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are included as organisms that may be or may contain plant pests, and are regulated if they meet the definition of plant pest in § 340.14
NOTE: Any genetically engineered organism composed of DNA or RNA sequences, organelles, plasmids, parts, copies, and/or analogs, of or from any of the groups of organisms listed below shall be deemed a regulated article if it also meets the definition of plant pest in §340.1.
All members of groups containing plant viruses, and all other plant and insect vi
Genus Bradyrhizobium Genus Agrobacterium Genus Phyllobacterium Family Enterobacteriaceae Genus Erwinia
Family Streptomycetaceae Genus Streptomyces
'Any organism belonging to any taxa contained within any listed genera or taxa is only considered to be a plant pest if the organism "can directly or indirectly injure, or cause disease, or damage in any plants or parts thereof, or any processed, manufactured, or other products of plants." Thus a particular unlisted species within a listed genus would be deemed a plant pest for purposes of $340.2, if the scientific literature refers to the organism as a cause of direct or indirect injury, disease, or damage to any plants, plant parts or products of plants. (If there is any question concerning the plant pest status of an organism belonging to any listed genera or taxa, the person proposing to introduce the organism in question should consult with APHIS to determine if the organism is subject to regulation.)
Order Stylommatophora Subfamily Strophocheilacea
Genus Atherigona Family Otitidae
Genus Euxeta Family Syrphidae Family Tephritidae
Family Siricidae Family Tenthredinidae Family Torymidae
Unclassified organisms and/or organisms whose classification is unknown.
(b) Exemptions. (1) A limited permit for interstate movement shall not be required for genetic material from any plant pest contained in Escherichia coli genotype K-12 (strain K-12 and its derivatives), sterile strains of Saccharomyces cerevisiae, or asporogenic strains of Bacillus subtilis, provided that all the following conditions are met:
(i) The microorganisms are shipped in a container that meets the requirements of §340.8(b)(3);
(ii) The cloned genetic material is maintained on a nonconjugation proficient plasmid and the host does not contain other conjugation proficient plasmids or generalized transducing phages;
(iii) The cloned material does not include the complete infectious genome of a known plant pest;
(iv) The cloned genes are not carried on an expression vector if the cloned genes code for:
(A) A toxin to plants or plant products, or a toxin to organisms beneficial to plants; or
(B) Other factors directly involved in eliciting plant disease (i.e., cell wall degrading enzymes); or
(C) Substances acting as, or inhibitory to, plant growth regulators.
(2) A limited permit for interstate movement is not required for genetic material from any plant pest contained in the genome of the plant Arabidopsis thaliana, provided that all of the following conditions are met:
(i) The plants or plant materials are shipped in a container that meets the requirements of §340.8(b) (1), (2), and
$340.3 Notification for the introduction of certain regulated articles.
(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:
(i) One of the following plant species:
cotton (Gossypium hirsutum L.);
(ii) Any additional plant species that BBEP has determined may be safely introduced in accordance with the eligibility criteria set forth in paragraph (b)(2) through (b)(6) of this section and the performance standards set forth in paragraph (c) of this section.
(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 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 use.
(5) To ensure the introduced genetic sequences do not pose a significant risk of the creation of any new plant virus, they must be:
(i) Noncoding regulatory sequences of known function, or
(ii) Sense or antisense genetic constructs derived from viral coat protein 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, or (iii) Antisense genetic constructs derived from noncapsid 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.
(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, Biotechnology, Biologics, and Environmental Protection, Biotechnology Permits, 4700 River Road, Unit 147, Riverdale, Maryland 207371237.
(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 I will be in accordance with the provisions of this section.
(3) Notification must be submitted to BBEP:
(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 the Director, BBEP, within 12 months after the start of the field test, and every 12 months through the duration of the field test. Final reports for