§ 53.1416 Contents of applications for combined licenses; technical information.
(a) The application must contain an FSAR that describes the facility and the limits on its operation and presents a safety analysis of the SSCs of the facility as a whole. The Commission will require, before issuance of a COL, that information normally contained in engineering documents, such as analyses, drawings, procurement specifications, or construction and installation specifications, be completed and available for audit if the more detailed information is necessary for the Commission to verify the information in the application and make its safety determination. The FSAR must include the following information, at a level of detail sufficient to enable the Commission to reach a final conclusion on all safety matters that must be resolved by the Commission before issuance of a COL:
(1) Site information. An application for a COL for a commercial nuclear reactor must include the site information required for an early site permit in § 53.1146(a)(1)(iv) through (x).
(2) Design information. An application for a COL for a commercial nuclear plant must include the design information equivalent to that required for a standard design certification as defined in § 53.1239(a)(2) through (7), (a)(9), (a)(11), (a)(12), (a)(14) through (21), and (a)(23).
(3) Technical qualifications. A description of the technical qualifications of the applicant to engage in the proposed activities in accordance with the regulations in this chapter.
(4) Integrity assessment program. A description of an Integrity Assessment Program that addresses the elements described in § 53.870.
(5) Safeguards information. A description of the program to protect Safeguards Information against unauthorized disclosure in accordance with the requirements in §§ 73.21 and 73.22 of this chapter, as applicable.
(6) Emergency response facility or facilities. Description of the locations and capabilities to be established for command and control, support, and coordination of onsite and offsite, as applicable, functions during reactor accident conditions.
(7) Role of personnel. (i) A description of the completed assessments related to the role of personnel in ensuring safe operations considering the analyses required by § 53.730. These assessments must include the following:
(A) Human factors engineering design requirements of § 53.730(a);
(B) Human system interface design requirements of § 53.730(b);
(C) Concept of operations of § 53.730(c); and
(D) Functional requirements analysis and function allocation of § 53.730(d);
(ii) A description of the program to be used for evaluating and applying operating experience as required by § 53.730(e);
(iii) A staffing plan and supporting analyses as required by § 53.730(f).
(8) Training, examination, and proficiency programs. (i) A description of the training, examination, and proficiency programs required by § 53.730(g); and
(ii) A description of the training programs required by § 53.830.
(9) Emergency plan. Emergency plans complying with the requirements of § 53.855.
(i) The emergency plan must include, as applicable, all emergency plan certifications that have been obtained from the State, local, and participating Tribal governmental agencies with emergency planning responsibilities. The certifications must state that—
(A) The proposed emergency plans are practicable;
(B) These agencies are committed to participating in any further development of the plans, including any required field demonstrations; and
(C) These agencies are committed to executing their responsibilities under the plans in the event of an emergency.
(ii) If certifications cannot be obtained after sustained, good faith efforts by the applicant, then the application must contain information, including a utility plan, sufficient to show that the proposed plans provide reasonable assurance that adequate protective measures can and will be taken in the event of a radiological emergency at the site.
(10) Organization. A description of the applicant's organizational structure, allocations of responsibilities and authorities, and personnel qualifications requirements for operation.
(11) Maintenance program. A description of a maintenance program under § 53.715.
(12) Quality assurance. A description of the QAP under § 53.865.
(13) Radiation protection program. A radiation protection program description under § 53.850.
(14) Security program. A physical security plan that describes how the applicant will comply with § 53.860 (and 10 CFR part 11, if applicable, including the identification and description of jobs as required by § 11.11(a) of this chapter, at the proposed facility). The plan must list tests, inspections, audits, and other means to be used to demonstrate compliance with the requirements of 10 CFR parts 11 and 73, if applicable.
(15) Safeguards contingency plan. A safeguards contingency plan in accordance with the criteria set forth in appendix C to 10 CFR part 73. The safeguards contingency plan must include plans for dealing with threats, thefts, and radiological sabotage, as defined in 10 CFR part 73, relating to the SNM and nuclear facilities licensed under this chapter and in the applicant's possession and control. Each application for this type of license must include the information contained in the applicant's safeguards contingency plan.
1
(Implementing procedures required for this plan need not be submitted for approval.)
1 A physical security plan that contains all the information required in both § 73.55 or § 73.100 of this chapter and appendix C to 10 CFR part 73 demonstrates compliance with the requirement for a contingency plan.
(16) Security training and qualification. A training and qualification plan that describes how the applicant will demonstrate compliance with the criteria set forth in § 73.100 of this chapter or appendix B to 10 CFR part 73.
(17) Cybersecurity plan. A cybersecurity plan in accordance with the criteria set forth in § 73.54 or § 73.110 of this chapter.
(18) Security, safeguards, and cybersecurity plan implementation. A description of the implementation of the physical security plan, safeguards contingency plan, training and qualification plan, and cybersecurity plan. Each applicant who prepares a physical security plan, a safeguards contingency plan, a training and qualification plan, or a cybersecurity plan must protect the plans and other related Safeguards Information against unauthorized disclosure in accordance with the requirements of §§ 73.21 and 73.22 of this chapter.
(19) Fire protection program. A description of the fire protection program under § 53.875.
(20) Inservice inspection/inservice testing program. Descriptions of inservice inspection and inservice testing programs under § 53.880.
(21)-(22) [Reserved]
(23) General employee training. A description of the training program required to demonstrate compliance with § 53.830 and its implementation.
(24) Fitness-for-duty program. A description of the FFD program under part 26 of this chapter and its implementation.
(25) Technical specifications. Proposed technical specifications prepared in accordance with the requirements of § 53.710(a).
(b) If there are SSCs of the plant for which research and development is necessary to confirm the adequacy of their design, a report which documents the resolution of any safety questions associated with such SSCs.
(c) A description of how the performance of each safety design feature has been demonstrated capable of fulfilling functional design criteria considering interdependent effects through either analysis, appropriate test programs, prototype testing, operating experience, or a combination thereof, in accordance with § 53.440(a).
(d) If the COL application references an early site permit, then the following requirements apply:
(1) The FSAR need not contain information or analyses submitted to the Commission in connection with the early site permit provided that the FSAR must either include or incorporate by reference the early site permit Site Safety Analysis Report and contain, in addition to the information and analyses otherwise required, information sufficient to demonstrate that the design of the facility falls within the site characteristics and design parameters specified in the early site permit.
(2) If the FSAR does not demonstrate that design of the facility falls within the site characteristics and design parameters, the application must include a request for a variance that complies with the requirements of §§ 53.1188(d) and 53.1437.
(3) The FSAR must demonstrate that all terms and conditions that have been included in the early site permit will be satisfied by the date of issuance of the COL. Any terms or conditions of the early site permit that could not be met by the time of issuance of the COL must be set forth as terms or conditions of the COL.
(4) If the early site permit approves complete and integrated emergency plans, or major features of emergency plans, then the FSAR must include any new or additional information that updates and corrects the information that was provided under § 53.1146(b)(2) and discuss whether the new or additional information materially changes the bases for compliance with the applicable requirements. The application must identify changes to the emergency plans or major features of emergency plans that have been incorporated into the proposed facility emergency plans and that constitute or would constitute a change in an emergency plan that results in reducing the licensee's capability to perform an emergency planning function in the event of a radiological emergency.
(5) If complete and integrated emergency plans are approved as part of the early site permit, new certifications meeting the requirements of paragraph (a)(9)(i) of this section are not required.
(e) If the COL application references a standard design approval, then the following requirements apply:
(1) The FSAR need not contain information or analyses submitted to the Commission in connection with the design approval, provided, however, that the FSAR must either include or incorporate by reference the standard design approval FSAR and must contain, in addition to the information and analyses otherwise required, information sufficient to demonstrate that the characteristics of the site fall within the site parameters specified in the design approval. In addition, the plant-specific information of the PRA, other SREs, or a combination thereof must use the information of the PRA, other SREs, or a combination thereof for the design approval and must be updated to account for site-specific design information and any design changes or departures.
(2) The FSAR must demonstrate that all terms and conditions that have been included in the design approval will be satisfied by the date of issuance of the COL.
(f) If the COL application references a standard design certification, then the following requirements apply:
(1) The FSAR need not contain information or analyses submitted to the Commission in connection with the standard design certification, provided, however, that the FSAR must either include or incorporate by reference the standard design certification FSAR and must contain, in addition to the information and analyses otherwise required, information sufficient to demonstrate that the site characteristics fall within the site parameters specified in the standard design certification. In addition, the plant-specific information of the PRA, other SREs, or a combination thereof must use the information of the PRA, other SREs, or a combination thereof for the standard design certification and must be updated to account for site-specific design information and any design changes or departures.
(2) The FSAR must demonstrate that the interface requirements established for the design under § 53.1239(a)(24) have been met.
(3) The FSAR must demonstrate that all requirements and restrictions set forth in the referenced standard design certification rule must be satisfied by the date of issuance of the COL. Any requirements and restrictions set forth in the referenced standard design certification rule that could not be satisfied by the time of issuance of the COL, must be set forth as terms or conditions of the COL.
(g) If the COL application references the use of one or more manufactured reactors licensed under § 53.1270, then the following requirements apply:
(1) The FSAR need not contain information or analyses submitted to the Commission in connection with the ML, provided, however, that the FSAR must either include or incorporate by reference the ML FSAR and must contain, in addition to the information and analyses otherwise required, information sufficient to demonstrate that the site characteristics fall within the site parameters specified in the ML. In addition, the plant-specific information of the PRA, other SREs, or a combination thereof must use the information of the PRA, other SREs, or a combination thereof for the manufactured reactor and must be updated to account for site-specific design information and any design changes or departures.
(2) The FSAR must demonstrate that the interface requirements established for the design have been met.
(3) The FSAR must demonstrate that all terms and conditions that have been included in the ML will be satisfied by the date of issuance of the COL. Any terms or conditions of the ML that could not be met by the time of issuance of the COL, must be set forth as terms or conditions of the COL.
(h) Each applicant for a COL under this part must protect Safeguards Information against unauthorized disclosure in accordance with the requirements in §§ 73.21 and 73.22 of this chapter, as applicable.