---
kind: "range"
citation: "10 C.F.R. §§ 53.1545–53.1565"
title: "10"
from: "53.1545"
to: "53.1565"
count: 4
url: "https://uscodex.org/cfr/10/53.1545..53.1565"
---

# §53.1545. Updating Final Safety Analysis Reports.

- (a) Each holder of an OL or COL under this part for which the Commission has made the finding under [§ 53.1452(g)](/cfr/10/53.1452.md?p=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](/cfr/10/53.1550.md);
  - (3) Updates to the probabilistic risk assessment (PRA), other systematic risk evaluations, or a combination thereof required under [§ 53.450(a)](/cfr/10/53.450.md?p=a);
  - (4) The cumulative effects of the changes to the facility or procedures on the margins to the safety criteria in §§ [53.210](/cfr/10/53.210.md), [53.220](/cfr/10/53.220.md), and [53.450(e)](/cfr/10/53.450.md?p=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](/cfr/10/53.040.md), 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](/cfr/10/53.1550.md) 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)](/cfr/10/53.1452.md?p=g) must submit an update to the FSAR annually by providing the information required in [paragraphs (a)(1) through (a)(5)](#a-1..a-5) of this section and meeting the requirements of [paragraph (b)](#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-1), [(a)(3) through (a)(5)](#a-3..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](/cfr/10/53.1530.md).

# §53.1550. Evaluating changes to facility as described in Final Safety Analysis Reports.

- (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](/cfr/10/53.1510.md) 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)](/cfr/10/53.450.md?p=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)](/cfr/10/53.450.md?p=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)](/cfr/10/53.220.md?p=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](/cfr/10/53.220.md).
    - (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)](/cfr/10/53.450.md?p=f) unless the results of the analysis under [§ 53.450(f)](/cfr/10/53.450.md?p=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)](/cfr/10/53.450.md?p=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)](#a), the FSAR (as updated) is considered to include FSAR changes since submittal of the last update of the FSAR under [§ 53.1545](/cfr/10/53.1545.md).
  - (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](/cfr/10/53.1525.md) 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](/cfr/10/53.1545.md).
  - (3) Licensees for which the NRC has docketed the certifications required under [§ 53.1070](/cfr/10/53.1070.md) 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)](#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)](#a-2) of this section.
  - (2) The licensee must submit, as specified in [§ 53.040](/cfr/10/53.040.md), 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)](/cfr/10/53.1452.md?p=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](/cfr/10/53.1595.md)—whichever is later. Records of changes in procedures must be maintained for a period of 5 years.

# §53.1560. Updating program documents included in licensing-basis information.

- (a) Each holder under this part of an OL or COL for which the Commission has made the finding under [§ 53.1452(g)](/cfr/10/53.1452.md?p=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](/cfr/10/53.1550.md);
  - (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](/cfr/10/53.040.md), 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](/cfr/10/53.1550.md) but not previously submitted to the Commission.
- (c) The updated program documents must be retained by the licensee until the Commission terminates their license.

# §53.1565. Evaluating changes to programs included in licensing-basis information.

- (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](/cfr/10/53.1560.md).
- (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)](/cfr/10/53.1452.md?p=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](/cfr/10/53.1545.md). 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](/cfr/10/53.040.md).
      - (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](/cfr/10/part50.md) 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)](/cfr/10/53.1452.md?p=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](/cfr/10/53.040.md). Changes made to NRC-accepted QA topical report descriptions must be submitted as specified in [§ 53.040](/cfr/10/53.040.md).
    - (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](/cfr/10/part50.md) 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)](#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)](#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)](/cfr/10/53.1452.md?p=g), must follow and maintain the effectiveness of an emergency plan that meets the requirements in appendix E to [part 50](/cfr/10/part50.md) of this chapter and the planning standards of [§ 50.47(b)](/cfr/10/50.47.md?p=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)](/cfr/10/53.1452.md?p=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](/cfr/10/50.160.md) or an emergency plan that meets the requirements in appendix E to [part 50](/cfr/10/part50.md) of this chapter and the planning standards of [§ 50.47(b)](/cfr/10/50.47.md?p=b).
    - (iii)
      - (A) Except as provided in [paragraph (d)(3)(iii)(B)](#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](/cfr/10/part50.md) of this chapter and the planning standards of [§ 50.47(b)](/cfr/10/50.47.md?p=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](/cfr/10/50.160.md) or the requirements in appendix E to [part 50](/cfr/10/part50.md) and the planning standards of [§ 50.47(b)](/cfr/10/50.47.md?p=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)](#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](/cfr/10/53.1510.md) and [53.1515](/cfr/10/53.1515.md), 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](/cfr/10/50.160.md) to this chapter or the requirements in appendix E to [part 50](/cfr/10/part50.md) of this chapter and the planning standards of [§ 50.47(b)](/cfr/10/50.47.md?p=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](/cfr/10/53.040.md), 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)](#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](/cfr/10/part73.md) 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](/cfr/10/subpartH.md) or [part 73](/cfr/10/part73.md) 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](/cfr/10/subpartH.md) or [part 73](/cfr/10/part73.md) 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](/cfr/10/53.1510.md), [53.1515](/cfr/10/53.1515.md), and [53.1520](/cfr/10/53.1520.md).
    - (ii) The licensee may make changes to the plans referenced in [paragraph (d)(4)(i)](#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](/cfr/10/53.040.md), 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](/cfr/10/part73.md) 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.