This subpart provides the requirements for each holder of a license for a commercial nuclear plant licensed under this part to maintain licensing-basis information as defined in § 53.020; evaluate changes to site characteristics, plant design features, and programmatic controls to determine needed approvals and revisions; and submit appropriate updates to the U.S. Nuclear Regulatory Commission (NRC).

(a) Each license issued under this part is subject to the provisions of the Atomic Energy Act of 1954, as amended, (the Act) and to all rules, regulations, and orders of the Commission. The terms and conditions of the license will be subject to amendment, revision, or modification, by reason of amendments of the Act or by reason of rules, regulations, and orders issued in accordance with the terms of the Act.

(b) Each license issued under this part must be subject to all conditions imposed as a matter of law by sections 401(a)(2) and 401(d) of the Federal Water Pollution Control Act, as amended (33 U.S.C.A. 1341(a)(2) and (d)).

(c) A holder of an operating license (OL) or combined license (COL) under this part may take reasonable action that departs from a license condition or a technical specification included in a license issued under this part in a national security emergency established by a law enacted by the Congress or by an order or directive issued by the President pursuant to statutes or the Constitution of the United States. The authority under this paragraph (c) must be exercised in accordance with law, including section 57e of the Act, and is in addition to the authority granted under § 53.740(h), which remains in effect unless otherwise directed by the Commission during a national security emergency. The authority under this paragraph (c) may be exercised—

(1) When this action is immediately needed to implement national security objectives as designated by the national command authority through the Commission; and

(2) No action consistent with license conditions and technical specifications that can satisfy national security objectives is immediately apparent.

(d)(1) If the NRC finds that the state of emergency preparedness does not provide reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency (including findings based on requirements of 10 CFR part 50, appendix E, section IV.D.3) and if the deficiencies (including deficiencies based on requirements of 10 CFR part 50, appendix E, section IV.D.3) are not corrected within 4 months of that finding, the Commission will determine whether the facility must be shut down or cease operations until such deficiencies are remedied or whether other enforcement action is appropriate. In determining whether a shutdown or other enforcement action is appropriate, the Commission will take into account, among other factors, whether the licensee can demonstrate to the Commission's satisfaction that the deficiencies in the plan are not significant for the plant in question, or that adequate interim compensating actions have been or will be taken promptly, or that that there are other compelling reasons for continued operation.

(2) If the planning standards for radiological emergency preparedness apply to offsite emergency response plans, or if the planning activities in § 50.160(b)(1)(iv)(B) apply, then the NRC will base its finding on a review of the Federal Emergency Management Agency findings and determinations as to whether State, participating Tribal, and local emergency plans are adequate and capable of being implemented, and on the NRC assessment as to whether the licensee's emergency plans are adequate and capable of being implemented. Nothing in this paragraph (d)(2) must be construed as limiting the authority of the Commission to take action under any other regulation or authority of the Commission or at any time other than that specified in this paragraph (d)(2).

(a) Sections 53.1510 through 53.1520 provide the process for a licensee to request and the NRC to issue amendments to licenses, including any conditions contained therein, technical specifications or other attachments to a license, and any orders issued by the NRC modifying a license. Sections 53.1525 and 53.1530 govern proposed changes to a commercial nuclear plant referencing a certified design or manufacturing license (ML).

(b) A licensee may propose changing licensing-basis information established by NRC regulations by requesting an exemption in accordance with § 53.080.

Whenever a holder of a license under this part desires to amend the license, an application for an amendment must be filed with the Commission, as specified in § 53.040, that fully describes the changes desired and, following as far as applicable, the form prescribed for original applications. Applications for amendments involving changes to plant structures, systems, and components (SSCs), programmatic controls, or the role of plant personnel must include an assessment of the changes in relation to the safety requirements in subpart B of this part and the analyses requirements of § 53.450 as applicable, an analysis of whether the amendment involves no significant hazards consideration using the standards in § 53.1520, and a consideration of environmental factors.

The Commission will use the following procedures for an application requesting an amendment to an OL or COL issued under this part.

(a) Public notices. (1)(i) The Commission may publish in the Federal Register under § 2.105 of this chapter an individual notice of proposed action for an amendment for which it makes a proposed determination that no significant hazards consideration is involved, or, at least once every 30 days, publish a periodic Federal Register notice of proposed actions, which identifies each amendment issued and each amendment proposed to be issued since the last such periodic notice, or it may publish both such notices.

(ii) For each amendment proposed to be issued, the notice will

(A) Contain the staff's proposed determination under the standards in § 53.1520;

(B) Provide a brief description of the amendment and of the facility involved;

(C) Solicit public comments on the proposed determination; and

(D) Provide for a 30-day comment period.

(iii) The comment period will begin on the day after the date of the publication of the first notice, and, normally, the amendment will not be granted until after this comment period expires.

(2) The Commission may inform the public about the final disposition of an amendment request for which it has made a proposed determination of no significant hazards consideration either by issuing an individual notice of issuance under § 2.106 of this chapter or by publishing such a notice in its periodic system of Federal Register notices. In either event, it will not make and will not publish a final determination of no significant hazards consideration unless it receives a request for a hearing on that amendment request.

(3) Where the Commission makes a final determination that no significant hazards consideration is involved and that the amendment should be issued, the amendment will be effective on issuance, even if adverse public comments have been received and even if an interested person meeting the provisions for intervention called for in § 2.309 of this chapter has filed a request for a hearing. The Commission need hold any required hearing only after it issues an amendment, unless it determines that a significant hazards consideration is involved, in which case the Commission will provide an opportunity for a prior hearing.

(4) Where the Commission finds that an emergency situation exists, in that failure to act in a timely way would result in derating or shutdown of a commercial nuclear reactor, or in prevention of either resumption of operation or of increase in power output up to the plant's licensed power level, it may issue a license amendment involving no significant hazards consideration without prior notice and opportunity for a hearing or for public comment. In such a situation, the Commission will not publish a notice of proposed determination on no significant hazards consideration but will publish a notice of issuance under § 2.106 of this chapter providing for opportunity for a hearing and for public comment after issuance. The Commission expects its licensees to apply for license amendments in a timely fashion. It will decline to dispense with notice and comment on the determination of no significant hazards consideration if it determines that the licensee has abused the emergency provision by failing to make timely application for the amendment and thus itself creating the emergency. Whenever an emergency situation exists, a licensee requesting an amendment must explain why this emergency situation occurred and why it could not avoid this situation, and the Commission will assess the licensee's reasons for failing to file an application sufficiently in advance of that event.

(5) Where the Commission finds that exigent circumstances exist, in that a licensee and the Commission must act quickly and that time does not permit the Commission to publish a Federal Register notice allowing 30 days for prior public comment, and it also determines that the amendment involves no significant hazards considerations, it—

(i)(A) Will either issue a Federal Register notice providing notice of an opportunity for hearing and allowing at least 2 weeks from the date of the notice for prior public comment; or

(B) Will use local media to provide reasonable notice to the public in the area surrounding a licensee's facility of the licensee's amendment and of its proposed determination as described in paragraph (a)(1) of this section, consulting with the licensee on the proposed media release and on the geographical area of its coverage;

(ii) Will provide for a reasonable opportunity for the public to comment, using its best efforts to make available to the public whatever means of communication it can for the public to respond quickly, and, in the case of telephone comments, have these comments recorded or transcribed, as necessary and appropriate;

(iii) When it has issued a local media release, may inform the licensee of the public's comments, as necessary and appropriate;

(iv) Will publish a notice of issuance under § 2.106 of this chapter;

(v) Will provide a hearing after issuance, if one has been requested by a person who satisfies the provisions for intervention specified in § 2.309 of this chapter; and

(vi) Will require the licensee to explain the exigency and why the licensee cannot avoid it and use its normal public notice and comment procedures in paragraph (a)(1) of this section if it determines that the licensee has failed to use its best efforts to make a timely application for the amendment in order to create the exigency and to take advantage of this procedure.

(6) Where the Commission finds that significant hazards considerations are involved, it will issue a Federal Register notice providing an opportunity for a prior hearing even in an emergency situation, unless it finds an imminent danger to the health or safety of the public, in which case it will issue an appropriate order or rule under 10 CFR part 2.

(b) State consultation. (1) At the time a licensee requests an amendment, it must notify the State in which its facility is located of its request by providing that State with a copy of its application and its reasoned analysis about no significant hazards considerations and indicate on the application that it has done so.

(2) The Commission will advise the State of its proposed determination about no significant hazards consideration normally by sending it a copy of the Federal Register notice.

(3) The Commission will make the names of the Project Manager or other NRC personnel it designated to consult with the State available to the State official designated to consult about its proposed determination. The Commission will consider any comments of that State official. If it does not hear from the State in a timely manner, it will consider that the State has no interest in its determination; nonetheless, to ensure that the State is aware of the application, before it issues the amendment, it will make a good faith effort to communicate directly with that official. (Inability to consult with a responsible State official following good faith attempts will not prevent the Commission from making effective a license amendment involving no significant hazards consideration.)

(4) The Commission will make a good faith attempt to consult with the State before it issues a license amendment involving no significant hazards consideration. If, however, it does not have time to use its normal consultation procedures because of an emergency situation, it will attempt to communicate directly with the appropriate State official. (Inability to consult with a responsible State official following good faith attempts will not prevent the Commission from making effective a license amendment involving no significant hazards consideration, if the Commission deems it necessary in an emergency situation.)

(5) After the Commission issues the requested amendment, it will send a copy of its determination to the State.

(c) Caveats about State consultation. (1) The State consultation procedures in paragraph (b) of this section do not give the State a right—

(i) To veto the Commission's proposed or final determination;

(ii) To a hearing on the determination before the amendment becomes effective; or

(iii) To insist upon a postponement of the determination or upon issuance of the amendment.

(2) These procedures do not alter present provisions of law that reserve to the Commission exclusive responsibility for setting and enforcing radiological health and safety requirements for commercial nuclear plants.

(a) In determining whether an amendment to a license will be issued to the applicant, the Commission will be guided by the considerations which govern the issuance of initial licenses to the extent applicable and appropriate. If the application is for amendment of an OL or COL and involves the material alteration of a commercial nuclear plant, a construction permit (CP) will be issued before the issuance of the amendment to the license, provided however, that if the application involves a material alteration to a manufactured reactor under this part before its installation at a site, or a COL before the date that the Commission makes the finding under § 53.1452(g), no application for or issuance of a CP is required. If the amendment involves a significant hazards consideration, the Commission will give notice of its proposed action—

(1) Under § 2.105 of this chapter before acting thereon; and

(2) As soon as practicable after the application has been docketed.

(b) The Commission will be particularly sensitive to a license amendment request that involves irreversible consequences (such as one that permits a significant increase in the amount of effluents or radiation emitted by a commercial nuclear plant).

(c) The Commission may make a final determination, under the procedures in § 53.1515, that a proposed amendment to an OL or a COL for a commercial nuclear plant under this part involves no significant hazards consideration, if operation of the plant in accordance with the proposed amendment would not—

(1) Involve a significant increase in the probability or consequences of an accident previously evaluated; or

(2) Create the possibility of a new or different kind of an accident from any accident previously evaluated; or

(3) Involve a significant reduction in a margin of safety.

(a) A holder of an OL or COL who references a design certification rule issued under this part must request an exemption if proposing to change 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 and that the special circumstances outweigh any decrease in safety that may result from the reduction in standardization caused by the departure.

(b) The request for an exemption must be included with any associated license amendment request, which must be requested and processed in accordance with §§ 53.1510, 53.1515, and 53.1520.

(c) Licensees must evaluate changes to the design as described in the Final Safety Analysis Report (FSAR) not involving changes to the certification information using the criteria in § 53.1550.

(a) The holder of an ML may make changes to the facility or procedures as described in the Final Safety Analysis Report (FSAR) associated with the ML without obtaining a license amendment pursuant to § 53.1510 if the change meets the criteria in § 53.1550(a)(1) and (2) using the specifications in § 53.1550(b). If needed, applications for amending an ML must be submitted and processed in accordance with §§ 53.1510, 53.1515, and 53.1520. In those cases where an ML references a design certification rule, the amendment application from the holder of the ML must also request an exemption from the design certification rule under § 53.1525 if proposing to change one or more elements of the certification information.

(b)(1) The holder of an ML must maintain records of changes to the facility or procedures made without a license amendment under paragraph (a) of this section. These records must include a written evaluation which provides the bases for the determination that the change does not require a license amendment under the criteria in paragraph § 53.1550(a)(2).

(2) The records of changes in the facility must be maintained until the expiration of an ML issued under this part, or the expiration of a renewed license issued under § 53.1295—whichever is later. Records of changes in procedures must be maintained for a period of 5 years.

(a) The holder of a CP or limited work authorization (LWA) under this part may request an amendment to the CP or LWA in order to gain Commission approval of the safety of selected design features or specifications, including proposed departures from a design certification rule or ML. Amendments to CPs or LWAs under this part must be requested and processed under §§ 53.1510 and 53.1520.

(b) The holder of a COL under this part for which the NRC has not yet made a finding in accordance with § 53.1452(g) must request amendments required by § 53.1525 or § 53.1550 no later than 45 days from the date the licensee begins the construction of the SSCs to implement the change or departure requiring NRC approval. The licensee proceeds with such changes at its own risk recognizing that there is a possibility that the amendment will not be granted.

(a) Sections 53.1545 through 53.1565 provide the process for a holder of an OL or COL to modify licensing-basis information and to evaluate potential changes to its facilities, procedures, programs, and organizations to determine if NRC approval is required.

(b) Definitions for the purposes of §§ 53.1545 through 53.1565—

Change means a modification or addition to, or removal from, the commercial nuclear plant or procedures that affects a design feature or related functional design criteria, method of performing or controlling the functions of design features, or an evaluation that demonstrates that intended functions will be accomplished.

Departure from a method of evaluation described in the Final Safety Analysis Report (FSAR) (as updated) used in establishing the functional design criteria for safety-related structures, systems, or components or in the safety analyses means—

(i) Changing any of the elements of the method described in the FSAR (as updated) unless the results of the analysis are conservative or essentially the same; or

(ii) Changing from a method described in the FSAR to another method unless that method has been approved by NRC for the intended application.

Facility as described in the FSAR (as updated) means—

(i) The SSCs that are described in the FSAR (as updated),

(ii) The design and performance requirements for such SSCs described in the FSAR (as updated), and

(iii) The evaluations or methods of evaluation included in the FSAR (as updated) for such SSCs which demonstrate that their intended function(s) will be accomplished.

Final Safety Analysis Report (as updated) means the FSAR submitted under § 53.1279, § 53.1369 or § 53.1416, as amended and supplemented, and as updated under § 53.1545, as applicable.

Procedures as described in the Final Safety Analysis Report (as updated) means those procedures that contain information described in the FSAR (as updated) such as how SSCs are operated and controlled (including assumed operator actions and response times).

(a) Each holder of an OL or COL under this part for which the Commission has made the finding under § 53.1452(g) must update the FSAR originally submitted as part of the application for the license every 24 months or more frequently to assure that the information included in the report contains the latest information developed. The submittal must include the effects on the content of the FSAR of—

(1) Changes made to the facility or procedures as described in the FSAR;

(2) Safety analyses and evaluations performed by the licensee either in support of approved license amendments or in support of conclusions that changes did not require a license amendment under § 53.1550;

(3) Updates to the probabilistic risk assessment (PRA), other systematic risk evaluations, or a combination thereof required under § 53.450(a);

(4) The cumulative effects of the changes to the facility or procedures on the margins to the safety criteria in §§ 53.210, 53.220, and 53.450(e) since the last FSAR update; and

(5) Analyses of new safety issues performed by or on behalf of the licensee at Commission request.

(b)(1) The licensee must submit revisions containing updated information to the Commission, under § 53.040, identifying the location of revised or new information.

(2) The submittal must include—

(i) A certification by a duly authorized officer of the licensee that either the information accurately presents changes made since the previous submittal, necessary to reflect information and analyses submitted to the Commission or prepared pursuant to Commission requirement, or that no such changes were made; and

(ii) An identification of changes made under the provisions of § 53.1550 but not previously submitted to the Commission.

(c) Each applicant for or holder of a COL under this part for which the Commission has not made the finding under § 53.1452(g) must submit an update to the FSAR annually by providing the information required in paragraphs (a)(1) through (a)(5) of this section and meeting the requirements of paragraph (b) of this section. Combined license applicants who have requested the NRC to suspend its review of the COL application and COL holders who have informed the NRC that they do not plan to pursue construction need not submit an annual update of the FSAR. If a COL applicant requests that the NRC resume its review, or a COL holder notifies the NRC that the COL holder plans to commence or resume construction, then the COL applicant or holder must submit to NRC an update to its FSAR within 90 days of the request or notification, as applicable, and annually thereafter.

(d) The FSAR (as updated) must be retained by the licensee until the Commission terminates its license.

(e) Each holder of an ML under this part must submit an update of the FSAR every 24 months or more frequently as necessary to facilitate dependent COL or CP applications. The submittal must include the effects of changes on the content of the FSAR as described in paragraphs (a)(1), (a)(3) through (a)(5), and (b) of this section and safety analyses and evaluations performed by the licensee either in support of approved license amendments or in support of conclusions that changes did not require a license amendment under § 53.1530.

(a) The holder of an OL or COL 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) without obtaining a license amendment pursuant to § 53.1510 only if—

(1) A change to the technical specifications incorporated in the license is not required; and

(2) The change meets all of the following criteria:

(i) Does not result in an increase to the frequency or consequences of an event sequence such that an event sequence not previously identified as risk significant becomes risk significant by the analyses performed in accordance with § 53.450(e).

(ii) Does not result in an increase to the frequency or consequences of an event sequence such that an event sequence exceeds the licensing-basis event evaluation criteria required to be established in accordance with § 53.450(e).

(iii) Does not involve either of the following:

(A) A change to the NRC-approved comprehensive risk metric(s) or associated risk performance objective under § 53.220(b); or

(B) An increase to the frequency or consequences of one or more event sequences such that any calculated comprehensive risk metric exceeds the associated risk performance objective established in accordance with § 53.220.

(iv) Does not involve a departure from a method of evaluation described in the FSAR (as updated) used in assessing design-basis accidents in accordance with § 53.450(f) unless the results of the analysis under § 53.450(f) are conservative or essentially the same, the revised method of evaluation has been previously approved by the NRC for the intended application, or the revised method of evaluation can be used under an NRC-endorsed consensus code or standard.

(v) Does not result in a change to the safety classification of an SSC from safety-related to either non-safety-related but safety-significant or non-safety-related.

(vi) Does not result in more than a minimal decrease in defense in depth.

(vii) [Reserved]

(viii) Does not result in the identification of a new design-basis accident in accordance with § 53.450(f).

(ix) Does not result in more than a minimal increase in the consequences of any design-basis accident.

(3) In implementing this paragraph (a), the FSAR (as updated) is considered to include FSAR changes since submittal of the last update of the FSAR under § 53.1545.

(4) The provisions in this section do not apply to changes to the facility or procedures when the applicable regulations establish more specific criteria for accomplishing such changes.

(b)(1) A licensee who references a design certification rule may make departures from the standard design, without prior Commission approval, unless the proposed departure involves a change to the design as described in the rule certifying the design, in which case the requirements of § 53.1525 are applicable.

(2) The licensee must maintain records of all departures from the certified design of the facility and these records must be maintained and available for audit until the termination of the license. The licensee must identify the location and nature of departures from licensing-basis information within supporting documents for a certified design within the updates to the Safety Analysis Report required by § 53.1545.

(3) Licensees for which the NRC has docketed the certifications required under § 53.1070 need not retain records of departures from the design of the facility associated with SSCs that have been permanently removed from service using an NRC-approved change process.

(c)(1) The licensee must maintain records of changes in the facility and procedures made under paragraph (a) of this section. These records must include a written evaluation which provides the bases for the determination that the change does not require a license amendment under paragraph (a)(2) of this section.

(2) The licensee must submit, as specified in § 53.040, a report containing a brief description of any departures and changes, including a summary of the evaluation of each. A report must be submitted at intervals not to exceed 24 months. For COLs, the report must be submitted at intervals not to exceed 6 months during the period from the date of application for a COL to the date the Commission makes its findings under § 53.1452(g).

(3) The records of changes in the facility must be maintained until the termination of an OL or COL issued under this part, or the termination of a renewed license issued under § 53.1595—whichever is later. Records of changes in procedures must be maintained for a period of 5 years.

(a) Each holder under this part of an OL or COL for which the Commission has made the finding under § 53.1452(g) must biennially or more frequently update the program documents submitted as part of an application to obtain or maintain the license to assure that the information included in the documents contains the latest information developed. The submittals must include the effects on the content of the program documents of—

(1) Changes made in the facility, procedures, licensee's organization, or site environs;

(2) Safety analyses and evaluations performed by the applicant or licensee either in support of approved license amendments or in support of conclusions that changes did not require a license amendment in accordance with § 53.1550;

(3) Analyses of new safety issues performed by or on behalf of the licensee at Commission request; and

(4) Changes to the programs as a result of operating experience, corrective actions, or other reasons deemed appropriate to ensure the programs serve their underlying purpose to support the requirements in subpart B of this part or other NRC regulations.

(b)(1) The licensee must submit revisions containing updated information to the Commission, as specified in § 53.040, identifying the location of revised or new information.

(2) The submittal must include—

(i) A certification by a duly authorized officer of the licensee that either the information accurately presents changes made since the previous submittals, necessary to reflect information and analyses submitted to the Commission or prepared pursuant to Commission requirement, or that no such changes were made; and

(ii) An identification of changes made under the provisions of § 53.1550 but not previously submitted to the Commission.

(c) The updated program documents must be retained by the licensee until the Commission terminates their license.

(a) A licensee may make changes to the facility, procedures, or organizations or address changes to site environs as described in the program documents included in licensing-basis information without obtaining prior NRC approval only if—

(1) A change to the technical specifications incorporated in the license is not required;

(2) An exemption from an NRC regulation is not required; and

(3) The change conforms to program-specific requirements included in regulations in this part, technical specifications, or the NRC-approved program document included and reviewed as part of a license application under subpart H or an amendment under this subpart.

(b) In implementing this section, the program documents (as updated) include changes since submittal of the last updates of the program documents pursuant to § 53.1560.

(c) The provisions in this section do not apply to changes to the program documents when the applicable regulations establish more specific criteria for accomplishing such changes.

(d) To make changes to the facility, procedures, or organizations or to address changes to site environs as described in the program documents included in licensing-basis information for individual programs, the following requirements must be satisfied:

(1) Quality assurance program—operation. (i) Each holder under this part of an OL or COL, after the Commission makes the finding under § 53.1452(g), may make a change to a previously accepted quality assurance program (QAP) description included or referenced in the Safety Analysis Report without prior NRC approval, provided the change does not reduce the commitments in the program description as accepted by the NRC. Changes to the QAP description that do not reduce the commitments must be submitted to the NRC in accordance with the requirements of § 53.1545. In addition to QAP changes involving administrative improvements and clarifications, spelling corrections, punctuation, or editorial items, the following changes are not considered to be reductions in commitment:

(A) The use of a quality assurance (QA) standard approved by the NRC which is more recent than the QA standard in the licensee's QAP at the time of the change;

(B) The use of a QA alternative or exception approved by an NRC safety evaluation, provided that the bases of the NRC approval are applicable to the licensee's facility;

(C) The use of generic organizational position titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific titles;

(D) The use of generic organizational charts to indicate functional relationships, authorities, and responsibilities, or, alternately, the use of descriptive text;

(E) The elimination of QAP information that duplicates language in QA regulatory guides and QA standards to which the licensee is committed; and

(F) Organizational revisions that ensure that persons and organizations performing QA functions continue to have the requisite authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations.

(ii) Changes to the QAP description that do reduce the commitments must be submitted to the NRC and receive NRC approval prior to implementation, as follows:

(A) Changes made to the QAP description as presented in the Safety Analysis Report or in a topical report must be submitted as specified in § 53.040.

(B) The submittal of a change to the Safety Analysis Report QAP description must include all pages affected by that change and must be accompanied by a forwarding letter identifying the change, the reason for the change, and the basis for concluding that the revised program incorporating the change continues to satisfy the criteria of appendix B to part 50 of this chapter and the Safety Analysis Report QAP description commitments previously accepted by the NRC (the letter need not provide the basis for changes that correct spelling, punctuation, or editorial items).

(C) A copy of the forwarding letter identifying the change must be maintained as a facility record for 3 years.

(D) Changes to the QAP description included or referenced in the Safety Analysis Report shall be regarded as accepted by the Commission upon receipt of a letter to this effect from the appropriate reviewing office of the Commission or 60 days after submittal to the Commission, whichever occurs first.

(2) Quality assurance program—siting, construction, and manufacturing. Each holder of an LWA, early site permit, CP, ML, or COL, before the Commission makes the finding under § 53.1452(g) of this chapter, under this part may make a change to a previously accepted QAP description included or referenced in the Safety Analysis Report without prior NRC approval, provided the change does not reduce the commitments in the program description previously accepted by the NRC. Changes to the QAP description that do not reduce the commitments must be submitted to NRC within 90 days. Changes to the QAP description that reduce the commitments must be submitted to NRC and receive NRC approval before implementation, as follows:

(i) Changes to the Safety Analysis Report must be submitted for review as specified in § 53.040. Changes made to NRC-accepted QA topical report descriptions must be submitted as specified in § 53.040.

(ii) The submittal of a change to the Safety Analysis Report QAP description must include all pages affected by that change and must be accompanied by a forwarding letter identifying the change, the reason for the change, and the basis for concluding that the revised program incorporating the change continues to satisfy the criteria of appendix B of part 50 of this chapter and the Safety Analysis Report QAP description commitments previously accepted by the NRC (the letter need not provide the basis for changes that correct spelling, punctuation, or editorial items).

(iii) A copy of the forwarding letter identifying the changes must be maintained as a facility record for 3 years.

(iv) Changes to the QAP description included or referenced in the Safety Analysis Report shall be regarded as accepted by the Commission upon receipt of a letter to this effect from the appropriate reviewing office of the Commission or 60 days after submittal to the Commission, whichever occurs first.

(3) Emergency preparedness program. (i) Definitions for the purpose of paragraph (d)(3) of this section:

(A) Change means an action that results in modification or addition to, or removal from, the licensee's emergency plan. All such changes are subject to the provisions of this section except where the applicable regulations establish specific criteria for accomplishing a particular change.

(B) Emergency plan means the document(s), prepared and maintained by the licensee, that identify and describe the licensee's methods for maintaining emergency preparedness and responding to emergencies. An emergency plan includes the plan as originally approved by the NRC and all subsequent changes made by the licensee with, and without, prior NRC review and approval under paragraph (d)(3) of this section.

(C) Emergency planning function means a capability or resource necessary to prepare for and respond to a radiological emergency.

(D) Reduction in effectiveness means 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.

(ii)(A) Except as provided in paragraph (d)(3)(ii)(B) of this section, a holder of an OL under this part, or a COL under this part after the Commission makes the finding under § 53.1452(g), must follow and maintain the effectiveness of an emergency plan that meets the requirements in appendix E to part 50 of this chapter and the planning standards of § 50.47(b).

(B) A holder of an OL under this part for a commercial nuclear plant consisting of small modular reactors (SMRs) or non-light-water reactors, or a holder of a COL under this part after the Commission makes the finding under § 53.1452(g) for a commercial nuclear plant consisting of either SMRs or non-light-water reactors, must follow and maintain the effectiveness of either an emergency plan that meets the requirements in § 50.160 or an emergency plan that meets the requirements in appendix E to part 50 of this chapter and the planning standards of § 50.47(b).

(iii)(A) Except as provided in paragraph (d)(3)(iii)(B) of this section, the licensee may make changes to its emergency plan without NRC approval only if the licensee performs and retains an analysis demonstrating that the changes do not reduce the effectiveness of the plan and the plan, as changed, continues to meet the requirements in appendix E to part 50 of this chapter and the planning standards of § 50.47(b).

(B) A license under this part for a commercial nuclear plant consisting of either SMRs or non-light-water reactors may make changes to its emergency plan without NRC approval only if the licensee performs and retains an analysis demonstrating that the changes do not reduce the effectiveness of the plan and the plan, as changed, continues to meet either the requirements in § 50.160 or the requirements in appendix E to part 50 and the planning standards of § 50.47(b).

(iv) The changes to a licensee's emergency plan that reduce the effectiveness of the plan as defined in paragraph (d)(3)(i)(D) of this section may not be implemented without prior approval by the NRC. A licensee desiring to make such a change must submit an application for an amendment to its license. In addition to the filing requirements of §§ 53.1510 and 53.1515, the request must include all emergency plan pages affected by that change and must be accompanied by a forwarding letter identifying the change, the reason for the change, and the basis for concluding that the licensee's emergency plan, as revised, will continue to meet either the requirements in § 50.160 to this chapter or the requirements in appendix E to part 50 of this chapter and the planning standards of § 50.47(b) of this chapter.

(v) The licensee must retain a record of each change to the emergency plan made without prior NRC approval for a period of three years from the date of the change and shall submit, as specified in § 53.040, a report of each such change, including a summary of its analysis, within 30 days after the change is put in effect.

(vi) The licensee must retain the emergency plan and each change for which prior NRC approval was obtained pursuant to paragraph (d)(3)(iv) of this section as a record until the Commission terminates the license for the nuclear power reactor.

(vii)(A) The licensee must provide for the development, revision, implementation, and maintenance of its emergency preparedness program. The licensee must ensure that all program elements are reviewed by persons who have no direct responsibility for the implementation of the emergency preparedness program either—

(1) At intervals not to exceed 12 months; or

(2) As necessary, based on an assessment by the licensee against performance indicators, and as soon as reasonably practicable after a change occurs in personnel, procedures, equipment, or facilities that potentially could adversely affect emergency preparedness, but no longer than 12 months after the change. In any case, all elements of the emergency preparedness program must be reviewed at least once every 24 months.

(B) The review must include an evaluation for adequacy of interfaces with State, participating Tribal, and local governments and of licensee drills, exercises, capabilities, and procedures. The results of the review, along with recommendations for improvements, must be documented, reported to the licensee's corporate and plant management, and retained for a period of 5 years. The part of the review involving the evaluation for adequacy of interface with State, participating Tribal, and local governments must be available to the appropriate State, participating Tribal, and local governments.

(4) Security programs. (i) The licensee must prepare and maintain safeguards contingency plan procedures in accordance with appendix C of part 73 of this chapter for affecting the actions and decisions contained in the Responsibility Matrix of the safeguards contingency plan. The licensee may not make a change that would decrease the safeguard effectiveness of a physical security plan, or guard training and qualification plan, or cybersecurity plan submitted under subpart H or part 73 of this chapter, or of the first four categories of information (Background, Generic Planning Base, Licensee Planning Base, Responsibility Matrix) contained in a licensee safeguards contingency plan submitted under subpart H or part 73 of this chapter, as applicable, without prior approval of the Commission. A licensee desiring to make such a change must submit an application for amendment to the licensee's license under §§ 53.1510, 53.1515, and 53.1520.

(ii) The licensee may make changes to the plans referenced in paragraph (d)(4)(i) of this section without prior Commission approval if the changes do not decrease the safeguards effectiveness of the plan. The licensee must maintain records of changes to the plans made without prior Commission approval for a period of 3 years from the date of the change, and must submit, as specified in § 53.040, a report containing a description of each change within 2 months after the change is made. Prior to the safeguards contingency plan being put into effect, the licensee must have—

(A) All safeguards capabilities specified in the safeguards contingency plan available and functional;

(B) Detailed procedures developed according to appendix C to part 73 of this chapter available at the licensee's site; and

(C) All appropriate personnel trained to respond to safeguards incidents as outlined in the plan and specified in the detailed procedures.

(iii) The licensee must provide for the development, revision, implementation, and maintenance of its safeguards contingency plan. The licensee must ensure that all program elements are reviewed by individuals independent of both security program management and personnel who have direct responsibility for implementation of the security program either—

(A) At intervals not to exceed 12 months; or

(B) As necessary, based on an assessment by the licensee against performance indicators, and as soon as reasonably practicable after a change occurs in personnel, procedures, equipment, or facilities that potentially could adversely affect security, but no longer than 12 months after the change. In any case, all elements of the safeguards contingency plan must be reviewed at least once every 24 months.

(iv) The review must include a review and audit of safeguards contingency procedures and practices, an audit of the security system testing and maintenance program, and a test of the safeguards systems along with commitments established for response by local law enforcement authorities. The results of the review and audit, along with recommendations for improvements, must be documented, reported to the licensee's corporate and plant management, and kept available at the plant for inspection for a period of 3 years.

(a) No commercial nuclear plant license issued under this part, or any right thereunder, shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of the license to any person, unless the Commission gives its consent in writing.

(b)(1) An application for transfer of a license must include—

(i) As much of the information described in §§ 53.1109, 53.1306, 53.1366, and 53.1413 with respect to the identity and technical and financial qualifications of the proposed transferee as would be required by those sections if the application were for an initial license. The Commission may require additional information such as data respecting proposed safeguards against hazards from radioactive materials and the applicant's qualifications to protect against such hazards.

(ii) A statement of the purposes for which the transfer of the license is requested, the nature of the transaction necessitating or making desirable the transfer of the license, and an agreement to limit access to Restricted Data or Classified National Security Information pursuant to § 53.1115. The Commission may require any person who submits an application for license pursuant to the provisions of this section to file a written consent from the existing licensee or a certified copy of an order or judgment of a court of competent jurisdiction attesting to the person's right (subject to the licensing requirements of the Act and these regulations) to possession of the facility or site involved.

(2) [Reserved]

(c) After appropriate notice to interested persons, including the existing licensee, and observance of such procedures as may be required by the Act or regulations or orders of the Commission, the Commission will approve an application for the transfer of a license, if the Commission determines—

(1) That the proposed transferee is qualified to be the holder of the license; and

(2) That transfer of the license is otherwise consistent with applicable provisions of law, regulations, and orders issued by the Commission pursuant thereto.

(a) When the holder of an OL or COL under this part has determined to permanently cease operations the licensee must, within 30 days, submit a written certification to the NRC, consistent with the requirements of § 53.1070.

(b) Once fuel has been permanently removed from the reactor system, the licensee must submit a written certification to the NRC that meets the requirements of § 53.1070.

(c)(1) Upon docketing of the certifications for permanent cessation of operations and permanent removal of fuel from the reactor system, or when a final legally effective order to permanently cease operations has come into effect, the license no longer authorizes operation of the reactor or emplacement or retention of fuel into the reactor system.

(2) Activities associated with decommissioning will be carried out in accordance with the requirements and procedures in subpart G of this part.

(3) The Commission shall terminate the license if it determines that—

(i) The remaining dismantlement has been performed in accordance with the approved license termination plan required in subpart G of this part; and

(ii) The final radiation survey and associated documentation, including an assessment of dose contributions associated with parts released for use before approval of the license termination plan, demonstrate that the facility and site have met the criteria for decommissioning in subpart E of 10 CFR part 20.

(d) A holder of a CP or COL under this part may request the termination of the license as well as licenses issued by the NRC under parts 30, 40, or 70 of this chapter prior to plant operations. Such requests may support an immediate NRC approval of the site for unrestricted use.

Each licensee under this part must at any time before termination of the license, upon request of the Commission, submit, as specified in § 53.040 written statements, signed under oath or affirmation, to enable the Commission to determine whether or not the license should be modified, suspended, or revoked. Except for information sought to verify licensee compliance with the current licensing basis for that facility, the NRC must prepare the reason or reasons for each information request prior to 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 such justification provided for an evaluation performed by the NRC staff must be approved by the Executive Director for Operations or his or her designee prior to issuance of the request.

A license or standard design approval issued under this part may be revoked, suspended, or modified, in whole or in part, for any material false statement in the application or in the supplemental or other statement of fact required of the applicant; or because of conditions revealed by the application or statement of fact of any report, record, inspection, or other means which would warrant the Commission to refuse to grant a license or approval on an original application; or for failure to manufacture a reactor, or construct or operate a facility in accordance with the terms of the license, provided, however, that failure to make timely completion of the proposed construction or alteration of a facility under a CP under this part shall be governed by the provisions of § 53.1342(b); or for violation of, or failure to observe, any of the terms and provisions of the Act, regulations, license, approval, or order of the Commission.

(a)(1) Backfitting means the modification of or addition to systems, structures, components, or design of a facility; or the design approval for a facility; or the procedures or organization required to design, construct or operate a facility; any of which may result from a new or amended provision in the Commission's regulations or the imposition of a regulatory staff position interpreting the Commission's regulations that is either new or different from a previously applicable staff position after the date of the commercial nuclear plant license issued under this part.

(2) Except as provided in paragraph (a)(4) of this section, the Commission shall require a systematic and documented analysis pursuant to paragraph (b) of this section for backfits which it seeks to impose.

(3) Except as provided in paragraph (a)(4) of this section, the Commission shall require the backfitting of a facility only when it determines, based on the analysis described in paragraph (b) of this section, that there is a substantial increase in the overall protection of the public health and safety or the common defense and security to be derived from the backfit and that the direct and indirect costs of implementation for that facility are justified in view of this increased protection.

(4) The provisions of paragraphs (a)(2) and (a)(3) of this section are inapplicable and, therefore, backfit analysis is not required and the standards in paragraph (a)(3) of this section do not apply where the Commission or staff, as appropriate, finds and declares, with appropriate documented evaluation for its finding, either—

(i) That a modification is necessary to bring a facility into compliance with a license or the rules or orders of the Commission, or into conformance with written commitments by the licensee; or

(ii) That regulatory action is necessary to ensure that the facility provides adequate protection to the health and safety of the public and is in accord with the common defense and security; or

(iii) That the regulatory action involves defining or redefining what level of protection to the public health and safety or common defense and security should be regarded as adequate.

(5) The Commission must always require the backfitting of a facility if it determines that such regulatory action is necessary to ensure that the facility provides adequate protection to the health and safety of the public and is in accord with the common defense and security.

(6) The documented evaluation required by paragraph (a)(4) of this section must include a statement of the objectives of and reasons for the modification and the basis for invoking the exception. If immediately effective regulatory action is required, then the documented evaluation may follow rather than precede the regulatory action.

(7) If there are two or more ways to achieve compliance with a license or the rules or orders of the Commission, or with written licensee commitments, or there are two or more ways to reach a level of protection which is adequate, then ordinarily the applicant or licensee is free to choose the way which best suits its purposes. However, should it be necessary or appropriate for the Commission to prescribe a specific way to comply with its requirements or to achieve adequate protection, then cost may be a factor in selecting the way, provided that the objective of compliance or adequate protection is met.

(b) In reaching the determination required by paragraph (a)(3) of this section, the Commission will consider how the backfit should be scheduled in light of other ongoing regulatory activities at the facility and, in addition, will consider information available concerning any of the following factors as may be appropriate and any other information relevant and material to the proposed backfit:

(1) The statement of the specific objectives that the proposed backfit is designed to achieve;

(2) The general description of the activity that would be required by the licensee or applicant in order to complete the backfit;

(3) The potential change in the risk to the public from the accidental off-site release of radioactive material;

(4) The potential impact on radiological exposure of facility employees;

(5) The installation and continuing costs associated with the backfit, including the cost of facility downtime or the cost of construction delay;

(6) The potential safety impact of changes in plant or operational complexity, including the relationship to proposed and existing regulatory requirements;

(7) The estimated resource burden on the NRC associated with the proposed backfit and the availability of such resources;

(8) The potential impact of differences in facility type, design or age on the relevancy and practicality of the proposed backfit;

(9) Whether the proposed backfit is interim or final and, if interim, the justification for imposing the proposed backfit on an interim basis.

(c) No licensing action will be withheld during the pendency of backfit analyses required by the Commission's rules.

(d) The Executive Director for Operations shall be responsible for implementation of this section, and all analyses required by this section shall be approved by the Executive Director for Operations or his or her designee.

Licenses may be renewed by the Commission upon expiration of the period of the license.