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known to the petitioner which are unfavorable to the petition.
(Name of petitioner) (Mailing address) (Telephone number)
(c) Administrative action on a petition. (1) A petition to amend the list of organisms which meets the requirements of paragraph (b) of this section will be filed by the Director of Biotechnology, Biologics, and Environmental Protection, stamped with the date of filing, and assigned a docket number. The docket number shall identify the file established for all submissions relating to the petition. Biotechnology, Biologics, and Environmental Protection, will promptly notify the petitioner in writing of the filing and docket number of a petition. If a petition does not meet the requirements of paragraph (b) of this section, the petitioner shall be sent a notice indicating how the petition is deficient.
(2) After the filing of a petition to amend the list of organisms USDA shall publish a proposal in the FEDERAL REGISTER to amend §340.2 and solicit comments thereon from the public. An interested person may submit written comments to the Director of Biotechnology, Biologics, and Environmental Protection on a filed petition, which shall become part of the docket file.
(3) The Director, BBEP 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 Director, BBEP shall concurrently take appropriate action (publication of a document in the FEDERAL REGISTER amending $340.2 of this part; or (ii) deny the petition in whole or in part. The petitioner shall be notified in writing of the Director, BBEP's decision. The decision shall be placed in the public docket file in the offices of Biotechnology, Biologics, and Environmental Protection, and in the form of a notice published in the FEDERAL REGISTER.
[52 FR 22908, June 16, 1987. Redesignated at 58 FR 17056, Mar. 31, 1993, as amended at 58 FR 17059, Mar. 31, 1993; 59 FR 67611, Dec. 30, 1994]
§340.6 Petition for determination of nonregulated status.
(a) General. Any person may submit to the Director, Biotechnology, Biologics, and Environmental Protection (BBEP), a petition to seek a determination that an article should not be regulated under this part. A petitioner may supplement, amend, or withdraw a petition in writing without prior approval of the Director, BBEP, and without affecting resubmission at any time until the Director, BBEP, rules on the petition. A petition for determination of nonregulated status shall be submitted in accordance with the procedure and format specified in this section.
(b) Submission procedures and format. A person shall submit two copies of a petition to the Animal and Plant Health Inspection Service, Biotechnology, Biologics, and Environmental Protection, Biotechnology Coordination and Technical Assistance, 4700 River Road, Unit 146, Riverdale, Maryland 20737-1237. The petition shall be dated and structured as follows:
PETITION FOR DETERMINATION OF
The undersigned submits this petition under 7 CFR 340.6 to request that the Director, BBEP, 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 un
favorable to a petition. If a person is not aware of any unfavorable information, the petition should state, "Unfavorable information: NONE."
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.
· (Name of Petitioner) (Mailing Address)
(c) Required data and information. The petition shall include the following 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 Director 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.
(d) Administrative action on a petition. (1) A petition for determination of nonregulated status under this part which meets the requirements of paragraphs (b) and (c) of this section will be filed by the Director, BBEP, stamped with the date of filing, and assigned a petition number. The petition number shall identify the file established for all submissions relating to the petition. The BBEP will promptly notify the petitioner in writing of the filing and the assigned petition number. If a petition does not meet the requirements specified in this section, the petitioner shall be sent a notice indicating how the petition is deficient.
(2) After the filing of a completed petition, APHIS shall publish a notice in the FEDERAL REGISTER. This notice shall specify that comments will be accepted from the public on the filed petition during a 60 day period commencing with the date of the notice. During the comment period, any interested person may submit to the Director, BBEP, written comments, regarding the filed petition, which shall become part of the petition file.
(3) The Director, BBEP, 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 Director's decision. The decision shall be placed in the public petition file in the offices of BBEP and notice of availability published in the FEDERAL REGISTER.
(e) Denial of a petition; appeal. (1) The Director's written notification of denial of a petition shall briefly set forth the reason for such denial. The written
notification shall be sent by certified mail. Any person whose petition has been denied may appeal the determination in writing to the Administrator within 10 days from receipt of the written notification of denial.
(2) The appeal shall state all of the facts and reasons upon which the 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.
[58 FR 17057, Mar. 31, 1993, as amended at 59 FR 67611, Dec. 30, 1994]
§ 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 Biotechnology, Biologics, and Environmental Protection at a port of entry designated by an asterisk in 7 CFR 319.37-14(b) 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.
[52 FR 22908, June 16, 1987. Redesignated at 58 FR 17056, Mar. 31, 1993, as amended at 58 FR 17059, Mar. 31, 1993]
$340.8 Container requirements for the movement of regulated articles.
(a) General requirements. A regulated article shall not be moved unless it complies with the provisions of paragraph (b) of this section, unless a variance has been granted in accordance with the provisions of paragraph (c) of this section. 8
(b) Container requirements—(1) Plants and plant parts. All plants or plant parts, except seeds, cells, and subcellular elements, shall be packed in a sealed plastic bag of at least 5 mil thickness, inside a sturdy, sealed, leakproof, outer shipping container constructed of corrugated fiberboard, corrogated cardboard, wood, or other material of equivalent strength.
(2) Seeds. All seeds shall be transported in a sealed plastic bag of at least 5 mil thickness, inside a sealed metal container, which shall be placed inside a second sealed metal container. Shock absorbing cushioning material shall be placed between the inner and outer metal containers. Each metal container shall be independently capable of protecting the seeds and preventing spillage or escape. Each set of metal containers shall then be enclosed in a sturdy outer shipping container constructed of corrugated fiberboard,
8 The requirements of this section are in addition to and not in lieu of any other packing requirements such as those for the transportation of etiologic agents prescribed by the Department of Transportation in Title 49 CFR or any other agency of the Federal government.
corrugated cardboard, wood, or other material of equivalent strength.
(3) Live microorganisms and/or etiologic agents, cells, or subcellular elements. All regulated articles which are live (noninactivated) microorganisms, or etiologic agents, cells, or subcellular elements shall be packed as specified below:
(i) Volume not exceeding 50 ml. Regulated articles not exceeding 50 ml shall be placed in a securely closed, watertight container (primary container, test tube, vial, etc.) which shall be enclosed in a second, durable watertight container (secondary container). Several primary containers may be enclosed in a single secondary container, if the total volume of all the primary containers so enclosed does not exceed 50 ml. The space at the top, bottom, and sides between the primary and secondary containers shall contain sufficient nonparticulate absorbent material (e.g., paper towel) to absorb the entire contents of the primary container(s) in case of breakage or leakage. Each set of primary and secondary containers shall then be enclosed in an outer shipping container constructed of corrugated fiberboard, corrugated cardboard, wood, or other material of equivalent strength.
(ii) Volume greater than 50 ml. Regulated articles which exceed a volume of 50 ml. shall comply with requirements specified in paragraph (b)(3)(i) of this section. In addition, a shock absorbing material, in volume at least equal to that of the absorbent material between the primary and secondary containers, shall be placed at the top, bottom, and sides between the secondary container and the outer shipping container. Single primary containers shall not contain more than 1,000 ml. of material. However, two or more primary containers whose combined volumes do not exceed 1,000 ml. may be placed in a single, secondary container. The maximum amount of micro-organisms or etiologic agents, cells, or subcellular elements which may be enclosed within a single outer shipping container shall not exceed 4,000 ml.
(iii) Dry ice. If dry ice is used as a refrigerant, it shall be placed outside the secondary container(s). If dry ice is used between the secondary container
and the outer shipping container, the shock absorbing material shall be placed so that the secondary container does not become loose inside the outer shipping container as the dry ice sublimates.
(4) Insects, mites, and related organisms. Insects, mites, and other small arthropods shall be packed for shipment as specified in this paragraph or in paragraph (b)(3) of this section. Insects (any life stage) shall be placed in an escape-proof primary shipping container (insulated vacuum container, glass, metal, plastic, etc.) and sealed to prevent escape. Such primary container shall be placed securely within a secondary shipping container of crushproof styrofoam or other material of equivalent strength; one or more rigid ice packs may also be placed within the secondary shipping container; and sufficient packing material shall be added around the primary container to prevent movement of the primary shipping container. The secondary (styrofoam or other) container shall be placed securely within an outer shipping container constructed of corrugated fiberboard, corrugated cardboard, wood, or other material of equivalent strength.
(5) Other macroscopic organisms. Other macroscopic organisms not covered in paragraphs (b) (1), (2), and (4) of this section which do not require continuous access to atmospheric oxygen shall be packaged as specified in paragraph (b)(3) or (b)(4) of this section. All macroscopic organisms which are not plants and which require continuous access to atmospheric oxygen shall be placed in primary shipping containers constructed of a sturdy, crush-proof frame of wood, metal, or equivalent strength material, surrounded by escape-proof mesh or netting of a strength and mesh size sufficient to prevent the escape of the smallest organism in the shipment, with edges and seams of the mesh or netting sealed to prevent escape of organisms. Each primary shipping container shall be securely placed within a larger secondary shipping container constructed of wood, metal, or equivalent strength material. The primary and secondary shipping containers shall then be placed securely within an outer ship
ping container constructed of corrugated fiberboard, corrugated cardboard, wood, or other material of equivalent strength, which outer container may have air holes or spaces in the sides and/or ends of the container, provided that the outer shipping container must retain sufficient strength to prevent crushing of the primary and secondary shipping containers.
(c) Request for a variance from container requirements. A responsible person who believes the container requirements normally applicable to the movement of the person's regulated article(s) are inappropriate due to unique circumstances (such as the nature, volume, or life stage of the regulated article) may submit in an application for a permit, a request for a variance from the container requirements. The request for a variance under this section shall consist of a short statement describing why the normally applicable container requirements are inappropriate for the regulated article which the person proposes to move and what container requirements the person would use in lieu of the normally prescribed container requirements. USDA shall advise the responsible person in writing at the time a permit is granted on the person's request for a variance.
[52 FR 22908, June 16, 1987. Redesignated at 58 FR 17056, Mar. 31, 1993]
§340.9 Cost and charges.
The services of the inspector during regularly assigned hours of duty and at the usual places of duty shall be furnished without cost.9 The U.S. Department of Agriculture will not be responsible for any costs or charges incident to inspections or compliance with the provisions of this part, other than for the services of the inspector.
[52 FR 22908, June 16, 1987. Redesignated at 58 FR 17056, Mar. 31, 1993]
'The Department's provisions relating to overtime charges for an inspector's services are set forth in 7 CFR part 354.
§ 351.1 Joint treatment generally.
Under various orders, quarantines, and regulations promulgated by the Administrator of the Animal and Plant Health Inspection Service under authority of the Plant Quarantine Act of August 20, 1912 (37 Stat. 315-319, 7 U.S.C. 151 et seq.), as amended, and the Federal Plant Pest Act of May 23, 1957 (71 Stat. 31-35; 7 U.S.C. 150aa-150jj), the entry into the United States of certain plants, plant products, and soil is prohibited or restricted. As an aid in enforcing these or subsequent orders, quarantines, and regulations, provisions have been made by the Plant Protection and Quarantine Programs of the U.S. Department of Agriculture, concurrently with the Postal and Customs Services, to insure closer inspection of such importations.
[24 FR 9923, Dec. 9, 1959, as amended at 36 FR 24917, Dec. 24, 1971; 37 FR 10554, May 25, 1972]
§ 351.2 Location of inspectors.
Inspectors of the Plant Protection and Quarantine Programs and customs officers are stationed at the following locations:
Anchorage, Alaska, Arlington, Va., Atlanta, Ga., Baltimore, Md., Baton Rouge, La., Blaine, Wash., Boston, Mass., Brownsville, Tex., Buffalo, N.Y., Calexico, Calif., Chantilly, Va., Charleston, S.C., Charlotte Amalie, St. Thomas, V.I., Chicago, Ill., Christiansted, St. Croix, V.I., Cleveland,