§ 53.1279 Contents of applications for manufacturing licenses; technical information.
(a) Final Safety Analysis Report-siting and design. The application must include an FSAR containing the information set forth below, with a level of design information sufficient to enable the Commission to judge the applicant's proposed means of ensuring that the manufacturing conforms to the design and to reach a final conclusion on all safety questions associated with the design, permit the preparation of construction and installation specifications by an applicant who seeks to use the manufactured reactor, and permit the preparation of acceptance and inspection requirements by the NRC. The application must include the following information:
(1) Site parameters. The site parameters postulated for the design under this part, including the design-basis external hazard levels for the relevant external hazards, and an analysis and evaluation of the design in terms of those site parameters.
(2) Design information. The design information equivalent to that required for a standard design certification as defined in § 53.1239(a)(2) through (27) for those portions of a commercial nuclear plant included in the manufactured reactor.
(3) Quality assurance program. A description of the QAP applied to the design, and to be applied to the fabrication and testing of the SSCs of the manufactured reactor under § 53.620(a)(6), including a discussion of how the applicable requirements of appendix B to part 50 of this chapter will be satisfied;
(4) Conceptual designs. Representative conceptual designs for one or more commercial nuclear plants using the manufactured reactor;
(5) Operating configurations. If multiple manufactured reactors may be installed at a commercial nuclear plant, a description of the possible operating configurations, including common systems, interface requirements, and system interactions. The final safety analysis must also account for differences among the possible configurations, including any restrictions that will be necessary during the construction and startup of a given manufactured reactor to ensure the safe operation of any commercial nuclear reactor already operating;
(6) Interface requirements. (i) The interface requirements between the manufactured reactor and the remaining portions of the commercial nuclear plant or connections to other facilities outside of the commercial nuclear plant.
(ii) Confirmation that interface requirements are verifiable through inspections, testing, or analysis. These requirements must be sufficiently detailed to allow for completion of the final safety analysis by license applicants that reference the manufactured reactor manufactured under this subpart. Applicants for a COL under this part will need to verify the interface requirements at the installation site. The method to be used for verification of interface requirements must be included as part of the proposed ITAAC required by § 53.1282(a).
(iii) Information to support development of radiation monitoring programs required under subpart F of this part by an applicant for a COL, including potential pathways for radionuclides produced within the manufactured reactor to enter interfacing systems.
(b) Final Safety Analysis Report—manufacturing information. The FSAR must include the following information related to the manufacturing processes, organization, controls, and inspections:
(1) A description, including references to generally accepted consensus codes and standards, of the processes that will be used to procure, fabricate, and assemble components that make up the manufactured reactor. The description should clearly define which activities are proposed to be within the scope of the ML and those, such as the making of a component to be procured from a separate company for installation in the manufactured reactor, that are not considered to be within the scope of the ML;
(2) A description of the organizational and management structure singularly responsible for direction of design and manufacture of the manufactured reactor. The information should include a description of the management plans, technical qualifications, and controls in place to demonstrate compliance with the requirements of § 53.620;
(3) A description of the inspections and tests to be performed as part of the manufacturing process, including the inspection of procured components, inspection and testing of fabrication processes such as the molding, welding, or coating of components, and inspections and testing of the assembled manufactured reactor or portions of the manufactured reactor;
(4) A description of the fitness-for-duty program required by part 26 of this chapter and its implementation.
(c) Final Safety Analysis Report—deployment of the completed manufactured reactor. The application must include a description of the following information related to the deployment of a manufactured reactor:
(1) Procedures governing the preparation of the manufactured reactor or portions of the manufactured reactor for shipping to the site where it is to be operated; the conduct of shipping; and verifying the condition of the shipped items upon receipt at the site;
(2) Details of the interaction of the design, manufacture, and installation of a manufactured reactor within the applicant's organization and the manner by which the applicant will ensure close integration between the designer, contractors, and any facility in which the manufactured reactor is to be installed;
(3) Measures to be used for the control of interfaces, including the consideration of key site parameters, between the holder of the ML and the holder of the COL or CP for the commercial nuclear plant at which the manufactured reactor is to be installed.
(d) Final Safety Analysis Report—special considerations for factory fueling. In addition to the above paragraphs (a) through (c) of this section, an application for an ML for a manufactured reactor that will be fueled at the factory under a 10 CFR part 70 license must include the following information related to loading fuel and the required features to prevent criticality and to otherwise provide assurance that the fueled manufactured reactor can be successfully transported, installed, and operated at a site for which the Commission has issued a COL or a CP and OL that authorizes construction and operation of a commercial nuclear plant using the manufactured reactor:
(1) A description of the procedures used during the fueling of the manufactured reactor that ensure that the configuration of fuel within the fueled manufactured reactor is consistent with the design and analyses supporting operation of the manufactured reactor under the COL or OL at the place of operation. The description may reference the applicable 10 CFR part 70 application and other sections of the Safety Analysis Report supporting the ML license application.
(i) The application must describe the measures taken for in-factory inspections and non-nuclear testing performed to ensure that the configuration of fuel within the fueled manufactured reactor is consistent with the design and analyses supporting operation of the manufactured reactor under the COL or OL at the place of operation.
(ii) The application must describe the design features included in the manufactured reactor to prevent criticality, the associated functional design criteria applied to those design features, and the physical and programmatic controls implemented during manufacturing, storage, and transport that are credited to assure the features function as designed when subject to potential hazards and human errors. The descriptions must include how those measures will be controlled during installation under the ML and removal under the COL or OL at the place of operation.
(2) A description of the procedures governing the transfer of responsibilities for the fueled manufactured reactor from the holder of the ML to the holder of the COL or CP and OL for the installation site.
(3) If available at the time of filing the ML application or, if not available at the time of filing the ML application, submitted as an amendment to the ML or ML application at the time of filing the Part 70 application, a description of the programs needed to demonstrate compliance with the requirements of § 53.620(d) and 10 CFR parts 70, 71, and 73 for the receipt, storage, and loading of SNM into a manufactured reactor and the transport of the fueled manufactured reactor to a site for which the Commission has issued a COL or CP and OL that authorizes construction and operation of a commercial nuclear plant using the manufactured reactor, including the following.
(i) A physical security program in accordance with § 53.620(d)(2)(i).
(ii) A cybersecurity program in accordance with § 53.620(d)(2)(i).