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removed from the means of convey- thorized by section 105 of the Federal ance:

Plant Pest Act (7 U.S.C. 150dd), section (1) The means of conveyance is ac- 10 of the Plant Quarantine Act of 1912, companied by certificate from an in- as amended (7 U.S.C. 164a), section 2 of spector, saying that the means of con- the Act of February 2, 1903, as amended veyance had been cleared of all garbage (21 U.S.C. 111), and section 306 of the and all fresh fruits and vegetables; and Act of July 17, 1930, as amended (19 the items cleared from the means of U.S.C. 1306), to prevent the disseminaconveyance as prescribed by this para- tion of plant pests and livestock or graph have been disposed of according poultry diseases. to the procedures for disposing of regu- (g)(1) All regulated garbage must be lated garbage, as specified in paragraph contained in tight, leak-proof covered (g)(1) of this section.

receptacles during storage on board a (ii) After being cleared of the garbage means of conveyance while in the terriand stores referred to in paragraph torial waters, or while otherwise with(d)(1)(i) of this section, the means of in the territory of the United States. conveyance has not moved to the con- All such receptacles shall be contained tinental United States from any terri- inside the guard rail if on a watercraft. tory or possession or from Hawaii; to Such regulated garbage shall not be any territory or possession from any unloaded from such means of conveyother territory or possession or from ance in the United States unless such Hawaii; or to Hawaii from any terri- regulated garbage is removed in tight, tory or possession.

leak-proof receptacles under the direc(2) Exception 2. Garbage on or re- tion of an Animal and Plant Health Inmoved from an aircraft is exempt from spection Service inspector to an aprequirements under paragraph (d) of proved facility for incineration, sterithis section if the following two condi- lization, or grinding into an approved tions are met when the garbage is on or sewage system, under supervision by removed from the aircraft:

such an inspector, or such regulated (1) The aircraft had been previously garbage is removed for other handling cleared of all garbage and all fresh in such manner and under such superfruits and vegetables; and the items vision as may, upon request in specific cleared from the aircraft as prescribed cases, be approved by the Adminisby this paragraph have been disposed of trator as complying with the applicaaccording to the procedures for dispos- ble laws for environmental protection ing of regulated garbage, as specified in and as adequate to prevent the dissemiparagraph (g)(1) of this section.

nation into or within the United States (ii) After the garbage and stores re- of plant pests and livestock or poultry ferred to in paragraph (d)(2)(i) of this diseases. section were removed, the aircraft has (2) Application for approval of a facilnot moved to the continental United ity or sewage system may be made in States from any territory or possession writing by the authorized representaor from Hawaii; to any territory or tive of any carrier or by the official possession from any other territory or having jurisdiction over the port or possession or from Hawaii; or to Ha- place of arrival of the means of conveywaii from any territory or possession. ance, to the Administrator, Animal

(e) Garbage that is commingled with and Plant Health Inspection Service, regulated garbage is also regulated gar- U.S. Department of Agriculture, Washbage.

ington, DC 20250. The application shall (f) Restrictions on regulated garbage. be endorsed by the operator of the fa(1) Regulated garbage shall not be on cility or sewage system. Approval will or removed from a means of convey- be granted if the Administrator deterance, or be disposed of, unless in ac- mines that the requirements set forth cordance with the provisions of this in this section are met. Approval may part. (2) Regulated garbage is subject be denied or withdrawn at any time, if to general surveillance for compliance the Administrator determines that with this section by Animal and Plant such requirements are not met, after Health Inspection Service inspectors notice of the proposed denial or withand to such disposal measures as au- drawal of the approval and the reasons

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! therefor, and an opportunity to dem6 onstrate or achieve compliance with I such requirements, has been afforded

to the operator of the facility or sew| age system and to the applicant for ap

proval. 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 Serviices, Animal, and Plant Health Inspeci tion Service, will cooperate with other

Federal, State, and local agencies re1

sponsible for enforcing other statutes 1

and regulations governing disposal of the regulated garbage to the end that such disposal shall be adequate to pre

vent the dissemination of plant pests 1

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 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 applicant.

(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 an approved facility in accordance with $330.400(g)(1). (Approved by the Office of Management and Budget under control number 0579-0054.) (39 FR 32320, Sept. 6, 1974, as amended at 43 FR 39954, Sept. 8, 1978; 45 FR 80268, Dec. 4, 1980; 48 FR 57466, Dec. 30, 1983; 58 FR 66248, Dec. 20, 1993)

Sec. 340.0 Restrictions on the introduction of

regulated articles. 340.1 Definitions. 340.2 Groups of organisms which are or con

tain plant pests and exemptions. 340.3 Notification for the introduction of

certain regulated articles. 340.4 Permits for the introduction of a regu

lated article. 340.5 Petition to amend the list of orga

nisms. 340.6 Petition for determination of

nonregulated status. 340.7 Marking and identity. 340.8 Container requirements for the move

ment of regulated articles. 340.9 Cost and charges.

AUTHORITY: 7 U.S.C. 150aa-150jj, 151-167, and 1622n; 31 U.S.C. 9701; 7 CFR 2.17, 2.51, and 371.2(c).

SOURCE: 52 FR 22908, June 16, 1987, unless otherwise noted.

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8340.0 Restrictions on the introduc

tion of regulated articles. (a) No person shall introduce any regulated article unless the Director, BBEP, is:

(1) Notified of the introduction in accordance with $340.3, or such introduction is authorized by permit in accordance with $340.4, or such introduction is conditionally exempt from permit requirements under $340.2(b); and

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

1 Part 340 regulates, among other things, the introduction of organisms and products altered or produced through genetic engineering which are plant posts 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 (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)

$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:

Animal and Plant Health Inspection Service (APHIS). An agency of the United States Department of Agriculture.

Courtesy permit. A written permit issued by the Director, BBEP, in accordance with $340.4(h).

Director, BBEP. The Director, or designee of the Director, of the Biotechnology, Biologics, and Environmental Protection (BBEP) division of the Animal and Plant Health Inspection Service.

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 in

serted 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 Director, BBEP, 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 Director, BBEP, for the introduction of a regulated article under conditions determined by the Director, BBEP, not to present a risk of plant pest introduction.

Person. Any individual, partnership, corporation, company, society, association, or other organized group.

Plant. Any living stage or form of any member of the plant kingdom 3 including, but not limited to, eukaryotic algae, mosses,

club mosses, ferns, angiosperms, gymnosperms, and lichens (which contain algae) including any parts (e.g. pollen, seeds, cells, tubers, stems) thereof, and any cellular components (e.g. plasmids, ribosomes, etc.) thereof.

Plant pest. Any living stage (including active and dormant forms) of insects, mites, nematodes, slugs, snails, protozoa, or other invertebrate ani

Act (7 U.S.C. 150 aa 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.

3 The taxonomic scheme for the plant kingdom is that found in Synopsis and Classification of Living Organisms by S.P. Parker, McGraw Hill (1984).

mals, bacteria, fungi, other parasitic plants or reproductive parts thereof; viruses; or any organisms similar to or allied with any of the foregoing; or any infectious agents or substances, which can directly or indirectly injure or cause disease or damage in or to any plants or parts thereof, or any processed, manufactured, or other products of plants.

Product. Anything made by or from, or derived from an organism, living or dead.

Recipient organism. The organism which receives genetic material from a donor organism.

Regulated article. Any organism which has been altered or produced through genetic engineering, if the donor organism, recipient organism, or vector or vector agent belongs to any genera or taxa designated in 8340.2 and meets the definition of plant pest, or is an unclassified organism and/or an organism whose classification is unknown, or any product which contains such an organism, or any other organism or product altered or produced through genetic engineering which the Director, BBEP, determines is a plant pest or has reason to believe is a plant pest. Excluded are recipient microorganisms which are not plant pests and which have resulted from the addition of genetic material from a donor organism where the material is well characterized and contains only non-coding regulatory regions.

Release into the environment. The use of a regulated article outside the constraints of physical confinement that are found in a laboratory, contained greenhouse, or a fermenter or other contained structure.

Responsible person. The person who has control and will maintain control over the introduction of the regulated article and assure that all conditions contained in the permit and requirements in this part are complied with. A responsible person shall be a resident of the United States or designate an agent who is a resident of the United States.

Secretary. The Secretary of Agriculture, or any other officer or employee of the Department of Agriculture to whom authority to act in

his/her stead has been or may hereafter be delegated.

Stably integrated. The cloned genetic material is contiguous with elements of the recipient genome and is replicated exclusively by mechanisms used by recipient genomic DNA.

State. Any State, the District of Columbia, American Samoa, Guam, Northern Mariana Islands, Puerto Rico, the Virgin Islands of the United States, and any other Territories or Districts of the United States.

State regulatory official. State official with responsibilities for plant health, or any other duly designated State official, in the State where the introduction is to take place.

United States. All of the States.

Vector of vector agent. Organisms or objects used to transfer genetic material from the donor organism to the recipient organism.

Well-characterized and contains only non-coding regulatory regions (e.g. operators, promoters, origins of replication, terminators, and ribosome binding regions). The genetic material added to a microorganism in which the following can be documented about such genetic material: (a) The exact nucleotide base sequence of the regulatory region and any inserted flanking nucleotides; (b) The regulatory region and any inserted flanking nucleotides do not code for protein or peptide; and (c) The regulatory region solely controls the activity of other sequences that code for protein or peptide molecules or act as recognition sites for the initiation of nucleic acid or protein synthesis. (52 FR 22908, June 16, 1987, as amended at 53 FR 12913, Apr. 20, 1988; 55 FR 53276, Dec. 28, 1990; 58 FR 17056, Mar. 31, 1993)

8340.2 Groups of organisms which are

or contain plant pests and exemp

tions. (a) Groups of organisms which are of contain plant pests. The organisms that are or contain plant pests are included in the taxa or group of organisms contained in the following list. Within any taxonomic series included on the list, the lowest unit of classification actually listed is the taxon or group which may contain organisms which are regulated. Organisms belonging to all lower taxa contained within the group listed

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