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Electronic Code of Federal Regulations

e-CFR data is current as of May 28, 2020

Title 7Subtitle BChapter IIIPart 340 → §340.1

Title 7: Agriculture

§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 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.

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

Plant. Any living stage or form of any member of the plant kingdom3 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.

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

Plant pest. Any living stage (including active and dormant forms) of insects, mites, nematodes, slugs, snails, protozoa, or other invertebrate animals, 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 §340.2 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 Administrator, 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 or 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; 62 FR 23956, May 2, 1997]

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