ML20210F407
| ML20210F407 | |
| Person / Time | |
|---|---|
| Issue date: | 07/21/1999 |
| From: | Travers W NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | Collins S, Paperiello C, Thadani A NRC (Affiliation Not Assigned), NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS), NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| References | |
| NUDOCS 9907300131 | |
| Download: ML20210F407 (69) | |
Text
MEMORANDUM TO: Ashok C. Thidani, Director, RES July 21, 1999 Samu:1 J. Collins, Director, NRR C rl J. Paperillio, Director, NMSS Karen D. Cyr, General Counsel, OGC Janice Dunn Lee, Director, OlP Paul H. Lohaus, Director, OSP James Lieberman, Director, OE Hubert J. Miller, Regional Administrator, RI Luis A. Reyes, Regional Administrator, Rll James E. Dyer, Regional Administrator, Rlli
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Ellis W. Merschoff, Regional Administrator, RIV.
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FROM:
William D. Travers i DC On Executive Director for Operations
SUBJECT:
PILOT STUDY FOR DRAFT MANAGEMENT DIRECTIVE 6.4,
" GENERIC ISSUE PROGRAM" In May,1998, an assessment of the NRC's Generic issue Program began. The assessment used the consultation services of Arthur Andersen LLP to take advantage of expertise that has been developed from assessment experience outside the NRC. The process included J
document reviews, database reviews and interviews with NRC staff who the team felt would provide specific insights into the program. Following the Generic Issue Program Assessment findings in September 1998, draft Management Directive (MD) 6.4, " Generic issue Program" was produced and distributed for cos;iment in April 1999, and again in June 1999.
in my letter to Dr. Dana Powers, Chairman, ACRS, dated May 24,1999, I indicated that the staff would conduct a pilot study to evaluate the effectiveness of using the draft MD. The attached draft MD which you have reviewed and commented on will be used to determine whether a candidate generic issue represents an adequate protection, substantial safety enhancement, or a burden reduction issue. It will also be used to identify a cost-effective solution to generic issues that need to be addressed, and then to implement and verify the solution or set of solutions for that generic issue, as appropriate. The draft MD allows members of the public, industry or the NRC to propose candidate reactor, materials, or waste generic issues for consideration.
The year-long pilot study using the draft MD will begin in August 1999, after which lessons leamed will be assessed, implemented, and a final MD will be forwarded to you for your review and concurrence prior to issuance.
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Attachment:
As stated cc w/atts.:
DISTRIBUTION w/att.:
Chairman Dicus File Center WITS (960088)
/
Commissioner Diaz PUBLIC ASummerour Commissioner McGaffigan REAHFB R/F ACRS File gIq,p[j 4
Commissioner Merrifield DSARE R/F PNorian SECY SRubin p: o/ I
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G:\\REAHFB\\edo641.wpd *SEE PREVIOUS CONCURRENCE To receive a copy of this document. Indicate in the box: "C" s Copy without attachment / enclosure
- E' = Copy with attachmest/ enclosure
'N" = No copy OFFICE REAHFB l
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MEMORANDUM TO: Ashok C. Thadani, Director, RES l
Samuel J. Collins, Director, NRR Carl J. Paperiello, Director, NMSS Karen D. Cyr, General Counsel, OGC Janice Dunn Lee, Director, OIP Paul H. Lohaus, Director, OSP James Lieberman, Director, OE Hubert J. Miller, Regional Administrator, RI Luis A. Reyes, Regional Administrator, Ril James E. Dyer, Regional Administrator, R Ellis W. Merschoff, Regional Administrat r, RIV l
FROM:
William D. Travers Executive Director for Operations
SUBJECT:
PlLOT STUDY FOR DRAFT M AGEMENT DIRECTIVE 6.4,
" GENERIC ISSUE PROGRAN) in my letter to Dr. Dana Powers, Chairman, AC
, dated May 24,1999, I indicated that the staff would conduct a pilot study to evaluate th effectiveness of using draft Management Directive (MD) 6.4, " Generic issue Program." he attached draft MD will be used to determine whether a candidate generic issue represe ' an adequate protection, substantial safety enhancement, or a burden reduction issue to identify cost-effective solutions to generic issues that need to be addressed, and then to i plement and verify the solution or set of solutions for each generic issue, as appropriate. Th draft MD allows members of the public, industry or the NRC to propose candidate reactor, m terials, or waste generic issues for consideration.
The year-long pilot study using the raft MD will begin in August 1999, after which lessons learned will be assessed, implem nted, and a final MD will be forwarded to you for your review and concurrence prior to issuan e.
Attachment:
As stated cc w/atts.:
DISTRIBUTION w/att.:
Chairman Dicus File Center WITS (960088)
Commissioner Diaz PUBLIC ASummerour Commissioner McG ffigan REAHFB R/F ACRS File Commissioner Me ifield DSARE R/F SECY PNorian SRubin G:\\REAHFB\\edo6 1 wpd To receive a copy of this document. Indicate in the box: "C' =
ut attachtnant/ enclosure "E' = Copy with attachment / enclosure "N* = No copy OFFICE REAHFB,p 74 REAHFB l F-gfAEAHFB l('
D:DSARE l6 DD:RES l
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July 21, 1999 MEMORANDUM TO: Ashok C. Thadani, Director, RES Samuel J. Collins, Director, NRR Carl J. Paperiello, Director, NMSS Karen D. Cyr, General Counsel, OGC l
Janice Dunn Lee, Director, OIP Paul H. Lohaus, Director, OSP James Lieberman, Director, OE Hubert J. Miller, Regional Administrator, RI Luis A. Reyes, Regional Administrator, Rll James E. Dyer, Regional Administrator, Rlli Ellis W. Merschoff, Regional Administrator, RIV FROM:
William D. Travers
^ ^ ^ - -
Executive Director for Operati[ns
SUBJECT:
PILOT STUDY FOR DRAFT MANAGEMENT DIRECTIVE 6.4,
" GENERIC ISSUE PROGRAM" In May,1998, an assessment of the NRC's Generic issue Program began. The assessment used the consultation services of Arther Andersen LLP to take advantage of expertise that has been developed from assessment experience outside the NRC. The process included 4
document reviews, database reviews, and interviews with NRC staff who the team felt would provide specific insights into the program. Following the Generic Issue Program Assessment findings in September 1998, draft Management Directive (MD) 6.4, " Generic issue Program" was produced and distributed for comment in April 1999, and again in June 1999.
in my letter to Dr. Dana Powers, Chairman, ACRS, dated May 24,1999, I indicated that the staff would conduct a pilot study to evaluate the effectiveness of using the draft MD. The I
attached draft MD which you have reviewed and commented on will be used to determine whether a candidate generic issue represents an adequate protection, substantial safety enhancement, or a burdan reduction issue. It will also be used to identify a cost-effective solution to generic issues that need to be addressed, and then to implement and verify the solution or set of solutions for that generic issue, as appropriate. The draft MD allows members of the public, industry or the NRC to propose candidate reactor, materials, or waste generic issues for consideration.
The year-long pilot study using the draft MD will begin in August 1999, after which lessons learned will be assessed, implemented, and a final MD will be forwarded to you for your review l
and concurrence prior to issuance.
Attachment:
As stated cc w/atts.:
Chairman Dicus Commissioner Diaz i
Commissioner McGaffigan Commissioner Merrifield SECY
Generic Issue Program Draft Management Directive 6.4 l
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Contents L
Policy introduction Objectives Organizational Responsibilities and Delegations of Authority The Commission Executive Director for Operations (EDO)
Director, Office of the General Counsel (OGC)
Advisory Committee on Reactor Safeguards (ACRS)
Advisory Committee on Nuclear Waste (ACNW)
Advisory Committee on Medical Uses of isotopes (ACMUI)
Director, Office of Nuclear Reactor Regulation (NRR)
Director, Office of Nuclear Materials Safety and Safeguards (NMSS)
Director, Office of Nuclear Regulatory Research (RES)
Regional Administrators Director, Office of International Programs (OIP)
Director, Office of State Programs (OSP)
Director, Office of Enforcement (OE)
Applicability Handbook References
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Generic issue Program Draft Directive 6.4 Policy it is the policy of the U.S. Nuclear Regulatory Commission to have an effective e
program for the resolution of generic issues that may involve new or revised rules, new or revised guidance, or revised interpretation of rules or guidance that affect licensees or certificate holders. A generic issue is a regulatory matter involving the design, construction, operation, or decommissioning of several, or a class of NRC licensees or certificate holders that is not sufficiently addressed by existing rules, guidance, or programs.
Introduction 3
The processes described in the Generic issue Program (GlP) will be used to e
determine whether a candidate generic issue represents an adequate protection, substantial safety enhancement, or a burden reduction issue; to identify a cost-effective solution to generic issues that need to be addressed, and then to implement and verify the solution or set of solutions for that generic issue, as appropriate. Administration of the GlP will be accomplished using an eight stage process:
Identification, Initial Screening, Technical Screening, Technical Assessment, Regulations and Guidance Development, Regulation and Guidance issuance, Implementation, and Verification.
Objectives To identify a cost-effective solution to a generic issue and to implement the e
solution or set of solutions for that generic issue, as appropriate, To ensure that the immediate and long-term safety, safeguards, and regulatory e
burden concerns identified as generic issues are documented, tracked, analyzed, implemented, verified, and resolved.
To ensure that program and regional offices maintain a coordinated and efficient capability to effectively:
identify generic issues, document generic issues, r
l track generic issues, screen generic issues, assess generic issues, impose new or revised requirements, relax requirements, and verify licensee implementation and effectiveness of the new or revised requirements.
To ensure that the public, Congress, Agreement States, licensees, certificate holders and appropriate agencies of foreign countries and international organizations are provided with current information regarding generic issues, including the actual or potential hazards to health and safety.
Organizational Responsibilities and Delegations of Authority The Commission Makes decisions on the resolution of the most serious generic issues that are e
brought to its attention after analyses determine that the significance to public health and safety requires the attention of the Commission.
Executive Director for Operations (EDO)
Oversees the GIP and directs the required action to the appropriate offices.
Oversees the agency's automated document management system for the collection, storage, retrieval, indexing, and distiibution of documents involving generic issues.
Disseminates selected documents associated with generic issues in accordance with distribution directions from the responsible NRC program office.
Director, Office of the General Counsel (OGC)
Provides legal advice, and assistance during the processing of generic issues.
]
e Assist with the interpretation of regulations and statutes relevant to generic i
issues.
Advisory Committee on Reactor Safeguards (ACRS) identifies candidate reactor generic issues and reviews the analyses of reactor e
generic issues.
Advises the Commission and staff on the processes and methodologies for e
addressing reactor generic issues, i
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i Advisory Committee on Nuclear Waste (ACNW) 1 Identifies candidate generic issues and reviews the analyses of generic issues related to waste management and decommissioning.
Advises the Commission and staff on the technical aspects and methodologies for addressing generic issues related to waste management and decommissioning.
Advisory Committee on the Medical Uses of Isotopes (ACMUI)
Identifies candidate generic issues and reviews the analyses of generic issues e
related to medical uses.
Advises the Commission and staff on the technical aspects and methodologies for addressing generic issues related to medical uses.
Director, Office of Nuclear Reactor Regulation (NRR)
Ensures that operational safety data is reviewed to identify candidate reactor generic issues in accordance with the requirements of Management Directive 8.5, ' Operational Safety Data Review" and this directive.
Monitors operational safety data to verify the effectiveness of actions taken by e
license es to resolve generic issues.
Assigns a representative, at branch chief level or higher, to serve on the Reactor e
or Materials Generic issue Review Panel, as appropriate. Assigns additional personnel to attend the panel meeting as needed.
Makes recommendations regarding the screening and classification of candidate reactor generic issues.
Develops new requirements, or revises requirements and guidance, as appropriate, based upon the technical assessment of reactor generic issues and l
industry initiatives to reduce regulatory burden.
I imposes requirements on licensees, as appropriate, based on the technical e
assessment of reactor generic issues.
Provides appropriate technical support to regional offices, as requested, during e
licensee implementation and verification of the resolution of reactor generic issues.
I Provides input and support for databases such as the Safety issue Management e
System (SIMS) and the Generic issue Management Control System (GIMCS).
j Conducts public meetings and documents review actions.
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Director, Office of Nuclear Materials Safety and Safeguards (NMSS)
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Ensures that operational safety data is reviewed to identify candidate materials e
and waste generic issues in accordance with the requirements of Management Directive 8.5, " Operational Safety Data Review" and this directive.
l Assigns a representative, at branch chief level or higher, to serve on the e
Materials or Reactor Generic Issue Review Panel, as appropriate. Assigns additional personnel to attend the panel meeting as needed.
Designates the Materials Generic issue Review Panel Chairperson. This shall e
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normally be the Director, Division of Industrial and Medical Nuclear Safety (IMNS).
Makes decisions regarding the initial screening and classification of candidate e
materials generic issues.
Conducts the technical screening of materials generic issues to determine whether development of a solution warrants expenditure of NRC resources.
Conducts technical assessments of materials generic issues to determine e
whether requirements or guidance are needed and to establish the technical bases for requirements or guidance.
)
Develops new requirements, or revised requirements and guidance, as e
appropriate, based upon the technical assessment of materials generic issues.
imposes requirements on licensees, as appropriate, based on the technical e
assessment of materials generic issues.
Provides appropriate technical support to regional offices, as requested, during licensee implementation and verification of the resolution of materials generic issues.
Provides input and support for databases such as SIMS and GIMCS.
Conducts public meetirigs and documents review actions.
l Director, Office of Nuclear Regelatory Research (RES)
{
Identifies reactor, materials, and waste generic issues from research programs, e
including national and international cooperative research programs as well as review of operational experience.
Assigns a representative, at branch chief level or higher, to serve on the e
Materials or Reactor Generic issue Review Panel, as appropriate. Assigns i
additional personnel to attend the panel meetings as needed. i
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Designates the chairperson of the Reactor Generic issue Review Panel.
Assigns a GIP Manager.
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e Makes recommendations regarding the initial screening and classification of candidate reactor and materials generic issues.
Conducts the technical screening of reactor generic issues to determine whether e
development of a solution warrants expenditure of NRC resources.
if appropriate, conducts the technical screening of materials generic issues to e
determine whether development of a solution warrants expenditure of NRC resources.
Conducts technical assessments of reactor generic issues to determine whether e
new or revised requirements or guidance is needed and to establish the j
technical basis for new or revised requirements or guidance.
if appropriate, conducts technical assessments of materials generic issues to e
determine whether requirements or guidance is needed and to establish the technical bases for requirements or guidance.
Develops methodologies to perform technical screenings and technical assessments of generic issues.
Coordinates data entry into databases (e.g., SIMS, GIMCS) on the status and documentation concerning issues processed in accordance with the GlP.
Compiles and issues quarterly reports on the status of issues processed in e
accordance with the GlP.
Assesses the effectiveness and efficiency of the GIP activities and takes action, i
e as appropriato, to improve the program.
Regional Administrators Identify candidate generic issues through inspection and investigation activities.
e Verify licensee implementation of requirements that may result from the e
resolution of generic issues.
e Coordinate regional efforts with other NRC offices that share responsibility for generic issues.
Director, Office of International Programs (OlP) e Serves as the principal contact for the establishment and administration of formal arrangements between NRC and the agencies of foreign countries and l
1 1
intemational organizations for the exchange and collection of information on generic issues.
Assists in the establishment and administration of systems for the effective e
review, tabulation, storage, and retrieval of information related to foreign generic issues.
Coordinates U.S. participation in the Nuclear Energy Agency and the International Atomic Energy Agency reporting systems, and transmits reports and information received on foreign generic issues to the appropriate offices for further consideration.
Director, Office of State Programs (OSP)
Advises, coordinates and reviews Agreement State participation in the review of e
operational safety data to identify candidate materials and waste generic issues in accordance with the requirements of Management Directive 8.5, " Operational Safety Data Review" and this directive.
Director, Office of Enforcement (OE)
Identifies candidate generic issues from review of reactor and materials enforcement issues.
Provides enforcement related support to program and regional offices for resolution of any enforcement issues involved with generic issues.
Applicability The policy and guidance in this directive and Handbook apply to NRC e
employees.
Handbook Handbook 6.4 describes activities involved in the processing of generic issues, e
provides guidelines to facilitate coordination of the activities of the NRC offices responsible for review of generic issues, and describes the elements necessary for a program for the management of the resolution of generic issues.
References Code of Federal Regulations, Title 10, " Energy."
Energy Reorganization Act of 1974, as amended, Sections 208 and 210.
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l NRC Management Directive -
2.2,
" Planning and Budgeting for Federal Information Processing Resources."
3.50, " Document Management."
l 3.7,
Unclassified Staff Publications in the NUREG Series."
l 6.3, "The Rulemaking Process."
8.1,
" Abnormal Occurrence Reporting Procedure."
8.2, "NRC Incident Response Plan."
8.4, "NRC Program for Management of Plant-Specific Backfitting of Nuclear Power Plants."
8.5,
" Operational Safety Data Review."
12,
" Security."
NUREG/BR-0053, " Regulations Handbook."
l NUREG/BR-0058, " Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission."
NUREG/BR-0184, " Regulatory Analysis Technical Evaluation Handbook."
l NUREG/BR-0224, " Guidelines for Conducting Public Meetings."
NUREG-0933, "A Prioritization of Generic Safety Issues."
l NUREG 1409, "Backfitting Guidelines."
l NUREG-1489,"A Review of NRC Staff Uses of Probabilistic Risk Assessment."
OMB Circular No. A-94, " Guidelines and Discount Rates for Benefit-Cost l
Analysis of Federal Programs."
l Regulatory Guide 1.174, "An Approach for Using Probabilistic Risk Assessment
[
in Risk-Informed Decisions on Plant-Specific Changes to the Licensing Basis."
"A Piain English Handbook," Office of Investor Education and Assistance, U.S.
Securities and Exchange Commission, August 1998.
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Generic issue Program a
Draft Handbook 6.4 k
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Contents Part i General Introduction Responsibilities Communication and Coordination Documentation Tracking Part 11 Overview of Generic issue Program Stages General Identification Stage Initial Screening Stage Technical Screening Stage Technical Assessment Stage Regulation and Guidance Development Stage Regulation and Guidance issuance Stage implementation Stage Verification Stage 1
Glossary Tables 1:
Overview of Generic issue Program for Stages 1-4; identification and Assessment 2:
Overview of Generic issue Program for Stages 5-8; Facility or Program Change l
and Verification l
B1:
USl Initial Screening Oriteria l l
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B2:
Possible Major Reduction in Assumed Degree of Protection Related to 1
Equipment Concerns
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Possible Major Reduction in Assumed Degree of Protection Related to Operator Concerns I
B4:
Possible Major Reduction in Assumed Degree of Protection Related to Emergency Response Concerns B5:
Potential Significant Reduction in Risk to the Public Related to Emergency Response Improvement B6:
Potential Significant Reduction in Risk to the Public Related to Equipment / Operator improvement Figures C1:
Overview of reactor adequate protection issue; Technical Screening Stage i
C2:
Overview of reactor substantial safety enhancement issue; Technical Screening l
Stage l
C3:
Overview of reactor burden reduction issue; Technical Screening Stage C4:
Large Early Release Frequency for reactor adequate protection and substantial safety enhancement issues; Technical Screening Stage CS:
Core Damage Frequency for reactor adequate protection and substantial safety enhancement issues; Technical Screening Stage C6:
ImpactNalue threshold for reactor substantial safety enhancement issue; Technical Screening Stage C7:
Large Early Release Frequency threshold for reactor burden reduction issue; Technical Screening Stage C8:
Core Damage Frequency for reactor burden reduction issue; Technical Screening Stage Appendices A - Candidate Generic issue Submittal Form B - Unresolved Safety issue Screening Criteria C - Criteria and Guidance for Technical Screening of Reactor Generic Issues D - Generic Issue Task Action Plan (TAP)
E - Quarterly Generic issue Status Report l
Part I General Introduction The Generic issue Program (GIP) is intended to determine whether a candidate generic issue represents an adequate protection issue, a substantial safety enhancement issue, or a burden reduction issue; to identify cost-effective solutions to generic issues, and then to implement and verify the adequacy of solutions for generic issues, as appropriate.
The following are generally not subject to the provisions of the GIP: obtaining information from licensees or certificate holders, increasing the staff's knowledge in a particular technical area, improving or maintaining the NRC's capability to make independent assessments of safety, administrative matters, or ensuring compliance with existing rules or written commitments.
In some instances, it may be necessary to obtain additional information from licensees or certificate holders to determine (1) whether adequate protection has been or would be maintained through license compliance, or (2) whether it would be appropriate to reduce the regulatory burden through relaxation or elimination of compliance with some regulatory requirement.
Because of the varying technical disciplines and level of difficulty encompassed by generic issues, the processing of generic issues, does not lend itself to a strict, proceduralized process. The guidance in this Handbook is intended to provide a useful, consistent framework for handling, tracking, and defining the minimum documentation associated with the processing of generic issues.
Only potential adequate protection, substantial safety enhancement,' and burden reduction issues are subjected to the processes of the GlP.
Resolution of a generic issue may involve developing and imposing new o
or revised rules, developing new or revised guidance, revising the interpretation of rules or guidance, or providing information for voluntary actions.
Resolution of a generic issue may affect licensees or certificate holders.
The process stages in the GIP are identification, Initial Screening, Technical Screening, Technical Assessment, Regulation and Guidance l
Development, Regulation and Guidance issuance, implementation, and Verification.
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Responsibilities Division Level Management Ensures that policy guidance on processing generic issues is followed.
l Provides the human and financial resources to process generic issues in e
accordance with the planning, budgeting, and management process.
Provides timely review of associated documents and records.
e Ensures that responsible project managers assigned to a particular generic issue have knowledge in the relevant technical area, and are knowledgeable with the GIP and its guidelines.
Ensures that potential reactor and materials generic issues that fall within the scope of the GIP are included in the process.
Provides timely review and approval of Quarterly Generic issue Status Reports prior to submittal to the GIP Manager.
Branch Level Management and Supervisors Ensures cost effective performance of work.
e Ensures that qualified staff are performing the work.
e Reviews work for accuracy and completeness.
e Provides timely review of associated documents and records.
e Ensures that work is performed in accordance with the description and schedule as specified in the approved generic issue Task Action Plan (TAP) in accordance with Appendix D.
Coordinates peer reviews of products produced during the processing of e
generic issues.
Ensures that status reports on generic issues are documented and submitted in accordance with requirements.
Reactor Generic issue Review Panel Receives and reviews candidate reactor generic issues, e
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Conducts initial screening of candidate reactor generic issues, e
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i Determines whether a candidate generic issue should be classified as e
either an adequate protection, a substantial safety enhancement, or a burden reduction issue, Defines the scope of reador generic issues, and e
Reviews any changes in scope of reactor generic issues.
e Materials Generic laste Review Panel Receives and reviews candidate materials generic issues, e
Conducts initial screening of candidate materials generic issues, o
Determines whether a candidate generic issue should be classified as e
either an adequate protection, a substantial safety enhancement, or a burden reduction issue, Defines the scope of materials generic issues, and e
Reviews any changes in the scope of materials generic issues.
e Generic lasue Program Manager Assigns alpha-numeric designations and titles to candidate generic e
issues received from submitters, Transmits to the Reactor or Materials Generic issue Review Panels, as e
appropriate, candidate generic issues that are provided by the submitter.
Supports the activities of the Reactor and Materials Generic Issue Review e
- Panels, Coordinates the issuance of Quarterly Generic issue Status Reports on o
open generic issues and candidate generic issues, i
e Coordinates the issuance of an annual report on open generic issues, if necessary, coordinates the issuance of an annual report on unresolved e
safety issues (USts), and Coordinates data entry into databases (e.g., SIMS, GIMCS) on the status e
and documentation concerning candidate generic issues and open generic issues. IE
Project Manager Prepares generic issue TAPS in accordance with Appendix D for each e
GIP stage following the Initial Screening Stage, Understands the generic issue scope, associated milestones, e
deliverables, and status of assigned generic issues Documents ongoing analyses, and the basis for decision-making, Prepares Quarterly Generic issue Status Reports for assigned issues in o
accordance with Appendix E, Prepares memoranda to the EDO for dropped or resolved generic issues, o
Coordinates public meetings, as needed, concerning assigned candidate e
generic issues, or open generic issues.
Performs or coordinates work in accordhnce with NRC policies and this e
directive, and Performs work in a timely manner.
e Communication and Coordination internal Effective communication and coordination between cognizant technical e
and licensing staff is essential for planning and timely completion of each of the stages of the GIP. This is also true for the project managers signed for each generic issue, and the GIP Manager. Discussions of plans for completing each stage of the GIP shall be held among r
. propriate staff and documented by the responsible project manager.
Cognizant technical and licensing staff should communicate frequently e
regarding the scope, progress, intermediate findings, expectations, and routine activities (e.g., inspections, safety evaluations) that may affect issue closure to ensure efficient use of resources.
External For significant generic issues, a public meeting should be held early in e
the Technical Assessment and Regulation and Guidance Development Stages of the GIP to inform the public and the industry about the scope of the issue, significance of the issue, and plans for closing the issue. The public and the industry should be given the opportunity to comment on the significance of the issue and plans for closing the issue.
Consideratiori should be given to coordinating closure of an issue with e
appropriate industry groups such as the Nuclear Energy Institute, owners groups, Electric Power Research Institute, the public, or others.
Meetings with extemal stakeholders will be held in accordance with NRC e
policy. Guidance on conducting public meetings is in NUREG/BR-0224,
" Guidelines for Conducting Public Meetings."
Documentation General Provisions Adequately documenting the work and decision-making associated with a e
generic issue or candidate generic issue is important. The documentation should be thorough enough that the work and decision-making can be understood by those who were not directly involved in the generic issue or candidate generic issue.
Tables 1 and 2 illustrate the documentation typically produced during the e
processing of a generic issue.
NUREG-xxxx (to be developed)
Contains summaries of generic issues and candidate issues processed in e
accordance with this directive.
Generic issues identified prior to the effective date of this directive are e
documented in NUREG-0933, "A Prioritization of Generic Safety Issues."
Closure Memorandum The responsible office for a generic issue (i.e., RES for reactor generic o
issues or NMSS for materials generic issues) shall inform the EDO by memorandum when a generic issue has been closed. The responsible project manager shall originate the closure memorandum for signature by the appropriate office director. Copies of the closure memorandum should be sent to the GIP Manager, the appropriate advisory committees (i.e., ACRS, ACNW or ACMUI) and the submitter of the issue. A generic issue is " closed" after it has been determined that the issue should be either dropped from any further analyses, or has been resolved. The memorandum should include the following:
description of the candidate generic issue or generic issue, description of the potential or actualimpset of the issue on safety or regu!atory burden, technical basis for classifying the issue as dropped or resolved, and f
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how the implementation of corrective actions was verified, if j
applicable.
Tracking General Provisions Each candidate generic issue or generic issue shall have an assigned e
alpha-numeric designation.
Quarterly Generic issue Status Reports and summaries should be written e
in accordance with "A Plain English Handbook" (see References).
Task Action Plan The TAP documents the plans, schedules, and assigned responsibilities for managing each generic issue through the specific stages of the GIP. See Appendix D for assignment of tasks contained within the TAP, During each stage after the Identification Stage, a TAP will be prepared e
and periodically updated, as appropriate, by the responsible project manager. Depending on the complexity of the generic issue, different project managers may be assigned the responsibility to cover different stages of the GIP.
The TAP describes the actions needed to complete a specific GIP stage.
e For example, a TAP prepared in the Technical Assessment Stage shouid only include the activities needed to complete that stage. The TAP should delineate the work to be done, assignment of major responsibilities, identification of project resource needs, and scheduling of milestone dates.
Office Level Tracking The scheduled completion date for each GIP stage and any significant milestones will be included in the tracking system and operating plan of the responsible office.
Generic issues should be assigned a Technical Assignment Control (TAC) number by the responsible office to facilitate tracking the expenditure of resources.
Quarterly Generic issue Status Report Quarterly Generic Issue Status Repons (guidance provided in Appendix E) are living documents that summarize the work and decision-making associated with a generic issue as it passes from one stage to another, and from one project manager to another, if needed.
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Each responsible project manager will piapare a Quarterly Generic issue i
Status Report for assigned candidate generic issues and generic issues.
l The GIP Manager will solicit and use the Quarterly Generic issue Status Reports to prepare an integrated report summarizing the status and activities related to open generic issues and candidate generic issues.
The integrated report will include only non-predecisional and non-proprietary information. Copies of the report will be sent to the EDO, ACRS, ACNW, ACMUI, and the Public Document Room (PDR).
AnnualRepon i
The GIP Manager will prepare an annual report that will be provided to the program offices for concurrence. This report will provide a summary of activities related to open generic issues that will be sent to the Commission.
9
l l
[ Blank page) 6
Part II Overview of Generic issue Program Stages General Only generic issues that potentially involve adequate protection, substantial safety enhancement, or burden reduction are included in the Generic issue Program (GIP).
The GIP consists of the following stages:
Identification, Initial Screening Technical Screening, Technical Assessment, Regulations and Guidance Development, Regulation and Guidance issuance, Implementation, and Verification.
Descriptions of each of the stages including products are given below and in Tables 1 and 2 of this Handbook.
Identification Stage Candidate generic issues (e.g., adequate protection issue, substantial safety enhancement issue, burden reduction issue) may be identified by organizations or individuals internal or external to the NRC, including the NRC staff, ACRS, ACNW, ACMUI, licensees, certificate holders, industry groups, or the general public.
Candidate generic issues may be identified by the NRC during routine activities.
Sources of candidate generic issues include, but are not limited to, NRC staff concerns, public concerns, license 3 event reports, morning reports, inspection reports, investigation reports, allegation reports, component failure reports,10 CFR Part 21 reports, industry reports, and reporN of operational events at foreign facilities.
Guidance for identifying generic issues from operational safety data reviews is contained in Management Directive 8.5, "Oper6tional Safety Data Review."
Individuals and organizational units within the NRC who wish to nominate a generic issue must complete the Candidate Generic issue Submittal Form contained in Appendix A. This form may also be used by parties outside the NRC to express their concerns to the staff for consideration as a candidate generic issue. i
Candidate generic issues are submitted to the GIP Manager, who will e
forward them to either the Reactor or Materials Generic Issue Review Panel, as appropriate. For candidate generic issues that involve both program areas, the GIP Manager will consult with the program offices to establish a combined review panelincluding representatives of NRR, NMSS, and RES.
Candidate generic issues may be previous generic issues that have either been dropped or resolved. This could occur if significant or new information becomes available that may affect their closure.
Initial Screening Stage During the Initial Screening Stage, the appropriate Generic Issue Review Panel determines whether the candidate generic issue (e.g., adequate protection issue, substantial safety enhancement issue, burden reduction issue) is a generic issue, whether the issue should be processeo in the GIP, should be dropped, or sent to another NRC program for review. Also. the scope of the candidate generic issue (and thus the generic issue) is defined at this stage.
The initial Screening Stage is complete after the appropriate Generic issue Review Panel reviews the information contained on the Candidate Generic Issue Submittal Form (See Appendix A), and submits its findings and recommendations to the Director of RES for reactor issues, or the Director of NMSS for materials issues.
This stage must be completed within 30 days upon receipt of a candidate generic issue.
The appropriate office director (or designee) assigns a responsible project manager to coordinate the initial screening of the generic issue.
The responsible project manager should be chosen based on the nature of the generic issue (i.e., adequate protection, substantial safety enhancement, or letrden reduction), or whether the proposed resolution involves a backfit, rulemaking, or burden reduction.
The Reactor or Materials Generic issue Review Panel reviews, and if necessary, revises the scope proposed by the submitter with assistance from the submitter. If the submitter is outside the NRC, this review should be in a public meeting.
The Reactor or Materials Generic issue Review Panel will perform initial screenings of candidate generic issues with assistance from the submitter, if appropriate. If the submitter is an individual or organization outside the NRC, this screening should be in a public meeting.
The Reactor or Materials Generic Issue Review Panel recommends whether the candidate generic issue is a generic issue, and if so, classifies it as either an adequate protection, a substantial safety enhancement, or a burden reduction issue.
For a candidate generic issue, an initial screening memorandum shall be originated by either the Reactor or Materials Generic issue Review Panel, as appropriate, and shall consist of a forwarding note with attached findings and recommended actions. Burden reduction issues may not lend themselves to the Technical Screening and Technical Assessment Stages. In some instances, the appropriate Generic issue Review Panel may recommend that the screening and assessment stages for burden reduction issues be waived, or performed at a lower level of effort. The basis for this recommendation shall be documented in the Panel's Initial Screening memorandum. As a minimum, the initial screening memorandum is to include a clear, concise description of the generic issue, its classification, safety significance, proposed action, and the Candidate Generic Issue Submittal Form (Appendix A) prepared by the submitter. The generic issue memoranda shall be sent to the Director, RES for reactor issues, or to the Director, NMSS for materials issues, as appropriate, through the GIP Manager for concurrence.
The responsible office director (RES for reactor generic issues or NMSS for materials generic issues) willinform the submitter of the candidate generic issue of the Generic issue Review Panel findings and recommendations by separate memorandum for internal submitters, and by letter for external submitters. The appropriate Generic issue Review Panel originates this information memorandum or letter. Copies of the memorandum or letter should be sent to the GIP Manager, ACRS, ACNW, or ACMUI, as appropriate.
The responsible project manager produces the Quarterly Generic issue Status Report in accordance with Appendix E for the assigned generic issue.
4 The supervisor of the responsible project manager submits the Quarterly Generic issue Status Report to the appropriate office director (or designee) for review and approval.
Technical Screening Stage The Technical Screening Stage is a " quick" look at the generic issue, using information that is readily available and with limited resources.
The main purposes of Technical Screening Stage is to (1) perform additional review of those generic issues that may represent an adequate protection issue, a substantial safety enhancement issue, or a burden reduction issue, (2) determine if these should be designated as USis and reported to Congress, and (3) identify a cost-effective solution to the generic issue.
r Technical screening also provides technical justification for dropping a generic issue that has little safety significance, would not result in a substantial safety enhancement, is not cost justifiable, or is an unwarranted regulatory burden.
Guidance for performing a technical screening of a reactor generic issue is provided in Appendices B and C. Guidance for performing a technical screening of a materials generic issue would use more qualitative methods, expert elicitation, and judgement. Additional guidance for performing a technical screening can be found in the References section of this directive.
The Technical Screening Stage must be completed within 6 months of the receipt of the candidate generic issue from the submitter.
The appropriate office director (or designee) assigns a responsible e
project manager to coordinate the technical screening of the generic issue. The responsible project manager should be chosen bated on the nature of the generic issue (i.e., adequate protection, substantial safety enhancement, or burden reduction), or whether the proposed resolution involves a backfit, rulemaking, or burden reduction.
The appropriate office director (or designee) assigns staff to perform the Technical Screening Stage if the proposed staff come from different l
offices, arrangements between offices will have to be made to obtain needed expertise. The technical screening staff should be chosen and approved based on the scope of the generic issue.
RES evaluates adequate protection and substantial safety enhancement issues against the USI screening criteria (see Appendix B).
RES conducts the technical screening of each reactor generic issue to determine whether it is likely to result in the benefits being sought (e.g.,
cost effective, increased safety, reduced burden) and thus merits additional expenditure of NRC resources.
NMSS conducts the technical screening of each materials generic issue e
to determine whether it is likely to result in the benefits being sought (e.g., cost effective, increased safety, reduced burden) and thus merits i
additional expenditure of NRC resources.
The responsible project manager prepares and maintains a Task Action e
l Plan (TAP) in accordance with Append x D, which includes the activities I
to complete the Technical Screening Stage.
l The supervisor of the responsible project manager submits the TAP and any substantive revisions to the TAP to the appropriate office director (or designee) for review and approval. A copy of the approved TAP is submitted to the GIP Manager. L
e The supervisor of the responsible project manager contacts the e
supervisors of the appropriate staff members assigned to perform the technical screening to request their assistance, directs the responsible project manager to initiate contractual action to procure the technical assistance (if technical expertise is not available internally) needed to perform the technical screening, or both, Completed technical screening analyses shall be documented and sent e
for peer review to the NRC organizational unit or units whose area of responsibility or specialized knowledge is substantially involved in the generic issue.
After the generic issue draft technical screening results have been peer reviewed, the appropriate Generic issue Review Panel will reconvene to address the comments and make changes to the findings and recommended actions, as appropriate.
The supervisor of the responsible project manager informs the Director of e
RES (for reactor issues), or the Director of NMSS (for materials issues),
as appropriate, by a memorandum of the findings and recommended actions. As a minimum, the memorandum shallinclude a clear, concise summation of the technical screening analysis, description of the recommended actions (e.g., drop or continue), and a copy of the technical screening analysis.
j After the technical screening analysis has been reviewed and a final l
e decision has been made by the appropriate office director, the supervisor of the responsible project manager informs the ACRS, ACNW, or ACMUI, as appropriate, by memorandum of the office director's final decision.
The Technical Screening Stage is complete when the Director of RES (for reactor generic issues) or the Director of NMSS (for materials generic issues) determines whether the generic issue should be dropped or continued to the Technical Assessment Stage.
if the generic issue is dropped, the responsible project manager shall e
originate a memorandum for signature by the responsible office director to the EDO, providing the basis for the decision, with copies to the GIP Manager, ACRS, ACNW, ACMUI and the submitter of the issue, The responsible project manager produces the Quarterly Generic issue e
Status Report for the assigned generic issue.
The supervisor of the responsible project manager submits the Quarterly l
Generic issue Status Report to the appropriate office director (or designee) for review and approval.
Copies of approved correspondence between the supervisor of the e
responsible project manager and the appropriate office director shall be sent to the GIP Manager and the submitter.
Technical screening analyses will be published in NUREG-xxxx (to be e
developed) or its supplements.
Technical Assessment Stage The Technical Assessment Stage is an "in-depth" study of a generic issue (e.g.,
adequate protection issue, substantial safety enhancement issue, burden reduction issue), and may involve contractor support. To form a technical basis for taking or not taking regulatory action, the Technical Assessment Stage may l
include:
a review of operational data and events, a review of related generic issues, experiments and tests, system analyses, a
l computational analyses, field studies, inspections, model development, I
probabilistic risk assessments, integrated safety assessments, and expert elicitation.
The extent of these activities vary in accordance with the scope, complexity, or significance of the generic issue, and the depth of information available on a given generic issue.
Typically, the activities performed during this stage will be documented in technical letter reports, NUREG reports, or NUREGICR reports.
With input from other offices and regions, completion s:hedules for technical assessments for specific generic issues, except USis, should be established by RES (for reactor generic issues) or NMSS (for materials generic issues) based on work prioritization schemes of the assigned office.
The appropriate office director (or designee) assigns a responsible project man ger to coordinate the technical assessment of the generic issue.
The appropriate office director (or designee) assigns staff to perform the Technical Assessment Stage. If the proposed staff come from different offices, arrangements between offices will have to be made to obtain needed expertise. The technical assessment staff should be chosen and approved based on the scope of the generic issue.
1 The supervisor of the responsible project manager contacts the
)
e supervisors of staff members assigned to perform the technical assessment, and as required, directs the responsible project manager to initiate contractual action (if technical expertise is not available internally) to procure the techrical assistance needed to perform the technical assessment.
l The responsible project manager for the technical assessment shall e
prepare and maintain a TAP for the activities needed to complete the Technical Assessment Stage.
l A copy of the approved generic issue TAP (including any revisions) and e
status reports shall be provided to the submitter of the issue. If these documents contain pre-decisional or proprietary information, OGC will 1
determine what information can be released to a non-NRC employee submitter, Either RES (for reactor issues) or NMSS (for materials issues), as o
appropriate, shall conduct or oversee the technical evaluation of the generic issue, verify the legitimacy of the concern expressed, verify that the benefits sought will be obtained, establish the technical basis for new or revised regulations or guidance, and identify solutions for the issue that are likely to result in substantial net plant safety improvements or reduction in regulatory burden without significant decrease in safety margin.
The supervisor of the responsible project manager for the technical assessment of the generic issue shall submit the TAP and any substantive revisions to the appropriate office director (or designee) for review and approval.
The responsible project manager produces the Quarterly Generic issue e
Status Report for the assigned generic issue, The supervisor of the responsible project manager submits the Quarterly e
Generic issue Status Report to the appropriate office director (or designee) for review and approval.
l e
After the generic issue technical assessment has been completed, the supervisor of the responsible project manager informs the Director of RES (for reactor issues) or the Director of NMSS (for materials issues) by a memorandum of the findings, and reques.ts appropriate actions, i
1 The Technical Assessment Stage is complete when the Director of RES e
(for reactor issues) sends a recommendation to the Director of NRR, or when the Director of NMSS (for materials issues) determines whether the issue should be dropped, new or revised rules or guidance are needed, or new or revised NRC programs are needed.
l j
I After the technical assessment of the generic issue has been completed, e
the supervisor of the responsible project manager informs the ACRS, ACNW, or ACMUI, as appropriate, by memorandum, of their findings.
Regulation and Guidance Development Stage The Regulation and Guidance Development Stage involves an in-depth review of potential facility or program changes to address the generic issue (e.0..
adequate protection issue, substantial safety enhancement issue, burden reduction issue), and selection of needed regulatory actions. Technical findings obtained during the Technical Assessment Stage are, as necessary, used as a basis to develop or revise rules, guidance, and programs. Products to be produced during the Regulation and Guidance Development Stage could include draft rules, regulatory guides, bulletins, generic letters, information notices, new or revised inspection procedures, and CRGR briefing packages.
Typically, NRC rules and guidance are contained in Title 10 of the Code of Federal Regulations, standard review plans, safety evaluation reports, bulletins, generic letters, information notices, and regulatory guides.
During the Regulation and Guidance Development Stage, coordination with outside organizations such as licensees, certificate holders, industry groups, and the public to elicit potential industry initiatives that could eliminate or supplement needed regulatory actions by the NRC is performed.
The development of rules, guidance, or programs can take from several months to a few years depending on the length of time required by the deliberations involved. If rulemaking is a potential option to address the generic issue, coordination between this MD and MD 6.3, "The Rulemaking Process" will be required. The generic issue TAP in accordance with this MD and the rulemaking plan in accordance with MD 6.3 will need to be coordinated to reduce duplication of effort.
The appropriate office director (or designee) assigns a responsible e
project manager for the Regulation and Guidance Development Stage to coordinate activities (both inside and outside NRC) to develop new or revised rules, guidance, or programs to address the generic issue.
The appropriate office director (or designee) assigns staff to perform the Regulation and Guidance Development Stage. If the proposed staff come frcm different offices, arrangements between offices will have to be made to obtain needed expertise. The regulation and guidance development staff should be chosen and approved based on the scope of the generic issue.
The supervisor of the responsible project manager contacts the supervisors of staff memb3rs assigned to perform the regulation and I
guidance development review to request their assistance.,
1 The responsible project manager shall prepare and maintain a TAP for activities needed to complete the Regulation and Guidance Development Stage for the generic issue.
The supervisor of the responsible project manager submits the TAP for e
the Regulation and Guidance Development Stage, including any substantive revisions, to either the office director of RES (for reactor generic issues) or NMSS (for materials generic issues) for review and approval.
If needed, NRR develops or revises regulations, guidance, or programs, o
and with support from RES as appropriate, performs regulatory and backfit analysis for the reactor generic issue based on the technical basis established during the Technical Assessment Stage.
if needed, NMSS develops or revises regulations, guidance, or programs, e
and develops regulatory analysis for the materials generic issue based on the technical basis established during the Technical Assessment Stage.
I After draft rules or guidance have been prepared or revised, the CRGR e
will be briefed if appropriate, and appropriate advisory committees (i.e.,
ACRS, ACNW, or ACMUI) will be informed by memorandum from the
{
supervisor of the responsible project manager, of corrective actions to address the generic issue.
Draft regulation, ga unce, or program changes shall be peer reviewed, comments addr.,9 A and final corrective actions developed for implementation tg iicensees and certificate holders, as appropriate. In addition, if a new rule, rule change, addition or change to the standard review plan or regulatory guide is specified as part of the corrective action, it must be issued for public comment with an appropriate Federal Register notice.
The responsible project manager for the Regulation and Guidance Development Stage prepares the Quarterly Generic issue Status Report.
The supervisor of the responsible project manager submits the Quarterly e
Generic issue Status Report to either the office director of RES (for reactor generic issues) or NMSS (for materials generic issues) for review and approval.
Copies of approved correspondence between the supervisor of the responsible project manager and the appropriate office director shall be l
sent to the GIP Manager, members of the appropriate Generic issue Review Panel, and the submitter. t
o e
j_
e The Regulation and Guidance Development Stage is complete when:
Either the Director of RES (for reactor issues) informs the Director of NRR that the issue should be dropped; new or revised regulations, guidance, or programs have been developed; and/or industry initiatives are accepted, at least in part, to address the generic issue, or NMSS determines whether the issue should be dropped; new or revised regulations, guidance, or programs have been developed; and/or industry initiatives are accepted, at least in part, to address the generic issue.
Regulation and Guidance issuance Stage Documents clearly describing the facility or program changes developed during the Regulation and Guidance Development Stage to address the generic issue shall be issued in a timely and effective manner. New or revised regulations require the review and approval of the Commission. Basic guidance documents necessary for regulation and guidance issuance are contained in the References section of this management directive.
The appropriate office director or designee (NRR for reactor genenc e
issues, and NMSS for materials generic issues) assigns a responsible project manager for the Regulation and Guidance issuance Stage to coordinate the activities (both inside and outside NRC) needed to issue new or revised rules, guidance, or programs to address the generic issue.
The responsible project manager prepares and maintains a TAP for activities needed to complete the Regulation and Guidance issuance Stage for the generic issue.
The supervisor of the responsible project manager submits the TAP for o
i the Regulation and Guidance issuance Stage, including any substantive revisions, to either the office director of RES (for reactor generic issues) or NMSS (for materials generic issues) for review and approval.
The responsible project manager for the Regulation and Guidance issuance Stage prepares the Quarterly Generic Issue Status Report.
1 The supervisor of the responsible project manager submits the Quarterly l
Generic Issue Status Report to either the office director of RES (for reactor generic issues) or NMSS (for materials generic issues) for review and approval.
Copies of approved correspondence between the supervisor of the e
responsible project manager and the appropriate office director shall be 1 1
L
E l
ll' sent to the GIP Manager, members of the appropriate Generic Issue Review Panel, and the submitter, l
The Regulation and Guidance issuance Stage is complete when the Director of RES (for reactor issues) informs the Director of NRR that new or revised regulations, guidance, or programs to address the generic issue have been issued, or when the Director of NMSS (for materials issues) issues new or revised regulations, guidance, or programs to address the generic issue.
Implementation Stage 1
The objective of the implementation Stage is to determine whether the licensee or certificate holder has established and is implementing a program to ensure that facility or program changes taken to address a generic issue (e.g., adequate protection issue, substantial safety enhancement issue, burden reduction issue) a are effective and in accordance with committments.
The implementation Stage occurs when the affected licensee or certificate holder perform the actions necessary to implement the regulatory action to resolve the generic issue. These may include modifications or additions to:
the systems, structures, components or design of a facility; the design approval or manufacturing license for a facility; or the technical specifications, procedures, programs, or organization required to design, construct, or operate a facility.
The appropriate office director (or designee) assigns a responsible project manager for the implementation Stage to coordinate the activities (both inside and outside NRC) needed to address generic issue facility or program changes.
The responsible project manager prepares and maintains a TAP for activities needed to complete the implementation Stage for the generic issue.
The supervisor of the responsible project manager submits the TAP for e
the implementation Stage, including any substantive revisions, to either the Director of RES (for reactor generic issues) or NMSS (for materials generic issues) for review and approval.
The supervisor of the responsible p.oject manager should contact the supervisors of the staff members assigned to review implementation of facility or program changes. Facility or program changes may involve interactions with industry groups, licensees, certificate holders, and/or the NRC.
l r
As required by the NRC, each licensee or certificate holder will establish e
a program, or ensure the effectiveness of its current program, to assess specific vulnerabilities to the generic issue, From this review, a facility or program change plan will be developed. For burden reduction issues, licensees or certificate holders opting to implement the relaxation of requirements, shall notify the NRC with its plans for implementation. The NRC will be notified by letter of the facility or program change plan in accordance with 10 CFR 50.54(f).
As required by the NRC, each licensee or certificate holder will inform the e
appropriate NRC program office by letter regarding proposed changes to programs, processes, or equipment, including schedules for implementation. Any substantive changes in the proposed or actual facility or program changes, or the implementation schedule will be reported to the NRC in accordance with 10 CFR 50.54(f). Copies of this correspondence shall be provided to the responsible project manager i
and the GIP Manager.
The responsible project manager for the implementation Stage prepares o
the Quarterly Generic Issue Status Report.
4 The supervisor of the responsible project manager submits the Quarterly e
Generic issue Status Report to either the office director of RES (for reactor generic issues) or NMSS (for materials generic issues) for review and approval.
Copies of approved correspondence between the supervisor of the responsible project manager and the appropriate office director shall be sent to the GIP Manager, members of the appropriate Generic issue Review Panel, and the submitter.
The implementation Stage is complete for an affected licensee or certificate holder once it has formally informed the appropriate NRC program office that facility or program changes have been implemented.
Verification Stage The objective of the Veri'ication Stage is to determine whether licensees or certificate holders have adequately demonstrated the efficacy of facility or program changes in addressing the generic issue (e.g., adequate protection issue, substantial safety enhancement issue, burden reduction issue).
The Verification Stage involves auditing and inspection of individual licensees and certificate holders to verify that effective actions have been implemented.
Depending on the number of affected licensees or certificate holders, and the risk significance of the generic issue, and the complexity of the corrective actions, it may not be necessary to periorm a 100 pucent inspection of facility or program changes taken to declare a generic issue resolved.
r The appropriate office director (or designee) assigns a responsible project manager for the Verification Stage to coordinate the activities l
(both inside and outside NRC) needed to address generic issue facility or program changes.
The responsible project manager prepares and maintains a TAP for activities needed to complete the Verification Stage for the generic issue.
The supervisor of the responsible project manager submits the TAP for the Verification Stage, including any substantive revisions, to either the Director of RES (for reactor generic issues) or NMSS (for materials t
generic issues) for review and approval.
As required by the NRC, each licensee or certificate holder will inform the NRC by letter upon completion of facility or program changes in accordance with 10 CFR 50.54(f). Forwarded information will include the results of analysis, studies, and tests.
As required by the NRC, changes made to structures, systems, components, processes, and programs to address the generic issue will be documented and provided to the NRC by letter in accordance with 10 CFR 50.54(f), for review, audit, and inspection to verify that appropriate facility or program changes have been completed.
Verification inspections at licensee or certificate holder facilities will generally be perfomied by the regions, with assistance from headquarters staff, as appropriate. Due to the ischnical nature of some generic issues, it may be appropriate to also use expert contractors or staff members.
Verification inspections will be performed, as appropriate, through Temporary Instructions to assess generic issue facility or program changes.
If appropriate, and commensurate with the generic issue, the inspector shall verify and document in an inspection report that the licensee or certificate holder has established plans for periodic verification of the continued effectiveness of the facility or program changes in resolving the generic issue.
If appropriate, and commensurate with the generic issue, NRC region or hesdquarters staff shall make recommendations for any continuing or routine inspections to be added to the NRC baseline inspection program.
l A copy of each verification inspection report shall be provided to the appropriate NRC program office for review and concurrence prior to issuance. t
if the inspection report's findings indicated that adequate facility or e
program changes had not been implemented, the NRC shall develop an order and issue it to the affected licensee. The order will require that the affected licensee or certifi ste holder repeat the Implementation Stage activities. In addition, the NRC shall reinspect the affected licencee or certificate holder for compliance.
The verification inspection reports shall be provided to the appropriate e
Generic issue Review Panel, the responsible project manager, the GlP Manager, and the submitter.
The responsible project manager for the Verification Stage prepares the e
Quarterly Generic Issue Status Report.
The supervisor of the responsible project manager submits the Quarterly e
Generic issue Status Report to either the office director of RES (for reactor generic issues) or NMSS (for materials generic issues) for review and approval.
Copies of approved correspondence between the supervisor of the responsible project manager and the appropriate office director shall be sent to the GIP Manager, members of the appropriate Generic issue Review Panel, and the submitter.
The Verification Stage is complete for an affected licensee or certificate holder once the final inspection report has been issued, and the appropriate NRC program office determines that facility or program changes are adequate. Documentation providing the basis for declaring the Verification Stage complete for a specific licansee or certificate holder shall be provided to the GIP Manager for review.
The Verification Stage is complete for all affected licensees or certificate holders, once:
all final verification inspection reports have been issued, the apprcepriate NRC program office has determined that facility or program changes are adequate to classify the generic issue as resolved, and i
the responsible project manager prepares a memorandum to the EDO through the GlP Manager z.nd RES, indicating the basis for j
declar;ng the generic issue as resolved.
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p Glossary Adequate Protection issue. A generic issue which primarily raises questions and concems on the adequacy of existing NRC requiremente and guidance for l
ensuring adequate protection of public health and safety.
Burden Reduction issue. A generic issue which has the effect of reducing unwarranted burden of unnecessary requirements on licensees or certificate holders, its purpose is to ease regulatory requirements while maintaining public health and safety.
Candidate Generic issue. A generic issue that has not had its initial screening and classification by the Reactor Generic issue Review Panel or Materials Generic Issue Review Panel.
Closed. Refers to candidate generic issues or generic issues that have either been dropped from further review, or generic issues that have been resolved.
Dropped. Status assigned to generic issues that are closed because the issue (1) does not warrant expenditure of NRC resources, (2) does not warrant regulatory actions, or (3) is not cost beneficial.
Generic issue. A regulatory matter involving the design, construction, operation, or decommissioning of several, or a class of NRC licensees or certificate holders that is not appropriately addressed by existing rules, guidance, or programs. A generic issue may be an adequate protection issue, a substantial safety enhancement issue, or a burden reduction issue.
Generic issue Program Manager. Person responsible for the overall management of the Generic issue Program.
Materials Generic Issue. A matter that is applicable to several, or a class of materials licensees or certificate holders.
Materials Generic issue Review Panel. An interoffice review board that reviews materials generic issues.
j Open. Status assigned to generic issues that have not been dropped or resolved.
Reactor Generic issue. A matter that is applicable to several, or a class of
)
nuclear reactors or reactor-related facilities.
Reactor Generic issue Review Panel. An interoffice review board that reviews I
reactor generic issues.- j
i i
Resolved. Status assigned to generic issues that have completed all the process stages of the Generic issue Program.
Responsible Project Manager. The person assigned to oversee one or more Generic issue Program Stages for a specific generic issue.
Submitter. An individual or organization that submits a candidate reactor or materials generic issue to the Generic issue Program Manager, and for review by either the Reactor Generic issue Review Panel, or the Materials Generic Issue Review Pane!.
Substantial Safety Enhancement issue. A generic issue which primarily results in cost beneficial safety improvements.
Unresolved Safety issue. A reactor generic issue that affects a number of nuclear power plants and poses important questions concerning the adequacy of existing safety requirements for which a final resolution has not yet been developed. An unresolved safety issue generally involves conditions that are not likely to be acceptable over the lifetime of the plants affected. Section 210 of the Energy Reorganization Act of 1974 requires the NRC to develop a plan for analysis of unresolved safety issues relating to nuclear reactors, to implement corrective measures with respect to such issues, and to include such plans in the annual report to Congress. '
s
[ Blank Page)
1 Appendix A Candidate Generic issue Submittal Form The content for each section shall be provided by the submitter.
1
- ~. - - - -. - -.
L Information Explanation / Comment (provided by submitter)
L (1) Proposed Title
! Provide a descriptive title.
4 l (2) Generic issue Type
[ Adequate protection issue, substantial safety enhancement l
issue, or burden reduction issue)
_q l (3) Description Provide a description of the proposed generic issue. Briefly l
(
discuss the background (bases) of the issue.
]
! (4) Operational Events List pertinent operational events.
(5) Affected Licensees,.
List the licensees or facilities that are affected and/or include an
{
! certificate holders, or estimate of the number of licensees or facilities that are
' facilities l affected.
(6) Safety issue Discuss the risk potential (i.e., potential contribution to risk, core l melt frequency, or public dose). Be as specific as possible in terms of an objectively observable characteristic, such as the presence or absence of a particular design feature.
_j (7) Possible solutions Sufficient attention should be devoted to the proposed issue to suggest a possible or attemative solution (e.g., design and hardware changes or additic,ns, procedural changes, changes l
l in plant staffing and/or management, accident management
{
t
.l l changes).
l a
l (8) Affected regulations List pertinent regulations and regulatory guidance.
]
! (9) Applicable standards List pertinent consensus standards.
(10) Industry initiatives List pertinent industry initiatives.
1 (11) Applicable references l List appropriate references (memoranda, NUREGs, etc.).
(12) Contact Submitter's name, organization / company, mailing address, e-I I mail address, and telephone number.
i
~~
~ ~ ~ ~ ~ ~
lndicate if information requested is either unknown or does not apply.
A-1
r l
1 Appendix B i
Unresolved Safety issue Screening Criteria i
General An unresolved safety issue is a matter affecting a number of nuclear power plants that poses important questions concerning the adequacy of existing safety requirements for which a fina!
resolution has not yet been developed; an unresolved safety issue generally involves conditions that are not likely to be acceptable over the lifetime of the plants affected. In 1977, Congress amended the Energy Reorganization Action of 1974 to include:
"Section 210. The Commission shall develop a plan providing for the specification and analysis of unresolved safety issues relating to nuclear reactors and shall take such actions as may be necessary to implement corrective measures with respect to such issues. Such plans shall be submitted to the Congress on or before January 1,1978, and progress reports shall be included in the annual report of the Commission thereafter."
The Joint Explanatory Statement of the House-Senate Conference Committee for Bill S.1131 provided the following additionalinformation regarding its deliberations of this portion of the bill:
)
"Section 3. The House amendment required development of a plan to resolve generic safety issues. The conferees agreed to a requirement that the plan be submitted to the Congress on... The Conferees also expressed the intent that this plan should identify and describe those safety issues, relating to nuclear power reactors, which are unresolved on the date of enactment. It should set forth: (1) Commission actions taken directly or indirectly to develop and implement corrective measures; (2) future actions planned concerning such measures; and (3) timetables and cost estimates of such actions. The Commission should indicate the priority it has assigned to each issue, and the basis on which priorities have been assigned."
In order to evaluate safety concerns, recommendations, or general safety issues and determine if these should be designated unresolved safety issues and reported to Congress as such, the process described below was developed. This process is intended to provide a systematic and consistent approach to evaluating these issues and judging their impact on risk to the public health and safety.
Initial Screening Criteria if the response is "true" to any of the criteria listed in Table B1, the generic issue is not an unresolved safety issue.
B-1 m
Table B1. USlInitial Screening Criteria r_.__.______
Criteria l T/F,
Explanatory Note
' The issue is not related to nuclear power l
l For example, the transportation of radioactive 3
- plant safey p_..
l materials.
l A staff position on the issue has been The purpose of this criterion is to eliminate those l
developed or is expected to be developed issues that are near resolution and, therefore, are 1 2 within six months.
not " unresolved" issues. Such issues do not warrant l
l the attention and resources normally associated with i
l i
I a USI.
7_-___._
3 : The issue is not generic.
j
_-_(.-... Y _ - _ -.__
l l4 i The issue is only indirectly related to l For example, recommended changes in the licensing i i
! nuclear power plant safety.
j process, NRC organization, and so forth.
i t
Definition of the issue requires long-term The basis for this criterion is to eliminate connrmatory or exploratory research.
investigative studies of matters for which no clearly
[5 defined safety deficiency or improvement has been l
)
{
identified, The issue is related to one already being
)
6 ' addressed as a USl and can reasonably be i i
or already is included in the current
{
j program.
l l
l The issue requires a policy decision rather j
! The purpose of this criterion is to eliminate those
, than a technical solution, r
l issues that require a management decision only and j
j do not represent potential deficiencies in existing
'7 i safety requirements for which a resolution must be l developed. In some cases, the results of these l policy decisions may require designation of new
. USts._ - - - -.
Candidate Unresolved Safety issues if all the responses are " false," the following tables should be used to evaluate the issue's generalimpact on various factors affecting safety. In order to use the following tables, the issue should be identified as either a deficiency or an improvement, and the issue should be identified as related to operations, equipment, or emergency response.
The questions in the following tables are intended to evaluate the impact of each candidate unresolved safety issue on the probability of an accident or transient; the probability of losing mitigating functions, given the event; and consequences given the event and loss of mitigating functions. The overall conclusion is based on the answers to the questions in the following tables regarding the potential to significantly affect the fission-product-barrier integrity, or the frequency of transients or accidents, safety functions, or emergency response capability.
Where possible, quantitative information should be used to answer the questions and arrive at conclusions on potentialimpact. However, qualitative likelihood estimates can be developed and used to draw conclusions.
B-2
n Table B2:
Possible Major Reduction in Assumed Degree of Protection i
Related to Equipment Concerns
, What is the potential deficiency?
What is the likelihood that the potential deficiency exists?
Impact on Structural impact on Frequency of impact on Safety Functions,
integrity of Fission Product Transients / Accidents t
Boundaries l
! What barriers are affected?
What systems are affected?
What systems are affected?
l What is the likelihood barriers will What is likelihood that systems will What is the likelihood that systems l (fail, given the deficiency?
fait due to frequency?
will fail?
j What transients / accidents could What safety functions are affected? !
result?
What is the likelihood that these What is the likelihood of loss of I
transients / accidents will occur?
safety functions?
Based on the above, would the Based on the above, is it likely that Based on the above,is it likely that { frequency of transients / accidents the deficiency would cause a loss
, fission product boundaries will fail
- be significantly increased by the of safety function when needed?
l
! due to this deficiency?
l potentialdeficiency?
Yes l
7 No l
Yes
.l
?
I No Yes I
?
l No I
t Yes - USI: Could result in a major reduction in the assumed degree of protection.
?-
Further Study: Further investigation is required to answer questions necessary to determine if a USI exists.
Noe Not USI: Deficiency does not result in a major reduction in the degree of protection.
B-3
c Table B3:
Possible Major Reduction in Assumed Degree of Protection Related to Operator Concerns
' What is the potential deficiency?
(What is the likelihood that the potential deficiency exists?
i l What is the likelihood that the deficiency will result in operator errors?
Impact on Frequency of impact on Safety Function Transients / Accidents l What systems are affected?
What systems are affected?
]
What is likelihood that systems will fail due to the What is the likelihood that the systems will fail?
l deficiency?
What transients / accidents could result?
What safety functions are affected?
j What is likelihood these transients / accidents will What is the likelihood of loss of safety functions?
occur?
l Based on above, is it likely that the deficien Based on the above, would the frequency of transients / accidents be significantly increased by the 7 potential deficiency?
cause loss of safety function when needed?
4 Yes j
[
Yes
?
l No
?
No Yes - USI: Could result in a possible major reduction in the assumed degree of protection.
?-
Further Study: Further investigation is required to answer questions necessary to determine if a USl exists.
No-Not USI: Deficiency does not result in a major reduction in the degree of protection.
B-4 1
Table B4:
Possible Major Reduction in Assumed Degree of Protection
[
Related to Emergency Response Concerns
' What is the potential deficiency?
F l What is the likelihood that the potential deficiency exists?
Impact on Event impact On Protective l Impact on Actions to Aid i
Assessment Actions Actions l
Affected Persons l What actions are affected?
What actions are affected?
l What actions are affected?
p 4
! What is the likelihood that incorrect What is the likelihood incorrect What is the likelihood incorrect i
! actions could result?
actions could result?
actions could result?
Based on above, is it likely that the !
Based on above,is it likely that the Based on above, is it likely that the dose to plant personnel and/or l
dose to plant personnel and/or dose to plant personnel and/or public can be significantly l
public will be significantly increased public will be significantly increased increased due to the potential due to the potential deficiency?
due to the potential deficiency?
deficiency?
l Yes
?
No l
Yes J _.?
l No Yes 7
No
_L_
Yes - USI: Could result in a possible major reduction in the assumed degree of protection.
?-
Further Study: Further investigation is required to answer questions necessary to determine if a US! exists.
No-Not USI: Deficiency does not result in a major reduction in the degree of protection.
B-5
Table B5:
Potential Significant Reduction in Risk to the Public
{
Related to Emergency Response improvement
, What is the potential improvement?
i Impact on Event impact on Protective impact on Actions to Aid Assessment Actions Actions Affected Persons i
j What actions are affected?
What actions are affected?
What actions are affected?
What is the likelihood that the What is the likelihood that the What is the likelihood that the i
effectiveness of these actions could effectiveness of these actions could effectiveness of these actions be significantly improved?
be significantly improved?
would be significantly improved?
Based on the above is it likely that Based on the above is it likely that Based on the above, is it likely that i dose to plant personnel and/or dose to plant personnel and/or dose to plant personnel and/or
' public can be significantly reduced public can be significantly reduced public can be significantly reduced
! by the improvement?
by the improvement?
by the improvement?
]
No
[No Yes
?
No Yes
?
Yes
?
Yes - USI: Could provide a potentially significant reduction in risk.
?-
Further Study: Further investigation is required to answer questions necessary to determine if a USl exists.
No-Not USI: Would not provide a potentially significant reduction in risk.
i
\\
l B-6 l
l-
i Table B6:
4 Potential Significant Reduction in Risk to the Public Related to Equipment / Operator Improvement What is the potential improvement?
Impact on Design Basis Impact on Frequency of I impact on Safety Functions l
Transient / Accidents Frequency of what Reliability of performing what safety transients / accidents could be functions could be increased by the reduced?
potential deficiency?
1 What is likelihood these l
transients / accidents would be reduced?
Based on above,is it likely that a i is it likely that a large reduction in large reduction in the frequency Based on above, is it likely that the risk will result by implementing this of transients / accidents will result safety function reliability will be i designchange?
from this improvement?
significantly increased?
L_ Yes l
7 No ]
Yes
?
Noj Yes ]
7 l
No Yes - USI: Could provide a potentially significant reduction in risk.
7-Further Study: Further investigation is required to answer questions necessary to determine if a USl exists.
No-Not USI: Would not provide a potentially significant reduction in risk.
B-7
Appendix C Criteria and Guidance for Technical Screening of Reactor Generic issues General Technical screening evaluates the possible safety implication of the generic issue in a disciplined, quantitative manner. Moreover, the approach is scrutable and more easily defended than a qualitative appro&ch.
Calculations should be kept relatively simple for the process to be cost effective and timely. To the maximum extent possible, existing analysis and calculations should be used to minimize the resources used during the Technical Screening Stage.
The intent of the adequate protection issue technical screening e
calculation is to determine '.vhether modifications to regulatory framework are necessary to ensure adequate protection of public health and safety, or that it is necessary to redefine the level of protection that is necessary for adequate protection, The intent of the substantive safety enhancement issue technical e
screening calculation is to determine if modifications will result in substantial safety improvements within justifiable costs to the industry and NRC.
The intent of the burden reduction issue technical screening calculation is e
to determine if public health and safety would continue to be adequately protected if the proposed relaxation or reduction in regulatory requirements or positions were implemented; if the cost savings attributed to the action would be substantial enough to justify taking the action; and whether any increase in risk is acceptable.
Approach Technical screening may involve estimating both the safety benefit of i
e implementing facility or program changes, and the cost of developing and implementing facility or program changes.
The safety benefit of a reactor generic issue is represented by the e
reduction in risk that the facility or program changes could achieve.
Safety benefit is ordinarily expressed in terms of the change in core damage frequency (CDF), change in large early release frequency (LERF), or the product of the frequency of an accident occurrence and the averted public dose (in person-rem) that would result in the event of the accident.
C-1
The issue is' identified and defined. Since issues are often complex and e
interrelated with other issues, careful definition of an issue's scope and bounds are essentialin arriving at a sound and applicable assessment.
A solution is assumed. This assumed solution is used to estimate costs e
and changes in risk. The assumed solution is not intended to pre-judge the final facility or program changes.
For adequate protection and substantial safety enhancement issues, a e
quantitative estimate is made of the safety benefit (i.e., accident probabilities and radiological consequences) attributable to the issue and the decrease in that risk (i.e., core damage frequency or exposure) that may be attainable by resolving the issue.
A quantitative estimate is made of the cost of resolution, e
A numerical impact /value ratio is calculated by dividing the estimated cost e
entailed by the estimated potential risk reduction. The ratio measures the safety benefit received in retum for the cost impact incurred.
For burden reduction issues, the proposed facility or program changes e
are used to estimate costs and change in risk. For industry proposed burden reduction issues, industry estimates of cost savings should be i
considered. Potential risk increases or decreases with the reduction in regulatory requirements should be estimated.
Using the appropriate thresholds, a determiration is made regarding e
whether the reactor generic issue should be:
Dropped - because the safety benefits being sought are not cost beneficial and thus do not warrant expenditure of NRC resources, or Continued - to the Technical Assessment Stage because the safety benefits sought may be cost beneficial and thus warrant expenditure of NRC resources.
The flow chart in Figures C1-C3 illustrates the basic approach for e
conducting a technical screening for adequate protection issues, substantive safety enhancement issues, and burden reduction issues.
Probabilistic Risk Assessrnent Guidance for Technical Screening e
Select a surrogate probability risk assessment (PRA). The PRA must be relevant to the reactor generic issue being addressed, reflect the current state of PRA technology, include both internal and external events unless it can be shown that some initiators can be excluded, and include low C-2
power and shutdown conditions unless the issue does not involve these conditions.
Some generic issues may involve situations or phenomena that were not e
known when the surrogate PRA was performed, so the existing model must be modified. This may be as simple as changing a component failure probability, or it may be a significant modification involving the addition of new fault trees and event trees to the model.
The analyst should be familiar with the surrogate PRA. That is, the analyst should be familiar with the system and component nomenclature used in the PRA, the modeling assumptions and limitations, the calculational tools used, and the truncation level.
The analyst should make use of up-to-date PRA information, including e
logic diagrams (such as event sequence diagrams, fault trees, and event trees), core damage frequency-to-risk transformations, data (such as component failure rates), and other risk performance displays such as dependency matrices, current design, and operational information.
The analysis should define the class of affected plants as specifically as e
possible and should make use of surrogate PRAs most closely resembling the class of affected plants.
Uncertainty analyses and mean values should be calculated whenever this is practical. Even when formal uncertainty analyses are not possible, sensitivity studiec should be performed to determine the impact of key assumptions, uncertainties in the inputs, and other factors. When no data
)
are readily available and the analyst must use engineering judgment, the J
documentation of the analysis should always explicitly so state and give the rationale for substituting for unavailable information.
The analysis should be as realistic as is practical. However, some e
conservatism may be used when bounding calculations can demonstrate that a generic issue should be dropped from consideration or realism is not possible because data are not readily available, The analysis should explicitly ensure that the truncation level of the base e
PRA is sufficiently low for calculations of differences (e.g., change in core damage frequency) to be meaningful. The issue being evaluated may well call the dropped sequences into consideration. That is, these sequences may no longer be negligible when the effect of the issue being evaluated is included. However, the analyst must recognize that as accident sequences with very low frequencies are considered, concerns as to the completeness and adequacy of the models become much more serious.
C-3
f The analysis should receive an independent review by staff knowledgeable in PRA and in the design of the affected systems or components, plus reviews by the individual or group that identified the issue and the group that would be responsible for the Regulation and Guidance Development Stage.
The documentation should not present calculational results with more significant figures than are appropriate. More than one significant figure in the mantissa is not appropriate in most cases. It should be noted, however, that if intermediate results are presented, a reader attempting to use these intermediate results in duplicating the calculation may not get exactly the same final results because of the round-off error.
The analysis should be documented with sufficient detail to enable the analysis to be repeated. In addition, sufficient explanatory materials should be provided to enable the reader to understand the significance of the calculations and to reconcile the various calculations with engineering judgment. The documentation should include:
a description of the event or issue, its relationship to safety, the calculational approach, a narrative description of the principal accident sequences, the basis for using engineering judgment in lieu of actual data, and a list of assumptions, including the choice of surrogate PRA, choice of parameters, source of basic data, and any mathematical approximations used.
Additional guidance is provided in Appendices of NUREG-1489, "A Review of NRC Staff Uses of Probabilistic Risk Assessment."
Cost Estimation Guidance for Technical Screening The values and impacts associated with a solution (i.e., action) should be identified. The values include, but are not limited to, enhancement of health and safety and protection of the environment. The impacts include, but are not limited to, direct costs to the NRC and Agreement
}
States; direct costs to the licensee; and adverse effects on health, safety, and the environment.
Values and impacts are assigned a monetary value (i.e., dollars) and expressed on a present-worth basis. The discount rate in OMB Circular A-94 should be used for discounting future benefits and costs.
Decisions should be based on the net present value associated with a solution (i.e., action). The net present va!ue is obtained by subtracting the total discounted impacts from the total of discounted values.
4 C-4 1
o l
The cost includes both the cost of developing the generic solution e
(typically NRC cost) and the cost of implementing the possible solution at
}
affected plants (typically industry cost). These costs may include design,
)
equipment, installation, test, operation, and maintenance.
NRC costs include issue identification, analysis, resolution, and report
)
e issuance; research to establish proposed specific changes to licensing I
requirements (or to determine that no change is required); technical assistance contracts (including associated NRC effort); discussions and correspondence with industry owners groups; plant reviews; and preparation and review of safety evaluation reports (SERs) and requirement documents.
The estimated cost of NRC professional time, The costs to industry generally consist of some combination of licensing; e
design; equipment procurement; installation; testing, inspection, monitoring, and periodic maintenance; and plant downtime to effect a change.
e industry labor costs.
Calculations of industry cost savings should assume that affected plants will take advantage of the change. However, the option of whether to take advantage of relaxed or reduced regulatory requirements is not mandatory.
Sunk costs, realized benefits (i.e., values), transfer payments should be e
ignored.
The estimates should be documented with sufficient detail to enable the estimates to be repeated. In addition, sufficient explanatory materials should be provided to enable the reader to understand the significance of the calculations and to reconcile the various calculations with professional judgment. The documentation should include:
a description of the issue, the calculational approach, the basis for using professionaljudgement in lieu of actual data, and a list of assumptions should be listed and justified, including the source of basic data and any mathematical approximations used.
C-5
impactNalue Guidance for Technical Screening e
The technical screening impact /value calculations are not intended to be applied as impact /value determinations for any regulatory proposal that may ultimately result from efforts to resolve the generic issue.
To the extent reasonably possible, quantitative estimates are made of the possible solutions to l
a substantial safety enhancement issue by calculating an impact /value ratio that reflects the relation between the risk redt'ction value expected to be achieved and the associated cost impact. See Figure C-6 for thresholds for " drop" and " continue."
e.
- The formula for the impact /value ratio (R) is:
Cost R = Safety _ Benefit where the safety benefit is the estimated risk reduction (event frequency x public dose averted) that may be achieved and the cost (in dollars) is l
the expense necessary to develop and implement a resolution in the number of plants involved.
l The formula for safety benefit is:
e l
Safety _ Benefit = (N)(F)(T)(D) where N =
number of reactors affected by the safety enhancement T=
average remaining life (years) of the affected plants, based on an original license period of 40 years, or plant shutdown date, whichever is smaller F=
accident frequency reduction (events / reactor-year)
D=
averted public dose (person-rem) l
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C-6
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Appendix D Generic issue Task Action Plan The content for each section of the Task Action Plan (TAP) shall be provided by the responsible project manager.
information l
Explanation / Comment' (1) Generic issue Title
[Obtained from the Gene ic issue Program Manager]
(2) Generic Issue Type (Obtained from the Generic lasue Program Manager) i (3) Generic issue Stage List the specific Generic issue Program Stage (4) Description Indicate the significance and generic applicabilit[ohbe issue.
_ _.a 4
(5) Operational events Discussion of initiating events or analyses thht led ta the determination that the generic issue needs to be addressed.
_ _. _(6) Originating document list Reference documents that identified tha generic issue.
-m (7) Regulatory assessment Qualitative or quantitative assessment of the safety significance of the issue, with an adequate technicaljustification for the time frame to complete the TAP. This justification should address why current regulatory actions are sufficient and additional regulatory action is unnecessary at this time. The technicaljustification ;'
should include the NRR staff rationale for continued facility oporation while the issue is being addressed. Note: This
- regulatory assessment
- n ay change
)
dependinD on the Generic Issue Program Stage.
+
_.a
, (8) Proposed actions Proposed actions and objectives of the TAP, such as new regulations, policy i
positions, generic communications, Commission paper, or others.-
i (9) Schedule milestones Major milestones in support of propcsed actions and a proposd schedule for j
their completion. Examples of milestones are completion of tests or research, inspections, public meetings, industry meetings, NRC inspections, major review / concurrence milestones (NRC offices, ACRS. ACNW, ACMUL CRGR, EDO), issuance of draft and final disposition documents, implementation status, l and verification status.
(10) Resource requirements State the estimated direct technical staff hours and contractor costs needed for completion of the TAP.
(11) Project manager (s)
Name(s) of individuals assigned to coordinate processing of the current generic t-issue stage.
7 (12) Other contacts List technical contacts. Include company / agency affination, position title, f
t i
addresses, phone numbers, e-mail addresses, etc.
J
{ (13) References List appropriate document references specific to the current Generic issue Program Stage.
IIndicate if information requested is either unknown or does not apply.
~
D-1
l Appendix E Quarterly Generic issue Status Report The report content for each section shall be provided by the responsible project manager.
Information Explanation / Comment' 4
y i (1) Genere issue Title
- [Provided by Genenc lasue Program Manager]
I i
! (2)Genertissue Type
[ [ Adequate protecton, substantial safety enhancement, or burden reduction issue]
i 3
List the current Genere lasue Program stage.
f f (. -) Generc lasue Stage l (4) SubmittalDate List the submittal date of the genene issue.
_~
(5) }nihal Screening Date List the instal Screening Stage completion date, or projected date. Include basis for date change from prevous report (6) Technical Screening Date i List the Techncal Screening Stage completion date, or projected date. Include basis for date change I
from previous report
_ __ q (7) Techncat Assessment Date List the Technical Assessment Stage completion date, or projected date. Include basis for date change j i
from previous report p
l (8) Regulabon and Guidance l date change from previous report. List the Regulation & Guidance Development Stage complet l Development Date l
-. ~.
--.a (9) Regulation and Guidance
[ List the Regulaton & Guidance issuance Stage completon date, or projected date, include basis for j
lasuance Date l date change from prevous report i
(10) tmplementatsori Stage Dato List the imp,ementaton Stage completion date, or projected date. Include basis for date change from i
4 _ previous report I
_.J (11)Venik. Mon Stage Date List the Versfcation Stage completon date, or projected date. Include basis for date change from
[
, previous report 3__._,__.__.___a f (Date
- 12) EDQ dosure memorandum List the EDO closure memo completon date indcabng either drop or Venfcation Stage complete.
L.~ -.-
l iw.-
(13) Responsible Project Managers Names of mdividuals assigned to coordinate processing vanous stages in the Genere issue Program (14) Techncal Assignment Control List all TAC numbers assgmed to the genere issue.
(TAC) Numters (15) Financial identificaton
] List all financialidentifcat!on numbers (tr tNs) assigned to contracts, if any, for techncal assistance.
number (s)
L f (te) Affected Regulations identify the ingulatory documents (e g, rules, regulatory guides, standard review plans, etc.) that may be affected by the resolution of the genere issue i
i
! (17) Sgnificant Correspondence l Identify significant internal and extemal correspondence that affected decision-making or that documents decison. making
}
r._
~
(18) Techncal Deliverables identify reports that have been produced by the NRC staff. NRC contractors, or industry dunng the processing of the genanc issue.
j (19) Milestones List completed milestones from the open Task Acton Plan.
t-I (20) Status Summary Summanze the status of the genene lasse if appropriate for the GlP stage, include individualIcensee l of cerufcste holder closure of the generte issue
' Indicate if information requested le either unknown or does not apply.
E-1 1
J