section_id,title_number,title_name,chapter,subchapter,part_number,part_name,subpart,subpart_name,section_number,section_heading,agency,authority,source_citation,amendment_citations,full_text 10:10:2.0.1.1.20.1.133.1,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,A,Subpart A—General Provisions,,§ 110.1 Purpose and scope.,NRC,,,"[49 FR 47197, Dec. 3, 1984; 49 FR 49841, Dec. 24, 1984, as amended at 55 FR 34519, Aug. 23, 1990; 56 FR 40692, Aug. 15, 1991; 58 FR 13001, Mar. 9, 1993; 61 FR 35602, July 8, 1996; 63 FR 1900, Jan. 13, 1998; 65 FR 70289, Nov. 22, 2000; 75 FR 44085, July 28, 2010]","(a) The regulations in this part prescribe licensing, enforcement, and rulemaking procedures and criteria, under the Atomic Energy Act, for the export of nuclear equipment and material, as set out in §§ 110.8 and 110.9, and the import of nuclear equipment and material, as set out in § 110.9a. This part also gives notice to all persons who knowingly provide to any licensee, applicant, contractor, or subcontractor, components, equipment, materials, or other goods or services, that relate to a licensee's or applicant's activities subject to this part, that they may be individually subject to NRC enforcement action for violation of § 110.7b. (b) The regulations in this part apply to all persons in the United States except: (1) Persons who import or export U.S. Munitions List nuclear items such as uranium depleted in the isotope-235 and incorporated in defense articles. These persons are subject to the regulations promulgated pursuant to the Arms Export Control Act and administered by the Department of State, Directorate of Defense Trade Controls, and the Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives, as authorized by section 110 of the International Security and Development Cooperation Act of 1980. (2) Persons who export uranium depleted in the isotope-235 and incorporated in commodities solely to take advantage of high density or pyrophoric characteristics. These persons are subject to the controls of the Department of Commerce under the Export Administration Act, as continued in force under Executive Order 13222 (August 22, 2001), as extended; (3) Persons who export nuclear referral list commodities such as bulk zirconium, rotor and bellows equipment, maraging steel, nuclear reactor related equipment, including process control systems and simulators. These persons are subject to the licensing authority of the Department of Commerce pursuant to 15 CFR part 730 et seq.; (4) Persons who import deuterium, nuclear grade graphite, or nuclear equipment other than production or utilization facilities. A uranium enrichment facility is not a production facility for the purposes of import; and (5) Shipments which are only passing through the U.S. (in bond shipments) do not require an NRC import or export license; however, they must comply with the Department of Transportation/IAEA packaging, and State transportation requirements." 10:10:2.0.1.1.20.1.133.10,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,A,Subpart A—General Provisions,,§ 110.8 List of nuclear facilities and equipment under NRC export licensing authority.,NRC,,,"[61 FR 35602, July 8, 1996, as amended at 65 FR 70290, Nov. 22, 2000; 86 FR 43404, Aug. 9, 2021]","(a) Nuclear reactors and especially designed or prepared equipment and components for nuclear reactors. (See Appendix A to this part.) (b) Plants for the separation of isotopes of uranium (source material or special nuclear material) including gas centrifuge plants, gaseous diffusion plants, aerodynamic enrichment plants, chemical exchange or ion exchange enrichment plants, laser based enrichment plants, plasma separation enrichment plants, electromagnetic enrichment plants, and especially designed or prepared equipment, other than analytical instruments, for the separation of isotopes of uranium. (See appendices to this part for lists of: gas centrifuge equipment—Appendix B; gaseous diffusion equipment—Appendix C; aerodynamic enrichment equipment—Appendix D; chemical exchange or ion exchange enrichment equipment—Appendix E; laser based enrichment equipment—Appendix F; plasma separation enrichment equipment—Appendix G; and electromagnetic enrichment equipment—Appendix H.) (c) Plants for the separation of the isotopes of lithium and especially designed or prepared assemblies and components for these plants. (See Appendix N to this part.) (d) Plants for the reprocessing of irradiated nuclear reactor fuel elements and especially designed or prepared assemblies and components for these plants. (See Appendix I to this part.) (e) Plants for the fabrication of nuclear reactor fuel elements and especially designed or prepared assemblies and components for these plants. (See Appendix O to this part.) (f) Plants for the conversion of uranium and plutonium and especially designed or prepared assemblies and components for these plants. (See Appendix J to this part.) (g) Plants for the production, separation, or purification of heavy water, deuterium, and deuterium compounds and especially designed or prepared assemblies and components for these plants. (See Appendix K to this part.) (h) Plants for the production of special nuclear material using accelerator-driven subcritical assembly systems capable of continuous operation above 5 MW thermal. (i) Other nuclear-related commodities are under the export licensing authority of the Department of Commerce." 10:10:2.0.1.1.20.1.133.11,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,A,Subpart A—General Provisions,,§ 110.9 List of Nuclear Material under NRC export licensing authority.,NRC,,,"[55 FR 30450, July 26, 1990, as amended at 70 FR 41939, July 21, 2005; 86 FR 55479, Oct. 6, 2021]","(a) Special Nuclear Material. (b) Source Material. (c) Byproduct Material. (d) Deuterium for nuclear end use. (e) Nuclear grade graphite for nuclear end use." 10:10:2.0.1.1.20.1.133.12,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,A,Subpart A—General Provisions,,§ 110.9a List of nuclear equipment and material under NRC import licensing authority.,NRC,,,"[49 FR 47198, Dec. 3, 1984. Redesignated at 55 FR 30450, July 26, 1990, and amended at 57 FR 18393, Apr. 30, 1992; 58 FR 13003, Mar. 9, 1993]","(a) Production and utilization facilities. (b) Special nuclear material. (c) Source material. (d) Byproduct material." 10:10:2.0.1.1.20.1.133.2,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,A,Subpart A—General Provisions,,§ 110.2 Definitions.,NRC,,,"[43 FR 21691, May 19, 1978]","As used in this part, Accelerator-produced radioactive material means any material made radioactive by a particle accelerator. Agreement for cooperation means any agreement with another nation or group of nations concluded under section 123 of the Atomic Energy Act. Atomic Energy Act means the Atomic Energy Act of 1954, as amended (42 U.S.C. 2011 et seq. ). Bulk material means any quantity of any one or more of the radionuclides listed in Table 1 of Appendix P to this part in a form that is: (1) Not a Category 1 radioactive source; (2) Not a Category 2 radioactive source; (3) Not plutonium-238; and (4) Deemed to pose a risk similar to or greater than a Category 2 radioactive source. Byproduct material means (1) Any radioactive material (except special nuclear material) yielded in, or made radioactive by, exposure to the radiation incident to the process of producing or utilizing special nuclear material; (2) The tailings or wastes produced by the extraction or concentration of uranium or thorium from ore (see 10 CFR 20.1003); (3)(i) Any discrete source of radium-226 that is produced, extracted, or converted after extraction, before, on, or after August 8, 2005, for use for a commercial, medical, or research activity; or (ii) Any material that has been made radioactive by use of a particle accelerator and is produced, extracted, or converted after extraction, before, on, or after August 8, 2005 for use for a commercial, medical, or research activity; and (4) Any discrete source of naturally occurring radioactive material, other than source material, that— (i) The Commission, in consultation with the Administrator of the Environmental Protection Agency, the Secretary of Energy, the Secretary of Homeland Security, and the head of any other appropriate Federal agency, determines would pose a threat similar to the threat posed by a discrete source of radium-226 to the public health and safety or the common defense and security; and (ii) Before, on, or after August 8, 2005 is extracted or converted after extraction for use in a commercial, medical, or research activity. Classified Information means Classified National Security Information under Executive Order 13526, as amended, or any predecessor or successor Executive Order and Restricted Data under the Atomic Energy Act. Commission means the United States Nuclear Regulatory Commission or its duly authorized representatives. Common defense and security means the common defense and security of the United States. Conversion facility means any facility for the transformation from one uranium chemical species to another, including conversion of uranium ore concentrates to uranium trioxide (UO3), conversion of UO3 to uranium dioxide (UO2), conversion of uranium oxides to uranium tetrafluoride (UF4) or uranium hexafluoride (UF6), conversion of UF4 to UF6, conversion of UF6 to UF4, conversion of UF4 to uranium metal, and conversion of uranium fluorides to UO2. Depleted uranium means uranium having a percentage of uranium-235 less than the naturally occurring distribution of uranium-235 found in natural uranium (less than 0.711 weight percent uranium-235). It is obtained from spent (used) fuel elements or as byproduct tails or residues from uranium isotope separation. Deuterium means deuterium and any deuterium compound, including heavy water, in which the ratio of deuterium atoms to hydrogen atoms exceeds 1:5000; and deuterium for nuclear end use means deuterium and any deuterium compound, including heavy water, in which the ratio of deuterium atoms to hydrogen atoms exceeds 1:5000, that is intended for use in a nuclear reactor. Export of deuterium and deuterium compounds, including heavy water, for non-nuclear end use is regulated by the Department of Commerce. Discrete source means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities. Disposal means permanent isolation of radioactive material from the surrounding environment. Dual-use means equipment and materials that may be used in nuclear or non-nuclear applications. Effective kilograms of special nuclear material means: (1) For plutonium and uranium-233, their weight in kilograms; (2) For uranium enriched 1 percent or greater in the isotope uranium-235, its element weight in kilograms multiplied by the square of its enrichment expressed as a decimal weight fraction; and (3) For uranium enriched below 1 percent in the isotope uranium-235, its element weight in kilograms multiplied by 0.0001. Embargoed means that no nuclear material or equipment can be exported to certain countries under an NRC general license. Exports to embargoed countries must be pursuant to a specific license issued by the NRC and require Executive Branch review pursuant to § 110.41. Exceptional circumstances means, with respect to exports from the United States of radioactive material listed in Table 1 of Appendix P of this part: (1) Cases of considerable health or medical need as acknowledged by the U.S. Government and the government of the importing country; (2) Cases where there is an imminent radiological hazard or security threat presented by one or more radioactive sources; and (3) Cases in which the exporting facility or U.S. Government maintains control of the radioactive material throughout the period the material is outside of the U.S. and removes the material at the conclusion of this period. Executive Branch means the Departments of State, Energy, Defense and Commerce. Export means to physically transfer nuclear equipment or material to a person or an international organization in a foreign country, except DOE distributions as authorized in Section 111 of the Atomic Energy Act or Section 110 of the International Security and Development Cooperation Act of 1980. General license means an export or import license effective without the filing of a specific application with the Commission or the issuance of licensing documents to a particular person. A general license is a type of license issued through rulemaking by the NRC and is not an exemption from the requirements in this part. A general license does not relieve a person from complying with other applicable NRC, Federal, and State requirements. Heels means small quantities of natural, depleted or low-enriched uranium (to a maximum of 20 percent), in the form of uranium hexafluoride (UF6) left in emptied transport cylinders being returned to suppliers after delivery of the product. High-enriched uranium means uranium enriched to 20 percent or greater in the isotope uranium-235. IAEA means the International Atomic Energy Agency. Import means import into the United States. Individual shipment means a shipment consisting of one lot of freight tendered to a carrier by one consignor at one place at one time for delivery to one consignee on one bill of lading. This lot may consist of: (1) Only one item or (2) A number of containers all listed on the same set of shipping documents. This one lot of freight or “distinct” shipment can be transported on the same carrier with other distinct shipments containing the same items as long as each shipment is covered by separate sets of shipping documents. The phrase introduced into a hearing means the introduction or incorporation of testimony or documentary matter into the record of a hearing. License means a general or specific export or import license issued pursuant to this part. Licensee means a person authorized by a specific or a general license to export or import nuclear equipment or material pursuant to this part. Low-enriched uranium means uranium enriched below 20 percent in the isotope uranium-235. Low-level waste compact, as used in this part, means a compact entered into by two or more States pursuant to the Low-Level Radioactive Waste Policy Amendments Act of 1985. Management means storage, packaging, or treatment of radioactive waste. Medical isotope, for the purposes of § 110.42(a)(9), includes molybdenum-99, iodine-131, xenon-133, and other radioactive materials used to produce a radiopharmaceutical for diagnostic or therapeutic procedures or for research and development. Natural uranium means uranium as found in nature, containing about 0.711 percent of uranium-235, 99.283 percent of uranium-238, and a trace (0.006 percent) of uranium-234. NPT means the Treaty on the Non-Proliferation of Nuclear Weapons (TIAS 6839). Non-nuclear weapon State means any State not a nuclear weapon State as defined in the Treaty on the Non-Proliferation of Nuclear Weapons. Nuclear weapon state means any State which has manufactured and exploded a nuclear weapon or other nuclear explosive device prior to January 1, 1967 (China, France, Russia, United Kingdom, United States). Non-Proliferation Act means the Nuclear Non-Proliferation Act of 1978 (Pub. L. 95-242). NRC Public Document Room means the facility at One White Flint North, 11555 Rockville Pike (first floor), Rockville, Maryland, where certain public records of the NRC that were made available for public inspection in paper or microfiche prior to the implementation of the NRC Agencywide Documents Access and Management System, commonly referred to as ADAMS, will remain available for public inspection. It is also the place where NRC makes computer terminals available to access the Publicly Available Records System (PARS) component of ADAMS on the NRC Web site, http://www.nrc.gov, and where copies can be viewed or ordered for a fee as set forth in § 9.35 of this chapter. The facility is staffed with reference librarians to assist the public in identifying and locating documents and in using the NRC Website and ADAMS. The NRC Public Document Room is open from 7:45 a.m. to 4:15 p.m., Monday through Friday, except on Federal holidays. Reference service and access to documents may also be requested by telephone (301-415-4737 or 800-397-4209) between 8:00 a.m. and 4:00 p.m., or by e-mail ( PDR.Resource@nrc.gov ), facsimile (301-415-3548), or letter (NRC Public Document Room, One White Flint North, 11555 Rockville Pike (first floor), Rockville, Maryland 20852-2738). NRC records means any documentary material made by, in the possession of, or under the control of the Commission under Federal law or in connection with the transaction of public business as evidence of any of the Commission's activities. NRC Web site, http://www.nrc.gov, is the Internet uniform resource locator name for the Internet address of the Web site where NRC will ordinarily make available its public records for inspection. Nuclear grade graphite for nuclear end use means graphite having a purity level better than ( i.e. , less than) 5 parts per million boron equivalent, as measured according to ASTM standard C1233-98 and intended for use in a nuclear reactor. (Nuclear grade graphite for non-nuclear end use is regulated by the Department of Commerce.) Nuclear reactor means an apparatus, other than an atomic weapon or nuclear explosive device, designed or used to sustain nuclear fission in a self-supporting chain reaction. Nuclear reactor internals means the major structures within a reactor vessel that have one or more functions such as supporting the core, maintaining fuel alignment, directing primary coolant flow, providing radiation shields for the reactor vessel, and guiding in-core instrumentation. Nuclear Referral List (NRL) means the nuclear-related, dual-use commodities on the Commerce Control List that are subject to the nuclear non-proliferation export licensing controls of the Department of Commerce. They are contained in 15 CFR part 774 of the Department of Commerce's Export Administration Regulations and are designated by the symbol (NP) as the reason for control. Nuclear Suppliers Group (NSG) is a group of nuclear supplier countries which seeks to contribute to the non-proliferation of nuclear weapons through the implementation of Guidelines for nuclear exports and nuclear-related exports. Obligations means the commitments undertaken by the U.S. Government or by foreign governments or groups of nations with respect to imports or exports of nuclear material (except byproduct material) and equipment listed in §§ 110.8 and 110.9. Imports and exports of material or equipment subject to these commitments involve conditions placed on the transfer of the material or equipment, such as peaceful end-use assurances, prior consent for retransfer, and exchanges of information on the import or export. The U.S. Government informs the licensee of obligations attached to material or equipment being imported into the United States and approves changes to those obligations. Packaging means one or more receptacles and wrappers and their contents, excluding any special nuclear material, source material or byproduct material, but including absorbent material, spacing structures, thermal insulation, radiation shielding, devices for cooling and for absorbing mechanical shock, external fittings, neutron moderators, nonfissile neutron absorbers and other supplementary equipment. Participant means a person, identified in a hearing notice or other Commission order, who takes part in a hearing conducted by the Commission under this part, including any person to whom the Commission grants a hearing or leave to intervene in an export or import licensing hearing, either as a matter of right or as a matter of discretion. Particle accelerator means any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and of discharging the resultant particulate or other radiation into a medium at energies usually in excess of 1 megaelectron volt. For purposes of this definition, “accelerator” is an equivalent term. Person means any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, Government agency, other than the Commission or the Department of Energy, except that the Department of Energy shall be considered a person within the meaning of the regulations in this part to the extent that its activities are subject to the licensing and related regulatory authority of the Commission pursuant to section 111 of the Atomic Energy Act; any State or political subdivision of, or any political entity within a State, any foreign government or nation or any political subdivision of any such government or nation, or other entity; and any legal successor, representative, agent, or agency of the foregoing. Physical security or Physical protection means measures to reasonably ensure that source or special nuclear material will only be used for authorized purposes and to prevent theft or sabotage. Production facility means any nuclear reactor or plant specially designed or used to produce special nuclear material through the irradiation of source material or special nuclear material, the chemical reprocessing of irradiated source or special nuclear material, or the separation of isotopes, other than a uranium enrichment facility for purposes of import. Public health and safety means the public health and safety of the United States. Radioactive material means source, byproduct, or special nuclear material. Radioactive waste, for the purposes of this part, means any material that contains or is contaminated with source, byproduct, or special nuclear material that by its possession would require a specific radioactive material license in accordance with this Chapter and is imported or exported for the purposes of disposal in a land disposal facility as defined in 10 CFR part 61, a disposal area as defined in Appendix A to 10 CFR part 40, or an equivalent facility; or recycling, waste treatment or other waste management process that generates radioactive material for disposal in a land disposal facility as defined in 10 CFR part 61, a disposal area as defined in Appendix A to 10 CFR part 40, or an equivalent facility. Radioactive waste does not include radioactive material that is— (1) Of U.S. origin and contained in a sealed source, or device containing a sealed source, that is being returned to a manufacturer, distributor or other entity which is authorized to receive and possess the sealed source or the device containing a sealed source; (2) A contaminant on any non-radioactive material (including service tools and protective clothing) used in a nuclear facility (an NRC- or Agreement State-licensed facility (or equivalent facility) or activity authorized to possess or use radioactive material), if the material is being shipped solely for recovery and beneficial reuse of the non-radioactive material in a nuclear facility and not for waste management purposes or disposal; (3) Exempted from regulation by the Nuclear Regulatory Commission or equivalent Agreement State regulations; (4) Generated or used in a U.S. Government waste research and development testing program under international arrangements; (5) Being returned by or for the U.S. Government or military to a facility that is authorized to possess the material; or (6) Imported solely for the purposes of recycling and not for waste management or disposal where there is a market for the recycled material and evidence of a contract or business agreement can be produced upon request by the NRC. The definition of radioactive waste in this part does not include spent or irradiated fuel. Radiopharmaceutical, for the purposes of § 110.42(a)(9), means a radioactive isotope that contains byproduct material combined with chemical or biological material and is designed to accumulate temporarily in a part of the body for therapeutic purposes or for enabling the production of a useful image for use in a diagnosis of a medical condition. Recipient country, for the purposes of § 110.42(a)(9), means Canada, Belgium, France, Germany, and the Netherlands. Restricted destinations means countries that are listed in § 110.29 based on recommendations from the Executive Branch. These countries may receive exports of certain materials and quantities under a general license, but some exports to restricted destinations will require issuance of a specific license by the NRC including Executive Branch review pursuant to § 110.41. Retransfer means the transport from one foreign country to another of nuclear equipment or nuclear material previously exported from the United States, or of special nuclear material produced through the use of source material or special nuclear material previously exported from the United States. Sealed source means any special nuclear material or byproduct material encased in a capsule designed to prevent leakage or escape of that nuclear material. Secretary means the Secretary of the Commission. Source material means: (1) Natural or depleted uranium, or thorium, other than special nuclear material; or (2) Ores that contain by weight 0.05 percent or more of uranium, thorium or depleted uranium. Special nuclear material means plutonium, uranium-233, or uranium enriched above 0.711 percent by weight in the isotope uranium-235. Specific activity means the radioactivity of a radionuclide per unit mass of that nuclide, expressed in the SI unit of terabecquerels per gram (TBq/g). Values of specific activity are found in Appendix A to part 71 of this chapter. Specific license means an export or import license document issued to a named person and authorizing the export or import of specified nuclear equipment or materials based upon the review and approval of an NRC Form 7 application filed pursuant to this part and other related submittals in support of the application. Storage means the temporary holding of radioactive material. Target means material subjected to irradiation in an accelerator or nuclear reactor to induce a reaction or produce nuclear material. Transfer means the transfer of possession from one person to another person. Transport means the physical movement of material from one location to another. Treatment means any method, technique, or process, including storage for radioactive decay, designed to change the physical, chemical or biological characteristics or composition of any radioactive material. Tritium means not only tritium but also includes compounds and mixtures containing tritium in which the ratio of tritium to hydrogen by atoms exceeds one part in 1,000. United States, when used in a geographical sense, includes Puerto Rico and all territories and possessions of the United States. Uranium enrichment facility means: (1) Any facility used for separating the isotopes of uranium or enriching uranium in the isotope 235, except laboratory scale facilities designed or used for experimental or analytical purposes only; or (2) Any equipment or device, or important component part especially designed for such equipment or device, capable of separating the isotopes of uranium or enriching uranium in the isotope 235. Utilization facility means: (1) Any nuclear reactor, other than one that is a production facility and (2) Any of the following major components of a nuclear reactor: (i) Reactor pressure vessel (designed to contain the core of a nuclear reactor); (ii) Reactor primary coolant pump or circulator; (iii) “On-line” reactor fuel charging and discharging machine; and (iv) Complete reactor control rod system. (3) A utilization facility does not include the steam turbine generator portion of a nuclear power plant." 10:10:2.0.1.1.20.1.133.3,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,A,Subpart A—General Provisions,,§ 110.3 Interpretations.,NRC,,,"[43 FR 21641, May 19, 1978, as amended at 90 FR 55633, Dec. 3, 2025]","Except as authorized by the Commission in writing, no interpretation of the meaning of the regulations in this part other than a written interpretation by the Commission's General Counsel is binding upon the Commission. This section shall cease to have effect on January 8, 2027, unless the NRC determines that the cessation deadline should be extended to a date not more than 5 years in the future after offering the public an opportunity to provide input on the costs and benefits of this section and considering that input. The NRC will publish a document in the Federal Register announcing its determination and revising or removing this section accordingly." 10:10:2.0.1.1.20.1.133.4,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,A,Subpart A—General Provisions,,§ 110.4 Communications.,NRC,,,"[68 FR 58824, Oct. 10, 2003, as amended at 74 FR 62686, Dec. 1, 2009; 80 FR 74982, Dec. 1, 2015; 83 FR 58466, Nov. 20, 2018]","Except where otherwise specified in this part, all communications and reports concerning the regulations in this part should be addressed to the Deputy Director of the NRC's Office of International Programs, either by telephone to 301-287-9057; by mail to the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; by hand delivery to the NRC's offices at 11555 Rockville Pike, Rockville, Maryland; or, where practicable, by electronic submission, for example, via Electronic Information Exchange, or CD-ROM. Electronic submissions must be made in a manner that enables the NRC to receive, read, authenticate, distribute, and archive the submission, and process and retrieve it a single page at a time. Detailed guidance on making electronic submissions can be obtained by visiting the NRC's Web site at http://www.nrc.gov/site-help/e-submittals.html; by e-mail to MSHD.Resource@nrc.gov; or by writing the Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. The guidance discusses, among other topics, the formats the NRC can accept, the use of electronic signatures, and the treatment of nonpublic information." 10:10:2.0.1.1.20.1.133.5,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,A,Subpart A—General Provisions,,§ 110.5 Licensing requirements.,NRC,,,"[56 FR 24684, May 31, 1991, as amended at 58 FR 13002, Mar. 9, 1993]","Except as provided under subpart B of this part, no person may export any nuclear equipment or material listed in § 110.8 and § 110.9, or import any nuclear equipment or material listed in § 110.9a, unless authorized by a general or specific license issued under this part." 10:10:2.0.1.1.20.1.133.6,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,A,Subpart A—General Provisions,,§ 110.6 Retransfers.,NRC,,,"[75 FR 44087, July 28, 2010, as amended at 83 FR 58466, Nov. 20, 2018]","(a) Retransfer of any nuclear equipment or material listed in §§ 110.8 and 110.9 (except byproduct material), including special nuclear material produced through the use of equipment, source material, or special nuclear material bearing obligations to the United States pursuant to an agreement for cooperation, requires authorization by the Department of Energy, unless the export to the new destination is authorized by the NRC under a specific or general license or an exemption from licensing requirements. See definition of “obligations” in § 110.2. (b) Requests for authority to retransfer are processed by the Department of Energy, National Nuclear Security Administration, Office of Nonproliferation and Arms Control, Washington, DC 20585." 10:10:2.0.1.1.20.1.133.7,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,A,Subpart A—General Provisions,,§ 110.7 Information collection requirements: OMB approval.,NRC,,,"[62 FR 52190, Oct. 6, 1997, as amended at 65 FR 70290, Nov. 22, 2000; 67 FR 67101, Nov. 4, 2002; 71 FR 19104, Apr. 13, 2006; 75 FR 44087, July 28, 2010; 76 FR 72087, Nov. 22, 2011; 85 FR 65664, Oct. 16, 2020]","(a) The Nuclear Regulatory Commission has submitted the information collection requirements contained in this part to the Office of Management and Budget (OMB) for approval as required by the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ). The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has approved the information collection requirements contained in this part under control numbers 3150-0036. (b) The approved information requirements contained in this part appear in §§ 110.7a, 110.10, 110.27, 110.32, 110.50, 110.52, 110.53, and 110.54. (c) This part contains information collection requirements in addition to those approved under the control number specified in paragraph (a) of this section. The information collection requirements contained in §§ 110.19, 110.20, 110.21, 110.22, 110.23, 110.31, 110.32, and 110.51, and NRC Form 7 are approved under control number 3150-0027." 10:10:2.0.1.1.20.1.133.8,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,A,Subpart A—General Provisions,,§ 110.7a Completeness and accuracy of information.,NRC,,,"[52 FR 49374, Dec. 31, 1987, as amended at 75 FR 44087, July 28, 2010]","(a) Information provided to the Commission by an applicant for a license or by a licensee or information required by statute or by the Commission's regulations, orders, or license conditions to be maintained by the applicant or the licensee shall be complete and accurate in all material respects. (b) Each licensee or applicant for a license shall notify the Commission of information identified by the applicant or licensee as having, for the regulated activity, a significant implication for public health and safety or common defense and security. An applicant or licensee violates this paragraph if the applicant or licensee fails to notify the Commission of information that the applicant or licensee has identified as having a significant implication for public health and safety or common defense and security. Notification shall be provided to the Administrator of the appropriate Regional Office within two working days of identifying the information. This requirement is not applicable to information which is already required to be provided to the Commission by other reporting or updating requirements." 10:10:2.0.1.1.20.1.133.9,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,A,Subpart A—General Provisions,,§ 110.7b Deliberate misconduct.,NRC,,,"[63 FR 1900, Jan. 13, 1998]","(a) Any licensee, applicant for a license, employee of a licensee or applicant; or any contractor (including a supplier or consultant), subcontractor, employee of a contractor or subcontractor of any licensee or applicant for a license, who knowingly provides to any licensee, applicant, contractor, or subcontractor, any components, equipment, materials, or other goods or services that relate to a licensee's or applicant's activities in this part, may not: (1) Engage in deliberate misconduct that causes or would have caused, if not detected, a licensee or applicant to be in violation of any rule, regulation, or order; or any term, condition, or limitation of any license issued by the Commission; or (2) Deliberately submit to the NRC, a licensee, an applicant, or a licensee's or applicant's contractor or subcontractor, information that the person submitting the information knows to be incomplete or inaccurate in some respect material to the NRC. (b) A person who violates paragraph (a)(1) or (a)(2) of this section may be subject to enforcement action in accordance with the procedures in 10 CFR part 2, subpart B. (c) For the purposes of paragraph (a)(1) of this section, deliberate misconduct by a person means an intentional act or omission that the person knows: (1) Would cause a licensee or applicant to be in violation of any rule, regulation, or order; or any term, condition, or limitation, of any license issued by the Commission; or (2) Constitutes a violation of a requirement, procedure, instruction, contract, purchase order, or policy of a licensee, applicant, contractor, or subcontractor." 10:10:2.0.1.1.20.10.133.1,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,J,Subpart J—Special Procedures for Classified Information in Hearings,,§ 110.120 Purpose and scope.,NRC,,,,"(a) This subpart contains special procedures concerning access to, and introduction of, classified information into hearings under this part. (b) These procedures do not in any way apply to classified information exchanged between the Executive Branch and the Commission not introduced into a hearing. Such information will be declassified to the maximum extent feasible. The public statements of the Commission staff and Executive Branch will, to the extent consistent with classification requirements, reflect consideration of any such classified information." 10:10:2.0.1.1.20.10.133.2,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,J,Subpart J—Special Procedures for Classified Information in Hearings,,§ 110.121 Security clearances and access to classified information.,NRC,,,,"(a) No person without a security clearance will have access to classified information. (b) Only the Commission will act upon an application for access to classified information. (c) To the extent practicable, applications for access to classified information shall describe the information to which access is desired and its level of classification (confidential, secret or other); the reasons for requesting access; the names of individuals for whom access is requested; and the reasons why access is requested for those individuals. (d) The Commission will consider requests for appropriate security clearances in reasonable numbers; conduct its review and grant or deny these in accordance with part 10 of this chapter; and make a reasonable charge to cover costs. (e) The Commission will not grant security clearances for access to classified information, unless it determines that the available unclassified information is inadequate on the subject matter involved. (f) When an application demonstrates that access to classified information not introduced into a hearing may be needed to prepare a participant's position on the hearing issues, the Commission may issue an order granting access to this information to the participant, his authorized representative or other persons. Access will be subject to the conditions in paragraphs (e) and (j) and will not be granted unless required security clearances have been obtained. (g) Once classified information has been introduced into a hearing, the Commission will grant access to a participant, his authorized representative or such other persons as the Commission determines may be needed by the participant to prepare his position on the hearing issues. Access will be subject to the conditions in paragraphs (e) and (j) of this section and will not be granted unless required security clearances have been obtained. (h) For good cause, the Commission may postpone action upon an application for access to classified information. (i) The Commission will grant access to classified information only up to the level for which the persons described in paragraphs (f) and (g) of this section are cleared and only upon an adequate commitment by them not to disclose such information subject to penalties as provided by law. (j) The Commission will not in any circumstances grant access to classified information: (1) Unless it determines that the grant is not inimical to the common defense and security; and (2) Which it has received from another Government agency, without the prior consent of the originating agency. (k) Upon completion of a hearing, the Commission will terminate all security clearances granted pursuant to the hearing and may require the disposal of classified information to which access has been granted or the observance of other procedures to safeguard this information." 10:10:2.0.1.1.20.10.133.3,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,J,Subpart J—Special Procedures for Classified Information in Hearings,,§ 110.122 Classification assistance.,NRC,,,,"On the request of any hearing participant or the presiding officer (if other than the Commission), the Commission will designate a representative to advise and assist the presiding officer or the participants with respect to security classification of information and the protective requirements to be observed." 10:10:2.0.1.1.20.10.133.4,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,J,Subpart J—Special Procedures for Classified Information in Hearings,,§ 110.123 Notice of intent to introduce classified information.,NRC,,,,"(a) A participant shall seek the required security clearances, where necessary, and file with the Secretary a notice of intent to introduce classified information into a hearing at the earliest possible time after the notice of hearing. (b) If a participant has not filed a notice of intent in accordance with this section, he may introduce classified information only if he gives to the other participants and the Commission prompt written notice of intent and only as permitted by the Commission when it determines that the public interest will not be prejudiced. (c) The notice of intent shall be unclassified and, to the extent consistent with classification requirements, state: (1) The subject matter of the classified information, which it is anticipated will be involved; (2) The highest level of classification of the information (confidential, secret or other); (3) When it is anticipated that the information would be introduced; and (4) The relevance and materiality of the information to the hearing issues." 10:10:2.0.1.1.20.10.133.5,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,J,Subpart J—Special Procedures for Classified Information in Hearings,,§ 110.124 Rearrangement or suspension of a hearing.,NRC,,,,"When a participant gives notice of intent to introduce classified information and other participants do not have the required security clearances, subject to § 110.121, the Commission may: (a) Suspend or rearrange the normal order of the hearing to give other participants an opportunity to obtain the required security clearances with minimum delay in the conduct of the hearing; or (b) Take such other action as it determines to be in the public interest." 10:10:2.0.1.1.20.10.133.6,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,J,Subpart J—Special Procedures for Classified Information in Hearings,,§ 110.125 Unclassified statements required.,NRC,,,,"(a) It is the obligation of hearing participants to introduce information in unclassified form wherever possible, and to declassify, to the maximum extent feasible, any classified information introduced into the hearing. This obligation rests on each participant whether or not any other participant has the required security clearances. (b) When classified information is offered for introduction into a hearing: (1) The participant offering it shall, to the extent consistent with classification requirements, submit to the presiding officer and other participants an unclassified statement describing the substance of the classified information as accurately and completely as possible; (2) In accordance with procedures agreed upon by the participants or prescribed by the presiding officer, and after notice to all participants and opportunity to be heard on the notice, the presiding officer will determine whether an unclassified statement may be substituted for the classified information in the hearing record without prejudice to the interest of any participant or the public; (3) If the Commission determines that the unclassified statement (together with such unclassified modifications as it finds are necessary or appropriate to protect the interest of other participants and the public) adequately sets forth information in the classified matter which is relevant and material to the issues in the hearing, it will direct that the classified matter be excluded from the record of the hearing; and (4) The Commission may postpone any of the procedures in this section until all other evidence has been received. However, a participant shall not postpone service of any unclassified statement required in this section." 10:10:2.0.1.1.20.10.133.7,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,J,Subpart J—Special Procedures for Classified Information in Hearings,,§ 110.126 Protection of classified information.,NRC,,,,"Nothing in this subpart shall relieve any person from safeguarding classified information as required by law and rules, regulations or orders of any Government agency." 10:10:2.0.1.1.20.11.133.1,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,K,Subpart K—Rulemaking,,§ 110.130 Initiation of rulemaking.,NRC,,,,The Commission may initiate action to amend the regulations in this part on its own initiative or in response to a petition. 10:10:2.0.1.1.20.11.133.2,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,K,Subpart K—Rulemaking,,§ 110.131 Petition for rulemaking.,NRC,,,"[43 FR 21641, May 19, 1978, as amended at 63 FR 15744, Apr. 1, 1998; 68 FR 58824, Oct. 10, 2003]","(a) A petition for rulemaking should be addressed to the Secretary of the Commission, for the attention of the Secretary's Rulemakings and Adjudications Staff. The petition should be sent using an appropriate method listed in § 110.4. (b) The petition shall state the basis for the requested amendment. (c) The petition may request the Commission to suspend all or part of any licensing proceeding under this part pending disposition of the petition. (d) The Secretary will assign a docket number to the petition, place a copy in the Public Document Room and notice its receipt in the Federal Register. (e) Publication may be limited by order of the Commission to the extent required by section 181 of the Atomic Energy Act." 10:10:2.0.1.1.20.11.133.3,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,K,Subpart K—Rulemaking,,§ 110.132 Commission action on a petition.,NRC,,,,"(a) The Commission may grant or deny the petition in whole or in part. (b) If the petition is granted, a notice of proposed rulemaking or a notice of rulemaking will be published in the Federal Register. (c) If the petition is denied, the petitioner will be informed of the grounds. (d) Commission action on a petition will normally follow, whenever appropriate, receipt and evaluation of Executive Branch views. (e) The Commission, in exercising the discretion authorized by section 4(a)(1) of the Administrative Procedure Act (5 U.S.C. 553(a)(1)), will decide what, if any, public rulemaking procedures will be followed." 10:10:2.0.1.1.20.11.133.4,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,K,Subpart K—Rulemaking,,§ 110.133 Notice of proposed rulemaking.,NRC,,,,"(a) When the Commission proposes to amend the regulations in this part, it will normally publish a notice of proposed rulemaking in the Federal Register. (b) A notice of proposed rulemaking will include: (1) The authority for the proposed rule; (2) The substance and purpose of the proposed rule; (3) Directions for public participation; (4) The time and place of any public hearing; and (5) If a hearing is to be held by other than the Commission, designating of a presiding officer and instructions for the conduct of the hearing. (c) A notice of proposed rulemaking will be published not less than 15 days before any hearing, unless the Commission for good cause provides otherwise in the notice." 10:10:2.0.1.1.20.11.133.5,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,K,Subpart K—Rulemaking,,§ 110.134 Public participation.,NRC,,,,"(a) The Commission may hold an oral hearing on a proposed rule or permit any person to participate in a rulemaking proceeding through the submission of written comments. (b) When it is in the public interest and is authorized by law, public rule-making procedures may be omitted and a notice of rulemaking published pursuant to § 110.135." 10:10:2.0.1.1.20.11.133.6,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,K,Subpart K—Rulemaking,,§ 110.135 Notice of rulemaking.,NRC,,,,"(a) Upon approval of an amendment, the Commission will publish in the Federal Register a notice of rule-making which includes a statement of its basis and purpose, effective date and, where appropriate, any significant variations from the amendment as proposed in any notice of proposed rulemaking. (b) The effective date of an amendment will normally be no earlier than 30 days after publication of the notice of rulemaking, unless the Commission for good cause provides otherwise in the notice." 10:10:2.0.1.1.20.2.133.1,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,B,Subpart B—Exemptions,,§ 110.10 General.,NRC,,,"[49 FR 47198, Dec. 3, 1984, as amended at 58 FR 13003, Mar. 9, 1993; 65 FR 70290, Nov. 22, 2000; 75 FR 44087, July 28, 2010]","(a) In response to a request or on its own initiative, the Commission may grant an exemption from the regulations in this part, if it determines that the exemption: (1) Is authorized by law; (2) Is not inimical to the common defense and security; and (3) Does not constitute an unreasonable risk to the public health and safety. (b) An exemption from statutory licensing requirements, as authorized by sections 57d, 62, and 81 of the Atomic Energy Act, will be granted only after coordination with the Executive Branch. (c) The granting of an exemption does not relieve any person from complying with the regulations of other U.S. Federal and/or State government agencies applicable to exports or imports under their authority." 10:10:2.0.1.1.20.2.133.2,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,B,Subpart B—Exemptions,,§ 110.11 Export of IAEA safeguards samples.,NRC,,,"[77 FR 27114, May 9, 2012]","(a) A person is exempt from the requirements for a license to export special nuclear, source, and byproduct material set forth in sections 53, 54d, 64, 81 and 82 of the Atomic Energy Act and from the regulations in this part to the extent that the person exports special nuclear, source, or byproduct material in IAEA safeguards samples. The samples must be exported in accordance with § 75.8 of this chapter, or a comparable U.S. Department of Energy order, and: (1) For special nuclear material, be in quantities not exceeding a combined total of 100 grams of contained plutonium, uranium-233, and uranium-235 per facility per year; (2) For source material, be in quantities not exceeding 5 kilograms per facility per year; and (3) For byproduct material, be in quantities not exceeding the values in § 30.71 of this chapter per shipment. (b) This exemption does not relieve any person from complying with parts 71 or 73 of this chapter or any Commission order under section 201(a) of the Energy Reorganization Act of 1974 (42 U.S.C. 5841(a))." 10:10:2.0.1.1.20.3.133.1,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,C,Subpart C—Licenses,,§ 110.19 Types of licenses.,NRC,,,"[75 FR 44087, July 28, 2010]",Licenses for the export and import of nuclear equipment and material in this part consist of general licenses and specific licenses. A general license is effective without the filing of an application with the Commission or the issuance of licensing documents to a particular person. A specific license is issued to a named person and is effective upon approval by the Commission of an application filed pursuant to the regulations in this part and issuance of licensing documents to the applicant. 10:10:2.0.1.1.20.3.133.10,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,C,Subpart C—Licenses,,§ 110.28 Embargoed destinations.,NRC,,,"[58 FR 13003, Mar. 9, 1993, as amended at 61 FR 35602, July 8, 1996; 65 FR 70291, Nov. 22, 2000; 70 FR 29936, May 25, 2005; 72 FR 1427, Jan. 12, 2007]","Cuba Iran Iraq North Korea Syria Sudan" 10:10:2.0.1.1.20.3.133.11,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,C,Subpart C—Licenses,,§ 110.29 Restricted destinations.,NRC,,,"[58 FR 13003, Mar. 9, 1993, as amended at 59 FR 48998, Sept. 26, 1994; 61 FR 35602, July 8, 1996; 70 FR 29936, May 25, 2005; 72 FR 1427, Jan. 12, 2007; 77 FR 11385, Feb. 27, 2012; 78 FR 8361, Feb. 6, 2013]","Afghanistan Andorra Angola Burma (Myanmar) Djibouti India Israel Libya Pakistan South Sudan" 10:10:2.0.1.1.20.3.133.12,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,C,Subpart C—Licenses,,§ 110.30 Members of the Nuclear Suppliers Group.,NRC,,,"[59 FR 48998, Sept. 26, 1994, as amended at 61 FR 35602, July 8, 1996; 65 FR 70291, Nov. 22, 2000; 75 FR 44089, July 28, 2010; 79 FR 39291, July 10, 2014]","Argentina Australia Austria Belarus Belgium Brazil Bulgaria Canada China Croatia Cyprus Czech Republic Denmark Estonia Finland France Germany Greece Hungary Iceland Ireland Italy Japan Kazakhstan Latvia Lithuania Luxembourg Malta Mexico Netherlands New Zealand Norway Poland Portugal Republic of Korea Romania Russia Serbia Slovak Republic Slovenia South Africa Spain Sweden Switzerland Turkey Ukraine United Kingdom" 10:10:2.0.1.1.20.3.133.13,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,C,Subpart C—Licenses,,§ 110.31 Application for a specific license.,NRC,,,"[75 FR 44089, July 28, 2010]","(a) A person shall file an application for a specific license to export or import with the Deputy Director of the NRC's Office of International Programs, using an appropriate method listed in § 110.4. (b) Applications for an export, import, amendment or renewal licenses or a request for an exemption from a licensing requirement under this part shall be filed on NRC Form 7. (c) An application for a specific license to export or import or a request for an exemption from a licensing requirement must be accompanied by the appropriate fee in accordance with the fee schedules in § 170.21 and § 170.31 of this chapter. A license application will not be processed unless the specified fee is received. (d) Each application on NRC Form 7 shall be signed by the applicant or licensee or a person duly authorized to act for and on behalf of the applicant or licensee. (e) Each person shall provide in the license application, as appropriate, the information specified in § 110.32. The Commission also may require the submission of additional information if necessary to complete its review. (f) An application may cover multiple shipments and destinations. (g) The applicant shall withdraw an application when it is no longer needed. The Commission's official files retain all documents related to a withdrawn application." 10:10:2.0.1.1.20.3.133.14,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,C,Subpart C—Licenses,,§ 110.32 Information required in an application for a specific license/NRC Form 7.,NRC,,,"[75 FR 44089, July 28, 2010, as amended at 82 FR 52826, Nov. 15, 2017]","(a) Name and address of applicant. (b) Name and address of any other party, including the supplier of equipment or material, if different from the applicant. (c) Country of origin of equipment or material, and any other countries that have processed the material prior to its import into the U.S. This is meant to include all obligations attached to the material, according to the definition of obligations in § 110.2. Licensees must keep records of obligations attached to material which they own or is in their possession. (d) Names and addresses of all intermediate and ultimate consignees, other than intermediate consignees performing shipping services only. (e) Dates of proposed first and last shipments. (f) Description of the equipment or material including, as appropriate, the following: (1) Maximum quantity of material in grams or kilograms (terabecquerels or TBq for byproduct material) and its chemical and physical form. (2) For enriched uranium, the maximum weight percentage of enrichment and maximum weight of contained uranium-235. (3) For nuclear equipment, the name of the facility and its total dollar value. (4) For nuclear reactors, the name of the facility, its design power level and its total dollar value. (5) For proposed exports or imports of radioactive waste, the volume, physical and chemical characteristics, route of transit of shipment, classification (as defined in § 61.55 of this chapter) if imported or exported for direct disposal at part 61 or equivalent Agreement State licensed facility, and ultimate disposition (including forms of management or treatment) of the waste. (6) For proposed imports of radioactive waste, the industrial or other process responsible for generation of the waste, and the status of the arrangements for disposition, including pertinent documentation of these arrangements. (7) Description of end use by all consignees in sufficient detail to permit accurate evaluation of the justification for the proposed export or import, including the need for shipment by the dates specified. (g)(1) For proposed exports of Category 1 quantities of material listed in Table 1 of appendix P to this part, pertinent documentation that the recipient of the material has the necessary authorization under the laws and regulations of the importing country to receive and possess the material. (2) For proposed exports of Category 2 quantities of material listed in Table 1 of appendix P to this part, pertinent documentation that the recipient of the material has the necessary authorization under the laws and regulations of the importing country to receive and possess the material. This documentation must be provided to the NRC at least 24 hours prior to the shipment. (3) Pertinent documentation shall consist of a copy of the recipient's authorization to receive and possess the material to be exported or a confirmation from the government of the importing country that the recipient is so authorized. The recipient authorization shall include the following information: (i) Name of the recipient; (ii) Recipient location and legal address or principal place of business; (iii) Relevant radionuclides and radioactivity being imported or that the recipient is authorized to receive and possess; (iv) Uses, if appropriate; and (v) The expiration date of the recipient's authorization (if any)." 10:10:2.0.1.1.20.3.133.2,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,C,Subpart C—Licenses,,§ 110.20 General license information.,NRC,,,"[49 FR 47198, Dec. 3, 1984, as amended at 58 FR 13003, Mar. 9, 1993; 59 FR 48997, Sept. 26, 1994; 60 FR 37563, July 21, 1995; 75 FR 44087, July 28, 2010; 86 FR 43404, Aug. 9, 2021]","(a) A person may use an NRC general license as authority to export or import nuclear equipment or material, if the nuclear equipment or material to be exported or imported is covered by the NRC general licenses described in §§ 110.21 through 110.27. If an export or import is not covered by the NRC general licenses described in §§ 110.21 through 110.27, a person must file an application with the Commission for a specific license in accordance with §§ 110.31 through 110.32. (b) In response to a petition or on its own initiative, the Commission may issue a general license for export or import if it determines that any exports or imports made under the general license will not be inimical to the common defense and security or constitute an unreasonable risk to the public health and safety and otherwise meet applicable statutory requirements. A general license is issued as a regulation after a rulemaking proceeding under subpart K of this part. Issuance of a general license is coordinated with the Executive Branch. (c) A general license does not relieve a person from complying with the regulations of other Government agencies applicable to exports or imports under their authority. (d) A general license for export may not be used if the exporter knows, or has reason to believe, that the material will be used in any illegal activity or any activity related to isotope separation, chemical reprocessing, heavy water production or the fabrication of nuclear fuel containing plutonium, unless these activities are generically authorized under an appropriate agreement for cooperation. (e) A person who uses an NRC general license as the authority to export or import may cite on the shipping documents the section of this part which authorizes the described export or import under general license, as a means of expediting U.S. Customs and Border Protection's processing of the shipment. (f) As specified in §§ 110.21 through 110.26, 110.28, 110.29, and 110.30 only certain countries are eligible recipients of equipment or material under NRC general licenses to export. The Commission will closely monitor these countries and may at any time remove a country from a general license in response to significant adverse developments in the country involved. A key factor in this regard is the nonproliferation credentials of the importing country." 10:10:2.0.1.1.20.3.133.3,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,C,Subpart C—Licenses,,§ 110.21 General license for the export of special nuclear material.,NRC,,,"[49 FR 47198, Dec. 3, 1984, as amended at 58 FR 13003, Mar. 9, 1993; 59 FR 48997, Sept. 26, 1994; 60 FR 37563, July 21, 1995; 65 FR 70290, Nov. 22, 2000; 70 FR 46066, Aug. 9, 2005; 75 FR 44087, July 28, 2010; 85 FR 86795, Dec. 31, 2020]","(a) Except as provided in paragraph (d) of this section, a general license is issued to any person to export the following to any country not listed in § 110.28: (1) Low-enriched uranium as residual contamination (17.5 parts per million or less) in any item or substance. (2) Plutonium containing 80 percent or more by weight of plutonium-238 in cardiac pacemakers. (3) Special nuclear material, other than plutonium-236 and plutonium-238, in sensing components in instruments, if no more than 3 grams of enriched uranium or 0.1 gram of plutonium or uranium-233 are contained in each sensing component. (4) Plutonium-236 and plutonium-238 when contained in a device, or a source for use in a device, in quantities of less than 3.7 × 10 −3 TBq (100 millicuries) of alpha activity (189 micrograms plutonium-236, 5.88 milligrams plutonium-238) per device or source. (b) Except as provided in paragraph (d) of this section, a general license is issued to any person to export the following to any country not listed in § 110.28 or § 110.29: (1) Special nuclear material, other than plutonium-236 and plutonium-238, in individual shipments of 0.001 effective kilogram or less (e.g., 1.0 gram of plutonium, uranium-233 or uranium-235, or 10 kilograms of 1 percent enriched uranium), not to exceed 0.1 effective kilogram per calendar year to any one country. (2) Special nuclear material in fuel elements as replacements for damaged or defective unirradiated fuel elements previously exported under a specific license, subject to the same terms as the original export license and the condition that the replaced fuel elements must be returned to the United States within a reasonable time period. (3) Uranium, enriched to less than 20 percent in uranium-235, in the form of uranium hexafluoride (UF6) heels in cylinders being returned to suppliers in EURATOM or the United Kingdom. (c) Except as provided in paragraph (d) of this section, a general license is issued to any person to export plutonium-236 or plutonium-238 to any country listed in § 110.30 in individual shipments of 1 gram or less, not to exceed 100 grams per calendar year to any one country. (d) The general licenses in paragraphs (a), (b), and (c) of this section do not authorize the export of special nuclear material in radioactive waste." 10:10:2.0.1.1.20.3.133.4,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,C,Subpart C—Licenses,,§ 110.22 General license for the export of source material.,NRC,,,"[75 FR 44088, July 28, 2010, as amended at 77 FR 27114, May 9, 2012; 87 FR 68032, Nov. 14, 2022]","(a) Except as provided in paragraph (e) of this section, a general license is issued to any person to export the following to any country not listed in § 110.28: (1) Uranium or thorium, other than uranium-230, uranium-232, thorium-227, and thorium-228, in any substance in concentrations of less than 0.05 percent by weight. (2) Thorium, other than thorium-227 and thorium-228, in incandescent gas mantles or in alloys in concentrations of 5 percent or less. (3) Thorium-227, thorium-228, uranium-230, and uranium-232 when contained in a device, or a source for use in a device, in quantities of less than 3.7 × 10 −3 TBq (100 millicuries) of alpha activity (3.12 micrograms thorium-227, 122 micrograms thorium-228, 3.7 micrograms uranium-230, 4.7 milligrams uranium-232) per device or source. (4) A general license is issued to any person to export uranium, enriched to less than 20 percent in U-235, in the form of UF6 heels in cylinders being returned to suppliers in EURATOM or the United Kingdom. (b) Except as provided in paragraph (e) of this section, a general license is issued to any person to export uranium or thorium, other than uranium-230, uranium-232, thorium-227, or thorium-228, in individual shipments of 10 kilograms or less to any country not listed in § 110.28 or § 110.29, not to exceed 1,000 kilograms per calendar year to any one country or 500 kilograms per calendar year to any one country when the uranium or thorium is Canadian-obligated. (c) Except as provided in paragraph (e) of this section, a general license is issued to any person to export uranium or thorium, other than uranium-230, uranium-232, thorium-227, or thorium-228, in individual shipments of 1 kilogram or less to any country listed in § 110.29, not to exceed 100 kilograms per calendar year to any one country. (d) Except as provided in paragraph (e) of this section, a general license is issued to any person to export uranium-230, uranium-232, thorium-227, or thorium-228 in individual shipments of 10 kilograms or less to any country listed in § 110.30, not to exceed 1,000 kilograms per calendar year to any one country or 500 kilograms per calendar year to any one country when the uranium or thorium is Canadian-obligated. (e) Paragraphs (a), (b), (c), and (d) of this section do not authorize the export under general license of source material in radioactive waste." 10:10:2.0.1.1.20.3.133.5,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,C,Subpart C—Licenses,,§ 110.23 General license for the export of byproduct material.,NRC,,,"[75 FR 44088, July 28, 2010, as amended at 82 FR 52826, Nov. 15, 2017]","(a) A general license is issued to any person to export byproduct material (see Appendix L to this part) to any country not listed in § 110.28 and subject to the following limitations: (1) The general license in this section does not authorize the export of byproduct material in the form of radioactive waste. (2) The general license in this section does not authorize the export of the following radionuclides: Americium-242m Californium-249 Californium-251 Curium-245 Curium-247 Americium-242m Californium-249 Californium-251 Curium-245 Curium-247 (3) For byproduct materials listed in Table 1 of Appendix P to this part, individual shipments under a general license for export must be less than the terabecquerel (TBq) values specified in Category 2 of Table 1 unless a more restrictive requirement applies. (4) The general license authorizes exports of the following radionuclides when contained in a device, or a source for use in a device, in quantities less than 3.7 × 10 −3 TBq (100 millicuries) of alpha activity per device or source, unless the export is to a country listed in § 110.30: Actinium-225 Actinium-227 Californium-248 Californium-250 Californium-252 Californium-253 Californium-254 Curium-240 Curium-241 Curium-242 Curium-243 Curium-244 Einsteinium-252 Einsteinium-253 Einsteinium-254 Einsteinium-255 Fermium-257 Gadolinium-148 Mendelevium-258 Neptunium-235 Polonium-208 Polonium-209 Polonium-210 Radium-223 Actinium-225 Actinium-227 Californium-248 Californium-250 Californium-252 Californium-253 Californium-254 Curium-240 Curium-241 Curium-242 Curium-243 Curium-244 Einsteinium-252 Einsteinium-253 Einsteinium-254 Einsteinium-255 Fermium-257 Gadolinium-148 Mendelevium-258 Neptunium-235 Polonium-208 Polonium-209 Polonium-210 Radium-223 (5)(i) For americium-241, exports under the general license to a country listed in § 110.29 must not exceed 3.7 × 10 −2 TBq (one curie) per shipment. (ii) For americium-241, exports under the general license to a country listed in § 110.29 that exceed 3.7 × 10 −2 TBq (one curie) per shipment, must be contained in industrial process control equipment or petroleum exploration equipment in quantities not exceeding 0.60 TBq (16 curies) per device and not exceeding 7.4 TBq/calendar year (200 curies/calendar year) to any one country. (iii) All exports of americium are subject to the reporting requirements listed in § 110.54(b). (6) For neptunium-235 and -237, exports under the general license must not exceed one gram for individual shipment and must not exceed a cumulative total of 10 grams per calendar year to any one country. All exports of neptunium are subject to the reporting requirements listed in § 110.54(b). (7) For polonium-210, exports under the general license, when contained in static eliminators, must not exceed 3.7 TBq (100 curies) per individual shipment. (8)(i) For tritium in any dispersed form (e.g., luminescent light sources and paint, accelerator targets, calibration standards, labeled compounds), exports under the general license must not exceed 0.37 TBq (10 curies (1.03 milligrams)) per item, not to exceed 37 TBq (1,000 curies (103 milligrams)) per shipment, or 370 TBq (10,000 curies (1.03 grams)) per calendar year to any one country. (ii) For tritium in any dispersed form (e.g., luminescent light sources and paint, accelerator targets, calibration standards, labeled compounds), exports under the general license to the countries listed in § 110.30 must not exceed the quantity of 1.48 TBq (40 curies (4.12 milligrams)) per item, not to exceed 37 TBq (1,000 curies (103 milligrams)) per shipment or 370 TBq (10,000 curies (1.03 grams)) per calendar year to any one country. (iii) For tritium in luminescent safety devices installed in an aircraft, exports under the general license must not exceed 1.48 TBq (40 curies (4.12 milligrams)) per light source. (iv) The general license in this section does not authorize the export of tritium for recovery or recycle purposes. (b) [Reserved]" 10:10:2.0.1.1.20.3.133.6,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,C,Subpart C—Licenses,,§ 110.24 General license for the export of deuterium for nuclear end use.,NRC,,,"[86 FR 55479, Oct. 6, 2021]","(a) A general license is issued to any person to export to any country not listed in § 110.28 or § 110.29: (1) Deuterium and deuterium compounds (other than heavy water) for nuclear end use in individual shipments of 10 kilograms or less, not to exceed 200 kilograms per calendar year to any one country; and (2) Heavy water for nuclear end use in individual shipments of 50 kilograms or less, not to exceed 1,000 kilograms per calendar year to any one country. (b) A general license is issued to any person to export to any country listed in § 110.29: (1) Deuterium and deuterium compounds (other than heavy water) for nuclear end use in individual shipments of 1 kilogram or less, not to exceed 5 kilograms per calendar year to any one country listed in § 110.29; and (2) Heavy water for nuclear end use in individual shipment of 5 kilograms or less, not to exceed 25 kilograms per calendar year to any one country listed in § 110.29." 10:10:2.0.1.1.20.3.133.7,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,C,Subpart C—Licenses,,§ 110.25 [Reserved],NRC,,,, 10:10:2.0.1.1.20.3.133.8,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,C,Subpart C—Licenses,,§ 110.26 General license for the export of nuclear reactor components.,NRC,,,"[75 FR 44089, July 28, 2010, as amended at 79 FR 39291, July 10, 2014]","(a) A general license is issued to any person to export to a destination listed in paragraph (b) of this section any nuclear reactor component of U.S. origin described in paragraphs (5) through (11) of appendix A to this part if— (1) The component will be used in a light or heavy water-moderated power or research reactor; or (2) The component is in semifabricated form and will be undergoing final fabrication or repair in those countries for either subsequent return to the United States for use in a nuclear power or research reactor in the United States or in one of the destinations listed in paragraph (b) of this section. (b) The export of nuclear reactor components under the general license established in paragraph (a) of this section is approved to the following destinations: Austria Belgium Bulgaria Canada Cyprus Czech Republic Denmark Estonia Finland France Germany Greece Hungary Indonesia Ireland Italy Japan Latvia Lithuania Luxembourg Malta Netherlands New Zealand Philippines Poland Portugal Republic of Korea Romania Slovak Republic Slovenia Spain Sweden Switzerland Taiwan United Kingdom (c) This general license does not authorize the export of components, in final or semi-fabricated form, for research reactors capable of continuous operation above 5 MW thermal. (d) This general license does not authorize the export of essentially complete reactors through piecemeal exports of facility components. When individual exports of components would amount in the aggregate to export of an essentially complete nuclear reactor, a facility export license is required. (e) All exports under paragraph (a) of this section are subject to the reporting requirements in § 110.54(c). U.S. Origin includes components produced or finished in the United States, even with non-U.S. content unless the foreign content is obligated by supplier government conditions, such as a prior consent for retransfer condition." 10:10:2.0.1.1.20.3.133.9,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,C,Subpart C—Licenses,,§ 110.27 General license for imports.,NRC,,,"[51 FR 47208, Dec. 31, 1986, as amended at 56 FR 38336, Aug. 13, 1991; 58 FR 13003, Mar. 9, 1993; 60 FR 37564, July 21, 1995; 61 FR 35602, July 8, 1996; 65 FR 70291, Nov. 22, 2000; 68 FR 31589, May 28, 2003; 70 FR 37991, July 1, 2005; 75 FR 44089, July 28, 2010; 77 FR 27114, May 9, 2012]","(a) Except as provided in paragraphs (b) and (c) of this section, a general license is issued to any person to import byproduct, source, or special nuclear material if the U.S. consignee is authorized to receive and possess the material under the relevant NRC or Agreement State regulations. (b) The general license in paragraph (a) of this section does not authorize the import of more than 100 kilograms per shipment of source and/or special nuclear material in the form of irradiated fuel. (c) Paragraph (a) of this section does not authorize the import under a general license of radioactive waste. (d) A person importing formula quantities of strategic special nuclear material (as defined in § 73.2 of this chapter) under this general license shall provide the notifications required by § 73.27 and § 73.72 of this chapter. (e) A general license is issued to any person to import the major components of a utilization facility as defined in § 110.2 for end-use at a utilization facility licensed by the Commission. (f) Importers of radioactive material listed in appendix P to this part must provide the notifications required by § 110.50." 10:10:2.0.1.1.20.4.133.1,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,D,Subpart D—Review of License Applications,,§ 110.40 Commission review.,NRC,,,"[75 FR 44090, July 28, 2010, as amended at 85 FR 86795, Dec. 31, 2020; 86 FR 55479, Oct. 6, 2021]","(a) Immediately after receipt of a license application for an export or import requiring a specific license under this part, the Commission will initiate its licensing review and, to the maximum extent feasible, will expeditiously process the application concurrently with any applicable review by the Executive Branch. (b) The Commissioners shall review a license application for export of the following: (1) A production or utilization facility. (2) More than 5 effective kilograms of high-enriched uranium, plutonium or uranium-233. (3) An export involving assistance to end uses related to isotope separation, chemical reprocessing, heavy water production, advanced reactors, or the fabrication of nuclear fuel containing plutonium, except for exports of source material or low-enriched uranium to EURATOM, the United Kingdom, or Japan for enrichment up to 5 percent in the isotope uranium-235, and those categories of exports which the Commission has approved in advance as constituting permitted incidental assistance. (4) The initial export to a country since March 10, 1978 of source or special nuclear material for nuclear end use. (5) An initial export to any country listed in § 110.28 or § 110.29 involving over: (i) 10 grams of plutonium, uranium-233 or high-enriched uranium; (ii) 1 effective kilogram of low-enriched uranium; (iii) 250 kilograms of source material; (iv) 250 kilograms of heavy water for nuclear end use; or (v) 37 TBq (1,000 curies) of tritium. (6) The export of radioactive material listed in Table 1 of Appendix P of this part involving: (i) Exceptional circumstances in § 110.42(e); or (ii) Category 1 quantities of material to any country listed in § 110.28. (c) The Commission will review export and import license applications raising significant policy issues. (d) If the Commission has not completed action on a license application within 60 days after receipt of the Executive Branch judgment, as provided for in § 110.41, or the license application when an Executive Branch judgment is not required, it will inform the applicant in writing of the reason for delay and, as appropriate, provide follow-up reports." 10:10:2.0.1.1.20.4.133.2,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,D,Subpart D—Review of License Applications,,§ 110.41 Executive Branch review.,NRC,,,"[43 FR 21641, May 19, 1978, as amended at 49 FR 47200, Dec. 3, 1984; 58 FR 13004, Mar. 9, 1993; 60 FR 37564, July 21, 1995; 61 FR 35602, July 8, 1996; 70 FR 41939, July 21, 2005; 70 FR 37992, July 1, 2005; 70 FR 46066, Aug. 9, 2005; 75 FR 44090, July 28, 2010; 85 FR 86795, Dec. 31, 2020; 86 FR 55479, Oct. 6, 2021]","(a) An application for a license to export the following will be promptly forwarded to the Executive Branch for review: (1) A production or utilization facility. (2) More than one effective kilogram of high-enriched uranium or 10 grams of plutonium or uranium-233. (3) Nuclear grade graphite for nuclear end use. (4) More than 3.7 TBq (100 Curies) of tritium; (5) Deuterium for nuclear end use, other than exports of deuterium to Canada; (6) One kilogram or more of source or special nuclear material to be exported under the US-IAEA Agreement for Cooperation. (7) An export involving assistance to end uses related to isotope separation, chemical reprocessing, heavy water production, advanced reactors, or the fabrication of nuclear fuel containing plutonium, except for exports of source material or low-enriched uranium to EURATOM, the United Kingdom, or Japan for enrichment up to 5 percent in the isotope uranium-235, and those categories of exports approved in advance by the Executive Branch as constituting permitted incidental assistance. (8) The initial export of nuclear material or equipment to a foreign reactor. (9) An export involving radioactive waste. (10) An export to any country listed in § 110.28 or § 110.29. (11) An export raising significant policy issues or subject to special limitations as determined by the Commission or the Executive Branch, including exports of radioactive material listed in Table 1 of appendix P to this part involving exceptional circumstances in § 110.42(e). (b) The Executive Branch will be requested to: (1) Provide its judgment as to whether the proposed export would be inimical to the common defense and security, along with supporting rationale and information. (2) Where applicable, confirm that the proposed export would be under the terms of an agreement for cooperation; and (3) Address the extent to which the export criteria in § 110.42 are met, if applicable, and the extent to which the recipient country or group of countries has adhered to the provisions of any applicable agreement for cooperation. (c) The Commission may request the Executive Branch to address specific concerns and provide additional data and recommendations as necessary." 10:10:2.0.1.1.20.4.133.3,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,D,Subpart D—Review of License Applications,,§ 110.42 Export licensing criteria.,NRC,,,"[49 FR 47200, Dec. 3, 1984, as amended at 55 FR 34519, Aug. 23, 1990; 58 FR 13004, Mar. 9, 1993; 58 FR 57964, Oct. 28, 1993; 60 FR 37564, July 21, 1995; 70 FR 37992, July 1, 2005; 70 FR 41939, July 21, 2005; 70 FR 46066, Aug. 9, 2005; 71 FR 20339, Apr. 20, 2006; 71 FR 40003, July 14, 2006; 79 FR 39291, July 10, 2014; 84 FR 63569, Nov. 18, 2019; 86 FR 55479, Oct. 6, 2021]","(a) The review of license applications for export for peaceful nuclear uses of production or utilization facilities 1 or for export for peaceful nuclear uses of special nuclear or source material requiring a specific license under this part is governed by the following criteria: 1 Export of nuclear reactors, reactor pressure vessels, reactor primary coolant pumps and circulators, “on-line” reactor fuel charging and discharging machines, and complete reactor control rod systems, as specified in paragraphs (1) through (4) of appendix A to this part, are subject to the export licensing criteria in § 110.42(a). Exports of nuclear reactor components, as specified in paragraphs (5) through (11) of appendix A to this part, when exported separately from the items described in paragraphs (1) through (4) of appendix A to this part, are subject to the export licensing criteria in § 110.42(b). (1) IAEA safeguards as required by Article III (2) of the NPT will be applied with respect to any such facilities or material proposed to be exported, to any such material or facilities previously exported and subject to the applicable agreement for cooperation, and to any special nuclear material used in or produced through the use thereof. (2) No such material or facilities proposed to be exported or previously exported and subject to the applicable agreement for cooperation, and no special nuclear material produced through the use of such material or facilities, will be used for any nuclear explosive device or for research on or development of any nuclear explosive device. (3) Adequate physical security measures will be maintained with respect to such material or facilities proposed to be exported and to any special nuclear material used in or produced through the use thereof. Physical security measures will be deemed adequate if such measures provide a level of protection equivalent to that set forth in § 110.44. (4) No such material or facilities proposed to be exported, and no special nuclear material produced through the use of such material, will be retransferred to the jurisdiction of any other country or group of countries unless the prior approval of the United States is obtained for such retransfer. (5) No such material proposed to be exported and no special nuclear material produced through the use of such material will be reprocessed, and no irradiated fuel elements containing such material removed from a reactor will be altered in form or content, unless the prior approval of the United States is obtained for such reprocessing or alteration. (6) With respect to exports of such material or facilities to nonnuclear weapon states, IAEA safeguards will be maintained with respect to all peaceful activities in, under the jurisdiction of, or carried out under the control of such state at the time of export. This criterion will not be applied if the Commission has been notified by the President in writing that failure to approve an export because this criterion has not been met would be seriously prejudicial to the achievement of United States nonproliferation objectives or otherwise jeopardize the common defense and security, in which case the provisions of section 128 of the Atomic Energy Act regarding Congressional review will apply. (7) The proposed export of a facility or of more than 0.003 effective kilograms of special nuclear material, other than plutonium containing 80 percent or more by weight of plutonium-238, would be under the terms of an agreement for cooperation. (8) The proposed export is not inimical to the common defense and security and, in the case of facility exports, does not constitute an unreasonable risk to the public health and safety in the United States. (9)(i) Except as provided in paragraph (a)(9)(ii) of this section, with respect to exports of high-enriched uranium to be used as a fuel or target in a nuclear research or test reactor, the Commission determines that: (A) There is no alternative nuclear reactor fuel or target enriched to less than 20 percent in the isotope U-235 that can be used in that reactor; (B) The proposed recipient of the uranium has provided assurances that, whenever an alternative nuclear reactor fuel or target can be used in that reactor, it will use that alternative fuel or target in lieu of highly-enriched uranium; and (C) The United States Government is actively developing an alternative nuclear reactor fuel or target that can be used in that reactor. (ii) With regard to a Recipient Country, the Commission may issue a license authorizing the export of high-enriched uranium for medical isotope production, including shipment to and use at intermediate and ultimate consignees, if the Commission determines that: (A) The Recipient Country that supplies an assurance letter to the United States Government in connection with the consideration by the Commission of the export license application has informed the United States Government that any intermediate consignees and the ultimate consignee specified in the export license application are required to use the high-enriched uranium solely for the production of medical isotopes; and (B) The high-enriched uranium will be irradiated only in a reactor in the Recipient Country that— ( 1 ) Uses an alternative nuclear fuel; or ( 2 ) Is the subject of an agreement with the United States Government to convert to an alternative nuclear reactor fuel when alternative nuclear reactor fuel can be used in the reactor. (iii) A fuel or target “can be used” in a nuclear research or test reactor if— (A) The fuel or target has been qualified by the Reduced Enrichment Research and Test Reactor Program of the Department of Energy; and (B) Use of the fuel or target will permit the large majority of ongoing and planned experiments and isotope production to be conducted in the reactor without a large percentage increase in the total cost of operating the reactor. (b) The review of license applications for the export of nuclear equipment, other than a production or utilization facility, and for deuterium for nuclear end use and nuclear grade graphite for nuclear end use is governed by the following criteria: (1) IAEA safeguards as required by Article III (2) of the NPT will be applied with respect to such equipment or material. (2) No such equipment or material will be used for any nuclear explosive device or for research on or development of any nuclear explosive device. (3) No such equipment or material will be retransferred to the jurisdiction of any other country or group of countries without the prior consent of the United States. (4) The proposed export is not inimical to the common defense and security. (c) Except where paragraph (d) is applicable, the review of license applications for export of byproduct material or for export of source material for non-nuclear end uses requiring a specific license under this part is governed by the criterion that the proposed export is not inimical to the common defense and security. (d) The review of license applications for the export of radioactive waste requiring a specific license under this part is governed by the following criteria: (1) The proposed export is not inimical to the common defense and security. (2) The receiving country, after being advised of the information required by § 110.32(f)(5), finds that it has the administrative and technical capacity and regulatory structure to manage and dispose of the waste and consents to the receipt of the radioactive waste. In the case of radioactive waste containing a nuclear material to which paragraph (a) or (b) of this section is applicable, the criteria in this paragraph (d) shall be in addition to the criteria provided in paragraph (a) or (b) of this section. (e) In making its findings under paragraphs (a)(8) and (c) of this section for proposed exports of radioactive material listed in Appendix P to this part, the NRC shall consider: (1) Whether the foreign recipient is authorized based on the authorization or confirmation required by § 110.32(g) to receive and possess the material under the laws and regulations of the importing country; (2) Whether the importing country has the appropriate technical and administrative capability, resources and regulatory structure to manage the material in a safe and secure manner; (3) For proposed exports of Category 1 amounts of radioactive material listed in Table 1 of Appendix P to this part, whether the government of the importing country provides consent to the United States Government for the import of the material; (4) In cases where the importing country does not have the technical and administrative capability described in paragraph (e)(2) of this section, and in cases where there is insufficient evidence of the recipient's authorization to receive and possess the material to be exported, described in paragraph (e)(1) of this section, whether exceptional circumstances exist, and if so, whether the export should be licensed in light of those exceptional circumstances and the risks, if any, to the common defense and security of the proposed export; (5) For proposed exports under exceptional circumstances of Category 1 or Category 2 amounts of radioactive material listed in Table 1 of Appendix P to this part, whether the government of the importing country provides consent to the United States Government for the import of the material; (6) For proposed exports of radioactive material listed in Table 1 of Appendix P to this part under the exceptional circumstance in which there is a considerable health or medical need as acknowledged by the U.S. Government and the importing country, whether the United States and the importing country have, to the extent practicable, made arrangements for the safe and secure management of the radioactive sources during and at the end of their useful life; (7) Based upon the available information, whether the foreign recipient has engaged in clandestine or illegal procurement of radioactive material listed in Table 1 of Appendix P to the part; (8) Based upon available information, whether an import or export authorization for radioactive material listed in Table 1 of Appendix P to this part has been denied to the recipient or importing country, or whether the recipient or importing country has diverted any import or export of radioactive material previously authorized; and (9) Based upon available information, whether there is a risk of diversion or malicious acts involving radioactive material in Table 1 of Appendix P to this part." 10:10:2.0.1.1.20.4.133.4,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,D,Subpart D—Review of License Applications,,§ 110.43 Import licensing criteria.,NRC,,,"[60 FR 37565, July 21, 1995, as amended at 70 FR 37992, July 1, 2005; 75 FR 44090, July 28, 2010]","The review of license applications for imports requiring a specific license under this part is governed by the following criteria: (a) The proposed import is not inimical to the common defense and security. (b) The proposed import does not constitute an unreasonable risk to the public health and safety. (c) Any applicable requirements of subpart A of part 51 of this chapter are satisfied. (d) With respect to the import of radioactive waste, an appropriate facility has agreed to accept and is authorized to possess the waste for management or disposal as confirmed by NRC consultations with, as applicable, the Agreement State in which the facility is located and low-level waste compact commission(s)." 10:10:2.0.1.1.20.4.133.5,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,D,Subpart D—Review of License Applications,,§ 110.44 Physical security standards.,NRC,,,"[75 FR 44090, July 28, 2010, as amended at 79 FR 39291, July 10, 2014]","(a) Physical security measures in recipient countries must provide protection at least comparable to the recommendations in the current version of IAEA publication, “Nuclear Security Recommendations on Physical Protection of Nuclear Material and Nuclear Facilities” (INFCIRC/225/Revision 5), January 2011, which is incorporated by reference in this part. This incorporation by reference was approved by the Director of the Office of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Notice of any changes made to the material incorporated by reference will be published in the Federal Register. Copies of INFCIRC/225/Revision 5 may be obtained from the Marketing and Sales Unit, Publishing Section, IAEA, Vienna International Centre, P.O. Box 100, 1400 Vienna Austria; Fax: 43 1 2600 29302; telephone: 43 1 2600 22417; email: sales.publications@iaea.org ; Web site: http://www.iaea.org/books. You may inspect a copy at the NRC Library, 11545 Rockville Pike, Rockville, Maryland 20852-2738, telephone: 301-415-4737 or 1-800-397-4209, between 8:30 a.m. and 4:15 p.m.; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html. (b) Commission determinations on the adequacy of physical security measures are based on: (1) Receipt by the appropriate U.S. Executive Branch Agency of written assurances from the relevant recipient country government that physical security measures providing protection at least comparable to the recommendations set forth in INFCIRC/225/Revision 5. (2) Information obtained through country visits, information exchanges, or other sources. Determinations are made on a country-wide basis and are subject to continuing review. Appendix M to this part describes the different categories of nuclear material to which physical security measures are applied." 10:10:2.0.1.1.20.4.133.6,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,D,Subpart D—Review of License Applications,,§ 110.45 Issuance or denial of licenses.,NRC,,,"[49 FR 47201, Dec. 3, 1984. Redesignated and amended at 60 FR 37565, July 21, 1995; 70 FR 37992, July 1, 2005; 75 FR 44091, July 28, 2010]","(a) The Commission will issue an export license if it has been notified by the State Department that it is the judgment of the Executive Branch that the proposed export will not be inimical to the common defense and security, and: (1) Finds, based upon a reasonable judgment of the assurances provided and other information available to the Federal government, that the applicable criteria in § 110.42, or their equivalent, are met. (2) Finds that there are no material changed circumstances associated with an export license application (except for byproduct material applications) from those existing at the time of issuance of a prior license to export to the same country, if the prior license was issued under the provisions of paragraph (a)(1) of this section. (b) The Commission will issue an import license if it finds that: (1) The proposed import will not be inimical to the common defense and security; (2) The proposed import will not constitute an unreasonable risk to the public health and safety; (3) The requirements of subpart A of part 51 of this chapter (to the extent applicable to the proposed import) have been satisfied; and (4) With respect to a proposed import of radioactive waste, an appropriate facility has agreed to accept and is authorized to posses the waste for management or disposal as confirmed by NRC consultations with, as applicable, the Agreement State(s) in which the facility is located and the low-level waste compact commission(s). (c) With respect to a proposed import of radioactive material listed in Table 1 of Appendix P to this part: (1) If the Commission authorizes a proposed import of Category 1 or Category 2 amounts of radioactive material, it will take appropriate steps to ensure that a copy of the recipient authorization, or confirmation by the U.S. Government that the recipient is authorized to receive and possess the source or sources to be exported, is provided to the Government of the exporting country or to the exporting facility. (2) If the Commission authorizes a proposed import of Category 1 amounts of radioactive material, it will take appropriate steps to ensure that a copy of the consent of the United States Government to the import is provided to the government of the exporting country in cases where it is requested by such government. (d) If, after receiving the Executive Branch judgment that the issuance of a proposed export license will not be inimical to the common defense and security, the Commission does not issue the proposed license on a timely basis because it is unable to make the statutory determinations required under the Atomic Energy Act, the Commission will publicly issue a decision to that effect and will submit the license application to the President. The Commission's decision will include an explanation of the basis for the decision and any dissenting or separate views. The provisions in this paragraph do not apply to Commission decisions regarding applications for specific licenses to export byproduct material, including radioactive material listed in Table 1 of appendix P to this part, or radioactive waste. (e) The Commission will deny: (1) Any export license application for which the Executive Branch judgment does not recommend approval; (2) any byproduct material export license application for which the Commission is unable to make the finding in paragraph (a)(1) of this section; or (3) any import license application for which the Commission is unable to make the finding in paragraph (b) of this section. The applicant will be notified in writing of the reason for denial." 10:10:2.0.1.1.20.4.133.7,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,D,Subpart D—Review of License Applications,,§ 110.46 Conduct resulting in termination of nuclear exports.,NRC,,,"[43 FR 21641, May 19, 1978, as amended at 49 FR 47202, Dec. 3, 1984. Redesignated at 60 FR 37565, July 21, 1995]","(a) Except as provided in paragraph (c) of this section, no license will be issued to export nuclear equipment or material, other than byproduct material, to any non-nuclear weapon state that is found by the President to have, after March 10, 1978: (1) Detonated a nuclear explosive device; (2) Terminated or abrogated IAEA safeguards; (3) Materially violated an IAEA safeguards agreement; or (4) Engaged in activities involving source or special nuclear material and having direct significance for the manufacture or acquisition of nuclear explosive devices, and failed to take steps which represent sufficient progress toward terminating such activities. (b) Except as provided in paragraph (c) of this section, no license will be issued to export nuclear equipment or material, other than byproduct material, to any country or group of countries that is found by the President to have, after March 10, 1978: (1) Materially violated an agreement for cooperation with the United States or the terms of any other agreement under which nuclear equipment or material has been exported; (2) Assisted, encouraged or induced any non-nuclear weapon state to engage in activities involving source or special nuclear material and having direct significance for the manufacture or acquistion of nuclear explosive devices, and failed to take steps which represent sufficient progress toward terminating such assistance, encouragement or inducement; or (3) Entered into an agreement for the transfer of reprocessing equipment, materials or technology to the sovereign control of a non-nuclear weapon state, except in connection with an international fuel cycle evaluation in which the United States is a participant or pursuant to an international agreement or understanding to which the United States subscribes. (c) Under section 129 of the Atomic Energy Act, the President may waive the requirement for the termination of exports to a country described in paragraph (a) or (b) of this section after determining in writing that the cessation of exports would seriously prejudice the achievement of United States nonproliferation objectives or otherwise jeopardize the common defense and security. If the President makes this determination, the Commission will issue licenses to export to that country, if other applicable statutory provisions are met." 10:10:2.0.1.1.20.5.133.1,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,E,Subpart E—License Terms and Related Provisions,,§ 110.50 Terms.,NRC,,,"[75 FR 44091, July 28, 2010, as amended at 85 FR 65664, Oct. 16, 2020; 86 FR 43404, Aug. 9, 2021]","(a) General and specific licenses. (1) Each license is subject to all applicable provisions of the Atomic Energy Act and other applicable law and to all applicable rules, regulations, decisions and orders of the Commission. (2) Each license is subject to amendment, suspension, revocation or incorporation of separate conditions when required by amendments of the Atomic Energy Act or other applicable law, or by other rules, regulations, decisions or orders issued in accordance with the terms of the Atomic Energy Act or other applicable law. (3) A licensee authorized to export or import nuclear material is responsible for compliance with applicable requirements of this chapter, unless a domestic licensee of the Commission has assumed that responsibility and the Commission has been so notified. (4) Each license authorizes export or import only and does not authorize any person to receive title to, acquire, receive, possess, deliver, use, transport or transfer any nuclear equipment or material subject to this part. (5) Each license issued by the NRC for the export or import of nuclear material authorizes only the export or import of that nuclear material and accompanying packaging, fuel element, hardware, or other associated devices or products. (6) No nuclear equipment license confers authority to export or import nuclear material. (7) Each nuclear equipment export license authorizes the export of only those items required for use in the foreign nuclear installation for which the items are intended. (8) A licensee shall not proceed to export or import and shall notify the Commission promptly if he knows or has reason to believe that the packaging requirements of part 71 of this chapter have not been met. (b) Specific licenses. (1) Each specific license will have an expiration date. (2) A licensee may export or import only for the purpose(s) and/or end-use(s) stated in the specific export or import license issued by NRC. (3) Unless a license specifically authorizes the export of certain foreign-obligated nuclear material or equipment, a licensee may not ship such material or equipment until: (i) The licensee has requested and the Commission has issued an amendment to the license authorizing such shipment; or (ii) The licensee has given at least 40 days advance notice of the intended shipment in writing to the Deputy Director, Office of International Programs (OIP); and (iii) The Deputy Director, OIP has: (A) Obtained confirmation, through either the Department of Energy or State, that the foreign government in question has given its consent to the intended shipment pursuant to its agreement for cooperation with the United States; and (B) Communicated this in writing to the licensee. (c) Advanced notification. (1) A licensee authorized to export or import the radioactive material listed in Appendix P to this part is responsible for notifying NRC and, in cases of exports, the government of the importing country in advance of each shipment. A list of points of contact in importing countries is available at NRC's Office of International Programs Web site, accessible on the NRC Public Web site at http://www.nrc.gov. (2) The NRC's office responsible for receiving advance notifications for all export and import shipments is the NRC Headquarters Operations Center. Notifications to the NRC Headquarters Operations Center are to be submitted by email (preferred method) or faxed using the contact information specified in appendix A to 10 CFR part 73 of this chapter. In the subject line of the email or on the fax cover page include “10 CFR 110.50(c) Notification.” To contact the NRC Operations Center, use the same email address or call the telephone number in appendix A to 10 CFR part 73. For questions or concerns on submitting these advance notifications to the NRC, please contact the Office of International Programs at 301-287-9056. (3) Notifications may be electronic or in writing on business stationery, and must contain or be accompanied by the information which follows. (i) For export notifications: (A) 10 CFR part 110 export license number and expiration date; (B) Name of the individual and licensee making the notification, address, and telephone number; (C) Foreign recipient name, address, and end use location(s) (if different than recipient's address); (D) Radionuclides and activity level in TBq, both for single and aggregate shipments; (E) Make, model and serial number, for any Category 1 and 2 sealed sources, if available; (F) End use in the importing country, if known; (G) Shipment date; and (H) A copy of the foreign recipient's authorization or confirmation of that authorization from the government of the importing country as required by § 110.32(g) unless the authorization has already been provided to the NRC. (ii) For import notifications: (A) Name of individual and licensee making the notification, address, and telephone number; (B) Recipient name, location, and address (if different than above); (C) Name, location, address, contact name and telephone number for exporting facility; (D) Radionuclides and activity level in TBq, both for single and aggregate shipments; (E) Make, model and serial number, radionuclide, and activity level for any Category 1 and 2 sealed sources, if available; (F) End use in the U.S.; (G) Shipment date from exporting facility and estimated arrival date at the end use location; and (H) NRC or Agreement State license number to possess the import in the U.S. and expiration date. (4) Export notifications must be received by the NRC at least 7 days in advance of each shipment, to the extent practical, but in no case less than 24 hours in advance of each shipment. Import notifications must be received by the NRC at least 7 days in advance of each shipment. (5) Advance notifications containing the above information must be controlled, handled, and transmitted in accordance with § 2.390 of this chapter and other applicable NRC requirements governing protection of sensitive information. (d) A specific license may be transferred, disposed of or assigned to another person only with the approval of the Commission by license amendment." 10:10:2.0.1.1.20.5.133.2,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,E,Subpart E—License Terms and Related Provisions,,§ 110.51 Amendment and renewal of licenses.,NRC,,,"[75 FR 44092, July 28, 2010]","(a) Amendments. (1) Applications for amendment of a specific license shall be filed on NRC Form 7 in accordance with §§ 110.31 and 110.32 and shall specify the respects in which the licensee desires the license to be amended and the grounds for such amendment. (2) An amendment is not required for: (i) Changes in monetary value (but not amount or quantity); (ii) Changes in the names and/or mailing addresses within the same countries of the intermediate or ultimate consignees listed on the license; or (iii) The addition of intermediate consignees in any of the importing countries specified in the license (for a nuclear equipment license only). (b) Renewals. (1) Applications for renewal of a specific license shall be filed on NRC Form 7 in accordance with §§ 110.31 and 110.32. (2) If an application to renew a license is submitted 30 days or more before the license expires, the license remains valid until the Commission acts on the renewal application. An expired license is not renewable. (c) General. In considering an application by a licensee to renew or amend a license, the Commission will apply, as appropriate, the same procedures and criteria it uses for initial license applications." 10:10:2.0.1.1.20.5.133.3,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,E,Subpart E—License Terms and Related Provisions,,"§ 110.52 Revocation, suspension, and modification.",NRC,,,"[43 FR 21641, May 19, 1978, as amended at 62 FR 59277, Nov. 3, 1997]","(a) A license may be revoked, suspended, or modified for a condition which would warrant denial of the original license application. (b) The Commission may require further information from a licensee to determine whether a license should be revoked, suspended, or modified. (c) Except when the common defense and security or public health and safety requires otherwise, no license will be revoked, suspended, or modified before the licensee is informed in writing of the grounds for such action and afforded the opportunity to reply and be heard under procedures patterned on those in subpart I." 10:10:2.0.1.1.20.5.133.4,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,E,Subpart E—License Terms and Related Provisions,,"§ 110.53 United States address, records, and inspections.",NRC,,,"[43 FR 21641, May 19, 1978, as amended at 53 FR 19263, May 27, 1988; 75 FR 44092, July 28, 2010]","(a) Each licensee (general or specific) shall have an office in the United States where papers may be served and where records required by the Commission will be maintained. (b)(1) Each license applicant or licensee (general or specific) shall maintain records concerning his exports or imports. The licensee shall retain these records for five years after each export or import except that byproduct material records must be retained for three years after the date of each export or import shipment. (2) Records which must be maintained pursuant to this part may be the original or a reproduced copy or microform if such reproduced copy or microform is duly authenticated by authorized personnel and the microform is capable of producing a clear and legible copy after storage for the period specified by Commission regulations. The record may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, must include all pertinent information such as stamps, initials, and signatures. The licensee shall maintain adequate safeguards against tampering with and loss of records. (c) Each licensee shall permit the Commission to inspect his records, premises, and activities pertaining to his exports and imports when necessary to fulfill the requirements of the Atomic Energy Act." 10:10:2.0.1.1.20.5.133.5,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,E,Subpart E—License Terms and Related Provisions,,§ 110.54 Reporting requirements.,NRC,,,"[75 FR 44092, July 28, 2010, as amended at 77 FR 27114, May 9, 2012; 86 FR 55479, Oct. 6, 2021; 88 FR 80950, Nov. 21, 2023]","(a)(1) Reports of exports of nuclear facilities and equipment, nuclear grade graphite for nuclear end use, and deuterium for nuclear end use shipped during the previous quarter must be submitted by licensees making exports under the general license or specific license of this part by January 15, April 15, July 15, and October 15 of each year on DOC/NRC Forms AP-M or AP-13, and associated forms. The reports must contain information on all nuclear facilities, equipment, and non-nuclear materials (nuclear grade graphite for nuclear end use and deuterium for nuclear end use) listed in Annex II of the Additional Protocol. (2) These required reports must be sent via facsimile to (202) 482-1731, emailed to aprp@bis.doc.gov, or hand-delivered or submitted by courier to the Bureau of Industry and Security, in hard copy, to the following address: Treaty Compliance Division, Bureau of Industry and Security, U.S. Department of Commerce, Attn: AP Reports, 14th Street and Pennsylvania Avenue, NW., Room 4515, Washington, DC 20230. Telephone: (202) 482-1001. (b) Persons making exports under the general license established by § 110.23(a) or under a specific license shall submit by February 1 of each year one copy of a report of all americium and neptunium shipments during the previous calendar year. This report shall be submitted to the Deputy Director, Office of International Programs at the address provided in § 110.4 or by electronic submission at 110.23reports@nrc.gov . The report must include: (1) A description of the material, including quantity in TBq and gram; (2) Approximate shipment dates; and (3) A list of recipient countries, end users, and intended use keyed to the items shipped. (c) Persons making exports under the general license established by § 110.26(a) shall submit by February 1 of each year one copy of a report of all components shipped during the previous calendar year. This report shall be submitted to the Deputy Director, Office of International Programs at the address provided in § 110.4 or by electronic submission at 110.26reports@nrc.gov . This report must include: (1) A description of the components keyed to the categories listed in appendix A to this part. (2) Approximate shipment dates. (3) A list of recipient countries and end users keyed to the items shipped." 10:10:2.0.1.1.20.6.133.1,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,F,,,§ 110.60 Violations.,NRC,,,"[75 FR 44092, July 28, 2010]","(a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of— (1) The Atomic Energy Act; (2) Title II of the Energy Reorganization Act of 1974; or (3) A regulation or order pursuant to those Acts. (b) The Commission may obtain a court order for the payment of a civil penalty imposed under section 234 of the Atomic Energy Act: (1) For violations of: (i) Sections 53, 57, 62, 63, 81, 82, 101, 103, 104, 107, or 109 of the Atomic Energy Act; (ii) Section 206 of the Energy Reorganization Act; (iii) Any rule, regulation, or order issued pursuant to the sections specified in paragraph (b)(1)(i) of this section; (iv) Any term, condition, or limitation of any license issued under the sections specified in paragraph (b)(1)(i) of this section. (2) For any violation for which a license may be revoked under section 186 of the Atomic Energy Act." 10:10:2.0.1.1.20.6.133.2,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,F,,,§ 110.61 Notice of violation.,NRC,,,,"(a) Before instituting any enforcement action the Commission will serve on the licensee written notice of violation, except as provided in paragraph (d). (b) The notice will state the alleged violation; require the licensee to respond in writing, within 20 days or other specified time; and may also require the licensee to state the corrective steps taken or to be taken and the date when full compliance will be achieved. (c) The notice may provide that, if an adequate and timely reply is not received, an order to show cause may be issued pursuant to § 110.62 or a proceeding instituted to impose a civil penalty pursuant to § 110.64. (d) The notice may be omitted and an order to show cause issued when the Commission determines that the violation is willful or that the public health, safety, or interest so requires." 10:10:2.0.1.1.20.6.133.3,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,F,,,§ 110.62 Order to show cause.,NRC,,,,"(a) In response to an alleged violation, described in § 110.60, the Commission may institute a proceeding to revoke, suspend, or modify a license by issuing an order to show cause: (1) Stating the alleged violation and proposed enforcement action; and (2) Informing the licensee of his right, within 20 days or other specified time, to file a written answer and demand a hearing. (b) An answer consenting to the proposed enforcement action shall constitute a waiver by the licensee of a hearing and of all rights to seek further Commission or judicial review. (c) The order to show cause may be omitted and an order issued to revoke, suspend, or modify the license in cases where the Commission determines that the violation is willful or that the public health, safety, or interest so requires." 10:10:2.0.1.1.20.6.133.4,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,F,,,"§ 110.63 Order for revocation, suspension, or modification.",NRC,,,,"(a) In response to an alleged violation described in § 110.60, the Commission may revoke, suspend, or modify a license by issuing an order: (1) Stating the violation and the effective date of the proposed enforcement action; and (2) Informing the licensee of his right, within 20 days or other specified time, to file a written answer and demand a hearing. (b) If an answer is not filed within the time specified, the enforcement action will become effective and permanent as proposed. (c) If a timely answer is filed, the Commission, after considering the answer, will issue an order dismissing the proceeding, staying the effectiveness of the order or taking other appropriate action. (d) The order may be made effective immediately, with reasons stated, pending further hearing and order, when the Commission determines that the violation is willful or that the public health, safety, or interest so requires." 10:10:2.0.1.1.20.6.133.5,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,F,,,§ 110.64 Civil penalty.,NRC,,,"[43 FR 21641, May 19, 1978, as amended at 62 FR 27495, May 20, 1997; 89 FR 51810, June 20, 2024]","(a) In response to a violation, the Commission may institute a proceeding to impose a civil penalty under section 234 of the Atomic Energy Act by issuing a notice to the licensee: (1) Stating the alleged violation and the amount of the proposed penalty; (2) Informing the licensee of his right, within 20 days or other specified time, to file a written answer; and (3) Advising that a delinquent payment for a subsequently imposed penalty may be referred to the Attorney General for collection pursuant to section 234c. of the Atomic Energy Act. (b) If an answer is not filed within the time specified, the Commission will issue an order imposing the proposed penalty. (c) If a timely answer is filed, the Commission, after considering the answer, will issue an order dismissing the proceeding or imposing a penalty subject to any required hearing. (d) If an order imposing a civil penalty is issued, the licensee may request a hearing within 20 days or other specified time. (e) Except when the matter has been referred to the Attorney General for collection, payment of penalties shall be made in U.S. funds using the electronic payment methods accepted at www.Pay.gov. (f) An enforcement action to impose a civil penalty will not itself revoke, modify, or suspend any license under this part." 10:10:2.0.1.1.20.6.133.6,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,F,,,§ 110.65 Settlement and compromise.,NRC,,,,"At any time after issuance of an order for any enforcement action under this subpart, an agreement may be entered into for settlement of the proceeding or compromise of a penalty. Upon approval by the Commission, or presiding officer if a hearing has been requested, the terms of the settlement or compromise will be embodied in the order disposing of the enforcement action." 10:10:2.0.1.1.20.6.133.7,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,F,,,§ 110.66 Enforcement hearing.,NRC,,,"[43 FR 21641, May 19, 1978, as amended at 75 FR 44093, July 28, 2010]","(a) If the licensee demands a hearing, the Commission will issue an order specifying the time and place. (b) A hearing pursuant to this subpart will be conducted under the procedures in subpart G of part 2 of this chapter." 10:10:2.0.1.1.20.6.133.8,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,F,,,§ 110.67 Criminal penalties.,NRC,,,"[57 FR 55080, Nov. 24, 1992; 57 FR 62605, Dec. 31, 1992, as amended at 60 FR 37565, July 21, 1995; 75 FR 44093, July 28, 2010]","(a) Section 223 of the Atomic Energy Act provides for criminal sanctions for willful violation of, attempted violation of, or conspiracy to violate, any regulation issued under sections 161b., 161i., or 161o. of the Atomic Energy Act. For purposes of section 223, all the regulations in 10 CFR part 110 are issued under one or more of sections 161b, 161i, or 161o, except for the sections listed in paragraph (b) of this section. (b) The regulations in part 110 that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§ 110.1, 110.2, 110.3, 110.4, 110.7, 110.10, 110.11, 110.30, 110.31, 110.32, 110.40, 110.41, 110.42, 110.43, 110.44, 110.45, 110.46, 110.51, 110.52, 110.60, 110.61, 110.62, 110.63, 110.64, 110.65, 110.66, 110.67, 110.70, 110.71, 110.72, 110.73, 110.80, 110.81, 110.82, 110.83, 110.84, 110.85, 110.86, 110.87, 110.88, 110.89, 110.90, 110.91, 110.100, 110.101, 110.102, 110.103, 110.104, 110.105, 110.106, 110.107, 110.108, 110.109, 110.110, 110.111, 110.112, 110.113, 110.120, 110.122, 110.124, 110.130, 110.131, 110.132, 110.133, 110.134, and 110.135." 10:10:2.0.1.1.20.7.133.1,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,G,Subpart G—Public Notification and Availability of Documents and Records,,§ 110.70 Public notice of receipt of an application.,NRC,,,"[75 FR 44093, July 28, 2010, as amended at 86 FR 55479, Oct. 6, 2021]","(a) The Commission will notice the receipt of each license application, including applications for amendment or renewal, for an export or import for which a specific license is required by making a copy available at the NRC Web site, http://www.nrc.gov. (b) The Commission will also publish in the Federal Register a notice of receipt of each license application, including applications for amendment or renewal, to export the following: (1) A production or utilization facility. (2) Five effective kilograms or more of plutonium, high-enriched uranium or uranium-233. (3) 10,000 kilograms or more of heavy water for nuclear end use. (Note: Does not apply to exports of heavy water to Canada for nuclear end use.) (4) Nuclear grade graphite for nuclear end use. (5) Radioactive waste. (c) The Commission will also publish in the Federal Register a notice of receipt of a license application, including applications for amendment or renewal, for an import of radioactive waste for which a specific license is required." 10:10:2.0.1.1.20.7.133.2,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,G,Subpart G—Public Notification and Availability of Documents and Records,,§ 110.71 Notice of withdrawal of an application.,NRC,,,"[64 FR 48955, Sept. 9, 1999]","The Commission will notice the withdrawal of an application by making a copy available at the NRC Web site, http://www.nrc.gov." 10:10:2.0.1.1.20.7.133.3,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,G,Subpart G—Public Notification and Availability of Documents and Records,,§ 110.72 Public availability of documents.,NRC,,,"[43 FR 21641, May 19, 1978, as amended at 60 FR 37565, July 21, 1995; 64 FR 48955, Sept. 9, 1999]","Unless exempt from disclosure under part 9 of this chapter, the following documents pertaining to each license and license application for an import or export requiring a specific license under this part will be made available at the NRC Web site, http://www.nrc.gov, and/or at the NRC Public Document Room: (a) The license application and any requests for amendments; (b) Commission correspondence with the applicant or licensee; (c) Federal Register notices; (d) The Commission letter requesting Executive Branch views; (e) Correspondence from the State Department with Executive Branch views; (f) Correspondence from foreign governments and international organizations; (g) Filings pursuant to subpart I and Commission and Executive Branch responses, if any; (h) If a hearing is held, the hearing record and decision; (i) A statement of staff conclusions; and (j) The license, requests for license amendments and amendments." 10:10:2.0.1.1.20.7.133.4,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,G,Subpart G—Public Notification and Availability of Documents and Records,,§ 110.73 Availability of NRC records.,NRC,,,"[43 FR 21641, May 19, 1978, as amended at 69 FR 2281, Jan. 14, 2004]","(a) Commission records under this part will be made available to the public only in accordance with part 9 of this chapter. (b) Proprietary information provided under this part may be protected under Part 9 and § 2.390(b), (c), and (d) of this chapter." 10:10:2.0.1.1.20.8.133.1,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,H,Subpart H—Public Participation Procedures Concerning License Applications,,§ 110.80 Basis for hearings.,NRC,,,"[75 FR 44093, July 28, 2010]",The procedures in this part will constitute the exclusive basis for hearings on export and import license applications. 10:10:2.0.1.1.20.8.133.10,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,H,Subpart H—Public Participation Procedures Concerning License Applications,,§ 110.89 Filing and service.,NRC,,,"[72 FR 49154, Aug. 28, 2007]","(a) Hearing requests, intervention petitions, answers, replies and accompanying documents must be filed with the Commission by delivery or by mail to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff or via the E-Filing system, following the procedure set forth in 10 CFR 2.302. Filing by mail is complete upon deposit in the mail. Filing via the E-Filing system is completed by following the requirements described in 10 CFR 2.302(d). (b) All filing and Commission notices and orders must be served upon the applicant; the General Counsel, U.S. Nuclear Regulatory Commission, Washington, DC 20555; the Executive Secretary, Department of State, Washington, DC 20520; and participants if any. Hearing requests, intervention petitions, and answers and replies must be served by the person filing those pleadings. (c) Service is completed by: (1) Delivering the paper to the person; or leaving it in his office with someone in charge; or, if there is no one in charge, leaving it in a conspicuous place in the office; or, if he has no office or it is closed, leaving it at his usual place of residence with some occupant of suitable age and discretion; (2) Following the requirements for E-Filing in 10 CFR 2.305; (3) Depositing it in the United States mail, express mail, or expedited delivery service, properly stamped and addressed; or (4) Any other manner authorized by law, when service cannot be made as provided in paragraphs (c)(1) through (3) of this section. (d) Proof of service, stating the name and address of the person served and the manner and date of service, shall be shown, and may be made by: (1) Written acknowledgment of the person served or an authorized representative; (2) The certificate or affidavit of the person making the service; or (3) Following the requirements for E-Filing in 10 CFR 2.305. (e) The Commission may make special provisions for service when circumstances warrant." 10:10:2.0.1.1.20.8.133.11,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,H,Subpart H—Public Participation Procedures Concerning License Applications,,§ 110.90 Computation of time.,NRC,,,"[72 FR 49154, Aug. 28, 2007]","(a) In computing any period of time, the day of the act, event, or default after which the designated period of time begins to run is not included. The last day of the period so computed is included unless it is a Saturday or Sunday, a Federal legal holiday at the place where the action or event is to occur, or a day upon which, because of an emergency closure of the Federal government in Washington, DC, NRC Headquarters does not open for business, in which event the period runs until the end of the next day that is not a Saturday, Sunday, holiday, or emergency closure. (b) In time periods of less than seven (7) days, intermediate Saturdays, Sundays, Federal legal holidays, and emergency closures are not counted. (c) Whenever an action is required within a prescribed period by a document served under § 110.89 of this part, no additional time is added to the prescribed period except as set forth in 10 CFR 2.306(b). (d) To be considered timely, a document must be served: (1) By 5 p.m. Eastern Time for a document served in person or by expedited service; and (2) By 11:59 p.m. Eastern Time for a document served by the E-Filing system." 10:10:2.0.1.1.20.8.133.12,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,H,Subpart H—Public Participation Procedures Concerning License Applications,,§ 110.91 Commission consultations.,NRC,,,"[49 FR 47203, Dec. 3, 1984]","The Commission may consult at any time on a license application with the staff, the Executive Branch or other persons." 10:10:2.0.1.1.20.8.133.2,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,H,Subpart H—Public Participation Procedures Concerning License Applications,,§ 110.81 Written comments.,NRC,,,"[43 FR 21641, May 19, 1978, as amended at 62 FR 27495, May 20, 1997; 75 FR 44093, July 28, 2010]","(a) The Commission encourages written comments from the public regarding export and import license applications. The Commission will consider and, if appropriate, respond to these comments. (b) These comments should be submitted within 30 days after public notice of receipt of the application on the NRC Web site or in the Federal Register and addressed to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff. (c) The Commission will provide the applicant with a copy of the comments and, if appropriate, a reasonable opportunity for response." 10:10:2.0.1.1.20.8.133.3,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,H,Subpart H—Public Participation Procedures Concerning License Applications,,§ 110.82 Hearing request or intervention petition.,NRC,,,"[43 FR 21641, May 19, 1978, as amended at 49 FR 47202, Dec. 3, 1984; 60 FR 37565, July 21, 1995; 60 FR 55183, Oct. 30, 1995; 65 FR 70291, Nov. 22, 2000; 75 FR 44093, July 28, 2010]","(a) A person may request a hearing or petition for leave to intervene on a license application for an import or export requiring a specific license. (b) Hearing requests and intervention petitions must: (1) State the name, address and telephone number of the requestor or petitioner; (2) Set forth the issues sought to be raised; (3) Explain why a hearing or an intervention would be in the public interest and how a hearing or intervention would assist the Commission in making the determinations required by § 110.45. (4) Specify, when a person asserts that his interest may be affected, both the facts pertaining to his interest and how it may be affected, with particular reference to the factors in § 110.84. (c) Hearing requests and intervention petitions will be considered timely only if filed not later than: (1) 30 days after notice of receipt in the Federal Register, for those applications published in the Federal Register ; (2) 30 days after publication of notice on the NRC Web site at http://www.nrc.gov; (3) 30 days after notice of receipt in the Public Document Room; or (4) Such other time as may be provided by the Commission." 10:10:2.0.1.1.20.8.133.4,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,H,Subpart H—Public Participation Procedures Concerning License Applications,,§ 110.83 Answers and replies.,NRC,,,"[43 FR 21641, May 19, 1978, as amended at 49 FR 47203, Dec. 3, 1984]","(a) Unless otherwise specified by the Commission, an answer to a hearing request or intervention petition may be filed within 30 days after the request or petition has been served. (b) Unless otherwise specified by the Commission, a reply to an answer may be filed within 10 days after all timely answers have been filed. (c) Answers and replies should address the factors in § 110.84." 10:10:2.0.1.1.20.8.133.5,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,H,Subpart H—Public Participation Procedures Concerning License Applications,,§ 110.84 Commission action on a hearing request or intervention petition.,NRC,,,"[43 FR 21641, May 19, 1978, as amended at 49 FR 47203, Dec. 3, 1984]","(a) In an export licensing proceeding, or in an import licensing proceeding in which a hearing request or intervention petition does not assert or establish an interest which may be affected, the Commission will consider: (1) Whether a hearing would be in the public interest; and (2) Whether a hearing would assist the Commission in making the statutory determinations required by the Atomic Energy Act. (b) If a hearing request or intervention petition asserts an interest which may be affected, the Commission will consider: (1) The nature of the alleged interest; (2) How that interest relates to issuance or denial; and (3) The possible effect of any order on that interest, including whether the relief requested is within the Commission's authority, and, if so, whether granting relief would redress the alleged injury. (c) Untimely hearing requests or intervention petitions may be denied unless good cause for failure to file on time is established. In reviewing untimely requests or petitions, the Commission will also consider: (1) The availability of other means by which the requestor's or petitioner's interest, if any, will be protected or represented by other participants in a hearing; and (2) The extent to which the issues will be broadened or action on the application delayed. (d) Before granting or denying a hearing request or intervention petition, the Commission will review the Executive Branch's views on the license application and may request further information from the petitioner, requester, the Commission staff, the Executive Branch or others. (e) The Commission will deny a request or petition that pertains solely to matters outside its jurisdiction. (f) If an issue has been adequately explored in a previous licensing hearing conducted pursuant to this part, a request for a new hearing in connection with that issue will be denied unless: (1) A hearing request or intervention petition establishes that an interest may be affected; or (2) The Commission determines that changed circumstances or new information warrant a new hearing. (g) After consideration of the factors covered by paragraphs (a) through (f), the Commission will issue a notice or order granting or denying a hearing request or intervention petition. Upon the affirmative vote of two Commissioners a hearing will be ordered. A notice granting a hearing will be published in the Federal Register and will specify whether the hearing will be oral or consist of written comments. A denial notice will set forth the reasons for denial." 10:10:2.0.1.1.20.8.133.6,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,H,Subpart H—Public Participation Procedures Concerning License Applications,,§ 110.85 Notice of hearing consisting of written comments.,NRC,,,,"(a) A notice of hearing consisting of written comments will: (1) State the issues to be considered; (2) Provide the names and addresses of participants; (3) Specify the time limits for participants and others to submit written views and respond to any written comments; and (4) State any other instructions the Commission deems appropriate. (b) The Secretary will give notice of any hearing under this section and § 110.86 to any person who so requests." 10:10:2.0.1.1.20.8.133.7,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,H,Subpart H—Public Participation Procedures Concerning License Applications,,§ 110.86 Notice of oral hearing.,NRC,,,,"(a) A notice of oral hearing will: (1) State the time, place and issues to be considered; (2) Provide names and addresses of participants; (3) Designate the presiding officer; (4) Specify the time limit for participants and others to indicate whether they wish to present views; and (5) State any other instructions the Commission deems appropriate. (b) If the Commission is not the presiding officer, the notice of oral hearing will also state: (1) When the jurisdiction of the presiding officer commences and terminates; (2) The powers of the presiding officer; and (3) Instructions to the presiding officer to certify promptly the completed hearing record to the Commission without preliminary decision or findings, unless the Commission directs otherwise." 10:10:2.0.1.1.20.8.133.8,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,H,Subpart H—Public Participation Procedures Concerning License Applications,,§ 110.87 Conditions in a notice or order.,NRC,,,,"(a) A notice or order granting a hearing or permitting intervention may restrict irrelevant or duplicative testimony, or require common interests to be represented by a single spokesman. (b) If a participant's interests do not extend to all the issues in the hearing, the notice or order may limit his participation accordingly. (c) Unless authorized by the Commission, the granting of participation will not broaden the hearing issues." 10:10:2.0.1.1.20.8.133.9,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,H,Subpart H—Public Participation Procedures Concerning License Applications,,§ 110.88 Authority of the Secretary.,NRC,,,,"The Secretary is authorized to prescribe time schedules and other procedural arrangements, when not covered by this part, and rule on related procedural requests." 10:10:2.0.1.1.20.9.133.1,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,I,Subpart I—Hearings,,§ 110.100 Public hearings.,NRC,,,,Hearings under this part will be public unless the Commission directs otherwise. 10:10:2.0.1.1.20.9.133.10,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,I,Subpart I—Hearings,,§ 110.109 Motions and requests.,NRC,,,,"(a) Motions and requests shall be addressed to the presiding officer, and, if written, also filed with the Secretary and served on other participants. (b) Other participants may respond to the motion or request. Responses to written motions or requests shall be filed within 5 days after service. (c) When the Commission does not preside, in response to a motion or request, the presiding officer may refer a ruling or certify a question to the Commission for decision and notify the participants. (d) Unless otherwise ordered by the Commission, a motion or request, or the certification of a question or referral of a ruling, shall not stay or extend any aspect of the hearing." 10:10:2.0.1.1.20.9.133.11,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,I,Subpart I—Hearings,,§ 110.110 Default.,NRC,,,,"When a participant fails to act within a specified time, the presiding officer may consider him in default, issue an appropriate ruling and proceed without further notice to the defaulting participant." 10:10:2.0.1.1.20.9.133.12,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,I,Subpart I—Hearings,,§ 110.111 Waiver of a rule or regulation.,NRC,,,"[43 FR 21641, May 19, 1978, as amended at 62 FR 59277, Nov. 3, 1997]","(a) A participant may petition that a Commission rule or regulation be waived with respect to the license application under consideration. (b) The sole ground for a waiver shall be that, because of special circumstances concerning the subject of the hearing, application of a rule or regulation would not serve the purposes for which it was adopted. (c) Waiver petition shall specify why application of the rule or regulation would not serve the purposes for which it was adopted. (d) Other participants may, within 10 days, file a response to a waiver petition. (e) When the Commission does not preside, the presiding officer will certify the waiver petition to the Commission, which, in response, will grant or deny the waiver or direct any further proceedings. (f) Regardless of whether a waiver is granted or denied, a separate petition for rulemaking may be filed pursuant to subpart K of this part." 10:10:2.0.1.1.20.9.133.13,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,I,Subpart I—Hearings,,§ 110.112 Reporter and transcript for an oral hearing.,NRC,,,"[43 FR 21641, May 19, 1978, as amended at 64 FR 48955, Sept. 9, 1999; 75 FR 44093, July 28, 2010]","(a) A reporter designated by the Commission will record an oral hearing and prepare the official hearing transcript. (b) Except for any portions containing classified information, Restricted Data, Safeguards Information, proprietary information, or other sensitive unclassified information, transcripts will be made available at the NRC Web site, http://www.nrc.gov, and/or at the NRC Public Document Room. (c) Corrections of the official transcript may be made only as specified by the Secretary." 10:10:2.0.1.1.20.9.133.14,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,I,Subpart I—Hearings,,§ 110.113 Commission action.,NRC,,,"[43 FR 21641, May 19, 1978, as amended at 64 FR 48955, Sept. 9, 1999]","(a) Upon completion of a hearing, the Commission will issue a written opinion including its decision on the license application, the reasons for the decision and any dissenting views. (b) While the Commission will consider fully the hearing record, the licensing decision will be based on all relevant information, including information which might go beyond that in the hearing record. (c) If the Commission considers information not in the hearing record in reaching its licensing decision, the hearing participants will be informed and, if not classified or otherwise privileged, the information will be made available at the NRC Web site, http://www.nrc.gov, and furnished to the participants. (d) The Commission may issue a license before completion of a hearing if it finds that: (1) Prompt issuance is required in the public interest, particularly the common defense and security; and (2) A participant establishing that his interest may be affected has been provided a fair opportunity to present his views. (e) The Commission may: (1) Defer any hearing; (2) Consolidate applications for hearing; (3) Narrow or broaden the hearing issues; and (4) Take other action, as appropriate." 10:10:2.0.1.1.20.9.133.2,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,I,Subpart I—Hearings,,§ 110.101 Filing and service.,NRC,,,,Filing and service of hearing documents shall be pursuant to § 110.89. 10:10:2.0.1.1.20.9.133.3,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,I,Subpart I—Hearings,,§ 110.102 Hearing docket.,NRC,,,,"For each hearing, the Secretary will maintain a docket which will include the hearing transcript, exhibits and all papers filed or issued pursuant to the hearing." 10:10:2.0.1.1.20.9.133.4,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,I,Subpart I—Hearings,,§ 110.103 Acceptance of hearing documents.,NRC,,,"[72 FR 49154, Aug. 28, 2007]","(a) Each document filed or issued must be clearly legible and bear the docket number, license application number, and hearing title. (b) Each document shall be filed in one original and signed by the participant or their authorized representative, with their address and date of signature indicated. The signature is a representation that the document is submitted with full authority, the signer knows its contents, and that, to the best of his knowledge, the statements made in it are true. (c) Filings submitted using the E-filing system must follow the requirements outlined in 10 CFR 2.304. (d) A document not meeting the requirements of this section may be returned with an explanation for nonacceptance and, if so, will not be docketed." 10:10:2.0.1.1.20.9.133.5,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,I,Subpart I—Hearings,,§ 110.104 Presiding officer.,NRC,,,,"(a) The full Commission will ordinarily be the presiding officer at a hearing under this part. However, the Commission may provide in a hearing notice that one or more Commissioners, or any other person as provided by law, will preside. (b) A participant may submit a written motion for the disqualification of any person presiding. The motion shall be supported by affidavit setting forth the alleged grounds for disqualification. If the presiding officer does not grant the motion or the person does not disqualify himself, the Commission will decide the matter. (c) If any presiding officer designated by the Commission deems himself disqualified, he shall withdraw by notice on the record after notifying the Commission. (d) If a presiding officer becomes unavailable, the Commission will designate a replacement. (e) Any motion concerning the designation of a replacement presiding officer shall be made within 5 days after the designation. (f) Unless otherwise ordered by the Commission, the jurisdiction of a presiding officer other than the Commission commences as designated in the hearing notice and terminates upon certification of the hearing record to the Commission, or when the presiding officer is disqualified." 10:10:2.0.1.1.20.9.133.6,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,I,Subpart I—Hearings,,§ 110.105 Responsibility and power of the presiding officer in an oral hearing.,NRC,,,,"(a) The presiding officer in any oral hearing shall conduct a fair hearing, develop a record that will contribute to informed decisionmaking, and, within the framework of the Commission's orders, have the power necessary to achieve these ends, including the power to: (1) Take action to avoid unnecessary delay and maintain order; (2) Dispose of procedural requests; (3) Question participants and witnesses, and entertain suggestions as to questions which may be asked of participants and witnessess; (4) Order consolidation of participants; (5) Establish the order of presentation; (6) Hold conferences before or during the hearing; (7) Establish reasonable time limits; (8) Limit the number of witnesses; and (9) Strike or reject duplicative or irrelevant presentations. (b) Where the Commission itself does not preside: (1) The presiding officer may certify questions or refer rulings to the Commission for decision; (2) Any hearing order may be modified by the Commission; and (3) The presiding officer will certify the completed hearing record to the Commission, which may then issue its opinion on the hearing or provide that additional testimony be presented." 10:10:2.0.1.1.20.9.133.7,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,I,Subpart I—Hearings,,§ 110.106 Participation in a hearing.,NRC,,,,"(a) Unless otherwise limited by this part or by the Commission, participants in a hearing may submit: (1) Initial and concluding written statements of position on the issues; (2) Written questions to the presiding officer; and (3) Written responses and rebuttal testimony to the statements of other participants. (b) Participants in an oral hearing may also submit oral statements, questions, responses and rebuttal testimony. (c) A participant in an import licensing hearing establishing that his interest may be affected, may be accorded additional procedural rights under subpart G of part 2 with respect to resolution of domestic factual issues regarding the public health, safety and environment of the United States, and the protection of the United States public against domestic theft, diversion or sabotage, to the extent that such issues are separable from the nondomestic issues associated with the license application." 10:10:2.0.1.1.20.9.133.8,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,I,Subpart I—Hearings,,§ 110.107 Presentation of testimony in an oral hearing.,NRC,,,,"(a) All direct testimony in an oral hearing shall be filed no later than 7 days before the hearing or as otherwise ordered or allowed. (b) Written testimony will be received into evidence in exhibit form. (c) Unless proscribed under § 110.87, members of groups which are designated as participants may testify in their individual capacities. (d) Participants may present their own witnesses. (e) Testimony by the Commission and the Executive Branch will be presented only by persons officially designated for that purpose. (f) Participants and witnesses will be questioned orally or in writing and only by the presiding officer. Questions may be addressed to individuals or to panels of participants or witnesses. (g) The presiding officer may accept written testimony from a person unable to appear at the hearing, and may request him to respond to questions. (h) No subpoenas will be granted at the request of participants for attendance and testimony of participants or witnesses or the production of evidence." 10:10:2.0.1.1.20.9.133.9,10,Energy,I,,110,PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL,I,Subpart I—Hearings,,§ 110.108 Appearance in an oral hearing.,NRC,,,,"(a) A participant may appear in a hearing on his own behalf or be represented by an authorized representative. (b) A person appearing shall file a written notice stating his name, address and telephone number, and if an authorized representative, the basis of his eligibility and the name and address of the participant on whose behalf he appears. (c) A person may be excluded from a hearing for disorderly, dilatory or contemptuous conduct, provided he is informed of the grounds and given an opportunity to respond." 14:14:3.0.1.1.1.0.1.1,14,Aeronautics and Space,I,G,110,PART 110—GENERAL REQUIREMENTS,,,,§ 110.1 Applicability.,FAA,,,,This part governs all operations conducted under subchapter G of this chapter. 14:14:3.0.1.1.1.0.1.2,14,Aeronautics and Space,I,G,110,PART 110—GENERAL REQUIREMENTS,,,,§ 110.2 Definitions.,FAA,,,"[Docket FAA-2009-0140, 76 FR 7486, Feb. 10, 2011, as amended by Docket FAA-2018-0119, Amdt. 110-2, 83 FR 9172, Mar. 5, 2018; Docket FAA-2022-1563, Amdt. 110-3, 88 FR 48087, July 26, 2023]","For the purpose of this subchapter, the term— All-cargo operation means any operation for compensation or hire that is other than a passenger-carrying operation or, if passengers are carried, they are only those specified in § 121.583(a) or § 135.85 of this chapter. Commercial air tour means a flight conducted for compensation or hire in an airplane, powered-lift, or rotorcraft where a purpose of the flight is sightseeing. The FAA may consider the following factors in determining whether a flight is a commercial air tour: (1) Whether there was a holding out to the public of willingness to conduct a sightseeing flight for compensation or hire; (2) Whether the person offering the flight provided a narrative that referred to areas or points of interest on the surface below the route of the flight; (3) The area of operation; (4) How often the person offering the flight conducts such flights; (5) The route of flight; (6) The inclusion of sightseeing flights as part of any travel arrangement package; (7) Whether the flight in question would have been canceled based on poor visibility of the surface below the route of the flight; and (8) Any other factors that the FAA considers appropriate. Commuter operation means any scheduled operation conducted by any person operating one of the following types of aircraft with a frequency of operations of at least five round trips per week on at least one route between two or more points according to the published flight schedules: (1) Rotorcraft; or (2) Airplanes or powered-lift that: (i) Are not turbojet-powered; (ii) Have a maximum passenger-seat configuration of 9 seats or less, excluding each crewmember seat; and (iii) Have a maximum payload capacity of 7,500 pounds or less. Direct air carrier means a person who provides or offers to provide air transportation and who has control over the operational functions performed in providing that transportation. DOD commercial air carrier evaluator means a qualified Air Mobility Command, Survey and Analysis Office cockpit evaluator performing the duties specified in Public Law 99-661 when the evaluator is flying on an air carrier that is contracted or pursuing a contract with the U.S. Department of Defense (DOD). Domestic operation means any scheduled operation conducted by any person operating any aircraft described in paragraph (1) of this definition at locations described in paragraph (2) of this definition: (1) Airplanes or powered-lift that: (i) Are turbojet-powered; (ii) Have a passenger-seat configuration of more than 9 passenger seats, excluding each crewmember seat; or (iii) Have a payload capacity of more than 7,500 pounds. (2) Locations: (i) Between any points within the 48 contiguous States of the United States or the District of Columbia; or (ii) Operations solely within the 48 contiguous States of the United States or the District of Columbia; or (iii) Operations entirely within any State, territory, or possession of the United States; or (iv) When specifically authorized by the Administrator, operations between any point within the 48 contiguous States of the United States or the District of Columbia and any specifically authorized point located outside the 48 contiguous States of the United States or the District of Columbia. Empty weight means the weight of the airframe, engines, propellers, rotors, and fixed equipment. Empty weight excludes the weight of the crew and payload, but includes the weight of all fixed ballast, unusable fuel supply, undrainable oil, total quantity of engine coolant, and total quantity of hydraulic fluid. Flag operation means any scheduled operation conducted by any person operating any aircraft described in paragraph (1) of this definition at locations described in paragraph (2) of this definition: (1) Airplanes or powered-lift that: (i) Are turbojet-powered; (ii) Have a passenger-seat configuration of more than 9 passenger seats, excluding each crewmember seat; or (iii) Have a payload capacity of more than 7,500 pounds. (2) Locations: (i) Between any point within the State of Alaska or the State of Hawaii or any territory or possession of the United States and any point outside the State of Alaska or the State of Hawaii or any territory or possession of the United States, respectively; or (ii) Between any point within the 48 contiguous States of the United States or the District of Columbia and any point outside the 48 contiguous States of the United States and the District of Columbia; or (iii) Between any point outside the U.S. and another point outside the U.S. Justifiable aircraft equipment means any equipment necessary for the operation of the aircraft. It does not include equipment or ballast specifically installed, permanently or otherwise, for the purpose of altering the empty weight of an aircraft to meet the maximum payload capacity. Kind of operation means one of the various operations a certificate holder is authorized to conduct, as specified in its operations specifications, i.e., domestic, flag, supplemental, commuter, or on-demand operations. Maximum payload capacity means: (1) For an aircraft for which a maximum zero fuel weight is prescribed in FAA technical specifications, the maximum zero fuel weight, less empty weight, less all justifiable aircraft equipment, and less the operating load (consisting of minimum flightcrew, foods and beverages, and supplies and equipment related to foods and beverages, but not including disposable fuel or oil). (2) For all other aircraft, the maximum certificated takeoff weight of an aircraft, less the empty weight, less all justifiable aircraft equipment, and less the operating load (consisting of minimum fuel load, oil, and flightcrew). The allowance for the weight of the crew, oil, and fuel is as follows: (i) Crew—for each crewmember required by the Federal Aviation Regulations— (A) For male flightcrew members—180 pounds. (B) For female flightcrew members—140 pounds. (C) For male flight attendants—180 pounds. (D) For female flight attendants—130 pounds. (E) For flight attendants not identified by gender—140 pounds. (ii) Oil—350 pounds or the oil capacity as specified on the Type Certificate Data Sheet. (iii) Fuel—the minimum weight of fuel required by the applicable Federal Aviation Regulations for a flight between domestic points 174 nautical miles apart under VFR weather conditions that does not involve extended overwater operations. Maximum zero fuel weight means the maximum permissible weight of an aircraft with no disposable fuel or oil. The zero fuel weight figure may be found in either the aircraft type certificate data sheet, the approved Aircraft Flight Manual, or both. Noncommon carriage means an aircraft operation for compensation or hire that does not involve a holding out to others. On-demand operation means any operation for compensation or hire that is one of the following: (1) Passenger-carrying operations conducted as a public charter under part 380 of this chapter or any operations in which the departure time, departure location, and arrival location are specifically negotiated with the customer or the customer's representative that are any of the following types of operations: (i) Common carriage operations conducted with airplanes or powered-lift, including any that are turbojet-powered, having a passenger-seat configuration of 30 seats or fewer, excluding each crewmember seat, and a payload capacity of 7,500 pounds or less. The operations described in this paragraph do not include operations using a specific airplane or powered-lift that is also used in domestic or flag operations and that is so listed in the operations specifications as required by § 119.49(a)(4) of this chapter for those operations are considered supplemental operations; (ii) Noncommon or private carriage operations conducted with airplanes or powered-lift having a passenger-seat configuration of less than 20 seats, excluding each crewmember seat, and a payload capacity of less than 6,000 pounds; or (iii) Any rotorcraft operation. (2) Scheduled passenger-carrying operations conducted with one of the following types of aircraft, other than turbojet-powered aircraft, with a frequency of operations of less than five round trips per week on at least one route between two or more points according to the published flight schedules: (i) Airplanes or powered-lift having a maximum passenger-seat configuration of 9 seats or less, excluding each crewmember seat, and a maximum payload capacity of 7,500 pounds or less; or (ii) Rotorcraft. (3) All-cargo operations conducted with airplanes or powered-lift having a payload capacity of 7,500 pounds or less, or with rotorcraft. Passenger-carrying operation means any aircraft operation carrying any person, unless the only persons on the aircraft are those identified in §§ 121.583(a) or 135.85 of this chapter, as applicable. An aircraft used in a passenger-carrying operation may also carry cargo or mail in addition to passengers. Principal base of operations means the primary operating location of a certificate holder as established by the certificate holder. Provisional airport means an airport approved by the Administrator for use by a certificate holder for the purpose of providing service to a community when the regular airport used by the certificate holder is not available. Regular airport means an airport used by a certificate holder in scheduled operations and listed in its operations specifications. Scheduled operation means any common carriage passenger-carrying operation for compensation or hire conducted by an air carrier or commercial operator for which the certificate holder or its representative offers in advance the departure location, departure time, and arrival location. It does not include any passenger-carrying operation that is conducted as a public charter operation under part 380 of this chapter. Supplemental operation means any common carriage operation for compensation or hire conducted with any aircraft described in paragraph (1) of this definition that is a type of operation described in paragraph (2) of this definition: (1) Airplanes or powered-lift that: (i) Have a passenger-seat configuration of more than 30 seats, excluding each crewmember seat. (ii) Have a payload capacity of more than 7,500 pounds. (iii) Are propeller-powered and: (A) Have a passenger-seat configuration of more than 9 seats and less than 31 seats, excluding each crewmember seat; and (B) Are used in domestic or flag operations but are so listed in the operations specifications as required by § 119.49(a)(4) of this chapter for such operations. (iv) Are turbojet-powered and: (A) Have a passenger seat configuration of 1 or more but less than 31 seats, excluding each crewmember seat; and (B) Are used in domestic or flag operations and are so listed in the operations specifications as required by § 119.49(a)(4) of this chapter for such operations. (2) Types of operation: (i) Operations for which the departure time, departure location, and arrival location are specifically negotiated with the customer or the customer's representative. (ii) All-cargo operations. (iii) Passenger-carrying public charter operations conducted under part 380 of this chapter. Wet lease means any leasing arrangement whereby a person agrees to provide an entire aircraft and at least one crewmember. A wet lease does not include a code-sharing arrangement. When common carriage is not involved or operations not involving common carriage means any of the following: (1) Noncommon carriage. (2) Operations in which persons or cargo are transported without compensation or hire. (3) Operations not involving the transportation of persons or cargo. (4) Private carriage. Years in service means the calendar time elapsed since an aircraft was issued its first U.S. or first foreign airworthiness certificate." 21:21:2.0.1.1.10.1.1.1,21,Food and Drugs,I,B,110,"PART 110—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD",A,Subpart A—General Provisions,,§ 110.3 Definitions.,FDA,,,,"The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) are applicable to such terms when used in this part. The following definitions shall also apply: (a) Acid foods or acidified foods means foods that have an equilibrium pH of 4.6 or below. (b) Adequate means that which is needed to accomplish the intended purpose in keeping with good public health practice. (c) Batter means a semifluid substance, usually composed of flour and other ingredients, into which principal components of food are dipped or with which they are coated, or which may be used directly to form bakery foods. (d) Blanching, except for tree nuts and peanuts, means a prepackaging heat treatment of foodstuffs for a sufficient time and at a sufficient temperature to partially or completely inactivate the naturally occurring enzymes and to effect other physical or biochemical changes in the food. (e) Critical control point means a point in a food process where there is a high probability that improper control may cause, allow, or contribute to a hazard or to filth in the final food or decomposition of the final food. (f) Food means food as defined in section 201(f) of the act and includes raw materials and ingredients. (g) Food-contact surfaces are those surfaces that contact human food and those surfaces from which drainage onto the food or onto surfaces that contact the food ordinarily occurs during the normal course of operations. “Food-contact surfaces” includes utensils and food-contact surfaces of equipment. (h) Lot means the food produced during a period of time indicated by a specific code. (i) Microorganisms means yeasts, molds, bacteria, and viruses and includes, but is not limited to, species having public health significance. The term “undesirable microorganisms” includes those microorganisms that are of public health significance, that subject food to decomposition, that indicate that food is contaminated with filth, or that otherwise may cause food to be adulterated within the meaning of the act. Occasionally in these regulations, FDA used the adjective “microbial” instead of using an adjectival phrase containing the word microorganism. (j) Pest refers to any objectionable animals or insects including, but not limited to, birds, rodents, flies, and larvae. (k) Plant means the building or facility or parts thereof, used for or in connection with the manufacturing, packaging, labeling, or holding of human food. (l) Quality control operation means a planned and systematic procedure for taking all actions necessary to prevent food from being adulterated within the meaning of the act. (m) Rework means clean, unadulterated food that has been removed from processing for reasons other than insanitary conditions or that has been successfully reconditioned by reprocessing and that is suitable for use as food. (n) Safe-moisture level is a level of moisture low enough to prevent the growth of undesirable microorganisms in the finished product under the intended conditions of manufacturing, storage, and distribution. The maximum safe moisture level for a food is based on its water activity (a w ). An a w will be considered safe for a food if adequate data are available that demonstrate that the food at or below the given a w will not support the growth of undesirable microorganisms. (o) Sanitize means to adequately treat food-contact surfaces by a process that is effective in destroying vegetative cells of microorganisms of public health significance, and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer. (p) Shall is used to state mandatory requirements. (q) Should is used to state recommended or advisory procedures or identify recommended equipment. (r) Water activity (a w ) is a measure of the free moisture in a food and is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature." 21:21:2.0.1.1.10.1.1.2,21,Food and Drugs,I,B,110,"PART 110—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD",A,Subpart A—General Provisions,,§ 110.5 Current good manufacturing practice.,FDA,,,,"(a) The criteria and definitions in this part shall apply in determining whether a food is adulterated (1) within the meaning of section 402(a)(3) of the act in that the food has been manufactured under such conditions that it is unfit for food; or (2) within the meaning of section 402(a)(4) of the act in that the food has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. The criteria and definitions in this part also apply in determining whether a food is in violation of section 361 of the Public Health Service Act (42 U.S.C. 264). (b) Food covered by specific current good manufacturing practice regulations also is subject to the requirements of those regulations." 21:21:2.0.1.1.10.1.1.3,21,Food and Drugs,I,B,110,"PART 110—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD",A,Subpart A—General Provisions,,§ 110.10 Personnel.,FDA,,,"[51 FR 22475, June 19, 1986, as amended at 54 FR 24892, June 12, 1989]","The plant management shall take all reasonable measures and precautions to ensure the following: (a) Disease control. Any person who, by medical examination or supervisory observation, is shown to have, or appears to have, an illness, open lesion, including boils, sores, or infected wounds, or any other abnormal source of microbial contamination by which there is a reasonable possibility of food, food-contact surfaces, or food-packaging materials becoming contaminated, shall be excluded from any operations which may be expected to result in such contamination until the condition is corrected. Personnel shall be instructed to report such health conditions to their supervisors. (b) Cleanliness. All persons working in direct contact with food, food-contact surfaces, and food-packaging materials shall conform to hygienic practices while on duty to the extent necessary to protect against contamination of food. The methods for maintaining cleanliness include, but are not limited to: (1) Wearing outer garments suitable to the operation in a manner that protects against the contamination of food, food-contact surfaces, or food-packaging materials. (2) Maintaining adequate personal cleanliness. (3) Washing hands thoroughly (and sanitizing if necessary to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated. (4) Removing all unsecured jewelry and other objects that might fall into food, equipment, or containers, and removing hand jewelry that cannot be adequately sanitized during periods in which food is manipulated by hand. If such hand jewelry cannot be removed, it may be covered by material which can be maintained in an intact, clean, and sanitary condition and which effectively protects against the contamination by these objects of the food, food-contact surfaces, or food-packaging materials. (5) Maintaining gloves, if they are used in food handling, in an intact, clean, and sanitary condition. The gloves should be of an impermeable material. (6) Wearing, where appropriate, in an effective manner, hair nets, headbands, caps, beard covers, or other effective hair restraints. (7) Storing clothing or other personal belongings in areas other than where food is exposed or where equipment or utensils are washed. (8) Confining the following to areas other than where food may be exposed or where equipment or utensils are washed: eating food, chewing gum, drinking beverages, or using tobacco. (9) Taking any other necessary precautions to protect against contamination of food, food-contact surfaces, or food-packaging materials with microorganisms or foreign substances including, but not limited to, perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin. (c) Education and training. Personnel responsible for identifying sanitation failures or food contamination should have a background of education or experience, or a combination thereof, to provide a level of competency necessary for production of clean and safe food. Food handlers and supervisors should receive appropriate training in proper food handling techniques and food-protection principles and should be informed of the danger of poor personal hygiene and insanitary practices. (d) Supervision. Responsibility for assuring compliance by all personnel with all requirements of this part shall be clearly assigned to competent supervisory personnel." 21:21:2.0.1.1.10.1.1.4,21,Food and Drugs,I,B,110,"PART 110—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD",A,Subpart A—General Provisions,,§ 110.19 Exclusions.,FDA,,,,"(a) The following operations are not subject to this part: Establishments engaged solely in the harvesting, storage, or distribution of one or more “raw agricultural commodities,” as defined in section 201(r) of the act, which are ordinarily cleaned, prepared, treated, or otherwise processed before being marketed to the consuming public. (b) FDA, however, will issue special regulations if it is necessary to cover these excluded operations." 21:21:2.0.1.1.10.2.1.1,21,Food and Drugs,I,B,110,"PART 110—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD",B,Subpart B—Buildings and Facilities,,§ 110.20 Plant and grounds.,FDA,,,,"(a) Grounds. The grounds about a food plant under the control of the operator shall be kept in a condition that will protect against the contamination of food. The methods for adequate maintenance of grounds include, but are not limited to: (1) Properly storing equipment, removing litter and waste, and cutting weeds or grass within the immediate vicinity of the plant buildings or structures that may constitute an attractant, breeding place, or harborage for pests. (2) Maintaining roads, yards, and parking lots so that they do not constitute a source of contamination in areas where food is exposed. (3) Adequately draining areas that may contribute contamination to food by seepage, foot-borne filth, or providing a breeding place for pests. (4) Operating systems for waste treatment and disposal in an adequate manner so that they do not constitute a source of contamination in areas where food is exposed. If the plant grounds are bordered by grounds not under the operator's control and not maintained in the manner described in paragraph (a) (1) through (3) of this section, care shall be exercised in the plant by inspection, extermination, or other means to exclude pests, dirt, and filth that may be a source of food contamination. (b) Plant construction and design. Plant buildings and structures shall be suitable in size, construction, and design to facilitate maintenance and sanitary operations for food-manufacturing purposes. The plant and facilities shall: (1) Provide sufficient space for such placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food. (2) Permit the taking of proper precautions to reduce the potential for contamination of food, food-contact surfaces, or food-packaging materials with microorganisms, chemicals, filth, or other extraneous material. The potential for contamination may be reduced by adequate food safety controls and operating practices or effective design, including the separation of operations in which contamination is likely to occur, by one or more of the following means: location, time, partition, air flow, enclosed systems, or other effective means. (3) Permit the taking of proper precautions to protect food in outdoor bulk fermentation vessels by any effective means, including: (i) Using protective coverings. (ii) Controlling areas over and around the vessels to eliminate harborages for pests. (iii) Checking on a regular basis for pests and pest infestation. (iv) Skimming the fermentation vessels, as necessary. (4) Be constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair; that drip or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials; and that aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating food or food-contact surfaces with clothing or personal contact. (5) Provide adequate lighting in hand-washing areas, dressing and locker rooms, and toilet rooms and in all areas where food is examined, processed, or stored and where equipment or utensils are cleaned; and provide safety-type light bulbs, fixtures, skylights, or other glass suspended over exposed food in any step of preparation or otherwise protect against food contamination in case of glass breakage. (6) Provide adequate ventilation or control equipment to minimize odors and vapors (including steam and noxious fumes) in areas where they may contaminate food; and locate and operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food, food-packaging materials, and food-contact surfaces. (7) Provide, where necessary, adequate screening or other protection against pests." 21:21:2.0.1.1.10.2.1.2,21,Food and Drugs,I,B,110,"PART 110—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD",B,Subpart B—Buildings and Facilities,,§ 110.35 Sanitary operations.,FDA,,,"[51 FR 22475, June 19, 1986, as amended at 54 FR 24892, June 12, 1989]","(a) General maintenance. Buildings, fixtures, and other physical facilities of the plant shall be maintained in a sanitary condition and shall be kept in repair sufficient to prevent food from becoming adulterated within the meaning of the act. Cleaning and sanitizing of utensils and equipment shall be conducted in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials. (b) Substances used in cleaning and sanitizing; storage of toxic materials. (1) Cleaning compounds and sanitizing agents used in cleaning and sanitizing procedures shall be free from undesirable microorganisms and shall be safe and adequate under the conditions of use. Compliance with this requirement may be verified by any effective means including purchase of these substances under a supplier's guarantee or certification, or examination of these substances for contamination. Only the following toxic materials may be used or stored in a plant where food is processed or exposed: (i) Those required to maintain clean and sanitary conditions; (ii) Those necessary for use in laboratory testing procedures; (iii) Those necessary for plant and equipment maintenance and operation; and (iv) Those necessary for use in the plant's operations. (2) Toxic cleaning compounds, sanitizing agents, and pesticide chemicals shall be identified, held, and stored in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials. All relevant regulations promulgated by other Federal, State, and local government agencies for the application, use, or holding of these products should be followed. (c) Pest control. No pests shall be allowed in any area of a food plant. Guard or guide dogs may be allowed in some areas of a plant if the presence of the dogs is unlikely to result in contamination of food, food-contact surfaces, or food-packaging materials. Effective measures shall be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. The use of insecticides or rodenticides is permitted only under precautions and restrictions that will protect against the contamination of food, food-contact surfaces, and food-packaging materials. (d) Sanitation of food-contact surfaces. All food-contact surfaces, including utensils and food-contact surfaces of equipment, shall be cleaned as frequently as necessary to protect against contamination of food. (1) Food-contact surfaces used for manufacturing or holding low-moisture food shall be in a dry, sanitary condition at the time of use. When the surfaces are wet-cleaned, they shall, when necessary, be sanitized and thoroughly dried before subsequent use. (2) In wet processing, when cleaning is necessary to protect against the introduction of microorganisms into food, all food-contact surfaces shall be cleaned and sanitized before use and after any interruption during which the food-contact surfaces may have become contaminated. Where equipment and utensils are used in a continuous production operation, the utensils and food-contact surfaces of the equipment shall be cleaned and sanitized as necessary. (3) Non-food-contact surfaces of equipment used in the operation of food plants should be cleaned as frequently as necessary to protect against contamination of food. (4) Single-service articles (such as utensils intended for one-time use, paper cups, and paper towels) should be stored in appropriate containers and shall be handled, dispensed, used, and disposed of in a manner that protects against contamination of food or food-contact surfaces. (5) Sanitizing agents shall be adequate and safe under conditions of use. Any facility, procedure, or machine is acceptable for cleaning and sanitizing equipment and utensils if it is established that the facility, procedure, or machine will routinely render equipment and utensils clean and provide adequate cleaning and sanitizing treatment. (e) Storage and handling of cleaned portable equipment and utensils. Cleaned and sanitized portable equipment with food-contact surfaces and utensils should be stored in a location and manner that protects food-contact surfaces from contamination." 21:21:2.0.1.1.10.2.1.3,21,Food and Drugs,I,B,110,"PART 110—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD",B,Subpart B—Buildings and Facilities,,§ 110.37 Sanitary facilities and controls.,FDA,,,,"Each plant shall be equipped with adequate sanitary facilities and accommodations including, but not limited to: (a) Water supply. The water supply shall be sufficient for the operations intended and shall be derived from an adequate source. Any water that contacts food or food-contact surfaces shall be safe and of adequate sanitary quality. Running water at a suitable temperature, and under pressure as needed, shall be provided in all areas where required for the processing of food, for the cleaning of equipment, utensils, and food-packaging materials, or for employee sanitary facilities. (b) Plumbing. Plumbing shall be of adequate size and design and adequately installed and maintained to: (1) Carry sufficient quantities of water to required locations throughout the plant. (2) Properly convey sewage and liquid disposable waste from the plant. (3) Avoid constituting a source of contamination to food, water supplies, equipment, or utensils or creating an unsanitary condition. (4) Provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor. (5) Provide that there is not backflow from, or cross-connection between, piping systems that discharge waste water or sewage and piping systems that carry water for food or food manufacturing. (c) Sewage disposal. Sewage disposal shall be made into an adequate sewerage system or disposed of through other adequate means. (d) Toilet facilities. Each plant shall provide its employees with adequate, readily accessible toilet facilities. Compliance with this requirement may be accomplished by: (1) Maintaining the facilities in a sanitary condition. (2) Keeping the facilities in good repair at all times. (3) Providing self-closing doors. (4) Providing doors that do not open into areas where food is exposed to airborne contamination, except where alternate means have been taken to protect against such contamination (such as double doors or positive air-flow systems). (e) Hand-washing facilities. Hand-washing facilities shall be adequate and convenient and be furnished with running water at a suitable temperature. Compliance with this requirement may be accomplished by providing: (1) Hand-washing and, where appropriate, hand-sanitizing facilities at each location in the plant where good sanitary practices require employees to wash and/or sanitize their hands. (2) Effective hand-cleaning and sanitizing preparations. (3) Sanitary towel service or suitable drying devices. (4) Devices or fixtures, such as water control valves, so designed and constructed to protect against recontamination of clean, sanitized hands. (5) Readily understandable signs directing employees handling unprotected food, unprotected food-packaging materials, of food-contact surfaces to wash and, where appropriate, sanitize their hands before they start work, after each absence from post of duty, and when their hands may have become soiled or contaminated. These signs may be posted in the processing room(s) and in all other areas where employees may handle such food, materials, or surfaces. (6) Refuse receptacles that are constructed and maintained in a manner that protects against contamination of food. (f) Rubbish and offal disposal. Rubbish and any offal shall be so conveyed, stored, and disposed of as to minimize the development of odor, minimize the potential for the waste becoming an attractant and harborage or breeding place for pests, and protect against contamination of food, food-contact surfaces, water supplies, and ground surfaces."