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:
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
Animal and Plant Health Inspection Service (APHIS). An agency of the United States Department of Agriculture.
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.
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.
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.
From any State
into or through any other State
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.
Person. Any individual, partnership, corporation, company, society, association, or other organized group.
Any living stage or form of any member of the plant
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.
The 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.
Anything made by or from, or derived from an organism
, living or dead.
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.
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.
, 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.
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.
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]