POLICY ISSUE

(Information)

January 30, 2007 SECY-07-0022

FOR: The Commissioners

FROM: Luis A. Reyes

Executive Director for Operations /RA/

SUBJECT: STATUS REPORT ON PROPOSED IMPROVEMENTS TO THE GENERIC

ISSUES PROGRAM

PURPOSE:

To inform the Commission about improvements to the Generic Issues Program (GIP), which the

staff of the U.S. Nuclear Regulatory Commission (NRC) will implement to ensure

comprehensive and timely resolution of future generic issues (GIs). The staff will implement

these conceptual GIP improvements through a revision to Management Directive 6.4, “Generic

Issues Program.”

BACKGROUND:

In the Staff Requirements Memorandum (SRM), dated August 31, 2005, issued in response to

SECY-05-0126, “Summary Of Activities Related To Generic Safety Issues,” the Commission

directed the staff to develop a plan to focus renewed attention to the GIP that will resolve the older

GIs still on the books, and ensure that future GIs are resolved in a timely manner. In response to

the SRM, on March 29, 2006, the staff submitted a plan to the Commission (ADAMS Accession

#ML053570259), identifying a two-phased approach to improve its timeliness in resolving

existing GIs (Phase I), and its intention to perform a more comprehensive and fundamental

reevaluation of the GIP (Phase II).

Subsequently, in July 2006, the staff submitted SECY-06-0161, “Summary of Activities Related

to Generic Safety Issues.” In that summary, the staff reported completion of Phase I with a 

CONTACTS: Patrick W. Baranowsky, RES/DRASP

(301) 415-7493
The Commissioners -2-

Jack W. Foster, RES/DRASP

(301) 415-6250

number of accomplishments, and informed the Commission that Phase II had been initiated

with a meeting of program office representatives in May 2006. The staff also committed to

provide future status updates to the Commission.

DISCUSSION:

As reported in SECY-06-161, the main objective of Phase II is to reevaluate and enhance

the current program to significantly reduce the time required to resolve GIs. During Phase II,

an inter-office working group representing the Office of Nuclear Reactor Regulation (NRR), the

Office of Nuclear Regulatory Research (RES), the Office of Nuclear Security and Incident

Response (NSIR), the Office of Nuclear Materials Safety and Safeguards (NMSS) and the

Office of Federal and State Materials and Environmental Management Programs (FSME)

examined various aspects of the GIP to identify programmatic and process changes,

and develop a consensus approach to make the program more effective. In particular,

the working group proposed the following actions to improve the GIP:

(1) Ensure timeliness of issue resolution. 

(2) Clarify roles and responsibilities of the participating offices.

(3) Increase participation of the nuclear industry key stakeholders and other stakeholders,

as appropriate.

(4) Establish clear interfaces between the GIP and other program office processes and

activities used to address GIs outside the GIP.

Objectives

The objective of the proposed improvements is that the new GIP will address only those issues

that have significant generic implications related to risk or security that cannot be more effectively

handled by other regulatory programs and processes. Toward that end, the staff will also consider

whether an issue can be resolved under the existing programs and processes, or by industry

initiatives, before beginning assessment under the formal GIP. In addition, for timely and effective

GI resolution, a consistent process (i.e., from issue screening to the identification of possible

regulatory solution(s)) needs to be uniformly implemented across the offices. Moreover,

the roles and responsibilities of the offices, accountability at all stages of GI assessment,

and the necessary inter-office interaction need to be clearly defined. The GI assessment process

may also involve the participation of key stakeholders, when feasible, to identify the possible

regulatory solution(s). Enclosure 1 presents an illustration of the GIP in perspective with other

regulatory programs and processes. 

Approach

The working group developed the following principles for developing GIP improvements:
The Commissioners -3-

(1) Provide centralized leadership for GIP management and strengthen the involvement

of regulatory offices (i.e., responsible for implementation of resolutions) in all stages of

GIP.

(2) Ensure consistent implementation of the GI assessment process across the offices

(i.e., the same process would be applied to address nuclear power reactor issues,

nuclear materials and/or radioactive waste issues, and security-related issues).

(3) Enhance the screening process such that the same criteria are consistently applied to

identify those issues that are appropriate for the GIP (see Enclosure 2); revise various

stages of the GIP; and employ enhanced risk-informed techniques to focus on timely

assessment of GIs.

(4) Enhance the staff’s ability to resolve issues by using all existing regulatory tools,

programs, and processes, with early involvement of key nuclear industry and other

stakeholders, as appropriate.

To accomplish these principles of improving the GIP, the following elements will be incorporated in

Management Directive 6.4, “Generic Issues Program”:

(1) With the appropriate regulatory office involvement, RES will have overall responsibility

for GIP management, including routine tracking and documentation of GIP status as

well as periodic reporting to Congress and the Commission.

(2) The appropriate regulatory office will have well-defined roles, responsibilities,

and accountability in all stages of GI assessment and resolution.

(3) All offices will be involved with applying the screening criteria to identify issues that are

suitable for the GIP. Issues for which the risk or safety significance cannot be adequately

determined due to phenomena or other uncertainties, and would require long-term studies

and/or experimental research to establish the risk or safety significance will be excluded

from the GIP, consistent with current processes specified in MD 6.4.

(4) Issues, particularly high-risk issues, that should be addressed by other NRC programs

and processes or industry initiatives, will be appropriately directed to those programs

and processes. The role of the GIP will be clarified with the roles of other programs that

address the concerns of employees and stakeholders such as the Differing Professional

Opinion (DPO) Program and the Allegation Program to ensure that GIP does not serve

as an alternative to these programs.

(5) To gain efficiency and effectiveness and improve timely assessment of GIs, the staff will

employ enhanced risk-informed techniques, which have already been developed as part

of other established programs (e.g., the Accident Sequence Precursor [ASP] Program). 

(6) RES will ensure necessary inter-office coordination throughout the process. After the

issue is screened in as a formal GI, the GIP will consider participation by nuclear

industry stakeholders, when feasible, to identify possible solutions (e.g., a regulatory

product or industry initiative).

(7) The GI process will be concluded when the regulatory product is identified. The

regulatory office will proceed, under other established programs and processes,

to develop and implement the identified regulatory solution, and perform appropriate

verification.
The Commissioners -4-

With the above programmatic improvements, the staff is targeting to complete formal GI

assessments within 1-2 years. In some cases, depending upon the technical complexity of the

individual issue, the GI assessment process may require additional time. Such cases will be

noted in annual reports to the Commission. Enclosure 3 compares the existing GIP and the

new GIP, highlighting the potential impact of the proposed improvements.

The staff’s routine tracking and documentation of GIP status will be specified in MD 6.4 and

other Program Office Instructions, as appropriate.

Management Directive 6.4 is currently being revised to implement these conceptual

improvements. The identification, treatment, and processing of new Unresolved Safety Issues

(USIs) will also be addressed in the revision of MD 6.4. As a result, the GI and USI assessment

processes will be consistently applied across the offices for processing these issues in a

comprehensive and timely manner. The staff will keep the Commission apprised of any

significant developments in the implementation of its plan to focus renewed attention to the GIP.

RESOURCES:

Total resources required for this activity are $1,600K and 7.0 FTE in FY 2007, and $2,050K and

6.7 FTE in FY 2008. These resources are included in the budgets for FY 2007 and FY 2008 as

follows: FY 2007 - RES $1,600K and 6.0 FTE, NRR 0.4 FTE, NMSS 0.2 FTE, FSME 0.2 FTE,

and NSIR 0.2 FTE; and FY 2008 - RES $2,050K and 5.7 FTE, NRR 0.4 FTE, NMSS 0.2 FTE,

FSME 0.2 FTE, and NSIR 0.2 FTE.

COORDINATION:

The Office of the General Counsel has reviewed this package and has no legal objection. 

The Office of the Chief Financial Officer has also reviewed this package and has no objection.

/RA/

Luis A. Reyes

Executive Director

 for Operations

Enclosures:

1. Generic Issues Program in Perspective 

 with Other Regulatory Programs and 

 Processes

2. Guidance on Enhanced Issue Screening 

 Criteria

3. Comparison of the Main Attributes of the 

 Existing and Proposed Generic Issue 

 Program (GIP) and Resulting Program 

 Improvements
The Commissioners -4-

With the above programmatic improvements, the staff is targeting to complete formal GI

assessments within 1-2 years. In some cases, depending upon the technical complexity of the

individual issue, the GI assessment process may require additional time. Such cases will be

noted in annual reports to the Commission. Enclosure 3 compares the existing GIP and the

new GIP, highlighting the potential impact of the proposed improvements.

The staff’s routine tracking and documentation of GIP status will be specified in MD 6.4 and

other Program Office Instructions, as appropriate.

Management Directive 6.4 is currently being revised to implement these conceptual

improvements. The identification, treatment, and processing of new Unresolved Safety Issues

(USIs) will also be addressed in the revision of MD 6.4. As a result, the GI and USI assessment

processes will be consistently applied across the offices for processing these issues in a

comprehensive and timely manner. The staff will keep the Commission apprised of any

significant developments in the implementation of its plan to focus renewed attention to the GIP.

RESOURCES:

Total resources required for this activity are $1,600K and 7.0 FTE in FY 2007, and $2,050K and

6.7 FTE in FY 2008. These resources are included in the budgets for FY 2007 and FY 2008 as

follows: FY 2007 - RES $1,600K and 6.0 FTE, NRR 0.4 FTE, NMSS 0.2 FTE, FSME 0.2 FTE,

and NSIR 0.2 FTE; and FY 2008 - RES $2,050K and 5.7 FTE, NRR 0.4 FTE, NMSS 0.2 FTE,

FSME 0.2 FTE, and NSIR 0.2 FTE.

COORDINATION:

The Office of the General Counsel has reviewed this package and has no legal objection. 

The Office of the Chief Financial Officer has also reviewed this package and has no objection.

/RA/

Luis A. Reyes

Executive Director

 for Operations

Enclosures:

1. Generic Issues Program in Perspective 

 with Other Regulatory Programs and 

 Processes

2. Guidance on Enhanced Issue Screening 

 Criteria

3. Comparison of the Main Attributes of the 

 Existing and Proposed Generic Issue 

 Program (GIP) and Resulting Program 

 Improvements

ML063460239 WITS200600316

OFFICE GSI C GSI C TECH ED N OERA N DRASP NRR FSME

NAME RTripathi JFoster PGarrity PBaranowsky FEltawila BBoger (PTKuo for) CMiller

DATE 12/27/06 12/27/06 12/27/06 12/28/07 1/05 /07 1/17/07 1/17/07

OFFICE NSIR NMSS OGC OCFO RES DMDMRS EDO

NAME RZimmerman JStrosnider JMoore JFunches BSheron MVirgilio LReyes

DATE 1/17/07 1/12/07 1/18/07 1/18/07 1/18 /07 01/30/07 01/30/07

OFFICIAL RECORD COPY
Generic Issues Program in Perspective with Other Regulatory Programs and 

 

Proposed (Candidate) Issue

•Rulemaking•Regulatory Guidance•SRP Update•Voluntary Industry Initiatives•Licensing Actions•Inspection & Enforcement•Generic Communications

Implementation 

Verification

Regulatory Office Process

(Examples)

Safety / Risk Assessment•Risk Assessment•Security Assessment

Generic Issues Program 

(RES & Regulatory Office Involvement)

Regulatory Assessment•Identify Solutions•Develop Technical Bases •Perform Cost-Benefit Analysis•Identify Regulatory Product•To Regulatory Office for 

Development

•Close the formal GI 

Assessment Process

RES•User Need Research•Over-the-Horizon Res.•Long-Term Studies

Need More Information & 

Review

No, Issue Not Understood or Well-Defined

No, Issue Is Well-Defined, Solution Known, Technical / Regulatory Basis Understood

Yes

To Regulatory Office To Regulatory Office

Issue becomes formal GI

Issue closed out as formal GI

GI Screening

Enhanced GIP

Screening Criteria

Proposed (Candidate) Issue

•Rulemaking•Regulatory Guidance•SRP Update•Voluntary Industry Initiatives•Licensing Actions•Inspection & Enforcement•Generic Communications

Implementation 

Verification

Regulatory Office Process

(Examples)

Safety / Risk Assessment•Risk Assessment•Security Assessment

Generic Issues Program 

(RES & Regulatory Office Involvement)

Regulatory Assessment•Identify Solutions•Develop Technical Bases •Perform Cost-Benefit Analysis•Identify Regulatory Product•To Regulatory Office for 

Development

•Close the formal GI 

Assessment Process

RES•User Need Research•Over-the-Horizon Res.•Long-Term Studies

Need More Information & 

Review

No, Issue Not Understood or Well-Defined

No, Issue Is Well-Defined, Solution Known, Technical / Regulatory Basis Understood

Yes

To Regulatory Office To Regulatory Office

Issue becomes formal GI

Issue closed out as formal GI

GI Screening

Enhanced GIP

Screening Criteria
Guidance on Enhanced Issue Screening Criteria

The safety / risk and regulatory assessment stages of a formal GI will address only those

issues that meet the following criteria. 

• The issue affects public health and safety, the common defense and security, or the

environment.

• The issue applies to two or more facilities and/or licensees/certificate holders, or holders

of other regulatory approvals.

• The issue cannot be readily addressed through other regulatory programs and processes;

existing regulations, policies, or guidance; or voluntary industry initiatives.

• The issue can be resolved by new or revised regulation, policy, or guidance.

• The issue’s risk or safety significance can be adequately determined (i.e., it does not

involve phenomena or other uncertainties that would require long-term studies and/or

experimental research to establish the risk or safety significance).

• The issue is well-defined, discrete, and technical.

• Resolution of the issue may potentially involve review, analysis, or action by the affected

licensees, certificate holders, or holders of other regulatory approvals.

 

Enclosure 2
Comparison of the Main Attributes

Steps in the Generic Issue (GI) Resolution Process Resulting GIP Improvements 

Existing GIP Proposed GIP

GI Identification:

Designate the proposed

(candidate) issue as a

GI

Average: 1 month

GI Screening:

Apply the Enhanced

Screening Criteria to the

proposed (candidate) issue. 

A candidate issue becomes

a GI only if it meets the

screening criteria

Target Duration: 2 months

Consistency will be ensured as all offices will use the

same screening criteria for GI identification:

• Issues involving user need research (long-term

studies or over-the-horizon research) will be

provided to the appropriate program

• Only those issues will be included that are welldefined and discrete; cannot be handled more

effectively by other programs; are not covered by

the existing regulations, policy or guidance; and

have possible solution(s)

Technical Screening:

Assess risk or security

significance 

Average: 2 years

Safety / Risk Assessment:

Conduct risk or security

assessment using

enhanced risk-informed

techniques 

Target Duration: 4 months

• Program office will be directly involved.

• Cooperation between RES and the program

office(s) will be enhanced

• Use of tailored risk-informed techniques already

developed as a part of other established program

[e.g., Accident Sequence Precursor (ASP)]

• Issues involving low risk- or security-significance

will be excluded

• In some cases existing models may need to be

supplemented to perform a credible risk

assessment (may take more than 4 months).

Technical Assessment:

• Identify regulatory

solution

• Develop technical

basis

Average: 8 years

Regulatory Assessment:

• Identify regulatory

solution(s)

• Develop technical basis 

• Conduct cost-benefit or

backfit analysis, as

appropriate

• Send to the regulatory

office for regulatory

product development

Target Duration: 1-2 years

With the program office leading the effort:

• Greater interaction between the offices, as

necessary

• When feasible, an option of inviting participation

from key nuclear industry stakeholders, or other

stakeholders, early in the process to identify

regulatory solution(s)

• Flexible process to permit use of all available tools

to ensure timely GI resolution

• RES to assist, as necessary, in developing

technical basis for the regulatory solution(s)

Regulatory Product

Development

Duration: Varies

N/A

• The GIP will remain separate from, but will 

complement, other regulatory processes 

• The formal GI process will end after the technical

assessment stage, when the technical assessment

establishes the technical basis for the regulatory

solution and the program office begins the

regulatory product development

• The program office will complete development of

the regulatory product, and ensure its

implementation and verification – outside the GIP

• Routine tracking and documentation of GIP status,

individual GIs, and candidate GIs will be specified in

MD 6.4 and other Program Office Instructions, as

appropriate

Issuance of new or

revised regulation

and/or guidance

Duration: Varies

Implementation

Duration: Varies

Verification

Duration: Varies

The GI Resolution

Process continues

through Implementation

and Verification. 

Total Duration: 

5 – 10 years

The GI assessment

process ends with

regulatory assessment –

when the technical basis for

the regulatory solution(s) is

identified. 

Target Duration: 1–2 years

• In most cases, shorter technical assessment time;

no long-term studies or research 

• In some instances, technical assessment may take

longer because more complex issues may be

processed under the GIP

• The regulatory office will ensure GI resolution and

closure of the issue 

• Implementation and verification processes will be

conducted outside the GIP

Enclosure 3