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346 Part 340—Introduction of Or- Ganisms and Products Al- Tered Or Produced Through Genetic Engineering Which Are Plant Pests

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346 Part 340—Introduction of Or- Ganisms and Products Al- Tered Or Produced Through Genetic Engineering Which Are Plant Pests § 331.19 7 CFR Ch. III (1–1–20 Edition) (b) Prior to issuing a certificate of (vi) Actions taken to respond to the registration to an individual or entity, release; and APHIS may inspect and evaluate their (vii) Hazards posed by the release. premises and records to ensure compli- (2) A completed APHIS/CDC Form 3 ance with this part. must be submitted within 7 calendar days. § 331.19 Notification of theft, loss, or release. [70 FR 13278, Mar. 18, 2005, as amended at 77 FR 61077, Oct. 5, 2012] (a) An individual or entity must im- mediately notify APHIS or CDC upon § 331.20 Administrative review. discovery of the theft or loss of a select (a) An individual or entity may ap- agent or toxin. Thefts or losses must be peal a denial, revocation, or suspension reported even if the select agent or of registration under this part. The ap- toxin is subsequently recovered or the peal must be in writing, state the fac- responsible parties are identified. tual basis for the appeal, and be sub- (1) The theft or loss of a select agent mitted to the Administrator within 30 or toxin must be reported by telephone, calendar days of the decision. facsimile, or e-mail. The following in- (b) An individual may appeal a de- formation must be provided: nial, limitation, or revocation of access (i) The name of the select agent or approval under this part. The appeal toxin and any identifying information must be in writing, state the factual (e.g., strain or other characterization basis for the appeal, and be submitted information); to the Administrator within 180 cal- (ii) An estimate of the quantity sto- endar days of the decision. len or lost; (c) The Administrator’s decision con- (iii) An estimate of the time during stitutes final agency action. which the theft or loss occurred; (iv) The location (building, room) [77 FR 61077, Oct. 5, 2012] from which the theft or loss occurred; and PART 340—INTRODUCTION OF OR- (v) The list of Federal, State, or local GANISMS AND PRODUCTS AL- law enforcement agencies to which the TERED OR PRODUCED THROUGH individual or entity reported, or in- GENETIC ENGINEERING WHICH tends to report, the theft or loss. ARE PLANT PESTS OR WHICH (2) A completed APHIS/CDC Form 3 THERE IS REASON TO BELIEVE ARE must be submitted within 7 calendar PLANT PESTS days. (b) An individual or entity must no- Sec. tify APHIS or CDC immediately upon 340.0 Restrictions on the introduction of discovery of a release of a select agent regulated articles. or toxin outside of the primary barriers 340.1 Definitions. of the biocontainment area. 340.2 Groups of organisms which are or con- (1) The release of a select agent or tain plant pests and exemptions. toxin must be reported by telephone, 340.3 Notification for the introduction of facsimile, or e-mail. The following in- certain regulated articles. formation must be provided: 340.4 Permits for the introduction of a regu- lated article. (i) The name of the select agent or 340.5 Petition to amend the list of orga- toxin and any identifying information nisms. (e.g., strain or other characterization 340.6 Petition for determination of nonregu- information); lated status. (ii) An estimate of the quantity re- 340.7 Marking and identity. leased; 340.8 Container requirements for the move- (iii) The time and duration of the re- ment of regulated articles. lease; 340.9 Cost and charges. (iv) The location (building, room) AUTHORITY: 7 U.S.C. 7701–7772 and 7781–7786; from which the release occurred; and 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3. (v) The number of individuals poten- SOURCE: 52 FR 22908, June 16, 1987, unless tially exposed at the entity; otherwise noted. 346 VerDate Sep<11>2014 13:13 Jun 23, 2020 Jkt 250016 PO 00000 Frm 00356 Fmt 8010 Sfmt 8010 Y:\SGML\250016.XXX 250016 Animal and Plant Health Inspection Service, USDA § 340.1 § 340.0 Restrictions on the introduc- Administrator. The Administrator of tion of regulated articles. the Animal and Plant Health Inspec- (a) No person shall introduce any reg- tion Service (APHIS) or any other em- ployee of APHIS to whom authority ulated article unless the Administrator has been or may be delegated to act in is: the Administrator’s stead. (1) Notified of the introduction in ac- Animal and Plant Health Inspection cordance with § 340.3, or such introduc- Service (APHIS). An agency of the tion is authorized by permit in accord- United States Department of Agri- ance with § 340.4, or such introduction culture. is conditionally exempt from permit requirements under § 340.2(b); and Antecedent organism. An organism that has already been the subject of a (2) Such introduction is in con- determination of nonregulated status formity with all other applicable re- by APHIS under § 340.6, and that is used strictions in this part. 1 as a reference for comparison to the (b) Any regulated article introduced regulated article under consideration not in compliance with the require- under these regulations. ments of this part shall be subject to Courtesy permit. A written permit the immediate application of such re- issued by the Administrator, in accord- medial measures or safeguards as an ance with § 340.4(h). inspector determines necessary to pre- Donor organism. The organism from vent the introduction of such plant which genetic material is obtained for pests. 2 transfer to the recipient organism. [52 FR 22908, June 16, 1987, as amended at 58 Environment. All the land, air, and FR 17056, Mar. 31, 1993; 62 FR 23956, May 2, water; and all living organisms in asso- 1997; 66 FR 21058, Apr. 27, 2001; 83 FR 11866, ciation with land, air and water. Mar. 19, 2018; 84 FR 2429, Feb. 7, 2019] Expression vector. A cloning vector de- § 340.1 Definitions. signed so that a coding sequence in- serted at a particular site will be tran- Terms used in the singular form in scribed and translated into protein. this part shall be construed as the plu- Genetic engineering. The genetic modi- ral, and vice versa, as the case may de- fication of organisms by recombinant mand. The following terms, when used DNA techniques. in this part, shall be construed, respec- Inspector. Any employee of the Ani- tively, to mean: mal and Plant Health Inspection Serv- ice, U.S. Department of Agriculture, or 1 Part 340 regulates, among other things, other person, authorized by the Admin- the introduction of organisms and products istrator, in accordance with law to en- altered or produced through genetic engi- force the provisions of this part. neering that are plant pests or are believed Interstate. From any State into or to be plant pests. The introduction into the United States of such articles also may be through any other State. subject to other regulations promulgated Introduce or introduction. To move under the Plant Protection Act (7 U.S.C. into or through the United States, to 7701–7772) and found in 7 CFR parts 319, 330, release into the environment, to move and 360. For example, under regulations pro- interstate, or any attempt thereat. mulgated in ‘‘Subpart H—Plants for Plant- Move (moving, movement). To ship, ing’’ (7 CFR 319.37–5 of this chapter), a per- mit is required for the importation of certain offer for shipment, offer for entry, im- classes of plants for planting whether such port, receive for transportation, carry, plants are genetically engineered or not. Ac- or otherwise transport or move, or cordingly, individuals should refer to those allow to be moved into, through, or regulations before importing any plants for within the United States. planting. Organism. Any active, infective, or 2 An inspector may hold, seize, quarantine, dormant stage or life form of an entity treat, apply other remedial measures to, de- characterized as living, including stroy, or otherwise dispose of plants, plant pests, or other articles in accordance with vertebrate and invertebrate animals, sections 411, 412, 421, and 434 of the Plant plants, bacteria, fungi, mycoplasmas, Protection Act (7 U.S.C. 7711, 7712, 7731, and mycoplasma-like organisms, as well as 7754). entities such as viroids, viruses, or any 347 VerDate Sep<11>2014 13:13 Jun 23, 2020 Jkt 250016 PO 00000 Frm 00357 Fmt 8010 Sfmt 8010 Y:\SGML\250016.XXX 250016 § 340.1 7 CFR Ch. III (1–1–20 Edition) entity characterized as living, related trator, determines is a plant pest or to the foregoing. has reason to believe is a plant pest. Permit. A written permit issued by Excluded are recipient microorganisms the Administrator, for the introduction which are not plant pests and which of a regulated article under conditions have resulted from the addition of ge- determined by the Administrator, not netic material from a donor organism to present a risk of plant pest introduc- where the material is well character- tion. ized and contains only non-coding reg- Person. Any individual, partnership, ulatory regions. corporation, company, society, associa- Release into the environment. The use tion, or other organized group. of a regulated article outside the con- Plant. Any living stage or form of straints of physical confinement that any member of the plant kingdom 3 in- are found in a laboratory, contained cluding, but not limited to, eukaryotic greenhouse, or a fermenter or other algae, mosses, club mosses, ferns, contained structure. angiosperms, gymnosperms, and Responsible person. The person who lichens (which contain algae) including has control and will maintain control any parts (e.g.
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