10 C.F.R. Subpart B—Standard Design Certifications
Title 10 - Energy
This subpart set out the requirements and procedures applicable to Commission issuance of rules granting standard design certification for nuclear power facilities separate from the filing of an application for a construction permit or combined license for such facility. (a) Appendix M to this part governs the issuance of licenses to manufacture nuclear power reactors to be installed and operated at sites not identified in the manufacturing license application. Appendix N governs licenses to construct and operate nuclear power reactors of duplicate design at multiple sites. These appendices may be used independently of the provisions in this subpart unless the applicant also wishes to use a certified standard design approved under this subpart. (b) Appendix O governs the NRC staff review and approval of preliminary and final standard designs. A NRC staff approval under appendix O in no way affects the authority of the Commission or the presiding officer in any proceeding under 10 CFR part 2. Subpart B of part 52 governs Commission approval, or certification, of standard designs by rulemaking. (c) A final design approval under appendix O is a prerequisite for certification of a standard design under this subpart. An application for a final design approval must state whether the applicant intends to seek certification of the design. If the applicant does so intend, the application for the final design approval must, in addition to containing the information required by appendix O, comply with the applicable requirements of part 52, subpart B, particularly §§52.45 and 52.47. [54 FR 15386, Apr. 18, 1989, as amended at 69 FR 2277, Jan. 14, 2004] (a)(1) Any person may seek a standard design certification for an essentially complete nuclear power plant design which is an evolutionary change from light water reactor designs of plants which have been licensed and in commercial operation before the effective date of this rule. (2) Any person may also seek a standard design certification for a nuclear power plant design which differs significantly from the light water reactor designs described in paragraph (a)(1) of this section or utilizes simplified, inherent, passive, or other innovative means to accomplish its safety functions. (b) An application for certification may be filed notwithstanding the fact that an application for a construction permit or combined license for such a facility has not been filed. (c)(1) Because a final design approval under appendix O of this part is a prerequisite for certification of a standard design, a person who seeks such a certification and does not hold, or has not applied for, a final design approval, shall file with the Director of Nuclear Reactor Regulation an application for a final design approval and certification. (2) Any person who seeks certification but already holds, or has applied for, a final design approval, also shall file with the Director of Nuclear Reactor Regulation an application for certification, because the NRC staff may require that the information before the staff in connection with the review for the final design approval be supplemented for the review for certification. (d) The applicant must comply with the filing requirements of 10 CFR 50.30(a) (1)–(4), and (6) and 50.30(b) as they would apply to an application for a nuclear power plant construction permit. The following portions of §50.4, which is referenced by §50.30(a)(1), are applicable to the extent technically relevant: paragraphs (a); (b), except for paragraphs (6); (c); and (e). (a) The requirements of this paragraph apply to all applications for design certification. (1) An application for design certification must contain: (i) The technical information which is required of applicants for construction permits and operating licenses by 10 CFR part 20, part 50 and its appendices, and parts 73 and 100, and which is technically relevant to the design and not site-specific; (ii) Demonstration of compliance with any technically relevant portions of the Three Mile Island requirements set forth in 10 CFR 50.34(f) except paragraphs (f)(1)(xii), (f)(2)(ix) and (f)(3)(v); (iii) The site parameters postulated for the design, and an analysis and evaluation of the design in terms of such parameters; (iv) Proposed technical resolutions of those Unresolved Safety Issues and medium- and high-priority Generic Safety Issues which are identified in the version of NUREG–0933 current on the date six months prior to application and which are technically relevant to the design; (v) A design-specific probabilistic risk assessment; (vi) Proposed tests, inspections, analyses, and acceptance criteria which are necessary and sufficient to provide reasonable assurance that, if the tests, inspections and analyses are performed and the acceptance criteria met, a plant which references the design is built and will operate in accordance with the design certification. (vii) The interface requirements to be met by those portions of the plant for which the application does not seek certification. These requirements must be sufficiently detailed to allow completion of the final safety analysis and design-specific probabilistic risk assessment required by paragraph (a)(1)(v) of this section; (viii) Justification that compliance with the interface requirements of paragraph (a)(1)(vii) of this section is verifiable through inspection, testing (either in the plant or elsewhere), or analysis. The method to be used for verification of interface requirements must be included as part of the proposed tests, inspections, analyses, and acceptance criteria required by paragraph (a)(1)(vi) of this section; and (ix) A representative conceptual design for those portions of the plant for which the application does not seek certification, to aid the staff in its review of the final safety analysis and probabilistic risk assessment required by paragraph (a)(1)(v) of this section, and to permit assessment of the adequacy of the interface requirements called for by paragraph (a)(1)(vii) of this subsection. (2) The application must contain a level of design information sufficient to enable the Commission to judge the applicant's proposed means of assuring that construction conforms to the design and to reach a final conclusion on all safety questions associated with the design before the certification is granted. The information submitted for a design certification must include performance requirements and design information sufficiently detailed to permit the preparation of acceptance and inspection requirements by the NRC, and procurement specifications and construction and installation specifications by an applicant. The Commission will require, prior to design certification, that information normally contained in certain procurement specifications and construction and installation specifications be completed and available for audit if such information is necessary for the Commission to make its safety determination. (3) The staff shall advise the applicant on whether any technical information beyond that required by this section must be submitted. (b) This paragraph applies, according to its provisions, to particular applications: (1) The application for certification of a nuclear power plant design which is an evolutionary change from light water reactor designs of plants which have been licensed and in commercial operation before the effective date of this rule must provide an essentially complete nuclear power plant design except for site-specific elements such as the service water intake structure and the ultimate heat sink. (2)(i) Certification of a standard design which differs significantly from the light water reactor designs described in paragraph (b)(1) of this section or utilizes simplified, inherent, passive, or other innovative means to accomplish its safety functions will be granted only if (A)(1) The performance of each safety feature of the design has been demonstrated through either analysis, appropriate test programs, experience, or a combination thereof; (2) Interdependent effects among the safety features of the design have been found acceptable by analysis, appropriate test programs, experience, or a combination thereof; (3) Sufficient data exist on the safety features of the design to assess the analytical tools used for safety analyses over a sufficient range of normal operating conditions, transient conditions, and specified accident sequences, including equilibrium core conditions; and (4) The scope of the design is complete except for site-specific elements such as the service water intake structure and the ultimate heat sink; or (B) There has been acceptable testing of an appropriately sited, full-size, prototype of the design over a sufficient range of normal operating conditions, transient conditions, and specified accident sequences, including equilibrium core conditions. If the criterion in paragraph (b)(2)(i)(A)(4) of this section is not met, the testing of the prototype must demonstrate that the non-certified portion of the plant cannot significantly affect the safe operation of the plant. (ii) The application for final design approval of a standard design of the type described in this subsection must propose the specific testing necessary to support certification of the design, whether the testing be prototype testing or the testing required in the alternative by paragraph (b)(2)(i)(A) of this section. The Appendix O final design approval of such a design must identify the specific testing required for certification of the design. (3) An application seeking certification of a modular design must describe the various options for the configuration of the plant and site, including variations in, or sharing of, common systems, interface requirements, and system interactions. The final safety analysis and the probabilistic risk assessment should also account for differences among the various options, including any restrictions which will be necessary during the construction and startup of a given module to ensure the safe operation of any module already operating. [54 FR 15386, Apr. 18, 1989, as amended at 68 FR 54142, Sept. 16, 2003] Applications filed under this subpart will be reviewed for compliance with the standards set out in 10 CFR part 20, part 50 and its appendices, and parts 73 and 100 as they apply to applications for construction permits and operating licenses for nuclear power plants, and as those standards are technically relevant to the design proposed for the facility. The fee charged for the review of an application for the initial issuance or renewal of a standard design certification are set forth in 10 CFR 170.21 and shall be paid in accordance with 10 CFR 170.12. [56 FR 31499, July 10, 1991] (a) A standard design certification is a rule that will be issued in accordance with the provisions of subpart H of 10 CFR part 2, as supplemented by the provisions of this section. The Commission shall initiate the rulemaking after an application has been filed under §52.45 and shall specify the procedures to be used for the rulemaking. The notice of proposed rulemaking published in the (b) Following the submission of comments on the proposed design certification rule, the Commission may, at its discretion, hold a legislative hearing under the procedures in Subpart O of part 2 of this chapter. The Commission shall publish a notice in the (c) Notwithstanding anything in 10 CFR 2.390 to the contrary, proprietary information will be protected in the same manner and to the same extent as proprietary information submitted in connection with applications for construction permits and operating licenses under 10 CFR part 50, provided that the design certification shall be published in chapter I of this title. [69 FR 2277, Jan. 14, 2004] The Commission shall refer a copy of the application to the Advisory Committee on Reactor Safeguards (ACRS). The ACRS shall report on those portions of the application which concern safety. After conducting a rulemaking proceeding under §52.51 on an application for a standard design certification and receiving the report to be submitted by the Advisory Committee on Reactor Safeguards under §52.53, and upon determining that the application meets the applicable standards and requirements of the Atomic Energy Act and the Commission's regulations, the Commission shall issue a standard design certification in the form of a rule for the design which is the subject of the application. (a) Except as provided in paragraph (b) of this section, a standard design certification issued pursuant to this subpart is valid for fifteen years from the date of issuance. (b) A standard design certification continues to be valid beyond the date of expiration in any proceeding on an application for a combined license or operating license which references the standard design certification and is docketed either before the date of expiration of the certification, or, if a timely application for renewal of the certification has been filed, before the Commission has determined whether to renew the certification. A design certification also continues to be valid beyond the date of expiration in any hearing held under §52.103 before operation begins under a combined license which references the design certification. (c) An applicant for a construction permit or combined license may, at its own risk, reference in its application a design for which a design certification application has been docketed but not granted. (a) Not less than twelve nor more than thirty-six months prior to expiration of the initial fifteen-year period, or any later renewal period, any person may apply for renewal of the certification. An application for renewal must contain all information necessary to bring up to date the information and data contained in the previous application. The Commission will require, prior to renewal of certification, that information normally contained in certain procurement specifications and construction and installation specifications be completed and available for audit if such information is necessary for the Commission to make its safety determination. Notice and comment procedures must be used for a rulemaking proceeding on the application for renewal. The Commission, in its discretion, may require the use of additional procedures in individual renewal proceedings. (b) A design certification, either original or renewed, for which a timely application for renewal has been filed remains in effect until the Commission has determined whether to renew the certification. If the certification is not renewed, it continues to be valid in certain proceedings, in accordance with the provisions of §52.55. (c) The Commission shall refer a copy of the application for renewal to the Advisory Committee on Reactor Safeguards (ACRS). The ACRS shall report on those portions of the application which concern safety and shall apply the criteria set forth in §52.59. (a) The Commission shall issue a rule granting the renewal if the design, either as originally certified or as modified during the rulemaking on the renewal, complies with the Atomic Energy Act and the Commission's regulations applicable and in effect at the time the certification was issued, and any other requirements the Commission may wish to impose after a determination that there is a substantial increase in overall protection of the public health and safety or the common defense and security to be derived from the new requirements and that the direct and indirect costs of implementation of those requirements are justified in view of this increased protection. In addition, the applicant for renewal may request an amendment to the design certification. The Commission shall grant the amendment request if it determines that the amendment will comply with the Atomic Energy Act and the Commission's regulations in effect at the time or renewal. If the amendment request entails such an extensive change to the design certification that an essentially new standard design is being proposed, an application for a design certification shall be filed in accordance with §52.45 and 52.47 of this part. (b) Denial of renewal does not bar the applicant, or another applicant, from filing a new application for certification of the design, which proposes design changes which correct the deficiencies cited in the denial of the renewal. Each renewal of certification for a standard design will be for not less than ten nor more than fifteen years. (a)(1) Notwithstanding any provision in 10 CFR 50.109, while a standard design certification is in effect under §§52.55 or 52.61, the Commission may not modify, rescind, or impose new requirements on the certification, whether on its own motion, or in response to a petition from any person, unless the Commission determines in a rulemaking that a modification is necessary either to bring the certification or the referencing plants into compliance with the Commission's regulations applicable and in effect at the time the certification was issued, or to assure adequate protection of the public health and safety or the common defense and security. The rulemaking procedures must provide for notice and opportunity for public comment. (2) Any modification the NRC imposes on a design certification rule under paragraph (a)(1) of this section will be applied to all plants referencing the certified design, except those to which the modification has been rendered technically irrelevant by action taken under paragraphs (a)(3), (a)(4), or (b) of this section. (3) While a design certification is in effect under §52.55 or §52.61, unless (i) a modification is necessary to secure compliance with the Commission's regulations applicable and in effect at the time the certification was issued, or to assure adequate protection of the public health and safety or the common defense and security, and (ii) special circumstances as defined in 10 CFR 50.12(a) are present, the Commission may not impose new requirements by plant-specific order on any part of the design of a specific plant referencing the design certification if that part was approved in the design certification. In addition to the factors listed in §50.12(a), the Commission shall consider whether the special circumstances which §50.12(a)(2) requires to be present outweigh any decrease in safety that may result from the reduction in standardization caused by the plant-specific order. (4) Except as provided in 10 CFR 2.758, in making the findings required for issuance of a combined license or operating license, or for any hearing under §52.103, the Commission shall treat as resolved those matters resolved in connection with the issuance or renewal of a design certification. (b)(1) An applicant or licensee who references a standard design certification may request an exemption from one or more elements of the design certification. The Commission may grant such a request only if it determines that the exemption will comply with the requirements of 10 CFR 50.12(a). In addition to the factors listed in §50.12(a), the Commission shall consider whether the special circumstances which §50.12(a)(2) requires to be present outweigh any decrease in safety that may result from the reduction in standardization caused by the exemption. The granting of an exemption on request of an applicant must be subject to litigation in the same manner as other issues in the operating license or combined license hearing. (2) Subject §50.59, a licensee who references a standard design certification may make changes to the design of the nuclear power facility, without prior Commission approval, unless the proposed change involves a change to the design as described in the rule certifying the design. The licensee shall maintain records of all changes to the facility and these records must be maintained and available for audit until the date of termination of the license. (c) The Commission will require, prior to granting a construction permit, combined license, or operating license which references a standard design certification, that information normally contained in certain procurement specifications and construction and installation specifications be completed and available for audit if such information is necessary for the Commission to make its safety determinations, including the determination that the application is consistent with the certified design. This information may be acquired by appropriate arrangements with the design certification applicant. [54 FR 15386, Apr. 18, 1989, as amended at 69 FR 2277, Jan. 14, 2004]
Title 10: Energy
PART 52—EARLY SITE PERMITS; STANDARD DESIGN CERTIFICATIONS; AND COMBINED LICENSES FOR NUCLEAR POWER PLANTS
Subpart B—Standard Design Certifications
§ 52.41 Scope of subpart.
§ 52.43 Relationship to appendices M, N, and O of this part.
§ 52.45 Filing of applications.
§ 52.47 Contents of applications.
§ 52.48 Standards for review of applications.
§ 52.49 Fees for review of applications.
§ 52.51 Administrative review of applications.
§ 52.53 Referral to the ACRS.
§ 52.54 Issuance of standard design certification.
§ 52.55 Duration of certification.
§ 52.57 Application for renewal.
§ 52.59 Criteria for renewal.
§ 52.61 Duration of renewal.
§ 52.63 Finality of standard design certifications.
