lated article (e.g., greenhouses, laboratory, or growth chamber location; field trial location; pilot project location; production, propagation, and manufacture location; proposed sale and distribution location);

(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., culture medium, or host material) accompanying the regulated article during movement; and

(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. An application for the interstate movement or importation of a regulated article shall be submitted at least 60 days in advance of the first proposed interstate movement and at least 60 days prior to each importation. An initial review shall be completed by Plant Protection and Quarantine within 15 days of the receipt of the application. If the application is complete, the responsible person shall be notified of the date of receipt of the application for purposes of advising the applicant when the 60 day review period commenced. If the application is not complete, the responsible person will be advised what additional information must be submitted. Plant Protection and Quarantine shall commence the 60 day review period upon receipt of the additional information, assuming the additional information submitted is adequate. When it is determined that an application is complete, Plant Protection and Quarantine shall submit to the State department of agriculture of the State of destination of the regulated article a copy of the initial review and the application marked, “CBI Deleted", or "No CBI" for State notification and review.

(1) Limited permit for interstate movement. The responsible person may apply for a single limited permit for the interstate movement of multiple regulated articles in lieu of submit

ting an application for each individual interstate movement. Each limited permit issued shall be numbered and shall be valid for one year from the date of issuance. If a permit is sought for multiple interstate movements between contained facilities the responsible individual shall specify in the permit application all the regulated articles to be moved interstate; the origins and destinations of all proposed shipments; a detailed description of all the contained facilities where regulated articles will be utilized at destination; and a description of the containers that will be used to transport the regulated articles. A limited permit for interstate movement of a regulated article shall only be valid for the movement of those regulated articles moving between those locations specified in the application. If a person seeks to move regulated articles other than those specified in the application, or to a location other than those listed in the application, a supplemental application shall be submitted to Plant Protection and Quarantine. No person shall move a regulated article interstate unless the number of the limited permit appears on the outside of the shipping container. The responsible person shipping a regulated article interstate shall keep records for one year demonstrating that the regulated article arrived at its intended destination. The responsible person seeking a limited permit for interstate movement shall submit on an application form obtained from Plant Protection and Quarantine the data required by paragraphs (b) (1), (2), (4), (6), (7), (9), and (11) through (14) of this section.

(2) Limited permit for importation. The responsible person seeking a permit for the importation of a regulated article shall submit an application for a permit prior to the importation of each shipment of regulated articles. The responsible person importing a regulated article shall keep records for one year demonstrating that the regulated article arrived at its intended destination. The responsible person seeking a limited permit for importation shall submit on an application form obtained from Plant Protection and Quarantine data required by

paragraphs (b) (1), (2), (4), (6), (7), (9), and (11) through (14) of this section."

(d) Premises inspection. An inspector may inspect the site or facility where regulated articles are proposed, pursuant to a permit, to be released into the environment or contained after their interstate movement or importation. Failure to allow the inspection of a premises prior to the issuance of a permit or limited permit shall be grounds for the denial of the permit.

(e) Administrative action on applications. After receipt and review by Plant Protection and Quarantine of the application and the data submitted pursuant to paragraph (a) of this section, including any additional information requested by Plant Protection and Quarantine, a permit shall be granted or denied. If a permit is denied, the applicant shall be promptly informed of the reasons why the permit was denied and given the opportunity to appeal the denial in accordance with the provisions of paragraph (g) of this section. If a permit is granted, the permit will specify the applicable conditions for introduction of the regulated article under this part.

(f) Permit conditions. A person who is issued a permit and his/her employees or agents shall comply with the following conditions, and any supplemental conditions which shall be listed on the permit, as deemed by the Deputy Administrator to be necessary to prevent the dissemination and establishment of plant pests:

(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 dissemi

'Renewals may receive shorter review. In the case of a renewal for a limited permit for importation that has been issued less than one year earlier, APHIS will notify the responsible person within 15 days that either: (1) The renewal permit is approved or (2) that a 60 day review period is necessary because the conditions of the original permit have changed.

nation 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 Deputy 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 Deputy Administrator to be necessary to prevent the spread of plant pests;

(9) A person who has been issued a permit shall submit to Plant Protection and Quarantine monitoring reports on the performance characteristics of the regulated article, in accordance with any monitoring reporting requirements that may be specified in a permit;

(10) Plant Protection and Quarantine 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 at a port of entry which is designated by an asterisk in 7 CFR 319.37-14(b);

(ii) Notify Plant Protection and Quarantine 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. Any permit which has been issued may be withdrawn by an inspector or the Deputy Administrator if he/ she determines that the holder thereof has not complied with one or more of the conditions listed on the permit. APHIS will confirm the reasons for the withdrawal of the permit in writing within ten (10) days. Any person whose permit has been withdrawn or any person who has been denied a permit may appeal the decision in writing to the Deputy Administrator within ten (10) days after receiving the written notification of the withdrawal or denial. The appeal shall state all of the facts and reasons upon which the person relies to show that the permit was wrongfully withdrawn or denied. The Deputy Administrator shall grant or deny the appeal, in writing, stating the reasons for the decision as promptly as circumstances allow. If there is a conflict as to any material fact, a hearing shall be held to resolve such conflict. Rules of practice concerning such a hearing will be adopted by the Administrator.

(h) Courtesy permit-(1) Issuance. The Deputy Administrator may issue a courtesy permit for the introduction of organisms modified through genetic engineering which are not subject to regulation under this part to facilitate movement when the movement might otherwise be impeded because of the similarity of the organism to other organisms regulated under this part.

(2) Application. A person seeking a courtesy permit shall submit on an application form obtained from Plant Protection and Quarantine data required by paragraphs (b) (1), (2), and (5) of this section and shall indicate such data is being submitted as a request for a courtesy permit. A person should also include a statement explaining why he or she believes the organism or product does not come within the definition of a regulated article. The application shall be submitted at least 60 days prior to the time the courtesy permit is sought.

(3) Administrative action. Plant Protection and Quarantine shall complete an initial review within 15 days of the date of receipt of the application. If the application is complete, the responsible individual shall be notified of the date of receipt of the application for purposes of advising the applicant when the 60 day review period commenced. If the application is not complete, the responsible individual will be advised what additional information must be submitted, and shall commence the 60 day review period upon receipt of the additional information, assuming the additional information submitted is adequate. Within 60 days from the date of receipt of a complete application, Plant Protection and Quarantine will either issue a courtesy permit or advise the responsible individual that a permit is required under paragraph (b) or (c) of this section.

§ 340.4 Petition to amend the list of organisms.

(a) General. Any person may submit to the Deputy Administrator a petition to amend the list of organisms in § 340.2 of this part by adding or deleting any genus, species, or subspecies. A petitioner may supplement, amend, or withdraw a petition in writing without prior approval of the Deputy Administrator and without prejudice to resubmission at any time until the Deputy Administrator rules on the petition. A petition to amend the list of organisms shall be submitted in accordance with the procedures and format specified by this section.

(b) Submission procedures and format. A person shall submit two copies of a petition to the Deputy Administrator of Plant Protection and Quarantine, in care of the Director of the Biotechnology and Environmental Coordination Staff, Animal and Plant Health Inspection Service, U.S. Department of Agriculture, 6505 Belcrest Road, Room 406, Federal Building, Hyattsville, Maryland 20782. The petition should be dated, and structured as follows:

PETITION TO AMEND 7 CFR 340.2

The undersigned submits this petition under 7 CFR 340.4 to request the Deputy Administrator of Plant Protection and Quarantine, to [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 § 340.21.

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. (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 the Biotechnology and Environmental Coordination Staff, 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. The Biotechnology and Environmental Coordination Staff, will promtply 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 or 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 the Biotechnology and Environmental Coordination Staff on a filed petition, which shall become part of the docket file.

(3) The Deputy Administrator shall furnish a response to each petitioner within 180 days of receipt of the petition. The response will either: (1) Approve the petition in whole or in part in which case the Deputy Administrator shall concurrently take appropriate action (publication of a document in the FEDERAL REGISTER amending § 340.2 of this part; or (ii) deny the petition in whole or in part. The petitioner shall be notified in writing of the Deputy Administrator's decision. The decision shall be placed in the public docket file in the offices of the Biotechnology and Environmental Coordination Staff, and in the form of a notice published in the FEDERAL REGIS

TER.

§ 340.5 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 Plant Protection Quarantine 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.

§ 340.6 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

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 ty the Department of Transportation in

(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, corrugated cardboard, wood, or other material of equivalent strength.

(3) Live microorganisms and/or etiologic agents, cells, or subcellular elements. All regulated articles which are live (non-inactivated) microorganisms, or 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,

Title 49 CFR or any other agency of the Federal government.