10 C.F.R. Subpart H—Additional Requirements for Certain Licensees Authorized To Possess a Critical Mass of Special Nuclear Material
Title 10 - Energy
Source: 65 FR 56226, Sept. 18, 2000, unless otherwise noted.
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 applicant or licensee shall evaluate, in the integrated safety analysis performed in accordance with §70.62, its compliance with the performance requirements in paragraphs (b), (c), and (d) of this section. (b) The risk of each credible high-consequence event must be limited. Engineered controls, administrative controls, or both, shall be applied to the extent needed to reduce the likelihood of occurrence of the event so that, upon implementation of such controls, the event is highly unlikely or its consequences are less severe than those in paragrahs (b)(1)–(4) of this section. High consequence events are those internally or externally initiated events that result in: (1) An acute worker dose of 1 Sv (100 rem) or greater total effective dose equivalent; (2) An acute dose of 0.25 Sv (25 rem) or greater total effective dose equivalent to any individual located outside the controlled area identified pursuant to paragraph (f) of this section; (3) An intake of 30 mg or greater of uranium in soluble form by any individual located outside the controlled area identified pursuant to paragraph (f) of this section; or (4) An acute chemical exposure to an individual from licensed material or hazardous chemicals produced from licensed material that: (i) Could endanger the life of a worker, or (ii) Could lead to irreversible or other serious, long-lasting health effects to any individual located outside the controlled area identified pursuant to paragraph (f) of this section. If an applicant possesses or plans to possess quantities of material capable of such chemical exposures, then the applicant shall propose appropriate quantitative standards for these health effects, as part of the information submitted pursuant to §70.65 of this subpart. (c) The risk of each credible intermediate-consequence event must be limited. Engineered controls, administrative controls, or both shall be applied to the extent needed so that, upon implementation of such controls, the event is unlikely or its consequences are less than those in paragraphs (c)(1)–(4) of this section. Intermediate consequence events are those internally or externally initiated events that are not high consequence events, that result in: (1) An acute worker dose of 0.25 Sv (25 rem) or greater total effective dose equivalent; (2) An acute dose of 0.05 Sv (5 rem) or greater total effective dose equivalent to any individual located outside the controlled area identified pursuant to paragraph (f) of this section; (3) A 24-hour averaged release of radioactive material outside the restricted area in concentrations exceeding 5000 times the values in Table 2 of Appendix B to Part 20; or (4) An acute chemical exposure to an individual from licensed material or hazardous chemicals produced from licensed material that: (i) Could lead to irreversible or other serious, long-lasting health effects to a worker, or (ii) Could cause mild transient health effects to any individual located outside the controlled area as specified in paragraph (f) of this section. If an applicant possesses or plans to possess quantities of material capable of such chemical exposures, then the applicant shall propose appropriate quantitative standards for these health effects, as part of the information submitted pursuant to §70.65 of this subpart. (d) In addition to complying with paragraphs (b) and (c) of this section, the risk of nuclear criticality accidents must be limited by assuring that under normal and credible abnormal conditions, all nuclear processes are subcritical, including use of an approved margin of subcriticality for safety. Preventive controls and measures must be the primary means of protection against nuclear criticality accidents. (e) Each engineered or administrative control or control system necessary to comply with paragraphs (b), (c), or (d) of this section shall be designated as an item relied on for safety. The safety program, established and maintained pursuant to §70.62 of this subpart, shall ensure that each item relied on for safety will be available and reliable to perform its intended function when needed and in the context of the performance requirements of this section. (f) Each licensee must establish a controlled area, as defined in §20.1003. In addition, the licensee must retain the authority to exclude or remove personnel and property from the area. For the purpose of complying with the performance requirements of this section, individuals who are not workers, as defined in §70.4, may be permitted to perform ongoing activities (e.g., at a facility not related to the licensed activities) in the controlled area, if the licensee: (1) Demonstrates and documents, in the integrated safety analysis, that the risk for those individuals at the location of their activities does not exceed the performance requirements of paragraphs (b)(2), (b)(3), (b)(4)(ii), (c)(2), and (c)(4)(ii) of this section; or (2) Provides training that satisfies 10 CFR 19.12(a)(1)–(5) to these individuals and ensures that they are aware of the risks associated with accidents involving the licensed activities as determined by the integrated safety analysis, and conspicuously posts and maintains notices stating where the information in 10 CFR 19.11(a) may be examined by these individuals. Under these conditions, the performance requirements for workers specified in paragraphs (b) and (c) of this section may be applied to these individuals. (a) Safety program. (1) Each licensee or applicant shall establish and maintain a safety program that demonstrates compliance with the performance requirements of §70.61. The safety program may be graded such that management measures applied are graded commensurate with the reduction of the risk attributable to that item. Three elements of this safety program; namely, process safety information, integrated safety analysis, and management measures, are described in paragraphs (b) through (d) of this section. (2) Each licensee or applicant shall establish and maintain records that demonstrate compliance with the requirements of paragraphs (b) through (d) of this section. (3) Each licensee or applicant shall maintain records of failures readily retrievable and available for NRC inspection, documenting each discovery that an item relied on for safety or management measure has failed to perform its function upon demand or has degraded such that the performance requirements of §70.61 are not satisfied. These records must identify the item relied on for safety or management measure that has failed and the safety function affected, the date of discovery, date (or estimated date) of the failure, duration (or estimated duration) of the time that the item was unable to perform its function, any other affected items relied on for safety or management measures and their safety function, affected processes, cause of the failure, whether the failure was in the context of the performance requirements or upon demand or both, and any corrective or compensatory action that was taken. A failure must be recorded at the time of discovery and the record of that failure updated promptly upon the conclusion of each failure investigation of an item relied on for safety or management measure. (b) Process safety information. Each licensee or applicant shall maintain process safety information to enable the performance and maintenance of an integrated safety analysis. This process safety information must include information pertaining to the hazards of the materials used or produced in the process, information pertaining to the technology of the process, and information pertaining to the equipment in the process. (c) Integrated safety analysis. (1) Each licensee or applicant shall conduct and maintain an integrated safety analysis, that is of appropriate detail for the complexity of the process, that identifies: (i) Radiological hazards related to possessing or processing licensed material at its facility; (ii) Chemical hazards of licensed material and hazardous chemicals produced from licensed material; (iii) Facility hazards that could affect the safety of licensed materials and thus present an increased radiological risk; (iv) Potential accident sequences caused by process deviations or other events internal to the facility and credible external events, including natural phenomena; (v) The consequence and the likelihood of occurrence of each potential accident sequence identified pursuant to paragraph (c)(1)(iv) of this section, and the methods used to determine the consequences and likelihoods; and (vi) Each item relied on for safety identified pursuant to §70.61(e) of this subpart, the characteristics of its preventive, mitigative, or other safety function, and the assumptions and conditions under which the item is relied upon to support compliance with the performance requirements of §70.61. (2) Integrated safety analysis team qualifications. To assure the adequacy of the integrated safety analysis, the analysis must be performed by a team with expertise in engineering and process operations. The team shall include at least one person who has experience and knowledge specific to each process being evaluated, and persons who have experience in nuclear criticality safety, radiation safety, fire safety, and chemical process safety. One member of the team must be knowledgeable in the specific integrated safety analysis methodology being used. (3) Requirements for existing licensees. Individuals holding an NRC license on September 18, 2000 shall, with regard to existing licensed activities: (i) By April 18, 2001, submit for NRC approval, a plan that describes the integrated safety analysis approach that will be used, the processes that will be analyzed, and the schedule for completing the analysis of each process. (ii) By October 18, 2004, or in accordance with the approved plan submitted under §70.62(c)(3)(i), complete an integrated safety analysis, correct all unacceptable performance deficiencies, and submit, for NRC approval, an integrated safety analysis summary, including a description of the management measures, in accordance with §70.65. The Commission may approve a request for an alternative schedule for completing the correction of unacceptable performance deficiencies if the Commission determines that the alternative is warranted by consideration of the following: (A) Adequate compensatory measures have been established; (B) Whether it is technically feasible to complete the correction of the unacceptable performance deficiency within the allotted 4-year period; (C) Other site-specific factors which the Commission may consider appropriate on a case-by-case basis and that are beyond the control of the licensee. (iii) Pending the correction of unacceptable performance deficiencies identified during the conduct of the integrated safety analysis, the licensee shall implement appropriate compensatory measures to ensure adequate protection. (d) Management measures. Each applicant or licensee shall establish management measures to ensure compliance with the performance requirements of §70.61. The measures applied to a particular engineered or administrative control or control system may be graded commensurate with the reduction of the risk attributable to that control or control system. The management measures shall ensure that engineered and administrative controls and control systems that are identified as items relied on for safety pursuant to §70.61(e) of this subpart are designed, implemented, and maintained, as necessary, to ensure they are available and reliable to perform their function when needed, to comply with the performance requirements of §70.61 of this subpart. (a) Baseline design criteria. 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) Quality standards and records. 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) Natural phenomena hazards. The design must provide for adequate protection against natural phenomena with consideration of the most severe documented historical events for the site. (3) Fire protection. The design must provide for adequate protection against fires and explosions. (4) Environmental and dynamic effects. 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) Chemical protection. 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) Emergency capability. 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 (iii) Onsite emergency facilities and services that facilitate the use of available offsite services. (7) Utility services. The design must provide for continued operation of essential utility services. (8) Inspection, testing, and maintenance. 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) Criticality control. The design must provide for criticality control including adherence to the double contingency principle. (10) Instrumentation and controls. The design must provide for inclusion of instrumentation and control systems to monitor and control the behavior of items relied on for safety. (b) Facility and system design and facility layout must be based on defense-in-depth practices.1 1 As used in §70.64, Requirements for new facilities or new processes at existing facilities, defense-in-depth practices means a design philosophy, applied from the outset and through completion of the design, that is based on providing successive levels of protection such that health and safety will not be wholly dependent upon any single element of the design, construction, maintenance, or operation of the facility. The net effect of incorporating defense-in-depth practices is a conservatively designed facility and system that will exhibit greater tolerance to failures and external challenges. The risk insights obtained through performance of the integrated safety analysis can be then used to supplement the final design by focusing attention on the prevention and mitigation of the higher-risk potential accidents. (1) Preference for the selection of engineered controls over administrative controls to increase overall system reliability; and (2) Features that enhance safety by reducing challenges to items relied on for safety. (a) In addition to the contents required by §70.22, each application must include a description of the applicant's safety program established under §70.62. (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. (a) An application for a license from an applicant subject to subpart H will be approved if the Commission determines that the applicant has complied with the requirements of §§70.21, 70.22, 70.23, and 70.60 through 70.65. (b) Submittals by existing licensees in accordance with §70.62(c)(3)(i) will be approved if the Commission determines that: (1) The integrated safety analysis approach is in accordance with the requirements of §§70.61, 70.62(c)(1), and 70.62(c)(2); and (2) The schedule is in compliance with §70.62(c)(3)(ii). (c) Submittals by existing licensees in accordance with §70.62(c)(3)(ii) will be approved if the Commission determines that: (1) The requirements of §70.65(b) are satisfied; and (2) The performance requirements in §70.61 (b), (c) and (d) are satisfied, based on the information in the ISA Summary, together with other information submitted to NRC or available to NRC at the licensee's site. (a) The licensee shall establish a configuration management system to evaluate, implement, and track each change to the site, structures, processes, systems, equipment, components, computer programs, and activities of personnel. This system must be documented in written procedures and must assure that the following are addressed prior to implementing any change: (1) The technical basis for the change; (2) Impact of the change on safety and health or control of licensed material; (3) Modifications to existing operating procedures including any necessary training or retraining before operation; (4) Authorization requirements for the change; (5) For temporary changes, the approved duration (e.g., expiration date) of the change; and (6) The impacts or modifications to the integrated safety analysis, integrated safety analysis summary, or other safety program information, developed in accordance with §70.62. (b) Any change to site, structures, processes, systems, equipment, components, computer programs, and activities of personnel must be evaluated by the licensee as specified in paragraph (a) of this section, before the change is implemented. The evaluation of the change must determine, before the change is implemented, if an amendment to the license is required to be submitted in accordance with §70.34. (c) The licensee may make changes to the site, structures, processes, systems, equipment, components, computer programs, and activities of personnel, without prior Commission approval, if the change: (1) Does not: (i) Create new types of accident sequences that, unless mitigated or prevented, would exceed the performance requirements of §70.61 and that have not previously been described in the integrated safety analysis summary; or (ii) Use new processes, technologies, or control systems for which the licensee has no prior experience; (2) Does not remove, without at least an equivalent replacement of the safety function, an item relied on for safety that is listed in the integrated safety analysis summary; (3) Does not alter any item relied on for safety, listed in the integrated safety analysis summary, that is the sole item preventing or mitigating an accident sequence that exceeds the performance requirements of §70.61; and (4) Is not otherwise prohibited by this section, license condition, or order. (d)(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. (2) For changes that do not require pre-approval under §70.72, the licensee shall submit to NRC annually, within 30 days after the end of the calendar year during which the changes occurred, a brief summary of all changes to the records required by §70.62(a)(2) of this subpart. (3) For all changes that affect the integrated safety analysis summary, the licensee shall submit to NRC annually, within 30 days after the end of the calendar year during which the changes occurred, revised integrated safety analysis summary pages. (e) If a change covered by §70.72 is made, the affected on-site documentation must be updated promptly. (f) The licensee shall maintain records of changes to its facility carried out under this section. These records must include a written evaluation that provides the bases for the determination that the changes do not require prior Commission approval under paragraph (c) or (d) of this section. These records must be maintained until termination of the license. Applications for renewal of a license must be filed in accordance with §§2.109, 70.21, 70.22, 70.33, 70.38, and 70.65 of this chapter. Information contained in previous applications, statements, or reports filed with the Commission under the license may be incorporated by reference, provided that these references are clear and specific. (a) Reports to NRC Operations Center. (1) Each licensee shall report to the NRC Operations Center the events described in Appendix A to Part 70. (2) Reports must be made by a knowledgeable licensee representative and by any method that will ensure compliance with the required time period for reporting. (3) The information provided must include a description of the event and other related information as described in §70.50(c)(1). (4) Follow-up information to the reports must be provided until all information required to be reported in §70.50(c)(1) of this subpart is complete. (5) Each licensee shall provide reasonable assurance that reliable communication with the NRC Operations Center is available during each event. (b) Written reports. Each licensee that makes a report required by paragraph (a)(1) of this section shall submit a written follow-up report within 30 days of the initial report. The written report must contain the information as described in §70.50(c)(2). (a) For each licensee, this provision shall apply to Subpart H requirements as soon as the NRC approves that licensee's ISA Summary pursuant to §70.66. For requirements other than Subpart H, this provision applies regardless of the status of the approval of a licensee's ISA Summary. (1) Backfitting is defined as the modification of, or addition to, systems, structures, or components of a facility; or to the procedures or organization required to operate a facility; any of which may result from a new or amended provision in the Commission rules or the imposition of a regulatory staff position interpreting the Commission rules that is either new or different from a previous NRC staff position. (2) Except as provided in paragraph (a)(4) of this section, the Commission shall require a systematic and documented analysis pursuant to paragraph (b) of this section for backfits which it seeks to impose. (3) Except as provided in paragraph (a)(4) of this section, the Commission shall require the backfitting of a facility only when it determines, based on the analysis described in paragraph (b) of this section, that there is a substantial increase in the overall protection of the public health and safety or the common defense and security to be derived from the backfit and that the direct and indirect costs of implementation for that facility are justified in view of this increased protection. (4) The provisions of paragraphs (a)(2) and (a)(3) of this section are inapplicable and, therefore, backfit analysis is not required and the standards in paragraph (a)(3) of this section do not apply where the Commission finds and declares, with appropriately documented evaluation for its finding, any of the following: (i) That a modification is necessary to bring a facility into compliance with Subpart H of this part; (ii) That a modification is necessary to bring a facility into compliance with a license or the rules or orders of the Commission, or into conformance with written commitments by the licensee; (iii) That regulatory action is necessary to ensure that the facility provides adequate protection to the health and safety of the public and is in accord with the common defense and security; or (iv) That the regulatory action involves defining or redefining what level of protection to the public health and safety or common defense and security should be regarded as adequate. (5) The Commission shall always require the backfitting of a facility if it determines that the regulatory action is necessary to ensure that the facility provides adequate protection to the health and safety of the public and is in accord with the common defense and security. (6) The documented evaluation required by paragraph (a)(4) of this section must include a statement of the objectives of and reasons for the modification and the basis for invoking the exception. If immediate effective regulatory action is required, then the documented evaluation may follow, rather than precede, the regulatory action. (7) If there are two or more ways to achieve compliance with a license or the rules or orders of the Commission, or with written license commitments, or there are two or more ways to reach an adequate level of protection, then ordinarily the licensee is free to choose the way that best suits its purposes. However, should it be necessary or appropriate for the Commission to prescribe a specific way to comply with its requirements or to achieve adequate protection, then cost may be a factor in selecting the way, provided that the objective of compliance or adequate protection is met. (b) In reaching the determination required by paragraph (a)(3) of this section, the Commission will consider how the backfit should be scheduled in light of other ongoing regulatory activities at the facility and, in addition, will consider information available concerning any of the following factors as may be appropriate and any other information relevant and material to the proposed backfit: (1) Statement of the specific objectives that the proposed backfit is designed to achieve; (2) General description of the activity that would be required by the licensee in order to complete the backfit; (3) Potential change in the risk to the public from the accidental release of radioactive material and hazardous chemicals produced from licensed material; (4) Potential impact on radiological exposure or exposure to hazardous chemicals produced from licensed material of facility employees; (5) Installation and continuing costs associated with the backfit, including the cost of facility downtime; (6) The potential safety impact of changes in facility or operational complexity, including the relationship to proposed and existing regulatory requirements; (7) The estimated resource burden on the NRC associated with the proposed backfit and the availability of such resources; (8) The potential impact of differences in facility type, design, or age on the relevancy and practicality of the proposed backfit; and (9) Whether the proposed backfit is interim or final and, if interim, the justification for imposing the proposed backfit on an interim basis. (c) No license will be withheld during the pendency of backfit analyses required by the Commission's rules. (d) The Executive Director for Operations shall be responsible for implementation of this section, and all analyses required by this section shall be approved by the Executive Director for Operations or his or her designee. [65 FR 56226, Sept. 18, 2000]
Title 10: Energy
PART 70—DOMESTIC LICENSING OF SPECIAL NUCLEAR MATERIAL
Subpart H—Additional Requirements for Certain Licensees Authorized To Possess a Critical Mass of Special Nuclear Material
§ 70.60 Applicability.
§ 70.61 Performance requirements.
§ 70.62 Safety program and integrated safety analysis.
§ 70.64 Requirements for new facilities or new processes at existing facilities.
§ 70.65 Additional content of applications.
§ 70.66 Additional requirements for approval of license application.
§ 70.72 Facility changes and change process.
§ 70.73 Renewal of licenses.
§ 70.74 Additional reporting requirements.
§ 70.76 Backfitting.
