(a) Serving of applications. (1) Each filing of an application for a standard design approval, standard design certification, or license under this part, and any amendments to the applications, must be submitted to the U.S. Nuclear Regulatory Commission (NRC) under § 53.040, as applicable.

(i) Any person, except one excluded by § 53.1118, may file an application for a manufacturing license (ML), combined license (COL), construction permit (CP), or operating license (OL) under this part with the Director, Office of Nuclear Reactor Regulation.

(ii) Any person who may apply for a CP or for a COL under this part, may file an application for an early site permit (ESP) with the Director, Office of Nuclear Reactor Regulation. An application for an early site permit may be filed notwithstanding the fact that an application for a CP or a COL has not been filed in connection with the site for which a permit is sought.

(iii) Any person may submit a proposed standard design for a commercial nuclear plant to the NRC for its review. The submittal may consist of either the final design for the entire facility or the final design for major portions thereof.

(iv) An application for design certification may be filed notwithstanding the fact that an application for a CP, COL, or ML for such a facility has not been filed. The application must comply with §§ 2.811 through 2.819 of this chapter.

(2) Each applicant for a construction permit (CP), early site permit, combined license (COL), or manufacturing license (ML) under this part must, upon notification by the presiding officer designated to conduct the public hearing required by the Atomic Energy Act of 1954, as amended, (the Act) update the application and serve the updated copies of the application or parts of it, eliminating all superseded information, together with an index of the updated application, as directed by the presiding officer. Any subsequent amendment to the application must be served on those served copies of the application and must be submitted to the NRC as specified in § 53.040, as applicable.

(3) The applicant must make a copy of the updated application available at the public hearing for the use of any other parties to the proceeding and must certify that the updated copies of the application contain the current contents of the application submitted in accordance with the requirements under this part.

(4) At the time of filing an application, the Commission will make available at the NRC website, https://www.nrc.gov, a copy of the application, subsequent amendments, and other records pertinent to the matter that is the subject of the application for public inspection and copying.

(5) The serving of copies required by this section must not occur until the application has been docketed under § 2.101(a) of this chapter. Copies must be submitted to the Commission, as specified in § 53.040, as applicable, to enable the Director, Office of Nuclear Reactor Regulation to determine whether the application is sufficiently complete to permit docketing.

(b) Oath or affirmation. Each application for a standard design approval, standard design certification, or license, including, whenever appropriate, a CP or early site permit, or amendment of it, and each amendment of each application must be executed in a signed original by the applicant or duly authorized officer thereof under oath or affirmation.

(c)-(d) [Reserved]

(e) Filing fees. Each application for a standard design approval, standard design certification, or commercial nuclear plant license under this part, including, whenever appropriate, a CP, COL, operating license (OL), ML, or early site permit, other than a license exempted from 10 CFR part 170, must be accompanied by the fee prescribed in 10 CFR part 170. No fee will be required to accompany an application for renewal, amendment, or termination of a CP, OL, COL, or ML, except as provided in § 170.21 of this chapter.

(f) Environmental report. An application for a CP, OL, early site permit, design certification, COL, or ML for a commercial nuclear plant must be accompanied by an environmental report required under 10 CFR part 51.

Except as provided in § 53.1120, no person within the United States may transfer or receive in interstate commerce, manufacture, produce, transfer, acquire, possess, or use any utilization facility except as authorized by a license issued by the Commission.

(a) An applicant may combine several applications in one application for different kinds of licenses under the regulations in this chapter.

(b) The Commission may combine in a single license the activities of an applicant which would otherwise be licensed separately.

An applicant may incorporate by reference in its application information contained in previous applications, statements, or reports filed with the Commission, provided, however, that such references are clear and specific.

Each application must include, unless otherwise indicated in this subpart—

(a) Name of applicant;

(b) Address of applicant;

(c) Description of business or occupation of applicant;

(d)(1) If applicant is an individual, the citizenship of applicant;

(2) If applicant is a partnership, the name, citizenship and address of each partner and the principal location where the partnership does business;

(3) If applicant is a corporation or an unincorporated association, the following information:

(i) The State where it is incorporated or organized and the principal location where it does business;

(ii) The names, addresses and citizenship of its directors and of its principal officers; and

(iii) Whether it is owned, controlled, or dominated by an alien, a foreign corporation, or foreign government, and if so, give details; or

(4) If the applicant is acting as agent or representative of another person in filing the application, identify the principal and furnish information required under this paragraph (d) with respect to such principal;

(e) The class and type of license applied for, the use to which the facility will be put, the period of time for which the license is sought, and a list of other licenses, except operator's licenses, issued or applied for in connection with the proposed facility;

(f) [Reserved]

(g)(1) Except as provided in paragraph (g)(2) of this section, if the application is for an OL or COL for a commercial nuclear plant, or if the application is for an early site permit for a commercial nuclear plant and contains plans for coping with emergencies under § 53.1146(b)(2)(ii), the applicant must submit the radiological emergency response plans of State, local, and participating Tribal governmental entities in the United States that are wholly or partially within the plume exposure pathway emergency planning zone (EPZ), 1 and the plans of State governments wholly or partially within the ingestion pathway EPZ. 2 If the application is for an early site permit that, under § 53.1146(b)(2)(i), proposes major features of the emergency plans describing the EPZs, then the descriptions of the EPZs must meet the requirements of this paragraph (g)(1). Generally, the plume exposure pathway EPZ for a commercial nuclear plant must consist of an area about 10 miles (16 km) in radius and the ingestion pathway EPZ must consist of an area about 50 miles (80 km) in radius. The exact size and configuration of the EPZs surrounding a particular commercial nuclear plant must be determined in relation to the local emergency response needs and capabilities as they are affected by such conditions as demography, topography, land characteristics, access routes, and jurisdictional boundaries. The size of the EPZs also may be determined on a case-by-case basis for gas-cooled reactors and for reactors with an authorized power level less than 250 megawatt thermal. The plans for the ingestion pathway must focus on such actions as are appropriate to protect the food ingestion pathway.

(2) Applicants for commercial nuclear plants consisting of either small modular reactors or non-light-water reactors complying with § 50.160 of this chapter who apply for a CP, an OL, a COL, or an early site permit under this part must submit as part of the application the analysis used to determine whether the criteria in § 53.1109(g)(2)(i)(A) and (B) are met and, if they are met, the size of the plume exposure pathway EPZ.

(i) The plume exposure pathway EPZ is the area within which:

(A) Public dose, as defined in § 20.1003 of this chapter, is projected to exceed 10 millisieverts (1 rem) total effective dose equivalent over 96 hours from the release of radioactive materials from the facility considering accident likelihood and source term, timing of the accident sequence, and meteorology; and

(B) Pre-determined, prompt protective measures are necessary.

(ii) If the application is for an OL or COL or if the application is for an early site permit and contains plans for coping with emergencies under § 53.1146(b)(2)(ii), and if the plume exposure pathway EPZ extends beyond the site boundary:

(A) The applicant must submit radiological emergency response plans of State, local, and participating Tribal governmental entities in the United States that are wholly or partially within the plume exposure pathway EPZ.

(B) The exact configuration of the plume exposure pathway EPZ surrounding the facility shall be determined in relation to the local emergency response needs and capabilities as they are affected by such conditions as demography, topography, land characteristics, access routes, and jurisdictional boundaries.

(iii) If the application is for an early site permit that, under § 53.1146(b)(2)(i), proposes major features of the emergency plans and describes the EPZ, and if the EPZ extends beyond the site boundary, then the exact configuration of the plume exposure pathway EPZ surrounding the facility must be determined in relation to the local emergency response needs and capabilities as they are affected by such conditions as demography, topography, land characteristics, access routes, and jurisdictional boundaries.

(h) [Reserved]

(i) A list of the names and addresses of such regulatory agencies as may have jurisdiction over the rates and services incident to the proposed activity, and a list of trade and news publications which circulate in the area where the proposed activity will be conducted and which are considered appropriate to give reasonable notice of the application to those municipalities, private utilities, public bodies, and cooperatives, which might have a potential interest in the facility; and

(j) If the application contains Restricted Data or classified National Security information, confirmation that all Restricted Data and classified National Security information are separated from the unclassified information.

(a) Each CP, early site permit, and COL under this part may include conditions to address environmental issues during construction. These conditions are to be set out in an attachment to the license, which is incorporated in and made a part of the license. These conditions will be derived from information contained in the environmental report submitted pursuant to § 51.50 of this chapter, as analyzed and evaluated in the NRC record of decision and will identify the obligations of the licensee in the environmental area, including, as appropriate, requirements for reporting and keeping records of environmental data, and any conditions and monitoring requirement for the protection of the nonaquatic environment.

(b) Each license authorizing operation of a commercial nuclear plant under this part, and each license for a commercial nuclear plant for which the certification of permanent cessation of operations required under § 53.1070 has been submitted may include conditions to address environmental issues during operation and decommissioning. These conditions are to be set out in an attachment to the license, which is incorporated in and made a part of the license. These conditions will be derived from information contained in the environmental report or the supplement to the environmental report submitted under §§ 51.50 and 51.53 of this chapter as analyzed and evaluated in the NRC record of decision, and will identify the obligations of the licensee in the environmental area, including, as appropriate, requirements for reporting and keeping records of environmental data and any conditions and monitoring requirement for the protection of the nonaquatic environment.

As part of its application and in any event before the receipt of Restricted Data or classified National Security Information or the issuance of a license or standard design approval under this part, or before the Commission has adopted a final standard design certification rule under this part, the applicant must agree in writing that it will 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 and/or 95. The agreement of the applicant becomes part of the license or standard design approval.

Any person who is a citizen, national, or agent of a foreign country, or any corporation, or other entity which the Commission knows or has reason to believe is owned, controlled, or dominated by an alien, a foreign corporation, or a foreign government, will be ineligible to apply for and obtain a license unless—

(a) The Commission determines that issuance of the applicable license to the entity is not inimical to the common defense and security or the health and safety of the public; and

(b) The entity is an alien, corporation, or other entity that is owned, controlled, or dominated by the government of, a corporation that is incorporated in, or an alien who is a citizen or national of Australia, Austria, Belgium, Canada, Chile, Colombia, Costa Rica, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea, Latvia, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, or the United Kingdom.

Nothing in this part must be deemed to require a license for—

(a) The manufacture, production, or acquisition by the Department of Defense of any utilization facility authorized pursuant to section 91 of the Act or the use of such facility by the Department of Defense or by a person under contract with and for the account of the Department of Defense;

(b) Except to the extent that the Department of Energy facilities of the types subject to licensing pursuant to section 202 of the Energy Reorganization Act of 1974, as amended, are involved—

(1)(i) The processing, fabrication or refining of special nuclear material (SNM) or the separation of SNM, or the separation of SNM from other substances by a prime contractor of the Department of Energy under a prime contract for—

(A) The performance of work for the Department of Energy at a United States Government-owned or controlled site;

(B) Research in, or development, manufacture, storage, testing or transportation of, atomic weapons or components thereof; or

(C) The use or operation of a utilization facility in a United States owned vehicle or vessel; or

(ii) The processing, fabrication or refining of SNM of the separation of SNM, or the separation of SNM from other substances by a prime contractor or subcontractor of the Commission or the Department of Energy under a prime contract or subcontract when the Commission determines that the exemption of the prime contractor or subcontractor is authorized by law; and that, under the terms of the contract or subcontract, there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety; or

(2)(i) The construction or operation of a utilization facility for the Department of Energy at a United States Government-owned or controlled site, including the transportation of the utilization facility to or from such site and the performance of contract services during temporary interruptions of such transportation; or the construction or operation of a utilization facility for the Department of Energy in the performance of research in, or development, manufacture, storage, testing, or transportation of, atomic weapons or components thereof; or the use or operation of a utilization facility for the Department of Energy in a United States Government-owned vehicle or vessel; provided that such activities are conducted by a prime contractor of the Department of Energy under a prime contract with the Department of Energy; or

(ii) The construction or operation of a utilization facility by a prime contractor or subcontractor of the Commission or the Department of Energy under his or her prime contract or subcontract when the Commission determines that the exemption of the prime contractor or subcontractor is authorized by law; and that, under the terms of the contract or subcontract, there is adequate assurance that the work thereunder can be accomplished without undue risk to the public health and safety; or

(c) The transportation or possession of any utilization facility by a common or contract carrier or warehouse employee in the regular course of carriage for another or storage incident thereto.

Applications and documents submitted to the Commission in connection with applications may be made available for public inspection under the provisions of part 2 of this chapter.

A COL may be transferred under § 53.1570.

The filing of an application for a renewed license must be in accordance with § 53.1595.

Each COL for a facility that has permanently ceased operations continues in effect beyond the expiration date to authorize ownership and possession of the facility until the Commission notifies the licensee in writing that the license is terminated. During this period of continued effectiveness, the licensee must—

(a) Take actions necessary to decommission and decontaminate the facility and continue to maintain the facility, including, where applicable, the storage, control and maintenance of the spent fuel, in a safe condition; and

(b) Conduct activities in accordance with all other restrictions applicable to the facility in accordance with the NRC's regulations and the provisions of the COL for the facility.

(a) Except as otherwise specified in this section, the provisions of this section apply to CP, OL, and COL applications for commercial nuclear plants of identical design (the “common design”) under this part.

(b) Each application for a CP, OL, or COL submitted pursuant to this section must be submitted as specified in § 53.1300, § 53.1360, or § 53.1410, respectively, and § 2.101 of this chapter. Each application must state that the applicant wishes to construct a facility identical to a facility proposed for one or more sites other than the applicant's (the “common design”), and the applicant wishes to have the application considered under this section. Each application must list each of the other applications to be treated together under this section or specify that such other applications will be submitted to the NRC within 12 months of submittal of the first application.

(c) Each application must include the information required by the applicable sections of this subpart, provided, however, that the application must identify the common design, and, if applicable, reference a standard design certification or standard design approval under this part, or the use of a reactor manufactured under this part. The FSAR for each application must either incorporate by reference or include the final safety analysis of the common design, including, if applicable, the FSAR for the referenced standard design certification, standard design approval, or the manufactured reactor.

(d) Each application submitted pursuant to this section must contain an environmental report under § 53.1312(a)(1), § 53.1372(a), or § 53.1419(a)(1), as applicable, that complies with the applicable provisions of 10 CFR part 51, provided, however, that the application may incorporate by reference a single environmental report on the environmental impacts of the common design that are applicable to each site.

(e) Upon a determination that each application is acceptable for docketing under § 2.101 of this chapter, each application will be docketed and a notice of docketing for each application will be published in the Federal Register, under § 2.104 of this chapter, provided, however, that the notice must state that the application will be processed under the provisions of this section and subpart D of 10 CFR part 2. At the discretion of the Commission, a single notice of docketing for multiple applications may be published in the Federal Register.

(f) The NRC must prepare an environmental assessment or draft and final environmental impact statements for each of the applications under 10 CFR part 51. Scoping under §§ 51.28 and 51.29 of this chapter for each of the license applications may be conducted simultaneously and joint scoping may be conducted with respect to the environmental issues relevant to the common design. If the applications reference a standard design certification, then the environmental assessment or environmental impact statement for each of the applications must incorporate by reference the standard design certification environmental assessment. If the applications do not reference a standard design certification, then the NRC must prepare environmental assessments or draft and final supplemental environmental impact statements which address severe accident mitigation design alternatives for the common design, which must be incorporated by reference into the environmental assessment or environmental impact statement prepared for each application. Scoping under §§ 51.28 and 51.29 of this chapter for the supplemental environmental impact statement may be conducted simultaneously and may be part of the scoping for each of the applications.

(g) The ACRS must report on each of the applications as required by the applicable sections of this subpart. Each report must be limited to those safety matters for each application that are not relevant to the common design. In addition, the ACRS must separately report on the safety of the common design, provided, however, that the report need not address the safety of a referenced standard design certification or reactor manufactured under this part.

(h) The Commission must designate a presiding officer to conduct the proceeding with respect to the health and safety, common defense and security, and environmental matters relating to the common design and affecting at least two applications. The hearing will be governed by the applicable provisions of subparts A, C, G, L, N, and O of 10 CFR part 2 relating to applications for CPs, OLs, and COLs. The presiding officer must issue a partial initial decision on the common design.

(i) If the design for the power reactor(s) proposed in a particular application is not identical to the others, that application may not be processed under this section and subpart D of 10 CFR part 2.

(j) As used in this section, the design of a nuclear power reactor included in a single referenced Safety Analysis Report means the design of those SSCs important to radiological health and safety and the common defense and security.

(a) Limited work authorization. An application for a limited work authorization (LWA) under this part may be submitted as part of an application for an early site permit, CP, or COL under this part as required in § 53.1130(a)(2).

(b) Early site permit. (1) A holder of an early site permit may request an LWA.

(2) An application for a CP or COL under this part may, but need not, reference an early site permit.

(c) Standard design approval. An application for a standard design approval under this part may, but need not, reference an OL or custom COL under this part that is essentially the same as the information supporting the standard design for which approval is being requested.

(d) Standard design certification. An application for a standard design certification under this part may, but need not, reference an OL or custom COL under this part that is essentially the same as the standard design for which certification is being requested.

(e) Manufacturing license. (1) A manufactured reactor or portions thereof as defined in an ML issued under this part may be either transported to and installed at a site for which a COL or CP under this part has been issued or exported in accordance with part 110.

(2) An ML applicant under this part may reference a standard design certification or a standard design approval under this part in its application.

(f) Construction permit. An application for a CP may, but need not, reference a standard design certification, standard design approval, or ML issued under this part, respectively, and may also reference an early site permit issued under this part. In the absence of a demonstration that an entity other than the one originally sponsoring a standard design certification is qualified to supply a design, the Commission will entertain an application for a CP that references a standard design certification issued under this part only if the entity that sponsored the certification supplies the design for the applicant's use.

(g) Operating license. (1) An application for an OL under this part may, but need not, reference an early site permit, standard design certification, or standard design approval issued under this part. In the absence of a demonstration that an entity other than the one originally sponsoring a standard design certification is qualified to supply a design, the Commission will entertain an application for an OL that references a standard design certification issued under this part only if the entity that sponsored the certification supplies the design for the applicant's use.

(2) The holder of a CP must, at the time of submission of the Final Safety Analysis Report (FSAR), file an application for an OL.

(h) Combined licenses. An application for a COL under this part may, but need not, reference an early site permit, standard design certification, standard design approval, or ML issued under this part. In the absence of a demonstration that an entity other than the one originally sponsoring and obtaining a standard design certification is qualified to supply a design, the Commission will entertain an application for a COL that references a standard design certification issued under this part only if the entity that sponsored the certification supplies the design for the applicant's use.

(a) Request for limited work authorization. (1) Any person to whom the Commission may otherwise issue either a license or permit related to a commercial nuclear plant may request an LWA allowing that person to perform the driving of piles, subsurface preparation, placement of backfill, concrete, or permanent retaining walls within an excavation, and installation of the foundation, including placement of concrete, any of which are for a structure, system, or component (SSC) of the facility for which either a CP or COL is otherwise required under § 53.610.

(2) An application for an LWA may be submitted as part of a complete application for a CP or COL in accordance with § 2.101(a)(1) through (a)(5) of this chapter, or as a partial application in accordance with § 2.101(a)(9) of this chapter. An application for an LWA by the holder of an early site permit must be submitted as a complete application in accordance with § 2.101(a)(1) through (a)(4) of this chapter.

(3) The application must include—

(i) A Safety Analysis Report required by § 53.1146, § 53.1309 or § 53.1416, as applicable, a description of the activities requested to be performed, and the design and construction information otherwise required by the Commission's rules and regulations to be submitted for a CP or COL under this part but limited to those portions of the facility that are within the scope of the LWA. The Safety Analysis Report must demonstrate that activities conducted under the LWA will be conducted in compliance with the technically relevant Commission requirements in 10 CFR chapter I applicable to the design of those portions of the facility within the scope of the LWA;

(ii) An environmental report in accordance with § 51.49 of this chapter; and

(iii) A plan for redress of activities performed under the LWA, should limited work activities be terminated by the holder, or the LWA be revoked by the NRC or upon effectiveness of the Commission's final decision denying the associated CP or COL application, as applicable.

(b) Issuance of limited work authorization. (1) The Director, Office of Nuclear Reactor Regulation may issue an LWA only after—

(i) The NRC staff issues the final environmental impact statement for the LWA under part 51 of this chapter;

(ii) The presiding officer makes the finding in § 51.105(c) or § 51.107(d) of this chapter, as applicable;

(iii) The Director determines that the applicable standards and requirements of the Act, and the Commission's regulations applicable to the activities to be conducted under the LWA, have been met, the applicant is technically qualified to engage in the activities authorized, and that issuance of the LWA will provide reasonable assurance of adequate protection to public health and safety and will not be inimical to the common defense and security; and

(iv) The presiding officer finds that there are no unresolved safety issues relating to the activities to be conducted under the LWA that would constitute good cause for withholding the authorization.

(2) Each LWA will specify the activities that the holder is authorized to perform.

(c) Effect of limited work authorization. Any activities undertaken under an LWA are entirely at the risk of the applicant and, except as to the matters determined under paragraph (b)(1) of this section, the issuance of the LWA has no bearing on the issuance of a CP or COL with respect to the requirements of the Act and rules, regulations, or orders issued under the Act. The environmental impact statement for a CP or COL application for which an LWA was previously issued will not address, and the presiding officer will not consider, the sunk costs of the holder of the LWA in determining the proposed action (i.e., issuance of the CP or COL).

(d) Implementation of redress plan. If construction is terminated by the holder, the underlying application is withdrawn by the applicant or denied by the NRC, or the LWA is revoked by the NRC, then the holder must begin implementation of the redress plan in a reasonable time. The holder must also complete the redress of the site no later than 18 months after termination of construction, revocation of the LWA, or upon effectiveness of the Commission's final decision denying the associated CP application or the associated COL application, as applicable.

Sections 53.1140 through 53.1188 set out the requirements and procedures applicable to Commission issuance of an early site permit under this part for approval of a site for a commercial nuclear plant separate from the filing of an application for a CP or COL for the facility.

The application must contain all of the information required by § 53.1109(a) through (d) and (j).

(a) The application must contain—

(1) A Site Safety Analysis Report that must include the following:

(i) The specific number, type, and thermal power level of the facilities, or range of possible facilities, for which the site may be used;

(ii) The anticipated maximum levels of radiological and thermal effluents each facility will produce;

(iii) The type of cooling systems, including intakes and outflows, where appropriate, that may be associated with each facility;

(iv) The boundaries of the site;

(v) The proposed general location of each facility on the site;

(vi) The external hazards and site characteristics required by this part;

(vii) The location and description of any nearby industrial, military, or transportation facilities and routes;

(viii) The existing and projected future population profile of the area surrounding the site;

(ix) A description and assessment of the site on which a facility is to be located. The assessment must address the requirements of subpart D of this part;

(x) Information demonstrating that site characteristics are such that adequate security plans and measures can be developed; and

(xi) A description of the quality assurance program (QAP) required by appendix B to part 50 of this chapter applied to site-related activities for the future design, fabrication, construction, and testing of the SSCs of a facility or facilities that may be constructed on the site.

(2) A complete environmental report as required by § 51.50(b) of this chapter.

(b)(1) The Site Safety Analysis Report must identify physical characteristics of the proposed site, such as egress limitations from the area surrounding the site, that could pose a significant impediment to the development of emergency plans. If physical characteristics are identified that could pose a significant impediment to the development of emergency plans, the application must identify measures that would, when implemented, mitigate or eliminate the significant impediment.

(2) The Site Safety Analysis Report may also—

(i) Propose major features of the emergency plans, under either § 50.160 or the requirements in appendix E to part 50 and § 50.47(b) of this chapter, as applicable, such as the exact size and configuration of the EPZs, for review and approval by the NRC, in consultation with the Federal Emergency Management Agency (FEMA), as applicable, in the absence of complete and integrated emergency plans; or

(ii) Propose complete and integrated emergency plans for review and approval by the NRC, in consultation with FEMA, as applicable, in accordance with either § 50.160 or the requirements in appendix E to part 50 and § 50.47(b) of this chapter. To the extent approval of emergency plans is sought, the application must contain the information required by § 53.1109(g).

(3) Emergency plans submitted under paragraph (b)(2)(ii) of this section must include the proposed inspections, tests, and analyses that the holder of a COL referencing the early site permit must perform, and the acceptance criteria that are necessary and sufficient 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 conformity with the emergency plans, the provisions of the Act, and the Commission's rules and regulations. Major features of an emergency plan submitted under paragraph (b)(2)(i) of this section may include proposed inspections, tests, analyses, and acceptance criteria (ITAAC).

(4) Under paragraphs (b)(1) and (b)(2)(i) of this section, the Site Safety Analysis Report must include, where appropriate, a description of contacts and arrangements made with Federal, State, participating Tribal, and local governmental agencies with emergency planning responsibilities. The Site Safety Analysis Report must contain any certifications that have been obtained. If these certifications, where appropriate, cannot be obtained, the Site Safety Analysis Report must contain information, including a utility plan, sufficient to show that the proposed plans provide reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency at the site. Under the option set forth in paragraph (b)(2)(ii) of this section, the applicant must make good faith efforts, where appropriate, to obtain from the same governmental agencies certifications that—

(i) The proposed emergency plans are practicable;

(ii) These agencies are committed to participating in any further development of the plans, including any required field demonstrations; and

(iii) That these agencies are committed to executing their responsibilities under the plans in the event of an emergency.

(c) An applicant may request that an LWA under § 53.1130 be issued in conjunction with the early site permit. The application must include the information otherwise required by § 53.1130.

(d) Each applicant for an early site permit under this part must protect safeguards information against unauthorized disclosure in accordance with the requirements in §§ 73.21 and 73.22 of this chapter, as applicable.

(a) Standards for review of applications. Applications filed under this part will be reviewed according to the applicable standards set out in this part. In addition, the Commission must prepare an environmental impact statement during review of the application, under the applicable provisions of 10 CFR part 51. The Commission must determine, after consultation with FEMA, as applicable, whether the information required of the applicant by § 53.1146(b)(1) shows that there is no significant impediment to the development of emergency plans that cannot be mitigated or eliminated by measures proposed by the applicant, whether any major features of emergency plans submitted by the applicant under § 53.1146(b)(2)(i) are acceptable under either § 50.160 or appendix E to part 50 and § 50.47(b) of this chapter, and whether any emergency plans submitted by the applicant under § 53.1146(b)(2)(ii) provide reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency.

(b) Administrative review of applications; hearings. An early site permit application is subject to all procedural requirements in 10 CFR part 2, including the requirements for docketing in § 2.101(a)(1) through (4) of this chapter, and the requirements for issuance of a notice of hearing in § 2.104(a) and (d) of this chapter, provided that the designated sections may not be construed to require that the environmental report, or draft or final environmental impact statement includes an assessment of the benefits of construction and operation of the reactor or reactors, or an analysis of alternative energy sources. The presiding officer in an early site permit hearing must not admit contentions proffered by any party concerning an assessment of the benefits of construction and operation of the reactor or reactors, or an analysis of alternative energy sources if those issues were not addressed by the applicant in the early site permit application. All hearings conducted on applications for early site permits filed under this part are governed by the procedures contained in subparts C, G, L, and N of 10 CFR part 2, as applicable.

The Commission must refer a copy of the application for an early site permit to the Advisory Committee on Reactor Safeguards (ACRS). The ACRS must report on those portions of the application which concern safety.

(a) After conducting a hearing under § 53.1149(b) and receiving the report to be submitted by the ACRS under § 53.1155, the Commission may issue an early site permit, in the form the Commission deems appropriate, if the Commission finds that—

(1) An application for an early site permit 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 site is in conformity with the provisions of the Act and the Commission's regulations;

(4) The applicant is technically qualified to engage in any activities authorized;

(5) The proposed ITAAC, including any on emergency planning, are necessary and sufficient, within the scope of the early site permit, to provide reasonable assurance that the facility has been constructed and will be operated in conformity with the license, the provisions of the Act, and the Commission's regulations;

(6) Issuance of the permit will not be inimical to the common defense and security or to the health and safety of the public;

(7) Any significant adverse environmental impact resulting from activities requested under § 53.1146(c) can be redressed; and

(8) The findings required by 10 CFR part 51 have been made.

(b) The early site permit must specify the site characteristics, design parameters, and terms and conditions of the early site permit the Commission deems appropriate. Before issuance of either a CP or COL referencing an early site permit, the Commission must find that any relevant terms and conditions of the early site permit have been met. Any terms or conditions of the early site permit that could not be met by the time of issuance of the CP or COL, must be set forth as terms or conditions of the CP or COL.

(c) The early site permit must specify those § 53.1130(b) activities requested under § 53.1146(c) that the permit holder is authorized to perform.

If the activities authorized by § 53.1158(c) are performed and the site is not referenced in an application for a CP or a COL issued under this part while the permit remains valid, then the early site permit remains in effect solely for the purpose of site redress, and the holder of the permit must redress the site under the terms of the site redress plan required by § 53.1146(c). If, before redress is complete, a use not envisaged in the redress plan is found for the site or parts thereof, the holder of the permit must carry out the redress plan to the greatest extent possible consistent with the alternate use.

(a) Except as provided in paragraph (b) of this section, an early site permit issued under this subpart may be valid for not less than 10, nor more than 20 years from the date of issuance.

(b) An early site permit continues to be valid beyond the date of expiration in any proceeding on a CP application or a COL application that references the early site permit and is docketed before the date of expiration of the early site permit, or, if a timely application for renewal of the permit has been docketed, before the Commission has determined whether to renew the permit.

(c) An applicant for a CP or COL may, at its own risk, reference in its application a site for which an early site permit application has been docketed but not granted.

(d) Upon issuance of a CP or COL, a referenced early site permit is subsumed, to the extent referenced, into the CP or COL.

A holder of an early site permit may request an LWA under § 53.1130.

An application to transfer an early site permit will be processed under § 53.1570.

(a) Not less than 12, nor more than 36 months before the expiration date stated in the early site permit, or any later renewal period, the permit holder may apply for a renewal of the permit. An application for renewal must contain all information necessary to bring up to date the information and data contained in the previous application.

(b) Any person whose interests may be affected by renewal of the permit may request a hearing on the application for renewal. The request for a hearing must comply with § 2.309 of this chapter. If a hearing is granted, notice of the hearing will be published under § 2.309 of this chapter.

(c) An early site permit, 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 permit. If the permit is not renewed, it continues to be valid in certain proceedings in accordance with the provisions of § 53.1164(b).

(a) The Commission must grant the renewal if it determines that—

(1) The site complies with the Act, the Commission's regulations, and orders applicable and in effect at the time the site permit was originally issued; and

(2) Any new requirements the Commission may wish to impose—

(i) Are necessary for adequate protection to public health and safety or common defense and security;

(ii) Are necessary for compliance with the Commission's regulations, and orders applicable and in effect at the time the site permit was originally issued; or

(iii) Would provide 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 implementation of those requirements are justified in view of this increased protection.

(b) A denial of renewal under the provisions of § 53.1176(a) does not bar the permit holder or another applicant from filing a new application for the site which proposes changes to the site or the way that it is used to correct the deficiencies cited in the denial of the renewal.

Each renewal of an early site permit may be for not less than 10, nor more than 20 years, plus any remaining years on the early site permit then in effect before renewal.

A site for which an early site permit has been issued under this part may be used for purposes other than those described in the permit, including the location of other types of energy facilities. The permit holder must inform the Director, Office of Nuclear Reactor Regulation (Director), of any significant uses for the site which have not been approved in the early site permit. The information about the activities must be given to the Director at least 30 days in advance of any actual construction or site modification for the activities. The information provided could be the basis for imposing new requirements on the permit, under the provisions of § 53.1188. If the permit holder informs the Director that the holder no longer intends to use the site for a commercial nuclear plant, the Director may terminate the permit.

(a) Commission finality. (1) While an early site permit is in effect under § 53.1164 or § 53.1179, the Commission may not change or impose new site characteristics, design parameters, or terms and conditions, including emergency planning requirements, on the early site permit unless the Commission—

(i) Determines that a modification is necessary to bring the permit or the site into compliance with the Commission's regulations and orders applicable and in effect at the time the permit was issued;

(ii) Determines the modification is necessary to assure adequate protection of the public health and safety or the common defense and security;

(iii) Determines that a modification is necessary based on an update under paragraph (b) of this section; or

(iv) Issues a variance requested under paragraph (d) of this section.

(2) In making the findings required for issuance of a CP, COL, or OL, or the findings required by § 53.1452(g), or in any enforcement hearing other than one initiated by the Commission under paragraph (a)(1) of this section, if the application for the CP, COL, or OL references an early site permit, the Commission must treat as resolved those matters resolved in the proceeding on the application for issuance or renewal of the early site permit, except as provided for in paragraphs (b), (c), and (d) of this section.

(i) If the Commission grants a CP application that references an early site permit and an application for an OL references the CP, the Commission must treat as resolved those matters resolved in the proceeding for the issuance or renewal of the early site permit, except as provided for in paragraphs (b), (c), and (d) of this section.

(ii) If the early site permit approved an emergency plan (or major features thereof) that is in use by a licensee of a commercial nuclear plant, the Commission must treat as resolved changes to the early site permit emergency plan (or major features thereof) that are identical to changes made to the licensee's emergency plans under § 53.1565 occurring after issuance of the early site permit.

(iii) If the early site permit approved an emergency plan (or major features thereof) that is not in use by a licensee of a commercial nuclear plant, the Commission must treat as resolved changes that are equivalent to those that could be made under § 53.1565 without prior NRC approval had the emergency plan been in use by a licensee.

(b) Updating of early site permit-emergency preparedness. An applicant for a CP, OL, or COL who has filed an application referencing an early site permit issued under this subpart must update the emergency preparedness information that was provided under § 53.1146(b) and discuss whether the updated information materially changes the bases for compliance with applicable NRC requirements.

(c) Hearings and petitions. (1) In any proceeding for the issuance of a CP, OL, or COL referencing an early site permit, contentions on the following matters may be litigated in the same manner as other issues material to the proceeding:

(i) The nuclear reactor proposed to be built does not fit within one or more of the site characteristics or design parameters included in the early site permit;

(ii) One or more of the terms and conditions of the early site permit have not been met;

(iii) A variance requested under paragraph (d) of this section is unwarranted or should be modified;

(iv) New or additional information is provided in the application that substantially alters the bases for a previous NRC conclusion or constitutes a sufficient basis for the Commission to modify or impose new terms and conditions related to emergency preparedness; or

(v) Any significant environmental issue that was not resolved in the early site permit proceeding, or any issue involving the impacts of construction and operation of the facility that was resolved in the early site permit proceeding for which significant new information has been identified.

(2) Any person may file a petition requesting that the site characteristics, design parameters, or terms and conditions of the early site permit be modified, or that the permit be suspended or revoked. The petition will be considered under § 2.206 of this chapter. Before construction commences, the Commission must consider the petition and determine whether any immediate action is required. If the petition is granted, an appropriate order will be issued. Construction under the CP or COL will not be affected by the granting of the petition unless the order is made immediately effective. Any change required by the Commission in response to the petition must demonstrate compliance with the requirements of paragraph (a)(1) of this section.

(d) Variances. An applicant for a CP, OL, or COL referencing an early site permit may include in its application a request for a variance from one or more site characteristics, design parameters, or terms and conditions of the early site permit, or from the Site Safety Analysis Report. In determining whether to grant the variance, the Commission must apply the same technically relevant criteria applicable to the application for the original or renewed early site permit. Once a CP or COL referencing an early site permit is issued, variances from the early site permit will not be granted for that CP or COL.

(e) Early site permit amendment. The holder of an early site permit may not make changes to the early site permit or the Site Safety Analysis Report without prior Commission approval. The request for a change to the early site permit must be in the form of an application for a license amendment and must demonstrate compliance with the requirements of §§ 53.1510 and 53.1520.

Sections 53.1200 through 53.1221 set out procedures for the filing, NRC staff review, and referral to the ACRS of standard designs, or major portions thereof, for a commercial nuclear plant under this part.

The application must contain all of the information required by § 53.1109(a) through (c) and (j).

(a) Major portion of a standard design. If the applicant seeks review of a major portion of a standard design, the application need only contain the information required by this section to the extent the requirements are applicable to the major portion of the standard design for which NRC staff approval is sought. If an applicant seeks approval of a major portion of the design, the scope of the application for which approval is sought must include all functional design criteria necessary to demonstrate compliance with the safety criteria in §§ 53.210, 53.220 and 53.450(e), as applicable, for the major portion of the standard design for which NRC staff approval is sought. Such applicants must identify conditions related to interfaces with systems outside the scope of the major portion of the standard design for which NRC staff approval is sought, and functional or physical boundary conditions between the major portion of the standard design for which NRC staff approval is sought and the remainder of the standard design. These conditions must be demonstrated when the standard design approval is incorporated into a subsequent CP, design certification, ML, or COL application.

(b) Final Safety Analysis Report. The application must contain an FSAR that describes the facility and the limits on its operation, presents a safety analysis of the SSCs and of the facility, or major portions thereof, for which the applicant seeks design approval, 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) Design information. Except as specified in this paragraph (b), an application for a standard design approval for a commercial nuclear plant must include the design information equivalent to that required for a standard design certification under § 53.1239(a)(2) through (27) for those portions of a commercial nuclear plant included in the standard design approval.

(a) In addition to the FSAR, the application must also include the following:

(1) 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 safety-related (SR) SSCs and non-safety-related but safety-significant (NSRSS) SSCs provide the capabilities and reliabilities required to demonstrate compliance with the safety criteria of § 53.220.

(2) Safeguards information. A description of the program to protect Safeguards Information against unauthorized disclosure in accordance with the requirements in §§ 73.21 and 73.22 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).

Applications filed under this part will be reviewed under the standards set out in 10 CFR parts 20, 53, and 73.

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.

(a) Upon completion of its review of a submittal under §§ 53.1200 through 53.1221 and receipt of a report by the ACRS under § 53.1215, the NRC staff must publish a determination in the Federal Register as to whether or not the design is acceptable, subject to appropriate terms and conditions, and make an analysis of the design in the form of a report available at the NRC website, https://www.nrc.gov.

(b) A standard design approval issued under this section is valid for 15 years from the date of issuance and may not be renewed. A design approval continues to be valid beyond the date of expiration in any proceeding on an application for a CP, OL, COL, or ML under this part that references the design approval and is docketed before the date of expiration of the design approval.

(a) An approved design must be used by and relied upon by the NRC staff and the ACRS in their reviews of any standard design certification or individual facility license application under this part that incorporates by reference a standard design approved under this part unless there exists significant new information that substantially affects the earlier determination or other good cause.

(b) The determination and report by the NRC staff do not constitute a commitment to issue a permit or license, or in any way affect the authority of the Commission, Atomic Safety and Licensing Board Panel, or presiding officers in any proceeding under part 2 of this chapter.

(c) Except for information requests seeking to verify compliance with the current licensing basis of the standard design approval, information requests to the holder of a standard design approval must be evaluated before issuance to ensure that the burden to be imposed on respondents is justified in view of the potential safety significance of the issue to be addressed in the requested information. Each evaluation performed by the NRC staff must be in accordance with § 53.1580 and must be approved by the Executive Director for Operations or authorized designee before issuance of the request.

(d) The Commission will require, before granting a CP, COL, OL, or ML that references a standard design approval, 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 design approval information. This information may be acquired by appropriate arrangements with the design approval applicant.

Sections 53.1230 through 53.1263 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.

The application must contain all of the information required by § 53.1109(a) through (c) and (j).

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 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 and the functional design criteria required by §§ 53.410 and 53.420 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 and established in accordance with § 53.220 during licensing-basis events (LBEs).

(ii) A description of how design features demonstrate compliance with the requirements of § 53.440(a) through (i) and (k) through (m).

(4) Design features supporting normal operations. A description of the design features required by § 53.425 to support the holder of an OL or COL complying with § 53.260 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.

(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 and 53.420 and the safety criteria in §§ 53.210 and 53.220 and necessary to maintain consistency with analyses required by § 53.450.

(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), 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.

(9) Design features supporting the protection of plant workers. A description of the design features required by § 53.430 to support the holder of an OL or COL complying with § 53.270.

(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.

(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).

(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).

(13) Integrity assessment program. A description of a design integrity assessment program that addresses the elements described in § 53.440(d).

(14) [Reserved]

(15) Criticality. Information demonstrating how the applicant will comply with requirements for criticality accidents in § 53.440(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).

(17) SSC classification. (i) The classification of SSCs according to their safety significance under § 53.460(a).

(ii) For SR and NSRSS SSCs, the conditions under which they must perform the safety functions required by § 53.230, 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) and associated results.

(19) Analyses. A description of the analyses performed under § 53.450(b) through (g) that includes the following information:

(i) A description of the analysis of LBEs and its results, as described in § 53.240. This analysis description must—

(A) Address the elements in § 53.450(e) and (f); and

(B) Under § 53.460(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 of this part.

(ii)(A) A description of how SSCs relied on to meet the safety criteria defined in § 53.210 are protected against or designed to withstand the effects of external hazards under § 53.510.

(B) The information necessary to demonstrate that the commercial nuclear plant complies with the earthquake engineering criteria in § 53.480.

(iii) A description of the defense-in-depth measures required by § 53.250.

(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).

(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).

(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).

(vii) A description of the results of other analyses required by § 53.450(g).

(20) Special treatments. A description of special treatments established as required by § 53.460.

(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). 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 of this chapter were satisfied.

(23) Design features and controls to address the minimization of contamination. The information required by § 20.1406 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).

(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) 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) 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) are addressed;

(ii) A description of how the human system interface design requirements of § 53.440(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);

(iv) A functional requirements analysis and function allocation that is of sufficient scope and detail to address the requirements of § 53.440(n)(4).

(b) [Reserved]

(a) In addition to the FSAR, the application must also include the following:

(1) Environmental report. An environmental report as required by § 51.55 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.

(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 and 73.22 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).

(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, 51, 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 of 10 CFR part 2, 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) 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), the Commission decides that a legislative hearing should be held, the information required by § 2.1502(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 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) of this chapter and specify whether the Commission or a presiding officer will conduct the legislative hearing.

(3) Notwithstanding anything in § 2.390 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, to the extent practicable.

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.

(a) After conducting a rulemaking proceeding under § 53.1242 on an application for a standard design certification and receiving the report to be submitted by the ACRS under § 53.1245, 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 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 and/or 95, as applicable.

(a) Except as provided in paragraph (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 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.

(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.

(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.

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

(a)(1) While a standard design certification rule is in effect under § 53.1251 or § 53.1260, 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), except for § 53.1263(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) must provide for notice and opportunity for public comment.

(3) 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)(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, 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 are present. In addition to the factors listed in § 53.080, the Commission must consider whether the special circumstances which § 53.080 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 of this chapter, in making the findings required for issuance of a COL, CP, OL, or ML, or for any hearing under § 53.1452, 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. In addition to the factors listed in § 53.080, the Commission must consider whether the special circumstances that § 53.080 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.

Sections 53.1270 through 53.1295 set out the requirements and procedures applicable to Commission issuance of a license under this part authorizing manufacture of manufactured reactors to be installed at sites not identified in the ML application.

Each application for an ML must include the information contained in § 53.1109(a) through (e), and (j).

(a) Final Safety Analysis Report-siting and design. The application must include an FSAR containing the information set forth below, with a level of design information sufficient to enable the Commission to judge the applicant's proposed means of ensuring that the manufacturing conforms to the design and to reach a final conclusion on all safety questions associated with the design, permit the preparation of construction and installation specifications by an applicant who seeks to use the manufactured reactor, and permit the preparation of acceptance and inspection requirements by the NRC. The application 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) Design information. The design information equivalent to that required for a standard design certification as defined in § 53.1239(a)(2) through (27) for those portions of a commercial nuclear plant included in the manufactured reactor.

(3) Quality assurance program. A description of the QAP applied to the design, and to be applied to the fabrication and testing of the SSCs of the manufactured reactor under § 53.620(a)(6), including a discussion of how the applicable requirements of appendix B to part 50 of this chapter will be satisfied;

(4) Conceptual designs. Representative conceptual designs for one or more commercial nuclear plants using the manufactured reactor;

(5) Operating configurations. If multiple manufactured reactors may be installed at a commercial nuclear plant, a description of the possible operating configurations, including common systems, interface requirements, and system interactions. The final safety analysis must also account for differences among the possible configurations, including any restrictions that will be necessary during the construction and startup of a given manufactured reactor to ensure the safe operation of any commercial nuclear reactor already operating;

(6) Interface requirements. (i) The interface requirements between the manufactured reactor and the remaining portions of the commercial nuclear plant or connections to other facilities outside of the commercial nuclear plant.

(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 manufactured reactor manufactured under this subpart. Applicants for a COL under this part will need to verify the interface requirements at the installation site. The method to be used for verification of interface requirements must be included as part of the proposed ITAAC required by § 53.1282(a).

(iii) Information to support development of radiation monitoring programs required under subpart F of this part by an applicant for a COL, including potential pathways for radionuclides produced within the manufactured reactor to enter interfacing systems.

(b) Final Safety Analysis Report—manufacturing information. The FSAR must include the following information related to the manufacturing processes, organization, controls, and inspections:

(1) A description, including references to generally accepted consensus codes and standards, of the processes that will be used to procure, fabricate, and assemble components that make up the manufactured reactor. The description should clearly define which activities are proposed to be within the scope of the ML and those, such as the making of a component to be procured from a separate company for installation in the manufactured reactor, that are not considered to be within the scope of the ML;

(2) A description of the organizational and management structure singularly responsible for direction of design and manufacture of the manufactured reactor. The information should include a description of the management plans, technical qualifications, and controls in place to demonstrate compliance with the requirements of § 53.620;

(3) A description of the inspections and tests to be performed as part of the manufacturing process, including the inspection of procured components, inspection and testing of fabrication processes such as the molding, welding, or coating of components, and inspections and testing of the assembled manufactured reactor or portions of the manufactured reactor;

(4) A description of the fitness-for-duty program required by part 26 of this chapter and its implementation.

(c) Final Safety Analysis Report—deployment of the completed manufactured reactor. The application must include a description of the following information related to the deployment of a manufactured reactor:

(1) Procedures governing the preparation of the manufactured reactor or portions of the manufactured reactor for shipping to the site where it is to be operated; the conduct of shipping; and verifying the condition of the shipped items upon receipt at the site;

(2) Details of the interaction of the design, manufacture, and installation of a manufactured reactor within the applicant's organization and the manner by which the applicant will ensure close integration between the designer, contractors, and any facility in which the manufactured reactor is to be installed;

(3) Measures to be used for the control of interfaces, including the consideration of key site parameters, between the holder of the ML and the holder of the COL or CP for the commercial nuclear plant at which the manufactured reactor is to be installed.

(d) Final Safety Analysis Report—special considerations for factory fueling. In addition to the above paragraphs (a) through (c) of this section, an application for an ML for a manufactured reactor that will be fueled at the factory under a 10 CFR part 70 license must include the following information related to loading fuel and the required features to prevent criticality and to otherwise provide assurance that the fueled manufactured reactor can be successfully transported, installed, and operated at a site for which the Commission has issued a COL or a CP and OL that authorizes construction and operation of a commercial nuclear plant using the manufactured reactor:

(1) A description of the procedures used during the fueling of the manufactured reactor that ensure that the configuration of fuel within the fueled manufactured reactor is consistent with the design and analyses supporting operation of the manufactured reactor under the COL or OL at the place of operation. The description may reference the applicable 10 CFR part 70 application and other sections of the Safety Analysis Report supporting the ML license application.

(i) The application must describe the measures taken for in-factory inspections and non-nuclear testing performed to ensure that the configuration of fuel within the fueled manufactured reactor is consistent with the design and analyses supporting operation of the manufactured reactor under the COL or OL at the place of operation.

(ii) The application must describe the design features included in the manufactured reactor to prevent criticality, the associated functional design criteria applied to those design features, and the physical and programmatic controls implemented during manufacturing, storage, and transport that are credited to assure the features function as designed when subject to potential hazards and human errors. The descriptions must include how those measures will be controlled during installation under the ML and removal under the COL or OL at the place of operation.

(2) A description of the procedures governing the transfer of responsibilities for the fueled manufactured reactor from the holder of the ML to the holder of the COL or CP and OL for the installation site.

(3) If available at the time of filing the ML application or, if not available at the time of filing the ML application, submitted as an amendment to the ML or ML application at the time of filing the Part 70 application, a description of the programs needed to demonstrate compliance with the requirements of § 53.620(d) and 10 CFR parts 70, 71, and 73 for the receipt, storage, and loading of SNM into a manufactured reactor and the transport of the fueled manufactured reactor to a site for which the Commission has issued a COL or CP and OL that authorizes construction and operation of a commercial nuclear plant using the manufactured reactor, including the following.

(i) A physical security program in accordance with § 53.620(d)(2)(i).

(ii) A cybersecurity program in accordance with § 53.620(d)(2)(i).

(a) Inspections, tests, analyses, and acceptance criteria. (1) The application must contain proposed inspections, tests, and analyses that the COL or CP holder must perform, and the acceptance criteria that are necessary and sufficient to provide reasonable assurance that, if the inspections, tests, and analyses are performed and the acceptance criteria met:

(i) The reactor has been manufactured in conformity with the ML, the provisions of the Act, and the Commission's rules and regulations; and

(ii) The manufactured reactor will be operated in conformity with the approved design and any license authorizing operation of the manufactured reactor.

(2) If the application references a standard design certification, the ITAAC contained in the certified design must apply to those portions of the facility design that are covered by the design certification.

(3) If the application references a standard design certification, the application may include a notification that a required inspection, test, or analysis in the design certification ITAAC has been successfully completed and that the corresponding acceptance criterion has been met. The Federal Register notice required by § 53.1285 must indicate that the application includes this notification.

(b) Environmental report. (1) The application must contain an environmental report as required by § 51.54 of this chapter.

(2) If the ML application references a standard design certification, the environmental report need not contain a discussion of severe accident mitigation design alternatives for the manufactured reactor as used in a commercial nuclear plant.

(c) Safeguards information. The application must contain a description of the program to protect safeguards information against unauthorized disclosure in accordance with the requirements in §§ 73.21 and 73.22 of this chapter, as applicable.

(d) Performance demonstration. 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).

(a) Standards for review of applications. Applications for MLs under this part will be reviewed according to the applicable standards set out in this subpart as well as applicable standards in 10 CFR parts 20, 25, 26, 51, 53, 70, 71, 73, and 75.

(b) Administrative review of applications, hearings. A proceeding on an ML is subject to all applicable procedural requirements contained in 10 CFR part 2, including the requirements for docketing in § 2.101(a)(1) through (4) of this chapter, and the requirements for issuance of a notice of proposed action in § 2.105 of this chapter, provided, however, that the designated sections may not be construed to require that the environmental report or draft or final environmental impact statement include an assessment of the benefits of constructing and/or operating the manufactured reactor or an evaluation of alternative energy sources. All hearings on MLs are governed by the hearing procedures contained in 10 CFR part 2, subparts C, E, G, L, and N.

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.

(a) After completing any hearing under § 53.1285(b), and receiving the report submitted by the ACRS, the Commission may issue an ML if the Commission finds that—

(1) Applicable standards and requirements of the Act and the Commission's regulations have been met;

(2) There is reasonable assurance that the manufactured reactor will be manufactured, and can be transported, incorporated into a commercial nuclear plant, and operated in conformity with the ML, the provision of the Act, and the Commission's regulations;

(3) The proposed manufactured reactor can be incorporated into a commercial nuclear plant and operated at sites having characteristics that fall within the site parameters postulated for the design of the manufactured reactors without undue risk to the health and safety of the public;

(4) The applicant is technically qualified to design and manufacture the proposed manufactured reactor;

(5) The proposed ITAAC are necessary and sufficient, within the scope of the ML, to provide reasonable assurance that the manufactured reactor has been manufactured and will be operated in conformity with the license, the provisions of the Act, and the Commission's regulations;

(6) The issuance of a license to the applicant will not be inimical to the common defense and security or to the health and safety of the public; and

(7) The findings required by 10 CFR part 51 have been made.

(b) Each ML issued under this subpart must specify—

(1) Terms and conditions as the Commission deems necessary and appropriate;

(2) Technical specifications for operation of the manufactured reactor, as the Commission deems necessary and appropriate;

(3) Significant site parameters and significant design characteristics for the manufactured reactor;

(4) The interface requirements to be met by the site-specific elements of the facility, such as the energy conversions systems and ultimate heat sink, not within the scope of the manufactured reactor; and

(5) The entity with design authority for the manufactured reactor covered by the license.

(a)(1) During the term of an ML issued under this part, the Commission may not modify, rescind, or impose new requirements on the design of the manufactured reactor, or the requirements for the manufacture of the manufactured reactor, unless the Commission determines that a modification is necessary to bring the design of the reactor or its manufacture into compliance with the Commission's requirements applicable and in effect at the time the ML was issued, or to provide reasonable assurance of adequate protection to public health and safety or common defense and security.

(2) Any modification to the design of a manufactured reactor that is imposed by the Commission under paragraph (a)(1) of this section will be applied to all manufactured reactors manufactured under the license, including those that have already been transported and sited, except those manufactured reactors to which the modification has been rendered technically irrelevant or otherwise unnecessary by action taken under § 53.1530, § 53.1550, or paragraph (b) of this section.

(3) In making the findings required under this part for issuance of a COL, CP, or OL, in any hearing under § 53.1452, or in any enforcement hearing other than one initiated by the Commission under paragraph (a)(1) of this section, for which a manufactured reactor manufactured under this subpart is referenced or used, the Commission must treat as resolved those matters resolved in the proceeding on the application for issuance or renewal of the ML, including the adequacy of design of the manufactured reactor, the costs and benefits of severe accident mitigation design alternatives, and the bases for not incorporating severe accident mitigation design alternatives into the design of the manufactured reactor to be manufactured.

(b) An applicant who references or uses a manufactured reactor manufactured under an ML under this part may include in the application a request for a departure from the design characteristics, site parameters, terms and conditions, or approved design of the manufactured reactor. The Commission may grant a request only if it determines that the departure will comply with the requirements of § 53.080 The granting of a departure on request of an applicant is subject to litigation in the same manner as other issues in the COL or CP hearing.

An ML issued under this part is valid for not less than 5, nor more than 40 years from the date of issuance. Upon expiration of the ML, the manufacture of any uncompleted manufactured reactors must cease unless a timely application for renewal has been docketed with the NRC.

An ML may be transferred under § 53.1570.

(a)(1) Not less than 12 months, nor more than 5 years before the expiration of the ML, or any later renewal period, the holder of the ML issued under this part may apply for a renewal of the license. An application for renewal must contain all information necessary to bring up to date the information and data contained in the previous application.

(2) The filing of an application for a renewed license must be in accordance with subpart A of 10 CFR part 2 and § 53.1100.

(3) An ML issued under this part, either original or renewed, for which a timely application for renewal has been filed, remains in effect until the Commission has made a final determination on the renewal application.

(4) Any person whose interest may be affected by renewal of the license may request a hearing on the application for renewal. The request for a hearing must comply with § 2.309 of this chapter. If a hearing is granted, notice of the hearing will be published in accordance with § 2.104 of this chapter.

(b) The Commission may grant the renewal if the Commission determines—

(1) The ML complies with the Act and the Commission's regulations and orders applicable and in effect at the time the ML was originally issued; and

(2) Any new requirements the Commission may wish to impose are—

(i) Necessary for adequate protection to public health and safety or common defense and security;

(ii) Necessary for compliance with the Commission's regulations and orders applicable and in effect at the time the ML was originally issued; or

(iii) 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 implementation of those requirements are justified in view of this increased protection.

(c) A renewed ML may be issued for a term of not less than 5, nor more than 40 years, plus any remaining years on the ML then in effect before renewal. The renewed license must be subject to the requirements of § 53.1288.

Sections 53.1300 through 53.1348 set out the requirements and procedures applicable to Commission issuance of a CP for commercial nuclear plants. A CP for the construction of a commercial nuclear plant under this part will be issued before the issuance of an OL if the application is otherwise acceptable and will be converted upon completion of the facility and Commission action, into an OL as provided under §§ 53.1360 through 53.1405.

An application for a CP must include the information required by § 53.1109 and the following information:

(a) Information sufficient to demonstrate to the Commission the financial qualification of the applicant to carry out, under the regulations in this chapter, the activities for which the permit is sought. As applicable, the applicant should provide information that demonstrates that the applicant appears to be financially qualified to cover estimated construction costs and related fuel cycle costs, including estimates of the total construction costs and related fuel cycle costs of the facility, a financial capacity plan, and any source(s) of funds available at the time of application to cover these costs. If available funding at the time of application is 50 percent or less, the applicant should include proposed license conditions to facilitate verification that funding is available prior to the start of construction.

(b) If the applicant proposes to construct or alter a facility, the application must state the earliest and latest dates for completion of the construction or alteration.

The application must contain a Preliminary Safety Analysis Report (PSAR) that describes the facility and the limits on its operation and presents a preliminary safety analysis of the SSCs of the facility as a whole. The PSAR must include the following information, at a level of detail sufficient to enable the Commission to reach a conclusion on safety matters that must be resolved by the Commission before issuance of a CP:

(a)(1) Site information. An application for a CP for a commercial nuclear reactor must include the site information equivalent to that required for an early site permit in § 53.1146(a)(1)(iv) through (x).

(2) Design information. Except as specified in this paragraph (a)(2), an application for a CP for a commercial nuclear plant must include the design information equivalent to that required for a standard design certification as defined in § 53.1239(a)(2) through (a)(21), (a)(23), and § 53.1239(a)(26) through (27).

(i) Quality assurance program. A description of the QAP to be applied to the design, fabrication, construction, and testing of the SSCs of the facility under § 53.610(a)(6), including a discussion of how the requirements of appendix B to part 50 of this chapter will be satisfied.

(ii) Preliminary design information. The information provided in the application may include some aspects of the design that are not fully developed, and the information is therefore preliminary. The completed design, including any changes during construction, must be described in the FSAR required in § 53.1369 that supports an application for an OL.

(iii) Planned research or testing. Descriptions of how design features and related functional design criteria will fulfill the safety criteria in subpart B and how that has been or will be demonstrated through either analysis, appropriate test programs, experience, or a combination thereof. Where any design feature has not been fully developed or demonstrated to fulfill the functional design criteria at the time of an application for a CP, the applicant must provide a plan for future analysis, research and development, test programs, gathering of experience, or a combination thereof to provide reasonable confidence that the required demonstration will be available for an application for an OL

(iv) Programmatic controls. Descriptions of the programmatic controls may include those to be provided in the FSAR or other licensing-basis documents because they are necessary to achieve and maintain the reliability and capability of SSCs relied upon to demonstrate compliance with the established safety criteria and functional design criteria required in subpart B, and to maintain consistency with analyses required by § 53.450.

(3) Technical qualifications. A description of the technical qualifications of the applicant to engage in the proposed activities under the regulations in this chapter.

(4) Emergency preparedness. A description of the applicant's preliminary plans for coping with emergencies based on:

(i) Except as provided in paragraph (a)(4)(ii) of this section, the requirements in appendix E to part 50.

(ii) For a commercial nuclear plant consisting of either small modular reactors or non-light-water reactors, the requirements in either § 50.160 or appendix E to part 50.

(5) Physical security. A report that provides a preliminary description of how the site characteristics support the development of adequate security plans and measures consistent with the requirements in § 53.540.

(6) Fitness-for-duty program. A description of the fitness-for-duty (FFD) program required by 10 CFR part 26 and its implementation.

(b) A description of the program to protect Safeguards Information against unauthorized disclosure in accordance with the requirements in §§ 73.21 and 73.22 of this chapter, as applicable.

(a) In addition to the PSAR, the application must include the following:

(1) An environmental report either under § 51.50(a) of this chapter if an LWA under § 53.1130 is not requested in conjunction with the CP application, or under §§ 51.49 and 51.50(a) of this chapter if an LWA is requested in conjunction with the CP application; or

(2) If the applicant wishes to request that an LWA under § 53.1130 be issued before issuance of the CP, the information otherwise required by § 53.1130, in accordance with either § 2.101(a)(1) through (a)(5), or § 2.101(a)(9) of this chapter.

(b) If the CP application references an early site permit, standard design approval, standard design certification, or ML issued under this part, then the following requirements apply:

(1) The PSAR need not contain information or analyses submitted to the Commission in connection with the referenced NRC approval, license,, or certification, provided, however, that the PSAR incorporates the material by reference and confirms that the site and design of the facility falls within parameter values postulated in the referenced NRC approval, license, or certification.

(2) The PSAR must provide a means to demonstrate that all terms and conditions that have been included in the referenced NRC approval, license, or certification will be satisfied by the date of issuance of the OL, as appropriate. If the PSAR does not demonstrate that each site characteristic falls within the corresponding postulated site parameter and each design characteristic of the facility falls within the corresponding postulated design parameter, the application must justify a departure, variance, or exemption from the referenced NRC approval, license, or certification in regard to that particular site or design characteristic in compliance with the requirements of this part.

(3) If a referenced early site permit approves complete and integrated emergency plans, or major features of emergency plans, then the PSAR must include any new or additional information that updates and corrects the information that was provided under § 53.1146(b)(2) and discuss whether the new or additional information materially changes the bases for compliance with the applicable requirements.

(a) Standards for review of applications. Applications filed under this part will be reviewed according to the standards set out in 10 CFR parts 20, 51, 53, 73, and 140.

(b) Administrative review of applications; hearings. A proceeding on a CP application is subject to all applicable procedural requirements contained in 10 CFR part 2, including the requirements for docketing (§ 2.101 of this chapter) and issuance of a notice of hearing (§ 2.104 of this chapter). All hearings on CP applications are governed by the procedures contained in 10 CFR part 2.

If the application for a CP under this part references an early site permit, standard design approval, standard design certification, or ML, the scope and nature of matters resolved for the application are governed by the relevant provisions addressing finality, including §§ 53.1188, 53.1221, 53.1263, and 53.1288.

The Commission must refer a copy of the application to the ACRS. The ACRS must report on those portions of the application that concern safety and must apply the standards referenced in § 53.1315, in accordance with the finality provisions in § 53.1318.

(a) If the application does not reference an early site permit which authorizes the holder to perform the activities under § 53.1130, the applicant may not perform those activities without obtaining the separate authorization required by § 53.1130. Authorization may be granted only after the presiding officer in the proceeding on the application has made the findings and determination required by § 53.1130(b)(1)(ii) and (iv), and the Director, Office of Nuclear Reactor Regulation makes the determination required by § 53.1130(b)(1)(iii).

(b) If, after an applicant has performed the activities permitted by paragraph (a) of this section, the application for the CP is withdrawn or denied, then the applicant must implement an approved site redress plan.

(a) Applicants for a CP under this part, or any amendment to a CP, may include in the application a request for an exemption from one or more of the Commission's regulations. The Commission may grant a request if it determines that the exemption complies with § 53.080.

(b) An applicant for a CP who has filed an application referencing an NRC approval, license, or certification issued under this part may include in the application a request for exemptions, departures, or variances related to the subject referenced NRC approval, license, or certification. In determining whether to grant the departure, variance, or exemption, the Commission must apply the same technically relevant criteria as were applicable to the application for the original or renewed approval, license, or certification.

(a) After conducting a hearing in accordance with § 53.1315 and receiving the report submitted by the ACRS, the Commission may issue a CP only if the Commission finds that—

(1) The applicant has described the proposed design of the facility and has identified the major features or components incorporated therein for the protection of the health and safety of the public;

(2) Such further technical or design information as may be required to complete the safety analysis, and which can reasonably be left for later consideration, will be supplied in the FSAR;

(3) Safety features or components, if any, that require research and development have been described by the applicant and the applicant has identified, and there will be conducted, a research and development program reasonably designed to resolve any safety questions associated with such features or components; and

(4) On the basis of the foregoing, there is reasonable assurance of the following—

(i) Such safety questions will be satisfactorily resolved at or before the latest date stated in the application for completion of construction of the proposed facility; and

(ii) Taking into consideration the site criteria contained in subpart D to this part, the proposed facility can be constructed and operated at the proposed location without undue risk to the health and safety of the public.

(b) A CP must contain the terms and conditions for the permit, as the Commission deems necessary and appropriate. The Commission may, in its discretion, incorporate in any CP provisions requiring the applicant to furnish periodic reports of the progress and results of research and development programs designed to resolve safety questions.

Notwithstanding any provision in § 53.1590, a CP constitutes an authorization to proceed with construction but does not constitute Commission approval of the safety of any design feature or specification unless the applicant specifically requests such approval and such approval is incorporated in the permit. The applicant, at its option, may request such approvals in the CP or by amendment to the CP. If approved by the NRC and included in the permit, the NRC will consider modifications to the approved design features or specifications in accordance with § 53.1590.

(a) A CP will state the earliest and latest dates for completion of construction or alteration of the facility, not to exceed 40 years from date of issuance.

(b) If the proposed construction or alteration of the facility is not completed by the latest completion date, the CP shall expire, and all rights are forfeited. However, upon good cause shown, the Commission will extend the completion date for a reasonable period of time. The Commission will recognize, among other things, developmental problems attributed to the experimental nature of the facility or fire, flood explosion, strike, sabotage, domestic violence, enemy action an act of the elements, and other acts beyond the control of the permit holder, as a basis for extending the completion date.

A CP may be transferred under § 53.1570.

When a permit holder has determined to permanently cease construction, the holder must, within 30 days, submit a written certification to the NRC.

Sections 53.1360 through 53.1405 set out the requirements and procedures applicable to Commission issuance of an OL for a nuclear power facility.

An application for an OL must include the information required by § 53.1109 and, except for an electric utility applicant, information sufficient to demonstrate to the Commission the financial qualification of the applicant to carry out, in accordance with the regulations in this chapter, the activities for which the license is sought. As applicable, the applicant must submit information that demonstrates the applicant appears to be financially qualified to cover estimated operation costs for the period of the license. The applicant must submit estimates for total annual operating costs for each of the first 5 years of operation of the facility and a financial capacity plan and must indicate any source(s) of funds available at the time of application to cover these costs. If available funding at the time of application is 50 percent or less, the applicant should include proposed license conditions to facilitate verification that funding is available prior to the start of operations.

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 of the facility as a whole. The FSAR must include the following information, at a level of detail sufficient to enable the Commission to reach a final conclusion on all safety matters that must be resolved by the Commission before issuance of an OL:

(a) Site information. An application for an OL for a commercial nuclear reactor must include the site information equivalent to that required for an early site permit in § 53.1146(a)(1)(iv) through (x), including all current information, such as the results of environmental and meteorological monitoring programs, which has been developed since issuance of the CP, relating to site evaluation factors identified in this part.

(b) Design information. Except as specified in this paragraph (b), an FSAR for an OL for a commercial nuclear plant must include the final design information equivalent to that required for a standard design certification as defined in § 53.1239(a)(2) through (7), (a)(9), (a)(11) and (12), (a)(14) through (21), (a)(23), and (a)(25).

(1) The completed design, including any changes during construction, must be described.

(2) Where any design feature had not been fully developed or demonstrated at the time of application for the CP, the applicant must provide the analysis, research and development, test programs, gathering of experience, or a combination thereof to provide the required demonstration to fulfill the functional design criteria.

(c) [Reserved]

(d) Integrity assessment program. A description of an Integrity Assessment Program that addresses the elements described in § 53.870.

(e) Safeguards information. A description of the program to protect Safeguards Information against unauthorized disclosure in accordance with the requirements in §§ 73.21 and 73.22 of this chapter, as applicable.

(f) Emergency response facility or facilities. Description of location and capabilities to be established for command and control, support, and coordination of onsite and offsite, as applicable, functions during reactor accident conditions.

(g) Role of personnel. (1) A description of the completed assessments related to the role of personnel in ensuring safe operations considering the analyses required by § 53.730. These assessments must include the following:

(i) Human factors engineering design requirements of § 53.730(a);

(ii) Human system interface design requirements of § 53.730(b);

(iii) Concept of operations of § 53.730(c);

(iv) Functional requirements analysis and function allocation of § 53.730(d);

(2) A description of the program to be used for evaluating and applying operating experience as required by § 53.730(e);

(3) A staffing plan and supporting analyses as required by § 53.730(f).

(h) Training, examination, and proficiency programs. (1) A description of the training, examination, and proficiency programs required by § 53.730(g);

(2) A description of the training programs required by § 53.830.

(i) Emergency plan. Emergency plans complying with the requirements of § 53.855.

(1) Include all emergency plan certifications, as applicable, that have been obtained from the State, local, and participating Tribal governmental agencies with emergency planning responsibilities that are wholly or partially within the EPZ plume exposure pathway. These certifications must state that—

(i) The proposed emergency plans are practicable;

(ii) These agencies are committed to participating in any further development of the plans, including any required field demonstrations; and

(iii) These agencies are committed to executing their responsibilities under the plans in the event of an emergency.

(2) If certifications cannot be obtained after sustained, good faith efforts by the applicant, then the application must contain information, including a utility plan, sufficient to show that the proposed plans provide reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency at the site.

(3) If complete and integrated emergency plans were approved as part of an early site permit, or submitted, reviewed, and approved as part of the CP application, new certifications that demonstrate compliance with the requirements of paragraph (i)(1) of this section are not required.

(j) Organization. A description of the applicant's organizational structure, allocations of responsibilities and authorities, and personnel qualifications requirements for operation.

(k) Maintenance program. A description of a maintenance program under § 53.715.

(l) Quality assurance. A description of the QAP that demonstrates compliance with the requirements under § 53.865.

(m) Radiation protection program. A radiation protection program description under § 53.850.

(n) Security program. A physical security plan that describes how the applicant will comply with § 53.860 (and 10 CFR part 11, if applicable, including the identification and description of jobs as required by § 11.11(a) of this chapter, at the proposed facility). The plan must list tests, inspections, audits, and other means to be used to demonstrate compliance with the requirements of 10 CFR parts 11 and 73, if applicable.

(o) Safeguards contingency plan. A safeguards contingency plan in accordance with the criteria set forth in appendix C to 10 CFR part 73. The safeguards contingency plan must include plans for dealing with threats, thefts, and radiological sabotage, as defined in 10 CFR part 73, relating to the SNM and nuclear facilities licensed under this chapter and in the applicant's possession and control. Each application for this type of license must include the information contained in the applicant's safeguards contingency plan. (Implementing procedures required for this plan need not be submitted for approval.) 1

(p) Security training and qualification. A training and qualification plan that describes how the applicant will demonstrate compliance with the criteria set forth in § 73.100 of this chapter or appendix B to 10 CFR part 73.

(q) Cybersecurity plan. A cybersecurity plan in accordance with the criteria set forth in § 73.54 or § 73.110 of this chapter.

(r) Security, safeguards, and cybersecurity plan implementation. A description of the implementation of the physical security plan, safeguards contingency plan, training and qualification plan, and cybersecurity plan. Each applicant who prepares a physical security plan, a safeguards contingency plan, a training and qualification plan, or a cybersecurity plan must protect the plans and other related Safeguards Information against unauthorized disclosure in accordance with the requirements of §§ 73.21 and 73.22 of this chapter.

(s) Fire protection program. A description of the fire protection program under § 53.875.

(t) Inservice inspection/inservice testing program. A description of the inservice inspection and inservice testing programs under § 53.880.

(u)-(v) [Reserved]

(w) General employee training. A description of the training program required to demonstrate compliance with § 53.830 and its implementation.

(x) Fitness-for-duty program. A description of the FFD program required by 10 CFR part 26 and its implementation.

(y) Other programs. A description and evaluation of the results of the applicant's programs, including research and development, if any, to demonstrate that any safety questions identified at the CP stage have been resolved.

(z) Safety design feature performance. A description of how the performance of each safety 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).

(aa) Technical specifications. Proposed technical specifications prepared in accordance with the requirements of § 53.710(a).

In addition to the FSAR, the application must also include the following:

(a) Environmental report. An environmental report in accordance with § 51.53(b) of this chapter.

(b) Availability controls (if not included in the FSAR). A description of the controls on plant operations, including availability controls, to provide reasonable confidence of safe operation and that the configurations and special treatments for SR and NSRSS SSCs provide the capabilities and reliabilities required to satisfy the safety criteria of § 53.220 if not addressed by Technical Specifications under § 53.1369(aa).

(a) Standards for review of applications. Applications filed under this part will be reviewed according to the standards set out in 10 CFR parts 20, 26, 51, 53, 73, and 140.

(b) Administrative review of applications; hearings. A proceeding on an OL is subject to all applicable procedural requirements contained in 10 CFR part 2, including the requirements for docketing (§ 2.101 of this chapter) and issuance of a notice of hearing (§ 2.104 of this chapter). All hearings on OLs are governed by the procedures contained in 10 CFR part 2.

The Commission must refer a copy of the application to the ACRS. The ACRS must report on those portions of the application that concern safety and must apply the standards referenced in § 53.1375.

(a) Applicants for an OL under this part, or any amendment to an OL, may include in the application a request for an exemption from one or more of the Commission's regulations. The Commission may grant an exemption request if it determines that the exemption complies with § 53.080.

(b) An applicant for an OL who has filed an application referencing an NRC approval, permit, license, or certification issued under this part may include in the application a request for departures, variances, or exemptions related to the subject referenced NRC approval, permit, license, or certification. In determining whether to grant the departure, variance, or exemption, the Commission must apply the same technically relevant criteria as were applicable to the application for the original or renewed approval, license, or certification.

Upon completion of the construction or alteration of a facility, in compliance with the terms and conditions of the construction permit and subject to any necessary testing of the facility for health or safety purposes, the Commission will, in the absence of good cause shown to the contrary, issue an OL or an appropriate amendment of the license, as the case may be.

(a)(1) After receiving the report submitted by the ACRS, the Commission may issue an OL if the Commission finds that—

(i) Construction of the facility has been substantially completed in conformity with the CP and the application as amended, the provisions of the Act, and the rules and regulations of the Commission;

(ii) Any required notifications to other agencies or bodies have been duly made;

(iii) The facility will operate in conformity with the application as amended, the provisions of the Act, and the rules and regulations of the Commission;

(iv) There is reasonable assurance that—

(A) The activities authorized by the OL can be conducted without endangering the health and safety of the public; and

(B) Such activities will be conducted in compliance with the regulations in this chapter.

(v) The applicant is technically and financially qualified to engage in the activities authorized, however, no finding of financial qualification is necessary for an electric utility applicant for an OL;

(vi) Issuance of the license will not be inimical to the common defense and security or to the health and safety of the public;

(vii) The applicable provisions of 10 CFR part 140 have been satisfied; and

(viii) The findings required by 10 CFR part 51 have been made.

(2) [Reserved]

(b) [Reserved]

(c) The OL will include appropriate provisions with respect to any uncompleted items of construction and such limitations or conditions as are required to assure that operation during the period of the completion of such items will not endanger public health and safety.

(d) The Commission will issue an OL in such form and containing such conditions and limitations, including technical specifications, as it deems necessary and appropriate.

After issuance of an OL, the Commission may not modify, add, or delete any term or condition of the OL, except in accordance with the provisions of § 53.1590.

The Commission will issue an OL under this part for the term requested by the applicant, not to exceed 40 years from the date of issuance, or for the estimated useful life of the facility if the Commission determines that the estimated useful life is less than the term requested.

An OL may be transferred under § 53.1570.

The filing of an application for a renewed license must be in accordance with § 53.1595.

Each OL for a facility that has permanently ceased operations continues in effect beyond the expiration date to authorize ownership and possession of the facility until the Commission notifies the licensee in writing that the license is terminated. During this period of continued effectiveness, the licensee must—

(a) Take actions necessary to decommission and decontaminate the facility and continue to maintain the facility, including, where applicable, the storage, control, and maintenance of the spent fuel in a safe condition; and

(b) Conduct activities in accordance with all other restrictions applicable to the facility in accordance with the NRC's regulations and the provisions of the OL for the facility.

Sections 53.1410 through 53.1461 set out the requirements and procedures applicable to Commission issuance of COLs for commercial nuclear plants under this part.

An application for a COL must include the information required by § 53.1109 and, except for an electric utility applicant in regard to financial assurance required after a Commission finding under § 53.1452, the application must include information sufficient to demonstrate to the Commission the financial qualification of the applicant to carry out, in accordance with the regulations in this chapter, the activities for which the permit or license is sought. As applicable, the following should be provided:

(a) The information that demonstrates that the applicant appears to be financially qualified to cover estimated construction costs and related fuel cycle costs, including estimates of the total construction costs and related fuel cycle costs of the facility, a financial capacity plan, and any source(s) of funds available at the time of application to cover these costs. If available funding at the time of application is 50 percent or less, the applicant should include proposed license conditions to facilitate verification that funding is available prior to the start of construction.

(b) The applicant must submit information that demonstrates the applicant appears to be financially qualified to cover estimated operation costs for the period of the license. The applicant must submit estimates for total annual operating costs for each of the first 5 years of operation of the facility, a financial capacity plan and indicate any source(s) of funds available at the time of application to cover these costs. If available funding at the time of application is 50 percent or less, the applicant should include proposed license conditions to facilitate verification that funding is available prior to the start of operations.

(a) The application must contain an FSAR that describes the facility and the limits on its operation and presents a safety analysis of the SSCs of the facility as a whole. The Commission will require, before issuance of a COL, 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. The FSAR must include the following information, at a level of detail sufficient to enable the Commission to reach a final conclusion on all safety matters that must be resolved by the Commission before issuance of a COL:

(1) Site information. An application for a COL for a commercial nuclear reactor must include the site information required for an early site permit in § 53.1146(a)(1)(iv) through (x).

(2) Design information. An application for a COL for a commercial nuclear plant must include the design information equivalent to that required for a standard design certification as defined in § 53.1239(a)(2) through (7), (a)(9), (a)(11), (a)(12), (a)(14) through (21), and (a)(23).

(3) 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.

(4) Integrity assessment program. A description of an Integrity Assessment Program that addresses the elements described in § 53.870.

(5) Safeguards information. A description of the program to protect Safeguards Information against unauthorized disclosure in accordance with the requirements in §§ 73.21 and 73.22 of this chapter, as applicable.

(6) Emergency response facility or facilities. Description of the locations and capabilities to be established for command and control, support, and coordination of onsite and offsite, as applicable, functions during reactor accident conditions.

(7) Role of personnel. (i) A description of the completed assessments related to the role of personnel in ensuring safe operations considering the analyses required by § 53.730. These assessments must include the following:

(A) Human factors engineering design requirements of § 53.730(a);

(B) Human system interface design requirements of § 53.730(b);

(C) Concept of operations of § 53.730(c); and

(D) Functional requirements analysis and function allocation of § 53.730(d);

(ii) A description of the program to be used for evaluating and applying operating experience as required by § 53.730(e);

(iii) A staffing plan and supporting analyses as required by § 53.730(f).

(8) Training, examination, and proficiency programs. (i) A description of the training, examination, and proficiency programs required by § 53.730(g); and

(ii) A description of the training programs required by § 53.830.

(9) Emergency plan. Emergency plans complying with the requirements of § 53.855.

(i) The emergency plan must include, as applicable, all emergency plan certifications that have been obtained from the State, local, and participating Tribal governmental agencies with emergency planning responsibilities. The certifications must state that—

(A) The proposed emergency plans are practicable;

(B) These agencies are committed to participating in any further development of the plans, including any required field demonstrations; and

(C) These agencies are committed to executing their responsibilities under the plans in the event of an emergency.

(ii) If certifications cannot be obtained after sustained, good faith efforts by the applicant, then the application must contain information, including a utility plan, sufficient to show that the proposed plans provide reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency at the site.

(10) Organization. A description of the applicant's organizational structure, allocations of responsibilities and authorities, and personnel qualifications requirements for operation.

(11) Maintenance program. A description of a maintenance program under § 53.715.

(12) Quality assurance. A description of the QAP under § 53.865.

(13) Radiation protection program. A radiation protection program description under § 53.850.

(14) Security program. A physical security plan that describes how the applicant will comply with § 53.860 (and 10 CFR part 11, if applicable, including the identification and description of jobs as required by § 11.11(a) of this chapter, at the proposed facility). The plan must list tests, inspections, audits, and other means to be used to demonstrate compliance with the requirements of 10 CFR parts 11 and 73, if applicable.

(15) Safeguards contingency plan. A safeguards contingency plan in accordance with the criteria set forth in appendix C to 10 CFR part 73. The safeguards contingency plan must include plans for dealing with threats, thefts, and radiological sabotage, as defined in 10 CFR part 73, relating to the SNM and nuclear facilities licensed under this chapter and in the applicant's possession and control. Each application for this type of license must include the information contained in the applicant's safeguards contingency plan. 1 (Implementing procedures required for this plan need not be submitted for approval.)

(16) Security training and qualification. A training and qualification plan that describes how the applicant will demonstrate compliance with the criteria set forth in § 73.100 of this chapter or appendix B to 10 CFR part 73.

(17) Cybersecurity plan. A cybersecurity plan in accordance with the criteria set forth in § 73.54 or § 73.110 of this chapter.

(18) Security, safeguards, and cybersecurity plan implementation. A description of the implementation of the physical security plan, safeguards contingency plan, training and qualification plan, and cybersecurity plan. Each applicant who prepares a physical security plan, a safeguards contingency plan, a training and qualification plan, or a cybersecurity plan must protect the plans and other related Safeguards Information against unauthorized disclosure in accordance with the requirements of §§ 73.21 and 73.22 of this chapter.

(19) Fire protection program. A description of the fire protection program under § 53.875.

(20) Inservice inspection/inservice testing program. Descriptions of inservice inspection and inservice testing programs under § 53.880.

(21)-(22) [Reserved]

(23) General employee training. A description of the training program required to demonstrate compliance with § 53.830 and its implementation.

(24) Fitness-for-duty program. A description of the FFD program under part 26 of this chapter and its implementation.

(25) Technical specifications. Proposed technical specifications prepared in accordance with the requirements of § 53.710(a).

(b) If there are SSCs of the plant for which research and development is necessary to confirm the adequacy of their design, a report which documents the resolution of any safety questions associated with such SSCs.

(c) A description of how the performance of each safety 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).

(d) If the COL application references an early site permit, then the following requirements apply:

(1) The FSAR need not contain information or analyses submitted to the Commission in connection with the early site permit provided that the FSAR must either include or incorporate by reference the early site permit Site Safety Analysis Report and contain, in addition to the information and analyses otherwise required, information sufficient to demonstrate that the design of the facility falls within the site characteristics and design parameters specified in the early site permit.

(2) If the FSAR does not demonstrate that design of the facility falls within the site characteristics and design parameters, the application must include a request for a variance that complies with the requirements of §§ 53.1188(d) and 53.1437.

(3) The FSAR must demonstrate that all terms and conditions that have been included in the early site permit will be satisfied by the date of issuance of the COL. Any terms or conditions of the early site permit that could not be met by the time of issuance of the COL must be set forth as terms or conditions of the COL.

(4) If the early site permit approves complete and integrated emergency plans, or major features of emergency plans, then the FSAR must include any new or additional information that updates and corrects the information that was provided under § 53.1146(b)(2) and discuss whether the new or additional information materially changes the bases for compliance with the applicable requirements. The application must identify changes to the emergency plans or major features of emergency plans that have been incorporated into the proposed facility emergency plans and that constitute or would constitute a change in an emergency plan that results in reducing the licensee's capability to perform an emergency planning function in the event of a radiological emergency.

(5) If complete and integrated emergency plans are approved as part of the early site permit, new certifications meeting the requirements of paragraph (a)(9)(i) of this section are not required.

(e) If the COL application references a standard design approval, then the following requirements apply:

(1) The FSAR need not contain information or analyses submitted to the Commission in connection with the design approval, provided, however, that the FSAR must either include or incorporate by reference the standard design approval FSAR and must contain, in addition to the information and analyses otherwise required, information sufficient to demonstrate that the characteristics of the site fall within the site parameters specified in the design approval. In addition, the plant-specific information of the PRA, other SREs, or a combination thereof must use the information of the PRA, other SREs, or a combination thereof for the design approval and must be updated to account for site-specific design information and any design changes or departures.

(2) The FSAR must demonstrate that all terms and conditions that have been included in the design approval will be satisfied by the date of issuance of the COL.

(f) If the COL application references a standard design certification, then the following requirements apply:

(1) The FSAR need not contain information or analyses submitted to the Commission in connection with the standard design certification, provided, however, that the FSAR must either include or incorporate by reference the standard design certification FSAR and must contain, in addition to the information and analyses otherwise required, information sufficient to demonstrate that the site characteristics fall within the site parameters specified in the standard design certification. In addition, the plant-specific information of the PRA, other SREs, or a combination thereof must use the information of the PRA, other SREs, or a combination thereof for the standard design certification and must be updated to account for site-specific design information and any design changes or departures.

(2) The FSAR must demonstrate that the interface requirements established for the design under § 53.1239(a)(24) have been met.

(3) The FSAR must demonstrate that all requirements and restrictions set forth in the referenced standard design certification rule must be satisfied by the date of issuance of the COL. Any requirements and restrictions set forth in the referenced standard design certification rule that could not be satisfied by the time of issuance of the COL, must be set forth as terms or conditions of the COL.

(g) If the COL application references the use of one or more manufactured reactors licensed under § 53.1270, then the following requirements apply:

(1) The FSAR need not contain information or analyses submitted to the Commission in connection with the ML, provided, however, that the FSAR must either include or incorporate by reference the ML FSAR and must contain, in addition to the information and analyses otherwise required, information sufficient to demonstrate that the site characteristics fall within the site parameters specified in the ML. In addition, the plant-specific information of the PRA, other SREs, or a combination thereof must use the information of the PRA, other SREs, or a combination thereof for the manufactured reactor and must be updated to account for site-specific design information and any design changes or departures.

(2) The FSAR must demonstrate that the interface requirements established for the design have been met.

(3) The FSAR must demonstrate that all terms and conditions that have been included in the ML will be satisfied by the date of issuance of the COL. Any terms or conditions of the ML that could not be met by the time of issuance of the COL, must be set forth as terms or conditions of the COL.

(h) Each applicant for a COL under this part must protect Safeguards Information against unauthorized disclosure in accordance with the requirements in §§ 73.21 and 73.22 of this chapter, as applicable.

(a) In addition to the FSAR, the application must also include the following:

(1) Environmental report. (i) An environmental report either in accordance with § 51.50(c) of this chapter if an LWA under § 53.1130 is not requested in conjunction with the COL application, or in accordance with §§ 51.49 and 51.50(c) of this chapter if an LWA is requested in conjunction with the COL application; or

(ii) If the applicant wishes to request that an LWA under § 53.1130 be issued before issuance of the COL, the information otherwise required by § 53.1130, in accordance with either § 2.101(a)(1) through (a)(4), or § 2.101(a)(9) 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 of safe operation and that the configurations and special treatments for SR SSCs and NSRSS SSCs provide the capabilities and reliabilities required to satisfy the safety criteria of § 53.220 if not addressed by Technical Specifications under § 53.1416(a)(25); and

(3) Inspections, tests, analyses, and acceptance criteria. The proposed inspections, tests, and analyses, including those applicable to emergency planning, that the licensee must perform, and the acceptance criteria that are necessary and sufficient 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 conformity with the COL, the provisions of the Act, and the Commission's rules and regulations.

(i) If the application references an early site permit with ITAAC, the early site permit ITAAC must apply to those aspects of the COL which are approved in the early site permit.

(ii) If the application references a standard design certification, the ITAAC contained in the certified design must apply to those portions of the facility design which are approved in the standard design certification.

(iii) If the application references an ML, the ITAAC contained in the ML must apply to those portions of the facility design which are approved in the ML.

(iv) If the application references an early site permit with ITAAC, a standard design certification, an ML, or a combination thereof, the application may include a notification that a required inspection, test, or analysis in the ITAAC has been successfully completed and that the corresponding acceptance criterion has been met. The Federal Register notice required by § 53.1422 of this chapter must indicate that the application includes this notification.

(b) [Reserved]

(a) Standards for review of applications. Applications filed under this part will be reviewed according to the standards set out in 10 CFR parts 20, 51, 53, 73, and 140.

(b) Administrative review of applications; hearings. A proceeding on a COL is subject to all applicable procedural requirements contained in 10 CFR part 2, including the requirements for docketing (§ 2.101 of this chapter) and issuance of a notice of hearing (§ 2.104 of this chapter). If an applicant requests a Commission finding on certain ITAAC with the issuance of the COL, then those ITAAC will be identified in the notice of hearing. All hearings on COLs are governed by the procedures contained in 10 CFR part 2.

If the application for a COL under this part references an early site permit, standard design certification rule, standard design approval, or ML, issued under this part, the scope and nature of matters resolved for the application and any COL issued are governed by the relevant provisions addressing finality, including §§ 53.1188, 53.1221, 53.1263, and 53.1288.

The Commission must refer a copy of the application to the ACRS. The ACRS must report on those portions of the application that concern safety and must apply the standards referenced in § 53.1422, in accordance with the finality provisions in § 53.1425.

(a) If the application for a COL under this part does not reference an early site permit which authorizes the holder to perform the activities under § 53.1130(b), the applicant may not perform those activities without obtaining the separate authorization required by § 53.1130(a). Authorization may be granted only after the presiding officer in the proceeding on the application has made the findings and determination required by § 53.1130(b)(1)(ii) and (b)(1)(iv), and the Director, Office of Nuclear Reactor Regulation makes the determination required by § 53.1130(b)(1)(iii).

(b) If, after an applicant has performed the activities permitted by a LWA issued under § 53.1130, the application for the COL is withdrawn or denied, then the applicant must implement the approved site redress plan.

(a) An applicant for a COL, or any amendment to a COL, may include in the application a request for an exemption from one or more of the Commission's regulations.

(1) If the request is for an exemption from any part of a referenced standard design certification rule, the Commission may grant the request if it determines that the exemption complies with any exemption provisions of the referenced standard design certification rule, or with § 53.1263 if there are no applicable exemption provisions in the referenced standard design certification rule.

(2) For all other requests for exemptions, the Commission may grant a request if it determines that the exemption complies with § 53.080.

(b) An applicant for a COL who has filed an application referencing an early site permit issued under § 53.1158 may include in the application a request for a variance from one or more site characteristics, design parameters, or terms and conditions of the permit, or from the Site Safety Analysis Report. In determining whether to grant the variance, the Commission must apply the same technically relevant criteria as were applicable to the application for the original or renewed site permit. Once a COL referencing an early site permit is issued, variances from the early site permit will not be granted for that CP or COL.

(c) An applicant for a COL who has filed an application referencing use of a manufactured reactor may include in the application a request for a departure from one or more design characteristics, site parameters, terms and conditions, or approved design of the manufactured reactor under the ML issued under § 53.1287. The Commission may grant such a request only if it determines that the departure will comply with the requirements of § 53.080, and that the special circumstances outweigh any decrease in safety that may result from the reduction in standardization caused by the departure.

(d) Issuance of a variance under paragraph (b) of this section or a departure under paragraph (c) of this section is subject to litigation during the COL proceeding in the same manner as other issues material to that proceeding.

(a)(1) After conducting a hearing under § 53.1422(b) and receiving the report submitted by the ACRS, the Commission may issue a COL if the Commission finds that—

(i) The applicable standards and requirements of the Act and the Commission's regulations have been met;

(ii) Any required notifications to other agencies or bodies have been duly made;

(iii) There is reasonable assurance that the facility will be constructed and will operate in conformity with the license, the provisions of the Act, and the Commission's regulations;

(iv) The applicant is technically and financially qualified to engage in the activities authorized; however, no finding of financial qualification is necessary for an electric utility applicant for a COL;

(v) Issuance of the license will not be inimical to the common defense and security or to the health and safety of the public; and

(vi) The findings required by 10 CFR part 51 have been made.

(2) The Commission may also find, at the time it issues the COL, that certain acceptance criteria in one or more of the ITAAC in a referenced early site permit, standard design certification, or ML have been met. This finding will finally resolve that those acceptance criteria have been met, those acceptance criteria will be deemed to be excluded from the COL, and findings under § 53.1452(g) with respect to those acceptance criteria are unnecessary.

(b) The Commission must identify within the COL the inspections, tests, and analyses, including those applicable to emergency planning, that the licensee must perform, and the acceptance criteria that, if met, are necessary and sufficient to provide reasonable assurance that the facility has been constructed and will be operated in conformity with the license, the provisions of the Act, and the Commission's rules and regulations.

(c) A COL must contain the terms and conditions, including technical specifications, as the Commission deems necessary and appropriate.

(a) After issuance of a COL, the Commission may not modify, add, or delete any term or condition of the COL, the design of the facility, the ITAAC contained in the license that are not derived from a referenced standard design certification or ML, except under the provisions of § 53.1452 or § 53.1590.

(b) If the COL does not reference a standard design certification, then a licensee may make changes in the facility as described in the FSAR (as updated) and make changes in the procedures as described in the FSAR (as updated) under the applicable change processes in § 53.1550.

(c) If the COL references a certified design, then—

(1) Changes to or departures from information within the scope of the referenced standard design certification rule are subject to the applicable change processes in that rule; and

(2) Changes that are not within the scope of the referenced standard design certification rule are subject to the applicable change processes in subpart I of this part, unless they also involve changes to or noncompliance with information within the scope of the referenced standard design certification rule. In these cases, the applicable provisions of this section and the standard design certification rule apply.

(d) [Reserved]

(e) The Commission may issue and make immediately effective any amendment to a COL upon a determination by the Commission that the amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person. The amendment may be issued and made immediately effective in advance of the holding and completion of any required hearing. The amendment will be processed under the procedures specified in § 53.1515.

(f) Any modification to, addition to, or deletion from the terms and conditions of a COL, including any modification to, addition to, or deletion from the inspections, tests, and analyses, or related acceptance criteria contained in the license is a proposed amendment to the license. There must be an opportunity for a hearing on the amendment.

(a) Licensee schedule for inspections, tests, or analyses. The licensee must submit to the NRC, no later than 1 year after issuance of the COL or at the start of construction as defined at § 53.020, whichever is later, its schedule for completing the inspections, tests, or analyses in the ITAAC. The licensee must submit updates to the ITAAC schedules every 6 months thereafter and, within 1 year of its scheduled date for initial loading of fuel (or, for a fueled manufactured reactor, within 1 year of its scheduled date for initiating the removal of the features to prevent criticality required under § 53.620(d)(1)), the licensee must submit updates to the ITAAC schedule every 30 days until the final notification is provided to the NRC under paragraph (c)(1) of this section.

(b) Licensee and applicant conduct of activities subject to ITAAC. With respect to activities subject to an ITAAC, an applicant for a COL may proceed at its own risk with design and procurement activities, and a licensee may proceed at its own risk with design, procurement, construction, and preoperational activities, even though the NRC may not have found that any one of the prescribed acceptance criteria are met.

(c) Licensee notifications—(1) ITAAC closure notification. The licensee must notify the NRC that prescribed inspections, tests, and analyses have been performed and that the prescribed acceptance criteria are met. The notification must contain sufficient information to demonstrate that the prescribed inspections, test, and analyses have been performed and that the prescribed acceptance criteria are met.

(2) ITAAC post-closure notifications. Following the licensee's ITAAC closure notifications under paragraph (c)(1) of this section until the Commission makes the finding under § 53.1452(g), the licensee must notify the NRC, in a timely manner, of new information that materially alters the basis for determining that either inspections, tests, or analyses were performed as required, or that acceptance criteria are met. The notification must contain sufficient information to demonstrate that, notwithstanding the new information, the prescribed inspections, tests, and analyses have been performed as required, and the prescribed acceptance criteria are met.

(3) Uncompleted ITAAC notification. If the licensee has not provided, by the date 225 days before the scheduled date for initial loading of fuel (or, for a fueled manufactured reactor, by the date 225 days before the scheduled date for initiating the removal of the features to prevent criticality required under § 53.620(d)(1)), the notification required by paragraph (c)(1) of this section for all ITAAC, then the licensee must notify the NRC that the prescribed inspections, tests, or analyses for all uncompleted ITAAC will be performed and that the prescribed acceptance criteria will be met prior to operation. The notification must be provided no later than the date 225 days before the scheduled date for initial loading of fuel (or, for a fueled manufactured reactor, no later than the date 225 days before the scheduled date for initiating the removal of the features to prevent criticality required under § 53.620(d)(1)), and must provide sufficient information to demonstrate that the prescribed inspections, tests, or analyses will be performed and the prescribed acceptance criteria for the uncompleted ITAAC will be met, including, but not limited to, a description of the specific procedures and analytical methods to be used for performing the prescribed inspections, tests, and analyses and determining that the prescribed acceptance criteria are met.

(4) All ITAAC complete notification. The licensee must notify the NRC that all ITAAC are complete.

(d) Licensee determination of noncompliance with ITAAC. (1) In the event that an activity is subject to an ITAAC derived from a referenced standard design certification and the licensee has not demonstrated that the prescribed acceptance criteria are met, the licensee may take corrective actions to successfully complete that ITAAC or request an exemption from the standard design certification ITAAC, as applicable. A request for an exemption must also be accompanied by a request for a license amendment under subpart I.

(2) In the event that an activity is subject to an ITAAC not derived from a referenced standard design certification and the licensee has not demonstrated that the prescribed acceptance criteria are met, the licensee may take corrective actions to successfully complete that ITAAC or request a license amendment under subpart I.

(e) NRC inspection, publication of notices, and availability of licensee notifications. The NRC must ensure that the prescribed inspections, tests, and analyses in the ITAAC are performed.

(1) At appropriate intervals until the last date for submission of requests for hearing under § 53.1452, the NRC must publish notices in the Federal Register of the NRC staff's determination of the successful completion of inspections, tests, and analyses.

(2) The NRC must make publicly available the licensee notifications under paragraph (c) of this section. The NRC must, no later than the date of publication of the notice of intended operation required by § 53.1452(a), make publicly available those licensee notifications under paragraph (c) of this section that have been submitted to the NRC at least 7 days before that notice.

(a) The licensee must notify the NRC of its scheduled date for initial loading of fuel no later than 270 days before the scheduled date and must notify the NRC of updates to its schedule every 30 days thereafter. 1 Not less than 180 days before the date scheduled for initial loading of fuel into a plant by a licensee that has been issued a COL under this part, the Commission must publish notice of intended operation in the Federal Register. 2 The notice must provide that any person whose interest may be affected by operation of the plant may, within 60 days, request that the Commission hold a hearing on whether the facility as constructed complies, or on completion will comply, with the acceptance criteria in the COL, except that a hearing must not be granted for those ITAAC that the Commission found were met under § 53.1440(a)(2).

(b) A request for hearing under paragraph (a) of this section must show, prima facie—

(1) That one or more of the acceptance criteria of the ITAAC in the COL have not been, or will not be, met; and

(2) The specific operational consequences of nonconformance that would be contrary to providing reasonable assurance of adequate protection of the public health and safety.

(c) The Commission, acting as the presiding officer, must determine whether to grant or deny the request for hearing under the applicable requirements of § 2.309 of this chapter. If the Commission grants the request, the Commission, acting as the presiding officer, must determine whether during a period of interim operation there will be reasonable assurance of adequate protection to the public health and safety. The Commission's determination must consider the petitioner's prima facie showing and any answers thereto. If the Commission determines there is such reasonable assurance, it must allow operation during an interim period under the COL.

(d) The Commission, in its discretion, must determine appropriate hearing procedures, whether informal or formal adjudicatory, for any hearing under paragraph (a) of this section, and must state its reasons therefor.

(e) The Commission must, to the maximum possible extent, render a decision on issues raised by the hearing request within 180 days of the publication of the notice provided by paragraph (a) of this section or by the anticipated date for initial loading of fuel into the reactor, whichever is later.

(f) A petition to modify the terms and conditions of the COL will be processed as a request for action under § 2.206 of this chapter. The petitioner must file the petition with the Secretary of the Commission. Before the licensed activity allegedly affected by the petition (fuel loading, low power testing, etc.) commences, the Commission must determine whether any immediate action is required. If the petition is granted, then an appropriate order will be issued. Fuel loading and operation under the COL will not be affected by the granting of the petition unless the order is made immediately effective.

(g) The licensee must not operate the facility until the Commission makes a finding that the acceptance criteria in the COL are met, except for those acceptance criteria that the Commission found were met under § 53.1440(a)(2). If the COL is for a modular design, each reactor unit may require a separate finding as construction proceeds.

(h) After the Commission has made the finding in paragraph (g) of this section, the ITAAC do not, by virtue of their inclusion in the COL, constitute regulatory requirements either for licensees or for renewal of the license; except for the specific ITAAC for which the Commission has granted a hearing under paragraph (a) of this section, all ITAAC expire upon final Commission action in the proceeding. However, subsequent changes to the facility or procedures described in the FSAR (as updated) must comply with the requirements in § 53.1443(e) or (f), as applicable.

A COL is issued for a specified period not to exceed 40 years from the date on which the Commission makes a finding that acceptance criteria are met under § 53.1452(g) or allowing operation during an interim period under the COL under § 53.1452(c).