PART 340—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 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: 90 FR 25124, June 16, 2025, unless otherwise noted. § 340.0 Restrictions on the introduction of regulated articles. (a) No person shall introduce any regulated article unless the Administrator is: (1) Notified of the introduction in accordance with § 340.3, or such introduction is authorized in accordance with § 340.4, or such introduction is conditionally exempt from permit requirements under § 340.2(b); and (2) Such introduction is in conformity with all other applicable restrictions in this part. 1 1 (b) Any regulated article introduced not in compliance with the requirements of this part shall be subject to the immediate application of such remedial measures or safeguards as an inspector determines necessary to prevent the introduction of such plant pests. 2 2 § 340.1 Definitions. Terms used in the singular form in this part shall be construed as the plural, and vice versa, as the case may demand. The following terms shall be construed, respectively, to mean: Administrator. Animal and Plant Health Inspection Service (APHIS). Antecedent organism. Courtesy permit. Donor organism. Environment. Expression vector. Genetic engineering. Inspector. Interstate. Introduce or introduction. Move (moving, movement). Organism. Permit. Person. Plant. 3 e.g., e.g., 3 Synopsis and Classification of Living Organisms Plant pest. Product. Recipient organism. Regulated article. Release into the environment. Responsible person. Secretary. Stably integrated. State. State regulatory official. United States. Vector or vector agent. Well-characterized and contains only non-coding regulatory regions e.g., § 340.2 Groups of organisms which are or contain plant pests and exemptions. (a) Groups of organisms which are or contain plant pests. if they meet the definition of plant pest in § 340.1. 4 4 Note: Any genetically engineered organism composed of DNA or RNA sequences, organelles, plasmids, parts, copies, and/or analogs, of or from any of the groups of organisms listed below shall be deemed a regulated article if it also meets the definition of plant pest in § 340.1. GROUP VIROIDS Superkingdom Prokaryotae Kingdom Virus All members of groups containing plant viruses, and all other plant and insect viruses 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 associated with plant diseases Gram-negative xylem-limited bacteria associated with plant diseases And all other bacteria associated with plant or insect diseases Rickettsiaceae Rickettgial-like organisms associated with insect diseases Class Mollicutes Order Mycoplasmatales 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 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 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. Escherichia coli Saccharomyces cerevisiae, Bacillus subtilis, (i) The microorganisms are shipped in a container that meets the requirements of § 340.8(b)(3); (ii) The cloned genetic material is maintained on a nonconjugation proficient plasmid and the host does not contain other conjugation proficient plasmids or generalized transducing phages; (iii) The cloned material does not include the complete infectious genome of a known plant pest; (iv) The cloned genes are not carried on an expression vector if the cloned genes code for: (A) A toxin to plants or plant products, or a toxin to organisms beneficial to plants; or (B) Other factors directly involved in eliciting plant disease ( i.e., (C) Substances acting as, or inhibitory to, plant growth regulators. (2) A limited permit for interstate movement is not required for genetic material from any plant pest contained in the genome of the plant Arabiodopsis thaliana, (i) The plants or plant materials are shipped in a container that meets the requirements of § 340.8(b)(1), (2), and (3); (ii) The cloned genetic material is stably integrated into the plant genome; (iii) The cloned material does not include the complete infectious genome of a known plant pest. § 340.3 Notification for the introduction of certain regulated articles. 5 5 (a) General. (b) Regulated articles eligible for introduction under the notification 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 considered 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 environment. (2) The introduced genetic material is “stably integrated” in the plant genome, as defined in § 340.1. (3) The function of the introduced genetic material is known and its expression in the regulated article does not result in plant disease. (4) The introduced genetic material does not: (i) Cause the production of an infectious entity, or (ii) Encode substances that are known or likely to be toxic to nontarget 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 genetic sequences do not pose a significant risk of the creation of any new plant virus, plant virus-derived sequences must be: (i) Noncoding regulatory sequences of known function, or (ii) Sense or antisense genetic constructs derived from viral genes from plant viruses that are prevalent and endemic in the area where the introduction 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 material 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. (c) Performance standards for 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 material is unlikely to be disseminated while in transit and must be maintained at the destination facility in such a way that there is no release into the environment. (2) When the introduction is an environmental release, the regulated article 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 environmental 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 article. (5) The field trial must be conducted such that: (i) The regulated article will not persist 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 subsequent seasons, or (ii) Volunteers shall be managed to prevent persistence in the environment. (d) Procedural requirements for notifying APHIS. (1) Notification should be directed to the Animal and Plant Health Inspection Service, Plant Protection and Quarantine, Biotechnology and Scientific Services, Biotechnology Permits, 4700 River Road, Unit 147, Riverdale, Maryland 20737-1237. (2) The notification shall include the following: (i) Name, title, address, telephone number, and signature of the responsible person; (ii) Information necessary to identify the regulated article(s), including: (A) The scientific, common, or trade names, and phenotype of regulated article, (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 recipient 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 environmental release, the expected duration of the introduction (release); and (v) A statement that certifies that introduction of the regulated article will be in accordance with the provisions 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 submitted to APHIS within 6 months after termination of the field test. Field test reports shall include the APHIS reference number, methods of observation, resulting data, and analysis regarding all deleterious effects on plants, nontarget organisms, or the environment. (5) The Administrator, shall be notified 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 inspect facilities and/or the field test site and any records necessary to evaluate compliance with the provisions of paragraphs (b) and (c) of this section. (e) Administrative action in response to notification. (2) The Administrator, will provide acknowledgement within 10 days of receipt that the interstate movement is appropriate under notification. (3) The Administrator, will provide acknowledgement within 30 days of receipt that the importation is appropriate under notification. (4) APHIS will provide acknowledgment within 30 days of receipt that the environmental release is appropriate under notification. Such acknowledgment will apply to field testing for 1 year from the date of introduction, and may be renewed annually by submission of an additional notification to APHIS. (5) A person denied permission for introduction of a regulated article under notification may apply for a permit for introduction of that regulated article without prejudice. § 340.4 Permits for the introduction of a regulated article. 6 6 (a) Application for permit. (b) Permit for release into the environment. 7 8 7 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 to identify the: Donor organism(s); recipient organism(s); vector or vector agent(s); constituent of each regulated article which is a product; and, regulated 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., (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 parental organism ( e.g., (6) A detailed description of the molecular biology of the system ( e.g., (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 purpose for the introduction of the regulated article including a detailed description of the proposed experimental and/or production design; (9) The quantity of the regulated article 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, release, and dissemination in the production of the: Donor organism; recipient organism; vector or vector agent; constituent of each regulated article which is a product; and regulated article; (11) A detailed description of the intended destination (including final and all intermediate destinations), uses, and/or distribution of the regulated article ( e.g., (12) A detailed description of the proposed procedures, processes, and safeguards which will be used to prevent escape and dissemination of the regulated article at each of the intended destinations; (13) A detailed description of any biological material ( e.g., (14) A detailed description of the proposed method of final disposition of the regulated article. (c) Limited permits for interstate movement or importation of a regulated article. (1) Limited permit for interstate movement. (2) Limited permit for importation. each 9 9 (d) Premises inspection. (e) Administrative action on applications. (f) Permit conditions. (1) The regulated article shall be maintained and disposed of (when necessary) in a manner so as to prevent the dissemination and establishment of plant pests. (2) All packing material, shipping containers, and any other material accompanying the regulated article shall be treated or disposed of in such a manner 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; (5) An inspector shall be allowed access, 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 article, and the date of importation; (7) The regulated article shall be subject to the application of measures determined by the Administrator to be necessary to prevent the accidental or unauthorized release of the regulated article; (8) The regulated article shall be subject to the application of remedial measures (including disposal) determined by the Administrator to be necessary 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 reference number, methods of observation, resulting data, and analysis regarding all deleterious effects on plants, nontarget organisms, or the environment. (10) APHIS shall be notified within the time periods and manner specified below, in the event of the following occurrences: (i) Orally notified immediately upon discovery and notify in writing within 24 hours in the event of any accidental or unauthorized release of the regulated 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 characteristics substantially different from those listed in the application for a permit or suffers any unusual occurrence (excessive mortality or morbidity, or unanticipated effect on non-target organisms); (11) A permittee or his/her agent and any person who seeks to import a regulated article into the United States shall: (i) Import or offer the regulated article for entry only through any USDA plant inspection station listed in accordance with § 319.37-8(a) of this chapter; (ii) Notify APHIS promptly upon arrival of any regulated article at a port of entry, of its arrival by such means as a manifest, customs entry document, 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. (h) Courtesy permit Issuance. (2) Application. (3) Administrative action. (Approved by the Office of Management and Budget under control number 0579-0216) § 340.5 Petition to amend the list of organisms. 10 10 (a) General. (b) Submission procedures and format. Petition To Amend 7 CFR 340.2 The undersigned submits this petition under 7 CFR 340.4 to request that the Administrator [add the following genus, species, or subspecies to the list of organisms in 7 CFR 340.2] or [to remove the following genus, species, 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 removed is not a plant pest or why there is reason to believe the genus, species, or subspecies 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 information. A person should also include representative 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 includes representative data and information known to the petitioner which are unfavorable to the petition. (Signature) ________________________ (Name of petitioner) ________________ (Mailing address) _________________ (Telephone number) ______________ (c) Administrative action on a petition. (2) After the filing of a petition to amend the list of organisms USDA shall publish a proposal in the Federal Register (3) The Administrator shall furnish a response to each petitioner within 180 days of receipt of the petition. The response will either: (i) Approve the petition in whole or in part in which case the Administrator shall concurrently take appropriate action (publication of a document in the Federal Register (ii) deny the petition in whole or in part. The petitioner shall be notified in writing of the Administrator's decision. The decision shall be placed in the public docket file in the offices of APHIS, and in the form of a notice published in the Federal Register § 340.6 Petition for determination of nonregulated status. 11 11 (a) General. (b) Submission procedures and format. Petition for Determination of Nonregulated Status The undersigned submits this petition under 7 CFR 340.6 to request that the Administrator, make a determination that the article should not be regulated under 7 CFR part 340. Signature _________________________ A. Statement of Grounds A person must present a full statement explaining the factual grounds why the organism 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 determination. The petition shall include all information set forth in paragraph (c) of 7 CFR 340.6. If there are portions of the petition deemed to contain trade secret or confidential business information (CBI), each page of the petition containing such information should be marked “CBI Copy”. In addition, those portions 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 deleted: “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 unfavorable to a petition. 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 to base a determination, and that it includes relevant data and information known to the petitioner which are unfavorable to the petition. (Signature) ________________________ (Name of petitioner) ________________ (Mailing address) _________________ (Telephone number) ________________ (c) Required data and information. (1) Description of the biology of the nonmodified recipient plant and information necessary to identify the recipient plant in the narrowest taxonomic grouping applicable. (2) Relevant experimental data and publications. (3) A detailed description of the differences in genotype between the regulated article and the nonmodified recipient organism. Include all scientific, common, or trade names, and all designations necessary to identify: the donor organism(s), the nature of the transformation system (vector or vector agent(s)), the inserted genetic material and its product(s), and the regulated article. Include country and locality where the donor, the recipient, and the vector organisms and the regulated articles are collected, developed, and produced. (4) A detailed description of the phenotype of the regulated article. Describe known and potential differences from the unmodified recipient organism that would substantiate that the regulated article is unlikely to pose a greater plant pest risk than the unmodified 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, impact on the weediness of any other plant with which it can interbreed, agricultural or cultivation practices, effects of the regulated article on nontarget organisms, indirect plant pest effects on other agricultural products, transfer of genetic information to organisms 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 unmodified recipient organism shall also be included. (5) Field test reports for all trials conducted under permit or notification procedures, involving the regulated article, that were submitted prior to submission of a petition for determination of nonregulated status or prior to submission 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 observation, resulting data, and analysis regarding all deleterious effects on plants, nontarget organisms, or the environment. (d) Administrative action on a petition. (2) After the filing of a completed petition, APHIS shall publish a notice in the Federal Register. (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 decision. The decision shall be placed in the public petition file in the offices of APHIS and notice of availability published in the Federal Register (e) Extensions to determinations of nonregulated status. (2) A person may request that APHIS extend a determination of nonregulated status to other organisms. Such a request shall include information to establish the similarity of the antecedent organism and the regulated articles in question. (3) APHIS will announce in the Federal Register (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. (2) The appeal shall state all of the facts and reasons upon which the person relies, including any new information, to show that the petition was wrongfully denied. The Administrator shall grant or deny the appeal, in writing, stating the reasons for the decision as promptly as circumstances allow. An informal hearing may be held by the Administrator if there is a dispute of a material fact. Rules of Practice concerning such a hearing will be adopted by the Administrator. § 340.7 Marking and identity. (a) Any regulated article to be imported other than by mail, shall, at the time of importation into the United States, plainly and correctly bear on the outer container the following information: (1) General nature and quantity of the contents; (2) Country and locality where collected, developed, manufactured, reared, cultivated or cultured; (3) Name and address of shipper, owner, or person shipping or forwarding the organism; (4) Name, address, and telephone number of consignee; (5) Identifying shipper's mark and number; and (6) Number of written permit authorizing the importation. (b) Any regulated article imported by mail, shall be plainly and correctly addressed and mailed to APHIS through any USDA plant inspection station listed in accordance with § 319.37-8(a) 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 collected, developed, manufactured, reared, cultivated, or cured; (3) Name and address of shipper, owner, or person shipping or forwarding the regulated article; and (4) Number of permit authorizing the importation. (c) Any regulated article imported into the United States by mail or otherwise 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. § 340.8 Container requirements for the movement of regulated articles. (a) General requirements. 12 12 (b) Container requirements Plants and plant parts. (2) Seeds. (3) Live microorganisms and/or etiologic agents, cells, or subcellular elements. (i) Volume not exceeding 50 ml. e.g., (ii) Volume greater than 50 ml. (iii) Dry ice. (4) Insects, mites, and related organisms. (5) Other macroscopic organisms. (c) Request for a variance from container requirements. § 340.9 Costs and charges. The services of the inspector during regularly assigned hours of duty and at the usual places of duty shall be furnished without cost. 13 13