§70.72. Facility changes and change process. — Inbound Citations

The regulations in § 70.61 through § 70.76 apply, in addition to other applicable Commission regulations, to each applicant or licensee that is or plans to be authorized to possess greater than a critical mass of special nuclear material, and engaged in enriched uranium processing, fabrication of uranium fuel or fuel assemblies, uranium enrichment, enriched uranium hexafluoride conversion, plutonium processing, fabrication of mixed-oxide fuel or fuel assemblies, scrap recovery of special nuclear material, or any other activity that the Commission determines could significantly affect public health and safety. The regulations in §§ 70.61 through 70.76 do not apply to decommissioning activities performed pursuant to other applicable Commission regulations including §§ 70.25 and 70.38 of this part. Also, the regulations in §§ 70.61 through 70.76 do not apply to activities that are certified by the Commission pursuant to part 76 of this chapter or licensed by the Commission pursuant to other parts of this chapter. Unless specifically addressed in §§ 70.61 through 70.76, implementation by current licensees of the subpart H requirements shall be completed no later than the time of the ISA Summary submittal required in § 70.62(c)(3)(ii).

(a) Each prospective applicant or licensee shall address the following baseline design criteria in the design of new facilities. Each existing licensee shall address the following baseline design criteria in the design of new processes at existing facilities that require a license amendment under § 70.72. The baseline design criteria must be applied to the design of new facilities and new processes, but do not require retrofits to existing facilities or existing processes (e.g., those housing or adjacent to the new process); however, all facilities and processes must comply with the performance requirements in § 70.61. Licensees shall maintain the application of these criteria unless the analysis performed pursuant to § 70.62(c) demonstrates that a given item is not relied on for safety or does not require adherence to the specified criteria.

(1) The design must be developed and implemented in accordance with management measures, to provide adequate assurance that items relied on for safety will be available and reliable to perform their function when needed. Appropriate records of these items must be maintained by or under the control of the licensee throughout the life of the facility.

(2) The design must provide for adequate protection against natural phenomena with consideration of the most severe documented historical events for the site.

(3) The design must provide for adequate protection against fires and explosions.

(4) The design must provide for adequate protection from environmental conditions and dynamic effects associated with normal operations, maintenance, testing, and postulated accidents that could lead to loss of safety functions.

(5) The design must provide for adequate protection against chemical risks produced from licensed material, facility conditions which affect the safety of licensed material, and hazardous chemicals produced from licensed material.

(6) The design must provide for emergency capability to maintain control of:

(i) Licensed material and hazardous chemicals produced from licensed material;

(ii) Evacuation of on-site personnel; and

(7) The design must provide for continued operation of essential utility services.

(8) The design of items relied on for safety must provide for adequate inspection, testing, and maintenance, to ensure their availability and reliability to perform their function when needed.

(9) The design must provide for criticality control including adherence to the double contingency principle.

(10) The design must provide for inclusion of instrumentation and control systems to monitor and control the behavior of items relied on for safety.

(b) The integrated safety analysis summary must be submitted with the license or renewal application (and amendment application as necessary), but shall not be incorporated in the license. However, changes to the integrated safety analysis summary shall meet the conditions of § 70.72. The integrated safety analysis summary must contain:

(1) A general description of the site with emphasis on those factors that could affect safety (i.e., meteorology, seismology);

(2) A general description of the facility with emphasis on those areas that could affect safety, including an identification of the controlled area boundaries;

(3) A description of each process (defined as a single reasonably simple integrated unit operation within an overall production line) analyzed in the integrated safety analysis in sufficient detail to understand the theory of operation; and, for each process, the hazards that were identified in the integrated safety analysis pursuant to § 70.62(c)(1)(i)-(iii) and a general description of the types of accident sequences;

(4) Information that demonstrates the licensee's compliance with the performance requirements of § 70.61, including a description of the management measures; the requirements for criticality monitoring and alarms in § 70.24; and, if applicable, the requirements of § 70.64;

(5) A description of the team, qualifications, and the methods used to perform the integrated safety analysis;

(6) A list briefly describing each item relied on for safety which is identified pursuant to § 70.61(e) in sufficient detail to understand their functions in relation to the performance requirements of § 70.61;

(7) A description of the proposed quantitative standards used to assess the consequences to an individual from acute chemical exposure to licensed material or chemicals produced from licensed materials which are on-site, or expected to be on-site as described in § 70.61(b)(4) and (c)(4);

(8) A descriptive list that identifies all items relied on for safety that are the sole item preventing or mitigating an accident sequence that exceeds the performance requirements of § 70.61; and

(9) A description of the definitions of unlikely, highly unlikely, and credible as used in the evaluations in the integrated safety analysis.

(1) For changes that require pre-approval under § 70.72, the licensee shall submit an amendment request to the NRC in accordance with §§ 70.34 and 70.65 of this chapter.

(b) The approved information collection requirements contained in this part appear in §§ 70.9, 70.17, 70.19, 70.20a, 70.20b, 70.21, 70.22, 70.24, 70.25, 70.32, 70.33, 70.34, 70.38, 70.39, 70.42, 70.50, 70.51, 70.52, 70.59, 70.61, 70.62, 70.64, 70.65, 70.72, 70.73, 70.74, and appendix A.