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animal (including poultry) material, and other refuse of any character whatsoever that has been associated with any such material on board any means of conveyance, and including food scraps, table refuse, galley refuse, food wrappers or packaging materials, and other waste material from stores, food preparation areas, passengers' or crews' quarters, dining rooms, or any other areas on means of conveyance. For purposes of this part, garbage also means meals and other food that were available for consumption by passengers and crew on an aircraft but were not consumed.

NOTE: Not all garbage is regulated for the purposes of this part. Garbage regulated for the purposes of this part is defined as "regulated garbage" in paragraphs (c) and (d) of this section.

(c) Garbage regulated because of movements outside the United States or Canada. For purposes of this part, garbage on or removed from a means of conveyance is regulated garbage, if, when the garbage is on or removed from the means of conveyance, the means of conveyance has been in any port outside the United States and Canada within the previous 2-year period. There are, however, two exceptions to this provision. These exceptions are as follows:

(1) Exception 1. Garbage on or removed in the United States from a means of conveyance other than an aircraft is exempt from requirements under paragraph (c) of this section, if the following conditions are met when the garbage is on or removed from the means of conveyance:

(i) The means of conveyance is accompanied by a certificate from an inspector stating the following:

(A) That the means of conveyance had previously been cleared of all garbage and of all meats and meat products, whatever the country of origin, except meats that are shelf-stable; all fresh and condensed milk and cream from countries designated in 9 CFR 94.1 as those in which foot-and-mouth disease exists; all fresh fruits and vegetables; and all eggs; and the items cleared from the means of conveyance as prescribed by this paragraph have been disposed of according to the procedures for disposing of regulated gar

bage, as specified in paragraph (g)(1) of this section.

(B) That the means of conveyance had then been cleaned and disinfected in the presence of the inspector; and

(ii) Since being cleaned and disinfected, the means of conveyance has not been in a non-Canadian foreign port.

(2) Exception 2. Garbage on or removed from an aircraft is exempt from requirements under paragraph (c) of this section if the following conditions are met when the garbage is on or removed from the aircraft:

(i) The aircraft had been cleared of all garbage and all stores; and the items cleared from the aircraft as prescribed by this paragraph have been disposed of according to the procedures for disposing of regulated garbage, as specified in paragraph (g)(1) of this section.

(ii) After the garbage and stores referred to in paragraph (c)(2)(i) of this section were removed, the aircraft has not been in a non-Canadian foreign port.

(d) Garbage regulated because of certain movements to or from Hawaii, territories, or possessions. For purposes of this part, garbage on or removed from a means of conveyance is regulated garbage, if at the time the garbage is on or removed from the means of conveyance, the means of conveyance has moved during the previous one-year period, either directly or indirectly, to the continental United States from any territory or possession or from Hawaii; to any territory or possession from any other territory or possession or from Hawaii, or to Hawaii from any territory or possession. There are, however, two exceptions to this provision. These exceptions are as follows:

(1) Exception 1. Garbage on or removed from a means of conveyance other than an aircraft is exempt from requirements under paragraph (d) of this section if the following two conditions are met when the garbage is on or removed from the means of convey

ance:

(i) The means of conveyance is accompanied by certificate from an inspector, saying that the means of conveyance had been cleared of all garbage and all fresh fruits and vegetables; and

the items cleared from the means of conveyance as prescribed by this paragraph have been disposed of according to the procedures for disposing of regulated garbage, as specified in paragraph (g)(1) of this section.

(ii) After being cleared of the garbage and stores referred to in paragraph (d)(1)(i) of this section, the means of conveyance has not moved to the continental United States from any territory or possession or from Hawaii; to any territory or possession from any other territory or possession or from Hawaii; or to Hawaii from any territory or possession.

(2) Exception 2. Garbage on or removed from an aircraft is exempt from requirements under paragraph (d) of this section if the following two conditions are met when the garbage is on or removed from the aircraft:

(i) The aircraft had been previously cleared of all garbage and all fresh fruits and vegetables; and the items cleared from the aircraft as prescribed by this paragraph have been disposed of according to the procedures for disposing of regulated garbage, as specified in paragraph (g)(1) of this section.

(ii) After the garbage and stores referred to in paragraph (d)(2)(i) of this section were removed, the aircraft has not moved to the continental United States from any territory or possession or from Hawaii; to any territory or possession from any other territory or possession or from Hawaii; or to Hawaii from any territory or possession.

(e) Garbage that is commingled with regulated garbage is also regulated garbage.

(f) Restrictions on regulated garbage. (1) Regulated garbage shall not be on or removed from a means of conveyance, or be disposed of, unless in accordance with the provisions of this part. (2) Regulated garbage is subject to general surveillance for compliance with this section by Animal and Plant Health Inspection Service inspectors and to such disposal measures as authorized by section 105 of the Federal Plant Pest Act (7 U.S.C. 150dd), section 10 of the Plant Quarantine Act of 1912, as amended (7 U.S.C. 164a), section 2 of the Act of February 2, 1903, as amended (21 U.S.C. 111), and section 306 of the Act of July 17, 1930, as amended (19

U.S.C. 1306), to prevent the dissemination of plant pests and livestock or poultry diseases.

(g)(1) All regulated garbage must be contained in tight, leak-proof covered receptacles during storage on board a means of conveyance while in the territorial waters, or while otherwise within the territory of the United States. All such receptacles shall be contained inside the guard rail if on a watercraft. Such regulated garbage shall not be unloaded from such means of conveyance in the United States unless such regulated garbage is removed in tight, leak-proof receptacles under the direction of an Animal and Plant Health Inspection Service inspector to an approved facility for incineration, sterilization, or grinding into an approved sewage system, under supervision by such an inspector, or such regulated garbage is removed for other handling in such manner and under such supervision as may, upon request in specific cases, be approved by the Administrator as complying with the applicable laws for environmental protection and as adequate to prevent the dissemination into or within the United States of plant pests and livestock or poultry diseases. Provided that, a cruise ship may dispose of regulated garbage in landfills at Alaskan ports only, if and only if the cruise ship does not have prohibited or restricted meat or animal products on board at the time it enters Alaskan waters for the cruise season, and only if the cruise ship, except for incidental travel through international waters necessary to navigate safely between ports, remains in Canadian and U.S. waters off the west coast of North America, and calls only at continental U.S. and Canadian ports during the entire cruise season.

(2) Application for approval of a facility or sewage system may be made in writing by the authorized representative of any carrier or by the official having jurisdiction over the port or place of arrival of the means of conveyance, to the Administrator, Animal and Plant Health Inspection Service, U.S. Department of Agriculture, Washington, DC 20250. The application shall be endorsed by the operator of the facility or sewage system. Approval will

be granted if the Administrator determines that the requirements set forth in this section are met. Approval may be denied or withdrawn at any time, if the Administrator determines that such requirements are not met, after notice of the proposed denial or withdrawal of the approval and the reasons therefor, and an opportunity to demonstrate or achieve compliance with such requirements, has been afforded to the operator of the facility or sewage system and to the applicant for approval. However, approval may also be withdrawn without such prior procedure in any case in which the public health, interest, or safety requires immediate action, and in such case, the operator of the facility or sewage system and the applicant for approval shall promptly thereafter be given notice of the withdrawal and the reasons therefor and an opportunity to show cause why the approval should be reinstated.

(h) The Plant Protection and Quarantine Programs and Veterinary Services, Animal, and Plant Health Inspection Service, will cooperate with other Federal, State, and local agencies responsible for enforcing other statutes and regulations governing disposal of the regulated garbage to the end that such disposal shall be adequate to prevent the dissemination of plant pests and livestock or poultry diseases and comply with applicable laws for environmental protection. The inspectors, in maintaining surveillance over regulated garbage movements and disposal, shall coordinate their activities with the activities of representatives of the Environmental Protection Agency and other Federal, State, and local agencies also having jurisdiction over such regulated garbage.

(i) As used in this section:

(1) Sterilization" means cooking regulated garbage at 212° F. for 30 minutes and disposal of the residue by burying in a landfill, except that the burial provisions do not apply to materials extracted from the residue after cooking and determined by the Administrator to be unsuitable for use as food or as soil additives.

(2) Incineration means to reduce the regulated garbage to ash by burning;

(3) Approved sewage system means a sewage system approved by the Administrator, Animal and Plant Health Inspection Service, upon his determination that the system is designed and operated in such a way as to preclude the discharge of sewage effluents onto land surfaces or into lagoons or other stationary waters, and otherwise is adequate to prevent the dissemination of plant pests and livestock or poultry diseases, and that is certified by an appropriate Government official as currently complying with the applicable laws for environmental protection.

(4) Approved facility means a facility approved by the Administrator, Animal and Plant Health Inspection Service, upon his determination that it has equipment and uses procedures that are adequate to prevent the dissemination of plant pests and livestock or poultry diseases, and that it is certified by an appropriate Government official as currently complying with the applicable laws for environmental protection.

(5) Carrier means the principal operator of a means of conveyance.

(j) Compliance agreement and cancellation. (1) Any person engaged in the business of handling or disposing of regulated garbage must first enter into a compliance agreement with the Animal and Plant Health Inspection Service (APHIS). Compliance agreement forms (PPQ Form 519) are available without charge from local USDA APHIS/Plant Protection and Quarantine offices, which are listed in telephone directories.

(2) A person who enters into a compliance agreement, and employees or agents of that person, shall comply with the following conditions and any supplemental conditions which shall be listed in the compliance agreement, as deemed by the Administrator to be necessary to prevent the dissemination into or within the United States of plant pests and livestock or poultry diseases:

(i) Comply with the provisions of 7 CFR 330.400;

(ii) Allow APHIS inspectors access to all records maintained by the person regarding handling or disposal of regulated garbage, and to all areas where

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handling or disposal of regulated garbage occurs;

(iii) Remove regulated garbage from a means of conveyance only in tight, leak-proof receptacles;

(iv) Move the receptacles of regulated garbage only to a facility approved in accordance with § 330.400(g)(2); and

(v) At the approved facility, dispose of the regulated garbage only through incineration, sterilization, grinding into a sewage system approved in accordance with §330.400(g)(2), or in any other manner approved by the Administrator and described in the compliance agreement.

(3) Approval for a compliance agreement may be denied at any time if the Administrator determines that the requirements set forth in this subpart are not met, after notice of, and the reasons for, the proposed denial of the approval, and an opportunity to demonstrate or achieve compliance with such requirements, has been afforded to the compliance agreement appli

cant.

(4) Any compliance agreement may be canceled in writing by the Administrator whenever it is found that the person who has entered into the compliance agreement has failed to comply with this subpart. Any person whose compliance agreement has been cancelled may appeal the decision, in writing, within 10 days after receiving written notification of the cancellation. The appeal must state all of the facts and reasons upon which the person relies to show that the compliance agreement was wrongfully cancelled. As promptly as circumstances allow, the Administrator will grant or deny the appeal, in writing, stating the reasons for the decision. A hearing will be held to resolve any conflict as to any material fact. Rules of practice concerning a hearing will be adopted by the Administrator. This administrative remedy must be exhausted before a person can file suit in court challenging the cancellation of a compliance agreement.

(5) Where a compliance agreement is denied or cancelled, regulated garbage may continue to be unloaded from a means of conveyance and disposed of at

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(2) Such introduction is in conformity with all other applicable restrictions in this part.1

(b) Any regulated article introduced not in compliance with the requirements of this part shall be subject to the immediate application of such remedial measures or safeguards as an inspector determines necessary to prevent the introduction of such plant pests.2

[52 FR 22908, June 16, 1987, as amended at 58 FR 17056, Mar. 31, 1993; 62 FR 23956, May 2, 1997]

$340.1 Definitions.

Terms used in the singular form in this part shall be construed as the plural, and vice versa, as the case may demand. The following terms, when used in this part, shall be construed, respectively, to mean:

Administrator. The Administrator of the Animal and Plant Health Inspection Service (APHIS) or any other employee of APHIS to whom authority has been or may be delegated to act in the Administrator's stead.

Animal and Plant Health Inspection Service (APHIS). An agency of the

1 Part 340 regulates, among other things, the introduction of organisms and products altered or produced through genetic engineering which are plant pests or which there is reason to believe are plant pests. The introduction into the United States of such articles may be subject to other regulations promulgated under the Federal Plant Pest Act (7 U.S.C. 150aa et seq.), the Plant Quarantine Act (7 U.S.C. 151 et seq.) and the Federal Noxious Weed Act (7 U.S.C. 2801 et seq.) and found in 7 CFR parts 319, 321, 330, and 360. For example under regulations promulgated in 7 CFR "Subpart-Nursery Stock" (7 CFR 319.37) a permit is required for the importation of certain classes of nursery stock whether genetically engineered or not. Thus, a person should consult those regulations prior to the importation of any nursery stock.

2 Pursuant to section 105 of the Federal Plant Pest Act (7 U.S.C. 150dd) the Secretary of Agriculture is authorized to order prompt removal from the United States or to seize, quarantine, treat, apply other remedial measures to, destroy, or otherwise dispose of, in such manner as the Secretary deems appropriate, certain regulated articles which are believed to be infested or infected by or contain a plant pest.

United States Department of Agriculture.

Antecedent organism. An organism that has already been the subject of a determination of nonregulated status by APHIS under § 340.6, and that is used as a reference for comparison to the regulated article under consideration under these regulations.

Courtesy permit. A written permit issued by the Administrator, in accordance with § 340.4(h).

Donor organism. The organism from which genetic material is obtained for transfer to the recipient organism.

Environment. All the land, air, and water; and all living organisms in association with land, air and water.

Expression vector. A cloning vector designed so that a coding sequence inserted at a particular site will be transcribed and translated into protein.

Genetic engineering. The genetic modification of organisms by recombinant DNA techniques.

Inspector. Any employee of the Animal and Plant Health Inspection Service, U.S. Department of Agriculture, or other person, authorized by the Administrator, in accordance with law to enforce the provisions of this part.

Interstate. From any State into or through any other State.

Introduce or introduction. To move into or through the United States, to release into the environment, to move interstate, or any attempt thereat.

Move (moving, movement). To ship, offer for shipment, offer for entry, import, receive for transportation, carry, or otherwise transport or move, or allow to be moved into, through, or within the United States.

Organism. Any active, infective, or dormant stage or life form of an entity characterized as living, including vertebrate and invertebrate animals, plants, bacteria, fungi, mycoplasmas, mycoplasma-like organisms, as well as entities such as viroids, viruses, or any entity characterized as living, related to the foregoing.

Permit. A written permit issued by the Administrator, for the introduction of a regulated article under conditions determined by the Administrator, not to present a risk of plant pest introduction.

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