This paper: ML15117A466

Last updated: 03/17/2016

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STAFF REPORT: 

10 CFR PART 52 APPLICATION REVIEWS— 

EFFICIENCY OPPORTUNITIES AND REVIEW TIMELINES
i 

EXECUTIVE SUMMARY

In a staff requirements memorandum dated September 16, 2014,1 the U.S. Nuclear Regulatory 

Commission (NRC) staff was directed by the Commission to continue the practice of conducting 

lessons learned reviews of the experience implementing Title 10 of the Code of Federal 

Regulations Part 52 (Part 52), “Licenses, Certifications, and Approvals for Nuclear Power 

Plants.” In particular, the staff was directed to address whether the NRC could capture greater 

efficiencies in the Part 52 review process and whether the NRC should update the estimates for 

the length of time it will take to perform new reactor reviews under Part 52, based on 

experience. 

Recognizing that there are several types of applications in Part 52, the staff chose to focus its 

studies on its experiences in reviewing standard design certifications (DCs) because DC 

applications may often include first-of-a-kind approaches that may introduce technical and policy 

challenges to the review process. Therefore, DC reviews are likely to result in more lessons 

learned and afford more opportunities to capture additional efficiency gains in a variety of 

supporting processes. The staff also considered recommendations and implementation impacts 

from the April 2013 Part 52 Lessons Learned Review.2

The staff has determined that the Part 52 DC review process is sound and allows for an 

efficient review, as long as an applicant submits a high-quality, technically sufficient 

application, commits to providing the resources necessary to support the staff’s review, and 

addresses key policy and technical issues during preapplication discussions with the staff. 

Additionally, the staff has made considerable efforts to implement the lessons learned from 

previous reviews and to implement other new changes to improve review efficiency. The 

staff will continue to monitor DC review efficiencies gained by implementation of the actions 

identified in this report, and will continue to look for opportunities to gain additional DC 

review efficiency. 

In summary, the staff believes that the goal for the length of time it should take to perform 

new DC safety reviews for large light-water reactors (LWRs) under Part 52 has been set 

appropriately at 42 months. The staff will undertake efforts to communicate the review 

assumptions and expectations to stakeholders in a comprehensive manner. 

Recognizing that some project delays are not attributable to the NRC staff, the staff intends to 

change the manner in which the project total project durations are calculated and 

communicated, to provide clearer information on the cause of schedule changes. 

The staff concludes that the findings and actions discussed in this report provide a sound basis 

for high quality safety, security and environmental reviews which are consistent with the NRC’s 

mission and responsive to applicant and stakeholder needs and expectations. 

 

1 Staff Requirements – Briefing on Strategic Programmatic Overview of the New Reactor Business Line, 

September 16, 2014 (Agencywide Documents Access and Management System 

(ADAMS) Accession No. ML14259A359) 

2 New Reactor Licensing Process Lessons Learned Review: 10 CFR Part 52, April 2013 

(ADAMS Accession No. ML13059A239) 
ii 

Table of Contents 

EXECUTIVE SUMMARY ............................................................................................................... i

Table of Contents .......................................................................................................................... ii

INTRODUCTION .......................................................................................................................... 1

1.0 BACKGROUND—THE STANDARD DESIGN CERTIFICATION PROCESS .................... 2

2.0 EVOLUTION OF SCHEDULING ASSUMPTIONS USED FOR DESIGN CERTIFICATION 

REVIEWS ........................................................................................................................... 7

FLIRA Assessment (SECY-01-0188) Schedule Assumptions ........................................... 7

LPP Schedule Assumptions ............................................................................................... 8

APR1400 Schedule Assumptions ...................................................................................... 9

3.0 FACTORS AFFECTING THE NRC’S DC REVIEW SCHEDULING ASSUMPTIONS ..... 10

4.0 STANDARD DESIGN CERTIFICATION REVIEWS CONDUCTED TO DATE ................ 11

4.1 Reactor Designs Certified prior to 2001 .................................................................... 11

4.1.1 U.S. Advanced Boiling-Water Reactor (ABWR) ............................................ 11

4.1.2 System 80+ ................................................................................................... 11

4.1.3 AP600 ............................................................................................................ 12

4.2 Reactor Designs Reviewed after 2001 (Post-FLIRA Assessment) ........................... 12

4.2.1 AP1000 and the AP1000 Amendment .......................................................... 12

4.2.2 ESBWR ......................................................................................................... 14

4.2.3 U.S. EPR (DC Review Suspended) .............................................................. 16

4.2.4 US-APWR (DC Review in Progress) ............................................................. 19

4.2.5 APR1400 (DC Review in Progress) .............................................................. 21

4.3 Summary of Design Certification Reviews ................................................................ 21

5.0 INCORPORATION OF LESSONS LEARNED IN DC REVIEWS .................................... 23

5.1 High-Quality Applications that Fully Address Relevant Regulatory Requirements 

and Staff Guidance Support the Conduct of the Review within a Predictable 

Timeframe ................................................................................................................. 23

5.2 Applicants and NRC Staff Must Commit Resources to Promptly and Thoroughly 

Respond to Requests for Additional Information and Substantive Technical 

Matters to Support a Predictable Review Schedule .................................................. 24

5.3 Early Identification and Timely Resolution of Complex Technical and Policy Issues 

Minimize Impacts on the Review Schedule ............................................................... 25

5.4 Improvements to All Aspects of Requests for Additional Information 

Can Contribute to a More Efficient Review ............................................................... 25

5.5 Living Our Mission ..................................................................................................... 26

5.6 Summary of Lessons Learned Being Applied to the APR1400 DC Review .............. 27

6.0 CONCLUSIONS ............................................................................................................... 29

6.1 Part 52 DC Review Efficiencies ................................................................................ 29

6.2 Updates to Part 52 DC Review Duration Metrics ...................................................... 29

6.3 Changing How Review Timeliness Goals and Schedules Are Calculated and 

Communicated .......................................................................................................... 31
ii 

ATTACHMENT – “LIVING OUR MISSION” (2 Pages) ............................................................... 33
1 

INTRODUCTION 

In a staff requirements memorandum (SRM) dated September 16, 2014,3 the U.S. Nuclear 

Regulatory Commission (NRC) staff was directed by the Commission to continue the practice 

of conducting lessons learned reviews of the experience implementing Title 10 of the Code of 

Federal Regulations Part 52 (10 CFR Part 52 or “Part 52”), “Licenses, Certifications, and 

Approvals for Nuclear Power Plants.” 

In particular, the staff was directed to address: (1) whether the NRC can capture greater 

efficiencies in the Part 52 review process; and (2) whether the staff should update the estimates 

for the length of time it will take to perform new reactor reviews under Part 52, based on 

experience. 

The staff most recently conducted lessons learned reviews of Part 52 application reviews, 

including combined licenses (COLs) and Standard Design Certifications (DCs) in April 2013, 

and identified actions for improvement. The staff has made significant progress on 

implementing these improvements. To address the Commission’s questions in the SRM, the 

staff chose to supplement the 2013 information by looking more closely at its experiences in 

reviewing DCs. This subset of Part 52 applications was selected for review because DC 

applications may often include first-of-a-kind approaches that may introduce technical and policy 

challenges to the review process. Therefore, DC reviews are likely to result in more lessons 

learned and afford more opportunities to capture additional efficiency gains in a variety of 

supporting processes. 

The report includes a brief background on the standard DC process in Part 52 and summaries 

of the staff’s review experiences for the advanced boiling-water reactor (ABWR), System 80+, 

Advanced Passive (AP) 600, AP1000, AP1000 amendment, Economic Simplified Boiling-Water 

Reactor (ESBWR), U.S. Evolutionary Power Reactor (EPR), U.S. Advanced Pressurized-Water 

Reactor (US-APWR), and APR1400 designs. The staff also considered recommendations and 

implementation impacts from the April 2013 Part 52 Lessons Learned Review 4 in forming its 

conclusions and responses to the SRM. 

 

3 Staff Requirements Memorandum M140910 – Briefing on Strategic Programmatic Overview of the New 

Reactor Business Line, September 16, 2014 (Agencywide Documents Access and Management System 

(ADAMS Accession No. ML14259A359) 

4 New Reactor Licensing Process Lessons Learned Review: 10 CFR Part 52, April 2013 

(ADAMS Accession No. ML13059A239) 
2 

1.0 BACKGROUND—THE STANDARD DESIGN 

CERTIFICATION PROCESS 

The U.S. Nuclear Regulatory Commission (NRC) issued Title 10 of the Code of Federal 

Regulations (10 CFR) Part 52, “Licenses, Certifications, and Approvals for Nuclear Power 

Plants,” on April 18, 1989. The rule principally provides for issuance of early site permits 

(ESPs), DCs, and combined construction permits and operating licenses (combined licenses, or 

COLs) for nuclear power reactors. Other licensing actions described in Part 52 include standard 

design approvals (SDAs) and manufacturing licenses (MLs). The rule codified the NRC’s policy 

statement on nuclear power plant standardization, which was intended to achieve the early 

resolution of licensing issues and to enhance the safety and reliability of nuclear power 

plants.5, 6

Subpart B of Part 52 describes the standard DC process. Under this process, the applicant 

submits a DC application, including a final safety analysis report (FSAR) that is sufficiently 

detailed to allow the staff to reach a final conclusion on all safety questions associated with the 

design before the certification is granted. By certifying a design, the NRC approves a nuclear 

power plant design, independent of an application to construct or operate a plant. Upon 

completion of its review of the DC application and through the NRC’s rulemaking process, the 

NRC certifies a design for 15 years. The certification can be renewed 7 for an additional 10 to 

15 years, with no restriction on the number of times a design can be renewed. When a COL 

applicant references a DC, design issues resolved during the DC review process will not require 

further review or hearing opportunities (the DC has “design finality”). 

In the 1990s, the NRC certified three designs in accordance with Subpart B, and codified each 

in an appendix to Part 52: 

(1) Appendix A to Part 52—Design Certification Rule for the U.S. Advanced Boiling Water 

Reactor (ABWR), certified in May 1997 (first implementation of the licensing process 

requirements under 10 CFR Part 52, Subpart B) 

(2) Appendix B to Part 52—Design Certification Rule for the System 80+ Design, certified in 

May 1997 

(3) Appendix C to Part 52—Design Certification Rule for the AP600 Design, certified in 

December 1999 

 

 

5 Final Rule, “Early Site Permits; Standard Design Certifications; and Combined Licenses for Nuclear Power 

Reactors” (54 FR 15372), April 18, 1989 (ADAMS Accession No. ML003711593) 

6 “Nuclear Power Plant Standardization” (52 FR 34884), September 15, 1987 

7 Provision added to Subpart B when Part 52 was amended (72 FR 49559), August 28, 2007 
3 

The ABWR and the System 80+ designs were considered to be “evolutionary” designs.8 These 

designs featured new developments in technology and system designs as well as safety 

enhancements. The DC review of these first two evolutionary designs created technical and 

administrative challenges for both the staff and applicants with respect to the level of detail to be 

provided for the design, the implementation of the NRC’s severe accident policy statement,9 and 

in determining the appropriate format and content for inspections, tests, analyses, and 

acceptance criteria (ITAAC). 

The AP600 was considered to be the first “advanced”10 light-water reactor (LWR) reviewed by 

the NRC. The DC review included policy and technical challenges associated with passive 

features of the design (e.g., the regulatory treatment of non-safety systems (RTNSS), ITAAC, 

the initial test program, analysis code documentation, and qualification). 

During the 1990s, the staff made considerable efforts to resolve technical and policy issues 

related to the DC reviews for both evolutionary and advanced designs under Part 52. A 

summary of the regulatory history of DCs is available at Agencywide Documents Access 

and Management System (ADAMS) Accession No. ML003761550. 

In late 2000, the Commission directed the staff to assess its readiness to review applications for 

licenses and to inspect new nuclear power plants.11

In late 2001, the staff documented its assessment in the Secretary of the Commission (SECY) 

paper SECY-01-0188, the “Future Licensing and Inspection Readiness Assessment” 12 (also 

called the “FLIRA” assessment). The staff concluded that the NRC and its licensing processes 

in Part 52 were ready to complete the new reactor licensing activities, such as the 

preapplication reviews for the AP1000 and the pebble bed modular reactor (PBMR), a high 

temperature gas-cooled reactor. Additionally, the report provided an extensive list of 

recommended actions to further support and enhance the staff’s readiness, with the intent that 

specific actions would be prioritized for implementation, as future licensing support needs were 

identified with additional certainty. 

The FLIRA assessment also discussed the initial resource estimates for specific licensing 

scenarios (including preapplication reviews of four designs, the review of two ESP applications, 

two DC applications, and two COL applications) and the licensing of plants under Part 50 that 

 

8 SECY-96-077, “Certification of Two Evolutionary Designs,” April 16, 1996 

(ADAMS Accession No. ML003708129) 

9 “Policy Statement on Severe Reactor Accidents regarding Future Designs and Existing Plants” 

(50 FR 32138), August 8, 1985 

10 “Advanced reactors” is the term previously used for reactor designs that differed significantly from the 

evolutionary light-water designs, or which incorporated, to a greater extent than evolutionary light-water 

designs do, simplified, inherent, passive, or other innovative means to accomplish their safety functions. 

Today, the passive large-light reactor designs are generally grouped with other evolutionary large light-water 

reactors and termed simply “new reactors.” See NUREG/BR-0356, “New Reactors: Striving for Enhanced 

Safety,” November 2011 (ADAMS Accession No. ML11343A026). 

11 SRM-COMJSM-00-0003, “Staff Readiness for New Nuclear Plant Construction and the Pebble Bed 

Reactor,” February 13, 2001 (ADAMS Accession No. ML010440409) 

12 SECY-01-0188, “Future Licensing and Inspection Readiness Assessment,” October 12, 2001 

(ADAMS Accession No. ML012350040) and supporting attachment (ADAMS Accession No. ML012140585) 
4 

have restarted construction or progress towards operation. These assessment efforts were the 

first step in establishing detailed schedule and resource estimates for new reactor licensing 

activities. Through the NRC’s planning, budgeting, and performance management process, the 

staff continued to refine the schedule and resource estimates for each licensing scenario 

assessed to establish detailed resource-loaded schedules for the applications received. 

From 2001 through early 2007, the FLIRA assessment schedule bases and assumptions were 

used for DC reviews for AP1000 and (initially) for the ESBWR reviews. Section 2 of this report 

contains more information on schedule assumptions. 

The FLIRA assessment forecasted that the DC review for the AP1000 would require 

significantly fewer resources than the review of the AP600 because of design commonalities 

between the two designs. The total duration of the AP1000 DC review (46 months) was about 

half the duration of the AP600 DC review (90 months). This result supported the FLIRA 

resource savings estimate for the review. The DC review duration for the ESBWR (109 months) 

was greater than the 60 months forecast by the FLIRA for the upper end of the review duration 

range for reasons described in Section 4 of this report. 

The planning model described in the FLIRA assessment was superseded in February 2007, 

when the Office of New Reactors (NRO, established in late 2006) published its New Reactor 

Licensing Program Plan (LPP).13 The plan outlined the use of a comprehensive planning, 

scheduling, and risk management framework with the associated system platform (Enterprise 

Project Management or “EPM” hardware and software) required for execution. The LPP 

included model schedule templates for DCs, ESPs, and COL applications. A set of simplifying 

assumptions was created and embedded in the templates that differed from the set of 

assumptions used in the FLIRA assessment. The specific schedule assumptions contained in 

the LPP are described in Section 2 of the document. The LPP became the basis for project 

planning within NRO, and was used for DC reviews of the AP1000 Amendment, the U.S. EPR, 

the US-APWR, and, later, in a modified form, for the APR1400. 

NRO’s LPP built upon the FLIRA assessment initial schedule assumptions and created an 

execution framework which defined the work, the schedule and resources required to complete 

the work, the processes to perform the work, and the necessary infrastructure to support the 

work (e.g., IT requirements for implementing the process). Part of this framework included a 

six-phase work sequence used as a template for COL reviews. DC review phases are similar, 

and the phases are described below. 

 

 

13 New Reactor Licensing Program Plan, Version 1.0, January 25, 2007 

(ADAMS Accession No. ML070720406 – NONPUBLIC) 
5 

Prior to submitting a DC application for acceptance, prospective applicants typically engage the 

NRC staff in preapplication activities. While voluntary, this key project phase is very important 

to align expectations between the staff and prospective applicants. The preapplication phase is 

also critical to identifying and resolving key policy and technical issues prior to submittal. 

Resolution of these items prior to application is a key schedule assumption. 

For DC reviews, an acceptance review is conducted before docketing, a safety review is 

performed, and rulemaking is conducted to certify the design after all safety issues have been 

resolved. The phases of the staff’s safety review are as follows: 

• Phase 1—Preliminary safety evaluation report (SER) and preparation of requests for 

additional information (RAIs) 

• Phase 2—SER with Open Items (OIs) 

• Phase 3—Advisory Committee on Reactor Safeguards (ACRS) review of SER with OIs 

• Phase 4—Advance SER with no OIs 

• Phase 5—ACRS review of Advance SER 

• Phase 6—Final SER with no OIs 

This review structure was originally illustrated in LPP Exhibit 3-4: “Gantt Chart of Major Scope 

Areas of a DC.” The following diagram reflects the activities, durations, and phase sequences 

shown in the LPP, with one modification noted below for rulemaking activities. 

ACCEPTANCE 

REVIEW

SAFETY REVIEW

SAFETY REVIEW

Phase 1

Phase 2

Phase 3

Phase 4

Phase 5

Phase 6

RULEMAKING

Start Year 1 Year 2 Year 3 Year 4

LPP Design Certification Review Process *

* Durations and phase overlaps are for illustrative purposes only and are subject to change.
6 

The rulemaking activity sequence shown above has been modified from the original LPP 

sequencing. In 2009, a business process Lean Six Sigma (LSS) review for rulemaking activities 

related to DC reviews was conducted.14 The staff identified the rulemaking duration rule of 

thumb used by the NRC as 12 months for a proposed rule and 12 months for a final rule 

(24 months total). As a result of process improvements identified and implemented by the LSS 

team and NRO, the schedule assumption basis for DC rulemaking was revised from 

19.5 months (used in SECY-09-0018 as a best estimate) to 12.5 months. SECY-09-0018 

assumed that rulemaking activities could begin before the completion of the last phase of the 

safety review, after all safety issues have been resolved (at the end of Phase 4). Rulemaking, 

using the optimized process, would be completed in 7.5 months after completion of Phase 6, as 

depicted in the graph above. 

 

14 SECY-09-0018, “Streamlining Design Certification Rulemakings,” January 30, 2009 

(ADAMS Accession No. ML082750046) 
7 

2.0 EVOLUTION OF SCHEDULING ASSUMPTIONS USED 

FOR DESIGN CERTIFICATION REVIEWS 

In the SRM for this topic, the Commission asked whether the staff should update the estimates 

for the length of time it will take to perform new reactor reviews under Part 52, based on 

experience. For example, schedules may be constructed using ranges of durations and 

resource levels to account for uncertainties in advance, or an idealized (“best case”) model may 

be constructed as a template, with the intent of being customized later for each project. 

Regardless of the chosen approach, the key assumptions underpinning the schedule should be 

realistic and should evolve consistent with review progress and accumulated experience. 

Early (pre-2001) DC reviews for the ABWR, System 80+, and AP600 designs prior to 2001 

were conducted using schedule assumptions that were custom-developed.15 These 

assumptions evolved with each successive DC review and certification and were described in 

the FLIRA assessment, then later in the LPP and the APR1400 review schedules, as described 

below. 

FLIRA Assessment (SECY-01-0188) Schedule Assumptions 

After October 2001, the staff derived its schedule assumptions for certifying a design under 

Part 52 primarily from SECY-01-0188. The levels of effort expended to certify the ABWR, 

System 80+, and AP600 designs prior to 2001 were used to estimate the duration and 

resources required for certifying other designs under Part 52. In that paper, the staff estimated 

that the review of a DC application would nominally take 42–60 months from submittal to the 

completion of rulemaking and granting of the certification, depending on the uniqueness of the 

design, whether there was a need for vendor testing and the extent of the testing program, and 

whether policy matters needed to be addressed. 

The relevant DC application schedule assumptions described in SECY-01-0188 are as follows: 

• Applications will be complete, high-quality submittals supported by sufficient research 

and development (where necessary), and any followup submittals will provide sufficient 

information to address the staff’s concerns. 

• All required testing and code development will be completed by the applicant in time to 

support the application. 

• Preapplication reviews will have been successfully completed with no remaining open 

policy or technical issues, or only a limited number of issues remain with a clear path to 

resolution identified to support future licensing activities. The support of vendors 

and preapplicants in accomplishing this milestone is implicit in this assumption. 

 

15 For an example, see SECY-97-051, “Schedule for Staff’s Review of the AP600 Design Certification 

Application,” February 26, 1997 (ADAMS Accession No. ML992920131). 
8 

• A fully staffed organizational structure exists at the time of the application to complete 

the review activities staffed with experienced, trained reviewers. Staff reviewers are not 

assumed to be dedicated to a single project (for example, a technical reviewer may work 

on a different project while waiting for an RAI response from an applicant). 

• Critical skills gaps identified in the FLIRA assessment are filled, as needed, to support 

the DC reviews. 

The staff expected, given its experience with certifying the three designs in the 1990s, that the 

subsequent review of an evolutionary LWR design would require less time to complete than the 

review of an LWR with an advanced design. 

LPP Schedule Assumptions 

NRO’s LPP issued in January 2007 included model schedule templates for DCs, early site 

permits, and COL applications. The total DC review duration of about 43 months includes a 

1-month acceptance review, 30 months for a safety review and 12 months for rulemaking. See 

the six-phase review diagram in Section 1 of this report for an overview of this model schedule. 

A set of simplifying assumptions, some different from those used in the FLIRA model, were 

incorporated in the LPP. The relevant DC application schedule assumptions are as follows: 

• Workplace infrastructure is in place including IT systems, processes, and procedures. 

• All activities and resources are represented in the schedules. 

• Sufficient staff resources at all skill levels are available. 

• Major risks are identified and managed. 

• Only high-quality applications accepted, SER process is to be completed within 

30 months. Unacceptable applications will be rejected. 

• RAI responses are timely. 

• Resources used in preparing safety evaluations are not redirected to other activities. 

• Interactions with ACRS are performed according to schedule milestones. 

• Conduct of tasks are not affected by Congressional, budget, or legal issues, or by 

changes to NRC policies. 

The LPP schedule assumptions indicate a shift towards the use of an idealized (“best case”) 

model as a baseline, to be adjusted later as necessary, based on the acceptance review results 

and other factors, including identification of technical issues and discussions with the applicant. 

Hence, a single duration goal is identified for a particular type of review (such as a DC), rather 

than a duration range. Examples of idealized assumptions include access to and availability of 

all skill sets for the duration of the project, timely (30-day) RAI responses, 12 months to 

complete all rulemaking, and no impacts on the schedule due to budget or legal factors. 

The LPP timeline for DC reviews is aggressive based on the staff’s experience to date and 

aligns roughly with the best-case review duration given in SECY-01-0188 (43 months total for 

an LPP DC schedule vs. 42–60 months per the FLIRA assessment). 
9 

After the LPP was issued for use, the 30-day acceptance review period assumed in the LPP 

was extended at the direction of the Commission to a period of 60 days.16 This change was 

made to allow time for the staff to determine both the completeness and technical sufficiency of 

an application. The staff implemented this change in the initial issuance of NRO Office 

Instruction NRO-REG-100 in September 2007.17

APR1400 Schedule Assumptions 

The EPM schedule for the APR1400 project was designed based on updated LPP DC 

templates, but it includes several assumption changes intended to make the schedule more 

realistic, based on experience. The 30-day acceptance review period was previously changed, 

as described above. The use of a 30-day RAI response time as the “timely” assumption in the 

LPP has been determined to be unrealistic for use as an average response time. To meet the 

requirement for a “high quality” application assumed in the LPP, the technical sufficiency 

standard for accepting an application has changed from having enough information to “begin” 

the review to having enough information to “conduct” the review. Actions taken to improve 

these assumptions include conducting management-level reviews of RAIs for quality and clarity 

prior to issuance, and collecting RAI response time data to identify realistic response time goals 

to be incorporated into the project schedule, and revising NRO-REG-100 to implement change 

to the acceptance review process. 

In contrast to the LPP model, the baseline DC application review schedule for the APR1400 

project includes 2 months for the application acceptance review, 42 months for the staff’s safety 

reviews, and completion of rulemaking 8 months after completion of the safety review (after 

Phase 6, approximately aligned with the SECY-09-0018 goal). The APR1400 is potentially a 

best-case example for a DC review execution—it is familiar technology; a high-quality 

application was submitted and accepted; there is sufficient staff availability; and the project has 

a high level of applicant support. The staff has also adopted a set of review process strategies 

to support safe and timely completion of the review (see Attachment). 

 

16 Staff Requirements – COMDEK-07-001/COMJSM-07-001 – “Report of the Combined License Review Task 

Force,” June 22, 2007 (ADAMS Accession No. ML071760109) 

17 NRO Office Instruction NRO-REG-100, “Acceptance Review Process for Design Certification and Combined 

License Applications,” initial issuance, September 26, 2007 (ADAMS Accession No. ML071980027) 
10 

3.0 FACTORS AFFECTING THE NRC’S DC REVIEW 

SCHEDULING ASSUMPTIONS 

The staff’s DC review experience to date provides a rich source of information about internal 

and external factors that support or inhibit review efficiency. 

Examples of these internal factors include staff resource management, work prioritization, 

support for hearings, review phase discipline, critical skills availability, budgetary limitations, 

computational tool availability for unique reactor designs, the overall staff workload and 

capacity, and resolution of policy issues that may require rulemaking, as identified summarily in 

the FLIRA assessment. Examples of the policy issues identified in the FLIRA assessment 

include: petitions for rulemaking regarding Part 52; financial qualifications and decommissioning 

funding; nuclear insurance requirements for modular reactors (Price-Anderson Act); annual fees 

for modular reactors; the continued waste storage rule; and alternative operator staffing 

approaches. 

Examples of external factors include application quality, applicant experience, the degree of 

design finality, whether or not the technology presented is familiar to the staff, and the 

availability of contracted subject matter expertise. Some external factors are out of the NRC’s 

control, such as regulatory and programmatic changes by other agencies (for example, the 

Department of Energy decision to de-prioritize development of the next-generation nuclear 

plant). Other external factors include public policy changes, such as the Energy Policy Act of 

2005, and external events. Some external factors can be foreseen and incorporated as risks in 

a project risk management program, but some are unforeseeable. Some of the factors are 

within the NRC’s span of control, and experience has provided lessons learned to be 

incorporated in future plans and schedules. The most significant of these experiential factors 

have been captured in the 2013 lessons learned report previously referenced. These factors 

are discussed further in Section 5. 

The staff continues to recognize and assess the impacts of these factors, continues to make 

improvements to the review process to minimize their impacts when possible, and continues to 

resolve policy issues that impact project plans and schedules. 
11 

4.0 STANDARD DESIGN CERTIFICATION 

REVIEWS CONDUCTED TO DATE 

This section provides an overview of reactor designs and DC reviews conducted by the staff 

to date.18 The purpose of the overview is to present a discussion of some of the factors that 

affected DC review timelines so that a context is available when reviewing the summary table 

of DC review dates and review durations at the end of the section. 

4.1 Reactor Designs Certified prior to 2001 

Reactor designs certified during this period used individualized schedules, schedule 

assumptions, and review workflows. 

4.1.1 U.S. Advanced Boiling-Water Reactor (ABWR) 

The ABWR is a single-cycle, force-circulation, boiling-water reactor (BWR) with a rated power of 

1,350 megawatts electric (MWe), designed by General Electric Co. (GE) Nuclear Energy. The 

design incorporates features of the BWR designs in Europe, Japan, and the United States, and 

uses digital instrumentation and controls and improved computer, turbine, and fuel technology. 

The design’s safety enhancements include protection against overpressurizing the containment, 

passive methods to cool accident debris, an independent water resupply system, 

three emergency diesels, and a combustion turbine as an alternate emergency power source. 

The NRC certified the U.S. ABWR design in May 1997. 

This design was the first to be reviewed and certified by the NRC under the 10 CFR Part 52, 

Subpart B (DC) process. Refer to Table 1 on page 22 of this report for the associated safety 

review and rulemaking durations and milestones. 

4.1.2 System 80+ 

The System 80+ reactor design is a 1,300-MWe pressurized-water reactor (PWR) with an 

updated Combustion Engineering (now Westinghouse Electric Company, LLC) System 80 

nuclear steam supply system and a balance-of-plant design developed by Duke Power Co. The 

design has a reactor depressurization system, a gas-turbine generator as an alternate 

alternating current (ac) power source beyond the required emergency diesel generators, and an 

in-containment refueling water storage tank to enhance the reactor’s safety and reliability. 

The NRC certified the System 80+ design in May 1997. 

Since the System 80+ design was the second evolutionary design to be reviewed under the 

Part 52 DC process, it required fewer staff resources than the ABWR review and certification. 

Refer to Table 1 for the associated safety review and rulemaking durations and milestones. 

 

18 Note that General Electric initially submitted the simplified boiling-water reactor (SBWR) design for NRC 

review, but subsequently withdrew the application in order to focus on larger reactor designs. Therefore, 

the SBWR review is not discussed further in this report. See SECY-96-068, “Status of the Staff’s Review of 

Advanced Reactor Designs,” April 1, 1996. (ADAMS Legacy Library Accession No. 9604080059) 
12 

4.1.3 AP600 

The AP600 is a 600-MWe PWR designed by Westinghouse Electric Company, LLC, that 

incorporates passive safety systems and simplified system designs. The passive systems 

respond to transients by relying on gravity and other natural forces rather than electric-powered 

pumps and other support systems. The system uses redundant, non-safety-related equipment 

and systems where possible to avoid unnecessary safety-related system activation. 

The NRC certified the AP600 design in December 1999. Because the design featured many 

unique design features, the staff was required to investigate and recommend to the Commission 

solutions for a variety of policy issues during the review. One such example was the need for 

policy direction for RTNSS.19 Additionally, extensive efforts were required to develop thermalhydraulic codes, and more independent confirmatory testing by the NRC was required for this 

review than for the other (previously) certified evolutionary designs. Refer to Table 1 for the 

associated safety review and rulemaking durations and milestones. 

4.2 Reactor Designs Reviewed after 2001 (Post-FLIRA Assessment) 

Section 2 of this report introduced the FLIRA assessment and the LPP review framework. 

These documents were used for the staff’s reviews of five additional standard DC applications 

and one amendment to a certified design.20 The following sections summarize the staff’s 

experiences in reviewing each of these applications, efforts to make reviews more efficient, and 

cover preapplication review, acceptance review, perspectives on the technical review, and 

rulemaking activities. 

4.2.1 AP1000 and the AP1000 Amendment 

The Westinghouse AP1000 is a two-loop PWR, based on the certified AP600 design, with 

a nominal net electric output of 1,110 MWe. This PWR relies on passive safety systems and 

simplified system designs, similar to the AP600 design, but generates more power by 

accommodating more fuel in a longer reactor vessel and using larger steam generators and a 

larger pressurizer. 

Westinghouse initiated preapplication discussions with the NRC and requested the staff to 

assess the applicability and the acceptability of the certified AP600 design to the AP1000 

standard DC review for scaling/testing, safety analysis codes, design acceptance criteria (DAC), 

 

19 Early passive cooling reactor designs, such as the AP600, used non-safety grade active systems to provide 

defense-in-depth capabilities for reactor coolant makeup and decay heat removal. Issues associated with 

the regulatory treatment of non-safety systems (RTNSS) were identified by the staff and policy 

recommendations were presented for Commission approval. These recommendations were approved by 

the Commission in Staff Requirements Memo (SRM)-SECY-95-132, “Policy and Technical Issues 

Associated with the Regulatory Treatment of Non-Safety Systems (RTNSS) in Passive Plant Designs 

(SECY-94-084),” June 28, 1995 (ADAMS Accession No. ML003708019) 

20 The FLIRA schedule assumptions were used for the AP1000 DC review and (initially) for the ESBWR 

review. The LPP schedule assumptions were used for the AP1000 Amendment, ESBWR, U.S. EPR, and 

US-APWR. Modified LPP schedule assumptions are being used for the APR1400 DC review. 
13 

and regulatory exemptions. Over the course of several months, the staff determined which 

conclusions from the AP600 review could be used in the AP1000 review and which items would 

require more review (e.g., thermal hydraulic code analysis). 

On March 28, 2002, Westinghouse submitted its application for the AP1000 standard DC. 

Upon completion of its acceptance review, the staff found that the application fulfilled the 

completeness requirements of 10 CFR Part 52, considered the application sufficiently complete, 

and docketed the application on June 25, 2002.21

The AP1000 review gained efficiencies from the assignment of staff reviewers, where possible, 

from the AP600 project. In addition, the development of the AP1000 SER benefited from the 

readily available and applicable portions of the AP600 conclusions. As a result, the NRC 

certified the AP1000 design on January 27, 2006. Refer to Table 1 below for the associated 

safety review and rulemaking durations and milestones. 

At about the same time the DC approval for the AP1000 was issued by the NRC, Westinghouse 

informed the staff of its plans to submit an amendment request to the AP1000 DC in the 

second quarter of 2007.22 The staff and Westinghouse started discussions on the amendment 

and on the additional AP1000 technical reports that Westinghouse planned to submit to the 

NRC for review. The purposes of the additional reports were to provide supplemental 

information regarding activities required to complete and close COL information items and 

ITAAC, to describe design changes and changes to the design control document (DCD) 

identified as a result of design completion activities, and to provide analysis activities to support 

extension of the design (such as extending the suitability of the design from hard rock 

foundations to soft soil foundations). Westinghouse intended for these reports to be 

incorporated into the FSAR referencing the AP1000 DC or incorporated into the DC through a 

supplemental rulemaking when the 10 CFR Part 52 revision permits such changes.23 

Additionally, in 2011, Westinghouse submitted Revision 19 of the DCD, providing information to 

(among other topics) address the aircraft impact assessment requirements of 10 CFR 50.150(a) 

for the AP1000 design.24

Although Westinghouse submitted an application to amend the AP1000 design certification rule 

(DCR) in mid-2007, the NRC delayed its acceptance review until after the promulgation of the 

 

21 Letter from J.E. Lyons to W.E. Cummins, “Acceptance of the Westinghouse Electric Company Application 

for Final Design Approval and Standard Design Certification for the AP1000 Design,” June 25, 2002 

(ADAMS Accession No. ML021760083) 

22 Letter dated July 14, 2006, “Westinghouse Response to NRC Regulatory Issue Summary 2006-06,” 

(ADAMS Accession No. ML062010136) 

23 Letter dated April 5, 2006, “AP1000 COL Design Change Review” (ADAMS Accession No. ML060970266) 

24 Letter dated June 13, 2011, “Westinghouse Electric Company – Updated Application to Amend the AP1000 

Nuclear Power Plant Design Certification Rule” (ADAMS Accession No. ML11171A301) 
14 

revision to 10 CFR Part 5225 and continued its review of the submitted technical reports.26 On 

January 18, 2008, the NRC docketed the supplemented application 27 and issued a letter stating 

that, “In its decision to docket, the NRC found that the information provided in most parts of the 

amendment request meets NRC regulations with respect to completeness and technical 

sufficiency.” Exceptions noted in the letter included the need to address long-term cooling water 

sources, and coping with debris generation from a loss-of-coolant-accident. These exceptions 

were identified as areas of uncertainty with regard to the NRC’s review schedule, dependent on 

receipt of additional information from Westinghouse. 

In its review of the amendment application, the staff focused on additional information to resolve 

design-related COL information items, the shield building design, and some design corrections 

and other vendor-identified design changes.28 It should be noted that the NRO staff reviewed 

the amendment at the same time that it was conducting reviews of many COL applications 

referencing the AP1000 design. On December 30, 2011, the NRC published the AP1000 DC 

amendment final rule in the Federal Register.29

Two factors influenced the review of the AP1000 DC amendment: (1) the simultaneous review 

of the DC application and several COL applications, including the Vogtle, Units 3 and 4, and 

Summer, Units 2 and 3, applications, and (2) the concurrent licensing and construction of the 

AP1000 design at two sites in China. Additional design and construction changes were 

identified during the ongoing international construction of AP1000 plants that impacted 

standardization of the AP1000 design. These changes were addressed by Westinghouse 

through the submittal of resulting design changes that impacted the NRC DC amendment 

review schedule. Refer to Table 1 below for the associated safety review and rulemaking 

durations and milestones. 

4.2.2 ESBWR 

The General Electric-Hitachi (GEH) ESBWR is a 1,594-MWe 30 reactor using natural circulation 

for normal operation with passive safety features. 

 

25 In 2007, the staff revised 10 CFR Part 52 to make changes throughout the Commission's regulations to 

ensure that all licensing processes in Part 52 were addressed, and to clarify the applicability of various 

requirements to each of the processes in Part 52 (i.e., early site permit, standard design approval, standard 

design certification, combined license, and manufacturing license). See Final Rule, “Licenses, Certifications, 

and Approvals for Nuclear Power Plants,” (72 FR 49352), August 28, 2007 

26 SECY-06-0220, “Final Rule to Update 10 CFR Part 52, ‘Licenses, Certifications, and Approvals for Nuclear 

Power Plants’ (RIN AG24),” October 31, 2006 (ADAMS Accession No. ML062910203) 

27 Letter from D. B. Matthews to W.E. Cummins, “Acceptance Review of the AP1000 Design Certification 

Amendment Application for Revision 16,” January 18, 2008 (ADAMS Accession No. ML073600743) 

28 Westinghouse submitted several revisions for the staff’s review; i.e., Revision 16 (May 26, 2007), through 

Revision 19 (June 13, 2011). 

29 Final Rule, “AP1000 Design Certification Amendment,” (76 FR 82079), December 30, 2011 

30 The original ESBWR submittal, through Revision 10 of the design control document, rated the design at 

1,390 MWe. 
15 

Beginning in April 2002, GEH (then GE) requested an NRC preapplication review on the 

ESBWR standard design. The initial scope of the preapplication reviews included an 

assessment of the technological basis for passive safety systems and the analysis methods for 

transients and accidents (e.g., the application of the TRAC-G thermal-hydraulic code to ESBWR 

loss-of-coolant accidents (LOCAs)). Later, the staff’s review expanded to include several 

technical and regulatory issues, including the reliance on passive systems to perform safety 

functions credited in the design basis for 72 hours following an initiating event. 

While engaged in the specifics of the preapplication reviews, the staff began development of the 

infrastructure needed to support the upcoming DC application review, such as the development 

of modeling capabilities for the NRC’s thermal-hydraulic system analysis code TRACE to 

assess the safety features of the ESBWR design. 

From August to October 2005, GE submitted and supplemented its application for the 

standard DC of the ESBWR. The NRC docketed the application on December 1, 2005.31 The 

staff requested additional information on unique design features, testing, and analytic codes, 

similar in scope to the information requested for the AP600 design. In October 2006, the Office 

of New Reactors was established and assumed licensing responsibilities for the ESBWR, and 

other Part 52 applications. In 2007, the staff revised 10 CFR Part 52 as previously noted, 

updated the standard review plan, and published a new standard format and content regulatory 

guide to support COL applications.32 The change in reviewers during the Nuclear Reactor 

Regulation (NRR)/NRO office transition and the influence of updated guidance for applications 

referencing the design contributed to an increase in the level of effort and time to complete the 

ESBWR DC review. 

Challenges to the schedule arose, and several factors may have contributed, including: (1) the 

expectations associated with a complete and technically sufficient application changed because 

of the revision of 10 CFR Part 52 and the update of associated guidance; (2) a large number of 

RAIs issued over a short period created processing challenges for the applicant to develop 

responses and for the staff to review the responses; and (3) the assumed applicant response 

time and staff review schedule did not account for the complexities of the technical issues 

needing more information nor the level of effort needed by the applicant to prepare the 

responses and by the staff to review them. 

The staff prepared preliminary SER chapters during its development of the RAIs; however, 

these working documents did not directly support the RAI concurrence process as a means to 

better understand the regulatory context of each of the RAIs. This insight led to a lessons 

learned example as summarized in Section 5.4 of this report. 

Similar to the staff’s experience in reviewing the AP1000 DC amendment, GEH introduced 

design changes late in the review process to account for feedback from prospective COL 

applicants referencing the ESBWR. The re-review of portions of the application related to 

 

31 Letter from D. B. Matthews to S.A. Hucik, “Acceptance of the General Electric Company Application for 

Final Design Approval and Standard Design Certification for the Economic Simplified Boiling Water Reactor 

(ESBWR) Design,” December 1, 2005 (ADAMS Accession No. ML053200311) 

32 Regulatory Guide 1.206, “Combined License Applications for Nuclear Power Plants (LWR Edition),” 

June 20, 2007 (ADAMS Accession No. ML070630042) 
16 

constructability and operation and maintenance (O&M) insights added time and resources to 

complete the review. 

Additional delays occurred when, in late 2011, the NRC notified GEH of the need for more 

information on the steam dryer design to support its safety findings in the final safety evaluation 

report (FSER). This issue was raised through operating experience of the power uprated fleet. 

With the submission of Revision 10 of the DCD, the staff resolved all remaining technical issues. 

In September 2014, the Commission approved the supplemental FSER and issued the final rule 

certifying the ESBWR design.33 Refer to Table 1 below for the associated safety review and 

rulemaking durations and milestones. 

4.2.3 U.S. EPR (DC Review Suspended) 

The U.S. EPR is a PWR designed by AREVA NP, Inc. (AREVA). The U.S. EPR design, rated at 

1,600 MWe, features four redundant trains of emergency cooling equipment. It should be noted 

that during the development of the U.S. EPR application and the staff’s review of the 

application, AREVA was also managing the construction of the EPR in Olkiluoto, Finland, and 

AREVA and Electricité de France (EdF) were managing the construction of another EPR in 

Flamanville, France. In addition, construction of other EPRs commenced in China 

(i.e., Taishan, Units 1 and 2, in 2009 and 2010, respectively). Similar to the experience gained 

during international construction of the AP1000 plants, these ongoing EPR construction 

activities provided additional information to further inform the staff’s review of the application. 

In late 2004, AREVA (then Framatome ANP, Inc.) informed the NRC of its intent to submit an 

application for the U.S. EPR standard DC in 2008. In addition, Framatome expected to offer 

informational meetings on the design in 2005 and to submit several specific topical reports in 

2006. Framatome considered the U.S. EPR design as evolutionary and did not anticipate 

requirements for new testing or research activities. 

Following the preapplication reviews, AREVA submitted an application for certification of the 

U.S. EPR standard design and the NRC docketed the application on February 25, 2008.34, 35 In 

the acceptance review notification and subsequent schedule letter, the staff identified certain 

technical areas that could challenge the staff’s review that included: (1) the approach to justify 

the amount of post-accident mixing in containment that makes it acceptable to not rely on active 

containment cooling; (2) the seismic and dynamic qualification of mechanical and electrical 

equipment; and (3) the emergency core cooling system strainer downstream effects on 

post-LOCA long-term core cooling with recirculation flow. 

 

 

33 Final Rule, “Economic Simplified Boiling-Water Reactor Design Certification,” (79 FR 61944), 

October 15, 2014 

34 Letter from G. Tesfaye to S. M. Sloan, “AREVA NP Inc. – Acceptance of the Application for Standard Design 

Certification of the U.S. EPR,” February 25, 2008 (ADAMS Accession No. ML080380357) 

35 Letter from G. Tesfaye to S. M. Sloan, “AREVA NP Inc. – U.S. EPR Standard Design Certification 

Application Review Schedule,” March 26, 2008 (ADAMS Accession No. ML080790431) 
17 

As the review progressed, delayed and inadequate responses to RAIs from AREVA became 

common. The causes for the delays may be attributed to one or more of the following: 

(1) the applicant’s need for more than 30 days to respond to the significant technical 

issues identified in the schedule letter and shortly after the start of the review; 

(2) the applicant’s choice to repeatedly revise the FSAR, resulting in more RAIs as the 

responses affected other sections that had already been reviewed, resulting in 

substantial effort to re-review those sections, going well beyond such efforts expended 

on other reviews; 

(3) the emergence of additional technical issues not identified in the initial schedule letter, 

particularly in the area of digital instrumentation and control (DI&C); and 

(4) the staff’s need for an iterative review to resolve the technical issues due to inadequate 

RAI responses from AREVA. 

Over the next 5 years, the staff issued six supplemental schedule letters and ultimately moved 

the target date for completion of the FSER to June 2015. In July 2013, after several attempts by 

AREVA to resolve issues related to DI&C, the staff informed AREVA that they had not provided 

sufficient basis for the staff to reach the necessary safety conclusion for the U.S. EPR DI&C 

design. In particular, the staff noted that AREVA had not demonstrated sufficient independence 

and diversity to meet the regulatory requirements at the current state of design; and that Areva’s 

DI&C design was unnecessarily complex for the performance of safety functions. This 

complexity was the major contributor to AREVA’s inability to demonstrate independence and 

diversity in the design. The staff committed to continuing the review of other technical issues, 

but would not issue a revised review schedule until AREVA responded to the DI&C issue.36

The NRC has been cooperating with the regulators in Finland, China, France, and other 

countries on review of the EPR design through the Multinational Design Evaluation Program 

(MDEP) EPR working group. The working group leverages regulatory resources by sharing 

information and experience on the safety design review to enhance the safety of the design. 

Participation in this cooperative efforts enables regulators to make timely licensing decisions 

through exchanging experience on design-related construction, commissioning, and operating 

experience. The working group also communicates its views and common positions to vendors 

regarding the basis of safety evaluations. 

The main technical issues consistently raised by the MDEP member countries were the 

independence of systems and the qualification of the DI&C platform. The working group issued a 

common position documenting aspects of the EPR design, where the countries had common 

agreement on the issues in March 2011 and produced a technical report discussing the major 

outcomes of its discussions in 2013. Through its participation in the MDEP working group, the 

staff learned of the challenges faced by other regulatory bodies in resolving the DI&C issues for 

 

36 Letter from D. B. Matthews to P. Salas, “NRC Staff Conclusions on Aspects of the U.S. EPR Digital 

Instrumentation and Control Systems Design,” July 2, 2013 (ADAMS Accession No. ML13168A571) 
18 

the EPR design. Participation in the working group helped all member regulators to address the 

issues in a cooperative manner. 

In an effort to reduce the number of rounds of RAIs needed to resolve technical issues, the 

staff introduced a two-phase RAI response protocol. In this new process, the applicant offers a 

preliminary RAI response to the staff for review and feedback before the submission of the final 

RAI response. The staff’s intent was to ensure that the applicant was addressing the staff’s 

concerns. However, the new process resulted in greater review effort by the staff and did not 

appear to yield any efficiencies in resolving the outstanding technical issues. Furthermore, the 

practice of submitting documents directly to the staff in lieu of the NRC’s Document Control 

Desk shifted the responsibility to the staff of ensuring the capture of submittals into ADAMS, 

which resulted in a greater workload for the project management staff. 

In late 2013, the applicant requested the NRC staff to focus its review on those SER chapters 

with few unresolved technical issues (i.e., the “near-term closure” chapters), while the applicant 

continued its design work and technical issue resolution for the remaining application 

chapters.37 The applicant’s plan included issuing FSAR markups of each chapter and “freezing” 

the design in these chapters to allow the staff to complete its reviews and issue its SER 

chapters with no OIs. The implementation of the applicant’s proposal simplified the schedule 

and made managing and tracking tasks more efficient. Concurrent with the implementation of 

this plan, the staff discontinued its use of the two-phase RAI protocol and established a weekly 

public teleconference call to clarify its RAIs with the applicant. 

After reviewing AREVA’s plan for closure of the near-term chapters, the staff provided AREVA 

with a revised schedule date for completion of Phase 4 reviews for those chapters only.38 Even 

with the reduced scope, the applicant encountered multiple budgetary challenges that further 

challenged the schedule. In late 2014, the staff completed a portion of its advance SER for the 

near-term chapters in accordance with the published schedule. 

After issuance of portions of the advance SER for the near-term chapters, the applicant pointed 

out instances of outdated information. The applicant made many revisions to the FSAR 

chapters after the staff had completed its reviews. These revisions required the staff to 

re-review its completed portions of the SER to ensure consistency with the current FSAR 

revision. The staff considered it prudent to confirm that any changes to the FSAR did not 

contradict its findings in all issued portions of the SER. 

In some instances, standardization of the U.S. EPR design with the units under construction 

overseas led to delays in AREVA’s RAI responses as well as changes to the design for which 

the technical staff had already completed its review and made a safety conclusion. 

 

37 Letter from P. Salas to the NRC, “Path Forward for U.S. EPR Design Certification Application,” 

October 21, 2013 (ADAMS Accession No. ML13297A305) 

38 Letter from F. Akstulewicz to P. Salas, “Review Schedule for the U.S. EPR Standard Design 

Certification Application Group A,” August 6, 2014 (ADAMS Accession No. ML14161A174) 
19 

On February 25, 2015,39 AREVA requested the NRC to suspend the safety review of the 

U.S. EPR standard DC application until further notice. Refer to Table 1 for the associated safety 

review and rulemaking durations and milestones. 

4.2.4 US-APWR (DC Review in Progress) 

The US-APWR developed by Mitsubishi Heavy Industries, Ltd. (MHI) is based on 

MHI’s Japanese APWR design in use at 24 sites in Japan. This design combines passive and 

active systems to support a plant rating of 1,600 MWe. 

For about 18 months, from July 2006 through December 2007, the staff conducted 

preapplication reviews of limited scope and duration. During this time, MHI submitted 12 topical 

reports related to LOCAs, I&C, fuel design, the advanced accumulator, and human factors 

engineering (HFE). 

In late 2007, MHI submitted its application for the US-APWR standard DC, and on 

February 29, 2008, the staff accepted the application for docketing.40 In the acceptance letter, 

the staff noted technical issues (e.g., subcompartment containment analyses and the sump 

strainer design) that would introduce uncertainty into the review schedule. Because of several 

meetings with the staff, MHI supplied supplemental information to address these issues.41

Initially, the staff’s review of the application began slowly because the project was not budgeted, 

or prioritized with the numerous other applications for DCs and COLs already in the review 

queue. Thus, the US-APWR review initially had a lack of sufficient, consistent technical 

resources, challenging the staff’s ability to maintain the review schedule. 

As the staff completed its preliminary SER and issued RAIs, several issues requiring additional 

review were identified. First, MHI modified the thermal hydraulic code used in its safety 

analysis. Therefore, the staff needed to review the modified code prior to reviewing the 

US-APWR accident analysis. Second, MHI changed the seismic analysis from the soil-spring 

interaction method to a finite element method, causing additional staff reviews. 

Although these and other issues delayed the next phase of the review (i.e., development of the 

SER with OIs), the NRC continued to work towards completing the review. After 3 years of 

reviewing the US-APWR application, the staff notified 42 MHI of a delay in completing its review, 

 

39 Letter from P. Salas to the NRC, “Request to Suspend Review of U.S. EPR Design Certification Application,” 

February 25, 2015 (ADAMS Accession No. ML15061A130)

40 Letter from J. A. Ciocco to Masahiko Kaneda, “Mitsubishi Heavy Industries Ltd. – Acceptance of the 

Application for Standard Design Certification of the US-APWR,” February 29, 2008 

(ADAMS Accession No. ML080420261) 

41 Meeting Summary, “Summary of the March 25, 2008 Meeting on the US-APWR Design Certification Review 

Schedule,” April 2, 2008 (ADAMS Accession No. ML080910038) 

42 Letter from D. B. Matthews to Y. Ogata, “Schedule Change for the United States – Advanced Pressurized 

Water Reactor Design Certification,” April 28, 2010 (ADAMS Accession No. ML100830739) 
20 

primarily because of the MHI changes in seismic analysis from the soil-spring interaction 

method to a finite element method. 

The NRC sent subsequent schedule change letters43, 44, 45 to MHI stating that the staff’s reviews 

would be further delayed due to incomplete information on the DI&C design and MHI’s delayed 

responses to staff’s RAIs; and MHI’s failure to address inconclusive test results supporting the 

Generic Safety Issue (GSI) -191 design commitments. 

Although the staff made progress in the review of several areas, the seismic review caused 

changes to the plant layout, and the new methods for addressing sliding stability of the nuclear 

island ultimately led to a significant delay in the review schedule. MHI submitted 163 technical 

reports (including test plans, test results, and other reports) in support of its application. MHI 

submitted 47 technical reports during the preapplication review period or within the first year of 

the staff’s review. Of the 116 technical reports submitted after the first year of the review, MHI 

identified an additional 75 technical reports to be submitted in support of its application and 

developed 41 technical reports to support the staff’s review. 

In late 2013, MHI informed the NRC of its intent to put into place a coordinated slowdown of its 

DCD licensing activities to focus its resources on the restart of the Japanese utilities since the 

Fukushima-Daiichi accident.46 MHI committed to working with the staff to sustain the ongoing 

review; however, it projected its reduced support to start by March 2014, for an indeterminate 

period dependent upon the success of bringing units in Japan on line and on the availability of 

the necessary expertise to refocus on the project. Therefore, the staff limited its review to a 

single chapter or two at a time starting with HFE, followed by I&C. As a result of MHI’s request, 

the project priority has been lowered within the NRC, and there may be future configuration 

management challenges associated with reviewing chapters one at a time rather than using an 

integrated review approach. 

Because of the limited availability of MHI resources to support the review, work remains to 

complete the review, including (1) completion of the HFE SER and an ACRS review, 

(2) completion of the seismic SER with OIs and an ACRS review, (3) completion of the 

introduction and plant description chapter, and (4) closure of OI’s in other remaining FSER 

chapters. 

The staff has not scheduled the latter phases of the review because of the technical issues 

it identified early in its review and the limited available resources from the applicant since the 

Fukushima-Daiichi accident. Refer to Table 1 for the associated safety review and rulemaking 

durations and milestones. 

 

43 Letter from D. B. Matthews to Y. Ogata, “Schedule Change for the United States – Advanced Pressurized 

Water Reactor Design Certification,” February 24, 2011 (ADAMS Accession No. ML110240150) 

44 Letter from D. B. Matthews to Y. Ogata, “Schedule Change for the United States – Advanced Pressurized 

Water Reactor Design Certification,” October 27, 2011 (ADAMS Accession No. ML112430036) 

45 Letter from D. B. Matthews to Y. Ogata, “Schedule Change for the United States – Advanced Pressurized 

Water Reactor Design Certification,” June 4, 2012 (ADAMS Accession No. ML12130A078) 

46 Letter from Y. Ogata to D. B. Matthews, “Adjustment to Ongoing Efforts for US-APWR Design Certification 

Application,” November 5, 2013 (ADAMS Accession No. ML13311A109) 
21 

4.2.5 APR1400 (DC Review in Progress) 

The APR1400 designed by Korea Hydro & Nuclear Power Co., Ltd. (KHNP) and the Korea 

Electric Power Corporation (KEPCO) is an evolutionary two-loop PWR design rated at 

1,400 MWe. The design is based on the System 80+, with revised design features to 

enhance safety. 

KHNP initially submitted the APR1400 application in December 2013. After completing its 

acceptance review, the staff determined the APR1400 application did not meet docketing 

requirements for completeness. KHNP resubmitted its application in December 2014, and it 

was accepted by the NRC for docketing in early March 2015.47

To assist in meeting the goal of submitting an acceptable DC application, the staff conducted a 

preapplication audit and extensive additional preapplication discussions with KHNP. To further 

support the goal of receiving a high-quality application, the staff updated NRO Office Instruction 

NRO-REG-104 in late 2014 for the conduct of preapplication readiness assessments. 

The APR1400 DC review project is currently on schedule. Some challenges associated with 

KHNP RAI response times are beginning to emerge, in part due to the volume and timing of 

RAIs being sent to KHNP. At this point, the overall schedule has not been impacted. 

Discussions with the applicant have emphasized the importance of improving RAI response 

time. Lessons learned from previous projects for RAI management are being applied to the 

APR1400 review and are discussed further in Section 5. The staff has also adopted a set of 

review process strategies to support safe and timely completion of the review (see Attachment). 

Refer to Table 1 for the associated safety review and rulemaking durations and milestones. 

4.3 Summary of Design Certification Reviews 

Table 1 summarizes the DC reviews conducted by the staff. The impacts of the various factors 

described above in the DC review summaries are clearly reflected in the overall review 

durations shown in Table 1. 

 

47 Letter from J. A. Ciocco to Dr. Ha-Hwang Jung, Korea Hydro and Nuclear Power Co., Ltd, and Dr. Hee-Yong 

Lee, Korea Electric Power Corporation – “Acceptance of the Application for Standard Design Certification of 

the APR1400,” March 4, 2015 (ADAMS Accession No. ML15041A455) 
22 

Table 1 Summary of Design Certification Reviews 

Proposed 

Design 

Duration of 

Acceptance 

Review 

(months)* 

Date DC 

Application 

Submitted 

Duration of 

Safety 

Review 

(months)* 

Duration of 

Rulemaking 

(months)* 

Date Certified 

ABWR 36 03/1989 a 61 34 05/1997 

System 80+ 26 03/1989 39 33 05/1997 

AP600 6 06/1992 69 15 12/1999 

AP1000 3 03/2002 27 19 01/2006 

AP1000 

amendment 

8 05/2007 43 17 12/2011 

ESBWR 4 08/2005 63 43 09/2014 

U.S. EPR 2 12/2007 Suspended at 

request of 

applicant, 

2/2015 

N/A N/A 

US-APWR 2 12/2007 Review 

slowdown 

initiated by 

applicant, 

11/2013 

TBD TBD 

APR1400 2 12/2014 b 42 13 

(8 months 

after issuance 

of the 

safety review) 

TBD 

* Durations shown may not reflect the actual staff level of effort because they may include schedule delays for 

a variety of reasons including resolution of technical and policy issues, applicant response delays or pause 

requests, the quality of applications, and other factors. See individual design summaries in Section 4 for 

additional information. Rulemaking activities may begin prior to completion of the safety review, so the net 

project duration is generally less than adding the safety review duration and the rulemaking duration together. 

a GE submitted the ABWR design certification application in piecemeal fashion from 09/1987–03/1989. 

b KHNP initially submitted the APR1400 application in 12/2013. After completing its acceptance review, the 

staff determined the APR1400 application to be unacceptable. KHNP resubmitted its application in 12/2014. 

 
23 

5.0 INCORPORATION OF LESSONS LEARNED IN 

DC REVIEWS 

Shortly after issuing the COLs for Vogtle, Units 3 and 4, and Summer, Units 2 and 3, the NRC 

conducted a lessons learned review to identify potential enhancements to its 10 CFR Part 52 

licensing processes to support more effective and efficient reviews of future applications.48 That 

report considered experiences from all types of Part 52 application reviews conducted by the 

staff. All of the short-term actions identified in the 2013 report were completed in January 2015. 

The three remaining items are longer in duration: (1) update Regulatory Guide (RG) 1.206, 

“Combined License Applications for Nuclear Power Plants (LWR [light-water reactor] Edition);” 

(2) incorporate Interim Staff Guidance (ISG)-11, “Finalizing Licensing-Basis Information,” into 

the RG 1.206 update; and (3) update NUREG-1555, “Standard Review Plans for Environmental 

Reviews for Nuclear Power Plants.” 49 These three remaining items are being addressed by the 

staff, consistent with NRO’s work prioritization and available resources. 

For this report, the staff revisited selected lessons learned identified in that 2013 report and 

identified additional areas for review that seemed likely to reveal additional opportunities for 

process improvements in the context of performing DC reviews. These lessons learned are 

discussed below. 

Finally, the report describes the specific lessons learned actions now being applied by the staff 

to the APR1400 DC review. 

5.1 High-Quality Applications that Fully Address Relevant Regulatory 

Requirements and Staff Guidance Support the Conduct of the Review 

within a Predictable Timeframe 

The DC review experiences described in Section 4 of this report provide examples of 

applications that challenged schedule and resource assumptions. While the DC applications 

accepted for docketing met the existing standard at the time of acceptance (i.e., the application 

was sufficient to “begin” the review), the need for a higher standard of application completeness 

became apparent. In response to the related lesson learned, as discussed in the 2013 report, 

the staff changed its acceptance standard from “sufficient to begin the review” to sufficient to 

“conduct” the review. This change is expected to provide significant review efficiency gains for 

both the staff and the applicant. 

 

48 Memorandum from R. W. Borchardt to Chairman MacFarlane, et al, “New Reactor Licensing 

Process Lessons Learned Review,” April 18, 2013 (ADAMS Accession No. ML13059A240) 

49 Memorandum from Michael E. Mayfield and Scott C. Flanders to Glenn M. Tracy, Director of the Office of 

New Reactors, “Completion of Near Term Actions in Response to the New Reactor Licensing Process 

Lessons Learned Review: Title 10 of the Code of Federal Regulations Part 52 Report,” April 23, 2015 

(ADAMS Accession No. ML15091A398) 
24 

The change was implemented in the latest revision of NRO Office Instruction NRO-REG-100, 

“Acceptance Review Process for Design Certification and Combined License Applications.” 50

The staff applied this revised standard to the initial acceptance review for the APR1400 

application submitted by KEPCO and KHNP and determined the APR1400 application to be 

unacceptable for docketing due to a lack of completeness.51 As a result of the staff’s 

determination and over the course of several months, the applicant engaged the staff to address 

the application weaknesses identified and to revise its application to meet the standard of 

“sufficient to conduct the review.” After reviewing the resubmitted application, the NRC 

accepted and docketed the application, consistent with the revised acceptance review standard.

5.2 Applicants and NRC Staff Must Commit Resources to Promptly and 

Thoroughly Respond to Requests for Additional Information and 

Substantive Technical Matters to Support a Predictable Review Schedule 

Section 4 of this report describes the staff’s experiences with DC applicants in which significant 

delays in the review schedule resulted from the applicant’s inability to respond to RAIs and 

substantive technical issues within the assumed 30-day response timeframe. Reasons for 

these delays included corporate decisions to refocus application review timing and scope, 

underestimation of resource needs for complex technical issue resolution, and in one case, the 

impacts of a natural disaster on an applicant’s operations. In each of these cases, the NRC 

staff made efforts to accommodate the needs of the applicants. These examples demonstrate 

the staff’s flexibility in working with applicants with special circumstances during the DC review. 

However, absent special circumstances, applicants must be prepared to commit the necessary 

resources to respond to RAIs and to resolve complex technical issues promptly. This support is 

especially critical during Phases 1 and 2 of the review, when the staff’s technical review efforts 

are highest. To support planned schedule milestones, the applicant must be prepared to 

support the response timeliness and technical sufficiency planning goals. One way the staff 

assists applicants in this regard is to communicate NRC staff support expectations to the 

potential applicant early in the preapplication period. The potential applicant can then examine 

these expectations in the context of their own organizational capacities and make adjustments 

early in the application review process, if needed. The EPM platform and the NRO planning 

and scheduling instruction 52 are being used to identify schedule risks and staff resource 

impacts resulting from delays associated with the applicant’s organizational capacities. 

For future DC reviews, the staff continues to evaluate the merits of revising the planning 

and scheduling baselines to ensure that schedule goals are realistic and experience based. 

One such change under consideration is to plan for a range of expected response times for 

 

50 NRO Office Instruction NRO-REG-100, “Acceptance Review Process for Design Certification and Combined 

License Applications,” Revision 2, December 18, 2014 (ADAMS Accession No. ML071980027) 

51 Letter from D. B. Matthews to B. Cho and H. Lee, “Korea Hydro and Nuclear Power Co., Ltd., and Korea 

Electric Power Corporation – Non-Acceptance of the Application for Standard Design Certification of the 

APR1400,” December 19, 2013 (ADAMS Accession No. ML13351A417) 

52 See NRO Office Instruction NRO-REG-116, “Planning and Scheduling,” Revision 0, May 9, 2013 

(ADAMS Accession No. ML12132A159 (Package) – NONPUBLIC) 
25 

RAIs and complex technical issues, on the order of 45–60 days for the most complex issues, 

considering feedback from the applicant in making the duration determination. 

The staff believes that the best way to minimize the applicant support requirements in the early 

phases of the application review is to ensure that the proposed design is mature and the 

application has the content and detail needed by the staff. As seen in the APR1400 review, this 

minimizes RAIs and unforeseen technical issues. Frequent communications between 

prospective applicants and the staff during the preapplication phase activities are key to 

achieving this goal. 

5.3 Early Identification and Timely Resolution of Complex Technical and Policy 

Issues Minimize Impacts on the Review Schedule 

When developing a new reactor review schedule, the staff assumes that the DC application 

contains sufficient details to resolve all safety issues. The staff also relies on preapplication 

discussions and early topical/technical report reviews to identify policy and technical issues for 

early resolution. Ideally, policy and technical issues will be resolved by the prospective 

applicant and the staff prior to application submission. This will enhance regulatory certainty 

and minimize application review schedule impacts. As the staff learns more about applicants’ 

plans to identify and address policy and technical issues related to their specific designs, the 

staff will engage with the Commission, as appropriate, to reach the earliest possible resolution 

of these issues. The staff will also continue to independently identify technical and policy issues 

that may be applicable to multiple reactor designs to improve the efficiency of future reviews. 

Examples of complex technical issues that required significant schedule adjustments during 

previous DC reviews include DI&C issues (U.S. EPR and US-APWR), structural design 

methodology changes (US-APWR), and system design issues (ESBWR). Section 4 of this 

report provides additional information on these issues. For each of these issues, the NRC staff 

proactively identified areas where the applications did not furnish information sufficient to reach 

a safety finding, and worked or is working with each applicant to obtain the required 

supplementary information. 

In order to achieve an efficient review, prospective applicants intent on pursuing a DC 

application should commit to working with the NRC staff to resolve technical issues (such as 

DI&C and seismic/structural challenges) early, and to reaching resolution before submitting an 

application. With its emphasis on preapplication communications, the revision to the NRO office 

instruction on acceptance reviews, and with the issuance of the NRO office instruction on 

preapplication readiness assessments, the staff has implemented the supporting elements of 

this lesson learned. 

5.4 Improvements to All Aspects of Requests for Additional Information 

Can Contribute to a More Efficient Review 

The staff’s DC review experiences have illustrated opportunities for improvement of RAIs across 

the RAI life cycle, including content quality, process management, eRAI platform 

enhancements, applicant responsiveness, technical sufficiency, closure criteria, and knowledge 
26 

management. Section 4 of this report describes some of the RAI challenges faced by the staff 

and applicants for DC applications for new nuclear plant designs. 

In the 2013 Lessons Learned report, the staff attributed the large number of RAIs to: (1) the 

lack of information in the application to support the conduct of the review; (2) the insufficient 

response to the RAIs that resulted in numerous, iterative RAIs; (3) the substantive RAIs related 

to testing, new computer analyses, or novel modeling methods to support new analyses that 

would typically take more than 30 days for the applicant to develop and submit a response to 

the staff for review; and (4) the lack of staff discipline in determining that subsequent RAIs 

would result in a timely resolution to the issue. 

In its 2013 report, the staff determined that improvements to the RAI management system 

would support a more efficient review by ensuring consistency and timely communication of 

issues to both management and the applicant. The staff has implemented improvements to its 

RAI management system and implementation guidance. These improvements include: 

(1) updated definitions and guidance on the status of the RAIs, including the capture of 

documentation supporting the closure of an RAI, but with the issue still unresolved; (2) more 

clearly defined roles and responsibilities for staff and managers; and (3) an updated office 

instruction on the purpose and use of the RAI management system.53

The staff is also working to improve the efficiency of the RAI process through several means 

other than those identified in the 2013 report. These include: (1) internally focusing on the 

quality and clarity of RAIs; (2) ensuring that an RAI is needed to reach a safety finding; 

(3) improving internal coordination to prevent duplicative RAIs; (4) applying an increased level of 

executive oversight of RAIs prior to issuance; (5) clearly communicating RAI response time and 

technical sufficiency expectations with applicants; (6) preparing preliminary or draft SERs before 

issuing RAIs, as learned during the ESBWR DC review; and (6) reviewing project schedule 

templates to include more realistic timeframes for RAI responses and resolution of related 

complex technical issues. 

Finally, the staff is making parallel efforts to minimize the need for RAIs. Example activities 

include: (1) early engagement with potential applicants to identify and clearly communicate 

NRC application requirements, guidance, and completeness and technical sufficiency 

expectations; and (2) an expanded use of informational conversations to enhance staff and 

applicant understanding of particular topics prior to the formal generation of RAIs. 

The staff anticipates that the combined effects of the improvement efforts noted above will 

support the interests of the applicants in maximizing the efficiency and effectiveness of the 

review process, and the interests of the staff in bringing specific reviews to closure in a 

structured and predictable manner. The staff continues to evaluate the impacts of implementing 

these improvements during its review of the APR1400 application by collecting and analyzing 

detailed process data for the RAI workflow. 

5.5 Living Our Mission 

 

53 NRO Office Instruction NRO-REG-101, “Processing Requests for Additional Information,” Revision 1, 

July 10, 2014 (ADAMS Accession No. ML14091A802) 
27 

In 2015, NRO published an internal guidance document for staff use entitled “Living Our 

Mission: An Enhanced Approach to New Reactor Reviews” (see Attachment). This document 

includes expectations for success for the staff and applicants, and strategies that support timely 

application review project execution. Important aspects of this document include an emphasis 

on the development of high-quality RAIs by the staff, and on other available methods to obtain 

needed information, such as meetings and audits. 

5.6 Summary of Lessons Learned Being Applied to the APR1400 DC Review 

NRO management established a 42-month goal review schedule for the APR1400 DC review, 

excluding rulemaking and the acceptance review. In summary, the management “best 

practices” and lessons learned being used for the staff’s review include: 

• implementing the revised NRO Office Instruction for RAIs for more rigorous acceptance 

review requirements (NRO-REG-101, published in July 2014); 

• implementing the NRO Office Instruction for conducting preapplication 

readiness assessments (NRO-REG-104, published in October 2014); 

• implementing the revised NRO Office Instruction for conducting acceptance reviews 

(NRO-REG-100, published in December 2014); 

• using an integrated, resourced project schedule that captures the key phases and review 

activities for all stakeholders and support organizations; 

• fine-tuning the level of detail in the schedule activity to optimize the balance between 

project management control and task assignment control (TAC) discipline; 

• using an officewide work prioritization system in order to coordinate review needs with 

available staff and with supporting Centers of Expertise (COEs); 

• optimizing the management of technical resources to support reviews and minimize 

turnover of technical reviewers; 

• maintaining appropriate focus on the information needed to reach safety findings for the 

most safety-significant areas (RAI discipline) when creating NRC RAIs and reviewing 

KHNP responses; 

• maximizing the use of the eRAI system to manage RAI correspondence, approval 

workflows, and status; 

• communicating the NRC expectation for RAI response times to applicants, and providing 

the opportunity to hold clarification calls on individual RAIs to ensure the applicant 

understands what information the staff is requesting and why; 

• maintaining appropriate review phase discipline as described in current NRO policy and 

guidance; 54

• placing additional emphasis on the project management functions of the review, 

including the collection and analysis of review workflow metrics that could reveal 

additional process improvement opportunities; 

 

54 Memorandum from F. Akstulewicz to NRO Division Directors and Deputy Division Directors, “Clarification 

of Phase Discipline Policy,” April 7, 2010 (ADAMS Accession No. ML100950260 – NONPUBLIC) 
28 

• preparing draft (preliminary) SERs before generating associated RAIs; 

• using applicant audits and confirmatory calculations when needed and appropriate; and 

• using the “Living our Mission” internal guidance document as a tool to reach review 

schedule goals safely. 

 
29 

6.0 CONCLUSIONS 

The staff developed this report in response to the Commission’s request for answers to 

two questions: 

(1) Can the NRC capture greater efficiencies in the Part 52 review process? 

(2) Should the NRC update the metrics for the length of time it will take to perform 

new reactor reviews under Part 52 based on experience? 

This report provides a historical summary of the staff’s DC application review experiences 

submitted under Part 52, and an analysis of how those experiences and other factors contribute 

to impacts on DC review schedules. The staff’s analysis concludes that lessons learned from 

review experiences are being appropriately identified and implemented. Additionally, the staff is 

working continuously to identify and communicate factors, which may cause review durations to 

extend beyond established goals. 

6.1 Part 52 DC Review Efficiencies 

The staff has determined that the Part 52 DC review process is sound and allows for an 

efficient review, as long as an applicant submits a high-quality, technically sufficient 

application, commits to providing the resources necessary to support the staff’s review, and 

addresses key policy and technical issues during preapplication discussions with the staff. 

Additionally, the staff has made considerable efforts to implement the lessons learned from 

previous reviews and to implement other new changes to improve review efficiency. 

The staff will continue to monitor DC review efficiency improvements gained by 

implementation of the actions identified in this report, and will continue to look for additional 

opportunities to gain additional DC review efficiency. 

The staff has also improved project schedule assumptions that have been used for many years 

in order to better reflect the NRC’s accumulated DC review experience. The use of improved 

assumptions, such as a more realistic RAI response time and a more accurate picture of staff 

resource capacities and availabilities, should lead to more accurate modeling of review projects 

and the associated resource requirements. This is particularly important in the NRC’s current 

operating environment in order to obtain the best possible match between staff critical skills, 

capacities, and review project resource demands. Better schedule assumptions should also 

provide project managers and technical staff with additional look-ahead time to mitigate 

schedule change impacts. 

6.2 Updates to Part 52 DC Review Duration Metrics 

The staff fully recognizes the value and importance of establishing challenging but achievable 

review timeliness goals, and the contribution of doing so to regulatory certainty. The staff also 

recognizes that, based on experience, fact-of-life changes during the review period, such as 

emerging technical issues or requests for review schedule changes by the applicant, can and 

often do occur. 
30 

The analysis of DC review experience has affirmed the staff’s approach of setting challenging, 

but achievable review duration goals and metrics, such as the 42-month DC safety review goal 

for large LWRs (like the KHNP APR1400) and the 39-month DC application review goal for 

small modular reactors (SMRs).55

From a communication perspective, the staff will place additional emphasis on explaining the 

planning and scheduling assumptions that support DC application review duration goals to all 

stakeholders in order to establish realistic review expectations. The review assumptions used 

for establishing the KHNP APR1400 review schedule provide the most up-to-date assumptions 

to be communicated. 

NUREG/BR-0468,56 “Frequently Asked Questions about License Applications for New Nuclear 

Power Reactors,” provides a specific estimate of the time required for the staff complete a COL 

review. The document says, “Generally, the NRC performs an acceptance review in 60 days, 

followed by a nominal 30-month detailed review for an application that references a certified 

design. Noncertified designs would take 48 to 60 months to review. The NRC also allows 

12 months for completion of the hearing.”57

There is no similar estimated timeline provided for DC reviews, either in the NUREG cited above 

or on the NRC public Internet Web site or in ADAMS. As noted above, the LPP, which did 

provide estimated review durations for DCs, is a nonpublic document used for staff planning 

purposes. While estimated DC durations for large LWRs have been discussed in various NRC 

forums, in Congressional testimony, and in independent reports by the Government 

Accountability Office (GAO),58 there is no public NRC document that provides this information in 

a detailed, consistent manner. 

In summary, the staff believes that the goal for the length of time it should take to perform 

new DC safety reviews under Part 52 has been set appropriately at 42 months. The staff 

will undertake efforts to communicate its review assumptions and expectations to 

stakeholders in a comprehensive manner. 

 

 

55 Public Meeting Slides “Baseline Schedule for SMR Design Certification Reviews,” February 24, 2014 

(ADAMS Accession No. ML14050A063) 56 NUREG/BR-0468, “Frequently Asked Questions about License Applications for New Nuclear Power 

Reactors,” December 2009 (ADAMS Accession No. ML092370545) 

57 Since NUREG/BR-0468 was issued in 2009, the NRC has issued COLs for Vogtle Units 3 and 4 (AP1000), 

Summer Units 2 and 3 (AP1000), Fermi Unit 3 (ESBWR) and STP Units 3 and 4 (ABWR). Total review and 

licensing times for these applications ranged from 47 months (Vogtle) to 101 months (STP). Acceptance 

review and hearing durations were within the NUREG estimated durations for all of these applications. 

Safety review durations for all COLs except STP have been adversely affected by significant delays with 

completing the safety reviews of the referenced design certifications. The STP review was delayed because 

of changes in the DC application reflecting a change in the nuclear steam supply system vendor from GE to 

Toshiba, and for policy matters related to foreign ownership and financial qualifications of the applicant. 

58 GAO Report No. GAO-15-652, “Nuclear Reactors Status and Challenges in Development and Deployment 

of New Commercial Concepts,” July 2015. Note that this report cites the NRC’s published small modular 

reactor (SMR) DC review estimate of 41 months (39 months plus a 2-month acceptance review), but 

incorrectly applies the estimated duration to any new LWR. 
31 

For large LWR DC reviews, the following review timeliness goals are being adopted: 

• 2 months for completion of the acceptance review 

• 42 months for completion of the safety review (factors such as the uniqueness of 

the design, the need for and extent of vendor testing required, and whether 

technical or policy matters are effectively addressed in pre-application reviews, will 

affect the ability of the staff to apply this goal in some cases) 

• 8 months after completion of Phase 4 of the safety review for completion of 

rulemaking (total rulemaking duration of 13 months) 

For SMR DC reviews, the recently established goal of 39 months from acceptance of the 

application to completion of rulemaking will continue to be used. This goal will be 

periodically reviewed as licensing experience for these reactors is accumulated. 

Further, the staff intends to review the existing published internal and external review 

duration guidance for each type of Part 52 application and to update the guidance as 

necessary to bring alignment with the review duration goals discussed above. 

6.3 Changing How Review Timeliness Goals and Schedules Are Calculated 

and Communicated 

As described in this report, application review durations can exceed the planned durations for a 

variety of reasons. Recognizing that some project delays are not attributable to the NRC staff, 

the staff intends to change the way project total project durations are calculated and 

communicated to provide clearer information on the cause of schedule changes. For example, 

an applicant’s request for a 1-year pause or slow-down to allow time to resolve a technical issue 

in a 42-month review schedule could be described as an “NRC safety review duration” of 

42 months and a “total review duration” of 54 months. In circumstances in which an applicant is 

not able to commit to or to provide the level of support resources necessary to accomplish a 

timely review, the NRC would consider formally suspending the application review. Similarly, if 

review delays are attributable to staff actions, that would be more clear. 

The staff will further develop the approach for capturing and presenting this information in a way 

that balances the needs of stakeholders to better understand the complexities of Part 52 

application review schedules, with the regulatory efficiency that the NRC commits to in its 

Principles of Good Regulation. 

The staff plans to inform stakeholders of these changes through a Regulatory Issue Summary 

(RIS) and to communicate review schedule expectations, by updating NUREG/BR-0468, and by 

discussing this broadly in meetings with prospective applicants and in appropriate public 

meetings and presentations. 

The staff plans to issue the RIS and revision to NUREG/BR-0468 by the end of 2016. 

Discussions of and presentations on the proposed update to the guidance are expected to begin 

in the summer of 2016 and continue as the update is finalized. 
32 

By communicating a more holistic picture of the overall schedule, all stakeholders should gain a 

better understanding of the staff’s level of effort. This picture could include the major review 

activities and durations, applicant response times, and other unique circumstances associated 

with each review project. 

The staff concludes that the changes discussed above, and other recent and on-going initiatives 

discussed in this report regarding the Part 52 reviews, provide a sound basis for high quality 

safety, security and environmental reviews which are consistent with the NRC’s mission and 

responsive to applicant and stakeholder needs and expectations. 

 
33 

ATTACHMENT – “LIVING OUR MISSION” (2 Pages) 

 
34 

 
35