(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. Any permit which has been issued may be withdrawn by an inspector or the Administrator if he/she determines that the holder thereof has not complied with one or more of the conditions listed on the permit.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 Any person whose permit has been withdrawn or any person who has been denied a permit may appeal the decision in writing to the Administrator within ten (10) days after receiving the written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The appeal shall state all of the facts and reasons upon which the person relies to show that the permit was wrongfully withdrawn or denied.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 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 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 APHIS 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. APHIS 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, APHIS will either issue a courtesy permit or advise the responsible individual that a permit is required under paragraph (b) or (c) of this section.

[52 FR 22908, June 16, 1987. Redesignated at 58 FR 17056, Mar. 31, 1993, as amended at 58 FR 17058, Mar. 31, 1993; 59 FR 67610, Dec. 30, 1994; 62 FR 23956, 23957, May 2, 1997]

$340.5 Petition to amend the list of organisms.10

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

(b) Submission procedures and format. A person shall submit two copies of a petition to the Animal and Plant Health Inspection Service, Biotechnology and Scientific Services, PPQ, 4700 Biotechnology Permits, River Road, Unit 147, Riverdale, Maryland 20737-1237. The petition should be dated, and structured as follows:

10 See footnote 5 in §340.3.

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. (1) A petition to amend the list of organisms which meets the requirements of paragraph (b) of this section will be filed by the APHIS, stamped with the date of filing, and assigned a docket number. The docket number shall identify the file established for all submissions relating to the petition. APHIS, will promptly notify the petitioner in writing of the filing and docket number of a petition. If a petition does not meet the requirements of paragraph (b) of this section, the petitioner shall be 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 APHIS on a filed petition, which shall become part of the docket file.

(3) The Administrator shall furnish a response to each petitioner within 180 days of receipt of the petition. The 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 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 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.

[52 FR 22908, June 16, 1987. Redesignated at 58 FR 17056, Mar. 31, 1993, as amended at 58 FR 17059, Mar. 31, 1993; 59 FR 67611, Dec. 30, 1994; 62 FR 23957, May 2, 1997]

$340.6 Petition for determination of nonregulated status. 11

(a) General. Any person may submit to the Administrator, a petition to seek a determination that an article should not be regulated under this part. A petitioner may supplement, amend, or withdraw a petition in writing without prior approval of the Administrator, and without affecting resubmission at any time until the Administrator, 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, Plant Protection and Quarantine, Biotechnology and Scientific Services, Biotechnology Coordination and Technical Assistance, 4700 River Road, Unit 146, Riverdale, Maryland 20737-1237. The petition shall be dated and structured as follows:

11 See footnote 5 in § 340.3.

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. 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 re

cipient 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. Fiedl 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. (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 Administrator, 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. APHIS 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 Administrator, written comments, regarding the filed petition, which shall become part of the petition file.

(3) The Administrator shall, based upon available information, furnish a response to each petitioner within 180 days of receipt of a completed petition. The response will either:

(i) Approve the petition in whole or in part; or

(ii) deny the petition.

The petitioner shall be notified in writing of the Administrator's 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. (1) The Administrator may determine that a regulated article does not pose a potential for plant pest risk, and should therefore not be regulated under this part, based on the similarity of that organism to an antecedent organism.

(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 all preliminary decisions to extend determinations of nonregulated status 30 days before the decisions become final and effective. If additional information becomes available that APHIS believes justifies changing its decision, it will issue a revised decision.

(4) If a request to APHIS to extend a determination of nonregulated status under this part is denied, APHIS will inform the submitter of that request of the reasons for denial. The submitter may submit a modified request or a separate petition for determination of nonregulated status without prejudice. (f) Denial of a petition; appeal. (1) The Administrator's written notification of denial of a petition shall briefly set forth the reason for such denial. The written notification shall be sent by certified mail. Any person whose 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; 62 FR 23957, May 2, 1997]

§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

imber of consignee;

(5) Identifying shipper's mark and imber; and

(6) Number of written permit authoring the importation.

(b) Any regulated article imported by ail, shall be plainly and correctly adessed and mailed to APHIS at a port entry designated by an asterisk in 7 R 319.37-14(b) and shall be accomnied by a separate sheet of paper thin the package plainly and corctly bearing the name, address, and lephone number of the intended repient, and shall plainly and correctly ar on the outer container the folwing information:

(1) General nature and quantity of e contents;

(2) Country and locality where colcted, developed, manufactured,

for

ared, cultivated, or cured; (3) Name and address of shipper, vner, or person shipping or arding the regulated article; and (4) Number of permit authorizing the portation;

(c) Any regulated article imported to the United States by mail or othwise shall, at the time of importation offer for importation into the United ates, be accompanied by an invoice packing list indicating the contents the shipment.

2 FR 22908, June 16, 1987. Redesignated at 58 R 17056, Mar. 31, 1993, as amended at 58 FR 059, Mar. 31, 1993; 62 FR 23958, May 2, 1997]

40.8 Container requirements for the movement of regulated articles. (a) General requirements. A regulated ticle shall not be moved unless it mplies with the provisions of paraaph (b) of this section, unless a variace has been granted in accordance th the provisions of paragraph (c) of is section. 12

(b) Container requirements—(1) Plants d plant parts. All plants or plant rts, except seeds, cells, and subcellar elements, shall be packed in a

12 The requirements of this section are in dition to and not in lieu of any other packg requirements such as those for the transrtation of etiologic agents prescribed by e Department of Transportation in Title 49 FR or any other agency of the Federal govnment.

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 (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