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

§ 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.

(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.