NEW REACTOR LICENSING PROCESS 

LESSONS LEARNED REVIEW: 

10 CFR PART 52 

 

 

 

 

 

 

 

 

 

 

April 2013
Executive Summary 

The U.S. Nuclear Regulatory Commission (NRC) fully implemented the licensing portion of 

its new reactor licensing process1 with the issuance of combined licenses (COLs) for Vogtle, 

Units 3 and 4, and V.C. Summer, Units 2 and 3. Following the issuance of these licenses, the 

NRC initiated a lessons learned review to identify potential enhancements to Title 10 of the 

Code of Federal Regulations (10 CFR) Part 52, “Licenses, Certifications, and Approvals for

Nuclear Power Plants,” licensing process and contribute to more effective and efficient 

reviews of future applications. This lessons learned review is limited to the licensing 

portion of Part 52 and does not include experiences from post-COL issuance activities. 

To facilitate this lessons learned review, the NRC conducted an extensive outreach effort to 

solicit feedback from external and internal stakeholders on their experiences using the new 

reactor licensing process. Specifically, the NRC staff drew on previous assessments of 

portions of the new reactor licensing process, lessons shared at the NRC’s 2012 Regulatory 

Information Conference, feedback received at a public meeting on lessons learned, and the 

results of internal and external surveys on the new reactor licensing process. 

Although design certification and combined license reviews have taken longer and have 

been more technically challenging than anticipated, the results of this lessons learned 

review revealed no significant problems or impediments associated with the Part 52 

licensing process. Its implementation achieved the intended result of resolving safety and 

environmental issues before authorizing plant construction. Overall, the NRC received 

positive feedback on the licensing process and best practices that made the successful 

execution of the Part 52 licensing process possible. The design-centered review approach, 

as supported by design-centered working groups, standard designs, and standard format 

and content of licensing applications, was frequently cited as a licensing process success. 

Several other best practices were identified, such as frequent meetings between the 

applicants and the NRC to resolve complex technical issues. 

As expected with any new process, the first-time implementation of the Part 52 licensing 

process has resulted in challenges. An evaluation of these challenges identified the 

following lessons: 

 

1. High-quality applications, with sufficient level of design detail and 

environmental information, are a significant contributor to overall project 

performance. 

 

1 10 CFR Part 52, “Licenses, Certifications, and Approvals for Nuclear Power Plants” 
2. Timely development and maintenance of regulatory guidance are important to 

support the development of a high-quality application as well as contribute to an 

efficient regulatory review. 

3. Strong design standardization contributes to an efficient regulatory review while 

on-going design changes have the opposite effect. 

4. Early identification and timely resolution of complex technical issues minimize 

impacts on the review schedules. 

5. Improvements to NRC’s management system for requests for additional 

information (RAIs) can further enhance project knowledge management and 

contribute to a more efficient review. 

6. Concurrent reviews of design certifications and combined license applications 

contribute to maximizing standardization. Design certification rulemakings 

should not commence until all design issues are resolved. 

7. Updates to the regulations incorporating lessons learned will contribute to an 

enhanced licensing process. 

Stakeholders also identified communications as a critical cross-cutting area. A 

commitment by all parties to engage in an open, transparent, and timely manner, more 

than any other action, has led to, and will continue to result in, the successful 

implementation of the Part 52 licensing process. 

This lessons learned review identified several planned and potential actions that can be 

used to enhance the licensing process and improve the efficiency of future licensing 

reviews. Planned actions for each of the lessons learned are listed below: 

1. Quality of Applications 

 The NRC staff plans to review its acceptance review guidance to identify 

areas in need of enhancement. 

 The NRC staff plans to adhere more strictly to acceptance review criteria for 

future applications. 

 The NRC staff plans to engage future applicants with regards to the best 

timing for pre-application audits. The audits will evaluate level of detail of 

the application to ensure consistency with lessons-learned in reviews since 

2006. 

 
2. New Reactor Review Guidance

 The NRC staff plans to update Regulatory Guide 1.206, “Combined License 

Applications for Nuclear Power Plants (LWR Edition),” consistent with 

budgeted resources. 

 The NRC staff will consider establishing a process for synchronizing updates 

to Regulatory Guide 1.206 with updates to the Standard Review Plan. The 

NRC staff will consider reorganizing Regulatory Guide 1.206 to be more 

consistent with the organization of the Standard Review Plan. The NRC staff 

will also incorporate review experience by considering the results of 

commonly asked RAIs and their respective responses when Regulatory Guide 

1.206 is updated. 

 The NRC staff plans to continue its systematic Standard Review Plan update, 

consistent with budgeted resources, in a timely manner to support combined 

license, design certification, early site permit, and limited work authorization 

application reviews. 

 The NRC staff plans to proceed with environmental review guidance updates, 

consistent with budgeted resources. 

3. Standardization 

 The NRC staff plans to review ISG-11, “Finalizing Licensing-Basis 

Information,” to identify areas in need of enhancement. 

 The NRC staff plans to work with industry to expand the design-centered 

working group role to address common technical issues to ensure

consistency across different design centers. 

4. Identification and Resolution of Technical Issues 

 The NRC staff plans to update its staff guidance to ensure consistent use of 

best practices that facilitate timely resolution of complex technical issues and 

to more quickly engage higher levels of NRC and applicant management, 

when necessary, to resolve complex technical issues. 

 The NRC staff plans to continue to engage stakeholders, including vendors, 

standards organizations, and other regulatory bodies on complex and 

evolving technologies to enhance safety while streamlining the review 

process. 

 
5. Knowledge Management

 The NRC staff plans to enhance its RAI management system to improve 

search capability, consistent with budgeted resources. 

 The NRC staff plans to continue to examine its RAI process to ensure that 

RAIs are tracked consistently across design centers and information is 

communicated to applicants and management in a timely fashion.

6. Application Timing and Sequencing

 The NRC staff plans to apply the rulemaking process for future design 

certifications consistent with the 2009 streamlined approach, in which all 

design issues have been resolved before rulemaking begins. 

7. Updates to Regulations 

 Although this lessons learned effort did not identify any significant problems 

or impediments with the Part 52 licensing process, it has identified areas that 

could be enhanced. In fact, the staff has been identifying and collecting ideas 

for improvements since the 2007 Part 52 update. The NRC staff plans to 

communicate potential regulatory enhancements to the Commission along 

with a proposed rulemaking plan to obtain Commission approval to move 

forward with an update to Part 52 and associated regulations. 

 
Table of Contents 

I. Background.....................................................................................................1 

II. Scope and Methodology.................................................................................2 

III. Analysis of Feedback and Suggested Enhancements..................................3 

IV. Path Forward and Summary.........................................................................18 

Appendix A – New Reactor Licensing Process..................................................A-1 

Appendix B – References......................................................................................B-1 
 Page 1 

I. BACKGROUND 

The U.S. Nuclear Regulatory Commission (NRC) revised its regulations in 1989 to establish 

Title 10 of the Code of Federal Regulations (10 CFR) Part 52, “Licenses, Certifications, and 

Approvals for Nuclear Power Plants,” (Part 52) as an alternative to the existing process for 

reactor licensing under 10 CFR Part 50 (Reference 1). The NRC updated Part 52 in 2007 

(72 FR 49517 and 72 FR 57446) to increase regulatory certainty and stability and to 

enhance the NRC's regulatory effectiveness and efficiency in implementing its licensing and 

regulatory approval processes. This new licensing and regulatory approval process 

encouraged design standardization and provided a more predictable licensing process by 

resolving safety and environmental issues before authorizing plant construction. Under 

Part 52, an applicant may seek a combined license (COL) that provides authorization to 

construct and operate— subject to specific conditions—a nuclear power plant. Part 52 also 

includes the design certification (DC) process to approve a standard reactor design, and the 

early site permit (ESP) process to approve the suitability of a site for a nuclear power 

facility. The process also includes provisions for approval to perform limited construction 

activities before a COL is issued under a limited work authorization (LWA). A brief 

description of these licensing processes is provided in Appendix A, “New Reactor Licensing 

Process,” to this report, and additional details are available in NUREG/BR-0468, 

“Frequently Asked Questions About License Applications for New Nuclear Power Reactors” 

(Reference 2). 

A growing interest in new nuclear power generation in the industry gained support from 

the U.S. Department of Energy in 2002, through its Nuclear Power 2010 program, and the 

U.S. Congress in 2005, through incentives included in the Energy Policy Act of 2005, which 

included production tax credits, loan guarantees, and standby support in the event of 

regulatory delays. In preparation for the submittal of a large number of applications to 

construct and operate new nuclear reactors, in 2006 the NRC created the Office of New 

Reactors (Reference 3) to better prepare the agency for the anticipated new reactor 

licensing and construction inspection activities. 

On September 17, 2009—by which time there had been three DC applications, two DC 

amendment applications, and COL applications for 28 reactors at 18 sites submitted to the 

NRC for review—U.S. Representatives Joe Barton and Greg Walden sent a letter to former 

Chairman Jaczko expressing concerns about potential regulatory delays in the licensing 

process for new reactors (Reference 4). In response, former NRC Chairman Jaczko 

requested that the Bipartisan Policy Center review the NRC’s licensing process for new 

reactors to determine whether there were unnecessary delays in that process caused either 

by the NRC or the nuclear industry. 

 
 Page 2 

The Bipartisan Policy Center issued its report on April 6, 2010 (Reference 5), and stated 

that it did not find any evidence that either the NRC or the nuclear industry had needlessly 

delayed or extended the licensing process. The Bipartisan Policy Center further concluded 

the following: 

Although the licensing process is new, both the NRC and the industry have 

done a remarkable job in very trying circumstances assuring the thorough 

and timely evaluation of license applications. The fact that all parties have 

experienced some problems in navigating the process was to be expected 

under the circumstances. But it is apparent that all those involved have been 

diligent in working through the issues in a forthright manner. 

Nonetheless, the Bipartisan Policy Center recommended that the Commission “... ensure 

that the lessons learned in the first round of applications are rigorously applied to make 

the processing of subsequent applications more efficient.” 

In response, the NRC staff has undertaken a review to identify, assess, and document 

enhancements to the new reactor licensing review process one year after issuance of the 

first COL. 

II. SCOPE AND METHODOLOGY 

The NRC staff reviewed the new reactor licensing process, and assessed the experiences to 

date to identify enhancements that would increase the effectiveness and efficiency in future 

application reviews. The results are discussed in Section III of this report. The scope of 

this effort included the ESP, LWA, DC, and COL licensing processes (see Appendix A). A 

separate NRC lessons learned effort has addressed the mandatory hearing process. 

Post-COL activities (e.g., license amendments; inspections, tests, analyses, and acceptance 

criteria inspectability and closure; construction inspection) are being assessed in a 

separate activity initiated upon completion of the first year of safety-related construction at 

Vogtle and Summer. 

The NRC staff drew on previous assessments of portions of the new reactor licensing 

process, lessons shared at the NRC’s 2012 Regulatory Information Conference, feedback 

received at a public meeting on lessons learned, and the results of internal and external 

surveys on the new reactor licensing process (References 6 - 18). In addition, lead project 

managers, first line supervisors, and team leaders of NRC technical and licensing staff were 

interviewed to gather additional insights and lessons learned from experiences performing 

the ESP, LWA, DC, and COL reviews.
 Page 3 

An NRC working group conducted this lessons learned effort. From the sources described 

above, the working group identified seven lessons and associated planned actions that have 

the potential for positive gains in licensing review effectiveness and efficiency. 

III. ANALYSIS OF FEEDBACK AND SUGGESTED ENHANCEMENTS

Overall, respondents commended the Part 52 process as an improvement over the 

two-step 10 CFR Part 50, “Domestic Licensing of Production and Utilization Facilities,” 

licensing process because of reduced regulatory uncertainty through early resolution of 

safety and environmental issues before authorizing plant construction. Respondents also 

generally found implementation of the licensing process to be effective. They cited several 

items as key factors in the success of the process, including standardization; development 

of the design-centered review approach (Reference 19), based on a concept of industry 

standardization of COL applications referencing a standard design; and the formation of 

design-centered working groups comprised of DC applicants and one or more COL 

applicants referencing the same design. From 2007 to the present, both the NRC and 

industry have developed and adopted numerous best practices and improvements, some of 

which are described in this report. Further licensing process enhancements were 

identified from feedback received, and those are presented under the areas discussed 

below. 

Lesson 1: Quality of Applications 

One of the most important factors in the success of the licensing process is the submittal of 

a complete and high-quality application. Many of the schedule challenges in past and 

ongoing reviews can be linked to application quality as a root cause. Stakeholders 

indicated three areas that would enhance the quality of applications: (1) pre-application 

engagement, (2) an enhanced acceptance review process, and (3) the availability of 

guidance on level of detail. 

Pre-application Engagement

The NRC highly encourages pre-application interactions, particularly in areas where 

applicants are proposing new concepts or novel design features. Feedback indicated that 

these interactions are most helpful when they are focused on specific topics and detailed 

enough to enable a thorough understanding of the concept or design feature. This 

enhances the staff’s ability to identify any related technical or policy issue and develop a 

timely course of action. 
 Page 4 

Additionally, pre-application interactions are most effective when initiated well in advance 

of the expected application date. This allows the NRC adequate time to address any 

significant technical or policy issues and develop new regulatory tools that may be needed 

in advance of the application. It also allows an applicant to address staff concerns before 

submittal, and to prepare a complete and high-quality application. 

Another component to pre-application interaction are pre-application audits. These 

interactions are intended to assess the applicant’s readiness to submit a complete and 

high-quality application. Experience has shown that such audits could be more effective if 

the audits evaluated level of detail and if they are completed well in advance of the planned 

application date so that the applicant has time to incorporate any needed changes. 

The NRC is incorporating these lessons learned in its current pre-application interactions. 

The NRC is currently engaged in comprehensive and detailed pre-application interactions 

in preparation for DC applications for small modular reactors. These efforts are primarily 

to support the development of design specific review guidance for small modular reactors 

that will inform content of the applications and enhance review efficiency. The staff is also 

engaged in detailed pre-application interactions with the Korea Hydro and Nuclear Power, 

in preparation for an anticipated application for certification of the APR1400 large light 

water reactor design in calendar year 2013. 

Acceptance Review Process

The NRC conducts acceptance reviews to ensure that the application is complete and of 

high quality before the NRC staff begins its detailed technical review. Acceptance reviews 

are conducted in accordance with the guidance in Office Instruction NRO-REG-100, 

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

(Reference 20). A robust and detailed acceptance review can identify challenging review 

areas early in the licensing process. This helps both staff and applicants to identify areas 

that warrant additional focus and resources, and supports the establishment of a 

predictable and stable review schedule. At the conclusion of the acceptance review, a 

determination is made to accept the application for docketing, or not. In some cases, the 

NRC determined that a new reactor application was acceptable for docketing, 

notwithstanding numerous deficiencies that were identified in the application that 

prevented the NRC from establishing a review schedule at the time of docketing. While this 

approach was deemed the best course of action at the time so the staff could begin to 

review the initial wave of COL applications, this ultimately led to significant challenges in 

conducting these reviews in an efficient manner and contributed to prolonged review 

schedules. The staff plans to adhere more strictly to acceptance review guidance for future 

applications to avoid these challenges in the future. 

 
 Page 5 

Guidance on Level of Detail

Feedback from stakeholders indicated ambiguity about the level of detail needed in order 

for an application to be docketed. As discussed in NRO-REG-100, the NRC staff uses 

Regulatory Guide 1.206 (Reference 21), which provides guidance on the standard format 

and content of COL applications, and the review guidance in NUREG-0800, the Standard 

Review Plan (Reference 22) and NUREG-1555, the Environmental Standard Review Plan 

(Reference 23). The information required to docket an application must be sufficient for 

the staff to conduct its review. Currently, the NRC staff is reviewing its acceptance review 

guidance in NRO-REG-100 for potential clarifications and enhancements to better 

differentiate what level of detail is acceptable for docketing. The staff also believes it is 

beneficial to update Regulatory Guide 1.206, the Standard Review Plan, and the 

Environmental Standard Review Plan to address ambiguity in the level of detail that the 

NRC considers sufficient to meet the NRC’s regulations. In the interim, applicants can 

enhance the efficiency of a review by modeling their application to address issues at the 

level of detail included in previous certified designs and previous authorized ESPs and 

COLs. 

Lesson 2: New Reactor Review Guidance

Stakeholders emphasized the importance of developing and maintaining regulatory 

guidance as a key factor in successful implementation of the licensing process. Some 

feedback indicated that the NRC should be more proactive rather than reactive in 

developing and issuing guidance to address emergent issues to support an effective and 

efficient licensing process. The staff agrees with this comment. 

In fact, to support the anticipated submittal of new reactor license applications, in 2007 the 

NRC issued a comprehensive update to the Standard Review Plan. This was the first 

comprehensive update to the Standard Review Plan since 1981. In addition, in 2007 the 

NRC issued Regulatory Guide 1.206 to provide guidance on information to be submitted in 

a COL application. NRC development of Regulatory Guide 1.206 and the update to the 

Standard Review Plan were resource intensive and comprehensive. This interoffice effort 

included extensive outreach through numerous public workshops. The NRC had 

previously developed guidance to support the reviews of ESP applications (Reference 24). 

In addition, a major update to the Part 52 regulations (Reference 25) was processed at the 

same time. Stakeholders noted the challenges that both the NRC staff and industry faced 

with the development and issuance of new and revised guidance, at the same time that the 

first wave of COL applications was being prepared for submittal; but recognized that the 

communications, public interaction, and outreach during the development of the new 
 Page 6 

reactor licensing regulatory infrastructure was helpful in facilitating effective 

implementation of the new licensing process. Both internal and external stakeholders 

credited the issuance of Regulatory Guide 1.206 and the comprehensive updates to the 

Standard Review Plan and Part 52 in 2007 as major accomplishments that helped facilitate 

application submittals that were of sufficient quality and completeness to begin NRC 

application reviews. 

Subsequent to the updates to the Standard Review Plan and Part 52 in 2007, the staff 

recognized the need to ensure that guidance was developed or revised in a timely manner 

when new technical issues arose during the reviews. To address this need, NRC issued 

several interim staff guidance (ISG) documents. The ISGs will be incorporated into the 

Standard Review Plan or Regulatory Guides, as applicable, as time and resources allow. 

Examples of ISGs that were issued to provide timely guidance include the following: 

 DC/COL-ISG-1, Interim Staff Guidance on Seismic Issues of High Frequency Ground 

Motion 

 DC/COL-ISG-7, Assessment of Normal and Extreme Winter Precipitation Loads on 

the Roofs of Seismic Category I Structures 

 DC/COL-ISG-015, Post-Combined License Commitments 

A complete listing of the DC/COL/ISGs may be found on the NRC’s public Web page: 

http://www.nrc.gov/reading-rm/doc-collections/isg/col-app-design-cert.html. 

For digital instrumentation and control systems, the staff also developed and issued several 

ISG documents to provide additional guidance on new issues associated with application of 

digital technology in new reactor design. Examples of ISGs applicable for new reactors 

include the following: 

 DI&C-ISG-02, Diversity and Defense-in-depth Issues 

 DI&C-ISG-04, Highly-Integrated Control Rooms – Communications Issues 

 DI&C-ISG-05, Highly-Integrated Control Rooms – Human Factors Issues 

DI&C-ISG-02 has already been incorporated into Revision 6 of Standard Review Plan 

Branch Technical Position 7-19, and other ISGs are to be incorporated into the formal staff 

guidance. These digital instrumentation and control ISGs are listed on the NRC’s public 
 Page 7 

Web page: http://www.nrc.gov/reading-rm/doc-collections/isg/digital-instrumentationctrl.html. 

The staff also recognized that a process was needed to address new regulatory 

requirements that arose during reviews. The most significant examples encountered 

during the licensing process were the new requirements put in place following the accident 

at Fukushima. In SECY-12-0069, “Process for Addressing Late-Breaking Issues during a 

Combined License Application Review,” dated May 4, 2012, the staff proposed a process to 

address post-Fukushima requirements and other “late-breaking” issues at various stages 

during the COL review process. In its Staff Requirements Memorandum, the Commission 

approved the staff’s proposed approach and stated that the staff should strive to raise new 

issues before the completion of the mandatory hearing in order to afford applicants and 

other potential interested parties the greatest opportunity to provide comment. 

It should be noted that applicants are required to meet all applicable regulations in effect at 

the time of DC, and at the time of issuance of the license or permit for COLs and ESPs. 

Therefore, it is prudent for the staff and applicants to be forward-thinking and proactive in 

addressing emerging technical and regulatory issues as they arise during the review 

process to avoid or mitigate schedule impacts. For example, new regulatory guidance and 

generic communications should be promptly evaluated by the NRC staff to ensure that 

when new guidance is being created to address new requirements, the guidance is clear 

about how it pertains specifically to new reactor applications.

Going forward, the staff continues its commitment to a continuous, on-going effort to 

update guidance. For example, several Standard Review Plan sections have been updated 

since 2007, including the following: 

 Standard Review Plan 2.5.4, Stability of Subsurface Materials and Foundations, 

Revision 4, May 2010 

 Branch Technical Position 7-19, Guidance for Evaluation of Diversity and 

Defense-in-Depth in Digital Computer-Based Instrumentation and Control Systems, 

Revision 6, July 2012 

 Standard Review Plan 13.6.6, Cyber Security Plan, Revision 0, November 2010 

(Initial issuance) 

 Standard Review Plan 13.6.1, Physical Security – Combined License and Operating 

Reactors, Revision 1, October 2010 
 Page 8 

 Standard Review Plan 13.6.2, Physical Security – Design Certification, Revision 1, 

October 2010 

The current version of all Standard Review Plan Sections may be found on the NRC’s public 

Web page: http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr0800/. 

The NRC staff is in the process of revising a significant number of Standard Review Plan 

sections to incorporate lessons learned from completed licensing reviews and to reflect 

guidance for the new regulatory requirements. The staff is focusing its guidance 

development efforts on review areas in which a significant number of complex requests for 

additional information (RAIs) have been needed, review areas that are typically a critical 

path on the review schedule, and areas that have needed more staff resources than 

anticipated. 

As one example, the areas of seismic analysis and structural (addressed in Standard Review 

Plan Sections 3.7 and 3.8) have proven to be challenging reviews. During the reviews of 

recent DC and COL applications, the NRC staff identified a number of significant issues 

related to seismic analysis and structural design that required the applicants to submit 

additional information. These reviews also tended to be resource intensive and a critical 

path on the review schedule. The lessons learned from these reviews were used to identify 

11 key technical areas related to seismic analysis and structural designs in which the NRC 

staff guidance in Standard Review Plan Sections 3.7 and 3.8 could be improved to facilitate 

a more effective and efficient review process for future applications. The enhanced review 

guidance is intended to clarify the technical issues and staff expectations, and ensure a 

more uniform review process. The draft revision to seismic and structural review guidance 

was published for use and comment in February 2013 (Reference 26). 

In addition, Standard Review Plan sections in several other technical areas also have been 

revised to incorporate lessons learned and were recently issued for public comment, 

including Standard Review Plan Chapter 12, “Radiation Protection” and Standard Review 

Plan Section 19.0, “Probabilistic Risk Assessment and Severe Accident Evaluation for New 

Reactors.” New Standard Review Plan Section 19.3, “Regulatory Treatment of Non-Safety 

Systems for Passive Advanced Light Water Reactors,” was issued to incorporate lessons 

learned from the review of the Economic Simplified Boiling-Water Reactor and AP 1000 

advanced passive reactor designs to support future reviews of small modular reactor 

designs incorporating passive features. New Standard Review Plan Section 19.5, 

“Adequacy of Design Features and Functional Capabilities Identified and Described for 

Withstanding Aircraft Impacts,” was issued to provide review guidance to address the 

requirements of 10 CFR 50.150, “Aircraft Impact Assessment,” and to reflect staff 
 Page 9 

experience with completed reviews. Further, a significant number of additional Standard 

Review Plan sections are scheduled to be issued this calendar year, including Standard 

Review Plan Sections 2.5.1 through 2.5.5, regarding site seismology and geology; Standard 

Review Plan Chapter 11, “Radioactive Waste Management;” Standard Review Plan Section 

14.3, “Inspections, Tests, Analyses, and Acceptance Criteria;” Standard Review Plan Chapter 

18, “Human Factors Engineering;” and new Standard Review Plan Section 19.4, “Loss of 

Large Area due to Explosions and Fire;” addressing the requirements of 10 CFR 50.54 

(h)(h)(2). The NRC plans to continue to develop Standard Review Plan updates to support 

future applications reviews, including the APR1400 and small modular reactor designs, 

consistent with budgeted resources. 

 

As a significant new initiative, the NRC has embarked on an effort to incorporate 

design-specific risk insights and lessons learned from the reviews of large light water 

reactors and apply these to future reviews of small modular reactors to make them more 

effective and efficient. To implement these insights and lessons learned, the NRC is 

developing design specific review standards for staff review of two anticipated small 

modular reactor DC applications2. These review standards will incorporate the lessons 

learned from staff reviews of both active and passive plant designs and provide greater 

focus on structures, systems, and components that perform significant functions important 

to minimizing the accident risk and ensuring plant safety. 

For example, in Chapter 7 of the mPower design specific review standard (Reference 27), 

the NRC incorporated key lessons learned with completed and ongoing reviews of digital 

instrumentation and control systems. All of the new reactor designs, such as AP1000, 

U.S. Evolutionary Power Reactor, Economic Simplified Boiling-Water Reactor, and the 

U.S. Advanced Pressurized-Water Reactor, contain highly-integrated and complex digital 

instrumentation and control systems and present issues that are not relevant to analog 

systems. The staff’s licensing reviews to determine the safety of these digital 

instrumentation and control systems have been resource-intensive and challenging. These 

reviews have often been on or near a critical path for each of the projects. To address the 

significant lessons learned from these reviews, the staff undertook an innovative, 

integrated approach to develop design specific review standards that will allow future 

review to be more effective and efficient. This integrated approach contributes to the 

 

2 The NRC Is currently in pre-application discussions with Generation mPower, LLC on their mPowerTM small modular 

reactor design and NuScale Power on their small modular reactor design. The NRC plans to issue design specific review 

standards for each these small modular reactor designs prior to expected submittal date of the DC applications. 
 Page 10 

efficiency of the staff reviews by facilitating the timely identification and resolution of the 

key safety issues involving digital instrumentation and control systems, and enhances the 

safety focus of the reviews by emphasizing the safety-significant aspects of the design. As 

one example, in the challenging area of communication independence, the guidance 

provides greater clarity with respect to the review steps and acceptance criteria. These 

modifications are intended to discourage unnecessary complexity by encouraging simpler 

designs with less interdivisional communications. Another example is that the guidance is 

restructured so that fundamental design principles for instrumentation and control design 

(e.g., redundancy, independence, and diversity and defense-in-depth), are explicitly 

discussed to focus the staff’s review. As experience is gained with using this new guidance, 

the NRC staff plans to apply the guidance more broadly to other new reactor application 

reviews. 

 

As discussed above, the NRC staff has made good progress on updating the Standard 

Review Plan. Feedback from stakeholders indicates that the NRC should also update 

Regulatory Guide 1.206 to be consistent with the updated Standard Review Plan 

information and to incorporate the review experience. The staff agrees this would be 

beneficial and will also consider the insights from RAIs issued and RAI responses to inform 

the update. Such an update could help reduce the number of future RAIs. The staff plans to 

proceed with an update to Regulatory Guide 1.206, consistent with budgeted resources. 

 

With regard to environmental reviews, there are a number of initiatives that are being 

considered or underway to update and enhance guidance. For example, the NRC plans to 

issue two environmental ISGs in calendar year 2013, one to clarify the guidance in the 

Environmental Standard Review Plan to incorporate lessons learned from completed 

reviews, and another to clarify the guidance as applied to environmental reviews for 

licensing applications for small modular reactors. While portions of the Environmental 

Standard Review Plan were updated in 2007, many sections have not been updated since 

2000. Consequently, a full update is needed to incorporate changes in review methods and 

numerous lessons learned over the past several years. Progress in updating the 

Environmental Standard Review Plan has been limited due to competing priorities and 

resource availability. 

The NRC also plans to update regulatory guides associated with the environmental reviews 

to incorporate lessons learned, specifically Regulatory Guide 4.2, “Preparation of 

Environmental Reports for Nuclear Power Stations,” which provides format and content 

guidance for environmental reports, and Regulatory Guide 4.7, “General Site Suitability 

Criteria for Nuclear Power Stations,” which provides specific technical guidance for 

determining the suitability of sites for the construction and operation of nuclear power 
 Page 11 

stations. The NRC plans to proceed with environmental review guidance updates, 

consistent with budgeted resources. 

In addition to NRC’s review guidance, the interactions between NRC and the other agencies 

with a role in the overall regulatory process could be enhanced. There are numerous other 

Federal and State regulatory agencies from which a COL or ESP applicant must receive 

regulatory approval, in addition to the requested NRC license or permit. Experience with 

the environmental review process has shown that applicants should resolve issues with 

other Federal and State permitting agencies early in the project development process, so 

that an issue with another regulatory agency does not cause a delay in the NRC’s review. 

For example, for sites where building the facility may involve impacts to wetlands that 

require a permit from the U.S. Army Corps of Engineers (USACE), the USACE may require 

an applicant to demonstrate that its proposal is the Least Environmentally Damaging 

Practicable Alternative (LEDPA). Applicants should ideally consider the USACE’s LEDPA 

requirements concurrent with preparing their environmental report as part of a COL or 

ESP application. Doing so will help ensure that an applicant’s assessment of potential 

environmental impacts will meet both NRC and USACE requirements. In light of these 

concerns, the NRC has worked with industry and other Federal and State agencies to 

develop guidance for potential applicants. As a result of these interactions, the industry 

has developed NEI 10-07, Revision 1 (Reference 28) to provide guidance to industry. The 

staff held two public meetings with other Federal and State agencies to help inform the 

guidance. The agencies involved included the U.S. Environmental Protection Agency, 

USACE, U.S. Fish and Wildlife Services, Bureau of Land Reclamation, Advisory Council on 

Historic Preservation, and the Commonwealth of Virginia. 

Lesson 3: Standardization

The DC process is designed to reduce licensing uncertainty by resolving design issues early 

in the licensing process and to facilitate standardization of future plants. To execute an 

effective and efficient review of multiple license applications referencing the same certified 

design, the NRC developed an implementation strategy that leveraged design 

standardization consistent with Commission policy. This implementation strategy is called 

the design-centered review approach and is based on a concept of industry standardization 

of COL applications referencing the same standard design. This approach uses, to the 

maximum extent practical, a “one issue, one review, one position–multiple applications” 

strategy. That is, for any given technical, policy, or regulatory issue, the NRC will review 

that issue one time and develop a single position. That position can then be applied across 

all COL applications within a design center, as applicable, without requiring further review 

by the NRC staff. 
 Page 12 

Standardization of COL information through the implementation of the design-centered 

review approach was a major factor that made implementation of Part 52 possible when 

regulations, guidance, and processes were under development. This approach also added 

efficiency to the licensing process. Stakeholders frequently cited this practice as 

particularly effective and regarded it as instrumental in the success of COL reviews. 

Stakeholders further indicated that the design-centered working groups that were 

established to support the design-centered review approach were effective in 

communicating and identifying issues early and resolving them within the established 

review schedule. Stakeholders mutually agreed on the effectiveness of the design-centered 

working groups and regarded it as a major factor in the success of the licensing process, so 

much so that it was suggested that the concept be a mandatory element of the licensing 

process. Also, because of its efficiency and prominent role in issue resolution, the 

design-centered working group concept can be expanded to address common technical 

issues to ensure consistency across different design centers. The staff agrees and continues 

to encourage the application of the design-centered review approach to certification and 

licensing reviews. 

One difficulty the staff encountered was the number of requests for substantial design 

changes initiated by DC and COL applicants during the application review process. In these 

cases, the NRC staff has to re-review portions of the DC application, thus causing schedule 

delays and reducing review efficiency. Feedback also indicated that changes to the sitespecific content in COL and ESP applications during ongoing application reviews can result 

in schedule delays and inefficiencies. 

Stakeholders commonly recognized that a “freeze point” in the design proposed in the DC, 

COL, or ESP application needs to be established, such that the NRC staff can perform its 

review efficiently and on a predictable schedule. Ideally, the design would be frozen before 

submittal to the NRC for review. Recognizing that this is not always achievable, minimizing 

changes after submittal of an application substantially increases the effectiveness and 

efficiency of the review. To provide guidance in this area, ISG-11, “Finalizing LicensingBasis Information,” (Reference 29) outlines a differentiation between the types of changes 

that must be made before certification or licensing and the types of changes that could be 

deferred until after certification or licensing. Feedback indicated that ISG-11 guidance 

could be further clarified. The NRC plans to evaluate the implementation of ISG-11 and 

determine if additional guidance is warranted. 
 Page 13 

Lesson 4: Identification and Resolution of Technical Issues

When the staff receives a DC, ESP, or COL application, an acceptance review is conducted to 

determine if the application is sufficiently complete for the staff to begin its review. If the 

application is accepted, a baseline review schedule is developed. That schedule is 

predicated on general expectations for the complexity of the review and on anticipated 

time for the applicant to respond to RAIs from the staff. 

Experience with the reviews that have been conducted shows that the staff identifies issues 

of varying complexity; some are simple clarifications, while others raise specific and 

detailed issues. Applicant responses to RAIs on simple to moderately complex issues 

generally are provided in the 30-day response time the staff anticipated in developing the 

review schedule. However, some of the complex issues, and resulting complex RAIs, may 

require detailed analysis or testing to resolve and have led to changes in the design. The 

time needed for an applicant to address complex issues and RAIs can significantly exceed 

the anticipated 30-day response time, which adversely affected the overall schedule for 

some reviews. 

The staff and industry have developed and applied best practices to address complex RAIs, 

and thereby minimize adverse schedule impacts. For example, the staff may issue draft 

RAIs before the final RAIs are issued to ensure a common understanding of the additional 

information being requested and the reason. The NRC staff may also hold public meetings 

with the applicant to discuss, in depth, difficult technical issues in an effort to resolve them 

in a timely manner. Stakeholders indicated another best practice the NRC uses to ensure 

that the staff understands the documentation supporting the application, which can 

facilitate the staff’s review of complex issues, is the conduct of audits. Despite the 

preceding actions, resolution of complex issues and the associated RAIs still presents 

significant challenges. These challenges are often exacerbated when multiple rounds of 

RAIs and responses result in little progress toward resolution. One lesson learned from the 

RAI and issue resolution experience is that both the staff and applicant need to identify 

issues as early as possible and elevate them expeditiously, openly, and candidly so that the 

root cause of the disagreement can be identified and addressed. When applicant response 

to an RAI does not lead to resolution, NRC division management will hold a meeting with 

the applicant to help bring closure or mutual agreement to the issue. The NRC staff plans to 

update its internal guidance to more quickly identify these complex issues, and engage 

higher levels of NRC and applicant management to resolve these disagreements and to 

bring about timely resolution. 
 Page 14 

Another aspect of technical issue resolution identified in industry feedback was the level of 

detail the NRC staff requested to reach its safety conclusions. The feedback indicated that 

in some cases, the industry felt that the NRC staff requested applicants to provide more 

information than was necessary to support the safety finding. Thus, there is the potential 

for more information to be included in the licensing basis (e.g. in the design control 

document or final safety analysis report) than is required to support the staff’s safety 

findings. A concern was expressed that the level of detail in the AP1000 design control 

document may necessitate changes to the licensing basis as the detailed design is 

completed and construction proceeds for the COLs. According to these industry 

commenters, determining the appropriate balance between the level of detail required for 

the NRC to reach safety conclusions (to allow design certification or license issuance and to 

achieve the finality and standardization contemplated by Part 52) and the flexibility to 

make changes during construction continues to be a challenge. Recent experience with the 

construction of the AP1000 reactor at the Vogtle and Summer sites indicate there is some 

merit to this comment. Such an example is the identification of a specific weld 

configuration to connect components of the steel-concrete composite modules. The 

relevant characteristic of the weld in this condition is the capacity, which would be 

achieved by selecting a weld type. Several weld configurations could be documented in the 

field. The issue of necessary level of detail will be considered during the NRC staff’s 

guidance development efforts, particularly with respect to updating Regulatory Guide 

1.206, discussed above in Lesson 2. In addition, the staff will incorporate post-COL 

implementation enhancements that are identified as part of the staff’s ongoing selfassessment, into a proposed rulemaking activity as appropriate. 

The staff believes that the primary issues causing schedule and resource problems have 

been due to application quality, completeness and level of detail, and technical issue 

resolution, and are not specifically due to Part 52 license process issues. Complex technical 

issues and evolving-technology issues (e.g., seismic, structural, and digital instrumentation 

and control) are being addressed under separate initiatives, such as the Standard Review 

Plan updates described under Lesson 2. 

Lesson 5: Knowledge Management

The NRC established the design-centered review approach to make the reviews of COL 

applications that reference the same standard design more efficient and effective. One 

result of design-centered review approach implementation is the standardization of 

common COL information. This approach leads to efficiency in reviews. 
 Page 15 

In the past, there were instances where the staff issued RAIs that were duplicative or not 

relevant to a specific design center, and so proved unnecessary for the particular recipient. 

This required expenditure of unnecessary resources but did not result in appreciable 

schedule impacts. A process to ensure consistency across design centers and, more 

importantly, maintain project knowledge for future applications would be beneficial. In 

2007 the staff developed an RAI management system in anticipation of the large number of 

applications expected. This system is also a database that has searching and reporting 

capabilities that allow reviewers to see prior questions that have been asked on the same 

section of the regulation. While the current system has some search capability, it is limited, 

and the NRC is exploring upgrades to the system to improve this feature. 

The NRC’s RAI system was recently upgraded to add features to assist with project 

knowledge management, including enhanced capabilities to monitor and track the status of 

RAIs. From the initiation of an RAI through its closure, there can be significant interaction 

between the NRC staff and applicant. It is essential for the staff and the applicant to have 

accurate and timely information regarding RAI status to facilitate timely resolution. The 

NRC recognized this as an area in need of improvement and recently formed an internal 

working group to examine how the NRC staff ensures RAIs are tracked consistently across 

design centers and that timely information about RAIs is communicated to applicants and 

management. 

Feedback also indicated that the NRC’s RAI system was not being used for environmental 

reviews to capture and track environmental RAIs. Recently, the NRC adopted the RAI 

process for environmental reviews, including the Levy and Bell Bend COL applications, and 

plans to follow this practice for future reviews. 

The broader subject of knowledge management has been recognized to be a continuing 

challenge. This is particularly true in highly specialized technical areas where a limited set 

of experts are available within and outside the agency. For example, the NRC has a limited 

number of reviewers for seismic margins assessments, as supplemented by contractor 

support. This can contribute to delays in resolving difficult technical issues. The NRC is 

evaluating this and other key review areas, where it would be prudent to develop more 

staff expertise in order to support parallel application reviews. The NRC is also taking 

actions to transfer knowledge from senior staff before they leave the agency. As an 

example, the NRC has conducted several knowledge management seminars with senior 

environmental review staff. It is important that such actions be considered by the industry 

as well to address limited technical resources. 
 Page 16 

Lesson 6: Application Timing and Sequencing

Concurrent DC and COL Reviews

To maximize the benefits of standardization and issue finality available under Part 52, a 

COL application should reference a certified design. However, most COL applicants have 

submitted applications referencing DC applications or DC amendment applications that are 

still under NRC review. Feedback indicated both benefits and challenges to this approach. 

It maximizes the ability to address issues generically in the DC thus enhancing design 

standardization and minimizing subsequent departures during COL reviews. However, 

feedback indicated that difficulties can arise if the first application referencing a particular 

design is submitted too quickly after the DC application is submitted. Subsequent changes 

to the standard design resulting from the review have required the COL applicant to 

supplement its COL application to a greater degree than the applicant expected during the 

review process, resulting in schedule impacts and increased costs. In summary, the Part 52 

licensing process allows for concurrent reviews. While this may incur some inefficiencies, 

there may be situations where the benefits outweigh the challenges. 

Commencement of Design Certification Rulemaking

Experience with DC rulemakings, such as the originally certified AP1000, indicated that 

some schedule efficiencies could be gained in the rulemaking process. To address this, the 

DC rulemaking process was streamlined in 2009 to reduce the nominal 24-month 

rulemaking process to 12.5 months and to initiate the rulemaking earlier in the review 

process (Reference 30). This shorter duration and earlier start were based on a number of 

assumptions, including that all design issues would be resolved and no design changes 

would be initiated after the rulemaking process is started. 

More recent experience has indicated that initiating the rulemaking process too early in the 

DC review can result in rework and schedule delays. For example, in an attempt to gain 

further schedule efficiencies, the rulemaking process for the AP1000 DC amendment began 

when some significant open items remained. There also were a number of “confirmatory 

items” for which final resolution had not been completed. Following publication of the 

proposed rule, the staff concluded that these items required evaluation beyond simple 

confirmation. In addition, the applicant submitted analysis changes that required 

additional review. The need for additional staff evaluation of such issues added to the 

complexity of moving from the proposed to final rules. 
 Page 17 

While other application-specific factors such as the unusually high volume of public 

comments also contributed to delays in the schedule, the AP1000 amendment rulemaking 

took 17 months to complete. This was, in part, due to ongoing review of design changes 

and associated RAI resolution, some of which were due to errors identified by the applicant 

after publication of the proposed rule for public comment. The staff continues to believe 

that completion of a final rule is possible in 12.5 months if all assumptions for the 

streamlined process are adhered to, including ensuring that all design issues have been 

resolved before the rulemaking begins. Accordingly, the NRC has scheduled future DC 

rulemakings in accordance with this approach. 

Lesson 7: Updates to Regulations 

The NRC updated Part 52 in 2007 to incorporate enhancements that were the result of 

lessons learned during DC and ESP reviews and stakeholder discussions about the ESP, DC, 

and COL review processes. For example, one key change included in the 2007 rulemaking 

was to include a DC amendment process. This process was provided to enhance 

standardization by further completing or correcting the certification information. This 

process allows an amendment to the DC notwithstanding otherwise applicable backfitting 

standards if, for example, the amendment (1) reduces unnecessary regulatory burden and 

maintains protection to public health and safety and common defense and security; 

(2) provides the detailed design information necessary to resolve selected design 

acceptance criteria; (3) corrects material errors in the certification information; 

(4) substantially increases overall safety, reliability, or security of a facility, and the costs of 

the change are justified in view of that increase; or (5) contributes to increased 

standardization of the certification information. 

During this same timeframe, the NRC also redefined construction by amending its 

regulations applicable to limited work authorizations (LWAs) (Reference 31) to clarify that 

certain activities associated with site development for production and utilization facilities 

are not defined as “construction” and therefore do not require NRC authorization, so they 

may commence before a construction permit or COL is issued. As a result of Commission 

direction that nuclear power plant designers take into account the potential effects of the 

impact of a large, commercial aircraft, the NRC issued regulations on aircraft impacts in 

2009 (Reference 32). 

Since the issuance of the 2007 Part 52 rule update, NRC staff has been gathering 

corrections, clarifications, and other potential enhancements to the regulations in Part 52 

and associated requirements. This effort was further informed by stakeholder feedback 
 Page 18 

obtained as part of this lessons learned effort. Examples of possible enhancements to 

regulations include: 

 Consider adding a process to allow changes in the information contained in an LWA. 

A process similar to that provided in 10 CFR 50.59, “Changes, Tests, and 

Experiments,” for changes not requiring prior NRC approval and 10 CFR 50.90, 

“Application for Amendment of License, Construction Permit, or Early Site Permit,” 

for license amendments is envisioned. 

 Consider a change to the 10 CFR Part 73, “Physical Protection of Plants and 

Materials,” requirements, particularly as they apply to holders of a COL. The 2009 

revision to 10 CFR Part 73 (i.e., 10 CFR 73.55(b)(4)) requires operating reactor 

security programs be implemented before receiving unirradiated fuel within the 

protected area. For a COL holder, this may impose an unnecessary burden because 

the possession and storage of unirradiated fuel is no different in radiological 

hazards or risks from a license issued under 10 CFR Part 70, “Domestic Licensing of 

Special Nuclear Material.” Therefore, the staff would revise Part 73 (3) to better 

align Part 52 licensing requirements to those in Part 50 which currently requires a 

holder of a construction permit to meet the 10 CFR Part 70 requirements for receipt 

of fuel on site and the Part 73 requirements for protecting a nuclear power reactor 

are implemented prior to receiving the operating license (i.e., just prior to 

irradiating fuel). 

In addition, the staff will incorporate post-COL implementation enhancements that are 

identified as part of the staff’s ongoing self-assessment, into a proposed rulemaking activity 

as appropriate. 

Lastly, the staff is preparing a notation-vote paper for Commission consideration of 

potential policy options relating to the NRC’s requirements and process for evaluating the 

financial qualifications for merchant plant COL applicants. Industry representatives have 

asserted that it is difficult, if not impossible, for merchant plant COL applicants to secure 

project funding to meet the financial qualifications requirements in advance of initial 

license issuance. The staff will describe various licensing approaches and discuss the 

benefits and challenges of those approaches for addressing financial qualifications for 

merchant plant COL applicants. 

 

The staff plans to communicate appropriate regulatory enhancements to the Commission 

along with a proposed rulemaking plan to obtain Commission approval to move forward 

with an update to Part 52 and associated regulations. The staff recognizes that the time 
 Page 19 

required to complete rulemaking would not support having a final rule in place in time to 

support development of future Part 52 applications including the anticipated small 

modular reactor and APR1400 applications. However, engaging the public and interested 

stakeholders in dialogue regarding these potential enhancements and moving forward with 

potential rulemaking are important steps in making the new reactor licensing process 

more effective and efficient. Further, through early interactions with stakeholders during 

the regulatory basis development, future applicants will be fully informed of any potential 

regulatory changes. 

IV. PATH FORWARD AND SUMMARY

Although DC and COL reviews have taken longer and have been more technically 

challenging than anticipated, the results of this lessons learned review revealed no 

significant problems or impediments associated with the Part 52 licensing process itself. 

The first-time implementation of the licensing process has resulted in challenges, as 

expected with any new process. Feedback indicated that many lessons have already been 

learned and applied, and best practices implemented. This lessons learned effort identified 

further enhancements that could be taken to address remaining challenges; these actions 

are listed below. The staff intends to assess the resource needs of the suggested actions 

and will address these needs through the Planning, Budgeting and Performance 

Management process. 

1. Quality of Applications

 The NRC staff plans to review its acceptance review guidance to identify areas in 

need of enhancement. 

 The NRC staff plans to adhere more strictly to acceptance review criteria for future 

applications. 

 The NRC staff plans to engage future applicants with regards to the best timing for 

pre-application audits. The audits will evaluate the level of detail of the application 

to ensure consistency with lessons-learned in reviews since 2006. 
 Page 20 

2. New Reactor Review Guidance

 The NRC staff plans to update Regulatory Guide 1.206, “Combined License 

Applications for Nuclear Power Plants (LWR Edition),” consistent with budgeted 

resources. 

 The NRC staff will consider establishing a process for synchronizing updates to 

Regulatory Guide 1.206 with updates to the Standard Review Plan. The NRC staff 

will consider reorganizing Regulatory Guide 1.206 to be more consistent with the 

organization of the Standard Review Plan. The NRC staff will also incorporate 

review experience by considering the results of commonly asked RAIs and their 

respective responses when Regulatory Guide 1.206 is updated. 

 The NRC staff plans to continue its systematic Standard Review Plan update, 

consistent with budgeted resources, in a timely manner to support COL, DC, ESP, 

and limited work authorization application reviews. 

 The NRC staff plans to proceed with environmental review guidance updates, 

consistent with budgeted resources. 

3. Standardization 

 The NRC staff plans to review ISG-11, “Finalizing Licensing-Basis Information,” to 

identify areas in need of enhancement. 

 The NRC staff plans to work with industry to expand the design-centered working 

group role to address common technical issues to ensure consistency across 

different design centers. 

4. Identification and Resolution of Technical Issues 

 The NRC staff plans to update its staff guidance to ensure consistent use of best 

practices that facilitate timely resolution of complex technical issues and to more 

quickly engage higher levels of NRC and applicant management, when necessary, to 

resolve complex technical issues. 

 The NRC staff plans to continue to engage stakeholders, including vendors, 

standards organizations, and other regulatory bodies on complex and evolving 

technologies to enhance safety while streamlining the review process. 
 Page 21 

5. Knowledge Management

 The NRC staff plans to enhance its RAI management system to improve search 

capability, consistent with budgeted resources. 

 The NRC staff plans to continue to examine its RAI process to ensure that RAIs are 

tracked consistently across design centers and information is communicated to 

applicants and management in a timely fashion.

6. Application Timing and Sequencing

 The NRC staff plans to apply the rulemaking process for future design certifications 

consistent with the 2009 streamlined approach, in which all design issues have been 

resolved before rulemaking begins. 

7. Updates to Regulations 

 Although this lessons learned effort did not identify any significant problems or 

impediments with the Part 52 licensing process, it has identified areas that could be 

enhanced. In fact, the staff has been identifying and collecting ideas for 

improvements since the 2007 Part 52 update. The NRC staff plans to communicate 

potential regulatory enhancements to the Commission along with a proposed 

rulemaking plan to obtain Commission approval to move forward with an update to 

Part 52 and associated regulations. 

In addition to the Part 52 process, the staff has identified technical topics that will be the 

subject of continuing attention. Issues of high technical complexity (e.g., seismic and 

structural issues), evolving technologies (e.g., digital I&C applications), and policy matters 

(e.g., financial qualifications) are among those that warrant the focus of NRC, applicants, 

and other external organizations to achieve desired improvements in Part 52 

implementation. 

One area that would require only minimal resources, but have the potential for substantial 

benefits to the licensing process, is a continued commitment by all parties to communicate 

more effectively. Even in the most challenging of circumstances, issues were most 

efficiently resolved when the NRC staff and applicants engaged in open, transparent, and 

timely communications. Effective communications, more than any other action, has led to 

successful implementation of the Part 52 licensing process. 
A-1 

Appendix A—New Reactor Licensing Process 

Early Site Permit

An early site permit (ESP) approves a site for one or more nuclear power facilities separate 

from the filing of an application for a construction permit or combined license (COL), 

providing early resolution and finality for siting issues. ESP requirements are contained in 

Subpart A, “Early Site Permits,” to Title 10 of the Code of Federal Regulations (10 CFR) 

Part 52, “License, Certifications, and Approvals for Nuclear Power Plants.” In reviewing an 

ESP application, the staff addresses site-safety issues, environmental issues, and plans for 

coping with emergencies, independent of the specific nuclear plant design review. ESPs are 

valid for 10 to 20 years and can be renewed for an additional 10 to 20 years. The NRC staff 

has issued ESPs for the Clinton, Grand Gulf, Vogtle, and North Anna sites. One ESP 

application is under NRC review for the Salem/Hope Creek site. 

Limited Work Authorization

A limited work authorization (LWA) is a part of the licensing process that provides 

Commission approval to perform a limited and defined set of construction activities on 

production and utilization facilities before a COL or construction permit (CP) for the facility 

is issued. The LWA rule is not specific to 10 CFR Part 52; the applicable definitions and 

safety provisions are contained in 10 CFR 50.10, “License Required: Limited Work 

Authorization,” which includes provisions for new reactor license applicants. An LWA 

application may be submitted in conjunction with an ESP or COL application (or a CP 

application under 10 CFR Part 50, “Domestic Licensing of Production and Utilization 

Facilities”), or in advance of the CP or COL application under 10 CFR 50.10(d)(2). Those 

applications address the proposed LWA scope of work. Per 10 CFR Part 51, an LWA is a 

major Federal action that requires the staff to prepare an environmental impact statement. 

The interim staff guidance document COL/ESP-ISG-004, “Interim Staff Guidance on the 

Definition of Construction and on Limited Work Authorizations,” dated February 23, 2009, 

provides guidance related to LWAs including the definition of construction, 

preconstruction activities, and those activities that require prior NRC approval. LWAs 

under the current rule have been granted for Vogtle Units 3 and 4. 

Design Certification

The design certification (DC) process allows an applicant to obtain Commission approval of 

a design through rulemaking. For COL applicants, referencing a certified design reduces 

licensing uncertainty by resolving design issues generically, outside the scope of the COL 

review. It also facilitates standardization of future plants. The requirements for DCs are 

contained in Subpart B, “Standard Design Certifications,” of 10 CFR Part 52. The review of a 
A-2 

standard design is focused on ensuring that the design is safe as a result of compliance with 

the Commission’s regulations. The DC review does not address site-specific design 

features, operational programs, and environmental impacts of building the design at a 

particular site. The process for a DC concludes with a rulemaking. Once issued, a DC is 

valid for 15 years. The Commission recently certified the amended AP1000 and advanced 

boiling-water reactor designs. The Commission previously certified the System 80+ and 

AP600 designs. The Economic Simplified Boiling-Water Reactor, U.S. Evolutionary Power 

Reactor and U.S. Advanced Pressurized-Water Reactor DC applications currently are under 

NRC review. 

Combined License

A combined license (COL) is a combined construction permit and conditional operating 

license. The requirements for a COL are contained in Subpart C, “Combined Licenses,” of 

10 CFR Part 52. It authorizes both construction and operation of a new nuclear power 

facility. A COL application can reference an ESP, a certified design, both, or neither, as long 

as it addresses all applicable requirements and provides sufficient information for the 

review. Per 10 CFR Part 51, issuance of a COL is a major Federal action that requires the 

staff to prepare an environmental impact statement. To date, four COLs have been issued 

for Vogtle, Units 2 and 3, and V.C. Summer, Units 3 and 4. Several additional COL 

applications currently are under NRC review. 
B-1 

Appendix B—References

1. U.S. Nuclear Regulatory Commission, “Licenses, Certifications, and Approvals for 

Nuclear Power Plants,” Federal Register, Vol. 54, No. 73, April 18, 1989, 

pp. 15372-15400 

2. U.S. Nuclear Regulatory Commission, “Frequently Asked Questions About License 

Applications for New Nuclear Power Reactors,” NUREG/BR-0468, December 2009 

[ML100470391] 

3. U.S. Nuclear Regulatory Commission, SRM-SECY-06-0144, “Proposed Reorganization of 

the Office of Nuclear Reactor Regulation and Region II,” July 21, 2006 [ML062050196] 

4. Letter from U.S. Representatives Joe Barton and Greg Walden, “New Plant Licensing,” 

September 17, 2009 [ML092610843] and memorandum from Chairman Jaczko’s 

tasking to staff [ML101180446] 

5. Letter from the Bipartisan Policy Center on the review of NRC’s licensing process for 

new reactors from Senator Pete Domenici and Dr. Richard Meserve, April 6, 2010 

[ML101060212] 

6. U.S. Department of Energy Report on Lessons Learned from the NP2010 Early Site 

Permit Program, Retrieved from: http://www.docstoc.com/docs/636882/DOEreleases-Report-on-Lessons-Learned-from-the-NP-Early-Site-Permit-Program , 

March 26, 2008 

7. Nuclear Energy Institute, “Lessons Learned from Initial Early Site Permit Experience,” 

NEI-08-03, Revision 0, February 2008 [ML13072B136] 

8. Westinghouse Electric Company LLC, “Report on AP1000® Design Certification And 

Design Finalization Project with Lessons Learned,” March 2011 [ML13074A028] 

9. “U.S. Regulatory Infrastructure Findings,” prepared by Margaret Harding and Cornelius 

Milmoe, November 2012 [ML13072B109] 

10. Presentation from the 2012 Regulatory Information Conference: (1) Vogtle Units 3 & 4, 

Charles Pierce, Regulatory Affairs Manager, Southern Company, Retrieved from: 

http://www.nrc.gov/public-involve/conferencesymposia/ric/past/2012/docs/abstracts/pierce_c_hv_th24.pdf, March 15, 2012 
B-2 

11. Presentation from the 2012 Regulatory Information Conference: (2) New Reactors 

Licensed Under 10 CFR Part 52: The End Game – Coordinating Rules, Licenses and 

Mandatory Hearings, Sandy Rupprecht, Vice President, AP1000 Product Delivery 

Systems, Westinghouse Electric Company, Retrieved from: 

http://www.nrc.gov/public-involve/conferencesymposia/ric/past/2012/docs/abstracts/Rupprecht_s_hv_th24.pdf , March 15, 2012 

12. Presentation from the 2012 Regulatory Information Conference: (3) The End Game – 

Rules, Licenses, and Mandatory Hearings, Francis Akstulewicz, Deputy Director, 

Division of New Reactor Licensing, Retrieved from: http://www.nrc.gov/publicinvolve/conferencesymposia/ric/past/2012/docs/abstracts/akstulewicz_f_hv_th24.pdf, March 15, 2012 

13. Presentation from the 2012 Regulatory Information Conference: (4) Lessons Learned 

in Design Certification of Civil Structures for the U.S. EPR, Darrell Gardner, Manager, 

Regulatory Affairs, U.S. EPR Licensing, AREVA, Retrieved from: 

http://www.nrc.gov/public-involve/conferencesymposia/ric/past/2012/docs/abstracts/gardnerd-hv-w8.pdf, March 14, 2012 

14. Presentation from the 2012 Regulatory Information Conference: (5) Challenges and 

Lessons Learned in Design and Analysis of Civil Structures for New Reactors, Vogtle 

COL Applicant Perspective of Presentation for the 2012 RIC: Challenges and Lessons 

Learned, Donald P. Moore, Principal and Consulting Engineer, Southern Nuclear 

Operating Company, Retrieved from: http://www.nrc.gov/public-involve/conferencesymposia/ric/past/2012/docs/abstracts/moored-hv-w8.pdf, March 14, 2012 

15. Presentation from the 2012 Regulatory Information Conference: (6) Challenges and 

Lessons Learned In Design and Analysis of Civil Structures for New Reactors, Steve 

Thomas, Engineering Manager, STP 3&4, Nuclear Innovation North America, Retrieved 

from: http://www.nrc.gov/public-involve/conferencesymposia/ric/past/2012/docs/abstracts/thomass-hv-w8.pdf, March 14, 2012 

16. Presentation from the 2012 Regulatory Information Conference: (7) Specification for 

Steel-Concrete Composite Structures for Safety-Related Nuclear Facilities: 

Development and Current Progress, Amit H. Varma, Associate Professor & University 

Faculty Scholar, Director of Center for Structural Engineering Emerging Technologies 

and Nuclear Power Plants (SEET-NPP), Purdue University, Bowen Laboratory, West 

Lafayette IN, Retrieved from: http://www.nrc.gov/public-involve/conferencesymposia/ric/past/2012/docs/abstracts/varmaa-hv-w8.pdf, March 14, 2012 
B-3 

17. Presentation from the 2012 Regulatory Information Conference: (8) Challenges in 

Review of Seismic/Structural Designs for New Reactors, Jim Xu, Ph. D, U.S. Nuclear 

Regulatory Commission, Retrieved from: http://www.nrc.gov/publicinvolve/conference-symposia/ric/past/2012/docs/abstracts/xuj-hv-w8.pdf, March 

14, 2012 

18. U.S. Nuclear Regulatory Commission meeting presentation and meeting summary, 

“New Reactor Licensing Process Lessons Learned,” October 11, 2012 [ML12285A290] 

19. U.S. Nuclear Regulatory Commission, Regulatory Issue Summary 2006-06, “New 

Reactor Standardization Needed to Support The Design-Centered Licensing Review 

Approach,” May 31, 2006 [ML053540251] 

20. U.S. Nuclear Regulatory Commission, Office Instruction NRO-REG-100, “Acceptance 

Review Process for Design Certification and Combined License Applications,” 

September 26, 2007 [ML071980027] 

21. U.S. Nuclear Regulatory Commission, Regulatory Guide 1.206, “Combined License 

Applications for Nuclear Power Plants (LWR Edition),” June 20, 2007 [ML070720184] 

22. U.S. Nuclear Regulatory Commission, Bibliographic Data Sheet (NRC Form 335), 

“Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power 

Plants: LWR Edition,” NUREG-0800, March 29, 2007 [ML070880680]

23. U.S. Nuclear Regulatory Commission, “Environmental Standard Review Plan --Standard 

Review Plans for Environmental Reviews for Nuclear Power Plants", NUREG-1555, 

July 2007 [ML071860393 

24. U.S. Nuclear Regulatory Commission, Review Standard (RS)-002, “Processing 

Applications for Early Site Permits,” May 3, 2004 [ML040700236] 

25. U.S. Nuclear Regulatory Commission, “Licenses, Certifications, and Approvals for 

Nuclear Power Plants,” Federal Register, Vol. 72, No. 166, August 28, 2007, 

pp. 49352-49566 

26. U.S. Nuclear Regulatory Commission, “Proposed Revision to Design of Structures, 

Components, Equipment and Systems” Federal Register, Vol. 78, No. 41, March 1, 2013, 

pp. 13911-13912. (Correction to this notice: U.S. Nuclear Regulatory Commission, 

“Proposed Revision to Design of Structures, Components, Equipment and Systems; 

Correction” Federal Register, Vol. 78, No. 48, March 12, 2013, 

pp. 15755-15755) 
B-4 

27. U.S. Nuclear Regulatory Commission , Draft – “Design-Specific Review Standard for 

mPowerTM iPWR,” Chapter 7.0, Instrumentation and Controls – Introduction and 

Overview of Review Process [ML12108A272]; Chapter 7.2 – System Characteristics 

[ML12179A151] 

28. Nuclear Energy Institute, NEI 10-07, Revision 1, “Industry Guideline for Effective PreApplication Interactions with Agencies Other Than NRC during the Early Site Permit 

Process,” January 2013 [ML13028A392] 

29. U.S. Nuclear Regulatory Commission, “Final Interim Staff Guidance on Finalizing 

Licensing Basis Information,” Federal Register, Vol. 74, No. 215, November 9, 2009, 

pp. 57715-57715 

30. U.S. Nuclear Regulatory Commission, SECY-09-0018, “Streamlining Design Certification 

Rulemakings,” January 1, 2009 [ML082750046] 

31. U.S. Nuclear Regulatory Commission, “Limited Work Authorizations for Nuclear Power 

Plants,” Federal Register, Vol. 72, No. 194, October 9, 2007, pp. 57416-57447 

32. U.S. Nuclear Regulatory Commission, “Consideration of Aircraft Impacts for New 

Nuclear Power Reactors,” Federal Register, Vol. 74, No. 112, June 12, 2009, 

pp. 28112-28147