---
kind: "range"
citation: "10 C.F.R. §§ 53.1230–53.1263"
title: "10"
from: "53.1230"
to: "53.1263"
count: 12
url: "https://uscodex.org/cfr/10/53.1230..53.1263"
---

# §53.1230. Standard design certifications.


[Sections 53.1230 through 53.1263](/cfr/10/53.1230..53.1263.md) set forth the requirements and procedures applicable to the Commission's issuance of rules granting standard design certifications for commercial nuclear plants under this part separate from the filing of an application for a CP or COL for such a facility.


# §53.1236. Contents of applications for standard design certifications; general information.


The application must contain all of the information required by § [53.1109(a) through (c)](/cfr/10/53.1109.md?p=a..c) and [(j)](/cfr/10/53.1109.md?p=j).


# §53.1239. Contents of applications for standard design certifications; technical information.


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. The Commission will require, before design certification, that information normally contained in engineering documents, such as analyses, drawings, procurement specifications, or construction and installation specifications, be completed and available for audit if the more detailed information is necessary for the Commission to verify the information in the application and make its safety determination.

- (a) **Final Safety Analysis Report.** The application must contain an FSAR that describes the facility and the limits on its operation, and presents a safety analysis of the SSCs, and must include the following information:
  - (1) **Site parameters.** The site parameters postulated for the design under this part, including the design-basis external hazard levels for the relevant external hazards, and an analysis and evaluation of the design in terms of those site parameters.
  - (2) **Plant description and safety functions—**
    - (i) **General plant description.** A general description of the commercial nuclear plant including reactor type, the intended use of the reactor, nuclear design (e.g., neutron spectrum, reactor control, multi-unit reactor control), overall layout of the plant including significant plant features and SSCs, maximum power level and the nature and inventory of radioactive materials.
    - (ii) **Safety functions.** A description of the primary and additional safety functions required under [§ 53.230](/cfr/10/53.230.md) and a summary of how each safety function is satisfied.
  - (3) **Design features and functional design criteria—licensing-basis events.**
    - (i) A description of the design features required by [§ 53.400](/cfr/10/53.400.md) and the functional design criteria required by §§ [53.410](/cfr/10/53.410.md) and [53.420](/cfr/10/53.420.md) that, when combined with corresponding human actions and programmatic controls, demonstrate that the plant will demonstrate compliance with the safety criteria defined in [§ 53.210](/cfr/10/53.210.md) and established in accordance with [§ 53.220](/cfr/10/53.220.md) during licensing-basis events (LBEs).
    - (ii) A description of how design features demonstrate compliance with the requirements of § [53.440(a) through (i)](/cfr/10/53.440.md?p=a..i) and [(k) through (m)](/cfr/10/53.440.md?p=k..m).
  - (4) **Design features supporting normal operations.** A description of the design features required by [§ 53.425](/cfr/10/53.425.md) to support the holder of an OL or COL complying with [§ 53.260](/cfr/10/53.260.md) during normal operations.
  - (5) [Reserved]
  - (6) **Earthquake engineering.** The information necessary to demonstrate that the commercial nuclear plant complies with the earthquake engineering criteria in [§ 53.480](/cfr/10/53.480.md).
  - (7) **Programmatic controls and interfaces.**
    - (i) A description of the corresponding programmatic controls and interfaces necessary to achieve and maintain the reliability and capability of SSCs relied upon to demonstrate compliance with the functional design criteria required by §§ [53.410](/cfr/10/53.410.md) and [53.420](/cfr/10/53.420.md) and the safety criteria in §§ [53.210](/cfr/10/53.210.md) and [53.220](/cfr/10/53.220.md) and necessary to maintain consistency with analyses required by [§ 53.450](/cfr/10/53.450.md).
    - (ii) For an application for a multi-unit commercial nuclear plant, the programmatic controls and interfaces must also be described for different modular configurations, as required by [§ 53.440(i)](/cfr/10/53.440.md?p=i), including any restrictions that will be necessary during the construction and startup of any given unit to ensure the safe operation of the overall commercial nuclear plant to be licensed under this part.
  - (8) **Programmatic controls for normal operations.** A description of how programmatic controls, including monitoring programs, would provide assurance that design features and procedures will enable the holder of an OL or COL to comply with [§ 53.260](/cfr/10/53.260.md).
  - (9) **Design features supporting the protection of plant workers.** A description of the design features required by [§ 53.430](/cfr/10/53.430.md) to support the holder of an OL or COL complying with [§ 53.270](/cfr/10/53.270.md).
  - (10) **Programmatic controls for protection of plant workers.** A description of how programmatic controls, including monitoring programs, would provide assurance that design features and procedures will enable the holder of an OL or COL to comply with [§ 53.270](/cfr/10/53.270.md).
  - (11) **Codes and standards.** A description of generally accepted consensus codes and standards used to design the design features, as required by [§ 53.440(b)](/cfr/10/53.440.md?p=b).
  - (12) **Materials.** A description of the materials used for SR and NSRSS SSCs and a description of the qualification of these materials for their service conditions over the plant lifetime, as required by [§ 53.440(c)](/cfr/10/53.440.md?p=c).
  - (13) **Integrity assessment program.** A description of a design integrity assessment program that addresses the elements described in [§ 53.440(d)](/cfr/10/53.440.md?p=d).
  - (14) [Reserved]
  - (15) **Criticality.** Information demonstrating how the applicant will comply with requirements for criticality accidents in [§ 53.440(m)](/cfr/10/53.440.md?p=m).
  - (16) **Multi-unit plants.** For an application for standard design certification of a multi-unit commercial nuclear plant, the possible operating configurations of the reactor units, including common systems, interface requirements, and system interactions, as required by [§ 53.440(i)](/cfr/10/53.440.md?p=i).
  - (17) **SSC classification.**
    - (i) The classification of SSCs according to their safety significance under [§ 53.460(a)](/cfr/10/53.460.md?p=a).
    - (ii) For SR and NSRSS SSCs, the conditions under which they must perform the safety functions required by [§ 53.230](/cfr/10/53.230.md), including environmental conditions.
  - (18) **Probabilistic risk assessment or other systematic risk evaluations (SREs).** A description of the probabilistic risk assessment (PRA), other SREs, or a combination thereof required by [§ 53.450(a)](/cfr/10/53.450.md?p=a) and associated results.
  - (19) **Analyses.** A description of the analyses performed under [§ 53.450(b) through (g)](/cfr/10/53.450.md?p=b..g) that includes the following information:
    - (i) A description of the analysis of LBEs and its results, as described in [§ 53.240](/cfr/10/53.240.md). This analysis description must—
      - (A) Address the elements in § [53.450(e)](/cfr/10/53.450.md?p=e) and [(f)](/cfr/10/53.450.md?p=f); and
      - (B) Under [§ 53.460(c)](/cfr/10/53.460.md?p=c)—

        (1) Describe any human actions that are necessary to prevent or mitigate LBEs;

        (2) Describe how those human actions are capable of being reliably performed under the postulated environmental conditions present; and

        (3) Describe how those human actions would be addressed by programs established under [subpart F](/cfr/10/subpartF.md) of this part.

    - (ii)
      - (A) A description of how SSCs relied on to meet the safety criteria defined in [§ 53.210](/cfr/10/53.210.md) are protected against or designed to withstand the effects of external hazards under [§ 53.510](/cfr/10/53.510.md).
      - (B) The information necessary to demonstrate that the commercial nuclear plant complies with the earthquake engineering criteria in [§ 53.480](/cfr/10/53.480.md).
    - (iii) A description of the defense-in-depth measures required by [§ 53.250](/cfr/10/53.250.md).
    - (iv) A description of all plant operating states where there is the potential for the uncontrolled release of radioactive material to the environment, as required by [§ 53.450(b)(4)](/cfr/10/53.450.md?p=b-4).
    - (v) A description of the events that challenge plant control and safety systems whose failure could lead to an undesirable end state and/or radioactive material release, as required by [§ 53.450(b)(5)](/cfr/10/53.450.md?p=b-5).
    - (vi) A description of the analytical codes used in modeling plant behavior in analyses of LBEs and how these codes are qualified for the range of conditions for which they were used, as required by [§ 53.450(d)](/cfr/10/53.450.md?p=d).
    - (vii) A description of the results of other analyses required by [§ 53.450(g)](/cfr/10/53.450.md?p=g).
  - (20) **Special treatments.** A description of special treatments established as required by [§ 53.460](/cfr/10/53.460.md).
  - (21) [Reserved]
  - (22) **Quality assurance.** A description of the QAP applied to the design of the SSCs of the commercial nuclear plant, as required by [§ 53.460(b)](/cfr/10/53.460.md?p=b). The description of the QAP for a commercial nuclear plant must include a discussion of how the applicable requirements of appendix B to [part 50](/cfr/10/part50.md) of this chapter were satisfied.
  - (23) **Design features and controls to address the minimization of contamination.** The information required by [§ 20.1406](/cfr/10/20.1406.md) of this chapter.
  - (24) **Interface requirements.**
    - (i) A description analysis, and evaluation of the interfaces between the standard design and the balance of the commercial nuclear plant that may impact the ability of the plant to demonstrate compliance with the functional design criteria or the safety criteria of subparts B and C of this part.
    - (ii) **Confirmation that interface requirements are verifiable through inspections, testing, or analysis.** These requirements must be sufficiently detailed to allow for completion of the final safety analysis by license applicants that reference the certified design under this subpart. The method to be used for verification of interface requirements must be included as part of the proposed ITAAC required by [§ 53.1241(a)(3)](/cfr/10/53.1241.md?p=a-3).
    - (iii) A representative conceptual design for those portions of the plant for which the application does not seek certification to aid the NRC in its review of the FSAR and to permit assessment of the adequacy of the interface requirements under [paragraph (a)(24)(i)](#a-24-i) of this section.
  - (25) **Technical qualifications.** A description of the technical qualifications of the applicant to engage in the proposed activities in accordance with the regulations in this chapter.
  - (26) **Technical specifications.** Proposed technical specifications prepared under [§ 53.710(a)](/cfr/10/53.710.md?p=a) for those areas addressed by the design certification.
  - (27) **Role of personnel.** Information to address the following for the role of personnel in ensuring safe operations:
    - (i) A description of how the human factors engineering design requirements of [§ 53.440(n)(1)](/cfr/10/53.440.md?p=n-1) are addressed;
    - (ii) A description of how the human system interface design requirements of [§ 53.440(n)(2)](/cfr/10/53.440.md?p=n-2) are addressed;
    - (iii) A concept of operations that is of sufficient scope and detail to address the requirements of [§ 53.440(n)(3)](/cfr/10/53.440.md?p=n-3);
    - (iv) A functional requirements analysis and function allocation that is of sufficient scope and detail to address the requirements of [§ 53.440(n)(4)](/cfr/10/53.440.md?p=n-4).
- (b) [Reserved]

# §53.1241. Contents of applications for standard design certifications; other application content.

- (a) In addition to the FSAR, the application must also include the following:
  - (1) **Environmental report.** An environmental report as required by [§ 51.55](/cfr/10/51.55.md) of this chapter.
  - (2) **Availability controls (if not included in the FSAR).** A description of the controls on plant operations, including availability controls, to provide reasonable confidence that the configurations and special treatments for SR and NSRSS SSCs provide the capabilities and reliabilities required to demonstrate compliance with the safety criteria of [§ 53.220](/cfr/10/53.220.md).
  - (3) **Inspections, tests, analyses, and acceptance criteria.** The proposed ITAAC that are necessary and sufficient to provide reasonable assurance that, if the inspections, tests, and analyses are performed and the acceptance criteria met, a facility that incorporates the design certification has been constructed and will be operated in conformity with the design certification, the provisions of the Act, and the Commission's rules and regulations.
  - (4) **Safeguards information.** A description of the program to protect Safeguards Information against unauthorized disclosure in accordance with the requirements in §§ [73.21](/cfr/10/73.21.md) and [73.22](/cfr/10/73.22.md) of this chapter, as applicable.
- (b) If there are SSCs of the plant which required research and development to confirm the adequacy of their design, provide a report in the application which documents the resolution of any safety questions associated with such SSCs.
- (c) A description of how the performance of each design feature has been demonstrated capable of fulfilling functional design criteria considering interdependent effects through either analysis, appropriate test programs, prototype testing, operating experience, or a combination thereof, in accordance with [§ 53.440(a)](/cfr/10/53.440.md?p=a).

# §53.1242. Review of applications.

- (a) **Standards for review of applications.** Applications filed under this part will be reviewed for compliance with the standards set out in 10 CFR parts [20](/cfr/10/part20.md), [51](/cfr/10/part51.md), 53, and 73.
- (b) **Administrative review of applications; hearings.**
  - (1) A standard design certification is a rule that will be issued under the provisions of [subpart H](/cfr/10/subpartH.md) of [10 CFR part 2](/cfr/10/part2.md), as supplemented by the provisions of this section. The Commission must initiate the rulemaking after an application has been filed under [§ 53.1100(a)(1)(iii)](/cfr/10/53.1100.md?p=a-1-iii) and must specify the procedures to be used for the rulemaking. The notice of proposed rulemaking published in the Federal Register must provide an opportunity for the submission of comments on the proposed design certification rule. If, at the time a proposed design certification rule is published in the Federal Register under this [paragraph (b)(1)](#b-1), the Commission decides that a legislative hearing should be held, the information required by [§ 2.1502(c)](/cfr/10/2.1502.md?p=c) of this chapter must be included in the Federal Register document for the proposed design certification.
  - (2) 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](/cfr/10/part2-subpartO.md) of this chapter. The Commission must publish a document in the Federal Register of its decision to hold a legislative hearing. The document must contain the information specified in [§ 2.1502(c)](/cfr/10/2.1502.md?p=c) of this chapter and specify whether the Commission or a presiding officer will conduct the legislative hearing.
  - (3) Notwithstanding anything in [§ 2.390](/cfr/10/2.390.md) of this chapter 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 licenses, provided that the design certification will be published in chapter I of this title.
- (c) **Reference to an issued operating license or combined license.** In those cases where a design certification application is preceded by the issuance of an OL or custom COL for a commercial nuclear plant that is essentially the same as the standard design for which certification is being requested, the NRC review will follow the processes for referencing a standard design approval in [§ 53.1221](/cfr/10/53.1221.md), to the extent practicable.

# §53.1245. Referral to the Advisory Committee on Reactor Safeguards.


The Commission must refer a copy of the application to the ACRS. The ACRS must report on those portions of the application which concern safety.


# §53.1248. Issuance of standard design certification.

- (a) After conducting a rulemaking proceeding under [§ 53.1242](/cfr/10/53.1242.md) on an application for a standard design certification and receiving the report to be submitted by the ACRS under [§ 53.1245](/cfr/10/53.1245.md), the Commission may issue a standard design certification in the form of a rule for the design that is the subject of the application, if the Commission determines that—
  - (1) The application demonstrates compliance with the applicable standards and requirements of the Act and the Commission's regulations;
  - (2) Notifications, if any, to other agencies or bodies have been duly made;
  - (3) There is reasonable assurance that the standard design conforms with the provisions of the Act and the Commission's regulations;
  - (4) The applicant is technically qualified;
  - (5) The proposed ITAAC are necessary and sufficient, within the scope of the standard design, to provide reasonable assurance that, if the inspections, tests, and analyses are performed and the acceptance criteria met, the facility has been constructed and will be operated in accordance with the design certification, the provisions of the Act, and the Commission's regulations;
  - (6) Issuance of the standard design certification will not be inimical to the common defense and security or to the health and safety of the public;
  - (7) The findings required by [part 51](/cfr/10/part51.md) of this chapter have been made; and
  - (8) **The applicant has implemented the QAP described or referenced in the Safety Analysis Report.**
- (b) The design certification rule must specify the site parameters, design characteristics, and any additional requirements and restrictions of the design certification rule.
- (c) After the Commission has adopted a final design certification rule, the applicant must not permit any individual to have access to or any facility to possess restricted data or classified National Security Information until the individual and/or facility has been approved for access under the provisions of [10 CFR parts 25](/cfr/10/part25.md) and/or 95, as applicable.

# §53.1251. Duration of certification.

- (a) Except as provided in [paragraph (b)](#b) of this section, a standard design certification issued under this subpart is valid for 40 years from the effective date of the rule.
- (b) A standard design certification continues to be valid beyond the date of expiration in any proceeding on an application for a COL or an OL under this part that 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 [§ 53.1452](/cfr/10/53.1452.md) before operation begins under a COL that references the design certification.
- (c) An applicant for a CP, OL, COL, or ML under this part may, at its own risk, reference in its application a design for which a design certification application has been docketed but not granted.

# §53.1254. Application for renewal.

- (a) Not less than 12 nor more than 36 months before the expiration of the initial 40-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, before renewal of certification, that information normally contained in engineering documents, such as analyses, drawings, procurement specifications, or construction and installation specifications, be completed and available for audit if the more detailed information is necessary for the Commission to verify the information in the application and 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 under [§ 53.1251](/cfr/10/53.1251.md).

# §53.1257. Criteria for renewal.

- (a) The Commission must 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 Act and the Commission's regulations applicable and in effect at the time the certification was issued.
- (b) The Commission may impose other requirements if it determines that—
  - (1) They are necessary for adequate protection to public health and safety or common defense and security;
  - (2) They are necessary for compliance with the Commission's regulations and orders applicable and in effect at the time the design certification was issued; or
  - (3) 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 the direct and indirect costs of implementing those requirements are justified in view of this increased protection.
- (c) In addition, the applicant for renewal may request an amendment to the design certification. The Commission must grant the amendment request if it determines that the amendment will comply with the Act and the Commission's regulations in effect at the time of 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 must be filed in accordance with this subpart.
- (d) 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 that correct the deficiencies cited in the denial of the renewal.

# §53.1260. Duration of renewal.


Each renewal of certification for a standard design will be for not less than 10, nor more than 40 years.


# §53.1263. Finality of standard design certifications.

- (a)
  - (1) While a standard design certification rule is in effect under [§ 53.1251](/cfr/10/53.1251.md) or [§ 53.1260](/cfr/10/53.1260.md), the Commission may not modify, rescind, or impose new requirements on the certification information, whether on its own motion, or in response to a petition from any person, unless the Commission determines in a rulemaking that the change—
    - (i) Is necessary either to bring the certification information or the referencing plants into compliance with the Commission's regulations applicable and in effect at the time the certification was issued;
    - (ii) Is necessary to provide adequate protection of the public health and safety or the common defense and security;
    - (iii) Reduces unnecessary regulatory burden and maintains protection to public health and safety and the common defense and security;
    - (iv) Provides the detailed design information to be verified under those ITAAC that are directed at certification information (i.e., design acceptance criteria);
    - (v) Is necessary to correct material errors in the certification information;
    - (vi) Substantially increases overall safety, reliability, or security of facility design, construction, or operation, and the direct and indirect costs of implementation of the rule change are justified in view of this increased safety, reliability, or security; or
    - (vii) **Contributes to increased standardization of the certification information.**
  - (2)
    - (i) In a rulemaking under [§ 53.1263(a)(1)](#a-1), except for [§ 53.1263(a)(1)(ii)](#a-1-ii), the Commission will give consideration to whether the benefits justify the costs for plants that are already licensed or for which an application for a permit or license is under consideration.
    - (ii) The rulemaking procedures for changes under [§ 53.1263(a)(1)](#a-1) must provide for notice and opportunity for public comment.
  - (3) Any modification the NRC imposes on a design certification rule under [paragraph (a)(1)](#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)(4)](#a-4) or (b) of this section.
  - (4) 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 rule if that part was approved in the design certification while a design certification rule is in effect under [§ 53.1248](/cfr/10/53.1248.md), 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 [§ 53.080](/cfr/10/53.080.md) are present. In addition to the factors listed in [§ 53.080](/cfr/10/53.080.md), the Commission must consider whether the special circumstances which [§ 53.080](/cfr/10/53.080.md) requires to be present outweigh any decrease in safety that may result from the reduction in standardization caused by the plant-specific order.
  - (5) Except as provided in [§ 2.335](/cfr/10/2.335.md) of this chapter, in making the findings required for issuance of a COL, CP, OL, or ML, or for any hearing under [§ 53.1452](/cfr/10/53.1452.md), the Commission must treat as resolved those matters resolved in connection with the issuance or renewal of a design certification rule.
- (b) An applicant who references a design certification rule may request an exemption from one or more elements of the certification information. The Commission may grant such a request only if it determines that the exemption will comply with the requirements of [§ 53.080](/cfr/10/53.080.md). In addition to the factors listed in [§ 53.080](/cfr/10/53.080.md), the Commission must consider whether the special circumstances that [§ 53.080](/cfr/10/53.080.md) 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 is subject to litigation in the same manner as other issues in the OL or COL hearing.
- (c) The Commission will require, before granting a CP, COL, OL, or ML that references a design certification rule, that information normally contained in engineering documents, such as analyses, drawings, procurement specifications, or construction and installation specifications, be completed and available for audit if the more detailed information is necessary for the Commission to verify the information in the application and make its safety determination, including the determination that the application is consistent with the certification information. This information may be acquired by appropriate arrangements with the design certification applicant.