1. School for drafting regulations Nuclear Safety Combined licensing approach Vienna, 2-7 December 2012 Tea Bilic Zabric

2. Introduction NPPs were licensed in USA under the two-step licensing process, requiring both a construction permit and an operating license from the NRC. In 1989, the NRC established an alternative licensing process under 10 CFR Part 52 that essentially combines a construction permit and an operating license, with certain conditions, into a single license

3. Introduction With attention directed to reforms needed in the NRC and the industry in the wake of the Three Mile Island accident, there was pursuant in licensing reform and standardisation. Two major studies of the TMI accident severely criticised the NRC’s approach to plant licensing and recommended a greater encouragement of, if not mandatory, standardisation and a change to one-step licensing of any new plants.

4. Introduction A Regulatory Reform Task Force was established and published for public comment in late 1981 to explore legislative and internal reforms of NRC’s licensing process. The Department of Energy submitted its own legislative proposal on behalf of the state Administration.

5. Introduction Both bills contained the major aspects of the licensing process embodied in Part 52: combined licences, certified designs and site permits. Although hearings were held on this legislation, the bills never passed the Congress. The experience was repeated in 1985 and 1987. but no serious effort to enact the legislation

6. Introduction By 1987, the NRC decided to pursue both a legislative and an administrative approach to encouraging standardisation and reforming its licensing process. NRC stated in a revised Policy Statement on standardisation that much of its legislative proposal could be accomplished under the NRC’s existing statutory authority and that it would develop proposed regulations to address licensing reform and standardisation.

7. Introduction Updating of the rule was accomplished in 2007 to clarify the interrelationship among design certifications, early site permits and combined licences as well as to the relationship between the technical criteria and requirements in 10 C.F.R. Part 50 applicable to nuclear plants and the procedural requirements in Part 52.

8. Introduction The revised rule was also intended to lay out in greater detail the licensing and hearing process associated with NRC findings on inspections, tests, analyses and acceptance criteria (ITAAC). These changes were directed at ensuring that the NRC’s adjudication of contentions on ITAAC findings would not unnecessarily delay the licensee’s scheduled plans for fuel loading and operation.

9. Combined Licence process The combined license process is based on an early approval of sites and on the certification of standardized plant design in advance of the license application The application for a combined license can incorporate by reference the early site permit and the design certification

10. Combined Licence process

11. Early site permit An early site permit resolves site safety, environmental protection, and emergency preparedness issues independent of a specific nuclear plant design. The early site permit application must address the safety and environmental characteristics of the site and evaluate potential physical impediments to developing an acceptable emergency plan.

12. Early site permit Site safety: site boundaries; seismic, meteorological, hydraulic, and geologic data; location and description of any industrial, military, or transportation facilities and routes; existing and projected future population of the surrounding area; planned number, type and power levels of reactor units evaluation of alternative sites;

13. Early site permit Emergency preparedness: proposed emergency plans or emergency preparedness information; population distribution and evacuation routs evaluation of physical impediments; security engineering and management.

14. Early site permit Environmental impact: surface water quality, hydrology and use; aquatic ecology; ground water quality and use; threatened or endangered species; air quality;

15. Early site permit Environmental impact: land use; uranium fuel cycle and waste management; human health socio-economics hypothetical accidents; and decommissioning

16. Early site permit To seek an ESP, the applicant must provide, a final safety analysis report (chapters 1, 2, 3, 11, 13, 15, 17, 18, 19) to allow evaluation of site suitability under the relevant requirements of 10 CFR Parts 50 and 100, an environmental report, and emergency preparedness information that can range from identifying major impediments to emergency planning to consideration of complete, detailed plans themselves.

17. Early site permit The applicant may use a “plant parameter envelope”, that set of values of plant design parameters that the applicant believes bounds the actual design characteristics of a plant which it might build at the site in the future. The applicant may also request authorisation to conduct limited construction activities prior to issuance of the ESP under a Limited Work Authorization (LWA), provided the necessary safety and environmental information.

18. Early site permit To aid in the review of ESP applications, the NRC has issued a review standard RS-002, Processing Applications for Early Site Permits (2004) NRC must prepare an EIS in accordance with its regulations implementing NEPA in 10 C.F.R. Part 51. A hearing is required on the application under an ESP is a partial construction permit

19. Early site permit NRC documents its findings on site safety characteristics and emergency planning in a Safety Evaluation Report and on environmental protection issues in Draft and Final Environmental Impact Statements Early site permit allows a limited work authorization to perform non-safety site preparation activities in advance of issuance of a combined license

20. Early site permit After the NRC staff and the Advisory Committee for Reactor Safety (ACRS) complete their safety reviews, the NRC issues a Federal Register notice for a mandatory public hearing. The early site permit is initially valid for no less than 10 and no more than 20 years and can be renewed for 10 to 20 years

21. Early site permit Recently issued Vogtle/SNC: Application filed March 2008 February 2012 receipt of COL VC-summer/SCANA/SCE&G: Application filed March 2008 March 2012 receipt of COL

22. Design certification NRC may approve and certify a standard nuclear plant design through a rulemaking, independent of a specific site. The design certification is valid for 15 years. NRC has issued design certifications: Advanced Boiling Water Reactor (ABWR) Advanced Passive 1000 (AP1000) (80+, AP600)

23. Design certification Design Certification Applications Currently Under Review: ABWR Design Certification Rule (DCR) Amendment South Texas Project Nuclear Operating Company Economic Simplified Boiling-Water Reactor (ESBWR) GE-Hitachi Nuclear Energy U.S. EPR AREVA Nuclear Power

24. Design certification Design Certification Applications Currently Under Review: U.S. Advanced Pressurized-Water Reactor (US-APWR) Mitsubishi Heavy Industries, Ltd. ABWR Design Certification Renewal Toshiba Corporation Power Systems Company ABWR Design Certification Renewal

25. Design certification A certified design may be referenced in applications to construct or operate a plant under Part 50 or in a COL application under Part 52. Issues concerning the adequacy of a design which were resolved during the course of the design certification rulemaking are not reconsidered in a combined license proceeding.

26. Design certification An application for a standard design certification must contain proposed inspections, tests, analyses, and acceptance criteria for the standard design. Additionally, the application must demonstrate how the applicant complies with the relevant regulations. Procedurally, design certifications are adopted through notice and comment rulemaking, although the Commission may, hold a legislative-style hearing on comments received on the proposed certification

27. Design certification An application must contain a level of design information sufficient to enable the NRC to reach a final conclusion on all safety questions associated with the design. In general terms, a design certification application should provide an essentially complete nuclear plant design, with the exception of site-specific design features such as intake structures and the ultimate heat sink.

28. Design certification The application presents the design basis, the limits on operation, and a safety analysis of structures, systems, and components of the facility as a whole. The scope and contents of the application are equivalent to the level of detail found in a Final Safety Analysis Report for a currently operating plant. The NRC staff prepares a Safety Evaluation Report that describes its review of the plant design and how the design meets applicable regulations

29. Design certification The ACRS reviews each application for a standard design certification, together with the NRC staff’s Safety Evaluation Report, in a public meeting. Upon determining that the application meets the relevant standards and requirements of the Atomic Energy Act and the applicable regulations, the NRC drafts a rule to issue the standard design certification.

30. Design certification Members of the public may submit written or oral comments on the proposed design certification rule The NRC may hold a hearing at its discretion

31. Design certification The applicant must develop ITAAC to ensure verification that the as-built plant conforms to the certified design. The NRC encourages the development, to the extent practicable, of ITAAC that are objective and non-discretionary in order to maximise regulatory stability and predictability and to enhance the possible replication of the “inspections and tests” exception to the conduct of hearings in the Administrative Procedure Act

32. Design certification The NRC cannot modify a certified design unless it finds that the design does not meet the applicable regulations in effect at the time of the design certification, or if it is necessary to modify the design to assure adequate protection of the public health and safety

33. Combined license The purpose of the combined license process is for resolving all safety and environmental issues before the authorizing construction. The combined license process requires clear division of responsibilities in different lifecycle stages among regulators, vendors and operators. The combined license process may refer to an early site permit, a standard design certification, both, or neither. Issues having resolved during the siting and design processes are precluded from reconsideration later at the combined license process.

34. Combined license Therefore, if there exist already an early site permit and a standard design certification, the regulatory review of the application of a combined license will only address the following three items: Qualifications Operation programmes, Inspections, tests, analyses, and acceptance criteria.

35. Combined license process The COL authorizes construction of the nuclear facility in a manner similar to a construction permit under the two-step process; however, the initial submissions of the applicant must contain essentially the same information required as in the two-step licensing process for the application of an operating license. The COL specifies inspections, tests, and analyses that the applicant must perform and also specifies the acceptance criteria in order to provide reasonable assurance that the NPP has been constructed and will be operated in conformity with relevant regulations and the license conditions

36. Combined license process After issuing a COL, at regular intervals during construction, the NRC publishes notices of the completion of the essential construction works in the Federal Register. Then, no less than 180 days before the date scheduled for initial loading of fuel, the NRC publishes a notice of intended operation of the facility in the Federal Register. The operation of the NPP is only permitted after the NRC has verified that the required inspections, tests, and analyses completed by the licensee meet acceptance criteria

37. Combined license process § 52.104 Duration of combined license A combined license is issued for a specified period not to exceed 40 years from the date on which the Commission makes a finding that acceptance criteria are met under § 52.103(g) or allowing operation during an interim period under the combined license under § 52.103(c)dateunder

38. Combined license process

39. The combined licensing process specified in 10 CFR Part 52 is developed according to a structured and systematic approach taking into account the experience in the design and operation of LWRs, in particular the design of the advanced reactors. This approach ensures the uniformity, consistency and defensibility in the development of regulations, including the proper selection of measures in the assessment of performance in the regulations.

40. Combined license process Advantages: Providing a stable, predicable and efficient licensing process Encouraging standardization of nuclear power plant designs Dealing with most important safety issues in the “pre-licensing” phase Reducing financial risk for the nuclear industry in construction of NPPs Offering the public opportunities for early participation in licensing activities Helping minimize duplications of regulatory efforts in the licensing process.

41. Combined license process Disadvantages: Adding new requirements Several units on the same site…