§ 340.3 - Definitions.

§ 340.3 Notification for the introduction of certain regulated articles.^[5]

(a) General. Certain regulated articles may be introduced without a permit, provided that the introduction is in compliance with the requirements of this section. Any other introduction of regulated articles require a permit under § 340.4, with the exception of introductions that are conditionally exempt from permit requirements under § 340.2(b) of this part.

(b) Regulated articles eligible for introduction under the notification procedure. Regulated articles which meet all of the following six requirements and the performance standards set forth in paragraph (c) of this section are eligible for introduction under the notification procedure.

(1) The regulated article is any plant species that is not listed as a noxious weed in regulations at 7 CFR part 360 under the Plant Protection Act (7 U.S.C. 7712), and, when being considered for release into the environment, the regulated article is not considered by the Administrator to be a weed in the area of release into the environment.

(2) The introduced genetic material is “stably integrated” in the plant genome, as defined in § 340.1.

(3) The function of the introduced genetic material is known and its expression in the regulated article does not result in plant disease.

(4) The introduced genetic material does not:

(i) Cause the production of an infectious entity, or

(ii) Encode substances that are known or likely to be toxic to nontarget organisms known or likely to feed or live on the plant species, or

(iii) Encode products intended for pharmaceutical or industrial use.

(5) To ensure that the introduced genetic sequences do not pose a significant risk of the creation of any new plant virus, plant virus-derived sequences must be:

(i) Noncoding regulatory sequences of known function, or

(ii) Sense or antisense genetic constructs derived from viral genes from plant viruses that are prevalent and endemic in the area where the introduction will occur and that infect plants of the same host species, and that do not encode a functional noncapsid gene product responsible for cell-to-cell movement of the virus.

(6) The plant has not been modified to contain the following genetic material from animal or human pathogens:

(i) Any nucleic acid sequence derived from an animal or human virus, or

(ii) Coding sequences whose products are known or likely causal agents of disease in animals or humans.

(c) Performance standards for introductions under the notification procedure. The following performance standards must be met for any introductions under the notification procedure.

(1) If the plants or plant materials are shipped, they must be shipped in such a way that the viable plant material is unlikely to be disseminated while in transit and must be maintained at the destination facility in such a way that there is no release into the environment.

(2) When the introduction is an environmental release, the regulated article must be planted in such a way that they are not inadvertently mixed with non-regulated plant materials of any species which are not part of the environmental release.

(3) The plants and plant parts must be maintained in such a way that the identity of all material is known while it is in use, and the plant parts must be contained or devitalized when no longer in use.

(4) There must be no viable vector agent associated with the regulated article.

(5) The field trial must be conducted such that:

(i) The regulated article will not persist in the environment, and

(ii) No offspring can be produced that could persist in the environment.

(6) Upon termination of the field test:

(i) No viable material shall remain which is likely to volunteer in subsequent seasons, or

(ii) Volunteers shall be managed to prevent persistence in the environment.

(d) Procedural requirements for notifying APHIS. The following procedures shall be followed for any introductions under the notification procedure:

(1) Notification should be directed 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.

(2) The notification shall include the following:

(i) Name, title, address, telephone number, and signature of the responsible person;

(ii) Information necessary to identify the regulated article(s), including:

(A) The scientific, common, or trade names, and phenotype of regulated article,

(B) The designations for the genetic loci, the encoded proteins or functions, and donor organisms for all genes from which introduced genetic material was derived, and

(C) The method by which the recipient was transformed;

(iii) The names and locations of the origination and destination facilities for movement or the field site location for the environmental release; and the size of the introduction,

(iv) The date and, in the case of environmental release, the expected duration of the introduction (release); and

(v) A statement that certifies that introduction of the regulated article will be in accordance with the provisions of this section.

(3) Notification must be submitted to APHIS:

(i) At least 10 days prior to the day of introduction, if the introduction is interstate movement.

(ii) At least 30 days prior to the day of introduction, if the introduction is an importation.

(iii) At least 30 days prior to the day of introduction, if the introduction is an environmental release.

(4) Field test reports must be submitted to APHIS within 6 months after termination of the field test. Field test reports shall include the APHIS reference number, methods of observation, resulting data, and analysis regarding all deleterious effects on plants, nontarget organisms, or the environment.

(5) The Administrator, shall be notified of any unusual occurrence within the time periods and in the manner specified in § 340.4(f)(10).

(6) Access shall be allowed for APHIS and State regulatory officials to inspect facilities and/or the field test site and any records necessary to evaluate compliance with the provisions of paragraphs (b) and (c) of this section.

(e) Administrative action in response to notification.

(1) APHIS will provide copies of all notifications to appropriate State regulatory official(s) for review within 5 business days of receipt. Comments to APHIS from appropriate State regulatory officials in response to notifications for interstate movement of regulated articles will not be required by APHIS prior to acknowledgment, although States may provide their reviews to APHIS at their discretion.

(2) The Administrator, will provide acknowledgement within 10 days of receipt that the interstate movement is appropriate under notification.

(3) The Administrator, will provide acknowledgement within 30 days of receipt that the importation is appropriate under notification.

(4) APHIS will provide acknowledgment within 30 days of receipt that the environmental release is appropriate under notification. Such acknowledgment will apply to field testing for 1 year from the date of introduction, and may be renewed annually by submission of an additional notification to APHIS.

(5) A person denied permission for introduction of a regulated article under notification may apply for a permit for introduction of that regulated article without prejudice.

[58 FR 17056, Mar. 31, 1993, as amended at 59 FR 67610, Dec. 30, 1994; 62 FR 23956, May 2, 1997; 66 FR 21058, Apr. 27, 2001; 68 FR 46436, Aug. 6, 2003]

Footnotes - 340.3

^[5] APHIS may issue guidelines regarding scientific procedures, practices, or protocols which it has found acceptable in making various determinations under the regulations. A person may follow an APHIS guideline or follow different procedures, practices, or protocols. When different procedures, practices, or protocols are followed, a person may, but is not required to, discuss the matter in advance with APHIS to help ensure that the procedures, practices, or protocols to be followed will be acceptable to APHIS

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:

Access. The ability during regular business hours to enter, or pass to and from, a location, inspect, and/or obtain or make use or copies of any records, data, or samples necessary to evaluate compliance with this part and all conditions of a permit issued in accordance with § 340.5.

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.

Agent. A person who is designated by the responsible person to act in whole or in part on behalf of the permittee to maintain control over an organism under permit during its movement and to ensure compliance with all applicable permit conditions and the requirements in this part. Multiple agents may be associated with a single responsible person or permit. Agents may be, but are not limited to, brokers, farmers, researchers, or site cooperators. An agent must be at least 18 years of age and be a legal resident of the United States.

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

Article. Any material or tangible object that could harbor plant pests.

Contained facility. A structure for the storage and/or propagation of living organisms designed with physical barriers capable of preventing the escape of the organisms. Examples include but are not limited to laboratories, growth chambers, fermenters, and containment greenhouses.

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.

Gene pool. Germplasm within which sexual recombination is possible as a result of hybridization, including via methods such as embryo culture or bridging crosses.

Genetic engineering. Techniques that use recombinant, synthesized, or amplified nucleic acids to modify or create a genome.

Import (importation). To move into, or the act of movement into, the territorial limits of the United States.

Inspector. Any individual authorized by the Administrator or by the Commissioner of Customs and Border Protection, Department of Homeland Security, to enforce the regulations in this part.

Interstate. From one State into or through any other State or within the District of Columbia, the Commonwealth of the Northern Mariana Islands, the Commonwealth of Puerto Rico, Guam, the Virgin Islands of the United States, or any other territory or possession of the United States.

Mechanism of action (MOA). The biochemical process(es) through which genetic material determines a trait.

Move (moving, movement). To carry, enter, import, mail, ship, or transport; aid, abet, cause, or induce the carrying, entering, importing, mailing, shipping, or transporting; to offer to carry, enter, import, mail, ship, or transport; to receive to carry, enter, import, mail, ship, or transport; to release into the environment; or to allow any of the above activities to occur.

Organism. Any active, infective, or dormant stage of 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 authorization, including by electronic methods, by the Administrator to move organisms regulated under this part and associated articles under conditions prescribed by the Administrator.

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

Plant. Any plant (including any plant part) for or capable of propagation, including a tree, a tissue culture, a plantlet culture, pollen, a shrub, a vine, a cutting, a graft, a scion, a bud, a bulb, a root, or a seed.

Plant pest. Any living stage of a protozoan, nonhuman animal, parasitic plant, bacterium, fungus, virus or viroid, infectious agent or other pathogen, or any article similar to or allied with any of the foregoing, that can directly or indirectly injure, cause damage to, or cause disease in any plant or plant product.

Plant pest risk. The potential for direct or indirect injury to, damage to, or disease in any plant or plant product resulting from introducing or disseminating a plant pest, or the potential for exacerbating the impact of a plant pest.

Plant product.

(1) Any flower, fruit, vegetable, root, bulb, seed, or other plant part that is not included in the definition of plant; or

(2) Any manufactured or processed plant or plant part.

Recipient organism. The organism whose nucleic acid sequence will be modified through the use of genetic engineering.

Release into the environment (environmental release). The use of an organism outside the physical constraints of a contained facility.

Responsible person. The individual responsible for maintaining control over a GE organism under permit during its movement and for ensuring compliance with all conditions contained in any applicable permit as well as with other requirements in this part and in the Plant Protection Act (7 U.S.C. 7701 et seq.). This individual must sign the permit application, and must be at least 18 years of age, and must be a legal resident of the United States.

Secure shipment. Shipment in a container or a means of conveyance of sufficient strength and integrity to withstand leakage of contents, shocks, pressure changes, and other conditions incident to ordinary handling in transportation.

State. Any of the several States of the United States, the Commonwealth of the Northern Mariana Islands, the Commonwealth of Puerto Rico, the District of Columbia, Guam, the Virgin Islands of the United States, or any other territories or possessions of the United States.

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

Trait. An observable (able to be seen or otherwise identified) characteristic of an organism.

Unauthorized release. The intentional or accidental movement of an organism under a permit issued pursuant to this part in a manner not authorized by the permit; or the intentional or accidental movement without a permit of an organism that is subject to the regulations in this part.