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| 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 |
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| 10:10:2.0.1.1.6.1.76.1 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | A | Subpart A—General Provisions | § 60.1 Purpose and scope. | NRC | [69 FR 2279, Jan. 14, 2004] | This part prescribes rules governing the licensing (including issuance of a construction authorization) of the U.S. Department of Energy to receive and possess source, special nuclear, and byproduct material at a geologic repository operations area sited, constructed, or operated in accordance with the Nuclear Waste Policy Act of 1982, as amended. This part does not apply to any activity licensed under another part of this chapter. This part does not apply to the licensing of the U.S. Department of Energy to receive and possess source, special nuclear, and byproduct material at a geologic repository operations area sited, constructed, or operated at Yucca Mountain, Nevada, in accordance with the Nuclear Waste Policy Act of 1992, as amended, and the Energy Policy Act of 1992, subject to part 63 of this chapter. 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 § 60.11. | ||||
| 10:10:2.0.1.1.6.1.76.10 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | A | Subpart A—General Provisions | § 60.10 Completeness and accuracy of information. | NRC | [52 FR 49372, Dec. 31, 1987] | (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 applicant or licensee 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 only 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. | ||||
| 10:10:2.0.1.1.6.1.76.11 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | A | Subpart A—General Provisions | § 60.11 Deliberate misconduct. | NRC | [63 FR 1898, 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. | ||||
| 10:10:2.0.1.1.6.1.76.2 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | A | Subpart A—General Provisions | § 60.2 Definitions. | NRC | [48 FR 28217, June 21, 1983, as amended at 50 FR 29647, July 22, 1985; 51 FR 27162, July 30, 1986; 53 FR 43421, Oct. 27, 1988; 61 FR 64267, Dec. 4, 1996; 64 FR 48953, Sept. 9, 1999; 69 FR 76601, Dec. 22, 2004; 76 FR 72086, Nov. 22, 2011] | As used in this part: Accessible environment means: (1) The atmosphere; (2) The land surface; (3) Surface water; (4) Oceans; and (5) The portion of the lithosphere that is outside the postclosure controlled area. Affected Indian Tribe means any Indian Tribe (1) within whose reservation boundaries a repository for high-level radioactive waste or spent fuel is proposed to be located; or (2) whose Federally defined possessory or usage rights to other lands outside of the reservation's boundaries arising out of Congressionally ratified treaties or other Federal law may be substantially and adversely affected by the locating of such a facility; Provided, That the Secretary of the Interior finds, upon the petition of the appropriate governmental officials of the Tribe, that such effects are both substantial and adverse to the Tribe. Anticipated processes and events means those natural processes and events that are reasonably likely to occur during the period the intended performance objective must be achieved. To the extent reasonable in the light of the geologic record, it shall be assumed that those processes operating in the geologic setting during the Quaternary Period continue to operate but with the perturbations caused by the presence of emplaced radioactive waste superimposed thereon. Barrier means any material or structure that prevents or substantially delays movement of water or radionuclides. Candidate area means a geologic and hydrologic system within which a geologic repository may be located. Commencement of construction means clearing of land, surface or subsurface excavation, or other substantial action that would adversely affect the environment of a site, but does not include changes desirable for the temporary use of the land for public recreational uses, site characterization activities, other preconstruction monitoring and investigation necessary to establish background information related to the suitability of a site or to the protection of environmental values, or procurement … | ||||
| 10:10:2.0.1.1.6.1.76.3 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | A | Subpart A—General Provisions | § 60.3 License required. | NRC | (a) DOE shall not receive or possess source, special nuclear, or byproduct material at a geologic repository operations area except as authorized by a license issued by the Commission pursuant to this part. (b) DOE shall not commence construction of a geologic repository operations area unless it has filed an application with the Commission and has obtained construction authorization as provided in this part. Failure to comply with this requirement shall be grounds for denial of a license. | |||||
| 10:10:2.0.1.1.6.1.76.4 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | A | Subpart A—General Provisions | § 60.4 Communications and records. | NRC | [53 FR 19251, May 27, 1988, as amended at 53 FR 43421, Oct. 27, 1988; 68 FR 58813, Oct. 10, 2003; 74 FR 62682, Dec. 1, 2009; 80 FR 74980, Dec. 1, 2015] | (a) Except where otherwise specified, all communications and reports concerning the regulations in this part and applications filed under them should be sent by mail addressed: ATTN: Document Control Desk: Director, Office of Nuclear Material Safety and Safeguards, 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. (b) Each record required by this part must be legible throughout the retention period specified by each Commission regulation. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. 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. | ||||
| 10:10:2.0.1.1.6.1.76.5 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | A | Subpart A—General Provisions | § 60.5 Interpretations. | NRC | [46 FR 13980, Feb. 25, 1981, as amended at 90 FR 55631, Dec. 3, 2025] | Except as specifically authorized by the Commission, in writing, no interpretation of the meaning of the regulations in this part by any officer or employee of the Commission other than a written interpretation by the General Counsel will be considered 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. | ||||
| 10:10:2.0.1.1.6.1.76.6 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | A | Subpart A—General Provisions | § 60.6 Exemptions. | NRC | The Commission may, upon application by DOE, any interested person, or upon its own initiative, grant such exemptions from the requirements of the regulations in this part as it determines are authorized by law, will not endanger life or property or the common defense and security, and are otherwise in the public interest. | |||||
| 10:10:2.0.1.1.6.1.76.7 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | A | Subpart A—General Provisions | § 60.7 License not required for certain preliminary activities. | NRC | The requirement for a license set forth in § 60.3(a) of this part is not applicable to the extent that DOE receives and possesses source, special nuclear, and byproduct material at a geologic repository: (a) For purposes of site characterization; or (b) For use, during site characterization or construction, as components of radiographic, radiation monitoring, or similar equipment or instrumentation. | |||||
| 10:10:2.0.1.1.6.1.76.8 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | A | Subpart A—General Provisions | § 60.8 Information collection requirements: Approval. | NRC | [61 FR 64268, Dec. 4, 1996, as amended at 62 FR 52188, Oct. 6, 1997; 73 FR 78605, Dec. 23, 2008; 85 FR 65663, 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 number 3150-0127. (b) The approved information collection requirements contained in this part appear in §§ 60.47, 60.62, 60.63, 60.65. (c) In § 60.47, IAEA Design Information Questionnaire forms are approved under control number 3150-0056, and DOC/NRC Forms AP-1, AP-A, and associated forms are approved under control number 0694-0135. | ||||
| 10:10:2.0.1.1.6.1.76.9 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | A | Subpart A—General Provisions | § 60.9 Employee protection. | NRC | [58 FR 52411, Oct. 8, 1993, as amended at 60 FR 24552, May 9, 1995; 61 FR 6765, Feb. 22, 1996; 68 FR 58813, Oct. 10, 2003; 72 FR 63974, Nov. 14, 2007; 73 FR 30459, May 28, 2008; 79 FR 66605, Nov. 10, 2014] | (a) Discrimination by a Commission licensee, an applicant for a Commission license, or a contractor or subcontractor of a Commission licensee or applicant against an employee for engaging in certain protected activities is prohibited. Discrimination includes discharge and other actions that relate to compensation, terms, conditions, or privileges of employment. The protected activities are established in section 211 of the Energy Reorganization Act of 1974, as amended, and in general are related to the administration or enforcement of a requirement imposed under the Atomic Energy Act or the Energy Reorganization Act. (1) The protected activities include but are not limited to: (i) Providing the Commission or his or her employer information about alleged violations of either of the statutes named in paragraph (a) introductory text of this section or possible violations of requirements imposed under either of those statutes; (ii) Refusing to engage in any practice made unlawful under either of the statutes named in paragraph (a) introductory text or under these requirements if the employee has identified the alleged illegality to the employer; (iii) Requesting the Commission to institute action against his or her employer for the administration or enforcement of these requirements; (iv) Testifying in any Commission proceeding, or before Congress, or at any Federal or State proceeding regarding any provision (or proposed provision) of either of the statutes named in paragraph (a) introductory text. (v) Assisting or participating in, or is about to assist or participate in, these activities. (2) These activities are protected even if no formal proceeding is actually initiated as a result of the employee assistance or participation. (3) This section has no application to any employee alleging discrimination prohibited by this section who, acting without direction from his or her employer (or the employer's agent), deliberately causes a violation of any requirement of the Energy Reorganization Act of 1974, as a… | ||||
| 10:10:2.0.1.1.6.10.89.1 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | J | Subpart J—Violations | § 60.181 Violations. | NRC | [57 FR 55076, Nov. 24, 1992] | (a) The Commission may obtain an injunction or other court order to prevent a violation of the provisions of— (1) The Atomic Energy Act of 1954, as amended; (2) Title II of the Energy Reorganization Act of 1974, as amended; or (3) A regulation or order issued 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 of 1954, as amended; (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 of 1954, as amended. | ||||
| 10:10:2.0.1.1.6.10.89.2 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | J | Subpart J—Violations | § 60.183 Criminal penalties. | NRC | [57 FR 55076, Nov. 24, 1992] | (a) Section 223 of the Atomic Energy Act of 1954, as amended, 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 Act. For purposes of section 223, all the regulations in part 60 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 60 that are not issued under sections 161b, 161i, or 161o for the purposes of section 223 are as follows: §§ 60.1, 60.2, 60.3, 60.5, 60.6, 60.7, 60.8, 60.15, 60.16, 60.17, 60.18, 60.21, 60.22, 60.23, 60.24, 60.31, 60.32, 60.33, 60.41, 60.42, 60.43, 60.44, 60.45, 60.46, 60.51, 60.52, 60.61, 60.62, 60.63, 60.64, 60.65, 60.101, 60.102, 60.111, 60.112, 60.113, 60.121, 60.122, 60.130, 60.131, 60.132, 60.133, 60.134, 60.135, 60.137, 60.140, 60.141, 60.142, 60.143, 60.150, 60.151, 60.152, 60.162, 60.181, and 60.183. | ||||
| 10:10:2.0.1.1.6.2.76.1 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | B | Subpart B—Licenses | § 60.15 Site characterization. | NRC | [46 FR 13980, Feb. 25, 1981, as amended at 48 FR 28219, June 21, 1983. Redesignated and amended at 51 FR 27162, July 30, 1986; 54 FR 27871, July 3, 1989] | (a) Prior to submittal of an application for a license to be issued under this part DOE shall conduct a program of site characterization with respect to the site to be described in such application. (b) Unless the Commission determines with respect to the site described in the application that it is not necessary, site characterization shall include a program of in situ exploration and testing at the depths that wastes would be emplaced. (c) The program of site characterization shall be conducted in accordance with the following: (1) Investigations to obtain the required information shall be conducted in such a manner as to limit adverse effects on the long-term performance of the geologic repository to the extent practical. (2) The number of exploratory boreholes and shafts shall be limited to the extent practical consistent with obtaining the information needed for site characterization. (3) To the extent practical, exploratory boreholes and shafts in the geologic repository operations area shall be located where shafts are planned for underground facility construction and operation or where large unexcavated pillars are planned. (4) Subsurface exploratory drilling, excavation, and in situ testing before and during construction shall be planned and coordinated with geologic repository operations area design and construction. | ||||
| 10:10:2.0.1.1.6.2.76.2 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | B | Subpart B—Licenses | § 60.16 Site characterization plan required. | NRC | [51 FR 27162, July 30, 1986] | Before proceeding to sink shafts at any area which has been approved by the President for site characterization, DOE shall submit to the Director, for review and comment, a site characterization plan for such area. DOE shall defer the sinking of such shafts until such time as there has been an opportunity for Commission comments thereon to have been solicited and considered by DOE. | ||||
| 10:10:2.0.1.1.6.2.76.3 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | B | Subpart B—Licenses | § 60.17 Contents of site characterization plan. | NRC | [51 FR 27163, July 30, 1986] | The site characterization plan shall contain— (a) A general plan for site characterization activities to be conducted at the area to be characterized, which general plan shall include: (1) A description of such area, including information on quality assurance programs that have been applied to the collection, recording, and retention of information used in preparing such description. (2) A description of such site characterization activities, including the following— (i) The extent of planned excavations; (ii) Plans for any onsite testing with radioactive material, including radioactive tracers, or nonradioactive material; (iii) Plans for any investigation activities that may affect the capability of such area to isolate high-level radioactive waste; (iv) Plans to control any adverse impacts from such site characterization activities that are important to safety or that are important to waste isolation; and (v) Plans to apply quality assurance to data collection, recording, and retention. (3) Plans for the decontamination and decommissioning of such area, and for the mitigation of any significant adverse environmental impacts caused by site characterization activities, if such area is determined unsuitable for application for a construction authorization for a geologic repository operations area; (4) Criteria, developed pursuant to section 112(a) of the Nuclear Waste Policy Act of 1982, to be used to determine the suitability of such area for the location of a geologic repository; and (5) Any other information which the Commission, by rule or order, requires. (b) A description of the possible waste form or waste package for the high-level radioactive waste to be emplaced in such geologic repository, a description (to the extent practicable) of the relationship between such waste form or waste package and the host rock at such area, and a description of the activities being conducted by DOE with respect to such possible waste form or waste package or their relationship; and (c) A conceptual design for… | ||||
| 10:10:2.0.1.1.6.2.76.4 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | B | Subpart B—Licenses | § 60.18 Review of site characterization activities. | NRC | [51 FR 27163, July 30, 1986, as amended at 64 FR 48954, Sept. 9, 1999] | 2 In addition to the review of site characterization activities specified in this section, the Commission contemplates an ongoing review of other information on site investigation and site characterization, in order to allow early identification of potential licensing issues for timely resolution. This activity will include, for example, a review of the environmental assessments prepared by DOE at the time of site nomination, and review of issues related to long lead time exploratory shaft planning and procurement actions by DOE prior to issuance of site characterization plans. (a) The Director shall cause to be published in the Federal Register a notice that a site characterization plan has been received from DOE and that a staff review of such plan has begun. The notice shall identify the area to be characterized and the NRC staff members to be consulted for further information. (b) The Director shall make a copy of the site characterization plan available at the Public Document Room. The Director shall also transmit copies of the published notice of receipt to the Governor and legislature of the State in which the area to be characterized is located and to the governing body of any affected Indian Tribe. The Director shall provide an opportunity, with respect to any area to be characterized, for the State in which such area is located and for affected Indian Tribes to present their views on the site characterization plan and their suggestions with respect to comments thereon which may be made by NRC. In addition, the Director shall make NRC staff available to consult with States and affected Indian Tribes as provided in Subpart C of this part. (c) The Director shall review the site characterization plan and prepare a site characterization analysis with respect to such plan. In the preparation of such site characterization analysis, the Director may invite and consider the views of interested persons on DOE's site characterization plan and may review and consider comments made in connection with public he… | ||||
| 10:10:2.0.1.1.6.2.77.5 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | B | Subpart B—Licenses | § 60.21 Content of application. | NRC | [46 FR 13980, Feb. 25, 1981, as amended at 48 FR 28219, June 21, 1983; 54 FR 27871, July 3, 1989; 61 FR 64268, Dec. 4, 1996; 63 FR 26961, May 15, 1998; 73 FR 63571, Oct. 24, 2008] | (a) An application shall consist of general information and a Safety Analysis Report. An environmental impact statement shall be prepared in accordance with the Nuclear Waste Policy Act of 1982, as amended, and shall accompany the application. Any Restricted Data or National Security Information shall be separated from unclassified information. (b) The general information shall include: (1) A general description of the proposed geologic repository identifying the location of the geologic repository operations area, the general character of the proposed activities, and the basis for the exercise of licensing authority by the Commission. (2) Proposed schedules for construction, receipt of waste, and emplacement of wastes at the proposed geologic repository operations area. (3) A detailed plan to provide physical protection of high-level radioactive waste in accordance with § 73.51 of this chapter. This plan must include the design for physical protection, the licensee's safeguards contingency plan, and security organization personnel training and qualification plan. The plan must list tests, inspections, audits, and other means to be used to demonstrate compliance with such requirements. (4) A description of the program to meet the requirements of § 60.78. (5) A description of site characterization work actually conducted by DOE at all sites considered in the application and, as appropriate, explanations of why such work differed from the description of the site characterization program described in the Site Characterization Report for each site. (c) The Safety Analysis Report shall include: (1) A description and assessment of the site at which the proposed geologic repository operations area is to be located with appropriate attention to those features of the site that might affect geologic repository operations area design and performance. The description of the site shall identify the location of the geologic repository operations area with respect to the boundary of the accessible environment. (i) The … | ||||
| 10:10:2.0.1.1.6.2.77.6 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | B | Subpart B—Licenses | § 60.22 Filing and distribution of application. | NRC | [54 FR 27871, July 3, 1989, as amended at 68 FR 58814, Oct. 10, 2003; 69 FR 2279, Jan. 14, 2004] | (a) An application for a construction authorization for a high-level radioactive waste repository at a geologic repository operations area, and an application for a license to receive and possess source, special nuclear, or byproduct material at a geologic repository operations area at a site which has been characterized, and any amendments thereto, and an accompanying environmental impact statement and any supplements, shall be signed by the Secretary of Energy or the Secretary's authorized representative and must be filed with the Director. (b) DOE shall maintain the capability to generate additional copies for distribution in accordance with written instructions from the Director or the Director's designee. (c) DOE shall, upon notification of the appointment of an Atomic Safety and Licensing Board, update the application, eliminating all superseded information, and supplement the environmental impact statement if necessary, and serve the updated application and environmental impact statement (as it may have been supplemented) as directed by the Board. At that time DOE shall also serve one such copy of the application and environmental impact statement on the Atomic Safety and Licensing Appeal Panel. Any subsequent amendments to the application or supplements to the environmental impact statement shall be served in the same manner. (d) At the time of filing of an application and any amendments thereto, one copy shall be made available in an appropriate location near the proposed geologic repository operations area (which shall be a public document room, if one has been established) for inspection by the public and updated as amendments to the application are made. The environmental impact statement and any supplements thereto shall be made available in the same manner. An updated copy of the application, and the environmental impact statement and supplements, shall be produced at any public hearing held by the Commission on the application, for use by any party to the proceeding. (e) The DOE shall certify t… | ||||
| 10:10:2.0.1.1.6.2.77.7 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | B | Subpart B—Licenses | § 60.23 Elimination of repetition. | NRC | In its application, environmental report, or Site Characterization Report, the DOE may incorporate by reference information contained in previous applications, statements, or reports filed with the Commission: Provided, That such references are clear and specific and that copies of the information so incorporated are available in the public document room located near the site of the proposed geologic repository. | |||||
| 10:10:2.0.1.1.6.2.77.8 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | B | Subpart B—Licenses | § 60.24 Updating of application and environmental impact statement. | NRC | [46 FR 13980, Feb. 25, 1981, as amended at 54 FR 27872, July 3, 1989] | (a) The application shall be as complete as possible in the light of information that is reasonably available at the time of docketing. (b) The DOE shall update its application in a timely manner so as to permit the Commission to review, prior to issuance of a license: (1) Additional geologic, geophysical, geochemical, hydrologic, meteorologic and other data obtained during construction. (2) Conformance of construction of structures, systems, and components with the design. (3) Results of research programs carried out to confirm the adequacy of designs. (4) Other information bearing on the Commission's issuance of a license that was not available at the time a construction authorization was issued. (c) The DOE shall supplement its environmental impact statement in a timely manner so as to take into account the environmental impacts of any substantial changes in its proposed actions or any significant new circumstances or information relevant to environmental concerns and bearing on the proposed action or its impacts. | ||||
| 10:10:2.0.1.1.6.2.78.10 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | B | Subpart B—Licenses | § 60.32 Conditions of construction authorization. | NRC | [46 FR 13980, Feb. 25, 1981, as amended at 48 FR 28221, June 21, 1983] | (a) A construction authorization shall include such conditions as the Commission finds to be necessary to protect the health and safety of the public, the common defense and security, or environmental values. (b) The Commission will incorporate in the construction authorization provisions requiring DOE to furnish periodic or special reports regarding: (1) Progress of construction, (2) any data about the site obtained during construction which are not within the predicted limits upon which the facility design was based, (3) any deficiencies in design and construction which, if uncorrected, could adversely affect safety at any future time, and (4) results of research and development programs being conducted to resolve safety questions. (c) The construction authorization will include restrictions on subsequent changes to the features of the geologic repository and the procedures authorized. The restrictions that may be imposed under this paragraph can include measures to prevent adverse effects on the geologic setting as well as measures related to the design and construction of the geologic repository operations area. These restrictions will fall into three categories of descending importance to public health and safety as follows: (1) Those features and procedures which may not be changed without: (i) 60 days prior notice to the Commission (ii) 30 days notice of opportunity for a prior hearing, and (iii) prior Commission approval; (2) those features and procedures which may not be changed without (i) 60 days prior notice to the Commission, and (ii) prior Commission approval; and (3) those features and procedures which may not be changed without 60 days notice to the Commission. Features and procedures falling in paragraph (c)(3) of this section may not be changed without prior Commission approval if the Commission, after having received the required notice, so orders. (d) A construction authorization shall be subject to the limitation that a license to receive and possess source, special nuclear, or byproduct m… | ||||
| 10:10:2.0.1.1.6.2.78.11 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | B | Subpart B—Licenses | § 60.33 Amendment of construction authorization. | NRC | (a) An application for amendment of a construction authorization shall be filed with the Commission fully describing any changes desired and following as far as applicable the format prescribed in § 60.21. (b) In determining whether an amendment of a construction authorization will be approved, the Commission will be guided by the considerations which govern the issuance of the initial construction authorization, to the extent applicable. | |||||
| 10:10:2.0.1.1.6.2.78.9 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | B | Subpart B—Licenses | § 60.31 Construction authorization. | NRC | [46 FR 13980, Feb. 25, 1981, as amended at 48 FR 28220, June 21, 1983; 54 FR 27872, July 3, 1989; 63 FR 26961, May 15, 1998] | Upon review and consideration of an application and environmental impact statement submitted under this part, the Commission may authorize construction if it determines: (a) Safety. That there is reasonable assurance that the types and amounts of radioactive materials described in the application can be received, possessed, and disposed of in a geologic repository operations area of the design proposed without unreasonable risk to the health and safety of the public. In arriving at this determination, the Commission shall consider whether: (1) DOE has described the proposed geologic repository including but not limited to: (i) The geologic, geophysical, geochemical and hydrologic characteristics of the site; (ii) the kinds and quantities of radioactive waste to be received, possessed, stored, and disposed of in the geologic repository operations area; (iii) the principal architectural and engineering criteria for the design of the geologic repository operations area; (iv) construction procedures which may affect the capability of the geologic repository to serve its intended function; and (v) features or components incorporated in the design for the protection of the health and safety of the public. (2) The site and design comply with the performance objectives and criteria contained in Subpart E of this part. (3) The DOE's quality assurance program complies with the requirements of Subpart G of this part. (4) The DOE's personnel training program complies with the criteria contained in Subpart H of this part. (5) The DOE's emergency plan complies with the criteria contained in Subpart I of this part. (6) The DOE's proposed operating procedures to protect health and to minimize danger to life or property are adequate. (b) Common defense and security. That there is reasonable assurance that the activities proposed in the application will not be inimical to the common defense and security. (c) Environmental. That, after weighing the environmental, economic, technical and other benefits against environ… | ||||
| 10:10:2.0.1.1.6.2.79.12 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | B | Subpart B—Licenses | § 60.41 Standards for issuance of a license. | NRC | [46 FR 13980, Feb. 25, 1981, as amended at 63 FR 26961, May 15, 1998] | A license to receive and possess source, special nuclear, or byproduct material at a geologic repository operations area may be issued by the Commission upon finding that: (a) Construction of the geologic repository operations area has been substantially completed in conformity with the application as amended, the provisions of the Atomic Energy Act, and the rules and regulations of the Commission. Construction may be deemed to be substantially complete for the purposes of this paragraph if the construction of (1) surface and interconnecting structures, systems, and components, and (2) any underground storage space required for initial operation are substantially complete. (b) The activities to be conducted at the geologic repository operations area will be in conformity with the application as amended, the provisions of the Atomic Energy Act and the Energy Reorganization Act, and the rules and regulations of the Commission. (c) The issuance of the license will not be inimical to the common defense and security and will not constitute an unreasonable risk to the health and safety of the public. (d) All applicable requirements of part 51 have been satisfied. | ||||
| 10:10:2.0.1.1.6.2.79.13 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | B | Subpart B—Licenses | § 60.42 Conditions of license. | NRC | [46 FR 13980, Feb. 25, 1981, as amended at 73 FR 63571, Oct. 24, 2008] | (a) A license issued pursuant to this part shall include such conditions, including license specifications, as the Commission finds to be necessary to protect the health and safety of the public, the common defense and security, and environmental values. (b) Whether stated therein or not, the following shall be deemed conditions in every license issued: (1) The license shall be subject to revocation, suspension, modification, or amendment for cause as provided by the Atomic Energy Act and the Commission's regulations. (2) The DOE shall at any time while the license is in effect, upon written request of the Commission, submit written statements to enable the Commission to determine whether or not the license should be modified, suspended or revoked. (3) The license shall be subject to the provisions of the Atomic Energy Act now or hereafter in effect and to all rules, regulations, and orders of the Commission. The terms and conditions of the license shall be subject to amendment, revision, or modification, by reason of amendments to or by reason of rules, regulations, and orders issued in accordance with the terms of the Atomic Energy Act. (c) Each license shall be deemed to contain the provisions set forth in Section 183 b-d, inclusive, of the Atomic Energy Act, whether or not these provisions are expressly set forth in the license. (d) The licensee (Department of Energy) shall ensure that Safeguards Information is protected against unauthorized disclosure in accordance with the requirements in § 73.21 and the requirements in § 73.22 or § 73.23 of this chapter, as applicable. The licensee (Department of Energy) shall ensure that classified information is protected in accordance with the requirements of parts 25 and 95 of this chapter, as applicable. | ||||
| 10:10:2.0.1.1.6.2.79.14 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | B | Subpart B—Licenses | § 60.43 License specification. | NRC | [46 FR 13980, Feb. 25, 1981, as amended at 48 FR 28221, June 21, 1983; 61 FR 64268, Dec. 4, 1996] | (a) A license issued under this part shall include license conditions derived from the analyses and evaluations included in the application, including amendments made before a license is issued, together with such additional conditions as the Commission finds appropriate. (b) License conditions shall include items in the following categories: (1) Restrictions as to the physical and chemical form and radioisotopic content of radioactive waste. (2) Restrictions as to size, shape, and materials and methods of construction of radioactive waste packaging. (3) Restrictions as to the amount of waste permitted per unit volume of storage space considering the physical characteristics of both the waste and the host rock. (4) Requirements relating to test, calibration, or inspection to assure that the foregoing restrictions are observed. (5) Controls to be applied to restricted access and to avoid disturbance to the postclosure controlled area and to areas outside the controlled area where conditions may affect isolation within the controlled area. (6) Administrative controls, which are the provisions relating to organization and management, procedures, recordkeeping, review and audit, and reporting necessary to assure that activities at the facility are conducted in a safe manner and in conformity with the other license specifications. | ||||
| 10:10:2.0.1.1.6.2.79.15 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | B | Subpart B—Licenses | § 60.44 Changes, tests, and experiments. | NRC | [46 FR 13980, Feb. 25, 1981, as amended at 52 FR 31612, Aug. 21, 1987; 68 FR 58814, Oct. 10, 2003] | (a)(1) Following authorization to receive and possess source, special nuclear, or byproduct material at a geologic repository operations area, the DOE may (i) make changes in the geologic repository operations area as described in the application, (ii) make changes in the procedures as described in the application, and (iii) conduct tests or experiments not described in the application, without prior Commission approval, provided the change, test, or experiment involves neither a change in the license conditions incorporated in the license nor an unreviewed safety question. (2) A proposed change, test, or experiment shall be deemed to involve an unreviewed safety question if (i) the likelihood of occurrence or the consequences of an accident or malfunction of equipment important to safety previously evaluated in the application is increased, (ii) the possibility of an accident or malfunction of a different type than any previously evaluated in the application is created, or (iii) the margin of safety as defined in the basis for any license condition is reduced. (b) The DOE shall maintain records of changes in the geologic repository operations area and of changes in procedures made pursuant to this section, to the extent that such changes constitute changes in the geologic repository operations area or procedures as described in the application. Records of tests and experiments carried out pursuant to paragraph (a) of this section shall also be maintained. These records shall include a written safety evaluation which provides the basis for the determination that the change, test, or experiment does not involve an unreviewed safety question. The DOE shall prepare annually, or at such shorter intervals as may be specified in the license, a report containing a brief description of such changes, tests, and experiments, including a summary of the safety evaluation of each. The DOE shall furnish the report to the appropriate NRC Regional Office shown in appendix D to part 20 of this chapter, by an appropriate method … | ||||
| 10:10:2.0.1.1.6.2.79.16 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | B | Subpart B—Licenses | § 60.45 Amendment of license. | NRC | (a) An application for amendment of a license may be filed with the Commission fully describing the changes desired and following as far as applicable the format prescribed for license applications. (b) In determining whether an amendment of a license will be approved, the Commission will be guided by the considerations that govern the issuance of the initial license, to the extent applicable. | |||||
| 10:10:2.0.1.1.6.2.79.17 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | B | Subpart B—Licenses | § 60.46 Particular activities requiring license amendment. | NRC | [46 FR 13980, Feb. 25, 1981, as amended at 48 FR 28221, June 21, 1983; 61 FR 64268, Dec. 4, 1996] | (a) Unless expressly authorized in the license, an amendment of the license shall be required with respect to any of the following activities: (1) Any action which would make emplaced high-level radioactive waste irretrievable or which would substantially increase the difficulty of retrieving such emplaced waste. (2) Dismantling of structures. (3) Removal or reduction of controls applied to restrict access to or avoid disturbance of the controlled area and to areas outside the postclosure controlled area where conditions may affect isolation within the controlled area. (4) Destruction or disposal of records required to be maintained under the provisions of this part. (5) Any substantial change to the design or operating procedures from that specified in the license. (6) Permanent closure. (7) Any other activity involving an unreviewed safety question. (b) An application for such an amendment shall be filed, and shall be reviewed, in accordance with the provisions of § 60.45. | ||||
| 10:10:2.0.1.1.6.2.80.18 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | B | Subpart B—Licenses | § 60.47 Facility information and verification. | NRC | [73 FR 78605, Dec. 23, 2008, as amended at 85 FR 65663, Oct. 16, 2020] | (a) In response to a written request by the Commission, each applicant for a construction authorization or license and each recipient of a construction authorization or a license shall submit facility information, as described in § 75.10 of this chapter, on IAEA Design Information Questionnaire forms, and site information on DOC/NRC Form AP-A and associated forms; (b) As required by the Additional Protocol, applicants and licensees specified in paragraph (a) of this section shall submit location information described in § 75.11 of this chapter on DOC/NRC Form AP-1 and associated forms; (c) Shall permit verification thereof by the International Atomic Energy Agency (IAEA) and take other action as necessary to implement the US/IAEA Safeguards Agreement, as described in part 75 of this chapter. | ||||
| 10:10:2.0.1.1.6.2.81.19 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | B | Subpart B—Licenses | § 60.51 License amendment for permanent closure. | NRC | [46 FR 13980, Feb. 25, 1981, as amended at 48 FR 28221, June 21, 1983; 54 FR 27872, July 3, 1989; 61 FR 64268, Dec. 4, 1996] | (a) DOE shall submit an application to amend the license prior to permanent closure. The submission shall consist of an update of the license application submitted under §§ 60.21 and 60.22, including: (1) A description of the program for post-permanent closure monitoring of the geologic repository. (2) A detailed description of the measures to be employed—such as land use controls, construction of monuments, and preservation of records—to regulate or prevent activities that could impair the long-term isolation of emplaced waste within the geologic repository and to assure that relevant information will be preserved for the use of future generations. As a minimum, such measures shall include: (i) Identification of the postclosure controlled area and geologic repository operations area by monuments that have been designed, fabricated, and emplaced to be as permanent as is practicable; and (ii) Placement of records in the archives and land record systems of local State, and Federal government agencies, and archives elsewhere in the world, that would be likely to be consulted by potential human intruders—such records to identify the location of the geologic repository operations area, including the underground facility, boreholes and shafts, and the boundaries of the postclosure controlled area, and the nature and hazard of the waste. (3) Geologic, geophysical, geochemical, hydrologic, and other site data that are obtained during the operational period pertinent to the long-term isolation of emplaced radioactive wastes. (4) The results of tests, experiments, and any other analyses relating to backfill of excavated areas, shaft sealing, waste interaction with the host rock, and any other tests, experiments, or analyses pertinent to the long-term isolation of emplaced wastes within the geologic repository. (5) Any substantial revision of plans for permanent closure. (6) Other information bearing upon permanent closure that was not available at the time a license was issued. (b) If necessary, so as to take into… | ||||
| 10:10:2.0.1.1.6.2.81.20 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | B | Subpart B—Licenses | § 60.52 Termination of license. | NRC | [46 FR 13980, Feb. 25, 1981, as amended at 48 FR 28222, June 21, 1983] | (a) Following permanent closure and the decontamination or dismantlement of surface facilities, DOE may apply for an amendment to terminate the license. (b) Such application shall be filed, and will be reviewed, in accordance with the provisions of § 60.45 and this section. (c) A license shall be terminated only when the Commission finds with respect to the geologic repository: (1) That the final disposition of radioactive wastes has been made in conformance with the DOE's plan, as amended and approved as part of the license. (2) That the final state of the geologic repository operations area conforms to DOE's plans for permanent closure and DOE's plans for the decontamination or dismantlement of surface facilities, as amended and approved as part of the license. (3) That the termination of the license is authorized by law, including sections 57, 62, and 81 of the Atomic Energy Act, as amended. | ||||
| 10:10:2.0.1.1.6.3.82.1 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | C | Subpart C—Participation by State Governments and Affected Indian Tribes | § 60.61 Provision of information. | NRC | [51 FR 27164, July 30, 1986, as amended at 64 FR 48954, Sept. 9, 1999] | (a) The Director shall provide to the Governor and legislature of any State in which a geologic repository operations area is or may be located, and to the governing body of any affected Indian Tribe, timely and complete information regarding determinations or plans made by the Commission with respect to the site characterization, siting, development, design, licensing, construction, operation, regulation, permanent closure, or decontamination and dismantlement of surface facilities, of such geologic repository operations area. (b) For purposes of this section, a geologic repository operations area shall be considered to be one which “may be located” in a State if the location thereof in such State has been described in a site characterization plan submitted to the Commission under this part. (c) Notwithstanding paragraph (a) of this section, the Director is not required to distribute any document to any entity if, with respect to such document, that entity or its counsel is included on a service list prepared pursuant to part 2 of this chapter. (d) Copies of all communications by the Director under this section are available at the NRC Web site, http://www.nrc.gov, and/or at the NRC Public Document Room, and copies are furnished to DOE. | ||||
| 10:10:2.0.1.1.6.3.82.2 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | C | Subpart C—Participation by State Governments and Affected Indian Tribes | § 60.62 Site review. | NRC | (a) Whenever an area has been approved by the President for site characterization, and upon request of a State or an affected Indian Tribe, the Director shall make NRC staff available to consult with representatives of such States and Tribes. (b) Requests for consultation shall be made in writing to the Director. (c) Consultation under this section may include: (1) Keeping the parties informed of the Director's views on the progress of site characterization. (2) Review of applicable NRC regulations, licensing procedures, schedules, and opportunities for State and Tribe participation in the Commission's regulatory activities. (3) Cooperation in development of proposals for State and Tribe participation in license reviews. | |||||
| 10:10:2.0.1.1.6.3.82.3 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | C | Subpart C—Participation by State Governments and Affected Indian Tribes | § 60.63 Participation in license reviews. | NRC | [51 FR 27164, July 30, 1986, as amended at 64 FR 48954, Sept. 9, 1999; 69 FR 2279, Jan. 14, 2004] | (a) State, local governmental bodies, and affected, Federally-recognized Indian Tribes may participate in license reviews as provided in subpart J of part 2 of this chapter. A State in which a repository for high-level radioactive waste is proposed to be located and any affected, Federally-recognized Indian Tribe shall have an unquestionable legal right to participate as a party in such proceedings. (b) In addition, whenever an area has been approved by the President for site characterization, a State or an affected Indian Tribe may submit to the Director a proposal to facilitate its participation in the review of a site characterization plan and/or license application. The proposal may be submitted at any time and must contain a description and schedule of how the State or affected Indian Tribe wishes to participate in the review, or what services or activities the State or affected Indian Tribe wishes NRC to carry out, and how the services or activities proposed to be carried out by NRC would contribute to such participation. The proposal may include educational or information services (seminars, public meetings) or other actions on the part of NRC, such as employment or exchange of State personnel under the Intergovernmental Personnel Act. (c) The Director shall arrange for a meeting between the representatives of the State or affected Indian Tribe and the NRC staff to discuss any proposal submitted under paragraph (b) of this section, with a view to identifying any modifications that may contribute to the effective participation by such State or Tribe. (d) Subject to the availability of funds, the Director shall approve all or any part of a proposal, as it may be modified through the meeting described above, if it is determined that: (1) The proposed activities are suitable in light of the type and magnitude of impacts which the State or affected Indian Tribe may bear; (2) The proposed activities: (i) Will enhance communications between NRC and the State or affected Indian Tribe; (ii) Will make a produ… | ||||
| 10:10:2.0.1.1.6.3.82.4 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | C | Subpart C—Participation by State Governments and Affected Indian Tribes | § 60.64 Notice to States. | NRC | If the Governor and legislature of a State have jointly designated on their behalf a single person or entity to receive notice and information from the Commission under this part, the Commission will provide such notice and information to the jointly designated person or entity instead of the Governor and legislature separately. | |||||
| 10:10:2.0.1.1.6.3.82.5 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | C | Subpart C—Participation by State Governments and Affected Indian Tribes | § 60.65 Representation. | NRC | Any person who acts under this subpart as a representative for a State (or for the Governor or legislature thereof) or for an affected Indian Tribe shall include in the request or other submission, or at the request of the Commission, a statement of the basis of his or her authority to act in such representative capacity. | |||||
| 10:10:2.0.1.1.6.4.82.1 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | D | Subpart D—Records, Reports, Tests, and Inspections | § 60.71 Records and reports. | NRC | [48 FR 28222, June 21, 1983, as amended at 53 FR 19251, May 27, 1988] | (a) DOE shall maintain such records and make such reports in connection with the licensed activity as may be required by the conditions of the license or by rules, regulations, and orders of the Commission as authorized by the Atomic Energy Act and the Energy Reorganization Act. (b) Records of the receipt, handling, and disposition of radioactive waste at a geologic repository operations area shall contain sufficient information to provide a complete history of the movement of the waste from the shipper through all phases of storage and disposal. DOE shall retain these records in a manner that ensures their useability for future generations in accordance with § 60.51(a)(2). | ||||
| 10:10:2.0.1.1.6.4.82.2 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | D | Subpart D—Records, Reports, Tests, and Inspections | § 60.72 Construction records. | NRC | [48 FR 28222, June 21, 1983, as amended at 53 FR 19251, May 27, 1988] | (a) DOE shall maintain records of construction of the geologic repository operations area in a manner that ensures their useability for future generations in accordance with § 60.51(a)(2). (b) The records required under paragraph (a) shall include at least the following: (1) Surveys of the underground facility excavations, shafts, and boreholes referenced to readily identifiable surface features or monuments; (2) A description of the materials encountered; (3) Geologic maps and geologic cross sections; (4) Locations and amount of seepage; (5) Details of equipment, methods, progress, and sequence of work; (6) Construction problems; (7) Anomalous conditions encountered; (8) Instrument locations, readings, and analysis; (9) Location and description of structural support systems; (10) Location and description of dewatering systems; and (11) Details, methods of emplacement, and location of seals used. | ||||
| 10:10:2.0.1.1.6.4.82.3 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | D | Subpart D—Records, Reports, Tests, and Inspections | § 60.73 Reports of deficiencies. | NRC | [48 FR 28222, June 21, 1983] | DOE shall promptly notify the Commission of each deficiency found in the characteristics of the site, and design and construction of the geologic repository operations area which, were it to remain uncorrected, could: (a) Be a substantial safety hazard, (b) represent a significant deviation from the design criteria and design bases stated in the application, or (c) represent a deviation from the conditions stated in the terms of a construction authorization or the license, including license specifications. The notification shall be in the form of a written report, copies of which shall be sent to the Director and to the appropriate Nuclear Regulatory Commission Regional Office listed in appendix D of part 20 of this chapter. | ||||
| 10:10:2.0.1.1.6.4.82.4 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | D | Subpart D—Records, Reports, Tests, and Inspections | § 60.74 Tests. | NRC | [48 FR 28222, June 21, 1983] | (a) DOE shall perform, or permit the Commission to perform, such tests as the Commission deems appropriate or necessary for the administration of the regulations in this part. These may include tests of: (1) Radioactive waste, (2) The geologic repository including its structures, systems, and components, (3) Radiation detection and monitoring instruments, and (4) Other equipment and devices used in connection with the receipt, handling, or storage of radioactive waste. (b) The tests required under this section shall include a performance confirmation program carried out in accordance with subpart F of this part. | ||||
| 10:10:2.0.1.1.6.4.82.5 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | D | Subpart D—Records, Reports, Tests, and Inspections | § 60.75 Inspections. | NRC | [48 FR 28222, June 21, 1983, as amended at 52 FR 31612, Aug. 21, 1987; 76 FR 72086, Nov. 22, 2011] | (a) DOE shall allow the Commission to inspect the premises of the geologic repository operations area and adjacent areas to which DOE has rights of access. (b) DOE shall make available to the Commission for inspection, upon reasonable notice, records kept by DOE pertaining to activities under this part. (c)(1) DOE shall upon requests by the Director, Office of Nuclear Material Safety and Safeguards, provide rent-free office space for the exclusive use of the Commission inspection personnel. Heat, air-conditioning, light, electrical outlets and janitorial services shall be furnished by DOE. The office shall be convenient to and have full access to the facility and shall provide the inspector both visual and acoustic privacy. (2) The space provided shall be adequate to accommodate a full-time inspector, a part-time secretary and transient NRC personnel and will be generally commensurate with other office facilities at the geologic repository operations area. A space of 250 square feet either within the geologic repository operations area's office complex or in an office trailer or other onsite space at the geologic repository operations area is suggested as a guide. For locations at which activities are carried out under licenses issued under other parts of this chapter, additional space may be requested to accommodate additional full-time inspectors. The Office space that is provided shall be subject to the approval of the Director, Office of Nuclear Material Safety and Safeguards. All furniture, supplies and communication equipment will be furnished by the Commission. (3) DOE shall afford any NRC resident inspector assigned to that location, or other NRC inspectors identified by the Regional Administrator as likely to inspect the facility, immediate unfettered access, equivalent to access provided regular employees, following proper identification and compliance with applicable access control measures for security, radiological protection and personal safety. | ||||
| 10:10:2.0.1.1.6.4.82.6 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | D | Subpart D—Records, Reports, Tests, and Inspections | § 60.78 Material control and accounting records and reports. | NRC | [63 FR 26961, May 15, 1998] | DOE shall implement a program of material control and accounting (and accidental criticality reporting) that is the same as that specified in §§ 72.72, 72.74, 72.76, and 72.78 of this chapter. | ||||
| 10:10:2.0.1.1.6.5.82.1 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | E | Subpart E—Technical Criteria | § 60.101 Purpose and nature of findings. | NRC | (a)(1) Subpart B of this part prescribes the standards for issuance of a license to receive and possess source, special nuclear, or byproduct material at a geologic repository operations area. In particular, § 60.41(c) requires a finding that the issuance of a license will not constitute an unreasonable risk to the health and safety of the public. The purpose of this subpart is to set out performance objectives and site and design criteria which, if satisfied, will support such a finding of no unreasonable risk. (2) While these performance objectives and criteria are generally stated in unqualified terms, it is not expected that complete assurance that they will be met can be presented. A reasonable assurance, on the basis of the record before the Commission, that the objectives and criteria will be met is the general standard that is required. For § 60.112, and other portions of this subpart that impose objectives and criteria for repository performance over long times into the future, there will inevitably be greater uncertainties. Proof of the future performance of engineered barrier systems and the geologic setting over time periods of many hundreds or many thousands of years is not to be had in the ordinary sense of the word. For such long-term objectives and criteria, what is required is reasonable assurance, making allowance for the time period, hazards, and uncertainties involved, that the outcome will be in conformance with those objectives and criteria. Demonstration of compliance with such objectives and criteria will involve the use of data from accelerated tests and predictive models that are supported by such measures as field and laboratory tests, monitoring data and natural analog studies. (b) Subpart B of this part also lists findings that must be made in support of an authorization to construct a geologic repository operations area. In particular, § 60.31(a) requires a finding that there is reasonable assurance that the types and amounts of radioactive materials described in the application ca… | |||||
| 10:10:2.0.1.1.6.5.82.2 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | E | Subpart E—Technical Criteria | § 60.102 Concepts. | NRC | [48 FR 28222, June 21, 1983, as amended at 61 FR 64268, Dec. 4, 1996] | This section provides a functional overview of subpart E. In the event of any inconsistency with definitions found in § 60.2, those definitions shall prevail. (a) The HLW facility. NRC exercises licensing and related regulatory authority over those facilities described in section 202 (3) and (4) of the Energy Reorganization Act of 1974. Any of these facilities is designated a HLW facility. (b) The geologic repository operations area. (1) This part deals with the exercise of authority with respect to a particular class of HLW facility—namely a geologic repository operations area. (2) A geologic repository operations area consists of those surface and subsurface areas that are part of a geologic repository where radioactive waste handling activities are conducted. The underground structure, including openings and backfill materials, but excluding shafts, boreholes, and their seals, is designated the underground facility. (3) The exercise of Commission authority requires that the geologic repository operations area be used for storage (which includes disposal ) of high-level radioactive wastes (HLW). (4) HLW includes irradiated reactor fuel as well as reprocessing wastes. However, if DOE proposes to use the geologic repository operations area for storage of radioactive waste other than HLW, the storage of this radioactive waste is subject to the requirements of this part. (c) Areas related to isolation. Although the activities subject to regulation under this part are those to be carried out at the geologic repository operations area, the licensing process also considers characteristics of adjacent areas that are defined in other ways. There is to be an area surrounding the underground facility referred to above, which is designated the postclosure controlled area, within which DOE is to exercise specified controls to prevent adverse human actions following permanent closure. The location of the controlled area is the site. The accessible environment is the atmosphere, land surface, surf… | ||||
| 10:10:2.0.1.1.6.5.82.3 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | E | Subpart E—Technical Criteria | § 60.111 Performance of the geologic repository operations area through permanent closure. | NRC | [48 FR 28222, June 21, 1983, as amended at 61 FR 64268, Dec. 4, 1996; 62 FR 59276, Nov. 3, 1997] | (a) Protection against radiation exposures and releases of radioactive material. The geologic repository operations area shall be designed so that until permanent closure has been completed, radiation exposures and radiation levels, and releases of radioactive materials to unrestricted areas, will be maintained within the limits specified in part 20 of this chapter and such generally applicable environmental standards for radioactivity as may have been established by the Environmental Protection Agency. (b) Retrievability of waste. (1) The geologic repository operations area shall be designed to preserve the option of waste retrieval throughout the period during which wastes are being emplaced and, thereafter, until the completion of a preformance confirmation program and Commission review of the information obtained from such a program. To satisfy this objective, the geologic repository operations area shall be designed so that any or all of the emplaced waste could be retrieved on a reasonable schedule starting at any time up to 50 years after waste emplacement operations are initiated, unless a different time period is approved or specified by the Commission. This different time period may be established on a case-by-case basis consistent with the emplacement schedule and the planned performance confirmation program. (2) This requirement shall not preclude decisions by the Commission to allow backfilling part or all of, or permanent closure of, the geologic repository operations area prior to the end of the period of design for retrievability. (3) For purposes of this paragraph, a reasonable schedule for retrieval is one that would permit retrieval in about the same time as that devoted to construction of the geologic repository operations area and the emplacement of wastes. | ||||
| 10:10:2.0.1.1.6.5.82.4 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | E | Subpart E—Technical Criteria | § 60.112 Overall system performance objective for the geologic repository after permanent closure. | NRC | The geologic setting shall be selected and the engineered barrier system and the shafts, boreholes and their seals shall be designed to assure that releases of radioactive materials to the accessible environment following permanent closure conform to such generally applicable environmental standards for radioactivity as may have been established by the Environmental Protection Agency with respect to both anticipated processes and events and unanticipated processes and events. | |||||
| 10:10:2.0.1.1.6.5.82.5 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | E | Subpart E—Technical Criteria | § 60.113 Performance of particular barriers after permanent closure. | NRC | (a) General provisions —(1) Engineered barrier system. (i) The engineered barrier system shall be designed so that assuming anticipated processes and events: (A) Containment of HLW will be substantially complete during the period when radiation and thermal conditions in the engineered barrier system are dominated by fission product decay; and (B) any release of radionuclides from the engineered barrier system shall be a gradual process which results in small fractional releases to the geologic setting over long times. For disposal in the saturated zone, both the partial and complete filling with groundwater of available void spaces in the underground facility shall be appropriately considered and analysed among the anticipated processes and events in designing the engineered barrier system. (ii) In satisfying the preceding requirement, the engineered barrier system shall be designed, assuming anticipated processes and events, so that: (A) Containment of HLW within the waste packages will be substantially complete for a period to be determined by the Commission taking into account the factors specified in § 60.113(b) provided, that such period shall be not less than 300 years nor more than 1,000 years after permanent closure of the geologic repository; and (B) The release rate of any radionuclide from the engineered barrier system following the containment period shall not exceed one part in 100,000 per year of the inventory of that radionuclide calculated to be present at 1,000 years following permanent closure, or such other fraction of the inventory as may be approved or specified by the Commission; provided, that this requirement does not apply to any radionuclide which is released at a rate less than 0.1% of the calculated total release rate limit. The calculated total release rate limit shall be taken to be one part in 100,000 per year of the inventory of radioactive waste, originally emplaced in the underground facility, that remains after 1,000 years of radioactive decay. (2) Geologic setting. The… | |||||
| 10:10:2.0.1.1.6.5.83.6 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | E | Subpart E—Technical Criteria | § 60.121 Requirements for ownership and control of interests in land. | NRC | [48 FR 28222, June 21, 1983, as amended at 61 FR 64268, Dec. 4, 1996] | (a) Ownership of land. (1) Both the geologic repository operations area and the postclosure controlled area shall be located in and on lands that are either acquired lands under the jurisdiction and control of DOE, or lands permanently withdrawn and reserved for its use. (2) These lands shall be held free and clear of all encumbrances, if significant, such as: (i) Rights arising under the general mining laws; (ii) easements for right-of-way; and (iii) all other rights arising under lease, rights of entry, deed, patent, mortgage, appropriation, prescription, or otherwise. (b) Additional controls. Appropriate controls shall be established outside of the postclosure controlled area. DOE shall exercise any jurisdiction and control over surface and subsurface estates necessary to prevent adverse human actions that could significantly reduce the geologic repository's ability to achieve isolation. The rights of DOE may take the form of appropriate possessory interests, servitudes, or withdrawals from location or patent under the general mining laws. (c) Water rights. (1) DOE shall also have obtained such water rights as may be needed to accomplish the purpose of the geologic repository operations area. (2) Water rights are included in the additional controls to be established under paragraph (b) of this section. | ||||
| 10:10:2.0.1.1.6.5.84.7 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | E | Subpart E—Technical Criteria | § 60.122 Siting criteria. | NRC | [48 FR 28222, June 21, 1983, as amended at 50 FR 29647, July 22, 1985; 61 FR 64269, Dec. 4, 1996] | (a)(1) A geologic setting shall exhibit an appropriate combination of the conditions specified in paragraph (b) of this section so that, together with the engineered barriers system, the favorable conditions present are sufficient to provide reasonable assurance that the performance objectives relating to isolation of the waste will be met. (2) If any of the potentially adverse conditions specified in paragraph (c) of this section is present, it may compromise the ability of the geologic repository to meet the performance objectives relating to isolation of the waste. In order to show that a potentially adverse condition does not so compromise the performance of the geologic repository the following must be demonstrated: (i) The potentially adverse human activity or natural condition has been adequately investigated, including the extent to which the condition may be present and still be undetected taking into account the degree of resolution achieved by the investigations; and (ii) The effect of the potentially adverse human activity or natural condition on the site has been adequately evaluated using analyses which are sensitive to the potentially adverse human activity or natural condition and assumptions which are not likely to underestimate its effect; and (iii)(A) The potentially adverse human activity or natural condition is shown by analysis pursuant to paragraph (a)(2)(ii) of this section not to affect significantly the ability of the geologic repository to meet the performance objectives relating to isolation of the waste, or (B) The effect of the potentially adverse human activity or natural condition is compensated by the presence of a combination of the favorable characteristics so that the performance objectives relating to isolation of the waste are met, or (C) The potentially adverse human activity or natural condition can be remedied. (b) Favorable conditions. (1) The nature and rates of tectonic, hydrogeologic, geochemical, and geomorphic processes (or any of such processes) operating w… | ||||
| 10:10:2.0.1.1.6.5.85.10 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | E | Subpart E—Technical Criteria | § 60.132 Additional design criteria for surface facilities in the geologic repository operations area. | NRC | [48 FR 28222, June 21, 1983, as amended at 61 FR 64270, Dec. 4, 1996] | (a) Facilities for receipt and retrieval of waste. Surface facilities in the geologic repository operations area shall be designed to allow safe handling and storage of wastes at the geologic repository operations area, whether these wastes are on the surface before emplacement or as a result of retrieval from the underground facility. (b) Surface facility ventilation. Surface facility ventilation systems supporting waste transfer, inspection, decontamination, processing, or packaging shall be designed to provide protection against radiation exposures and offsite releases as provided in § 60.111(a). (c) Radiation control and monitoring —(1) Effluent control. The surface facilities shall be designed to control the release of radioactive materials in effluents during Category 1 design basis events so as to meet the performance objectives of § 60.111(a). (2) Effluent monitoring. The effluent monitoring systems shall be designed to measure the amount and concentration of radionuclides in any effluent with sufficient precision to determine whether releases conform to the design requirement for effluent control. The monitoring systems shall be designed to include alarms that can be periodically tested. (d) Waste treatment. Radioactive waste treatment facilities shall be designed to process any radioactive wastes generated at the geologic repository operations area into a form suitable to permit safe disposal at the geologic repository operations area or to permit safe transportation and conversion to a form suitable for disposal at an alternative site in accordance with any regulations that are applicable. (e) Consideration of decommissioning. The surface facility shall be designed to facilitate decontamination or dismantlement to the same extent as would be required, under other parts of this chapter, with respect to equivalent activities licensed thereunder. | ||||
| 10:10:2.0.1.1.6.5.85.11 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | E | Subpart E—Technical Criteria | § 60.133 Additional design criteria for the underground facility. | NRC | [48 FR 28222, June 21, 1983, as amended at 50 FR 29648, July 22, 1985; 61 FR 64270, Dec. 4, 1996] | (a) General criteria for the underground facility. (1) The orientation, geometry, layout, and depth of the underground facility, and the design of any engineered barriers that are part of the underground facility shall contribute to the containment and isolation of radionuclides. (2) The underground facility shall be designed so that the effects of credible disruptive events during the period of operations, such as flooding, fires and explosions, will not spread through the facility. (b) Flexibility of design. The underground facility shall be designed with sufficient flexibility to allow adjustments where necessary to accommodate specific site conditions identified through in situ monitoring, testing, or excavation. (c) Retrieval of waste. The underground facility shall be designed to permit retrieval of waste in accordance with the performance objectives of § 60.111. (d) Control of water and gas. The design of the underground facility shall provide for control of water or gas intrusion. (e) Underground openings. (1) Openings in the underground facility shall be designed so that operations can be carried out safely and the retrievability option maintained. (2) Openings in the underground facility shall be designed to reduce the potential for deleterious rock movement or fracturing of overlying or surrounding rock. (f) Rock excavation. The design of the underground facility shall incorporate excavation methods that will limit the potential for creating a preferential pathway for groundwater to contact the waste packages or radionuclide migration to the accessible environment. (g) Underground facility ventilation. The ventilation system shall be designed to: (1) Control the transport of radioactive particulates and gases within and releases from the underground facility in accordance with the performance objectives of § 60.111(a), (2) Assure the ability to perform essential safety functions assuming occurrence of design basis events. (3) Separate the ventilation of excavation and waste emp… | ||||
| 10:10:2.0.1.1.6.5.85.12 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | E | Subpart E—Technical Criteria | § 60.134 Design of seals for shafts and boreholes. | NRC | [48 FR 28222, June 21, 1983, as amended at 50 FR 29648, July 22, 1985] | (a) General design criterion. Seals for shafts and boreholes shall be designed so that following permanent closure they do not become pathways that compromise the geologic repository's ability to meet the performance objectives or the period following permanent closure. (b) Selection of materials and placement methods. Materials and placement methods for seals shall be selected to reduce, to the extent practicable: (1) The potential for creating a preferential pathway for groundwater to contact the waste packages or (2) For radionuclide migration through existing pathways. | ||||
| 10:10:2.0.1.1.6.5.85.8 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | E | Subpart E—Technical Criteria | § 60.130 General considerations. | NRC | [69 FR 2280, Jan. 14, 2004] | (a) Pursuant to the provisions of § 60.21(c)(2)(i), an application for construction authorization for a high-level radioactive waste repository at a geologic repository operations area, and an application for a license to receive, possess, store, and dispose of high-level radioactive waste in the geologic repository operations area, must include the principal design criteria for a proposed facility. The principal design criteria establish the necessary design, fabrication, construction, testing, maintenance, and performance requirements for structures, systems, and components important to safety and/or important to waste isolation. Sections 60.131 through 60.134 specify minimum requirements for the principal design criteria for the geologic repository operations area. (b) These design criteria are not intended to be exhaustive. However, omissions in §§ 60.131 through 60.134 do not relieve DOE from any obligation to provide such features in a specific facility needed to achieve the performance objectives. | ||||
| 10:10:2.0.1.1.6.5.85.9 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | E | Subpart E—Technical Criteria | § 60.131 General design criteria for the geologic repository operations area. | NRC | [48 FR 28222, June 21, 1983, as amended at 61 FR 64269, Dec. 4, 1996] | (a) Radiological protection. The geologic repository operations area shall be designed to maintain radiation doses, levels, and concentrations of radioactive material in air in restricted areas within the limits specified in part 20 of this chapter. Design shall include: (1) Means to limit concentrations of radioactive material in air; (2) Means to limit the time required to perform work in the vicinity of radioactive materials, including, as appropriate, designing equipment for ease of repair and replacement and providing adequate space for ease of operation; (3) Suitable shielding; (4) Means to monitor and control the dispersal of radioactive contamination; (5) Means to control access to high radiation areas or airborne radioactivity areas; and (6) A radiation alarm system to warn of significant increases in radiation levels, concentrations of radioactive material in air, and of increased radioactivity released in effluents. The alarm system shall be designed with provisions for calibration and for testing its operability. (b) Protection against design basis events. The structures, systems, and components important to safety shall be designed so that they will perform their necessary safety functions, assuming occurrence of design basis events. (c) Protection against dynamic effects of equipment failure and similar events. The structures, systems, and components important to safety shall be designed to withstand dynamic effects such as missile impacts, that could result from equipment failure, and similar events and conditions that could lead to loss of their safety functions. (d) Protection against fires and explosions. (1) The structures, systems, and components important to safety shall be designed to perform their safety functions during and after credible fires or explosions in the geologic repository operations area. (2) To the extent practicable, the geologic repository operations area shall be designed to incorporate the use of noncombustible and heat resistant materials. (3) The geol… | ||||
| 10:10:2.0.1.1.6.5.86.13 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | E | Subpart E—Technical Criteria | § 60.135 Criteria for the waste package and its components. | NRC | (a) High-level-waste package design in general. (1) Packages for HLW shall be designed so that the in situ chemical, physical, and nuclear properties of the waste package and its interactions with the emplacement environment do not compromise the function of the waste packages or the performance of the underground facility or the geologic setting. (2) The design shall include but not be limited to consideration of the following factors: solubility, oxidation/reduction reactions, corrosion, hydriding, gas generation, thermal effects, mechanical strength, mechanical stress, radiolysis, radiation damage, radionuclide retardation, leaching, fire and explosion hazards, thermal loads, and synergistic interactions. (b) Specific criteria for HLW package design —(1) Explosive, pyrophoric, and chemically reactive materials. The waste package shall not contain explosive or pyrophoric materials or chemically reactive materials in an amount that could compromise the ability of the underground facility to contribute to waste isolation or the ability of the geologic repository to satisfy the performance objectives. (2) Free liquids. The waste package shall not contain free liquids in an amount that could compromise the ability of the waste packages to achieve the performance objectives relating to containment of HLW (because of chemical interactions or formation of pressurized vapor) or result in spillage and spread of contamination in the event of waste package perforation during the period through permanent closure. (3) Handling. Waste packages shall be designed to maintain waste containment during transportation, emplacement, and retrieval. (4) Unique identification. A label or other means of identification shall be provided for each waste package. The identification shall not impair the integrity of the waste package and shall be applied in such a way that the information shall be legible at least to the end of the period of retrievability. Each waste package identification shall be consistent with the waste… | |||||
| 10:10:2.0.1.1.6.5.87.14 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | E | Subpart E—Technical Criteria | § 60.136 Preclosure controlled area. | NRC | [61 FR 64270, Dec. 4, 1996] | (a) A preclosure controlled area must be established for the geologic repository operations area. (b) The geologic repository operations area shall be designed so that, for Category 2 design basis events, no individual located on or beyond any point on the boundary of the preclosure controlled area will receive the more limiting of a total effective dose equivalent of 0.05 Sv (5 rem), or the sum of the deep-dose equivalent and the committed dose equivalent to any individual organ or tissue (other than the lens of the eye) of 0.5 Sv (50 rem). The eye dose equivalent shall not exceed 0.15 Sv (15 rem), and the shallow dose equivalent to skin shall not exceed 0.5 Sv (50 rem). The minimum distance from the surface facilities in the geologic repository operations area to the boundary of the preclosure controlled area must be at least 100 meters. (c) The preclosure controlled area may be traversed by a highway, railroad, or waterway, so long as appropriate and effective arrangements are made to control traffic and to protect public health and safety. | ||||
| 10:10:2.0.1.1.6.5.88.15 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | E | Subpart E—Technical Criteria | § 60.137 General requirements for performance confirmation. | NRC | The geologic repository operations area shall be designed so as to permit implementation of a performance confirmation program that meets the requirements of subpart F of this part. | |||||
| 10:10:2.0.1.1.6.6.89.1 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | F | Subpart F—Performance Confirmation Program | § 60.140 General requirements. | NRC | (a) The performance confirmation program shall provide data which indicates, where practicable, whether: (1) Actual subsurface conditions encountered and changes in those conditions during construction and waste emplacement operations are within the limits assumed in the licensing review; and (2) Natural and engineered systems and components required for repository operation, or which are designed or assumed to operate as barriers after permanent closure, are functioning as intended and anticipated. (b) The program shall have been started during site characterization and it will continue until permanent closure. (c) The program shall include in situ monitoring, laboratory and field testing, and in situ experiments, as may be appropriate to accomplish the objective as stated above. (d) The program shall be implemented so that: (1) It does not adversely affect the ability of the natural and engineered elements of the geologic repository to meet the performance objectives. (2) It provides baseline information and analysis of that information on those parameters and natural processes pertaining to the geologic setting that may be changed by site characterization, construction, and operational activities. (3) It monitors and analyzes changes from the baseline condition of parameters that could affect the performance of a geologic repository. (4) It provides an established plan for feedback and analysis of data, and implementation of appropriate action. | |||||
| 10:10:2.0.1.1.6.6.89.2 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | F | Subpart F—Performance Confirmation Program | § 60.141 Confirmation of geotechnical and design parameters. | NRC | (a) During repository construction and operation, a continuing program of surveillance, measurement, testing, and geologic mapping shall be conducted to ensure that geotechnical and design parameters are confirmed and to ensure that appropriate action is taken to inform the Commission of changes needed in design to accommodate actual field conditions encountered. (b) Subsurface conditions shall be monitored and evaluated against design assumptions. (c) As a minimum, measurements shall be made of rock deformations and displacement, changes in rock stress and strain, rate and location of water inflow into subsurface areas, changes in groundwater conditions, rock pore water pressures including those along fractures and joints, and the thermal and thermomechanical response of the rock mass as a result of development and operations of the geologic repository. (d) These measurements and observations shall be compared with the original design bases and assumptions. If significant differences exist between the measurements and observations and the original design bases and assumptions, the need for modifications to the design or in construction methods shall be determined and these differences and the recommended changes reported to the Commission. (e) In situ monitoring of the thermomechanical response of the underground facility shall be conducted until permanent closure to ensure that the performance of the natural and engineering features are within design limits. | |||||
| 10:10:2.0.1.1.6.6.89.3 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | F | Subpart F—Performance Confirmation Program | § 60.142 Design testing. | NRC | (a) During the early or developmental stages of construction, a program for in situ testing of such features as borehole and shaft seals, backfill, and the thermal interaction effects of the waste packages, backfill, rock, and groundwater shall be conducted. (b) The testing shall be initiated as early as is practicable. (c) A backfill test section shall be constructed to test the effectiveness of backfill placement and compaction procedures against design requirements before permanent backfill placement is begun. (d) Test sections shall be established to test the effectiveness of borehole and shaft seals before full-scale operation proceeds to seal boreholes and shafts. | |||||
| 10:10:2.0.1.1.6.6.89.4 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | F | Subpart F—Performance Confirmation Program | § 60.143 Monitoring and testing waste packages. | NRC | (a) A program shall be established at the geologic repository operations area for monitoring the condition of the waste packages. Waste packages chosen for the program shall be representative of those to be emplaced in the underground facility. (b) Consistent with safe operation at the geologic repository operations area, the environment of the waste packages selected for the waste package monitoring program shall be representative of the environment in which the wastes are to be emplaced. (c) The waste package monitoring program shall include laboratory experiments which focus on the internal condition of the waste packages. To the extent practical, the environment experienced by the emplaced waste packages within the underground facility during the waste package monitoring program shall be duplicated in the laboratory experiments. (d) The waste package monitoring program shall continue as long as practical up to the time of permanent closure. | |||||
| 10:10:2.0.1.1.6.7.89.1 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | G | Subpart G—Quality Assurance | § 60.150 Scope. | NRC | As used in this part, quality assurance comprises all those planned and systematic actions necessary to provide adequate confidence that the geologic repository and its subsystems or components will perform satisfactorily in service. Quality assurance includes quality control, which comprises those quality assurance actions related to the physical characteristics of a material, structure, component, or system which provide a means to control the quality of the material, structure, component, or system to predetermined requirements. | |||||
| 10:10:2.0.1.1.6.7.89.2 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | G | Subpart G—Quality Assurance | § 60.151 Applicability. | NRC | The quality assurance program applies to all systems, structures and components important to safety, to design and characterization of barriers important to waste isolation and to activities related thereto. These activities include: site characterization, facility and equipment construction, facility operation, performance confirmation, permanent closure, and decontamination and dismantling of surface facilities. | |||||
| 10:10:2.0.1.1.6.7.89.3 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | G | Subpart G—Quality Assurance | § 60.152 Implementation. | NRC | DOE shall implement a quality assurance program based on the criteria of appendix B of 10 CFR part 50 as applicable, and appropriately supplemented by additional criteria as required by § 60.151. | |||||
| 10:10:2.0.1.1.6.8.89.1 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | H | Subpart H—Training and Certification of Personnel | § 60.160 General requirements. | NRC | Operations of systems and components that have been identified as important to safety in the Safety Analysis Report and in the license shall be performed only by trained and certified personnel or by personnel under the direct visual supervision of an individual with training and certification in such operation. Supervisory personnel who direct operations that are important to safety must also be certified in such operations. | |||||
| 10:10:2.0.1.1.6.8.89.2 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | H | Subpart H—Training and Certification of Personnel | § 60.161 Training and certification program. | NRC | DOE shall establish a program for training, proficiency testing, certification and requalification of operating and supervisory personnel. | |||||
| 10:10:2.0.1.1.6.8.89.3 | 10 | Energy | I | 60 | PART 60—DISPOSAL OF HIGH-LEVEL RADIOACTIVE WASTES IN GEOLOGIC REPOSITORIES | H | Subpart H—Training and Certification of Personnel | § 60.162 Physical requirements. | NRC | The physical condition and the general health of personnel certified for operations that are important to safety shall not be such as might cause operational errors that could endanger the public health and safety. Any condition which might cause impaired judgment or motor coordination must be considered in the selection of personnel for activities that are important to safety. These conditions need not categorically disqualify a person, so long as appropriate provisions are made to accommodate such conditions. | |||||
| 14:14:2.0.1.1.1.0.1.1 | 14 | Aeronautics and Space | I | D | 60 | PART 60—FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE | § 60.1 Applicability. | FAA | [Docket FAA-2002-12461, 71 FR 63426, Oct. 30, 2006, as amended by Docket FAA-2023-1275; Amdt. 60-8, 89 FR 92483, Nov. 21, 2024] | (a) This part prescribes the rules governing the initial and continuing qualification and use of all aircraft flight simulation training devices (FSTD) used for meeting training, evaluation, or flight experience requirements of this chapter for flight crewmember certification or qualification. Additional requirements for FSTD representing powered-lift are set forth in part 194 of this chapter. (b) The rules of this part apply to each person using or applying to use an FSTD to meet any requirement of this chapter. (c) The requirements of § 60.33 regarding falsification of applications, records, or reports also apply to each person who uses an FSTD for training, evaluation, or obtaining flight experience required for flight crewmember certification or qualification under this chapter. | |||||
| 14:14:2.0.1.1.1.0.1.10 | 14 | Aeronautics and Space | I | D | 60 | PART 60—FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE | § 60.14 Special equipment and personnel requirements for qualification of the FSTD. | FAA | [Docket FAA-2002-12461, 71 FR 63426, Oct. 30, 2006, as amended by Docket FAA-2022-1355, Amdt. 60-7, 87 FR 75711, Dec. 9, 2022] | When notified by the responsible Flight Standards office, the sponsor must make available all special equipment and qualified personnel needed to accomplish or assist in the accomplishment of tests during initial qualification, continuing qualification, or special evaluations. | |||||
| 14:14:2.0.1.1.1.0.1.11 | 14 | Aeronautics and Space | I | D | 60 | PART 60—FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE | § 60.15 Initial qualification requirements. | FAA | [Docket FAA-2002-12461, 71 FR 63426, Oct. 30, 2006, as amended by Docket FAA-2014-0391, Amdt. 60-4, 81 FR 18217, Mar. 30, 2016; Docket FAA-2022-1355, Amdt. 60-7, 87 FR 75711, Dec. 9, 2022] | (a) For each FSTD, the sponsor must submit a request to the responsible Flight Standards office to evaluate the FSTD for initial qualification at a specific level and simultaneously request the Training Program Approval Authority (TPAA) forward a concurring letter to the responsible Flight Standards office. The request must be submitted in the form and manner described in the applicable QPS. (b) The management representative described in § 60.9(c) must sign a statement (electronic signature is acceptable for electronic transmissions) after confirming the following: (1) The performance and handling qualities of the FSTD represent those of the aircraft or set of aircraft within the normal operating envelope. This determination must be made by a pilot(s) meeting the requirements of paragraph (d) of this section after having flown all of the Operations Tasks listed in the applicable QPS appendix relevant to the qualification level of the FSTD. Exceptions, if any, must be noted. The name of the person(s) making this determination must be available to the responsible Flight Standards office upon request. (2) The FSTD systems and sub-systems (including the simulated aircraft systems) functionally represent those in the aircraft or set of aircraft. This determination must be made by the pilot(s) described in paragraph (b)(1) of this section, or by a person(s) trained on simulator systems/sub-systems and trained on the operation of the simulated aircraft systems, after having exercised the operation of the FSTD and the pertinent functions available through the Instructor Operating Station(s). Exceptions, if any, must be noted. The name of the person(s) making this determination must be available to the responsible Flight Standards office upon request. (3) The cockpit represents the configuration of the specific type; or aircraft make, model, and series aircraft being simulated, as appropriate. This determination must be made by the pilot(s) described in paragraph (b)(1) of this section, or by a person(s) trained on th… | |||||
| 14:14:2.0.1.1.1.0.1.12 | 14 | Aeronautics and Space | I | D | 60 | PART 60—FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE | § 60.16 Additional qualifications for a currently qualified FSTD. | FAA | [Docket FAA-2002-12461, 71 FR 63426, Oct. 30, 2006, as amended by Docket FAA-2022-1355, Amdt. 60-7, 87 FR 75711, Dec. 9, 2022] | (a) A currently qualified FSTD is required to undergo an additional qualification process if a user intends to use the FSTD for meeting training, evaluation, or flight experience requirements of this chapter beyond the qualification issued for that FSTD. This process consists of the following: (1) The sponsor: (i) Must submit to the responsible Flight Standards office all modifications to the MQTG that are required to support the additional qualification. (ii) Must describe to the responsible Flight Standards office all modifications to the FSTD that are required to support the additional qualification. (iii) Must submit to the responsible Flight Standards office a confirmation statement as described in § 60.15(c) that a pilot, designated by the sponsor in accordance with § 60.15(d), has subjectively evaluated the FSTD in those areas not previously evaluated. (2) The FSTD must successfully pass an evaluation— (i) Consisting of all the elements of an initial evaluation for qualification in those circumstances where the responsible Flight Standards office has determined that all the elements of an initial evaluation for qualification is necessary; or (ii) Consisting of those elements of an initial evaluation for qualification designated as necessary by the responsible Flight Standards office. (b) In making the determinations described in paragraph (a)(2) of this section, the responsible Flight Standards office considers factors including the existing qualification of the FSTD, any modifications to the FSTD hardware or software that are involved, and any additions or modifications to the MQTG. (c) The FSTD is qualified for the additional uses when the responsible Flight Standards office issues an amended Statement of Qualification in accordance with § 60.15(h). (d) The sponsor may not modify the FSTD except as described in § 60.23. | |||||
| 14:14:2.0.1.1.1.0.1.13 | 14 | Aeronautics and Space | I | D | 60 | PART 60—FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE | § 60.17 Previously qualified FSTDs. | FAA | [Docket FAA-2002-12461, 71 FR 63426, Oct. 30, 2006; Amdt. 60-2, 72 FR 59599, Oct. 22, 2007, as amended by Docket FAA-2014-0391, Amdt. 60-4, 81 FR 18218, Mar. 30, 2016; Docket FAA-2022-1355, Amdt. 60-7, 87 FR 75711, Dec. 9, 2022] | (a) Unless otherwise specified by an FSTD Directive, further referenced in the applicable QPS, or as specified in paragraph (e) of this section, an FSTD qualified before May 31, 2016 will retain its qualification basis as long as it continues to meet the standards, including the objective test results recorded in the MQTG and subjective tests, under which it was originally evaluated, regardless of sponsor. The sponsor of such an FSTD must comply with the other applicable provisions of this part. (b) For each FSTD qualified before May 30, 2008, no sponsor may use or allow the use of or offer the use of such an FSTD after May 30, 2014 for flight crewmember training, evaluation or flight experience to meet any of the requirements of this chapter, unless that FSTD has been issued a Statement of Qualification, including the Configuration List and the List of Qualified Tasks in accordance with the procedures set out in the applicable QPS. (c) If the FSTD qualification is lost under § 60.27 and— (i) Restored under § 60.27 in less than (2) years, then the qualification basis (in terms of objective tests and subjective tests) for the re-qualification will be those against which the FSTD was originally evaluated and qualified. (ii) Not restored under § 60.27 for two (2) years or more, then the qualification basis (in terms of objective tests and subjective tests) for the re-qualification will be those standards in effect and current at the time of re-qualification application. (d) Except as provided in paragraph (e) of this section, any change in FSTD qualification level initiated on or after May 30, 2008 requires an evaluation for initial qualification in accordance with this part. (e) A sponsor may request that an FSTD be permanently downgraded. In such a case, the responsible Flight Standards office may downgrade a qualified FSTD without requiring and without conducting an initial evaluation for the new qualification level. Subsequent continuing qualification evaluations will use the existing MQTG, modified as nec… | |||||
| 14:14:2.0.1.1.1.0.1.14 | 14 | Aeronautics and Space | I | D | 60 | PART 60—FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE | § 60.19 Inspection, continuing qualification evaluation, and maintenance requirements. | FAA | [Docket FAA-2002-12461, 71 FR 63426, Oct. 30, 2006, as amended by Docket FAA-2014-0391, Amdt. 60-4, 81 FR 18218, Mar. 30, 2016; Docket FAA-2022-1355, Amdt. 60-7, 87 FR 75711, Dec. 9, 2022] | (a) Inspection. No sponsor may use or allow the use of or offer the use of an FSTD for flight crewmember training, evaluation, or flight experience to meet any of the requirements of this chapter unless the sponsor does the following: (1) Accomplishes all appropriate objective tests each year as specified in the applicable QPS. (2) Completes a functional preflight check within the preceding 24 hours. (b) Continuing qualification evaluation. (1) This evaluation consists of objective tests, and subjective tests, including general FSTD requirements, as described in the applicable QPS or as may be amended by an FSTD Directive. (2) The sponsor must contact the responsible Flight Standards office to schedule the FSTD for continuing qualification evaluations not later than 60 days before the evaluation is due. (3) The sponsor must provide the responsible Flight Standards office responsible Flight Standards office access to the objective test results in the MQTG and access to the FSTD for the length of time necessary for the responsible Flight Standards office to complete the required continuing qualification evaluations. (4) The frequency of the responsible Flight Standards office-conducted continuing qualification evaluations for each FSTD will be established by the responsible Flight Standards office and specified in the Statement of Qualification. (5) Continuing qualification evaluations conducted in the 3 calendar months before or after the calendar month in which these continuing qualification evaluations are required will be considered to have been conducted in the calendar month in which they were required. (6) No sponsor may use or allow the use of or offer the use of an FSTD for flight crewmember training or evaluation or for obtaining flight experience for the flight crewmember to meet any requirement of this chapter unless the FSTD has passed a responsible Flight Standards office-conducted continuing qualification evaluation within the time frame specified in the Statement of Qualification or with… | |||||
| 14:14:2.0.1.1.1.0.1.15 | 14 | Aeronautics and Space | I | D | 60 | PART 60—FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE | § 60.20 Logging FSTD discrepancies. | FAA | Each instructor, check airman, or representative of the Administrator conducting training, evaluation, or flight experience, and each person conducting the preflight inspection who discovers a discrepancy, including any missing, malfunctioning, or inoperative components in the FSTD, must write or cause to be written a description of that discrepancy into the discrepancy log at the end of the FSTD preflight or FSTD use session. | ||||||
| 14:14:2.0.1.1.1.0.1.16 | 14 | Aeronautics and Space | I | D | 60 | PART 60—FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE | § 60.21 Interim qualification of FSTDs for new aircraft types or models. | FAA | [Docket FAA-2002-12461, 71 FR 63426, Oct. 30, 2006, as amended by Docket FAA-2022-1355, Amdt. 60-7, 87 FR 75711, Dec. 9, 2022] | (a) A sponsor may apply for and the responsible Flight Standards office may issue an interim qualification level for an FSTD for a new type or model of aircraft, even though the aircraft manufacturer's aircraft data package is preliminary, if the sponsor provides the following to the satisfaction of the responsible Flight Standards office— (1) The aircraft manufacturer's data, which consists of at least predicted data, validated by a limited set of flight test data; (2) The aircraft manufacturer's description of the prediction methodology used to develop the predicted data; and (3) The QTG test results. (b) An FSTD that has been issued interim qualification is deemed to have been issued initial qualification unless the responsible Flight Standards office rescinds the qualification. Interim qualification terminates two years after its issuance, unless the responsible Flight Standards office determines that specific conditions warrant otherwise. (c) Within twelve months of the release of the final aircraft data package by the aircraft manufacturer, but no later than two years after the issuance of the interim qualification status, the sponsor must apply for initial qualification in accordance with § 60.15 based on the final aircraft data package approved by the aircraft manufacturer, unless the responsible Flight Standards office determines that specific conditions warrant otherwise. (d) An FSTD with interim qualification may be modified only in accordance with § 60.23. | |||||
| 14:14:2.0.1.1.1.0.1.17 | 14 | Aeronautics and Space | I | D | 60 | PART 60—FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE | § 60.23 Modifications to FSTDs. | FAA | [Docket FAA-2002-12461, 71 FR 63426, Oct. 30, 2006, as amended by Docket FAA-2014-0391, Amdt. 60-4, 81 FR 18218, Mar. 30, 2016; Docket FAA-2022-1355, Amdt. 60-7, 87 FR 75711, Dec. 9, 2022] | (a) Description of a modification. For the purposes of this part, an FSTD is said to have been modified when: (1) Equipment or devices intended to simulate aircraft appliances are added to or removed from FSTD, which change the Statement of Qualification or the MQTG; or (2) Changes are made to either software or hardware that are intended to impact flight or ground dynamics; changes are made that impact performance or handling characteristics of the FSTD (including motion, visual, control loading, or sound systems for those FSTD levels requiring sound tests and measurements); or changes are made to the MQTG. Changes to the MQTG which do not affect required objective testing results or validation data approved during the initial evaluation of the FSTD are not considered modifications under this section. (b) FSTD Directive. When the FAA determines that FSTD modification is necessary for safety of flight reasons, the sponsor of each affected FSTD must ensure that the FSTD is modified according to the FSTD Directive regardless of the original qualification standards applicable to any specific FSTD. (c) Using the modified FSTD. The sponsor may not use, or allow the use of, or offer the use of, the FSTD with the proposed modification for flight crewmember training or evaluation or for obtaining flight experience for the flight crewmember to meet any requirement of this chapter unless: (1) The sponsor has notified the responsible Flight Standards office and the TPAA of their intent to incorporate the proposed modification, and one of the following has occurred; (i) Twenty-one days have passed since the sponsor notified the responsible Flight Standards office and the TPAA of the proposed modification and the sponsor has not received any response from either the responsible Flight Standards office or the TPAA; (ii) Twenty-one days have passed since the sponsor notified the responsible Flight Standards office and the TPAA of the proposed modification and one has approved the proposed modification and the other… | |||||
| 14:14:2.0.1.1.1.0.1.18 | 14 | Aeronautics and Space | I | D | 60 | PART 60—FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE | § 60.25 Operation with missing, malfunctioning, or inoperative components. | FAA | [Docket FAA-2002-12461, 71 FR 63426, Oct. 30, 2006, as amended by Docket FAA-2022-1355, Amdt. 60-7, 87 FR 75711, Dec. 9, 2022] | (a) No person may knowingly use or allow the use of or misrepresent the capability of an FSTD for any maneuver, procedure, or task that is to be accomplished to meet training, evaluation, or flight experience requirements of this chapter for flight crewmember certification or qualification when there is a missing, malfunctioning, or inoperative (MMI) component that is required to be present and correctly operate for the satisfactory completion of that maneuver, procedure, or task. (b) Each MMI component as described in paragraph (a) of this section, or any MMI component installed and required to operate correctly to meet the current Statement of Qualification, must be repaired or replaced within 30 calendar days, unless otherwise required or authorized by the responsible Flight Standards office. (c) A list of the current MMI components must be readily available in or adjacent to the FSTD for review by users of the device. Electronic access to this list via an appropriate terminal or display in or adjacent to the FSTD is satisfactory. The discrepancy log may be used to satisfy this requirement provided each currently MMI component is listed in the discrepancy log. | |||||
| 14:14:2.0.1.1.1.0.1.19 | 14 | Aeronautics and Space | I | D | 60 | PART 60—FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE | § 60.27 Automatic loss of qualification and procedures for restoration of qualification. | FAA | [Docket FAA-2002-12461, 71 FR 63426, Oct. 30, 2006, as amended by Docket FAA-2022-1355, Amdt. 60-7, 87 FR 75711, Dec. 9, 2022] | (a) An FSTD qualification is automatically lost when any of the following occurs: (1) The FSTD is not used in the sponsor's FAA-approved flight training program in accordance with § 60.7(b)(5) or (b)(6) and the sponsor does not obtain and maintain the written statement as described in § 60.7(d)(2). (2) The FSTD is not inspected in accordance with § 60.19. (3) The FSTD is physically moved from one location and installed in a different location, regardless of distance. (4) The MQTG is missing or otherwise not available and a replacement is not made within 30 days. (b) If FSTD qualification is lost under paragraph (a) of this section, qualification is restored when either of the following provisions is met: (1) The FSTD successfully passes an evaluation: (i) For initial qualification, in accordance with §§ 60.15 and 60.17(c) in those circumstances where the responsible Flight Standards office has determined that a full evaluation for initial qualification is necessary; or (ii) For those elements of an evaluation for initial qualification, in accordance with §§ 60.15 and 60.17(c), as determined to be necessary by the responsible Flight Standards office. (2) The responsible Flight Standards office advises the sponsor that an evaluation is not necessary. (c) In making the determinations described in paragraph (b) of this section, the responsible Flight Standards office considers factors including the number of continuing qualification evaluations missed, the number of sponsor-conducted quarterly inspections missed, and the care that had been taken of the device since the last evaluation. | |||||
| 14:14:2.0.1.1.1.0.1.2 | 14 | Aeronautics and Space | I | D | 60 | PART 60—FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE | § 60.2 Applicability of sponsor rules to persons who are not sponsors and who are engaged in certain unauthorized activities. | FAA | (a) The rules of this part that are directed to a sponsor of an FSTD also apply to any person who uses or causes the use of an FSTD when— (1) That person knows that the FSTD does not have an FAA-approved sponsor; and (2) The use of the FSTD by that person is nonetheless claimed for purposes of meeting any requirement of this chapter or that person knows or should have known that the person's acts or omissions would cause another person to mistakenly credit use of the FSTD for purposes of meeting any requirement of this chapter. (b) A situation in which paragraph (a) of this section would not apply to a person would be when each of the following conditions are met: (1) The person sold or leased the FSTD and merely represented to the purchaser or lessee that the FSTD is in a condition in which it should be able to obtain FAA approval and qualification under this part; (2) The person does not falsely claim to be the FAA-approved sponsor for the FSTD; (3) The person does not falsely make representations that someone else is the FAA-approved sponsor of the FSTD at a time when that other person is not the FAA-approved sponsor of the FSTD; and (4) The person's acts or omissions do not cause another person to detrimentally rely on such acts or omissions for the mistaken conclusion that the FSTD is FAA-approved and qualified under this part at the time the FSTD is sold or leased. | ||||||
| 14:14:2.0.1.1.1.0.1.20 | 14 | Aeronautics and Space | I | D | 60 | PART 60—FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE | § 60.29 Other losses of qualification and procedures for restoration of qualification. | FAA | [Docket FAA-2002-12461, 71 FR 63426, Oct. 30, 2006, as amended by Docket FAA-2018-0119, Amdt. 60-5, 83 FR 9170, Mar. 5, 2018; Docket FAA-2022-1355, Amdt. 60-7, 87 FR 75711, Dec. 9, 2022] | (a) Except as provided in paragraph (c) of this section, when the responsible Flight Standards office determines that the FSTD no longer meets qualification standards, the following procedure applies: (1) The responsible Flight Standards office notifies the sponsor in writing that the FSTD no longer meets some or all of its qualification standards. (2) The responsible Flight Standards office sets a reasonable period (but not less than 7 days) within which the sponsor may submit written information, views, and arguments on the FSTD qualification. (3) After considering all material presented, the responsible Flight Standards office notifies the sponsor about the determination with regard to the qualification of the FSTD. (4) When the responsible Flight Standards office notifies the sponsor that some or all of the FSTD is no longer qualified, the action described in the notification becomes effective not less than 30 days after the sponsor receives that notice unless— (i) The responsible Flight Standards office finds under paragraph (c) of this section that there is an emergency requiring immediate action with respect to safety in air commerce; or (ii) The sponsor petitions the Executive Director of Flight Standards Service for reconsideration of the responsible Flight Standards office finding under paragraph (b) of this section. (b) When a sponsor seeks reconsideration of a decision from the responsible Flight Standards office concerning the FSTD qualification, the following procedure applies: (1) The sponsor must petition for reconsideration of that decision within 30 days of the date that the sponsor receives a notice that some or all of the FSTD is no longer qualified. (2) The sponsor must address its petition to the Executive Director, Flight Standards Service, Federal Aviation Administration, 800 Independence Ave., SW., Washington, DC 20591. (3) A petition for reconsideration, if filed within the 30-day period, suspends the effectiveness of the determination by the responsible Flight Standards office… | |||||
| 14:14:2.0.1.1.1.0.1.21 | 14 | Aeronautics and Space | I | D | 60 | PART 60—FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE | § 60.31 Recordkeeping and reporting. | FAA | [Docket FAA-2002-12461, 71 FR 63426, Oct. 30, 2006, as amended by Docket FAA-2022-1355, Amdt. 60-7, 87 FR 75711, Dec. 9, 2022] | (a) The FSTD sponsor must maintain the following records for each FSTD it sponsors: (1) The MQTG and each amendment thereto. (2) A record of all FSTD modifications affected under § 60.23 since the issuance of the original Statement of Qualification. (3) A copy of all of the following: (i) Results of the qualification evaluations (initial and each upgrade) since the issuance of the original Statement of Qualification. (ii) Results of the objective tests conducted in accordance with § 60.19(a) for a period of 2 years. (iii) Results of the previous three continuing qualification evaluations, or the continuing qualification evaluations from the previous 2 years, whichever covers a longer period. (iv) Comments obtained in accordance with § 60.9(b) for a period of at least 90 days. (4) A record of all discrepancies entered in the discrepancy log over the previous 2 years, including the following: (i) A list of the components or equipment that were or are missing, malfunctioning, or inoperative. (ii) The action taken to correct the discrepancy. (iii) The date the corrective action was taken. (iv) The identity of the person determining that the discrepancy has been corrected. (b) The records specified in this section must be maintained in plain language form or in coded form if the coded form provides for the preservation and retrieval of information in a manner acceptable to the responsible Flight Standards office. | |||||
| 14:14:2.0.1.1.1.0.1.22 | 14 | Aeronautics and Space | I | D | 60 | PART 60—FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE | § 60.33 [Reserved] | FAA | |||||||
| 14:14:2.0.1.1.1.0.1.23 | 14 | Aeronautics and Space | I | D | 60 | PART 60—FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE | § 60.35 Specific full flight simulator compliance requirements. | FAA | (a) No device will be eligible for initial or upgrade qualification to a FFS at Level C or Level D under this part unless it includes the equipment and appliances installed and operating to the extent necessary for the issuance of an airman certificate or rating. (b) No device will be eligible for initial or upgrade qualification to a FFS at Level A or Level B under this part unless it includes the equipment and appliances installed and operating to the extent necessary for the training, testing, and/or checking that comprise the simulation portion of the requirements for issuance of an airman certificate or rating. | ||||||
| 14:14:2.0.1.1.1.0.1.24 | 14 | Aeronautics and Space | I | D | 60 | PART 60—FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE | § 60.37 FSTD qualification on the basis of a Bilateral Aviation Safety Agreement (BASA). | FAA | [Docket FAA-2002-12461, 71 FR 63426, Oct. 30, 2006, as amended by Docket FAA-2022-1355, Amdt. 60-7, 87 FR 75711, Dec. 9, 2022] | (a) The evaluation and qualification of an FSTD by a contracting State to the Convention on International Civil Aviation for the sponsor of an FSTD located in that contracting State may be used as the basis for issuing a U.S. statement of qualification (see applicable QPS, attachment 4, figure 4) by the responsible Flight Standards office to the sponsor of that FSTD in accordance with— (1) A BASA between the United States and the Contracting State that issued the original qualification; and (2) A Simulator Implementation Procedure (SIP) established under the BASA. (b) The SIP must contain any conditions and limitations on validation and issuance of such qualification by the U.S. | |||||
| 14:14:2.0.1.1.1.0.1.3 | 14 | Aeronautics and Space | I | D | 60 | PART 60—FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE | § 60.3 Definitions. | FAA | In addition to the definitions in part 1 of this chapter, other terms and definitions applicable to this part are found in appendix F of this part. | ||||||
| 14:14:2.0.1.1.1.0.1.4 | 14 | Aeronautics and Space | I | D | 60 | PART 60—FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE | § 60.4 Qualification Performance Standards. | FAA | The Qualification Performance Standards (QPS) are published in appendices to this part as follows: (a) Appendix A contains the QPS for Airplane Flight Simulators. (b) Appendix B contains the QPS for Airplane Flight Training Devices. (c) Appendix C contains the QPS for Helicopter Flight Simulators. (d) Appendix D contains the QPS for Helicopter Flight Training Devices. (e) Appendix E contains the QPS for Quality Management Systems for FSTDs. (f) Appendix F contains the QPS for Definitions and Abbreviations for FSTDs. | ||||||
| 14:14:2.0.1.1.1.0.1.5 | 14 | Aeronautics and Space | I | D | 60 | PART 60—FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE | § 60.5 Quality management system. | FAA | [Docket FAA-2002-12461, 71 FR 63426, Oct. 30, 2006; Amdt. 60-2, 72 FR 59599, Oct. 22, 2007, as amended by Docket FAA-2018-0119, Amdt. 60-5, 83 FR 9170, Mar. 5, 2018; Docket FAA-2022-1355, Amdt. 60-7, 87 FR 75711, Dec. 9, 2022] | (a) After May 30, 2010, no sponsor may use or allow the use of or offer the use of an FSTD for flight crewmember training or evaluation or for obtaining flight experience to meet any requirement of this chapter unless the sponsor has established and follows a quality management system (QMS), currently approved by the responsible Flight Standards office, for the continuing surveillance and analysis of the sponsor's performance and effectiveness in providing a satisfactory FSTD for use on a regular basis as described in QPS appendix E of this part. (b) The QMS program must provide a process for identifying deficiencies in the program and for documenting how the program will be changed to address these deficiencies. (c) Whenever the responsible Flight Standards office finds that the QMS program does not adequately address the procedures necessary to meet the requirements of this part, the sponsor must, after notification by the responsible Flight Standards office, change the program so the procedures meet the requirements of this part. Each such change must be approved by the responsible Flight Standards office prior to implementation. (d) Within 30 days after the sponsor receives a notice described in paragraph (c) of this section, the sponsor may file a petition with the Executive Director of Flight Standards Service (the Executive Director) for reconsideration of the responsible Flight Standards office finding. The sponsor must address its petition to the Executive Director, Flight Standards Service, Federal Aviation Administration, 800 Independence Ave., SW., Washington, DC 20591. The filing of such a petition to reconsider stays the notice pending a decision by the Executive Director. However, if the Executive Director finds that there is a situation that requires immediate action in the interest of safety in air commerce, he may, upon a statement of the reasons, require a change effective without stay. | |||||
| 14:14:2.0.1.1.1.0.1.6 | 14 | Aeronautics and Space | I | D | 60 | PART 60—FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE | § 60.7 Sponsor qualification requirements. | FAA | [Docket FAA-2002-12461, 71 FR 63426, Oct. 30, 2006; Amdt. 60-2, 72 FR 59599, Oct. 22, 2007, as amended by Docket FAA-2022-1355, Amdt. 60-7, 87 FR 75711, Dec. 9, 2022] | (a) A person is eligible to apply to be a sponsor of an FSTD if the following conditions are met: (1) The person holds, or is an applicant for, a certificate under part 119, 141, or 142 of this chapter; or holds, or is an applicant for, an approved flight engineer course in accordance with part 63 of this chapter. (2) The FSTD will be used, or will be offered for use, in the sponsor's FAA-approved flight training program for the aircraft being simulated as evidenced in a request for evaluation submitted to the responsible Flight Standards office. (b) A person is a sponsor if the following conditions are met: (1) The person is a certificate holder under part 119, 141, or 142 of this chapter or has an approved flight engineer course in accordance with part 63 of this chapter. (2) The person has— (i) Operations specifications authorizing the use of the specific aircraft or set of aircraft and has an FAA-approved training program under which at least one FSTD, simulating the aircraft or set of aircraft and for which the person is the sponsor, is used by the sponsor as described in paragraphs (b)(5) or (b)(6) of this section; or (ii) Training specifications or an FAA-approved course of training under which at least one FSTD, simulating that aircraft or set of aircraft and for which the person is the sponsor, is used by the sponsor as described in paragraphs (b)(5) or (b)(6) of this section. (3) The person has a quality management system currently approved by the responsible Flight Standards office in accordance with § 60.5. (4) The responsible Flight Standards office has accepted the person as the sponsor of the FSTD and that acceptance has not been withdrawn by the FAA. (5) At least one FSTD (as referenced in paragraph (b)(2)(i) or (b)(2)(ii) of this section) that is initially qualified on or after May 30, 2008, is used within the sponsor's FAA-approved flight training program for the aircraft or set of aircraft at least once within the 12-month period following the initial/upgrade evaluation, and at least … | |||||
| 14:14:2.0.1.1.1.0.1.7 | 14 | Aeronautics and Space | I | D | 60 | PART 60—FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE | § 60.9 Additional responsibilities of the sponsor. | FAA | [Docket FAA-2002-12461, 71 FR 63426, Oct. 30, 2006, as amended by Docket FAA-2022-1355, Amdt. 60-7, 87 FR 75711, Dec. 9, 2022] | (a) The sponsor must allow the responsible Flight Standards office upon request to inspect the FSTD as soon as practicable. This inspection may include all records and documents relating to the FSTD, to determine its compliance with this part. (b) The sponsor must do the following for each FSTD: (1) Establish a mechanism to receive written comments regarding the FSTD and its operation in accordance with the QPS appendix E of this part. (2) Post in or adjacent to the FSTD the Statement of Qualification issued by the responsible Flight Standards office. An electronic copy of the Statement of Qualification that may be accessed by an appropriate terminal or display in or adjacent to the FSTD is satisfactory. (c) Each sponsor of an FSTD must identify to the responsible Flight Standards office by name, one individual to be the management representative (MR). (1) One person may serve as an MR for more than one FSTD, but one FSTD must not have more than one person serving in this capacity. (2) Each MR must be an employee of the sponsor with the responsibility and authority to— (i) Monitor the on-going qualification of assigned FSTDs to ensure that all matters regarding FSTD qualification are being carried out as provided for in this part; (ii) Ensure that the QMS is properly established, implemented, and maintained by overseeing the structure (and modifying where necessary) of the QMS policies, practices, and procedures; and (iii) Regularly brief sponsor's management on the status of the on-going FSTD qualification program and the effectiveness and efficiency of the QMS. (3) The MR serves as the primary contact point for all matters between the sponsor and the responsible Flight Standards office regarding the qualification of that FSTD as provided for in this part. (4) The MR may delegate the duties described in paragraph (c)(2) and (c)(3) of this section to an individual at each of the sponsor's locations. | |||||
| 14:14:2.0.1.1.1.0.1.8 | 14 | Aeronautics and Space | I | D | 60 | PART 60—FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE | § 60.11 FSTD use. | FAA | [Docket FAA-2002-12461, 71 FR 63426, Oct. 30, 2006, as amended by Docket FAA-2022-1355, Amdt. 60-7, 87 FR 75711, Dec. 9, 2022] | No person may use or allow the use of or offer the use of an FSTD for flight crewmember training or evaluation or for obtaining flight experience to meet any of the requirements under this chapter unless, in accordance with the QPS for the specific device, the FSTD meets all of the following: (a) Has a single sponsor who is qualified under § 60.7. The sponsor may arrange with another person for services of document preparation and presentation, as well as FSTD inspection, maintenance, repair, and servicing; however, the sponsor remains responsible for ensuring that these functions are conducted in a manner and with a result of continually meeting the requirements of this part. (b) Is qualified as described in the Statement of Qualification. (c) Remains qualified, through satisfactory inspection, continuing qualification evaluations, appropriate maintenance, and use requirements in accordance with this part and the applicable QPS. (d) Functions during day-to-day training, evaluation, or flight experience activities with the software and hardware that was evaluated as satisfactory by the responsible Flight Standards office and, if modified, modified only in accordance with the provisions of this part. However, this section does not apply to routine software or hardware changes that do not fall under the requirements of § 60.23. (e) Is operated in accordance with the provisions and limitations of § 60.25. | |||||
| 14:14:2.0.1.1.1.0.1.9 | 14 | Aeronautics and Space | I | D | 60 | PART 60—FLIGHT SIMULATION TRAINING DEVICE INITIAL AND CONTINUING QUALIFICATION AND USE | § 60.13 FSTD objective data requirements. | FAA | [Docket FAA-2002-12461, 71 FR 63426, Oct. 30, 2006, as amended by Docket FAA-2022-1355, Amdt. 60-7, 87 FR 75711, Dec. 9, 2022] | (a) Except as provided in paragraph (b) and (c) of this section, for the purposes of validating FSTD performance and handling qualities during evaluation for qualification, the data made available to the responsible Flight Standards office (the validation data package) must include the aircraft manufacturer's flight test data and all relevant data developed after the type certificate was issued ( e.g. , data developed in response to an airworthiness directive) if such data results from a change in performance, handling qualities, functions, or other characteristics of the aircraft that must be considered for flight crewmember training, evaluation, or for meeting experience requirements of this chapter. (b) The validation data package may contain flight test data from a source in addition to or independent of the aircraft manufacturer's data in support of an FSTD qualification, but only if this data is gathered and developed by that source in accordance with flight test methods, including a flight test plan, as described in the applicable QPS. (c) The validation data package may also contain predicted data, engineering simulation data, data from pilot owner or pilot operating manuals, or data from public domain sources, provided this data is acceptable to the responsible Flight Standards office. If found acceptable the data may then be used in particular applications for FSTD qualification. (d) Data or other material or elements must be submitted in a form and manner acceptable to the responsible Flight Standards office. (e) The responsible Flight Standards office may require additional objective data, which may include flight testing if necessary, if the validation data package does not support FSTD qualification requirements as described in this part and the applicable QPS appendix. (f) When an FSTD sponsor learns, or is advised by an aircraft manufacturer or other data provider, that an addition to, an amendment to, or a revision of data that may relate to FSTD performance or handling characteristics is av… | |||||
| 21:21:1.0.1.1.24.1.98.1 | 21 | Food and Drugs | I | A | 60 | PART 60—PATENT TERM RESTORATION | A | Subpart A—General Provisions | § 60.1 Scope. | FDA | [53 FR 7305, Mar. 7, 1988, as amended at 57 FR 56261, Nov. 27, 1992] | (a) This part sets forth procedures and requirements for the Food and Drug Administration's review of applications for the extension of the term of certain patents under 35 U.S.C. 156. Patent term restoration is available for certain patents related to drug products (as defined in 35 U.S.C. 156(f)(2)), and to medical devices, food additives, or color additives subject to regulation under the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act. Food and Drug Administration actions in this area include: (1) Assisting the United States Patent and Trademark Office in determining eligibility for patent term restoration; (2) Determining the length of a product's regulatory review period; (3) If petitioned, reviewing and ruling on due diligence challenges to the Food and Drug Administration's regulatory review period determinations; and (4) Conducting hearings to review initial Food and Drug Administration findings on due diligence challenges. (b) References in this part to the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted. | |||
| 21:21:1.0.1.1.24.1.98.2 | 21 | Food and Drugs | I | A | 60 | PART 60—PATENT TERM RESTORATION | A | Subpart A—General Provisions | § 60.2 Purpose. | FDA | (a) The purpose of this part is to establish a thorough yet efficient process for the Food and Drug Administration review of patent term restoration applications. To achieve this purpose, the regulations are intended to: (1) Facilitate determinations of patent term restoration eligibility and regulatory review period length, and (2) Ensure that parties interested in due diligence challenges will have an opportunity to participate in that process, including informal hearings. (b) The regulations are intended to complement those promulgated by the United States Patent and Trademark Office to implement those parts of the law which are under that agency's jurisdiction. These regulations shall be construed in light of these objectives. | ||||
| 21:21:1.0.1.1.24.1.98.3 | 21 | Food and Drugs | I | A | 60 | PART 60—PATENT TERM RESTORATION | A | Subpart A—General Provisions | § 60.3 Definitions. | FDA | [53 FR 7305, Mar. 7, 1988, as amended at 57 FR 56261, Nov. 27, 1992; 64 FR 399, Jan. 5, 1999] | (a) The definitions contained in 35 U.S.C. 156 apply to those terms when used in this part. (b) The following definitions of terms apply to this part: (1) The term Act means the Federal Food, Drug, and Cosmetic Act (secs. 201-901, 52 Stat. 1040 et seq. as amended (21 U.S.C. 301-392)). (2) Active ingredient means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or of animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect. (3) Applicant means any person who submits an application or an amendment or supplement to an application under 35 U.S.C. 156 seeking patent term restoration. (4) Application means an application for patent term restoration submitted under 35 U.S.C. 156. (5) Clinical investigation or study means any experiment that involves a test article and one or more subjects and that is either subject to requirements for prior submission to the Food and Drug Administration under section 505(i), 512(j), or 520(g) of the Federal Food, Drug, and Cosmetic Act, or is not subject to the requirements for prior submission to FDA under those sections of the Federal Food, Drug, and Cosmetic Act, but the results of which are intended to be submitted later to, or held for inspection by, FDA as part of an application for a research or marketing permit. The term does not include experiments that are subject to the provisions of part 58 regarding nonclinical laboratory studies. (6) Color additive means any substance that meets the definition in section 201(t) of the Act and which is subject to premarketing approval under section 721 of the Act. (7) Due diligence petition means a petition submitted under § 60.30(a). (8) FDA means the Food and Drug Administrati… | |||
| 21:21:1.0.1.1.24.2.98.1 | 21 | Food and Drugs | I | A | 60 | PART 60—PATENT TERM RESTORATION | B | Subpart B—Eligibility Assistance | § 60.10 FDA assistance on eligibility. | FDA | [57 FR 56261, Nov. 27, 1992] | (a) Upon written request from the U.S. Patent and Trademark Office, FDA will assist the U.S. Patent and Trademark Office in determining whether a patent related to a product is eligible for patent term restoration as follows: (1) Verifying whether the product was subject to a regulatory review period before its commercial marketing or use; (2) For human drug products, food additives, color additives, and medical devices, determining whether the permission for commercial marketing or use of the product after the regulatory review period is the first permitted commercial marketing or use of the product either: (i) Under the provision of law under which the regulatory review period occurred; or (ii) Under the process claimed in the patent when the patent claims a method of manufacturing the product that primarily uses recombinant deoxyribonucleic acid (DNA) technology in the manufacture of the product; (3) For animal drug products, determining whether the permission for commercial marketing or use of the product after the regulatory review period: (i) Is the first permitted commercial marketing or use of the product; or (ii) Is the first permitted commercial marketing or use of the product for administration to a food-producing animal, whichever is applicable, under the provision of law under which the regulatory review period occurred; (4) Informing the U.S. Patent and Trademark Office whether the patent term restoration application was submitted within 60 days after the product was approved for marketing or use, or, if the product is an animal drug approved for use in a food-producing animal, verifying whether the application was filed within 60 days of the first approval for marketing or use in a food-producing animal; and (5) Providing the U.S. Patent and Trademark Office with any other information relevant to the U.S. Patent and Trademark Office's determination of whether a patent related to a product is eligible for patent term restoration. (b) FDA will notify the U.S. Patent and Trademark Office of … | |||
| 21:21:1.0.1.1.24.3.98.1 | 21 | Food and Drugs | I | A | 60 | PART 60—PATENT TERM RESTORATION | C | Subpart C—Regulatory Review Period Determinations | § 60.20 FDA action on regulatory review period determinations. | FDA | [53 FR 7305, Mar. 7, 1988, as amended at 59 FR 14364, Mar. 28, 1994] | (a) FDA will consult its records and experts to verify the dates contained in the application and to determine the length of the product's regulatory review period under § 60.22. The application shall contain information relevant to the determination of the regulatory review period as stated in the “Guidelines for Extension of Patent Term Under 35 U.S.C. 156” published on October 9, 1984, in PTO's Official Gazette and as required by 37 CFR chapter I. (b) After determining the length of the regulatory review period, FDA will notify PTO in writing of its determination, send a copy of this determination to the applicant, and file a copy of the determination in the docket established for the application in FDA's Dockets Management Staff (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. (c) FDA will also publish the regulatory review period determination in the Federal Register. The notice will include the following: (1) The name of the applicant; (2) The trade name and generic name (if applicable) of the product; (3) The number of the patent for which an extension of the term is sought; (4) The approved indications or uses for the product; (5) An explanation of any discrepancies between the dates in the application and FDA records; (6) Where appropriate, an explanation that FDA has no record in which to review the date(s) contained in the application; and (7) The regulatory review period determination, including a statement of the length of the testing and approval phases and the dates used in calculating each phase. | |||
| 21:21:1.0.1.1.24.3.98.2 | 21 | Food and Drugs | I | A | 60 | PART 60—PATENT TERM RESTORATION | C | Subpart C—Regulatory Review Period Determinations | § 60.22 Regulatory review period determinations. | FDA | [53 FR 7305, Mar. 7, 1988, as amended at 57 FR 56262, Nov. 27, 1992; 64 FR 400, Jan. 5, 1999] | In determining a product's regulatory review period, which consists of the sum of the lengths of a testing phase and an approval phase, FDA will review the information in each application using the following definitions of the testing phase and the approval phase for that class of products. (a) For human drugs: (1) The testing phase begins on the date an exemption under section 505(i) of the Act becomes effective (or the date an exemption under former section 507(d) of the Act became effective) for the approved human drug product and ends on the date a marketing application under section 351 of the Public Health Service Act or section 505 of the act is initially submitted to FDA (or was initially submitted to FDA under former section 507 of the Act), and (2) The approval phase begins on the date a marketing application under section 351 of the Public Health Service Act or section 505(b) of the Act is initially submitted to FDA (or was initially submitted under former section 507 of the Act) and ends on the date the application is approved. (b) For food and color additives: (1) The testing phase begins on the date a major health or environmental effects test is begun and ends on the date a petition relying on the test and requesting the issuance of a regulation for use of the additive under section 409 or 721 of the Act is initially submitted to FDA. (2) The approval phase begins on the date a petition requesting the issuance of a regulation for use of the additive under section 409 or 721 of the Act is initially submitted to FDA and ends upon whichever of the following occurs last: (i) The regulation for the additive becomes effective; or (ii) Objections filed against the regulation that result in a stay of effectiveness are resolved and commercial marketing is permitted; or (iii) Proceedings resulting from objections to the regulation, after commercial marketing has been permitted and later stayed pending resolution of the proceedings, are finally resolved and commercial marketing is permitted. (c) For… | |||
| 21:21:1.0.1.1.24.3.98.3 | 21 | Food and Drugs | I | A | 60 | PART 60—PATENT TERM RESTORATION | C | Subpart C—Regulatory Review Period Determinations | § 60.24 Revision of regulatory review period determinations. | FDA | [53 FR 7305, Mar. 7, 1988, as amended at 59 FR 14364, Mar. 28, 1994; 67 FR 9585, Mar. 4, 2002] | (a) Any person may request a revision of the regulatory review period determination within 60 days after its initial publication in the Federal Register. The request shall be sent to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. The request shall specify the following: (1) The type of action requested; (2) The identity of the product; (3) The identity of the applicant; (4) The FDA docket number; and (5) The basis for the request for revision, including any documentary evidence. (b) Unless the applicant is the person requesting the revision, the applicant shall respond to the request within 15 days. In responding to the request, the applicant may submit information which is relevant to the events during the regulatory review period but which was not included in the original patent term restoration application. A request for a revision is not equivalent to a due diligence petition under § 60.30 or a request for a hearing under § 60.40. If no response is submitted, FDA will decide the matter on the basis of the information in the patent term restoration application, request for revision, and FDA records. (c) FDA shall apply the provisions of § 60.22 in considering the request for a revision of the regulatory review period determination. lf FDA revises its prior determination, FDA will notify PTO of the revision, send a copy of this notification to the applicant, and publish the revision in the Federal Register, including a statement giving the reasons for the revision. |
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