ML21190A012
| ML21190A012 | |
| Person / Time | |
|---|---|
| Issue date: | 07/08/2021 |
| From: | Joseph Sebrosky NRC/NRR/DANU |
| To: | Afzali A, Draffin C, Nichol M Nuclear Energy Institute, Southern Company Services, US Dept of Energy, Office of Nuclear Energy |
| References | |
| Download: ML21190A012 (53) | |
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The NRC anticipates the submission of power reactor CP applications within the next few years.
The review of these applications falls within the two-step licensing process under 10 CFR Part 50 and involves the issuance of a CP before an operating license (OL). The NRC last reviewed a power reactor CP in the 1970s. Most recently, the NRC issued combined construction and operating licenses (combined licenses) for power reactors through the one-step licensing process under 10 CFR Part 52 utilizing guidance in the Standard Review Plan (SRP, NUREG-0800) (Ref. 8) and Regulatory Guide (RG) 1.206 (Ref. 17, 18).
The licensing process under 10 CFR Part 50 allows an applicant to begin construction with preliminary design information as compared with the final design required for a combined license (COL) under 10 CFR Part 52. Although the two-step licensing process provides flexibility and a more limited safety review prior to construction, there is less finality on the design before the applicant commits to construction of the facility.
The SRP contains the staff review guidance for LWR applications submitted under 10 CFR Part 50 or 10 CFR Part 52. In addition, some insights on the level of detail that is required for the preliminary safety analysis report (PSAR) in support of the CP application may be obtained from RG 1.70, Revision 3, 1978, (Ref. 13) but these insights may be limited to the degree that the guidance does not account for subsequent requirements and NRC technical positions, or advances in technical knowledge. RG 1.206 provides guidance for COL applications and includes insights on the level of detail needed for final design information if the CP applicant chooses to provide such information.
The NRC is developing guidance for the safety review of non-LWR designs. The Advanced Reactor Content of Applications Project (ARCAP) document will reference existing guidance that may be applicable to non-LWR designs and recently developed non-LWR guidance for specific areas of review. The ARCAP is broader and encompasses the industry-led Technology-Inclusive Content of Application Project (TICAP). These projects build on the outcome of the Licensing Modernization Project (LMP), which provides guidance that focuses
on identifying licensing basis events; categorizing and establishing performance criteria for structures, systems, and components; and evaluating defense in depth for advanced reactor designs.
ARCAP guidance is being developed independently of the SRP for light water reactors.
Because ARCAP guidance is envisioned to use an application structure different than the SRP, Appendix C, Advanced Reactor Construction Permit Guidance, has been developed for applications that choose to follow this approach.
The NRC recently issued CPs for two non-power production and utilization facilities, SHINE Medical Isotopes (Ref. 9) and Northwest Medical Isotopes (Ref. 10). Some of the lessons learned from these reviews are applicable to the review of power reactor CP applications and are summarized below.
RATIONALE During the June 12, 2020, public meeting on the Advanced Reactor Content of Application Project for non-LWR designs, the Nuclear Energy Institute (NEI) and U. S. Nuclear Industry Council (USNIC) requested guidance for CP applicants within the next 1-2 years.
In a subsequent public meeting on July 31, 2020, the staff presented options to address industrys request to support the timeline of potential applications and received feedback that the interim staff guidance (ISG) option appears to address industrys needs for near-term CP guidance.
This draft white paper focuses on the safety review of power reactor CP applications and may be further developed into an ISG applicable to any LWR design, including designs similar to those recently reviewed under 10 CFR Part 52, and may refer to the applicable guidance for the review of non-LWR designs. It has been approximately 40 years since the staff reviewed a CP application for a power reactor. Although the LWR CP application guidance in RG 1.70 dates from the 1970s and the more recent LWR application guidance in RG 1.206 was developed for a COL application, these documents provide some insights on the level of detail to support an LWR CP application review as discussed above. For a non-LWR CP application, the ARCAP guidance provides information on the level of detail to meet the applicable requirements for a CP.
This draft white paper also includes a discussion of how the staffs safety review would address LWR applications that reference an approved design or other NRC approvals, specific CP safety review areas needing clarity, and applicability of ARCAP guidance.
GUIDANCE Requirements for a Power Reactor Construction Permit Application A number of regulations apply to a power reactor CP application, including:
10 CFR 50.30, Filing of application; oath or affirmation
10 CFR 50.33, Contents of applications; general information15
10 CFR 50.34, Contents of applications; technical information, particularly paragraph (a), Preliminary safety analysis report,
10 CFR 50.34a, Design objectives for equipment to control releases of radioactive material in effluents - nuclear power reactors
10 CFR 50.35, Issuance of construction permits
10 CFR 50.40, Common standards
10 CFR 50.55, Conditions of construction permits, early site permits, combined licenses, and manufacturing licenses
10 CFR 50.55a, Codes and standards
10 CFR Part 20, Standards of Protection Against Radiation
10 CFR Part 100, Reactor Site Criteria The regulations in 10 CFR 50.34(a) specify the minimum technical information in the preliminary safety analysis report (PSAR) accompanying a CP application, including a description and safety assessment of the site on which the facility is to be located. The site safety assessment is expected to include an analysis and evaluation of the major structures, systems and components (SSCs) of the facility that bear significantly on the acceptability of the site under the site evaluation factors identified in 10 CFR Part 100.
The regulations in 10 CFR 50.35, Issuance of construction permits, provide for the issuance of a CP in cases where the application does not provide sufficient information for the staff to approve all proposed design features and when certain criteria are met. In its early practices, the predecessor to the NRC, the Atomic Energy Commission (AEC), had issued a provisional CP when the applicant had not submitted all the technical information to complete the application and to approve all proposed design features. However, almost all issued provisional CPs were never converted to a final CP but instead merged into an operating license. Therefore, the AEC proposed to codify the Commissions practice for issuing a CP (34 FR 6540, April 16, 1969). The final amendment to the regulations in 10 CFR 50.35 eliminated the term provisional construction permit but retained the provisional criteria for issuing a CP (35 FR 5317, March 31, 1970). By issuing a CP, the Commission authorizes the construction of the facility described in the application, including the principal architectural and engineering criteria and identification of major features or components for the protection of the health and safety of the public.
The current regulations for issuing a CP in 10 CFR 50.35(a) have not been modified since 1970:
(a) When an applicant has not supplied initially all of the technical information required to complete the application and support the issuance of a construction permit which approves all proposed design features, the Commission may issue a construction permit if the Commission finds that (1) the applicant has described the proposed design of the facility, including, but not limited to, the principal architectural and engineering criteria for the design, and has identified the major features or components incorporated therein for the protection of the health and safety of the public; (2) such further technical or design
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information as may be required to complete the safety analysis, and which can reasonably be left for later consideration, will be supplied in the final safety analysis report; (3) safety features or components, if any, which require research and development have been described by the applicant and the applicant has identified, and there will be conducted, a research and development program reasonably designed to resolve any safety questions associated with such features or components; and that (4) on the basis of the foregoing, there is reasonable assurance that, (i) such safety questions will be satisfactorily resolved at or before the latest date stated in the application for completion of construction of the proposed facility, and (ii) taking into consideration the site criteria contained in part 100 of this chapter, the proposed facility can be constructed and operated at the proposed location without undue risk to the health and safety of the public.
In cases where a novel design has not sufficiently progressed and certain information is not available at the submission of the CP application, the PSAR should provide the criteria and bases used to develop the required information, the concepts and alternatives under consideration, and the schedule for completion of the design and submission of the missing information. In general, the PSAR should describe the preliminary design of the facility in sufficient detail to enable the staff to evaluate whether the facility can be constructed and operated without undue risk to the health and safety of the public.
The criteria in 10 CFR 50.35(a) focus on the safety aspects of the design, including the principal architectural and engineering criteria and the safety design features, as well as siting information to support construction of the facility. Given the advances in technology since the most recent amendment of the regulation, it may be easier for an applicant to provide more complete technical information in its CP application and thereby reduce the regulatory review in the subsequent licensing phase. As noted in 10 CFR 50.35(a), the findings above will be modified, if specifically requested by the applicant, for a complete CP application that includes all technical information, including the final design of the facility.
Under 10 CFR 50.35(b), a CP applicant may also request approval of any design features or specifications in its CP application. This request for approval would need more than preliminary information to support the staffs review to approve such design features or specifications. In such a case it would be expected that the level of design information available to support the approval of a proposed design feature in the application would be the same level of design information available for a 10 CFR Part 52 COL application. Guidance for the expected level of design information that is available to support a COL application can be found in RG 1.206. It should be noted that any approval, if granted, would apply only to the extent that the item has been fully addressed or treated in the application and would not extend beyond items or details not fully covered in the application. The regulation at 10 CFR 50.35(b) clarifies that a CP authorizes the applicant to proceed with construction but is not an approval of the safety of any design features or specifications unless the applicant requests for such approval and the approval is incorporated into the permit.
As described in 10 CFR 50.35(c), a license authorizing operation of the facility will not be issued until (1) the applicant submits, as part of an OL application, its final safety analysis report (FSAR) and (2) the Commission finds that the final design provides reasonable assurance that the health and safety of the public will not be endangered by operation of the facility. The FSAR
submitted with the OL should describe in detail the final design of the facility as constructed, identify the changes from the criteria, design, and bases in the PSAR, and discuss the bases and safety significance of the changes from the PSAR. Prior to the issuance of an operating license, the staff will review the applicants final design in the FSAR to determine whether all the Commission's safety requirements have been met. Based on this determination, the Commission would issue an OL and the applicant may then operate the facility in accordance with the terms of the OL and the Commissions regulations under the continued oversight by the NRC staff.
Lessons Learned from Recently Issued CPs Recently, the NRC issued permits for the construction of medical radioisotope facilities as non-power production and utilization facilities (NPUFs) licensed under 10 CFR Part 50. The Commission issued CPs to SHINE Medical Technologies, LLC in February 2016, and Northwest Medical Isotopes, LLC in May 2018. Lessons learned from the review of these NPUF CP applications include the following:
Pre-application engagement is key to providing near-term guidance to the applicant.
Early interactions supported common understanding of what information is needed in the PSAR and what information could be reasonably left for the FSAR accompanying the OL application, e.g., operational program descriptions.
If the PSAR includes preliminary or limited descriptions of the facilitys programs, structures, systems, or components, the staff may accept and approve the application with regulatory commitments from the applicant to provide complete information in its OL application.
The staffs construction permit safety review is focused on ensuring appropriate use of analysis methodologies to meet the requirements in the regulations.
In safety evaluations related to the CPs issued, the NRC staff noted applicant regulatory commitments regarding the resolution of items that were not necessary for the issuance of a construction permit, but that the applicant should address in the FSAR submitted with an operating license application. The CPs included conditions to ensure that the permit holder informed the NRC of safety significant areas of construction prior to the submission of an OL application. CP conditions of a confirmatory nature focused on additional information needed to address certain matters related to the safety of a final design and required the applicant to submit, prior to the completion of construction, periodic reports on such information to the NRC.
The NPUF lessons learned noted above may be applied for an effective and efficient safety review of the PSAR to determine whether the application meets the 10 CFR 50.35 requirements for issuing a CP. However, in drawing lessons from recent NPUF reviews, consideration should be given to the different technologies involved and the much more limited set of safety requirements that apply to an NPUF as opposed to a power reactor.
Consistent with past practice and experience, including the recent NPUF reviews discussed above, pre-application activities have proven effective in gaining early understanding of the applicants plans and its proposed facility design, supporting early resolution of unique design aspects of the facility, and preparing resources for the review of the application. Also, a recent
staff draft white paper (Ref. 5) on preapplication engagement to optimize application reviews provides information to advanced reactor developers on the benefits of robust preapplication engagement in order to optimize application reviews. Although directed to the advanced reactor community, the draft white paper describes a set of pre-application activities that may be applicable to LWR license applicants and, if fully executed, will enable the staff to offer more predictable and shorter schedules and other benefits during the review of a reactor license application.
Special Topics The previous section provides guidance on the overall approach for the safety review of a CP application recognizing that if an application does not provide the information to support the issuance of a construction permit that approves all proposed design features, it may still meet the criteria in 10 CFR 50.35(a) for the Commission to issue a CP.
This section provides additional guidance on potential CP application submissions and the effect of ongoing regulatory activities on the review of future CP applications.
Concurrent Applications A CP application may be accompanied by an application for a limited work authorization (LWA).
For the LWA review, the staff should refer to the guidance in COL/ESP-ISG-4 (Ref. 7) related to the definition of construction and limited work authorization.
Questions have been raised regarding the possibility of submitting the OL application before the CP is issued. The staff is still considering the legal and policy implications of this possibility.
For an OL application submitted before the construction permit is issued, a process would need to be developed to address the CP mandatory hearing (if not completed before the OL application is submitted) and the logistics associated with the OL hearing opportunity.
The staff notes that there are inherent complications associated with a concurrent CP and OL review. For example, as a result of the OL review, a need to reclassify SSCs (i.e., from non-safety-related to safety-related) could arise based on updated design information that was not available at the time of the CP. In such a case, extensive rework of both the CP and OL applications could be needed to address this reclassification.
CP Application Incorporating Prior NRC Approvals A CP application may incorporate prior NRC approvals by reference, including a standard design approval (SDA), a certified design (DC), or an early site permit (ESP). Each of these approvals is supported by a staff safety evaluation concluding that the applicant has met the specific regulatory requirements for approval and may be subject to conditions and additional requirements and restrictions. These prior NRC approvals have finality when referenced in a CP application as defined by the issue finality provisions for the particular Part 52 approval.
If the staff determines that the CP application demonstrates the applicability of the prior NRC approval including compliance with any associated conditions and additional requirements and restrictions, the staffs CP review regarding the referenced material would generally be limited to
an evaluation of (1) how the referenced approval conditions and additional requirements and restrictions are addressed in the CP application, and (2) any deviations from the referenced material that are subject to prior NRC review. Portions of the application not receiving prior NRC approval will be the focus of the NRC staffs CP review.
For a CP application referencing an ESP, the staffs review and evaluation may be more extensive in that the staff would conduct a safety review and evaluation of the proposed design of the facility, any requested variances from the ESP, the satisfaction of any relevant permit conditions, and the updating of emergency preparedness information in accordance with 10 CFR 52.39(b). As provided by 10 CFR 52.24(b), any ESP terms or conditions that cannot be met by CP issuance must be set forth as terms or conditions of the CP.
For a CP application referencing an SDA or DC, the staffs review and evaluation may be focused on the suitability of the selected site for the referenced design, the satisfaction of any additional requirements or restrictions for the approved design, and any design matters outside the scope of the referenced design. Under 10 CFR Part 52, a DC must be based on essentially complete design, while an SDA may approve only major features of the design; this difference may affect the level of design information that might be needed in the CP application. Also,Section IV.B in all issued design certification rules provides that [t]he Commission reserves the right to determine in what manner this appendix may be referenced by an applicant for a construction permit or operating license under 10 CFR part 50.
For a CP application referencing an ESP and an SDA or DC, the staffs review and evaluation would generally be focused on whether the referenced design fits within the characteristics of the approved site; whether the other applicable conditions, requirements, and restrictions in the referenced approvals are satisfied; whether deviations from the referenced approvals that require prior NRC approval comply with NRC regulations; and whether requirements for matters outside the scope of the referenced approvals are met.
Ongoing Regulatory Activities The NRC is currently pursuing the alignment of requirements in 10 CFR Parts 50 and 52 through rulemaking. The rulemaking is in its initial phases and may include additional licensing requirements for applications submitted under 10 CFR Part 50 (e.g., risk information). Until the final rule is issued, a CP application will be reviewed and evaluated in accordance with the existing regulations. The staff should continue to monitor the progress of the 10 CFR Parts 50 and 52 rulemaking since a CP applicant must comply with the applicable regulations that are in effect at the time the NRC issues the construction permit. A CP applicant may choose to provide risk information in its application and the staff should consider this information to enhance its review focus on the proposed safety design features of the facility.
The NRC is working on the advanced reactor content of application project (ARCAP) to develop technology-inclusive, risk-informed, and performance-based application guidance. The ARCAP guidance is intended for use by an advanced reactor applicant for a combined license, construction permit, operating license, design certification, standard design approval, or manufacturing license. Many of the topics covered in the ARCAP guidance may also be applicable to LWR designs, including updated siting guidance. The staff should consider the
updated guidance in the ARCAP, when finalized, for applicability to a CP application review as described in Appendix C of this document.
Receipt, Possession, and Use of Source, Byproduct and Special Nuclear Material This document does not provide guidance on the licensing requirements for byproduct, source, or special nuclear material under 10 CFR Parts 30, 40, and 70. The CP applicant may address the applicable materials licensing requirements with its CP application (in accordance with 10 CFR 50.31) or separately from the CP application.
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From a consequence perspective, the staff expects micro-reactors to more closely resemble nonpower reactors than large LWRs. Further, the site footprint of micro-reactors is likely to be substantially smaller than that of the existing power reactor fleet and the new reactors envisioned when the NRC promulgated the aircraft impact rule. Some micro-reactors might also be located underground, which could prevent a large commercial aircraft from striking safety-significant portions of a facility. A holistic risk-informed consideration of design-specific features, including the potential consequences of an aircraft impact, could provide a basis for meeting the underlying purpose of the rule and would be consistent with the Statements of Consideration, which stated that the NRC may need to issue exemptions and impose supplemental criteria for aircraft impact assessments of non-LWRs. Provided a micro-reactor applicant can make a case
for demonstrating compliance with the rule, the staff expects that existing regulatory processes are sufficient to address micro-reactor applications in the near term.
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