§ 340.4 - Regulatory status review.

§ 340.4 Permits for the introduction of a regulated article.⁶

(a) Application for permit. Two copies of a written application for a permit to introduce a regulated article, which may be obtained from APHIS, shall be submitted by the responsible person 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. If there are portions of the application deemed to contain trade secret or confidential business information (CBI), each page of the application containing such information should be marked “CBI Copy”. In addition, those portions of the application which are deemed “CBI” shall be so designated. The second copy shall have all such CBI deleted and shall be marked on each page of the application where CBI was deleted, “CBI Deleted”. If an application does not contain CBI then the first page of both copies shall be marked “No CBI”.

(b) Permit for release into the environment. An application for the release into the environment of a regulated article shall be submitted at least 120 days in advance of the proposed release into the environment. An initial review shall be completed by APHIS within 30 days of the 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 120 day review period commenced.^[7] If the application is not complete, the responsible individual will be advised what additional information must be submitted. APHIS shall commence the 120 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, APHIS shall submit to the State department of agriculture of the State where the release is planned, a copy of the initial review and a copy of the application marked, “CBI Deleted”, or “No CBI” for State notification and review. The application shall include the following information:^[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., mail, common carrier, baggage, or handcarried (and by whom));

(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., morphological or structural characteristics, physiological activities and processes, number of copies of inserted genetic material and the physical state of this material inside the recipient organism (integrated or extrachromosomal), products and secretions, growth characteristics);

(6) A detailed description of the molecular biology of the system (e.g., donor-recipient-vector) which is or will be used to produce the regulated article;

(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., 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 APHIS 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. APHIS 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, APHIS 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 submitting 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 APHIS. 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 APHIS, 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 APHIS data required by paragraphs (b) (1), (2), (4), (6), (7), (9), and (11) through (14) of this section.^[9]

(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 APHIS of the application and the data submitted pursuant to paragraph (a) of this section, including any additional information requested by APHIS, 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 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 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. 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

Regulatory status review.

(a)

(1) Any person may submit a request to APHIS for a regulatory status review, pursuant to paragraph (b)(3) of this section.

(2) Any person may request re-review of a GE plant previously found to be subject to this part after an initial review was conducted, provided that the request is supported by new, scientifically valid evidence bearing on the plant pest risk associated with movement of the plant.

(3) APHIS may also initiate a regulatory status review or re-review of a GE plant to identify whether it is subject to regulation under this part.

(4) Information submitted in support of a request for a regulatory status review or re-review must meet the requirements listed in paragraphs (a)(4)(i) through (iii) of this section.

(i) A description of the comparator plant(s), to include genus, species, and any relevant subspecies information;

(ii) The genotype of the modified plant, including a detailed description of the differences in genotype between the modified and unmodified plant; and

(iii) A detailed description of the new trait(s) of the modified plant.

(iv) Detailed information on how to meet the above-listed requirements can be found on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/biotechnology. If APHIS proposes revisions to the detailed information on the APHIS website, APHIS will make the proposed revisions available for notice and public comment prior to implementation.

(b)

(1) When APHIS receives a request for a regulatory status review of a GE plant, APHIS will conduct an initial review to determine whether there is a plausible pathway by which the GE plant, or any sexually compatible relatives that can acquire the engineered trait from the GE plant, would pose an increased plant pest risk relative to the plant pest risk posed by the respective non-GE or other appropriate comparator(s), based on the following factors:

(i) The biology of the comparator plant(s) and its sexually compatible relatives;

(ii) The trait and mechanism-of-action of the modification(s); and

(iii) The effect of the trait and mechanism-of-action on:

(A) The distribution, density, or development of the plant and its sexually compatible relatives;

(B) The production, creation, or enhancement of a plant pest or a reservoir for a plant pest;

(C) Harm to non-target organisms beneficial to agriculture; and

(D) The weedy impacts of the plant and its sexually compatible relatives.

(2) APHIS will complete the initial review within 180 days of receiving a request for a regulatory status review that meets the requirements specified in paragraph (a)(4) of this section, except in circumstances that could not reasonably have been anticipated. If APHIS does not identify a plausible pathway by which the GE plant or its sexually compatible relatives would pose an increased plant pest risk relative to the comparator(s) in the initial review, the GE plant is not subject to the regulations in this part. APHIS will post the plant, trait, and general description of the MOA on its website.

(b)(3)(i) If APHIS does identify a plausible pathway by which the GE plant or its sexually compatible relatives would pose an increased plant pest risk relative to the comparator(s) in the initial review, the requestor may apply for a permit and/or request that APHIS conduct an evaluation of the factor(s) of concern identified in the initial review to determine the likelihood and consequence of the plausible increased plant pest risk. APHIS may request additional information as needed to evaluate the factor(s) of concern.

(ii) For those GE plants for which such an evaluation is conducted, APHIS will publish the results of the evaluation in the Federal Register and will solicit and review comments from the public. Except in circumstances that could not reasonably have been anticipated, APHIS will complete these steps within 15 months of receiving a request for a regulatory status review that meets the requirements specified in paragraph (a)(4) of this section.

(iii) If APHIS finds that the GE plant and its sexually compatible relatives are unlikely to pose an increased plant pest risk relative to their comparator(s), the GE plant is not subject to this part. APHIS will publish its evaluation of the plant-trait-MOA combination in a subsequent Federal Register document and will also post it on the APHIS website. If APHIS does not make such a finding, the GE plant will remain regulated under this part, and its movement will be allowed only under permit in accordance with § 340.5.

(c) This section is applicable beginning April 5, 2021 for GE corn, soybean, cotton, potato, tomato, and alfalfa, and on October 1, 2021 for all GE plants.

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

0216)

[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; 68 FR 46436, Aug. 6, 2003; 72 FR 43523, Aug. 6, 2007; 83 FR 11867, Mar. 19, 2018]

Footnotes - 340.4

^[6] See footnote 5 in § 340.3.

^[7] The 120 day review period would be extended if preparation of an environmental impact statement in addition to an environmental assessment was necessary.

^[8] Application forms are available without charge from 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, or from local offices which are listed in telephone directories. A person should specify in requesting the application that the permit is for the introduction of a regulated article subject to regulation under part 340.

^[9] 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.

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