_____________

POLICY ISSUE

(Notation Vote)

April 1, 2015 SECY-15-0050

FOR: The Commissioners

FROM: Mark A. Satorius

Executive Director for Operations

SUBJECT: CUMULATIVE EFFECTS OF REGULATION PROCESS ENHANCEMENTS AND 

RISK PRIORITIZATION INITIATIVE

PURPOSE:

This paper responds to the Commission’s direction in Staff Requirements Memorandum 

(SRM)-COMSECY-14-0014, “Cumulative Effects of Regulation and Risk Prioritization Initiative: 

Update on Recent Activities and Recommendations for Path Forward,” dated July 18, 2014 

(Agencywide Documents Access and Management System (ADAMS) Accession 

No. ML14199A187). This paper provides the Commission with options for addressing the 

cumulative effects of regulation (CER) and the risk prioritization initiative (RPI) for operating 

power reactors. The options and the Nuclear Regulatory Commission (NRC) staff’s 

recommendation are based on recent CER and RPI activities and lessons learned, including 

CER case studies, RPI demonstration pilots, and stakeholder feedback. This paper does not 

contain any new commitments.

SUMMARY:

This paper provides four options for addressing CER and RPI. The first option maintains the 

status quo, which includes the current CER enhancements. The next three options augment 

current regulatory processes or propose changes to regulatory processes by incorporating risk 

insights to prioritize initial compliance and implementation dates for regulations and orders on a 

plant-specific basis for operating power reactors. 

CONTACTS: Steve Ruffin, NRR/DPR

301-415-1985

Antonios Zoulis, NRR/DRA

301-415-1209

 
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The staff recommends the Commission approve Option 2. This augments existing regulatory 

processes with a risk-informed prioritization method. In addition, the staff will explore using an 

internal expert panel to use risk information to enhance regulatory decision-making at the 

beginning stages of development of regulatory action as part of CER. The staff also 

recommends the Commission approve the pilot for Option 3, which would provide a voluntary 

opportunity for operating power reactor licensees to submit a plant-specific plan for initial 

compliance and implementation when the NRC develops a regulation. After obtaining feedback 

and lessons-learned from Option 2 and results of the pilot of Option 3, the staff would provide 

the Commission a paper on the results, and seek further direction if the staff believes it would 

be warranted. 

This paper was developed using feedback obtained from the public and with experience gained 

during tabletop and pilot exercises. The experience and feedback led to the four options 

described herein. This SECY also offers an update on staff efforts to address CER effects in 

the areas of operating power reactors, fuel-cycle facilities, Agreement State programs, and 

material licensees. 

BACKGROUND:

Consistent with Executive Order 13563, “Improving Regulation and Regulatory Review,” issued 

on January 18, 2011, and guidance provided by the Office of Management and Budget (OMB) 

memorandum, titled “Cumulative Effects of Regulation,” issued on March 20, 2012, the NRC 

staff’s CER efforts examine ways in which the agency may be able to enhance the efficiency 

with which it carries out regulatory actions, while mitigating the cumulative effect of regulatory 

activities on both the NRC and licensees. RPI would be intended to complement other CER

processes. If put into place, it could be a tool to reduce CER for operating reactor licensees. 

The goal is to enable NRC staff and licensees to focus resources on issues that are most 

significant to public safety using risk information. In addition, RPI could incentivize the further 

use and development of probabilistic risk assessment (PRA).

In COMSECY-14-0014, “Cumulative Effects of Regulation and Risk Prioritization Initiative: 

Update on Recent Activities and Recommendations for Path Forward,” April 9, 2014 (ADAMS 

Accession No. ML14069A061), NRC staff recommended that the deliverables for the following 

be merged:

• SRM-SECY-12-0137, “Implementation of the Cumulative Effects of Regulation Process 

Changes,” dated March 12, 2013 (ADAMS Accession No. ML13071A635)

• SRM-COMGEA-12-0001/COMWDM-12-0002, “Proposed Initiative to Improve Nuclear 

Safety and Regulatory Efficiency,” dated February 6, 2013 (ADAMS Accession 

No. ML13037A541)

Under the proposal, the staff would provide one notation vote paper, a summary of the results of 

case studies to review the accuracy of cost and schedule estimates used in the NRC’s 

regulatory analyses and a plan to sunset the development of a CER template. In 

SRM-COMSECY-14-0014, the Commission approved the NRC staff’s plan to merge the CER 

and RPI deliverables. The Commission also directed NRC staff to provide a notation vote paper 

that addresses consideration of the regulatory process changes required to support reliable, 
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efficient, and effective implementation of RPI in the long-term. The Commission directed NRC 

staff to provide a discussion on how corrective actions for findings, violations, and degraded or 

nonconforming conditions adverse to quality will be treated as part of RPI. This SECY paper 

addresses these Commission directives.

External Stakeholder Feedback on CER and RPI

The NRC staff held multiple public meetings to discuss the CER and RPI efforts for operating 

power reactors. (Public meetings before April 2014 are discussed in COMSECY-14-0014.) The 

NRC held its most recent public meeting on CER on October 9, 2014. That public meeting 

summary is available in ADAMS under Accession No. ML14316A022. 

The NRC staff received significant stakeholder input on RPI through the observation of generic 

and plant-specific tabletop exercises and the NRC staff’s participation in demonstration pilots of 

the Nuclear Energy Institute’s (NEI) draft prioritization process, which is discussed in 

Enclosure 2. Overall, the nuclear power industry expressed significant interest in using existing 

available risk information to prioritize regulatory activities. Industry evaluated a large number of 

issues during these exercises to demonstrate how risk insights can be used to prioritize both

plant-initiated and regulatory issues. The nuclear power industry indicated that further 

development of PRA capabilities as described in the 

SRM-COMGEA-12-0001/COMWDM-12-0002 would not be a prudent use of licensee resources 

at this time, given the large number of current regulatory activities facing the nuclear power 

industry, since the currently available risk information and tools are sufficient to support this 

effort.

RPI: NEI Draft Guidance Development and Demonstration Pilot Exercises

In October 2013, NEI began to develop a draft process as a potential way to address RPI for 

operating power reactors. NRC staff provided comments on NEI draft guidance at various 

stages using insights gained from tabletop exercises, demonstration pilots, and discussions with 

stakeholders during public meetings. NRC staff will continue to work with nuclear power 

industry and other stakeholders to evaluate possible endorsement of NEI guidance with 

appropriate clarifications and exceptions, if this initiative is approved by the Commission. The 

latest version of that guidance was submitted to the NRC by letter dated November 14, 2014 

(ADAMS Accession No. ML14325A681).

NEI’s draft process consists of three main elements: (1) generic prioritization by an industry 

generic assessment expert team (GAET) (Note: the GAET is the only component in the generic 

process; in addition some licensees may choose to use only the information obtained from the 

GAET or may chose not to participate in the RPI process at all), (2) plant-specific prioritization 

and scheduling by an integrated decision-making panel (IDP) of licensee experts, and (3) “issue 

aggregation.” The panel performing these elements would have expertise in PRA as well as 

other key areas, such as radiation protection, emergency preparedness, and nuclear security. 

The GAET’s conclusions from the generic prioritization component of the process would be 

passed on to operating power reactor licensees, which, in turn, would use that information 

during the plant-specific prioritization process to make the plant-specific determinations on the 

safety and security effect of each issue or activity. The IDP would then evaluate the issues as 

an integrated set and rank them relative to each other as part of issue aggregation, prioritizing 

items of higher safety significance over those of lower safety significance. 
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In COMSECY-14-0014, NRC staff described its observation of tabletop exercises of the draft 

process. Six operating power reactor licensees participated in the demonstration pilots: 

Palisades, H.B. Robinson, E.I. Hatch, Davis-Besse, Prairie Island, and V.C. Summer. 

The demonstration pilots were conducted between May and September of 2014. These 

licensees used the process described above. Each licensee prioritized 10 plant initiatives, such 

as: modifications and equipment replacement, regulatory obligations (e.g., National Fire 

Protection Association (NFPA) 805 implementation schedules), and docketed commitments 

associated with inspection findings. NRC staff observed all the activities at Palisades and H.B. 

Robinson. In addition, NRC staff observed a sample of issues from the remaining licensees. In 

September 2014, NRC staff held a public meeting to discuss the processes used by licensees 

to prioritize issues in security, emergency preparedness, and radiation protection. The risk 

significance of those issues is not easily amenable to quantification, and a small number of 

these issues were prioritized during the demonstration pilots. Enclosure 2 contains more details 

and insights obtained from the NRC staff’s participation in the demonstration pilots.

NRC staff also explored whether greater flexibility (including proposing alternatives or 

elimination) could be afforded if high quality, Level 1 and Level 2 PRAs were available. The 

amount of flexibility provided would be commensurate with the quality of risk information used to 

justify the request. If a licensee chose to develop greater PRA capability that was peer 

reviewed and consistent with Regulatory Guide 1.200, “An Approach for Determining the 

Technical Adequacy of Probabilistic Risk Assessment Results for Risk-Informed Activities” 

(ADAMS Accession No. ML090410014), then the licensee could propose an alternative or 

perhaps eliminate the issue altogether if the risk fell below established risk significance 

thresholds. However, based on stakeholder feedback, industry may not be prepared to conduct 

and maintain PRAs of the scope and quality that would be needed for NRC staff to allow a 

licensee to propose an alternative or to eliminate an issue. Furthermore, NRC staff would need 

to consider the effect of this option on legal, inspection, and enforcement issues. Consequently, 

the staff notes that, given the lack of experience in applying an RPI-type process and the 

substantial legal uncertainties, none of the options described in this paper include an elimination 

element.

DISCUSSION:

This paper provides the Commission with options and recommendations for CER and RPI for 

operating power reactors. The paper also provides an update of NRC staff efforts to address 

CER effects in the areas of operating power reactors, fuel-cycle facilities, Agreement State 

programs, and material licensees. These efforts are discussed in Enclosure 1.

The staff continues to make steady improvements in activities related to implementing CER. 

The rulemaking process enhancements to address CER (e.g., increased public interaction in all 

phases of the rulemaking process, publishing guidance with rules) have received positive 

feedback and are requirements per office rulemaking procedures. The NRC staff is encouraged 

by the increased public involvement in setting generic implementation schedules and feedback 

on at least one draft regulatory analysis. These activities will continue to be enhanced as part of 

Option 1.
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Regulatory Analysis Improvements

In SRM-SECY-12-0137, the Commission directed the staff to engage in case studies to 

evaluate the accuracy of cost and schedule estimates within regulatory analyses. The nuclear 

power industry completed those case studies and provided three recommendations related to:

the scope of the regulatory action, the early release of regulatory analysis and detailed 

implementation guidance, and cost estimates made in the regulatory analysis. NRC staff 

evaluated the industry’s recommendations, and has implemented additional regulatory analysis 

process enhancements as described in Enclosure 3. In addition, Enclosure 3 describes 

planned regulatory analysis updates, efforts made to improve cost estimating within regulatory 

analyses, and ways in which the risk insights gained from the generic prioritization component 

of the RPI process could be used to improve regulatory analyses.

CER Expansion to Generic Communications Program

In SRM-SECY-12-0137, the Commission directed that any expansion of the consideration of the 

CER should be considered in the broader context of RPI (e.g., guidance and generic 

communications). During CER public meetings in 2013, the nuclear power industry said there 

could be value in expanding the CER process enhancements to the generic communications 

program. In reviewing the processes for generic communications, NRC staff concluded that 

those processes already reflect elements of CER process enhancements. Those 

enhancements include providing opportunities for public interaction in the beginning stages of 

development and opportunities for public comment on some draft generic communications. As 

a pilot, NRC staff incorporated six CER questions in the Federal Register notices (FRNs) for two 

draft generic letters. NRC staff did not receive feedback that identified significant effects on the 

licensee’s ability to carry out other NRC regulatory requirements. However, as part of the pilot 

for an expert panel, discussed in Option 2 of this paper, the inclusion of generic communications 

could be considered as part of the regulatory actions evaluated under that option.

NRC staff plans to continue using the six CER questions in the FRNs for generic letters seeking 

information under Title 10 of the Code of Federal Regulations (10 CFR) 50.54(f), “Conditions of 

Licenses.” The six CER questions, findings and other considerations are discussed further in 

Enclosure 4.

Considerations for Implementing a Risk Prioritization Initiative

The SRM-COMGEA-12-0001/COMWDM-12-0002 directed the NRC staff to develop options for 

operating power reactors on “allowing licensees to propose to the NRC a prioritization of the 

implementation of regulatory actions as an integrated set and in a way that reflects their risk 

significance on a plant-specific basis.” That SRM also directed NRC staff to explore how such a 

process could enhance the use and development of PRA information. In this paper, NRC staff 

proposes four options for carrying out RPI in a manner that further addresses CER. Options 2 

and 3, if put in place would promote PRA by allowing operating power reactor licensees to use a 

risk-informed prioritization method to schedule regulatory actions using existing NRC regulatory 

processes based on currently available qualitative and quantitative PRA information and new 

PRA information emerging from other regulatory initiatives, such as industry implementation of 

the risk-informed fire protection standard, NFPA 805, and Fukushima-related initiatives. A 

fourth option (Option 4) explores a potential rulemaking that would promote the use of existing 
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PRA information and may incentivize operating power reactor licensees to develop new PRA 

information by enhancing their site-specific PRA models. 

SRM-COMSECY-14-0014 directed NRC staff to consider “how corrective actions for findings, 

violations, and degraded or nonconforming conditions adverse to quality will be treated as part 

of the risk prioritization initiative.” NRC staff, including regional NRC staff members who are 

experts in the reactor oversight process (ROP) area, evaluated this issue and sought 

stakeholder perspectives during public meetings. The nuclear power industry prefers that all 

issues, including those that are in response to items entered into their site-specific corrective 

action programs based on an NRC inspection finding, be part of the scope of RPI. Industry is of 

the view that such issues should be included under RPI because that would provide them with 

the ability to evaluate all issues when allocating resources, whether they are driven by 

inspections or otherwise. The NRC staff disagrees with the nuclear power industry on this 

aspect. RPI is generally intended to prioritize changes associated with the implementation of 

new or current requirements. The staff believes that licensees must restore compliance issues 

identified during inspections using existing processes associated with dispositioning inspection 

findings. As a result of the staff feedback to NEI, NEI revised its guidance to limit the proposed 

scope of RPI to docketed commitments resulting from inspection findings.

Discussion of CER and RPI Options for Operating Power Reactors

This discussion offers the options and recommendations for CER and RPI for operating power 

reactors. Each of these options builds upon the previous option(s), such that Option 2 includes 

the Option 1 CER process enhancements; Option 3 includes Options 1 and 2 CER and RPI 

enhancements; and Option 4 includes the CER and RPI enhancements in Options 1 through 3. 

The staff notes the NRC employs two approaches to address initial compliance and 

implementation schedule concerns: (1) “effective date” in the FRN (consistent with Office of the 

Federal Register limitations), or (2) implementation language in a paragraph of the specific rule, 

establishing the date for compliance with the rule. The NRC generally offers an opportunity for 

early stakeholder input on implementation schedule concerns. The NRC’s proposal, reflecting 

consideration of the early stakeholder input, would be reflected in the proposed rule (as 

approved by the Commission or the EDO, as applicable). Opportunity for stakeholder input on 

the NRC proposal in the proposed rule must ordinarily be provided as part of the proposed 

rule’s publication in the Federal Register. Final rule reflects the NRC decision-maker’s choice to 

use either effective date or implementation language.

Options 2 through 4 employ a risk-informed prioritization method guidance document. The 

guidance could be used two ways:

• The licensee could use the guidance to support processes that the NRC’s current 

regulatory framework allows. In those cases, the NRC would ultimately approve 

(through existing processes (i.e., exemptions or requests submitted during the proposed 

rule phase of prospective rulemakings) the plant-specific initial compliance and 

implementation schedules for regulations and orders.

• The process described in the guidance could be codified in the final rule language of 

prospective rules to allow licensees to establish plant-specific initial compliance and 

implementation schedules after final rule issuance OR a facilitating regulation could be 

issued to allow such a process for all future and existing regulations.
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In this Commission paper, the staff organizes the options in a step-wise manner per regulatory 

vehicle to gain experience with the guidance and gather lessons learned before moving on to 

the next step, as follows:

• Option 2 pertains to exemptions and enhances the current exemption process by 

providing guidance to support each scheduler request.

• Option 3 pertains to prospective rules. It would allow a licensee to use the guidance 

during the proposed rule phase to develop plant-specific initial compliance and 

implementation schedules to be included in the text of the applicable regulation.

Option 4 involves rulemaking to develop a regulation that would allow licensees to develop 

plant-specific initial compliance and implementation schedules for existing or future regulations 

(with the possibility of expanding this to orders). The regulation effectively would include 

(codify) the key elements of the guidance.

Option 1: Maintain the Status Quo

The NRC would maintain the existing regulatory processes. NRC staff would continue to carry 

out or pursue those CER and regulatory analysis improvements that the Commission already 

has approved for implementation.

Option 1: Implementation Considerations

Option 1 has no unresolved implementation issues. Maintaining the status quo would continue 

the current CER approach without the need for any new NRC staff resources. It would continue 

the current approach to regulation that is well-understood. The observed benefit of the CER 

process enhancements (e.g., increased stakeholder interaction in developing implementation 

schedules and draft regulatory analyses) would continue. However, Option 1 may not ensure 

that NRC and reactor licensee resources and activities are focused on the items of highest risk 

significance on a plant-specific basis. It may not resolve some industry CER concerns with 

existing or future requirements. It will not motivate reactor licensees to develop new PRA 

models. 

Option 2: Augment Regulatory Processes with RPI Method and Expert Panel Addressing CER

Under Option 2, the NRC would augment existing regulatory processes based on CER and RPI 

lessons-learned, best practices, and stakeholder feedback. This option consists of two parts. 

The first part proposes to augment current regulatory processes by allowing licensees to use a 

risk-informed prioritization method as the basis to request schedule changes for initial 

compliance and implementation dates for regulations and orders. These changes would be 

accomplished through existing processes (e.g., exemptions, docketed commitment changes, 

license amendments, and order modifications for operating power reactors). This augmented 

process would address changes to the implementation dates only. One NRC method to 

perform the prioritization would be through endorsement, in a regulatory guide, of an 

industry-developed risk-informed prioritization method (with appropriate clarifications and 

exceptions). The augmented regulatory process would facilitate the submittal, review, and 

regulatory determination of schedule change submittals, using risk information as a basis. NRC 
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staff would develop guidance to support the NRC’s review of these licensee submittals that use 

this risk-informed process. 

If a licensee chooses to adopt this augmented process, the licensee would use risk information 

and processes established in the regulatory guide to prioritize and rank regulatory actions to 

support its request for individual schedule changes based on the safety significance. This risk 

information as discussed earlier could be obtained from the GAET (as part of the generic 

assessment) or from the IDP (as part of the plant-specific assessment). Using the NRC’s 

current regulatory processes (i.e., 10 CFR 50.12, “Specific Exemptions,” or 10 CFR 50.90, 

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

amendments), a licensee may request exemptions or license amendments for scheduler 

purposes. However, there is no guidance available to ensure that these submittals are 

prepared and reviewed in a consistent manner. Documentation of a risk-informed prioritization 

method for schedule changes would clarify NRC staff expectations and streamline the NRC 

staff’s reviews of exemptions or license amendment requests. 

In the second part of this option, NRC staff would pilot an expert panel that would use risk 

insights and other relevant technical information as part of NRC’s generic process. The panel 

consisting of NRC’s senior managers and subject matter experts would consider proposed 

rules, orders and generic communications early in the development stages consistent with CER 

process enhancements. The panel could make recommendations to prioritize, schedule, or 

eliminate when appropriate, proposed rules, orders and generic communications across the 

Operating Reactor business line. The staff could use this information to ensure that the NRC’s 

resources and activities are focused on the items of highest risk significance.

As discussed in both the regulatory analysis improvements section and RPI Demonstration Pilot 

Exercises section above, insights gained during various public interactions on CER and RPI 

prompted NRC staff to propose exploring an expert panel. Specifically, during tabletops, the 

industry GAET deliberated to provide generic prioritization of issues using risk insights. These 

panels consisted of various industry subject matter experts from different utilities at various 

levels of their respective organizations.

Option 2: Implementation Considerations

For the first part of Option 2 the implementation considerations are as follows:

This option would support the agency’s efforts in CER and further the use of PRA risk insights. 

However, the implementation of a risk-informed prioritization process would require the NRC to 

develop a regulatory guide, supporting templates, and a standard review plan. This option 

would be voluntary. It could encourage licensees to use available risk insights to focus 

resources on issues that are most safety significant. 

For the first part of Option 2, NRC would issue guidance addressing how individual licensees 

could request a plant-specific initial compliance and implementation date for any regulation, 

order, docketed commitment and license condition. The request would be in the form of an 

exemption, docketed commitment changes, license amendments, and order modifications for 

operating power reactors and contain information developed to follow NRC guidance.
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Should the Commission direct NRC staff to put Option 2 in place, submittals (and consequently 

NRC staff reviews) could increase because some licensees may choose to adopt the RPI 

process. Because all future schedule requests would be submitted and reviewed on a 

case-by-case basis, NRC staff would have the opportunity to prevent the perpetual deferral 

where the safety benefit of the requirement is nullified by the delay, obviating the need for a predetermined backstop. If the Commission approves this option, the staff would develop principles 

or criteria, for Commission approval, governing the staff’s approach for addressing potential 

perpetual deferral situations. Alternatively, the Commission could consider whether a predetermined backstop is preferable. NRC staff would review the schedule requests and make a 

regulatory decision based on the merits of that request and any previous requests related to the 

same issue. Initially, more time may be needed to review these regulatory actions and adapt to 

the new process. However, as the licensees and NRC staff become more familiar with these 

types of reviews and the guidance, the resources to review these actions could be lessened. 

Option 2 offers only an interim solution for addressing current CER concerns because it would 

not ensure consideration of CER in the establishment of schedules for initial compliance and 

implementation of regulations.

The NRC staff evaluated the potential effect of putting Option 2 in place on inspection and 

enforcement functions and estimates that this impact would be low because only a subset of the 

plants will likely use this option. Therefore, the efforts to manage resources for inspection and 

enforcement will not likely increase significantly.

The resources for this part of Option 2 are unbudgeted. The time required to develop this 

process and develop regulatory guidance would be less than two years.

For the second part of Option 2 the implementation considerations are as follows:

If the Commission approves this part of Option 2, this would require added resources. The 

establishment of the panel would require the development of the infrastructure to support the 

panel. The inclusion of the panel in the regulatory process likely would extend the overall 

development schedule of rules, orders and generic communications. NRC staff notes that 

several panels exist within the NRC, including the Generic Issues Program, the Committee for 

Review of Generic Requirements and the Common Prioritization of Rulemaking. The NRC staff 

would need to ensure that such a panel would complement, and not conflict, with the functions 

of these existing panels. The pilot would consider whether such a panel could have the 

unintended consequence of creating unnecessary burdens or inefficiencies.

Option 3: Establish Voluntary Plant-Specific Implementation Schedules in Prospective New 

Rules (Operating Power Reactors Only)

In addition to augmenting the existing regulatory processes to include piloting an expert panel 

and inclusion of the risk-informed prioritization process described above, Option 3 addresses 

RPI by building on the first part of Option 2 in two approaches. In the first approach, licensees 

could submit, during the comment period of a proposed NRC regulation, a proposed 

plant-specific schedule to be codified in the text of the final regulation (analogous to the 

“implementation” language in the proposed rulemaking for 10 CFR 50.46c, “Emergency Core

Cooling System Performance during Loss-Of-Coolant Accidents.”). The information in the 

licensee’s comment submission would be based upon NRC guidance developed in Part 1 of 

Option 2. NRC inclusion of plant-specific compliance date in the language of the final regulation 
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would prevent the need for the NRC to issue an exemption to give the plant-specific compliance

and implementation schedule for initial compliance.

A second approach under Option 3, the NRC would codify the key attributes of NRC guidance 

on plant-specific schedule relief for initial compliance and implementation dates for regulations 

(developed in part 1 of Option 2) in the language of each NRC regulation which the NRC wishes 

to offer schedule relief. As with the first approach of Option 3, the second approach would 

prevent the need for the NRC to issue an exemption to offer the plant-specific compliance and 

implementation schedule for that regulation.

Based on insights gleaned through observing RPI tabletops and participating in pilot exercises, 

NRC staff concludes that flexible implementation schedules would allow licensees to use site- or 

unit-specific risk information to commit resources to matters of higher safety significance before 

those of less significance. In cases where the regulation permits licensee-determined 

implementation schedules, a generically applicable implementation or compliance date would 

also be set forth in the regulation for those licensees that do not wish to establish a site- or unitspecific implementation date. This would be similar to the NRC’s issuance of the 10 CFR 50.63, 

“Loss of All Alternating Current Power” (53 FR 23215, June 21, 1988), Station Blackout Rule 

that allowed licensees to submit to the NRR Office Director a date for completing the 

implementation of coping strategies to address a station blackout event.

Option 3: Implementation Considerations

Flexible implementation schedules could offer benefits with respect to reducing cumulative 

burden associated with regulations and are consistent with Executive Order 13563 and the 

OMB Memorandum discussed in the Background section. Using risk information, if available 

and applicable, to determine the flexible dates would enable NRC staff to reflect the safety 

significance of the prospective requirement in the requested schedules. Furthermore, this 

would allow licensees to focus resources on items of greatest safety significance sooner than 

those of lesser safety significance. This could motivate industry to use PRA and risk insights. 

This could result in a reduction of 10 CFR 50.12 exemptions requested given that the licensees 

would be allowed to submit voluntarily a plant-specific implementation plan when the NRC 

adopts a final rule. NRC staff would use guidance developed under Option 2 to describe how 

the risk insights could be used to support the risk-informed prioritization process. NRC staff 

does not believe that a backstop is required for this option for schedule requirements generated 

for future rules. Because all future schedule requests would be submitted and reviewed on a 

case-by-case basis, NRC staff would have the opportunity to prevent the perpetual deferral 

where the safety benefit of the requirement is nullified by the delay, obviating the need for a predetermined backstop. If the Commission approves this option, the staff would develop principles 

or criteria, for Commission approval, governing the staff’s approach for addressing potential 

perpetual deferral situations. Alternatively, the Commission could consider whether a predetermined backstop is preferable. 

Added NRC staff resources and time could be required to develop and issue rules that contain 

opportunities for flexible implementation. Similar to Option 2, this option would be voluntary and 

would not require licensees to use a risk-informed prioritization process and might not further 

encourage PRA development.
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Option 3 would have several other effects on resource and resource management in support of 

inspections and enforcement. Because Option 3 could result in varying implementation 

schedules, inspection planning could be more challenging. Extra resources might be needed to 

track and determine applicable implementation dates. Enforcement actions might become more 

varied and require added time and resources to close. However, enforcement and inspection 

resource disruptions could be managed, assuming sufficient communication and coordination of 

the proposed schedules and changes exist. Extra resources also would be required during the 

early stages of individual rulemakings. These would involve the staff’s solicitation of 

stakeholder input for specific schedules for implementation dates and the resolution of 

accommodative rule language. Tailored implementation dates could result in complex rule 

language, but the benefit could be increased focus of plant-specific resources on issues of 

higher safety significance. Any future changes to the implementation schedules would be 

managed under current regulatory processes for exemptions and would not require additional 

resources resulting from the implementation of Option 3.

Option 4: Initiate RPI Rulemaking to Allow Scheduling Flexibility for initial compliance and 

implementation of Regulations (Operating Power Reactors Only)

The SRM-COMGEA-2-0001/COMWDM-12-0002 directed NRC staff to evaluate a process that 

could obviate the need for exemptions and allow the licensees to prioritize the initial compliance

and implementation dates for regulations with plant-specific risk information and in an integrated 

set. 

Option 4 would address this direction in a limited fashion, by the NRC issuing a standalone “RPI 

Rule.” Such a rule, which would be voluntary, would establish a prioritization process enabling 

each licensee to make site-specific schedule changes to the initial compliance and 

implementation date for regulations in accordance with the process established in the rule 

without requesting an exemption.

The regulation whose initial compliance and implementation date could be changed under the 

RPI rule could be either:

• technical regulations specified (listed) in the RPI rule

• all technical regulations—existing and future

NRC staff considered the applicability of a backstop as part of Option 4, and is aware that the 

industry has proposed a backstop of three operating cycles. If the Commission selects this 

option, then NRC staff would evaluate the length of the backstop and whether that backstop 

should be commensurate with the risk-significance of the regulation whose compliance and 

implementation date is being deferred. 

To put the RPI rule in place, the NRC would endorse one method for implementing a risk 

prioritization process (i.e., the regulatory guide described in Options 2 and 3), officially pilot the 

process, audit the risk prioritization programs at licensees, and then incorporate NRC inspection 

and enforcement of the process under the ROP baseline inspection program and the 

enforcement manual. The licensee would carry out the prioritization process, and manage the 
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integrated compliance and implementation schedule of the regulations, which the licensee 

voluntarily chooses to be re-prioritized under the RPI rule. The bases of the schedule results 

would be subject to NRC inspection.

If NRC staff considers expanding the RPI rule to orders, the staff would evaluate expanding the 

scope and provide the Commission a paper with a recommendation.

Option 4: Implementation Considerations

This option could promote risk insights and potential development of PRA capability. This 

option would delineate the level of PRA development and regulatory flexibility available to the 

licensees. Furthermore, it would be analogous to other regulatory processes such as 

10 CFR 50.59, “Changes, Tests and Experiments,” and 10 CFR 50.65,” Requirements for 

Monitoring the Effectiveness of Maintenance at Nuclear Power Plants,” and allow the NRC staff 

the ability to inspect and enforce deviations from the proposed risk prioritization process. It 

would give operating power reactor licensees the flexibility in scheduling the initial compliance

and implementation date for regulations falling within the scope of the RPI rule. 

Pursuit of this option would require additional time and resources, beginning with the 

development of a new rule, including a “backstop” provision. The typical rulemaking process is 

approximately three years from the development of the regulatory basis to issuance of the final 

rule. Additional guidance would be needed to support the rule, which, while developed in 

parallel with the rulemaking, would require additional resources. Because this would be a shift 

in the NRC’s current regulatory processes, training would be required to make the NRC staff 

aware of the new process. This option would be adopted by licensees on a voluntary basis; 

hence, it would not incentivize the further development of PRA for licensees that do not choose 

to adopt it. Those licensees would still benefit from the current CER process enhancements of 

Option 1 and the added use of risk information if they elect to pursue the process outlined in 

Options 2 or 3. Future RPI rulemaking would not address immediate industry concerns with the 

CER effect of existing regulatory requirements—including matters such as orders and licensee 

non-compliances. Because issues in the areas of emergency preparedness, radiation 

protection, and in some cases security are not easily amenable to risk quantification, the staff 

would have to rely on qualitative risk insights as well as other attributes of the risk-informed 

framework (e.g., defense in depth, safety margins) to develop clear objective criteria in these 

areas.

The implementation, inspection, and enforcement could be modeled after other risk-informed 

initiatives such as the 10 CFR 50.65 rule (64 FR 38551, July 19, 1999). NRC staff would need 

to prevent adverse effects to the ROP because of this rule. Enforcement actions may be more 

varied and may require additional time and resources to disposition. This option may require 

the development of new baseline inspection procedures and additional training for inspectors. It 

could also result in potential impact to regional inspection planning and create unforeseen 

resource challenges.

 

Regulatory Process Change Required to Support RPI and Obviate the Need for Exemptions

The SRM-COMSECY-14-0014 directed NRC staff to “include consideration of the regulatory 

process changes required to support reliable, efficient, and effective implementation of the RPI 

in the long term (e.g., modification of the language of 10 CFR 50.12 to obviate the need for 
The Commissioners -13-

exemptions, provided that the risk prioritization is based on an appropriate PRA).” NRC staff 

reviewed 10 CFR 50.12 and its statement of considerations and concluded that 10 CFR 50.12 

exemptions should be used infrequently. As a result, NRC staff identified three possible 

approaches that, if carried out, would obviate a licensee’s need to request one or more 

exemptions to implement the RPI concept (as applied to initial implementation of new or 

amended regulations). 

The first approach would be for the NRC to include, in future rulemakings, detailed 

“implementation” language that specifies the NRC-approved method and acceptance criteria for 

carrying out the RPI concept as applied to that new or revised regulation’s initial 

implementation. This approach is reflected in the “second approach” of Option 3. A second 

approach would be to amend 10 CFR 50.12 (and any necessary conforming changes 

throughout 10 CFR Chapter I) to specify the NRC-approved method and acceptance criteria for 

carrying out the RPI concept as applied to that new or revised regulation’s initial 

implementation. A third approach would be to adopt a new standalone rule (and make 

conforming changes throughout 10 CFR Chapter I including 10 CFR 50.12), which would 

specify the NRC-approved method and acceptance criteria for carrying out the RPI concept as 

applied to that new or revised regulation’s initial implementation. NRC staff notes that the first 

approach (i.e., implementation language in all future rulemakings) is incorporated into Option 3, 

described in this paper. 

NRC staff considered the second and third approaches (rulemaking to amend 10 CFR 50.12 

and new standalone rule, respectively) in developing Option 4. NRC staff concluded that 

amending the existing 10 CFR 50.12 requirements would not be ideal for a dynamic process 

that could result in frequent schedule change requests. In addition, a rulemaking to add a new 

section in 10 CFR Part 50, “Domestic Licensing of Production and Utilization Facilities,” would 

be transparent and clear in communicating the intent of the new process. Therefore, NRC staff 

determined that a new rulemaking would be preferred over amending the existing 10 CFR 50.12 

requirements. From a resource perspective, resources required to amend an existing rule or to 

develop a new rule would be comparable.

NRC staff notes that added regulatory and practical issues would have to be addressed with 

respect to applying RPI principles to combined licenses (and possibly early site permits) issued 

under 10 CFR Part 52, “Licenses, Certifications, and Approvals for Nuclear Power Plants.” At 

this time, the RPI process does not appear to be relevant to either design certification 

applications or to final design certification rules issued under 10 CFR Part 52 (and currently 

codified in various appendices to 10 CFR Part 52). However, stakeholder input would be useful 

on this subject before the NRC staff presents a final recommendation for applying RPI principles 

to design certification rulemaking.

RECOMMENDATION:

The NRC staff recommends that the Commission:

1. Approve Option 2. Part 1 augments existing regulatory processes with a risk-informed 

prioritization method. Part 2 permits the staff to explore using an internal expert panel to 

use risk information to further enhance regulatory decision-making.
The Commissioners -14-

2. Approve the pilot for Option 3, which would offer a voluntary opportunity for power 

reactor licensees to submit a plant-specific implementation plan when NRC develops a 

rule.

If 1 and 2 above are approved, the staff would obtain lessons-learned and stakeholder feedback 

from implementing Option 1 and 2 and the pilot of Option 3. The staff would then provide a 

paper to the Commission with the results and a recommendation on whether to proceed with 

implementation of Option 3.

RESOURCE IMPLICATIONS:

The resources for CER activities are included as part of the current fiscal year (FY) President’s 

Budget (PB) and the FY 2016 Congressional Budget Justification (CBJ) under the Operating 

Reactors Business Line/Rulemaking Product Line/Rulemaking Support. If the Commission 

chooses the staff’s recommendation, the RPI activities would require resources in FY 2015 and 

FY 2016. There are no resources budgeted in FY 2015 and FY 2016 for this effort, and a 

resource reallocation would be required. Any resources for FY 2017 will be addressed in 

accordance with the Planning, Budgeting, and Performance Management Process. A more 

detailed breakdown of estimated resources for current and future years by Business 

Line/Product Line/Product and Office by FY are in Enclosure 5, “Resource Estimates.”

COORDINATION:

The Office of the General Counsel has reviewed this Commission paper and has no legal 

objection. The Office of the Chief Financial Officer has reviewed this Commission paper for 

resource implications and has no objection.
The Commissioners -15-

Interactions with the Advisory Committee on Reactor Safeguards

NRC staff presented a draft of this Commission paper to the Advisory Committee on Reactor 

Safeguards Reliability and PRA subcommittee on February 20, 2015, and to the full committee 

on March 6, 2015. The full committee documented its views and recommendations in a letter 

dated March 11, 2015 (ADAMS Accession No. ML15070A282).

/RA/

Mark A. Satorius 

Executive Director 

 for Operations

Enclosures:

1. Update on Staff Efforts to Address CER 

Effects on Fuel Cycle Facilities, Agreement State

 Programs and Radioactive Material Licensees 

2. NRC Staff Observations from Risk 

Prioritization Initiative Demonstration Pilots

3. Regulatory Analysis Improvements

4. Cumulative Effects of Regulation Expansion 

to Generic Communications Program

5. Resource Estimates 
The Commissioners -15-

Interactions with the Advisory Committee on Reactor Safeguards

NRC staff presented a draft of this Commission paper to the Advisory Committee on Reactor 

Safeguards Reliability and PRA subcommittee on February 20, 2015, and to the full committee 

on March 6, 2015. The full committee documented its views and recommendations in a letter 

dated March 11, 2015 (ADAMS Accession No. ML15070A282).

/RA/

Mark A. Satorius 

Executive Director 

 for Operations

Enclosures:

1. Update on Staff Efforts to Address CER 

Effects on Fuel Cycle Facilities, Agreement State

 Programs and Radioactive Material Licensees 

2. NRC Staff Observations from Risk 

Prioritization Initiative Demonstration Pilots

3. Regulatory Analysis Improvements

4. Cumulative Effects of Regulation Expansion 

to Generic Communications Program

5. Resource Estimates 

DISTRIBUTION: CMSY14-0014-1, 201300056 and 201300057

ADAMS Accession No.: Package: ML15034A360, SECY: ML15016A075, Enclosure 5: ML15034A366 * Via E-mail

OFFICIAL RECORD COPY

OFFICE NRR/DPR/PRMB NRR/DRA/APHB NRR/DPR/BC NRR/DRA/BC Tech Editor*

NAME SRuffin AZoulis TInverso SWeerakkody CHsu

DATE 01/20/2015 01/20/2015 01/21/2015 01/20/2015 03/12/2015

OFFICE NRR/DPR/DD NRR/DPR/D NRR/DRA/D* NRR/DORL/D* NRR/DIRS/D*

NAME AMohseni LKokajko JGiitter MEvans SMorris

DATE 01/30/2015 02/02/2015 02/02/2015 01/30/2015 02/02/2015

OFFICE OE/D* ADM/D* RES/D* NMSS/D* NRO/D*

NAME PHolahan CCarpenter BSheron CHaney GTracy

DATE 02/09/2015 02/13/2015 02/13/2015 2/23/2015 02/11/2015

OFFICE NSIR/D* OGC/GCLR/RMR* CFO* NRR/D EDO

NAME JWiggins MSpencer MWylie WDean

(JUhle for)

MSatorius

DATE 02/18/2015 3/12/2015 2/24/2015 3/26/2015 04/01/15
ENCLOSURE 1

Update on Staff Efforts to Address CER Effects on Fuel-Cycle Facilities, 

Agreement State Programs and Radioactive Material Licensees

The Office of Nuclear Material Safety and Safeguards (NMSS) has put in place initiatives to 

address the cumulative effects of regulation (CER) consistent with Commission direction in the 

SRM to SECY-11-0032, dated October 1, 2011, (Agencywide Documents Access and 

Management System (ADAMS) Accession No. ML112840466) and the SRM to SECY-12-0137, 

dated March 12, 2013 (ADAMS Accession No. ML13071A635). NMSS, in coordination with the 

Office of Nuclear Security and Incident Response, and Region II, created a fuel-cycle integrated 

schedule Gantt chart (integrated schedule) to list the major regulatory activities under 

development that affect fuel-cycle facilities. This integrated schedule facilitates discussions and 

seeks feedback from stakeholders (both internal and external) on the CER.

The integrated schedule contains a condensed overview of the significant NRC fuel-cycle 

regulatory activities. It offers a one-page graphical representation of the major rulemakings and 

guidance development milestones, scheduled public interactions, and links to related 

documents. This tool is used by the U.S. Nuclear Regulatory Commission (NRC) to:

• Supply an overview of significant regulatory activities for the next four years.

• Facilitate communications and interactions with stakeholders.

• Coordinate multiple regulatory activities and sequence the timing of milestones to reduce 

burden and improve efficiency.

• Focus efforts on activities with the most strategic plan benefit while managing existing 

resources.

• Evaluate the need to add, shed, or adjust assignments.

In addition to the integrated schedule, a supplement has been developed that offers the 

purpose, key information, related documents, and meeting information for each topic in the list. 

NMSS also meets quarterly with industry and stakeholders to discuss the status of items on the 

integrated schedule. Feedback from these meetings updates the integrated schedule, adjusts

milestones, and informs industry of progress on the various regulatory initiatives. The 

discussions also improve mutual understanding of the NRC’s drivers and metrics, and of the 

industry’s priorities for the items listed. Feedback has resulted in modifying milestones, 

adjusting comment periods, or rescheduling public meetings, as needed.

The CER quarterly meetings have resulted in improvements in communication with the internal 

and external fuel cycle stakeholders. NMSS has added CER to the fuel cycle public Web site, 

see http://www.nrc.gov/materials/fuel-cycle-fac/regs-guides-comm.html#cumeffects. 

Agreement State Programs and Radioactive Material Licensees CER Efforts

NMSS has put in place initiatives to address CER effects relative to Agreement State Programs 

and radioactive material licensees as directed in SRM-SECY-12-0137. 
-2-

For non-reactor and non-fuel-cycle licensees that the NRC shares regulatory authority with its 

Agreement State partners, the CER effects on radioactive material licensees are lessened 

because NRC’s regulatory actions, and their resulting effects are spread over a broad spectrum 

of different types of licensees (e.g., medical, industrial, academic, and low-level waste), as 

opposed to only one type of licensee. 

In accordance with SRM-SECY-12-0137, NRC staff regularly engages with the Organization of 

Agreement States, Inc. (OAS) to understand the effects of CER on Agreement States and 

determine how best to address this issue. These activities include:

• An Agreement State representative actively participates on the NRC CER working 

group.

• NRC staff supplies reports on NRC rulemakings with CER issues, as needed, in monthly 

calls to State agency representatives of the OAS and Conference of Radiation Control 

Program Directors.

• NRC staff annually meets with the OAS board to prioritize upcoming regulatory products 

affecting the Agreement States.

• NRC staff has supplied the fiscal year (FY) 2016/2017 Common Prioritization of 

Rulemaking rankings to Agreement States for their review and comment on the annual 

list of planned rulemaking activities.

In addition, to promote better outreach with our Agreement State partners, NMSS has revised 

its rulemaking procedures to ensure that when Agreement States are notified of any impending 

Federal Register publication of a Commission-approved proposed rule affecting their programs, 

the States are encouraged to notify their affected licensees. 

With regard to future activities, NRC staff and the Agreement States have proposed: 

(1) integrate CER-related issues during compatibility category determinations of proposed rules, 

and (2) review and revise NRC management directives and NRC policy statements that affect 

Agreement State programs to ensure that products consider Agreement State CER effects. 

In addition, the staff plans to address all future Agreement State CER and radioactive material 

licensees CER issues as a part of NMSS’s overall responsibilities for providing oversight of 

materials safety and security programs in the Agreement States and nationwide through the 

National Materials Program.
ENCLOSURE 2

NRC Staff Observations from Risk Prioritization Initiative Demonstration Pilots 

The purpose of the demonstration pilots of Nuclear Energy Institute’s (NEI) draft prioritization 

and scheduling implementation guidance was to evaluate how licensees can use an industry 

process to prioritize regulatory issues on a generic and plant-specific basis. 

COMSECY-2014-0014, “Cumulative Effects of Regulation and Risk Prioritization Initiative: 

Update on Recent Activities and Recommendations for Path Forward,” April 9, 2014 

((Agencywide Documents Access and Management System (ADAMS) Accession 

No. ML14069A061) and the follow-on staff requirements memorandum (SRM) (ADAMS 

Accession No. ML14199A187) informed the Commission on the NRC staff’s planned 

participation in the pilots and offered added direction to the NRC staff, respectively. 

COMSECY-2014-0014 specifically discussed details on (1) the pilot objectives and scope, 

(2) the number and names of pilot plants for NRC participation, (3) the approach to prioritization, 

and (4) the regulatory methods used to disposition changes identified during the prioritization. 

The table below illustrates NRC staff participation in the pilots. NRC staff included individuals 

supporting the risk prioritization initiative (RPI) working group as well as subject matter experts 

from various offices and regions.

NRC Staff Participation in Demonstration Pilots Activities (May - September 2014)

Generic Assessment and Characterization (ML14297A530)

NRC Participants

NEI Headquarters NRR (DRA, DPR)

NSIR

Plant-specific Prioritization and Aggregation

Integrated Decision-Making 

Panel

Issue Aggregation 

Panel

NRC Participants

Palisades NRR (DRA, DE, DORL, DIRS) 

NSIR (DSP)

Region III

NRR (DRA, DORL)

Region III

H.B. Robinson NRR (DRA, DE, DSS) NRR (DRA, DPR)

E.I. Hatch NRR (DRA) NRR (DRA)

Davis-Besse NRR (DRA)

NSIR (DSP) NRR (DRA)

Prairie Island NRR (DRA, JLD)

Region III NRR (DRA, DPR)

V.C. Summer NRR (DRA, DPR)

NSIR (DPR)

NRR (DRA, DPR)

NSIR (DPR)

Security, EP, and RP (ML14231B034)

Integrated Decision-Making 

Panel

Issue Aggregation 

Panel

NRC Participants

NRC Headquarters NRR (DRA, DPR), NSIR (DSP, DPR), Region III
-2-

Overall, the pilots illustrated that the process developed by NEI was effective in applying 

objective decision-making attributes to prioritize both regulatory activities and licensee initiatives 

on a generic and plant-specific basis. The integrated decision-making panel (IDP) used rational 

methods that were articulated clearly in draft NEI guidance. The staff observed that pilots 

simulated how an actual panel would work in a plant environment. The IDP participants shared 

their different areas of expertise and asked challenging questions. They considered both the 

positive and adverse effects of the proposed issues in their deliberations. Using available risk 

information when included in the IDP discussion, such as insights from the site-specific 

probabilistic risk assessment (PRA) models, facilitated risk-informing the process.

Some topics considered key factors contributing to public safety, such as emergency 

preparedness, radiation protection, security, and reliability (as it pertains to reliability of systems, 

structures, and components used to generate electricity and the stewardship of the plant site

because failure of such systems could cause plant transients), might not be appropriately 

assessed using readily available quantitative risk information. Consequently, the NEI guidance 

proposed other steps that relied on qualitative risk insights to the extent practical and flow charts 

to determine their overall priority. This draft process emulated some characteristics found in 

previous successful risk-informed activities, such as the NRC reactor oversight process, 

maintenance rule, and the severe accident mitigation alternatives approach for license renewal.

NRC staff noted that NEI should continue to refine its draft guidance to determine the relative 

importance of regulatory actions and licensee activities involving radiation protection, security, 

and emergency preparedness. Specifically, using qualitative risk information needed to 

navigate the assessments has the potential to be more subjective and very dependent on how 

an issue is characterized. NRC staff notes that improvements have been made on the 

characterization of issues related to security, emergency preparedness, and radiation protection 

in the revised NEI guidance. However, more work is still necessary to ensure those issues are 

being characterized correctly and consistently. 

Other information about the NRC staff’s observations can be found in “Summary of Staffs 

Observation of Industry Demonstration Pilot Activities of NEI Draft Guidance for Prioritization 

and Scheduling Implementation” (ADAMS Accession No, ML14302A269). In addition, NEI 

supplied its summary and observations of the demonstration pilots in the “Nuclear Energy 

Institute, Report on Prioritization and Scheduling Pilot” (ADAMS Accession No. ML14349A378). 
ENCLOSURE 3

Regulatory Analysis Improvements

In the staff requirements memorandum to SECY-12-0137 (“Implementation of the Cumulative 

Effects of Regulation Process Changes,” dated March 12, 2013, (Agencywide Documents 

Access and Management System (ADAMS) Accession No. ML13071A635), the Commission 

directed the U.S. Nuclear Regulatory Commission (NRC) staff to “perform ‘case studies’ to 

review the accuracy of cost and schedule estimates used in NRC’s regulatory analysis.” 

To address the SRM’s direction, in 2013 the staff engaged industry to seek volunteer facilities to 

perform case studies to review the accuracy of cost and schedule estimates used in NRC’s 

regulatory analyses. The Nuclear Energy Institute (NEI) working on the industry’s behalf 

interacted with the staff to select three regulations that affect the power reactor community to 

investigate the cost and schedule differences between the ex-ante NRC estimates and the 

ex-post industry results. As discussed in Enclosure 1 to COMSECY-14-0014, “Cumulative 

Effects of Regulation and Risk Prioritization Initiative: Update on Recent Activities and 

Recommendations for Path Forward,” April 9, 2014 (ADAMS Accession No. ML14069A061), 

NEI engaged the industry on case studies in the areas of fatigue management, fire protection, 

and physical security. During a public meeting on January 28, 2014 (ADAMS Accession 

No. ML14031A204), NEI presented an overview of the case studies (ADAMS Accession 

No. ML14028A452), which included their calculated high-level differences between estimated 

cost and actual implementation cost of each of the three regulations. Schedule differences 

between actual and estimated schedules and their effect on costs were not addressed. NEI 

supplied a handout with its final case study results and recommendations (ADAMS Accession 

No. ML14028A455). NEI recommended:

• Clearly define the scope, closure criteria, and characteristics so that realistic resources 

can be estimated for compliance with the new action or position.

• Before the regulation is first published for comment, the scope, regulatory analysis, and 

guidance of the regulation should receive early public input to help accurately estimate 

the costs and benefits of the regulation. This should be done before the public comment 

period for the proposed rule so that the basis for the proposed rule is as accurate as 

possible.

• Regulatory analyses should include information on the basic assumptions and sources 

that drive the high-level estimates. Furthermore, the regulatory analyses should offer a 

range of estimates based on various sensitivities instead of single point estimates.

After reviewing the results of the case studies, NRC staff identified that, to improve the 

regulatory analysis process, the staff should: 

• Develop and establish a clear understanding of the following during development of the 

regulatory basis for a prospective rule: (1) background, (2) regulatory issue, (3) 

objectives, (4) scope, and (5) affected entities.

• Consider performing, on a case-by-case basis and as part of the regulatory basis stage, 

a preliminary high-level cost assessment. The regulatory basis should also discuss how 

the backfit rule would apply to the proposed rulemaking. When practical, NRC staff 
-2-

should permit public input on methods and alternatives for resolving the regulatory issue, 

including any cost and backfit assessments, before publishing the proposed rule.

• Continue to incorporate recent regulatory analysis improvements and receive input from 

external stakeholders during the development of regulatory analyses.

These improvements also have been discussed in the cost-benefit update activities described in 

SECY-14-0002, “Plan for Updating the U.S. Nuclear Regulatory Commission’s Cost-Benefit 

Guidance” (ADAMS Accession No. ML13274A495), which is a two-phase process for updating 

the NRC’s cost estimating procedures. The first phase (i.e., administrative changes such as the 

consolidation of guidance documents), is expected to culminate with the release of draft 

guidance for public comment in the summer of 2015. The second phase will focus on 

addressing potential changes in policy and method, and will be a multiyear effort. Updating the 

guidance and improving the accuracy of the agency’s quantitative estimate is a priority for NRC 

staff. NRC staff notes that, as part of its plans to improve cost estimation, it is in the process of 

establishing contracts to obtain the necessary skill set that could perform independent cost 

estimates. Once the contract is in place, NRC staff expects to pilot this independent cost 

estimate process with a power reactor regulation.

Notwithstanding these planned improvements, NRC staff notes that the regulatory analyses 

studied were completed before the agency’s CER efforts. NRC staff believes that many of the 

CER improvements put in place in 2011 would have resulted in more accurate regulatory 

analyses estimates. For example, in publishing draft guidance for comment concurrent with 

proposed rules, the industry, public, and the NRC could have identified other cost and schedule 

implications in the lower-level implementation details in the guidance. The NRC now includes a 

specific request for detailed input on regulatory analyses. The industry and public have not 

routinely offered comments on draft regulatory analyses. Without this input, the NRC had 

difficulty refining its estimates between the proposed and final rule phases. 

NRC staff determined that information obtained during those discussions and documented in 

the subsequent report could further inform the agency’s regulatory analyses. During 

demonstrated pilots, NRC staff observed the generic characterization process described in the 

guidance and done by the generic assessment expert team (GAET). The GAET reviews 

regulatory actions and prepares a report on its deliberations, which would be supplied to NRC 

staff. As part of the deliberations, the GAET often discussed how a prospective regulatory 

action could affect different groups of entities (e.g., boiling-water reactors versus 

pressurized-water reactors). 

From these observations, NRC staff determined that the information garnered from the generic 

characterization activities described in NEI’s draft guidance and documented in its report could 

be used to improve and refine the NRC’s regulatory analysis work. Examples include specific 

cost and benefit breakdowns, differing implementation timelines, and differing requirements. 

The GAET discussions on risk insight could inform the consideration of potential benefits to 

public safety that is contained in the regulatory analysis. This information could identify 

individual cost elements that could be used to estimate the future costs of carrying out the 

prospective regulatory action offered during early interactions on a proposed rule.
ENCLOSURE 4

Cumulative Effects of Regulation Expansion to Generic Communications Program

In the staff requirements memorandum (SRM) to SECY-12-0137, “Implementation of the 

Cumulative Effects of Regulation Process Changes,” dated March 12, 2013, (Agencywide 

Documents Access and Management System (ADAMS) Accession No. ML13071A635), the 

Commission directed that “any expansion of the consideration of CER should be considered in 

the broader context of actions directed from COMGEA-12-0001/COMWDM-12-0002.” 

Through public meetings in calendar year 2013, the industry said there could be value in 

expanding the cumulative effects of regulation (CER) process enhancements to the generic 

communications program. In reviewing the processes for generic communications, the 

U.S. Nuclear Regulatory Commission (NRC) staff concluded that those processes already 

reflect the goals of CER by allowing for public interaction in the beginning stages of 

development, including opportunities for public comment on draft generic communications. 

However, as part of the pilot for an expert panel, discussed in Option 2, the inclusion of generic 

communications could be considered as part of the regulatory actions evaluated under that 

option.

In the Federal Register notices (FRNs) of two generic letters, the NRC staff included six CER 

questions:

1. In light of any current or projected cumulative effects, does this generic letter request 

provide sufficient time for licensees to respond with the information requested, including 

any need to develop this information through supporting engineering calculation or 

analyses?

2. If a current or projected cumulative effect poses a significant challenge, what should be 

done to address it? For example, if more time is required to develop and provide 

information, what period of time is sufficient? Are there equally effective alternatives to 

providing the requested information to the NRC that reduce the cumulative effect?

3. Do other (NRC or other regulatory agency) regulatory actions (e.g., orders, rules, 

generic letter, bulletins, and 50.54(f) requests) influence licensee responses to this draft 

generic letter? If so what are they and do you have a suggested approach to reduce the 

cumulative effects in light of these other regulatory actions?

4. Are there other projects that licensees are undertaking, plan to undertake, or should be 

undertaking that provide greater safety benefit, that might be displaced or delayed 

because of the expenditure of effort and resources to respond to this generic letter?

5. Are there unintended consequences associated with responding to this generic letter at 

this time?

6. Please comment on the NRC’s supporting justification for this generic letter.

Generic Letters

• NRC Generic Letter 20xx-xx: “Treatment of Natural Phenomena Hazards in Fuel Cycle 

Facilities” (ADAMS Accession No. ML13157A158). On November 6, 2014
-2-

(ADAMS Accession No. ML14316A411), the NRC received industry feedback to the 

CER questions. In summary, the industry response did not identify any significant effect 

on a licensee’s ability to carry out other significant NRC regulatory requirements or 

respond to the generic letter. However, because NRC staff previously stated its intent to 

issue NRC staff guidance in the form of an interim staff guidance (ISG) on the topic of 

natural phenomenon hazards, industry recommended that the draft ISG be issued 

before the release of the final generic letter. This industry recommendation is being 

carried out by the Office of Nuclear Material Safety and Safeguards (NMSS).

• NRC Generic Letter 201X-XX: “Monitoring of Neutron-Absorbing Materials in Spent Fuel 

Pools” (ADAMS Accession No. ML13100A086). The NRC did not receive any industry 

responses to the six CER questions. 

NRC staff plans to continue using the six CER questions in the FRNs for generic letters seeking 

information under Title 10 of the Code of Federal Regulations (10 CFR) 50.54(f), “Conditions of 

Licenses.”

Other Generic Communications

The staff did not identify the need to include the six CER questions in other forms of generic 

communications such as bulletins (BL), regulatory issue summaries (RIS), information notices 

(IN), security advisories (SA), or information assessment team advisories (IATA). The issuance 

of a BL communicates an urgent NRC safety, environmental, or security concern; therefore 

bulletins are not issued for public comment. For RIS, the generic communications program 

already emphasizes that staff interact early with external stakeholders before the development 

of the RIS. The issues communicated to industry in a RIS are typically long-standing issues that 

have been thoroughly vetted with external stakeholders. In addition, a RIS does not require the 

collection of information from licensees, so no licensee response is required following its 

issuance. IN inform licensees of operational experience and do not request a response. 

SA supply information on potential security events or recently identified vulnerabilities, do not 

require responses, and are usually not publicly available. IATA are time-sensitive information 

about potential security threats, do not require responses, and are not publicly available.