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(b) Prior to issuing a certificate of (vi) Actions taken to respond to the registration to an individual or entity, release; and APHIS may inspect and evaluate their (vii) Hazards posed by the release. premises and records to ensure compli- (2) A completed APHIS/CDC Form 3 ance with this part. must be submitted within 7 calendar days. § 331.19 Notification of theft, loss, or release. [70 FR 13278, Mar. 18, 2005, as amended at 77 FR 61077, Oct. 5, 2012] (a) An individual or entity must im- mediately notify APHIS or CDC upon § 331.20 Administrative review. discovery of the theft or loss of a select (a) An individual or entity may ap- agent or toxin. Thefts or losses must be peal a denial, revocation, or suspension reported even if the select agent or of registration under this part. The ap- toxin is subsequently recovered or the peal must be in writing, state the fac- responsible parties are identified. tual basis for the appeal, and be sub- (1) The theft or loss of a select agent mitted to the Administrator within 30 or toxin must be reported by telephone, calendar days of the decision. facsimile, or e-mail. The following in- (b) An individual may appeal a de- formation must be provided: nial, limitation, or revocation of access (i) The name of the select agent or approval under this part. The appeal toxin and any identifying information must be in writing, state the factual (e.g., strain or other characterization basis for the appeal, and be submitted information); to the Administrator within 180 cal- (ii) An estimate of the quantity sto- endar days of the decision. len or lost; (c) The Administrator’s decision con- (iii) An estimate of the time during stitutes final agency action. which the theft or loss occurred; (iv) The location (building, room) [77 FR 61077, Oct. 5, 2012] from which the theft or loss occurred; and PART 340—INTRODUCTION OF OR- (v) The list of Federal, State, or local GANISMS AND PRODUCTS AL- law enforcement agencies to which the TERED OR PRODUCED THROUGH individual or entity reported, or in- GENETIC ENGINEERING WHICH tends to report, the theft or loss. ARE PESTS OR WHICH (2) A completed APHIS/CDC Form 3 THERE IS REASON TO BELIEVE ARE must be submitted within 7 calendar PLANT PESTS days. (b) An individual or entity must no- Sec. tify APHIS or CDC immediately upon 340.0 Restrictions on the introduction of discovery of a release of a select agent regulated articles. or toxin outside of the primary barriers 340.1 Definitions. of the biocontainment area. 340.2 Groups of organisms which are or con- (1) The release of a select agent or tain plant pests and exemptions. toxin must be reported by telephone, 340.3 Notification for the introduction of facsimile, or e-mail. The following in- certain regulated articles. formation must be provided: 340.4 Permits for the introduction of a regu- lated article. (i) The name of the select agent or 340.5 Petition to amend the list of orga- toxin and any identifying information nisms. (e.g., strain or other characterization 340.6 Petition for determination of nonregu- information); lated status. (ii) An estimate of the quantity re- 340.7 Marking and identity. leased; 340.8 Container requirements for the move- (iii) The time and duration of the re- ment of regulated articles. lease; 340.9 Cost and charges. (iv) The location (building, room) AUTHORITY: 7 U.S.C. 7701–7772 and 7781–7786; from which the release occurred; and 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3. (v) The number of individuals poten- SOURCE: 52 FR 22908, June 16, 1987, unless tially exposed at the entity; otherwise noted.

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§ 340.0 Restrictions on the introduc- Administrator. The Administrator of tion of regulated articles. the Animal and Plant Health Inspec- (a) No person shall introduce any reg- tion Service (APHIS) or any other em- ployee of APHIS to whom authority ulated article unless the Administrator has been or may be delegated to act in is: the Administrator’s stead. (1) Notified of the introduction in ac- Animal and Plant Health Inspection cordance with § 340.3, or such introduc- Service (APHIS). An agency of the tion is authorized by permit in accord- United States Department of Agri- ance with § 340.4, or such introduction culture. is conditionally exempt from permit requirements under § 340.2(b); and Antecedent organism. An organism that has already been the subject of a (2) Such introduction is in con- determination of nonregulated status formity with all other applicable re- by APHIS under § 340.6, and that is used strictions in this part. 1 as a reference for comparison to the (b) Any regulated article introduced regulated article under consideration not in compliance with the require- under these regulations. ments of this part shall be subject to Courtesy permit. A written permit the immediate application of such re- issued by the Administrator, in accord- medial measures or safeguards as an ance with § 340.4(h). inspector determines necessary to pre- Donor organism. The organism from vent the introduction of such plant which genetic material is obtained for pests. 2 transfer to the recipient organism. [52 FR 22908, June 16, 1987, as amended at 58 Environment. All the land, air, and FR 17056, Mar. 31, 1993; 62 FR 23956, May 2, water; and all living organisms in asso- 1997; 66 FR 21058, Apr. 27, 2001; 83 FR 11866, ciation with land, air and water. Mar. 19, 2018; 84 FR 2429, Feb. 7, 2019] Expression vector. A cloning vector de- § 340.1 Definitions. signed so that a coding sequence in- serted at a particular site will be tran- Terms used in the singular form in scribed and translated into protein. this part shall be construed as the plu- Genetic engineering. The genetic modi- ral, and vice versa, as the case may de- fication of organisms by recombinant mand. The following terms, when used DNA techniques. in this part, shall be construed, respec- Inspector. Any employee of the Ani- tively, to mean: mal and Plant Health Inspection Serv- ice, U.S. Department of Agriculture, or 1 Part 340 regulates, among other things, other person, authorized by the Admin- the introduction of organisms and products istrator, in accordance with law to en- altered or produced through genetic engi- force the provisions of this part. neering that are plant pests or are believed Interstate. From any State into or to be plant pests. The introduction into the United States of such articles also may be through any other State. subject to other regulations promulgated Introduce or introduction. To move under the Plant Protection Act (7 U.S.C. into or through the United States, to 7701–7772) and found in 7 CFR parts 319, 330, release into the environment, to move and 360. For example, under regulations pro- interstate, or any attempt thereat. mulgated in ‘‘Subpart H— for Plant- Move (moving, movement). To ship, ing’’ (7 CFR 319.37–5 of this chapter), a per- mit is required for the importation of certain offer for shipment, offer for entry, im- classes of plants for planting whether such port, receive for transportation, carry, plants are genetically engineered or not. Ac- or otherwise transport or move, or cordingly, individuals should refer to those allow to be moved into, through, or regulations before importing any plants for within the United States. planting. Organism. Any active, infective, or 2 An inspector may hold, seize, quarantine, dormant stage or life form of an entity treat, apply other remedial measures to, de- characterized as living, including stroy, or otherwise dispose of plants, plant pests, or other articles in accordance with and invertebrate , sections 411, 412, 421, and 434 of the Plant plants, bacteria, fungi, mycoplasmas, Protection Act (7 U.S.C. 7711, 7712, 7731, and mycoplasma-like organisms, as well as 7754). entities such as viroids, viruses, or any

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entity characterized as living, related trator, determines is a plant pest or to the foregoing. has reason to believe is a plant pest. Permit. A written permit issued by Excluded are recipient microorganisms the Administrator, for the introduction which are not plant pests and which of a regulated article under conditions have resulted from the addition of ge- determined by the Administrator, not netic material from a donor organism to present a risk of plant pest introduc- where the material is well character- tion. ized and contains only non-coding reg- Person. Any individual, partnership, ulatory regions. corporation, company, society, associa- Release into the environment. The use tion, or other organized group. of a regulated article outside the con- Plant. Any living stage or form of straints of physical confinement that any member of the plant kingdom 3 in- are found in a laboratory, contained cluding, but not limited to, eukaryotic greenhouse, or a fermenter or other algae, mosses, club mosses, ferns, contained structure. angiosperms, gymnosperms, and Responsible person. The person who lichens (which contain algae) including has control and will maintain control any parts (e.g. pollen, seeds, cells, tu- over the introduction of the regulated bers, stems) thereof, and any cellular article and assure that all conditions components (e.g. plasmids, ribosomes, contained in the permit and require- etc.) thereof. ments in this part are complied with. A Plant pest. Any living stage (includ- responsible person shall be a resident ing active and dormant forms) of in- of the United States or designate an sects, , nematodes, slugs, snails, agent who is a resident of the United protozoa, or other invertebrate ani- States. mals, bacteria, fungi, other parasitic Secretary. The Secretary of Agri- plants or reproductive parts thereof; culture, or any other officer or em- viruses; or any organisms similar to or ployee of the Department of Agri- allied with any of the foregoing; or any culture to whom authority to act in infectious agents or substances, which his/her stead has been or may hereafter can directly or indirectly injure or be delegated. cause disease or damage in or to any Stably integrated. The cloned genetic plants or parts thereof, or any proc- material is contiguous with elements essed, manufactured, or other products of the recipient genome and is rep- of plants. licated exclusively by mechanisms Product. Anything made by or from, used by recipient genomic DNA. or derived from an organism, living or State. Any State, the District of Co- dead. lumbia, American Samoa, Guam, Recipient organism. The organism Northern Mariana Islands, Puerto which receives genetic material from a Rico, the Virgin Islands of the United donor organism. States, and any other Territories or Regulated article. Any organism which Districts of the United States. has been altered or produced through State regulatory official. State official genetic engineering, if the donor orga- with responsibilities for plant health, nism, recipient organism, or vector or or any other duly designated State offi- vector agent belongs to any genera or cial, in the State where the introduc- taxa designated in § 340.2 and meets the tion is to take place. definition of plant pest, or is an unclas- United States. All of the States. sified organism and/or an organism Vector or vector agent. Organisms or whose classification is unknown, or objects used to transfer genetic mate- any product which contains such an or- rial from the donor organism to the re- ganism, or any other organism or prod- cipient organism. uct altered or produced through ge- Well-characterized and contains only netic engineering which the Adminis- non-coding regulatory regions (e.g. oper- ators, promoters, origins of replication, 3 The taxonomic scheme for the plant king- terminators, and ribosome binding re- dom is that found in Synopsis and Classifica- gions). The genetic material added to a tion of Living Organisms by S.P. Parker, microorganism in which the following McGraw Hill (1984). can be documented about such genetic

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material: (a) The exact nucleotide base GROUP sequence of the regulatory region and VIROIDS any inserted flanking nucleotides; (b) The regulatory region and any inserted Superkingdom Prokaryotae flanking nucleotides do not code for protein or peptide; and (c) The regu- Kingdom Virus latory region solely controls the activ- All members of groups containing plant vi- ity of other sequences that code for ruses, and all other plant and insect vi- protein or peptide molecules or act as ruses recognition sites for the initiation of Kingdom Monera nucleic acid or protein synthesis. DIVISION BACTERIA [52 FR 22908, June 16, 1987, as amended at 53 FR 12913, Apr. 20, 1988; 55 FR 53276, Dec. 28, Family Pseudomonadaceae 1990; 58 FR 17056, Mar. 31, 1993; 62 FR 23956, Genus Pseudomonas May 2, 1997] Genus Xanthomonas Family Rhizobiaceae § 340.2 Groups of organisms which are Genus Rhizobium or contain plant pests and exemp- Genus Bradyrhizobium tions. Genus Agrobacterium (a) Groups of organisms which are or Genus Phyllobacterium contain plant pests. The organisms that Family Enterobacteriaceae Genus Erwinia are or contain plant pests are included Family Streptomycetaceae in the taxa or group of organisms con- Genus Streptomyces tained in the following list. Within any Family Actinomycetacease taxonomic series included on the list, Genus Actinomyces the lowest unit of classification actu- ally listed is the taxon or group which Coryneform group may contain organisms which are regu- Genus Clavibacter lated. Organisms belonging to all lower Genus Arthrobacter taxa contained within the group listed Genus Curtobacterium are included as organisms that may be Genus Corynebacteria Gram-negative phloem-limited bacteria asso- or may contain plant pests, and are ciated with plant diseases regulated if they meet the definition of Gram-negative xylem-limited bacteria asso- plant pest in § 340.1 4 ciated with plant diseases And all other bacteria associated with plant NOTE: Any genetically engineered orga- or insect diseases nism composed of DNA or RNA sequences, Rickettsiaceae organelles, plasmids, parts, copies, and/or Rickettgial-like organisms associated with analogs, of or from any of the groups of orga- insect diseases nisms listed below shall be deemed a regu- lated article if it also meets the definition of Class Mollicutes plant pest in § 340.1. Order Mycoplasmatales Family Spiroplasmataceae 4 Any organism belonging to any taxa con- Genus Spiroplasma tained within any listed genera or taxa is Mycoplasma-like organisms associated with only considered to be a plant pest if the or- plant diseases ganism ‘‘can directly or indirectly injure, or Mycoplasma-like organisms associated with cause disease, or damage in any plants or insect diseases parts thereof, or any processed, manufac- tured, or other products of plants.’’ Thus a Superkingdom Eukaryotae particular unlisted species within a listed genus would be deemed a plant pest for pur- Kingdom Plantae poses of § 340.2, if the scientific literature re- Subkingdom Thallobionta fers to the organism as a cause of direct or indirect injury, disease, or damage to any Division Chlorophyta plants, plant parts or products of plants. (If there is any question concerning the plant Genus Cephaleuros pest status of an organism belonging to any Genus Rhodochytrium listed genera or taxa, the person proposing Genus Phyllosiphon to introduce the organism in question should Division Myxomycota consult with APHIS to determine if the orga- nism is subject to regulation.) Class Plasmodiophoromycetes

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Division Eumycota Family Sarcoscyphaceae Class Chytridiomycetes Class Teliomycetes Order Chytridiales Class Phragmobasidiomycetes Class Oomycetes Family Auriculariaceae Family Ceratobasidiaceae Order Lagenidiales Family Lagenidiaceae Class Hymenomycetes Family Olpidiopsidaceae Order Peronosporales Order Exobasidiales Family Albuginaceae Order Agaricales Family Peronosporaceae Family Corticiaceae Family Pythiaceae Family Hymenochaetaceae Order Saprolegniales Family Echinodontiaceae Family Saprolegniaceae Family Fistulinaceae Family Leptolegniellaceae Family Clavariaceae Family Polyporaceae Class Zygomycetes Family Tricholomataceae Order Mucorales Class Hyphomycetes Family Choanephoraceae Family Mucoraceae Class Coelomycetes Family Entomophthoraceae And all other fungi associated with plant or Class Hemiascomycetes insect diseases Family Protomycetaceae Subkingdom Embryobionta Family Taphrinaceae NOTE: Organisms listed in the Code of Federal Class Loculoascomycetes Regulations as noxious weeds are regulated Order Myriangiales under the Federal Noxious Weed Act Family Elsinoeaceae Family Myriangiaceae Division Magnoliophyta Order Asterinales Order Dothideales Family Balanophoraceae—parasitic species Order Chaetothyriales Family Cuscutaceae—parasitic species Order Hysteriales Family Hydnoraceae—parasitic species Family Parmulariaceae Family Krameriaceae—parasitic species Family Phillipsiellaceae Family Lauraceae—parasitic species Family Hysteriaceae Genus Cassytha Order Pleosporales Family Lennoaceae—parasitic species Order Melanommatales Family Loranthaceae—parasitic species Family Myzodendraceae—parasitic species Class Plectomycetes Family Olacaceae—parasitic species Family —parasitic species Order Eurotiales Family Rafflesiaceae—parasitic species Family Ophiostomataceae Family Santalaceae—parasitic species Order Ascophaerales Family —parasitic species Class Pyrenomycetes Genus Genus Order Erysiphales Genus Buchnera Order Meliolales Genus Buttonia Order Xylariales Genus Castilleja Order Diaporthales Genus Centranthera Order Hypocreales Genus Cordylanthus Order Clavicipitales Genus Dasistoma Genus Class Discomycetes Genus Gerardia Order Phacidiales Genus Harveya Order Helotiales Genus Hyobanche Family Ascocorticiceae Genus Family Hemiphacidiaceae Genus Family Dermataceae Genus Melasma Family Sclerotiniaceae Genus Orthantha Order Cytarriales Genus Orthocarpus Order Medeolariales Genus Pedicularis Order Pezziales Genus Rhamphicarpa Family Sarcosomataceae Genus

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Genus Schwalbea Suborder Genus Seymeria Superfamily Ascoidea Genus Siphonostegia Superfamily Dermanyssoidea Genus Sopubia Order Genus Striga Suborder Genus Superfamily Eriophyoidea Family Viscaceae—parasitic species Superfamily Tetranychoidea Superfamily Eupodoidea Kingdom Animalia Superfamily Tydeoidea Superfamily Erythraenoidea Subkingdom Protozoa Superfamily Trombidioidea Genus Phytomonas Superfamily Hydryphantoidea Superfamily Tarsonemoidea And all Protozoa associated with insect Superfamily Pyemotoidea diseases Suborder Astigmata Subkingdom Eumetazoa Superfamily Hemisarcoptoidea Superfamily Acaroidea PHYLUM NEMATA Class Diplopoda CLASS SECERNENTEA Order Polydesmida Order Tylenchida Family Anguinidae Class Insecta Family Belonolaimidae Order Collembola Family Caloosiidae Family Sminthoridae Family Criconematidae Order Isoptera Family Dolichodoridae Order Thysanoptera Family Fergusobiidae Order Orthoptera Family Hemicycliophoridae Family Acrididae Family Heteroderidae Family Gryllidae Family Hoplolaimidae Family Gryllacrididae Family Meloidogynidae Family Gryllotalpidae Family Nacobbidae Family Phasmatidae Family Neotylenchidae Family Ronaleidae Family Nothotylenchidae Family Tettigoniidae Family Paratylenchidae Family Tetrigidae Family Pratylenchidae Order Hemiptera Family Tylenchidae Family Thaumastocoridae Family Tylenchulidae Family Aradidae Order Aphelenchida Superfamily Piesmatoidea Family Aphelenchoididae Superfamily Lygaeoidea Superfamily Idiostoloidea CLASS ADENOPHOREA Superfamily Coreoidea Order Dorylaimida Superfamily Pentatomoidea Family Longidoridae Superfamily Pyrrhocoroidea Family Trichodoridae Superfamily Tingoidea Superfamily Miroidea PHYLUM MOLLUSCA Order Homoptera Order Coleoptera CLASS GASTROPODA Family Anobiidae Subclass Pulmonata Family Apionidae Order Basommatophora Family Anthribidae Superfamily Planorbacea Family Bostrichidae 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

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Genus Helophorus (iv) The cloned genes are not carried Family Lyctidae on an expression vector if the cloned Family Meloidae genes code for: Family Mordellidae (A) A toxin to plants or plant prod- Family Platypodidae Family Scarabaeidae ucts, or a toxin to organisms beneficial Subfamily Melolonthinae to plants; or Subfamily Rutelinae (B) Other factors directly involved in Subfamily Cetoniinae eliciting plant disease (i.e., cell wall de- Subfamily Dynastinae grading enzymes); or Family Scolytidae (C) Substances acting as, or inhibi- Family Selbytidae tory to, plant growth regulators. Family Tenebrionidae Order Lepidoptera (2) A limited permit for interstate Order Diptera movement is not required for genetic Family Agromyzidae material from any plant pest contained Family Anthomyiidae in the genome of the plant Arabiodopsis Family Cecidomyiidae thaliana, provided that all of the fol- Family Chloropidae lowing conditions are met: Family Ephydridae (i) The plants or plant materials are Family Lonchaeidae shipped in a container that meets the Family Muscidae Genus Atherigona requirements of § 340.8(b) (1), (2), and Family Otitidae (3); Genus Euxeta (ii) The cloned genetic material is Family Syrphidae stably integrated into the plant ge- Family Tephritidae nome; Family Tipulidae (iii) The cloned material does not in- Order Hymenoptera clude the complete infectious genome Family Apidae of a known plant pest. Family Caphidae Family Chalcidae [52 FR 22908, June 16, 1987, as amended at 53 Family Cynipidae FR 12913, Apr. 20, 1988; 55 FR 53276, Dec. 28, Family Eurytomidae 1990; 58 FR 17056, Mar. 31, 1993] Family Formicidae Family Psilidae § 340.3 Notification for the introduc- Family Siricidae tion of certain regulated articles. 5 Family Tenthredinidae Family Torymidae (a) General. Certain regulated articles Family Xylocopidae may be introduced without a permit, provided that the introduction is in Unclassified organisms and/or organisms compliance with the requirements of whose classification is unknown. this section. Any other introduction of (b) Exemptions. (1) A limited permit regulated articles require a permit for interstate movement shall not be under § 340.4, with the exception of in- required for genetic material from any troductions that are conditionally ex- plant pest contained in Escherichia coli empt from permit requirements under genotype K–12 (strain K–12 and its de- § 340.2(b) of this part. rivatives), sterile strains of Saccharo- (b) Regulated articles eligible for intro- myces cerevisiae, or asporogenic strains duction under the notification procedure. of Bacillus subtilis, provided that all the Regulated articles which meet all of following conditions are met: the following six requirements and the (i) The microorganisms are shipped in a container that meets the require- 5 APHIS may issue guidelines regarding ments of § 340.8(b)(3); scientific procedures, practices, or protocols (ii) The cloned genetic material is which it has found acceptable in making var- maintained on a nonconjugation pro- ious determinations under the regulations. A ficient plasmid and the host does not person may follow an APHIS guideline or fol- contain other conjugation proficient low different procedures, practices, or proto- plasmids or generalized transducing cols. When different procedures, practices, or protocols are followed, a person may, but is phages; not required to, discuss the matter in ad- (iii) The cloned material does not in- vance with APHIS to help ensure that the clude the complete infectious genome procedures, practices, or protocols to be fol- of a known plant pest; lowed will be acceptable to APHIS.

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performance standards set forth in must be met for any introductions paragraph (c) of this section are eligi- under the notification procedure. ble for introduction under the notifica- (1) If the plants or plant materials tion procedure. are shipped, they must be shipped in (1) The regulated article is any plant such a way that the viable plant mate- species that is not listed as a noxious rial is unlikely to be disseminated weed in regulations at 7 CFR part 360 while in transit and must be main- under the Plant Protection Act (7 tained at the destination facility in U.S.C. 7712), and, when being consid- such a way that there is no release into ered for release into the environment, the environment. the regulated article is not considered (2) When the introduction is an envi- by the Administrator to be a weed in ronmental release, the regulated arti- the area of release into the environ- cle must be planted in such a way that ment. they are not inadvertently mixed with (2) The introduced genetic material non-regulated plant materials of any is ‘‘stably integrated’’ in the plant ge- species which are not part of the envi- nome, as defined in § 340.1. ronmental release. (3) The function of the introduced ge- (3) The plants and plant parts must netic material is known and its expres- be maintained in such a way that the sion in the regulated article does not identity of all material is known while result in plant disease. it is in use, and the plant parts must be (4) The introduced genetic material contained or devitalized when no does not: longer in use. (i) Cause the production of an infec- (4) There must be no viable vector tious entity, or agent associated with the regulated ar- (ii) Encode substances that are ticle. known or likely to be toxic to nontar- (5) The field trial must be conducted get organisms known or likely to feed such that: or live on the plant species, or (i) The regulated article will not per- (iii) Encode products intended for sist in the environment, and pharmaceutical or industrial use. (ii) No offspring can be produced that (5) To ensure that the introduced ge- could persist in the environment. netic sequences do not pose a signifi- cant risk of the creation of any new (6) Upon termination of the field test: plant virus, plant virus-derived se- (i) No viable material shall remain quences must be: which is likely to volunteer in subse- (i) Noncoding regulatory sequences of quent seasons, or known function, or (ii) Volunteers shall be managed to (ii) Sense or antisense genetic con- prevent persistence in the environ- structs derived from viral genes from ment. plant viruses that are prevalent and (d) Procedural requirements for noti- endemic in the area where the intro- fying APHIS. The following procedures duction will occur and that infect shall be followed for any introductions plants of the same host species, and under the notification procedure: that do not encode a functional (1) Notification should be directed to noncapsid gene product responsible for the Animal and Plant Health Inspec- cell-to-cell movement of the virus. tion Service, Plant Protection and (6) The plant has not been modified Quarantine, Biotechnology and Sci- to contain the following genetic mate- entific Services, Biotechnology Per- rial from animal or human pathogens: mits, 4700 River Road, Unit 147, River- (i) Any nucleic acid sequence derived dale, Maryland 20737–1237. from an animal or human virus, or (2) The notification shall include the (ii) Coding sequences whose products following: are known or likely causal agents of (i) Name, title, address, telephone disease in animals or humans. number, and signature of the respon- (c) Performance standards for introduc- sible person; tions under the notification procedure. (ii) Information necessary to identify The following performance standards the regulated article(s), including:

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(A) The scientific, common, or trade to notifications for interstate move- names, and phenotype of regulated ar- ment of regulated articles will not be ticle, required by APHIS prior to acknowl- (B) The designations for the genetic edgment, although States may provide loci, the encoded proteins or functions, their reviews to APHIS at their discre- and donor organisms for all genes from tion. which introduced genetic material was (2) The Administrator, will provide derived, and acknowledgement within 10 days of re- (C) The method by which the recipi- ceipt that the interstate movement is ent was transformed; appropriate under notification. (iii) The names and locations of the (3) The Administrator, will provide origination and destination facilities acknowledgement within 30 days of re- for movement or the field site location ceipt that the importation is appro- for the environmental release; and the priate under notification. size of the introduction, (4) APHIS will provide acknowledg- (iv) The date and, in the case of envi- ment within 30 days of receipt that the ronmental release, the expected dura- environmental release is appropriate tion of the introduction (release); and under notification. Such acknowledg- (v) A statement that certifies that ment will apply to field testing for 1 introduction of the regulated article year from the date of introduction, and will be in accordance with the provi- may be renewed annually by submis- sions of this section. sion of an additional notification to (3) Notification must be submitted to APHIS. APHIS: (5) A person denied permission for in- (i) At least 10 days prior to the day of troduction of a regulated article under introduction, if the introduction is notification may apply for a permit for interstate movement. introduction of that regulated article (ii) At least 30 days prior to the day without prejudice. of introduction, if the introduction is [58 FR 17056, Mar. 31, 1993, as amended at 59 an importation. FR 67610, Dec. 30, 1994; 62 FR 23956, May 2, (iii) At least 30 days prior to the day 1997; 66 FR 21058, Apr. 27, 2001; 68 FR 46436, of introduction, if the introduction is Aug. 6, 2003] an environmental release. § 340.4 Permits for the introduction of (4) Field test reports must be sub- 6 mitted to APHIS within 6 months after a regulated article. termination of the field test. Field test reports shall include the APHIS ref- (a) Application for permit. Two copies erence number, methods of observa- of a written application for a permit to tion, resulting data, and analysis re- introduce a regulated article, which garding all deleterious effects on may be obtained from APHIS, shall be plants, nontarget organisms, or the en- submitted by the responsible person to vironment. the Animal and Plant Health Inspec- (5) The Administrator, shall be noti- tion Service, Plant Protection and fied of any unusual occurrence within Quarantine, Biotechnology and Sci- the time periods and in the manner entific Services, Biotechnology Per- specified in § 340.4(f)(10). mits, 4700 River Road, Unit 147, River- (6) Access shall be allowed for APHIS dale, Maryland 20737–1237. If there are and State regulatory officials to in- portions of the application deemed to spect facilities and/or the field test site contain trade secret or confidential and any records necessary to evaluate business information (CBI), each page compliance with the provisions of para- of the application containing such in- graphs (b) and (c) of this section. formation should be marked ‘‘CBI (e) Administrative action in response to Copy’’. In addition, those portions of notification. (1) APHIS will provide cop- the application which are deemed ies of all notifications to appropriate ‘‘CBI’’ shall be so designated. The sec- State regulatory official(s) for review ond copy shall have all such CBI de- within 5 business days of receipt. Com- leted and shall be marked on each page ments to APHIS from appropriate State regulatory officials in response 6 See footnote 5 in § 340.3.

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of the application where CBI was de- article which is a product; and, regu- leted, ‘‘CBI Deleted’’. If an application lated article; does not contain CBI then the first (3) Names, addresses, and telephone page of both copies shall be marked numbers of the persons who developed ‘‘No CBI’’. and/or supplied the regulated article; (b) Permit for release into the environ- (4) A description of the means of ment. An application for the release movement (e.g., mail, common carrier, into the environment of a regulated ar- baggage, or handcarried (and by ticle shall be submitted at least 120 whom)); days in advance of the proposed release into the environment. An initial review (5) A description of the anticipated or shall be completed by APHIS within 30 actual expression of the altered genetic days of the receipt of the application. material in the regulated article and If the application is complete, the re- how that expression differs from the sponsible individual shall be notified of expression in the non-modified paren- the date of receipt of the application tal organism (e.g., morphological or for purposes of advising the applicant structural characteristics, physio- when the 120 day review period com- logical activities and processes, num- menced. 7 If the application is not com- ber of copies of inserted genetic mate- plete, the responsible individual will be rial and the physical state of this ma- advised what additional information terial inside the recipient organism must be submitted. APHIS shall com- (integrated or extrachromosomal), mence the 120 day review period upon products and secretions, growth char- receipt of the additional information, acteristics); assuming the additional information (6) A detailed description of the mo- submitted is adequate. When it is de- lecular biology of the system (e.g., termined that an application is com- donor-recipient-vector) which is or will plete, APHIS shall submit to the State be used to produce the regulated arti- department of agriculture of the State cle; where the release is planned, a copy of (7) Country and locality where the the initial review and a copy of the ap- donor organism, recipient organism, plication marked, ‘‘CBI Deleted’’, or vector or vector agent, and regulated ‘‘No CBI’’ for State notification and re- article were collected, developed, and view. The application shall include the following information: 8 produced; (1) Name, title, address, telephone (8) A detailed description of the pur- number, signature of the responsible pose for the introduction of the regu- person and type of permit requested lated article including a detailed de- (for importation, interstate movement, scription of the proposed experimental or release into the environment); and/or production design; (2) All scientific, common, and trade (9) The quantity of the regulated ar- names, and all designations necessary ticle to be introduced and proposed to identify the: Donor organism(s); re- schedule and number of introductions; cipient organism(s); vector or vector (10) A detailed description of the agent(s); constituent of each regulated processes, procedures, and safeguards which have been used or will be used in 7 The 120 day review period would be ex- the country of origin and in the United tended if preparation of an environmental States to prevent contamination, re- impact statement in addition to an environ- lease, and dissemination in the produc- mental assessment was necessary. tion of the: Donor organism; recipient 8 Application forms are available without charge from the Animal and Plant Health In- organism; vector or vector agent; con- spection Service, Plant Protection and Quar- stituent of each regulated article antine, Biotechnology and Scientific Serv- which is a product; and regulated arti- ices, Biotechnology Permits, 4700 River cle; Road, Unit 147, Riverdale, Maryland 20737– (11) A detailed description of the in- 1237, or from local offices which are listed in telephone directories. A person should speci- tended destination (including final and fy in requesting the application that the per- all intermediate destinations), uses, mit is for the introduction of a regulated ar- and/or distribution of the regulated ar- ticle subject to regulation under part 340. ticle (e.g., greenhouses, laboratory, or

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growth chamber location; field trial lo- issuance. If a permit is sought for mul- cation; pilot project location; produc- tiple interstate movements between tion, propagation, and manufacture lo- contained facilities the responsible in- cation; proposed sale and distribution dividual shall specify in the permit ap- location); plication all the regulated articles to (12) A detailed description of the pro- be moved interstate; the origins and posed procedures, processes, and safe- destinations of all proposed shipments; guards which will be used to prevent a detailed description of all the con- escape and dissemination of the regu- tained facilities where regulated arti- lated article at each of the intended cles will be utilized at destination; and destinations; a description of the containers that (13) A detailed description of any bio- will be used to transport the regulated logical material (e.g., culture medium, articles. A limited permit for inter- or host material) accompanying the state movement of a regulated article regulated article during movement; shall only be valid for the movement of and those regulated articles moving be- (14) A detailed description of the pro- tween those locations specified in the posed method of final disposition of the application. If a person seeks to move regulated article. regulated articles other than those (c) Limited permits for interstate move- specified in the application, or to a lo- ment or importation of a regulated article. cation other than those listed in the An application for the interstate move- application, a supplemental applica- ment or importation of a regulated ar- tion shall be submitted to APHIS. No ticle shall be submitted at least 60 days person shall move a regulated article in advance of the first proposed inter- interstate unless the number of the state movement and at least 60 days limited permit appears on the outside prior to each importation. An initial of the shipping container. The respon- review shall be completed by APHIS sible person shipping a regulated arti- within 15 days of the receipt of the ap- cle interstate shall keep records for plication. If the application is com- one year demonstrating that the regu- plete, the responsible person shall be lated article arrived at its intended notified of the date of receipt of the ap- destination. The responsible person plication for purposes of advising the seeking a limited permit for interstate applicant when the 60 day review pe- movement shall submit on an applica- riod commenced. If the application is tion form obtained from APHIS, the not complete, the responsible person data required by paragraphs (b) (1), (2), will be advised what additional infor- (4), (6), (7), (9), and (11) through (14) of mation must be submitted. APHIS this section. shall commence the 60 day review pe- (2) Limited permit for importation. The responsible person seeking a permit for riod upon receipt of the additional in- the importation of a regulated article formation, assuming the additional in- shall submit an application for a per- formation submitted is adequate. When mit prior to the importation of each it is determined that an application is shipment of regulated articles. The re- complete, APHIS shall submit to the sponsible person importing a regulated State department of agriculture of the article shall keep records for one year State of destination of the regulated demonstrating that the regulated arti- article a copy of the initial review and cle arrived at its intended destination. the application marked, ‘‘CBI De- The responsible person seeking a lim- leted’’, or ‘‘No CBI’’ for State notifica- ited permit for importation shall sub- tion and review. mit on an application form obtained (1) Limited permit for interstate move- from APHIS data required by para- ment. The responsible person may apply graphs (b) (1), (2), (4), (6), (7), (9), and for a single limited permit for the (11) through (14) of this section. 9 interstate movement of multiple regu- lated articles in lieu of submitting an 9 Renewals may receive shorter review. In application for each individual inter- the case of a renewal for a limited permit for state movement. Each limited permit importation that has been issued less than issued shall be numbered and shall be one year earlier, APHIS will notify the re- valid for one year from the date of sponsible person within 15 days that either:

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(d) Premises inspection. An inspector the place where the regulated article is may inspect the site or facility where located and to any records relating to regulated articles are proposed, pursu- the introduction of a regulated article; ant to a permit, to be released into the (6) The regulated article shall, when environment or contained after their possible, be kept identified with a label interstate movement or importation. showing the name of the regulated ar- Failure to allow the inspection of a ticle, and the date of importation; premises prior to the issuance of a per- (7) The regulated article shall be sub- mit or limited permit shall be grounds ject to the application of measures de- for the denial of the permit. termined by the Administrator to be (e) Administrative action on applica- necessary to prevent the accidental or tions. After receipt and review by unauthorized release of the regulated APHIS of the application and the data article; submitted pursuant to paragraph (a) of (8) The regulated article shall be sub- this section, including any additional ject to the application of remedial information requested by APHIS, a measures (including disposal) deter- permit shall be granted or denied. If a mined by the Administrator to be nec- permit is denied, the applicant shall be essary to prevent the spread of plant promptly informed of the reasons why pests; the permit was denied and given the (9) A person who has been issued a opportunity to appeal the denial in ac- permit shall submit to APHIS a field cordance with the provisions of para- test report within 6 months after the graph (g) of this section. If a permit is termination of the field test. A field granted, the permit will specify the ap- test report shall include the APHIS ref- plicable conditions for introduction of erence number, methods of observa- the regulated article under this part. tion, resulting data, and analysis re- (f) Permit conditions. A person who is garding all deleterious effects on issued a permit and his/her employees plants, nontarget organisms, or the en- or agents shall comply with the fol- vironment. lowing conditions, and any supple- (10) APHIS shall be notified within mental conditions which shall be listed the time periods and manner specified on the permit, as deemed by the Ad- below, in the event of the following oc- ministrator to be necessary to prevent currences: the dissemination and establishment of (i) Orally notified immediately upon plant pests: discovery and notify in writing within (1) The regulated article shall be 24 hours in the event of any accidental maintained and disposed of (when nec- or unauthorized release of the regu- essary) in a manner so as to prevent lated article; the dissemination and establishment of (ii) In writing as soon as possible but plant pests. not later than within 5 working days if (2) All packing material, shipping the regulated article or associated host containers, and any other material ac- organism is found to have characteris- companying the regulated article shall tics substantially different from those be treated or disposed of in such a man- listed in the application for a permit or ner so as to prevent the dissemination suffers any unusual occurrence (exces- and establishment of plant pests. sive mortality or morbidity, or unan- (3) The regulated article shall be kept ticipated effect on non-target orga- separate from other organisms, except nisms); as specifically allowed in the permit; (11) A permittee or his/her agent and (4) The regulated article shall be any person who seeks to import a regu- maintained only in areas and premises lated article into the United States specified in the permit; shall: (5) An inspector shall be allowed ac- (i) Import or offer the regulated arti- cess, during regular business hours, to cle for entry only through any USDA plant inspection station listed in ac- (1) The renewal permit is approved or (2) that cordance with § 319.37–8(a) of this chap- a 60 day review period is necessary because ter; the conditions of the original permit have (ii) Notify APHIS promptly upon ar- changed. rival of any regulated article at a port

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of entry, of its arrival by such means least 60 days prior to the time the as a manifest, customs entry docu- courtesy permit is sought. ment, commercial invoice, waybill, a (3) Administrative action. APHIS shall broker’s document, or a notice form complete an initial review within 15 provided for such purpose; and days of the date of receipt of the appli- (iii) Mark and identify the regulated cation. If the application is complete, article in accordance with § 340.5 of this the responsible individual shall be no- part. tified of the date of receipt of the ap- (g) Withdrawal or denial of a permit. plication for purposes of advising the Any permit which has been issued may applicant when the 60 day review pe- be withdrawn by an inspector or the riod commenced. If the application is Administrator if he/she determines not complete, the responsible indi- that the holder thereof has not com- vidual will be advised what additional plied with one or more of the condi- information must be submitted, and tions listed on the permit. APHIS will shall commence the 60 day review pe- confirm the reasons for the withdrawal riod upon receipt of the additional in- of the permit in writing within ten (10) formation, assuming the additional in- days. Any person whose permit has formation submitted is adequate. With- been withdrawn or any person who has in 60 days from the date of receipt of a been denied a permit may appeal the complete application, APHIS will ei- decision in writing to the Adminis- ther issue a courtesy permit or advise trator within ten (10) days after receiv- the responsible individual that a per- ing the written notification of the mit is required under paragraph (b) or withdrawal or denial. The appeal shall (c) of this section. state all of the facts and reasons upon (Approved by the Office of Management and which the person relies to show that Budget under control number 0579–0216) the permit was wrongfully withdrawn [52 FR 22908, June 16, 1987. Redesignated at 58 or denied. The Administrator shall FR 17056, Mar. 31, 1993, as amended at 58 FR grant or deny the appeal, in writing, 17058, Mar. 31, 1993; 59 FR 67610, Dec. 30, 1994; stating the reasons for the decision as 62 FR 23956, 23957, May 2, 1997; 68 FR 46436, promptly as circumstances allow. If Aug. 6, 2003; 72 FR 43523, Aug. 6, 2007; 83 FR there is a conflict as to any material 11867, Mar. 19, 2018] fact, a hearing shall be held to resolve such conflict. Rules of practice con- § 340.5 Petition to amend the list of or- 10 cerning such a hearing will be adopted ganisms. by the Administrator. (a) General. Any person may submit (h) Courtesy permit—(1) Issuance. The to the Administrator a petition to Administrator may issue a courtesy amend the list of organisms in § 340.2 of permit for the introduction of orga- this part by adding or deleting any nisms modified through genetic engi- genus, species, or subspecies. A peti- neering which are not subject to regu- tioner may supplement, amend, or lation under this part to facilitate withdraw a petition in writing without movement when the movement might prior approval of the Administrator otherwise be impeded because of the and without prejudice to resubmission similarity of the organism to other or- at any time until the Administrator ganisms regulated under this part. rules on the petition. A petition to (2) Application. A person seeking a amend the list of organisms shall be courtesy permit shall submit on an ap- submitted in accordance with the pro- plication form obtained from APHIS cedures and format specified by this data required by paragraphs (b) (1), (2), section. and (5) of this section and shall indi- (b) Submission procedures and format. cate such data is being submitted as a A person shall submit two copies of a request for a courtesy permit. A person petition to the Animal and Plant should also include a statement ex- Health Inspection Service, Bio- plaining why he or she believes the or- technology and Scientific Services, ganism or product does not come with- PPQ, Biotechnology Permits, 4700 in the definition of a regulated article. The application shall be submitted at 10 See footnote 5 in § 340.3.

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River Road, Unit 147, Riverdale, Mary- of this section, the petitioner shall be land 20737–1237. The petition should be sent a notice indicating how the peti- dated, and structured as follows: tion is deficient. (2) After the filing of a petition to PETITION TO AMEND 7 CFR 340.2 amend the list of organisms USDA The undersigned submits this petition shall publish a proposal in the FEDERAL under 7 CFR 340.4 to request that the Admin- REGISTER to amend § 340.2 and solicit istrator [add the following genus, species, or comments thereon from the public. An subspecies to the list of organisms in 7 CFR interested person may submit written 340.2] or [to remove the following genus, spe- comments to the APHIS on a filed peti- cies, or subspecies from the list of organisms in § 340.2]. tion, which shall become part of the docket file. A. Statement of Grounds (3) The Administrator shall furnish a (A person must present a full statement response to each petitioner within 180 explaining the factual grounds why the days of receipt of the petition. The re- genus, species, or subspecies to be added to sponse will either: (i) Approve the peti- § 340.2 of this part is a plant pest or why tion in whole or in part in which case there is reason to believe the genus, species, the Administrator shall concurrently or subspecies is a plant pest or why the take appropriate action (publication of genus, species, or subspecies sought to be re- a document in the FEDERAL REGISTER moved is not a plant pest or why there is rea- son to believe the genus, species, or sub- amending § 340.2 of this part; or (ii) species is not a plant pest. The petition deny the petition in whole or in part. should include copies of scientific literature The petitioner shall be notified in writ- which the petitioner is relying upon, copies ing of the Administrator’s decision. of unpublished studies, or data from tests The decision shall be placed in the pub- performed. The petition should not include lic docket file in the offices of APHIS, trade secret or confidential business informa- and in the form of a notice published in tion. the FEDERAL REGISTER. A person should also include representa- tive information known to the petitioner [52 FR 22908, June 16, 1987. Redesignated at 58 which would be unfavorable to a petition for FR 17056, Mar. 31, 1993, as amended at 58 FR listing or delisting. (If a person is not aware 17059, Mar. 31, 1993; 59 FR 67611, Dec. 30, 1994; of any unfavorable information the petition 62 FR 23957, May 2, 1997] should state, Unfavorable Information: NONE). § 340.6 Petition for determination of nonregulated status. 11 B. Certification (a) General. Any person may submit The undersigned certifies, that to the best to the Administrator, a petition to knowledge and belief of the undersigned, this petition includes all information and views seek a determination that an article on which the petitioner relies, and that it in- should not be regulated under this cludes representative data and information part. A petitioner may supplement, known to the petitioner which are unfavor- amend, or withdraw a petition in writ- able to the petition. ing without prior approval of the Ad- (Signature) lllllllllllllllll ministrator, and without affecting re- (Name of petitioner) llllllllllll submission at any time until the Ad- (Mailing address) llllllllllllll ministrator, rules on the petition. A (Telephone number) lllllllllllll petition for determination of nonregu- (c) Administrative action on a petition. lated status shall be submitted in ac- (1) A petition to amend the list of orga- cordance with the procedure and for- nisms which meets the requirements of mat specified in this section. paragraph (b) of this section will be (b) Submission procedures and format. filed by the APHIS, stamped with the A person shall submit two copies of a date of filing, and assigned a docket petition to the Animal and Plant number. The docket number shall iden- Health Inspection Service, Plant Pro- tify the file established for all submis- tection and Quarantine, Biotechnology sions relating to the petition. APHIS, and Scientific Services, Biotechnology will promptly notify the petitioner in Coordination and Technical Assistance, writing of the filing and docket number 4700 River Road, Unit 146, Riverdale, of a petition. If a petition does not meet the requirements of paragraph (b) 11 See footnote 5 in § 340.3.

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Maryland 20737–1237. The petition shall (3) A detailed description of the dif- be dated and structured as follows: ferences in genotype between the regu- lated article and the nonmodified re- PETITION FOR DETERMINATION OF NONREGULATED STATUS cipient organism. Include all scientific, common, or trade names, and all des- The undersigned submits this petition ignations necessary to identify: the under 7 CFR 340.6 to request that the Admin- istrator, make a determination that the arti- donor organism(s), the nature of the cle should not be regulated under 7 CFR part transformation system (vector or vec- 340. tor agent(s)), the inserted genetic ma- (Signature) lllllllllllllllll terial and its product(s), and the regu- lated article. Include country and lo- A. Statement of Grounds cality where the donor, the recipient, A person must present a full statement ex- and the vector organisms and the regu- plaining the factual grounds why the orga- lated articles are collected, developed, nism should not be regulated under 7 CFR and produced. part 340. The petitioner shall include copies of scientific literature, copies of unpublished (4) A detailed description of the phe- studies, when available, and data from tests notype of the regulated article. De- performed upon which to base a determina- scribe known and potential differences tion. The petition shall include all informa- from the unmodified recipient orga- tion set forth in paragraph (c) of 7 CFR 340.6. nism that would substantiate that the If there are portions of the petition deemed regulated article is unlikely to pose a to contain trade secret or confidential busi- ness information (CBI), each page of the pe- greater plant pest risk than the un- tition containing such information should be modified organism from which it was marked ‘‘CBI Copy’’. In addition, those por- derived, including but not limited to: tions of the petition which are deemed ‘‘CBI’’ Plant pest risk characteristics, disease shall be so designated. The second copy shall and pest susceptibilities, expression of have all such CBI deleted and shall have the gene product, new enzymes, or marked on each page where the CBI was de- changes to plant metabolism, leted: ‘‘CBI Deleted.’’ If a petition does not contain CBI, the first page of both copies weediness of the regulated article, im- shall be marked: ‘‘No CBI.’’ pact on the weediness of any other A person shall also include information plant with which it can interbreed, ag- known to the petitioner which would be un- ricultural or cultivation practices, ef- favorable to a petition. If a person is not fects of the regulated article on non- aware of any unfavorable information, the target organisms, indirect plant pest petition should state, ‘‘Unfavorable informa- effects on other agricultural products, tion: NONE.’’ transfer of genetic information to orga- B. Certification nisms with which it cannot interbreed, The undersigned certifies, that to the best and any other information which the knowledge and belief of the undersigned, this Administrator believes to be relevant petition includes all information and views to a determination. Any information on which to base a determination, and that known to the petitioner that indicates it includes relevant data and information that a regulated article may pose a known to the petitioner which are unfavor- greater plant pest risk than the un- able to the petition. modified recipient organism shall also (Signature) lllllllllllllllll be included. (Name of Petitioner) llllllllllll (5) Field test reports for all trials (Mailing Address) llllllllllllll conducted under permit or notification (Telephone Number) llllllllllll procedures, involving the regulated ar- (c) Required data and information. The ticle, that were submitted prior to sub- petition shall include the following in- mission of a petition for determination formation: of nonregulated status or prior to sub- (1) Description of the biology of the mission of a request for extension of a nonmodified recipient plant and infor- determination of nonregulated status mation necessary to identify the re- under paragraph (e) of this part. Field cipient plant in the narrowest taxo- test reports shall include the APHIS nomic grouping applicable. reference number, methods of observa- (2) Relevant experimental data and tion, resulting data, and analysis re- publications. garding all deleterious effects on

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plants, nontarget organisms, or the en- organism and the regulated articles in vironment. question. (d) Administrative action on a petition. (3) APHIS will announce in the FED- (1) A petition for determination of non- ERAL REGISTER all preliminary deci- regulated status under this part which sions to extend determinations of non- meets the requirements of paragraphs regulated status 30 days before the de- (b) and (c) of this section will be filed cisions become final and effective. If by the Administrator, stamped with additional information becomes avail- the date of filing, and assigned a peti- able that APHIS believes justifies tion number. The petition number changing its decision, it will issue a re- shall identify the file established for vised decision. all submissions relating to the peti- (4) If a request to APHIS to extend a tion. APHIS will promptly notify the determination of nonregulated status petitioner in writing of the filing and under this part is denied, APHIS will the assigned petition number. If a peti- inform the submitter of that request of tion does not meet the requirements the reasons for denial. The submitter specified in this section, the petitioner may submit a modified request or a shall be sent a notice indicating how separate petition for determination of the petition is deficient. nonregulated status without prejudice. (2) After the filing of a completed pe- (f) Denial of a petition; appeal. (1) The tition, APHIS shall publish a notice in Administrator’s written notification of the FEDERAL REGISTER. This notice denial of a petition shall briefly set shall specify that comments will be ac- forth the reason for such denial. The cepted from the public on the filed pe- written notification shall be sent by tition during a 60 day period com- certified mail. Any person whose peti- mencing with the date of the notice. tion has been denied may appeal the During the comment period, any inter- determination in writing to the Admin- ested person may submit to the Admin- istrator within 10 days from receipt of istrator, written comments, regarding the written notification of denial. the filed petition, which shall become (2) The appeal shall state all of the part of the petition file. facts and reasons upon which the per- (3) The Administrator shall, based son relies, including any new informa- upon available information, furnish a tion, to show that the petition was response to each petitioner within 180 wrongfully denied. The Administrator days of receipt of a completed petition. shall grant or deny the appeal, in writ- The response will either: ing, stating the reasons for the deci- (i) Approve the petition in whole or sion as promptly as circumstances in part; or allow. An informal hearing may be held (ii) deny the petition. by the Administrator if there is a dis- pute of a material fact. Rules of Prac- The petitioner shall be notified in tice concerning such a hearing will be writing of the Administrator’s deci- adopted by the Administrator. sion. The decision shall be placed in the public petition file in the offices of [58 FR 17057, Mar. 31, 1993, as amended at 59 APHIS and notice of availability pub- FR 67611, Dec. 30, 1994; 62 FR 23957, May 2, lished in the FEDERAL REGISTER. 1997] (e) Extensions to determinations of non- regulated status. (1) The Administrator § 340.7 Marking and identity. may determine that a regulated article (a) Any regulated article to be im- does not pose a potential for plant pest ported other than by mail, shall, at the risk, and should therefore not be regu- time of importation into the United lated under this part, based on the sim- States, plainly and correctly bear on ilarity of that organism to an ante- the outer container the following infor- cedent organism. mation: (2) A person may request that APHIS (1) General nature and quantity of extend a determination of nonregu- the contents; lated status to other organisms. Such a (2) Country and locality where col- request shall include information to es- lected, developed, manufactured, tablish the similarity of the antecedent reared, cultivated or cultured;

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(3) Name and address of shipper, (b) Container requirements—(1) Plants owner, or person shipping or for- and plant parts. All plants or plant warding the organism; parts, except seeds, cells, and subcel- (4) Name, address, and telephone lular elements, shall be packed in a number of consignee; sealed plastic bag of at least 5 mil (5) Identifying shipper’s mark and thickness, inside a sturdy, sealed, leak- number; and proof, outer shipping container con- (6) Number of written permit author- structed of corrugated fiberboard, izing the importation. corrogated cardboard, wood, or other (b) Any regulated article imported by material of equivalent strength. mail, shall be plainly and correctly ad- (2) Seeds. All seeds shall be trans- dressed and mailed to APHIS through ported in a sealed plastic bag of at any USDA plant inspection station least 5 mil thickness, inside a sealed listed in accordance with § 319.37–8(a) of metal container, which shall be placed this chapter and shall be accompanied inside a second sealed metal container. by a separate sheet of paper within the Shock absorbing cushioning material package plainly and correctly bearing shall be placed between the inner and the name, address, and telephone num- outer metal containers. Each metal ber of the intended recipient, and shall container shall be independently capa- plainly and correctly bear on the outer container the following information: ble of protecting the seeds and pre- (1) General nature and quantity of venting spillage or escape. Each set of the contents; metal containers shall then be enclosed (2) Country and locality where col- in a sturdy outer shipping container lected, developed, manufactured, constructed of corrugated fiberboard, reared, cultivated, or cured; corrugated cardboard, wood, or other (3) Name and address of shipper, material of equivalent strength. owner, or person shipping or for- (3) Live microorganisms and/or etiologic warding the regulated article; and agents, cells, or subcellular elements. All (4) Number of permit authorizing the regulated articles which are live (non- importation; inactivated) microorganisms, or etio- (c) Any regulated article imported logic agents, cells, or subcellular ele- into the United States by mail or oth- ments shall be packed as specified erwise shall, at the time of importation below: or offer for importation into the United (i) Volume not exceeding 50 ml. Regu- States, be accompanied by an invoice lated articles not exceeding 50 ml shall or packing list indicating the contents be placed in a securely closed, water- of the shipment. tight container (primary container, [52 FR 22908, June 16, 1987. Redesignated at 58 test tube, vial, etc.) which shall be en- FR 17056, Mar. 31, 1993, as amended at 58 FR closed in a second, durable watertight 17059, Mar. 31, 1993; 62 FR 23958, May 2, 1997; container (secondary container). Sev- 72 FR 43523, Aug. 6, 2007; 83 FR 11867, Mar. 19, eral primary containers may be en- 2018] closed in a single secondary container, if the total volume of all the primary § 340.8 Container requirements for the containers so enclosed does not exceed movement of regulated articles. 50 ml. The space at the top, bottom, (a) General requirements. A regulated and sides between the primary and sec- article shall not be moved unless it ondary containers shall contain suffi- complies with the provisions of para- cient nonparticulate absorbent mate- graph (b) of this section, unless a vari- rial (e.g., paper towel) to absorb the en- ance has been granted in accordance tire contents of the primary con- with the provisions of paragraph (c) of tainer(s) in case of breakage or leak- 12 this section. age. Each set of primary and secondary containers shall then be enclosed in an 12 The requirements of this section are in outer shipping container constructed of addition to and not in lieu of any other pack- ing requirements such as those for the trans- portation of etiologic agents prescribed by CFR or any other agency of the Federal gov- the Department of Transportation in Title 49 ernment.

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corrugated fiberboard, corrugated card- board, wood, or other material of board, wood, or other material of equivalent strength. equivalent strength. (5) Other macroscopic organisms. Other (ii) Volume greater than 50 ml. Regu- macroscopic organisms not covered in lated articles which exceed a volume of paragraphs (b) (1), (2), and (4) of this 50 ml. shall comply with requirements section which do not require contin- specified in paragraph (b)(3)(i) of this uous access to atmospheric oxygen section. In addition, a shock absorbing shall be packaged as specified in para- material, in volume at least equal to graph (b)(3) or (b)(4) of this section. All that of the absorbent material between macroscopic organisms which are not the primary and secondary containers, plants and which require continuous shall be placed at the top, bottom, and access to atmospheric oxygen shall be sides between the secondary container placed in primary shipping containers and the outer shipping container. Sin- constructed of a sturdy, crush-proof gle primary containers shall not con- frame of wood, metal, or equivalent tain more than 1,000 ml. of material. strength material, surrounded by es- However, two or more primary con- cape-proof mesh or netting of a tainers whose combined volumes do not strength and mesh size sufficient to exceed 1,000 ml. may be placed in a sin- prevent the escape of the smallest or- gle, secondary container. The max- ganism in the shipment, with edges and imum amount of micro-organisms or seams of the mesh or netting sealed to etiologic agents, cells, or subcellular prevent escape of organisms. Each pri- elements which may be enclosed within mary shipping container shall be se- a single outer shipping container shall curely placed within a larger secondary not exceed 4,000 ml. shipping container constructed of (iii) Dry ice. If dry ice is used as a re- wood, metal, or equivalent strength frigerant, it shall be placed outside the material. The primary and secondary secondary container(s). If dry ice is shipping containers shall then be used between the secondary container placed securely within an outer ship- and the outer shipping container, the ping container constructed of cor- shock absorbing material shall be rugated fiberboard, corrugated card- placed so that the secondary container board, wood, or other material of does not become loose inside the outer equivalent strength, which outer con- shipping container as the dry ice sub- tainer may have air holes or spaces in limates. the sides and/or ends of the container, (4) Insects, mites, and related orga- provided that the outer shipping con- nisms. Insects, mites, and other small tainer must retain sufficient strength shall be packed for ship- to prevent crushing of the primary and ment as specified in this paragraph or secondary shipping containers. in paragraph (b)(3) of this section. In- (c) Request for a variance from con- sects (any life stage) shall be placed in tainer requirements. A responsible per- an escape-proof primary shipping con- son who believes the container require- tainer (insulated vacuum container, ments normally applicable to the glass, metal, plastic, etc.) and sealed to movement of the person’s regulated ar- prevent escape. Such primary con- ticle(s) are inappropriate due to unique tainer shall be placed securely within a circumstances (such as the nature, vol- secondary shipping container of ume, or life stage of the regulated arti- crushproof styrofoam or other material cle) may submit in an application for a of equivalent strength; one or more permit, a request for a variance from rigid ice packs may also be placed the container requirements. The re- within the secondary shipping con- quest for a variance under this section tainer; and sufficient packing material shall consist of a short statement de- shall be added around the primary con- scribing why the normally applicable tainer to prevent movement of the pri- container requirements are inappro- mary shipping container. The sec- priate for the regulated article which ondary (styrofoam or other) container the person proposes to move and what shall be placed securely within an container requirements the person outer shipping container constructed of would use in lieu of the normally pre- corrugated fiberboard, corrugated card- scribed container requirements. USDA

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shall advise the responsible person in Protection and Quarantine Programs writing at the time a permit is granted of APHIS have made provisions with on the person’s request for a variance. the U.S. Postal and Customs Services to ensure closer inspection of prohib- [52 FR 22908, June 16, 1987. Redesignated at 58 FR 17056, Mar. 31, 1993; 62 FR 23956, May 2, ited or restricted imported articles. 1997] [66 FR 21059, Apr. 27, 2001]

§ 340.9 Cost and charges. § 351.2 Location of inspectors. The services of the inspector during Inspectors of the Plant Protection regularly assigned hours of duty and at and Quarantine Programs and customs the usual places of duty shall be fur- officers are stationed at the following nished without cost. 13 The U.S. Depart- locations: ment of Agriculture will not be respon- sible for any costs or charges incident Anchorage, Alaska, Arlington, Va., At- to inspections or compliance with the lanta, Ga., Baltimore, Md., Baton Rouge, La., Blaine, Wash., Boston, Mass., Browns- provisions of this part, other than for ville, Tex., Buffalo, N.Y., Calexico, Calif., the services of the inspector. Chantilly, Va., Charleston, S.C., Charlotte [52 FR 22908, June 16, 1987. Redesignated at 58 Amalie, St. Thomas, V.I., Chicago, Ill., FR 17056, Mar. 31, 1993; 62 FR 23956, May 2, Christiansted, St. Croix, V.I., Cleveland, 1997] Ohio., Corpus Christi, Tex., Dallas, Tex., Del Rio, Tex., Detroit, Mich., Douglas, Ariz., Dover, Del., Duluth, Minn., Eagle Pass, Tex., PART 351—IMPORTATION OF El Paso, Tex., Galveston, Tex., Hidalgo, Tex., PLANTS OR PLANT PRODUCTS BY Hilo, Hawaii, Hoboken, N.J., Honolulu, Ha- MAIL waii, Houston, Tex., Jacksonville, Fla., Ja- maica, L.I., N.Y., Key West, Fla., Laredo, Tex., McGuire AFB, N.J., Memphis, Tenn., AUTHORITY: 7 U.S.C. 7711–7714, 7721, 7754, Miami, Fla., Milwaukee, Wis., Mobile, Ala., and 7755; 7 CFR 2.22, 2.80, and 371.3. New Orleans, La., New York, N.Y., Newport Sec. News, Va., Nogales, Ariz., Norfolk, Va., Pen- 351.1 Joint treatment generally. sacola, Fla., Philadelphia, Pa., Port Arthur, 351.2 Location of inspectors. Tex., Port Canaveral, Fla., Port Everglades, 351.3 Procedure on arrival. Fla., Portland, Oreg., Presidio, Tex., 351.4 Records. Progreso, Tex., Ramey AFB, P.R., Roma, 351.5 Return or destruction. Tex., Rouses Point, N.Y., St. Paul, Minn., 351.6 Packages in closed mail dispatches. San Antonio, Tex., San Diego, Calif., San 351.7 Regulations governing importation by Francisco, Calif., San Juan, P.R., San Luis, mail of plant material for immediate ex- Ariz., San Pedro, Calif., San Ysidro, Calif., port. Savannah, Ga., Seattle, Wash., Tampa, Fla., CROSS REFERENCE: For customs regulations Toledo, Ohio, Washington, DC, West Palm governing importation of plants and plant Beach, Fla., Wilmington, N.C. products, see 19 CFR part 12. [28 FR 5203, May 24, 1963, as amended at 36 AUTHORITY: 7 U.S.C. 7701–7772 and 7781–7786; FR 24917, Dec. 24, 1971] 7 CFR 2.22, 2.80, and 371.3. § 351.3 Procedure on arrival. § 351.1 Joint treatment generally. All parcel post or other mail pack- The entry into the United States of ages from foreign countries which, ei- certain plants, plant products, and soil ther from examination or external evi- is prohibited or restricted through var- dence, are found or are believed to con- ious orders, quarantines, and regula- tain plants or plant products, shall be tions promulgated by the Adminis- dispatched for submission, or actually trator of the Animal and Plant Health submitted, to the plant quarantine in- Inspection Service (APHIS) under the spector at the most accessible location authority of the Plant Protection Act listed in § 351.2. The inspector shall (7 U.S.C. 7701–7772). To assist in enforc- pass upon the contents under the Plant ing the aforementioned orders, quar- Quarantine Act and Federal Plant Pest antines, and regulations, the Plant Act and with the cooperation of the customs and postal officers either 13 The Department’s provisions relating to (a) Release the package from further overtime charges for an inspector’s services plant quarantine examination and en- are set forth in 7 CFR part 354. dorse his decision thereon; or

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