITY: 7 U.S.C. 7701–7772 and 7781–7786; 7 CFR 2.22, 2.80, and 371.3. § 351.1 Joint treatment generally. The entry into the United States of certain plants, plant products, and soil is prohibited or restricted through var ious orders, quarantines, and regula tions promulgated by the Adminis trator of the Animal and Plant Health Inspection Service (APHIS) under the authority of the Plant Protection Act (7 U.S.C. 7701–7772). To assist in enforc ing the aforementioned orders, quar antines, and regulations, the Plant Protection and Quarantine Programs VerDate Sep<11>2014 09:24 Feb 15, 2018 Jkt 244016 PO 00000 Frm 00490 Fmt 8010 Sfmt 8010 Y:\SGML\244016.XXX 244016ns h a tt u ck o n D S K 9 F 9 S C 4 2 P R O D w ith C F R