ML21202A175

Rulemaking: Discussion Table for Preliminary Rule Language for the Part 53 Rulemaking: Subpart I - Maintaining and Revising Licensing Basis Information

ML21202A175
Person / Time
Issue date:	08/10/2021
From:	Robert Beall NRC/NMSS/DREFS/RRPB
To:
Beall, Robert
Shared Package
ML20289A534	List: ML20289A556 ML20289A591 ML20311A004 ML20337A422 ML20337A432 ML20349A267 ML21012A278 ML21012A284 ML21042B855 ML21083A031 ML21095A165 ML21106A001 ML21106A002 ML21112A195 ML21145A028 ML21145A029 ML21145A035 ML21145A043 ML21145A047 ML21148A062 ML21148A173 ML21202A162 ML21202A175 ML21202A178 ML21225A224 ML21243A076 ML21267A004 ML21267A006 ML21270A005 ML21308A026 ML21308A028 ML21348A123 ML22024A066 ML22125A000 ML22145A000 ML22146A041 ML22146A045 ML22160A039 ML22165A265
References
10 CFR Part 53, NRC-2019-0062, RIN 3150-AK31
Download: ML21202A175 (19)

Text

THIS PRELIMINARY PROPOSED RULE LANGUAGE AND ACCOMPANYING DISCUSSION IS BEING RELEASED TO SUPPORT INTERACTIONS WITH STAKEHOLDERS AND THE ADVISORY COMMITTEE ON REACTOR SAFEGUARDS (ACRS). THIS LANGUAGE HAS NOT BEEN SUBJECT TO COMPLETE NRC MANAGEMENT OR LEGAL REVIEW, AND ITS CONTENTS SHOULD NOT BE INTERPRETED AS OFFICIAL AGENCY POSITIONS.

THE NRC STAFF PLANS TO CONTINUE WORKING ON THE CONCEPTS AND DETAILS PROVIDED IN THIS DOCUMENT AND WILL CONTINUE TO PROVIDE OPPORTUNITIES FOR PUBLIC PARTICIPATION AS PART OF THE RULEMAKING ACTIVITIES.

AN IMPORTANT NOTE FOR THIS ITERATION IS THAT THE STAFF IS ACTIVELY ASSESSING VARIOUS ALTERNATIVE DESIGN/LICENSING APPROACHES TO ADDRESS COMMENTS THAT THE RULEMAKING SHOULD SUPPORT METHODOLOGIES THAT ARE LESS RELIANT ON PROBABILISTIC RISK ASSESSMENTS (PRA). THE DEVELOPMENT OF THIS SUBPART PRIMARILY REFLECTS A RISK-INFORMED OR PRA-CENTERED APPROACH. THE STAFF IS DEVELOPING ALTERNATIVE APPROACHES AND RELATED PRELIMINARY RULE SECTIONS FOR A FUTURE ITERATION THAT CAN BE CONSIDERED BY AND DISCUSSED WITH STAKEHOLDERS, NRC MANAGEMENT, AND THE COMMISSION.

THE STAFF IS PRIMARILY SEEKING INSIGHTS REGARDING THE CONCEPTS IN THIS PRELIMINARY LANGUAGE AND SECONDARILY SEEKING INSIGHTS RELATED TO DETAILS SUCH AS NUMERICAL VALUES FOR VARIOUS CRITERIA.

SUBPART I (Maintaining and Revising Licensing Basis Information) - PRELIMINARY RULE LANGUAGE (August 2021)

SUBPART I - Maintaining and Revising Licensing Basis Information Preliminary Language Discussion

§ 53.1300 Licensing Basis Information. Subpart I and some provisions within Subpart H Each holder of an early site permit, construction permit, define the requirements and processes for operating license, or combined license for a commercial nuclear plant maintaining licensing basis information by holders of licensed under this part shall maintain licensing basis information; early site permits, construction permits, operating evaluate changes to site characteristics, plant design features, and licenses and combined licenses. The subpart is programmatic controls to determine needed approvals and revisions; generally organized into those sections dealing with and submit appropriate updates to the NRC in accordance with the (1) licensing basis information that licensees are not requirements in this subpart. As used in this subpart, licensing basis authorized to change without NRC approval information refers to that information contained in regulations, orders, (e.g., licenses, regulations) and (2) licensing basis licenses, certifications, or approvals issued by the NRC for a commercial documents that licensees may change unless nuclear plant licensed under this part and that information submitted to specified criteria are not satisfied (e.g., FSAR, the NRC by an applicant or licensee in a safety analysis report, program program descriptions).

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description, or other information required to be maintained and submitted to the NRC in this part.

§ 53.1310 Changes to Licensing Basis Information Requiring Prior This section introduces the requirements for NRC Approval. proposing changes to the licensing basis information (a) Sections 53.1311 through 53.1313 define the process for a defined by licenses, orders, and regulations.

licensee to request and the NRC to issue amendments to licenses, which include an early site permit, construction permit, operating license, Note that changes to standard design certifications or combined license and any conditions contained therein, technical are addressed in Subpart H (§ 53.1239) and specifications or other attachments to a license, and any orders issued proposed changes by a licensee to information by the NRC modifying a license unless the order itself defines another related to a standard design certification or method for controlling revisions to the requirements included in the order manufacturing license are addressed in later or the order is revised or superseded by another order issued by the sections of this subpart.

NRC.

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

§ 53.1311 Application for amendment of license. This section provides the equivalent of § 50.90 for Whenever a holder of an early site permit, construction permit, applications to amend an early site permit, operating license, or combined license under this part desires to amend construction permit, operating license, or combined the license, an application for an amendment must be filed with the license issued under Part 53.

Commission, as specified in § 53.040 of this part, 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 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, the analyses requirements of

§ 53.450, its analysis about the issue of no significant hazards consideration using the standards in § 53.1313, and a consideration of environmental factors.

§ 53.1312 Public notices; State consultation. This section provides the equivalent of § 50.91 for The Commission will use the following procedures for an the NRCs processes related to applications to application requesting an amendment to an early site permit, amend an early site permit, construction permit, construction permit, operating license, or combined license under this operating license, or combined license issued under part. Part 53.

(a) Public notices.

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(1)(i) The Commission may publish in the Federal Register under

§ 2.105 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

§ 50.92, (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 on 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 nuclear power plant, or in prevention of either resumption of operation or of increase in power output up to the plant's licensed 3

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 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 two 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)(2) 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 4

licensee of the public's comments, as necessary and appropriate; (iv) Will publish a notice of issuance under § 2.106; (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; (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)(2) 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 available to the State official designated to consult with it about its proposed determination the names of the Project Manager or other NRC personnel it designated to consult with the State. 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.

(4) The Commission will make a good faith attempt to consult 5

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.

(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 nuclear power plants.

§ 53.1313 Issuance of amendment. This section provides the equivalent of § 50.92 for (a) In determining whether an amendment to a permit or license the NRCs processes related to applications to will be issued to the applicant, the Commission will be guided by the amend an early site permit, construction permit, considerations which govern the issuance of initial licenses or permits to operating license, or combined license issued under the extent applicable and appropriate. If the application involves the Part 53. Except for minor wording changes (e.g.,

material alteration of a licensed facility, a construction permit will be event sequence instead of event), the criteria are the issued before the issuance of the amendment to the license, provided same as those used in § 50.92.

however, that if the application involves a material alteration to a nuclear power reactor manufactured under § 53.xxxx before its installation at a site, or a combined license before the date that the Commission makes the finding under § 53.xxxx [52.103(g)], no application for a construction permit 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 6

amendment request that involves irreversible consequences (such as one that permits a significant increase in the amount of effluents or radiation emitted by a nuclear power plant).

(c) The Commission may make a final determination, under the procedures in § 53.1312, that a proposed amendment to an operating license or a combined license for a facility license under this part involves no significant hazards consideration, if operation of the facility in accordance with the proposed amendment would not:

(1) Involve a significant increase in the probability or consequences of an event sequence previously evaluated; or (2) Create the possibility of a new or different kind of an event sequence from any accident previously evaluated; or (3) Involve a significant reduction in a margin of safety.

§ 53.1315 Revising certification information within a design This section provides the requirements for the holder certification rule. of an operating license or combined license issued (a) A holder of an operating license or combined license who under Part 53 that references a design certification references a design certification rule issued under this part must request rule to propose an exemption from the specified an exemption if proposing to change one or more elements of the characteristics of the certified design. Other certification information. The Commission may grant such a request requirements related to design certification and only if it determines that the exemption will comply with the requirements changes to the DC by parties other than the holder of § 53.080. of an operating license or combined license is (b) The request for an exemption will be included with the included in Subpart H.

associated proposed changes to the license, which will be requested and processed in accordance with §§ 53.1311, 15.1312, and 53.1313.

(c) Licensees must evaluate changes to the facility as described in the final safety analysis not involving changes to the certification information using the criteria in § 53.1322.

§ 53.1316 Revising design information within a manufacturing From Subpart F of Part 52. This section provides license the requirements for the holder of an operating The holder of an operating or combined license under this part license or combined license issued under Part 53 who references or uses a nuclear power reactor manufactured under a that references a manufacturing license (ML) to manufacturing license under this part must request approval for a propose a departure from the specified departure from the design characteristics, site parameters, terms and characteristics of the manufactured reactor. Other conditions, or approved design of the manufactured reactor. The requirements related to the manufacturing license application for such departures must be submitted and processed in and changes to the ML by parties other than the accordance with §§ 53.1311, 15.1312, and 53.1313. In those cases holder of an operating license or combined license is 7

where a manufacturing license references a design certification rule, the included in Subpart H.

amendment application must also request an exemption from the design certification rule in accordance with § 53.1315 if one or more elements of the certification information are adversely affected by the proposed change. Licenses must evaluate changes to the facility as described in the final safety analysis report but outside of the scope of the referenced manufacturing license using the criteria in § 53.1322.

§ 53.1317 Amendments during construction This section provides the requirements for amending (a) The holder of a construction permit under this part may the permit or license the holder of a construction request an amendment to the construction permit in order to gain permit or combined license issued under Part 53.

Commission approval of the safety of selected design features or Paragraph (a) reflects the same requirements as specifications, including proposed departures from a design those in § 50.35(b). Paragraph (b) is similar to the certification rule or manufacturing license. Amendments to process for Part 52 changes during construction and construction permits under this part must be requested and processed may change as the issue is discussed and resolved in accordance with §§ 53.1311, 53.1312, and 53.1313. during the ongoing Parts 50/52 rulemaking.

(b) The holder of a combined license under this part for which the NRC has not yet made a finding in accordance with § 53.xxxx (52.103(g)) must request amendments required by §§ 53.1315 or 53.1322 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 request will not be granted.

§ 53.1320 Evaluating changes and updating licensing basis This section introduces the requirements for information without NRC prior approval. licensees to pursue changes to the licensing basis Sections 53.1321 through 53.1333 define the process for a information in licensee controlled documents such licensee to evaluate changes to their facilities, procedures, programs, as FSARs and program documents.

and organizations and to modify licensing basis information without NRC prior approval.

§ 53.1321 Updating final safety analysis reports. This section provides the equivalent of § 50.71 for (a) Each holder of an operating license or combined license the updating of FSARs. Assuming a risk-informed under this part for which the Commission has made the finding under approach in Subpart C results in PRA information

§ 53.xxxx (52.103(g)) must update the final safety analysis report being in the FSAR and therefore a separate PRA (FSAR) originally submitted as part of the application for the license update requirement (§ 50.71(h)) is not included in biennially or more frequently to assure that the information included in this iteration of Subpart I. This section assumes that 8

the report contains the latest information developed. The submittal shall the PRA results and the related margins to safety include the effects on the content of the FSAR of: criteria will be discussed in the FSAR and thus (1) changes made in the facility or procedures; would be updated under (a)(4) in this section. The (2) safety analyses and evaluations performed by the applicant routine reporting of these margins also support the or licensee either in support of approved license amendments or in criteria for allowing changes without NRC approval support of conclusions that changes did not require a license in the following section (§ 53.1322).

amendment in accordance with § 53.1322; (3) updates related to the probabilistic risk assessments required under § 53.450; (4) the cumulative effects of the changes to the facility or procedures since the last update on the margins to the safety criteria in

§§ 53.210, 53.220, 53.450(e), and 53.470.

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

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

(2) The submittal shall 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

§ 53.1322 but not previously submitted to the Commission.

(c) During the period from the docketing of an application for a combined license under subpart H until the Commission makes the finding under § 53.xxxx (52.103(g)), the update to the FSAR providing the information required in (a)(1) through (a)(5) of this section and meeting the requirements of paragraph (b) of this section must be submitted annually.

(d) The updated FSAR shall be retained by the licensee until the Commission terminates their license.

§ 53.1322 Evaluating changes to facility as described in final This section provides the equivalent of § 50.59 for safety analysis reports. evaluating changes to UFSAR and determining if a (a) A licensee may make changes in the facility as described in license amendment is required. The requirements 9

the UFSAR and make changes in the procedures as described in the include a risk-informed approach for assessing the UFSAR without obtaining a license amendment pursuant to § 53.1311 results of changes on LBEs and using criteria related only if: to the impact on margins to acceptance criteria. The (1) A change to the technical specifications incorporated in the specific criteria include:

license is not required and (2) The change meets all of the following criteria:

(i) Does not result in a change to the frequency or consequences Paragraph (2)(i) which is based on the identification of an event sequence such that an event sequence previously deemed of risk-significant event sequences required by not risk significant becomes risk significant by the analyses performed in § 53.450 and an evaluation to determine if a accordance with § 53.450(e). proposed change to the facility or procedures would (ii) Does not result in a change to the frequency or introduce a new risk-significant LBE consequences of an event sequence such that an event sequence deemed risk significant in accordance with § 53.450(e) has a decrease Paragraph (2)(ii) which addresses changes of 10 percent or more in the calculated margins to the LBE evaluation potentially affecting existing risk significant event criteria required to be established in accordance with § 53.450(e). sequences and assessing any reduction in margin to (iii) Does not result in a change to the frequency or the LBE evaluation criteria consequences of one or more event sequences such that the margin between the calculated cumulative risks posed by the commercial Paragraph (2)(iii) which addresses potential impacts nuclear plant and the safety criteria of § 53.220 decreases by 10 percent on the cumulative risks and any potential decreases or more. in margin to the safety criteria § 53.220. The use of (iv) Does not involve a departure from a method of evaluation a reduction of 10 percent in available margins is described in the UFSAR used in assessing margins in accordance with generally consistent with current practices for

§ 53.450(e) unless the results of the analysis are conservative or evaluating changes in 10 CFR 50.59 (see SOCs at essentially the same, the revised method of evaluation has been 64 FR 53382 and related guidance in NEI 96-07, previously approved by the NRC for the intended application, or the Revision 1).

revised method of evaluation can be used in accordance with an NRC endorsed consensus code or standard. Paragraph (2)(iv) which is similar to (v) For commercial nuclear plants licensed under this part for § 50.59(c)(2)(viii) and departures form previously which alternative evaluation criteria are applicable in accordance with approved methods of evaluating LBEs

§ 53.470, does not result in a change to the frequency or consequences of event sequences such that the calculated margins between the Paragraph (2)(v) which addresses facilities applying results for event sequences evaluated in accordance with § 53.450(e) alternative evaluation criteria by establishing a and the alternative evaluation criteria decreases by 25 percent or more. criterion related to the margins between LBEs and (3) In implementing this paragraph, the UFSAR is considered to the alternative evaluation criteria.

include FSAR changes since submittal of the last update of the UFSAR pursuant to § 53.1320.

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(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 Consistent with 10 CFR 52.63(b)(2) 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 § 53.1315 are applicable.

(2) The licensee shall maintain records of all departures from the certified design of the facility and these records must be maintained and available for audit until the date of termination of the license. The licensee will 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 § 53.1321.

(3) Licensees for which the NRC has docketed the certifications required under Subpart G of this part are not required to retain records of departures from the design of the facility associated with structures, systems, and components that have been permanently removed from service using an NRC-approved change process.

(c)(1) The licensee shall maintain records of changes in the facility and procedures made pursuant to 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 pursuant to paragraph (a)(2) of this section.

(2) The licensee shall submit, as specified in § 53.040 of this part, a report containing a brief description of any changes, including a summary of the evaluation of each. A report must be submitted at intervals not to exceed 24 months. For combined licenses, the report must be submitted at intervals not to exceed 6 months during the period from the date of application for a combined license to the date the Commission makes its findings under 10 CFR 53.yyy (52.103(g)).

(3) The records of changes in the facility must be maintained until the termination of an operating license or combined license issued under this part, or the termination of a renewed license issued under [ ],

whichever is later. Records of changes in procedures must be maintained for a period of 5 years.

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(d) [Reserved]

(e) [Reserved]

§ 53.1330 Control of licensing basis information in program descriptions.

Program documents are included in licensing basis information to describe programmatic contributions to meeting the requirements in Subpart B and to describe measures taken to ensure compliance with specific NRC regulations. §§ 53.1332 through 53.1333 define the process for a licensee to evaluate changes to the program documents included in the licensing basis information submitted to the NRC and to modify such programs without NRC prior approval.

§ 53.1332 Updating program documents included in licensing This section provides the equivalent of UFSAR basis information. updates for key program documents. This iteration (a) Each holder of an operating license or combined license provides a uniform approach for program under this part must biennially or more frequently update the program documents, which correspond to the programs documents submitted as part of the applications to obtain or maintain required under Subpart F. The staff is interested in the license to assure that the information included in the documents stakeholder views on the benefits of a common contains the latest information developed. The submittals shall include approach versus the current practice of establishing the effects on the content of the program documents of: program-specific requirements for reporting and (1) changes made in the facility, procedures, licensees change control.

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 § 53.1321; (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 or other NRC regulations.

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

(2) The submittal shall include (i) a certification by a duly authorized officer of the licensee that either the information accurately 12

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 § 53.1321 but not previously submitted to the Commission.

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

§ 53.1333 Evaluating changes to programs included in licensing This iteration provides a uniform approach for basis information. program documents, which correspond to the (a) A licensee may make changes to the facility, procedures, or programs required under Subpart F. The staff is organizations or address changes to site environs as described in the interested in stakeholder views on the benefits of a program documents included in licensing basis information without possibly developing a common approach versus the obtaining prior NRC approval only if: current practice of establishing program-specific (1) A change to the technical specifications incorporated in the requirements for reporting and change control. Note license is not required, that this current iteration includes pointers in (a)(2)

(2) An exemption from an NRC regulation is not required, and (a)(3) that would allow program-specific change (3) The change conforms to program-specific requirements control criteria to be defined in other regulations or included in regulations or technical specifications, administrative section of technical specifications.

(4) The change meets all of the following criteria: Where needed, the staff is seeking stakeholder (i) Does not result in a change to the frequency or consequences views on the appropriate location and possible of an event sequence such that an event sequence previously deemed criteria for evaluating specific program documents.

not risk significant becomes risk significant by the analyses performed in accordance with § 53.450(e).

(ii) Does not result in a change to the frequency or consequences of an event sequence such that an event sequence deemed risk significant in accordance with § 53.450(e) has a decrease of 10 percent or more in the calculated margins to the event category evaluation criteria required to be established in accordance with

§ 53.450(e).

(iii) Does not result in a change to the frequency or consequences of one or more event sequences such that the margin between the calculated cumulative risks posed by the commercial nuclear plant and the safety criteria of § 53.220 decreases by 10 percent or more.

(iv) Does not involve a departure from a method of evaluation described in the FSAR (as updated) used in assessing margins in 13

accordance with § 53.450(e) unless the revised method of evaluation has been previously approved by the NRC or can be used in accordance with an NRC endorsed consensus code or standard.

(v) For commercial nuclear plants licensed under this part for which alternative evaluation criteria are applicable in accordance with

§ 53.470, the change does not result in a change to the frequency or consequences of event sequences such that the calculated margins between the results for event sequences evaluated in accordance with

§ 53.450(e) .and the alternative threshold values decreases by 25 percent or more.

(5) In implementing this paragraph, the program documents (as updated) are considered to include changes since submittal of the last updates of the program documents pursuant to § 53.1331.

(6) 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.

§ 53.1340 Transfer of licenses or permits. This section provides the equivalent of § 50.80 for (a) No commercial nuclear plant license or permit issued under the possible transfer of an early site permit, this part, or any right thereunder, shall be transferred, assigned, or in construction permit, operating license, or combined any manner disposed of, either voluntarily or involuntarily, directly or license.

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 or permit shall include:

(i) For a commercial nuclear plant license or permit issued under this part, as much of the information described in §§ 53.1130, 53.xxxx, and 53.yyyy of this part 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 or permit is requested, the nature of the transaction necessitating or making desirable the transfer of the license or permit, and an agreement to limit access to Restricted Data pursuant to 14

§ 53.1140. The Commission may require any person who submits an application for license or permit 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 or permit, if the Commission determines:

(1) That the proposed transferee is qualified to be the holder of the license or permit; and (2) That transfer of the license or permit is otherwise consistent with applicable provisions of law, regulations, and orders issued by the Commission pursuant thereto.

§ 53.1350 Termination of license. This section provides the equivalent of § 50.82 for (a) When a licensee for a commercial nuclear plant licensed the possible termination of an operating license or under this part has determined to permanently cease operations the combined license.

licensee shall, within 30 days, submit a written certification to the NRC, consistent with the requirements of Subpart G.

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

(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 10 CFR part 53 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.

(3) The Commission shall terminate the license if it determines that (i) The remaining dismantlement has been performed in 15

accordance with the approved license termination plan required in Subpart G, 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 10 CFR part 20, subpart E.

§ 53.1360 Information requests. This section provides the equivalent of § 50.54(f) for The holder of an early site permit, construction permit, operating a possible request for information that the NRC license, or combined license shall at any time before expiration of the would issue to holders of an early site permit, license, upon request of the Commission, submit, as specified in construction permit, operating license, or combined

§ 53.040 written statements, signed under oath or affirmation, to enable license.

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.

§ 53.1370 Revocation, suspension, modification of licenses, This section provides the equivalent of § 50.100 for permits, and approvals for cause. the possible revocation, suspension, or modification A license, permit, or standard design approval issued under this of a license or permit.

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, permit, 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 permit or license, provided, however, that failure to make timely completion of the proposed construction or alteration of a facility under a construction permit a combined license under this part shall be governed by the 16

provisions of § 53.12xx; or for violation of, or failure to observe, any of the terms and provisions of the act, regulations, license, permit, approval, or order of the Commission.

§ 53.1380 Backfitting. This section provides the equivalent of § 50.109 for (a)(1) Backfitting is defined as the modification of or addition to the possible backfitting of requirements to holders of systems, structures, components, or design of a facility; or the licenses or permits. This first iteration may require procedures or organization required to design, construct or operate a additional measures to fully capture all of the finality facility; any of which may result from a new or amended provision in the provisions within Subpart H and the staff expects to Commission's regulations or the imposition of a regulatory staff position update and clarify as additional sections of Subpart interpreting the Commission's regulations that is either new or different H are developed.

from a previously applicable staff position after the date of the 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 appropriated 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 17

level of protection to the public health and safety or common defense and security should be regarded as adequate.

(5) The Commission shall 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 shall 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) Statement of the specific objectives that the proposed backfit is designed to achieve; (2) General description of the activity that would be required by the licensee or applicant in order to complete the backfit; (3) Potential change in the risk to the public from the accidental off-site release of radioactive material; (4) Potential impact on radiological exposure of facility employees; (5) Installation and continuing costs associated with the backfit, including the cost of facility downtime or the cost of construction delay; 18

(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 designee.

§ 53.1390 Renewal (TBD) A section may be added to more fully describe or reference the processes related to requesting and processing applications to renew early site permits, construction permits, operating licenses, and combined licenses.

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