(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.