§ 340.5 - Permits.

§ 340.5 Petition to amend the list of organisms.^[10] Permits.

(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 Permit requirement. A permit from APHIS is required for the movement of all GE organisms subject to the regulations under this part.

(b) Permit application requirements. All applications for permits must be submitted in accordance with the

procedures and format specified by

requirements of 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, Biotechnology Permits, 4700 River Road, Unit 147, Riverdale, Maryland 20737-1237. 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 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 The petition should include copies of scientific literature which the petitioner is relying upon, copies of unpublished studies, or data from tests performed.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]

Footnotes - 340.5

^[10] See footnote 5 in § 340.3.

The responsible person must apply for and obtain a permit through APHIS' website. The application must also include the following information:

(1) General information requirements for all permit applications. All permit applications must include the name, title, and contact information of the responsible person and agent (if any); the country (or countries) and locality (or localities) where the organism was collected, developed, manufactured, reared, cultivated, and cultured (as applicable); the organism's genus, species and any relevant subspecies and common name information; the intended activity (i.e., importation, interstate movement, or release into the environment of the GE organism); and information on the intended trait and the genotype of the intended trait. All permit applications must be signed by the responsible person.

(2) Information requirements for permit applications for interstate movement or importation. Applications for permits for interstate movement or importation of GE organisms must include the following additional information:

(i) The origin and destination of the GE organism, including information on the addresses and contact details of the sender and recipient, if different from the responsible person;

(ii) The quantity of the GE organism, the method of shipment, and means of ensuring the security of the shipment against unauthorized release of the organism; and

(iii) The manner in which packaging material, shipping containers, and any other material accompanying the organism will be disposed of to prevent unauthorized release.

(3) Information requirements for permit applications for release into the environment. Applications for permits for release of GE organisms into the environment must include information on all proposed environmental release sites, including land area (size), Global Positioning System coordinates, addresses, and land use history of the site and adjacent areas; and the name and contact information of a person at each environmental release site, if different from the responsible person. In the event that additional release sites are requested after the issuance of a permit, APHIS will evaluate and amend permits as appropriate, in accordance with paragraph (l) of this section.

(c) Exemption for GE Arabidopsis thaliana. A permit for interstate movement is not required for GE Arabidopsis thaliana, provided that it is moved as a secure shipment, the modified genetic material is stably integrated into the plant genome, and the modified material does not include the complete infectious genome of a plant pest.

(d) Exemption for GE disarmed Agrobacterium species. A permit for importation or interstate movement is not required for any GE disarmed Agrobacterium species, provided that it is moved as a secure shipment, the modified genetic material is stably integrated into the genome, and the modified material does not include the complete infectious genome of a plant pest.

(e) Exemption for Drosophila melanogaster. A permit for importation or interstate movement is not required for GE Drosophila melanogaster, provided that it is moved as a secure shipment and that any introduced genetic material is not designed to propagate through a population by biasing the inheritance rate.

(f) Exemption for certain microbial pesticides. A permit is not required for the movement of any GE microorganism product that is currently registered with the Environmental Protection Agency (EPA) as a microbial pesticide, so long as the microorganism is not a plant pest as defined in § 340.3.

(g) Exemption of certain plant-incorporated protectants. A permit is not required for the movement of any GE plant modified solely to contain a plant-incorporated protectant that is currently registered with EPA as a pesticide product pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq., FIFRA) or that is currently exempted from FIFRA pursuant to 40 CFR 174.21.

(h) Administrative actions -

(1) Review of permit applications. APHIS will review the permit application to determine whether it is complete. APHIS will notify the applicant orally or in writing if the application is incomplete, and the applicant will be provided the opportunity to revise the application. Once an application is complete, APHIS will review it to determine whether to approve or deny the application.

(2) APHIS assignment of permit conditions. If a permit application is approved, the Administrator will issue a permit with conditions as described in paragraph (i) of this section. Prior to issuance of a permit, the responsible person must agree in writing, in a manner prescribed by the Administrator, that the responsible person and all agents of the responsible person are aware of, understand, and will comply with the permit conditions. Failure to comply with this provision will be grounds for the denial of a permit.

(3) Inspections. All premises associated with the permit are subject to inspection before and after permit issuance, and all materials associated with the movement are subject to sampling after permit issuance. The responsible person and agents must provide inspectors access to premises, facilities, release locations, storage areas, waypoints, materials, equipment, means of conveyance, documents, and records related to the movement of organisms permitted under this part. Failure to provide access for inspection prior to the issuance of a permit will be grounds for the denial of a permit. Failure to provide access for inspection following permit issuance will be grounds for withdrawal of the permit.

(4) State or Tribal review and comment. The Administrator will submit for notification and review a copy of the permit application, without confidential business information (CBI), and any permit conditions to the appropriate State or Tribal regulatory official. Timely comments received from the State or Tribal regulatory official will be considered by the Administrator prior to permit issuance.

(5) Approval or denial of a permit. Except in circumstances that could not reasonably have been anticipated, APHIS will approve or deny the permit within:

(i) 45 days of receipt of a complete application for a permit for interstate movement or for importation; or

(ii) 120 days of receipt of a complete application for a permit for release into the environment.

(iii) The 120-day period may be extended if preparation of an environmental assessment or environmental impact statement is necessary.

(i) Permit conditions. The standard conditions listed in this paragraph (i) will be assigned to all permits issued under this section. The Administrator may assign supplemental permit conditions as deemed necessary to ensure confinement of the GE organism. Prior to issuance of a permit or an amended permit, the responsible person will be required to agree in writing or electronically that he or she and his or her agents will comply with the conditions of the permit, as described in this paragraph (i). If the responsible person does not agree to the conditions, the amendment will be denied.

(1) The organism under permit must be maintained and disposed of in a manner so as to prevent its unauthorized release, spread, dispersal, and/or persistence in the environment.

(2) The organism under permit must be kept separate from other organisms, except as specifically allowed in the permit.

(3) The organism under permit must be maintained only in areas and premises specified in the permit.

(4) The identity of the organism under permit must be maintained and verifiable at all times.

(5) Authorized activities may be engaged in only while the permit is valid; the duration for which the permit is valid will be listed on the permit itself.

(6) Records related to activities carried out under the permit must be maintained by the responsible person and must be of sufficient accuracy, quality, and completeness to demonstrate compliance with all permit conditions and requirements under this part. APHIS must be allowed access to all records, to include visual inspection and reproduction (e.g., photocopying, digital reproduction). The responsible person must submit reports and notices to APHIS, containing the information specified within the permit, at the times specified in the permit. At a minimum:

(i) Following an environmental release, environmental release reports must be submitted for all authorized release locations where the release occurred. Environmental release reports must contain details of sufficient accuracy, quality, and completeness to identify the location, shape, and size of the release and the organism(s) released into the environment. In the event no release occurs at an authorized location, an environmental release report of no environmental release must be submitted for all authorized locations where an environmental release did not occur. Unauthorized releases must be reported in accordance with paragraph (i)(9) of this section.

(ii) When the environmental release is of a plant, reports of volunteer monitoring activities and findings must be submitted for all authorized release locations where an environmental release occurred. If no monitoring activities are conducted, a volunteer monitoring report of no monitoring must be submitted indicating why no volunteer monitoring was done.

(7) Inspectors must be allowed access, during regular business hours, to all locations related to the permitted activities.

(8) The organism under permit must undergo the application of measures determined by the Administrator to be necessary to prevent its unauthorized release, spread, dispersal, and/or persistence in the environment.

(9) In the event of a possible or actual unauthorized release, the responsible person must contact APHIS as described in the permit within 24 hours of discovery and must subsequently supply a statement of facts in writing no later than 5 business days after discovery.

(10) The responsible person for a permit remains the responsible person for the permit unless a transfer of responsibility is approved by APHIS. The responsible person must contact APHIS to initiate any transfer. The new responsible person assumes all responsibilities for ensuring compliance with the existing permit and permit conditions and for meeting the requirements of this part.

(j) Denial or withdrawal of a permit. Permit applications may be denied, or permits withdrawn, in accordance with this paragraph.

(1) Denial of permits. The Administrator may deny, either orally or in writing, any application for a permit. If the denial is oral, the Administrator will then communicate, as promptly as circumstances allow, the denial, and the reasons for it, in writing. The Administrator may deny a permit application if:

(i) The Administrator concludes that the proposed actions, e.g., movements under permit, may not prevent the unauthorized release, spread, dispersal, and/or persistence in the environment of the organism; or

(ii) The Administrator determines that the responsible person or any agent of the responsible person has failed to comply with any material provision of this part, any other regulations issued pursuant to the Plant Protection Act (7 U.S.C. 7701 et seq.) or the Plant Protection Act itself;

(iii) In addition, no permit will be issued if the responsible person and his or her agents do not agree in writing, in accordance with paragraph (h)(2) of this section, to comply with the permit conditions or, in accordance with paragraph (h)(3) of this section, to allow inspection by APHIS.

(2) Withdrawal of permits. The Administrator may withdraw, either orally or in writing, any permit that has been issued. If the withdrawal is oral, the Administrator will communicate, as promptly as circumstances allow, the withdrawal, and the reasons for it, in writing. The Administrator may withdraw a permit if:

(i) Following issuance of the permit, the Administrator receives information that would have provided grounds for APHIS to deny the original permit application;

(ii) The Administrator determines that actions taken under the permit have resulted in the unauthorized release, spread, dispersal, and/or persistence in the environment of the organism under permit; or

(iii) The Administrator determines that the responsible person or any agent of the responsible person has failed to comply at any time with any material provision of this part or with any other regulations issued pursuant to the Plant Protection Act (7 U.S.C. 7701 et seq.). This includes failure to comply with the conditions of any permit issued.

(k) Appeal of denial or withdrawal of permit. Any person whose permit application has been denied or whose permit has been withdrawn may appeal the decision in writing to the Administrator.^[1] The applicant must submit in writing an acknowledgment of the denial or withdrawal, and a statement of intent to appeal, within 10 days after receiving written notification of the denial or withdrawal. The applicant may request additional time to prepare the appeal. The appeal must state all of the facts and reasons upon which the person relies to assert that the permit was wrongfully denied or withdrawn. The Administrator will 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.

(l) Amendment of permits -

(1) Amendment at responsible person's request. If the responsible person determines that circumstances have changed since the permit was initially issued and wishes the permit to be amended accordingly, the responsible person must request the amendment by contacting APHIS directly. The responsible person will have to provide supporting information justifying the amendment. APHIS will review the amendment request, and will amend the permit if APHIS determines that relatively minor changes are necessary. Requests for more substantive changes will require a new permit application. Prior to issuance of an amended permit, the responsible person will be required to agree in writing or electronically that he or she and his or her agents will comply with the conditions of the amended permit. If the responsible person does not agree to the conditions, the amendment will be denied.

(2) Amendment initiated by APHIS. APHIS may amend any permit and its conditions at any time, upon determining that the amendment is needed to address plant pest risks presented by the organism or the activities allowed under the permit. APHIS will notify the responsible person of the amendment to the permit and, as soon as circumstances allow, the reason(s) for it. The responsible person may have to agree in writing or electronically that he or she and his or her agents will comply with the conditions of the amended permit before APHIS will issue it. If APHIS requests such an agreement, and the responsible person does not accept it, the existing permit will be withdrawn.

(m) Shipping under a permit.

(1) All shipments of organisms under permit must be secure shipments. Organisms under permit must be shipped in accordance with the regulations in 49 CFR part 178.

(2) The container must be accompanied by a document that includes the names and contact details for the sender and recipient.

(3) For any organism to be imported into the United States, the outmost container must bear information regarding the nature and quantity of the contents; the country (or countries) and locality (localities) where collected, developed, manufactured, reared, cultivated, and cultured (as applicable); the name and address of the shipper, owner, or person shipping or forwarding the organism; the name, address, and telephone number of the consignee; the identifying shipper's mark and number; and the permit number authorizing the importation. For organisms imported under permits by mail, the container must also be addressed to a plant inspection station listed in the USDA Plants for Planting Manual, which can be accessed at: https://www.aphis.usda.gov/import_export/plants/manuals/ports/downloads/plants_for_planting.pdf. All imported containers of organisms under permits must be accompanied by an invoice or packing list indicating the contents of the shipment.

(4) Following the completion of the shipment, all packaging material, shipping containers, and any other material accompanying the organism will be devitalized consistent with supplemental permit conditions, or disposed of to prevent unauthorized release.

(n) Applicability date: This section is applicable beginning April 5, 2021.

(Approved by the Office of Management and Budget under control number 0579-0471)

Footnotes - 340.5

^[1] The Office of the Administrator, as established in § 371.2 of this chapter, will review appeals involving the denial or withdrawal of a permit. Appeals may be sent to Office of the Administrator, United States Department of Agriculture, Jamie L. Whitten Building, Room 312-E, 1400 Independence Ave. SW, Washington, DC 20250.