ML19149A308

SRM-18-0049: Enclosure 1 - Edit to Management Directive 8.4

ML19149A308
Person / Time
Issue date:	05/29/2019
From:	Annette Vietti-Cook NRC/SECY
To:
References
Download: ML19149A308 (16)

Text

U.S. NUCLEAR REGULATORY COMMISSION MANAGEMENT DIRECTIVE (MD)

MD 8.4 MANAGEMENT OF BACKFITTING, DT-XX-XX FORWARD FITTING, ISSUE FINALITY, AND INFORMATION COLLECTIONREQUESTS Volume 8: Licensee Oversight Programs Approved By: [Name and Title of Approving Official]

Date Approved: Month X, 2010X [Date of Final Approval]

Cert. Date: N/A, for the latest version of any NRC directive or handbook, see the online MD Catalog.

Issuing Office: Office of Nuclear Reactor Regulation Division of Inspection and Regional Support Contact Name: Timothy Reed EXECUTIVE

SUMMARY

Management Directive (MD) 8.4, Management of Backfitting, Issue Finality, and Information Collection, is retitled and revised to clarify the agencys roles and responsibilities for management of backfitting, forward fitting, issue finality, forward fitting, and information collectionrequests generically and on a facility-specific basis. MD 8.4 describes the roles and responsibilities of various offices and provides the policy to direct the U.S. Nuclear Regulatory Commission implementation of the backfitting provisions of Title 10 of the Code of Federal Regulations (10 CFR) for nuclear power reactor facilities licensees and selected nuclear materials facilitieslicensees; and the issue finality provisions of 10 CFR Part 52 for nuclear power reactors licensees, design certification applicants, and holders of related NRC permits and approvals,; as well asand the specific provisions of 10 CFR 50.54(f) and the corresponding requirements in 10 CFR Parts 52, 70, 72, and 76, and 10 CFR 2.204.

Accordingly, MD 8.4 is retitled from Management of Facility-Specific Backfitting and Information Collection to Management of Backfitting, Forward Fitting, Issue Finality, and Information RequestsCollection to clarify the intent and the objectives of the program.

TABLE OF CONTENTS Commented [A1]: Correct page numbers in Table of Contents as appropriate.

I. POLICY ............................................................................................................................ 333 II. OBJECTIVES .................................................................................................................. 444 For updates or revisions to policies contained in this MD that were issued after the MD was signed, please see the Yellow Announcement to Management Directive index (YA-to-MD index).

MD 8.4 MANAGEMENT OF BACKFITTING, FORWARD Date Approved: XX/XX/XXXX FITTING, ISSUE FINALITY, AND INFORMATION COLLECTIONREQUESTS III. ORGANIZATIONAL RESPONSIBILITIES AND DELEGATIONS OF AUTHORITY....... 555 A. Executive Director for Operations (EDO) ................................................................... 555 B. Office of the General Counsel (OGC) ...................................................................... 6656 C. Committee To Review Generic Requirements (CRGR) ............................................. 996 D. Director, Office of Nuclear Regulatory Research (RES) ........................................ 10107 E. Director, Office of Enforcement (OE) ..................................................................... 10108 F. Director, Office of Nuclear Security and Incident Response (NSIR) ...................... 11118 G. Director, Office of Nuclear Reactor Regulation (NRR); Director, Office of New Reactors (NRO); and Director, Office of Nuclear Material Safety and Safeguards (NMSS) ............................................................................................ 669 H. Regional Administrators (RAs) ................................................................................ 7711 I. Chief Human Capital Officer (CHCO)............................................................... 12121213 J. Chief Information Officer (CIO)............................................................................. 121213 IV. APPLICABILITY ........................................................................................................ 121213 V. DIRECTIVE HANDBOOK .......................................................................................... 121213 VI. REFERENCES........................................................................................................... 131313 For the latest version of any NRC directive or handbook, see the online MD Catalog. 2

MD 8.4 MANAGEMENT OF BACKFITTING, FORWARD Date Approved: XX/XX/XXXX FITTING, ISSUE FINALITY, AND INFORMATION COLLECTIONREQUESTS I. POLICY It is the policy of the U.S. Nuclear Regulatory Commission to have an effective program that will ensure that backfitting1 and forward fitting2 of nuclear power reactor facilitieslicensees3 and selected nuclear materials licensees and certificate holdersfacilities is appropriately 1

In this MD, the NRC uses the terms backfit and backfitting to mean backfitting as defined in 10 CFR 50.109, 70.76, 72.62, and 76.76 and violations of issue finality under 10 CFR Part 52. 10 CFR Part 52. Parts 50, Domestic Licensing of Production and Utilization Facilities, Part 52, Part 70, Domestic Licensing of Special Nuclear Material, Part 72, Licensing Requirements for the Independent Storage of Spent Nuclear Fuel, High-Level Radioactive Waste, and Reactor-Related Greater Than Class C Waste, and Part 76, Certification of Gaseous Diffusion Plants, are the only parts of the NRCs regulations that contain backfitting or issue finality provisions. Backfitting provisions implicitly apply, in part, to applicants for a power reactor renewed license due to the limitation in scope of the NRCs review under 10 CFR Part 54, Requirements for Renewal of Operating Licenses for Nuclear Power Plants. In 10 CFR 50.109, Backfitting, backfitting for a nuclear power reactor is defined as the modification of or addition to systems, structures, components, or design of a facility; or the design approval or manufacturing license for a facility; or the procedures or organization required to design, construct, or operate a facility; any of which may result from a new or amended provision in the Commissions regulations or the imposition of a regulatory staff position interpreting the Commissions regulations that is either new or different from a previously applicable staff position after certain dates. For select nuclear materials facilities, the backfitting definitions in 10 CFR 70.76, 72.62, and 76.76 are slightly different. The issue finality provisions in 10 CFR Part 52 are different from those in 10 CFR 50.109 and the wording and structure between the two groups of provisions differ significantly. The term "backfit" is not normally used in discussions relevant to new power reactors; the concept of "issue finality" is used rather than backfit. In this MD, the NRC uses the terms backfit and backfitting to encompass backfits as defined in 10 CFR 50.109, 70.76, 72.62, and 76.76, and issue finality matters under 10 CFR Part 52.

2 A forward fit is defined in Section 1.A of the attached handbook. as the imposition of a new or modified requirement or regulatory staff interpretation of a requirement that results in the modification of or addition to systems, structures, components, or design of a facility; or the design approval or manufacturing license for a facility; or the procedures or organization required to design, construct or operate a facility as a condition of approval by the NRC of a licensee-initiated request for a licensing action when the underlying request did not propose to comply with the new or revised requirement or interpretation. Such licensing actions may include a license amendment or a license renewal, although the normal application of the process in 10 CFR Part 54. "Requirements for Renewal of Operating Licenses for Nuclear Power Plants," does not generally constitute forward fitting. The NRC may condition its approval of such a licensing action on the use of a new or modified regulatory staff position only if 1) there is a direct nexus to the licensee's request and 2) the imposition of the new or modified requirement or regulatory staff position is essential to the NRG staff's determination of the acceptability of the licensee's request.

3 In this MD, the NRC uses the term nuclear power reactor licensees to refer to holders of 10 CFR Part 50 or Part 52 licenses, permits, or approvals, including: early site permits (ESPs),

standard design approvals (SDAs), combined licenses (COLs), and MLs; design certification (DC) applicants whose designs are certified in final DC rules (DCR); applicants for COLs if the application references an ESP, DCR, or SDA; and applicants for MLs if the application references a DCR or SDA. Specific definitions and terminology are included in 10 CFR Parts 50, 70, 72, and 76.

For the latest version of any NRC directive or handbook, see the online MD Catalog. 3

MD 8.4 MANAGEMENT OF BACKFITTING, FORWARD Date Approved: XX/XX/XXXX FITTING, ISSUE FINALITY, AND INFORMATION COLLECTIONREQUESTS documented and justified based on the backfitting provisions of applicable NRC regulations and the Commissions agencys backfitting and forward fitting policy and guidance.

Additionally, the NRC must ensure justify information requests to licensees are appropriate as required by applicable NRC regulations. under 10 CFR 50.54(f), Conditions of licenses.,

and 2.204, Demand for information.

The backfit and forward fit evaluation and analysis requirements ensure that the NRC demonstrates, before implementing the backfit or forward fit, that the backfitting action would meet certain standards that vary based on the type of facility. In accordance with the NRC Principles of Good Regulation and the Administrative Procedure Act, the backfitting rules and policies and the forward fitting policies provide the following:

(a) Regulatory stability, by ensuring that the changes the NRC makes are necessary or provide a substantial safety enhancement; (b) Reasoned and informed NRC decisionmaking, by requiring the proposed action be properly justified; and (c) Transparency of NRC decisionmaking, by requiring that the NRC document and make publicly available its analyses and evaluations.

II. OBJECTIVES Ensure NRC-licensed facilities provide adequate protection of public health and safety, promote the common defense and security, and allow for substantial improvements in both safety and security, beyond adequate protection, while minimizing avoiding any unjustified burden on the NRC, the public, or licensees when implementing a backfitting action.

Ensure that backfitting considerations are applied to the furtherance of substantive radiological public health and safety, or common defense and security objectives.

Ensure that backfitting applied to a nuclear power reactor licensee facility or nuclear materials licensee facility is appropriately justified and documented.

Ensure that forward fitting a nuclear power reactor facility or nuclear materials facility are appropriately justified and documented.

Ensure that NRC-proposed changes to previously approved Early Site Permits (ESP),

Design Certifications (DC), Standard Design Approvals (SDA), Combined Operating Licenses (COL), and Manufacturing Licenses (ML) (i.e., violations of issue finality under 10 CFR Part 52) are appropriately justified and documented.

For the latest version of any NRC directive or handbook, see the online MD Catalog. 4

MD 8.4 MANAGEMENT OF BACKFITTING, FORWARD Date Approved: XX/XX/XXXX FITTING, ISSUE FINALITY, AND INFORMATION COLLECTIONREQUESTS Ensure that any documented evaluation for an adequate protection backfitting justifications includes an imminent threat analysis.

Ensure that any documented evaluation for a compliance backfitting justifications includes some consideration of costs.

Ensure that any documented evaluation, or backfit, or forward fit analysis is risk-informed.

Ensure all information requests to licensees are justified as required by applicable NRC regulations.

III. ORGANIZATIONAL RESPONSIBILITIES AND DELEGATIONS OF AUTHORITY A. Executive Director for Operations (EDO)

1. Responsible for the NRCs backfitting process and ensuring proper implementation of the backfitting rules.

1.2. Responsible for the NRCs forward fitting process and ensuring proper implementation of the forward fitting policy.

2.3. Authorizes deviations from this MD when in the public interest and when the deviation otherwise complies with applicable agency guidelines and policies NRC regulations, public laws, and Executive Orders.

3.4. Delegates responsibility for facility-specific backfitting authority andand forward fitting actions to the program office Office Directors (ODs) and Regional Administrators (RAs), as appropriate.

5. Delegates information request authority and actions to the program ODs and RAs.

4.6. Reviews and modifies any proposed facility-specific backfitting or forward fitting action on his or her own initiative or at the appeal of the affected licensee or stakeholders.

For the latest version of any NRC directive or handbook, see the online MD Catalog. 5

MD 8.4 MANAGEMENT OF BACKFITTING, FORWARD Date Approved: XX/XX/XXXX FITTING, ISSUE FINALITY, AND INFORMATION COLLECTIONREQUESTS B. Director, Office of Nuclear Reactor Regulation (NRR); Director, Office of New Reactors (NRO); and Director, Office of Nuclear Material Safety and Safeguards (NMSS) Commented [A2]: Moved from below; other sections re-lettered as appropriate.

1. Identify backfitting and forward fitting actions applicable towithin its their programs.

2. Conduct backfitting and forward fitting analyses while coordinating with OGC, other program offices, NSIR, OE, RES, and regional offices, as appropriate. Coordinate backfitting actions with OGC, other program offices, NSIR, OE, RES, and regional offices to ensure consistency and uniformity.

2.3. Conduct an imminent threat analysis when the adequate protection exception is applied.

3.4. Provide the CRGR with an opportunity to review any required documented evaluation, or backfit, or forward fit analysis or any generic communication with backfitting or forward fitting concerns.

4.5. Request CRGR review of potential facility -specific backfit or forward fit, as deemed appropriate.

5.6. After approving supporting documentation, notify, or designate the relevant division director to notify, the affected entity or entities, e.g. the nuclear power reactor or nuclear materials licensee(s), of the backfitting or forward fitting action.

6.7. Ensure consistency among inspection procedures, regulations, office instructions, and current agency guidelines and policiesNUREG-1409.

7. Consult and coordinate with the regions, NSIR, RES, OE, and OGC, as appropriate, to resolve issues with backfitting actions for which the program office has oversight responsibility.

8. Coordinate security-related backfitting with the Director, NSIR, and the affected regional office and approves the supporting documentation for security-related backfitting within the program offices areas of responsibility.

9.8. Decide first-level licensee appeals on the imposition of all backfitting and forward fitting actions within the program offices area of responsibility and coordinates any appeals of security-related backfits with the Director, NSIR.

10.9. During the staffs evaluation and backfitting or forward fitting transmittal process, and any subsequent licensee appeal process, track each facility-specific backfitting or forward fitting action within the affected program office or region.

For the latest version of any NRC directive or handbook, see the online MD Catalog. 6

MD 8.4 MANAGEMENT OF BACKFITTING, FORWARD Date Approved: XX/XX/XXXX FITTING, ISSUE FINALITY, AND INFORMATION COLLECTIONREQUESTS 11.10. Ensure entry into ADAMS, as appropriate, of all documents and records related to backfitting and forward fitting originating in either the program office or the region (within the program offices area of responsibility), including communications, decisionmaking, and the outcome of backfitting appeals. Makes the backfitting and forward fitting decisions publicly available, consistent with applicable requirements and guidance.

12.11. Ensure appropriate training is available to the program office staff and ensure that the program office staff performance is in accordance with regulations, and current agency guidelines and policiesNUREG-1409.

13.12. Designate an office-level POC to coordinate and resolve backfitting and forward fitting questions or concerns from the staff as they relate to the responsibilities of each respective program office.

14.13. Ensure information requests are appropriate as required by applicable NRC regulations 10 CFR 50.54(f) and 2.204 is appropriately justified.

C. Regional Administrators (RAs) Commented [A3]: Moved from below; other sections re-lettered as appropriate.

1. Identify backfitting and forward fitting actions applicable towithin the regions.

2. Conduct backfitting and forward fitting analyses while coordinating with OGC, NSIR, OE, RES, and the office directors of NRR, NRO, and NMSS, as appropriate.

Coordinate with OGC, ODs, NSIR and other RAs to ensure consistency in backfitting implementation among the regions and program offices.

2.3. Conduct an imminent threat analysis when the adequate protection exception is applied.

3.4. Provide the CRGR with an opportunity to review any required documented evaluation or backfit or forward fit analysis before final approval.

4.5. After approving supporting documentation, notify, or designate the relevant division director to notify, the affected entity or entities, (e.g., the nuclear power reactor or nuclear materials licensee(s)), of the backfitting or forward fitting action.

5. Coordinate with other regions and either the Division of Inspection and Regional Support, NRR, or the Division of Construction Inspection and Operational Programs, NRO, as applicable, to ensure consistency among inspection procedures and regulations, and NUREG-1409.

For the latest version of any NRC directive or handbook, see the online MD Catalog. 7

MD 8.4 MANAGEMENT OF BACKFITTING, FORWARD Date Approved: XX/XX/XXXX FITTING, ISSUE FINALITY, AND INFORMATION COLLECTIONREQUESTS

6. Consult and coordinate with the Director, NSIR; OGC and/or regional counsel; and the appropriate program OD to resolve security-related, facility-specific backfitting actions.

7. Coordinate with the appropriate program office and NSIR, as necessary, to obtain the supporting documentation for proposed backfits.

8.7. Support the appropriate program office in processing licensee backfitting and forward fitting appeals that are within the regional area of responsibility.

9.8. Ensure entry into ADAMS, as appropriate, of all documents and records related to backfitting and forward fitting and originating in the region, including communications, decisionmaking, and the outcome of backfitting appeals. Makes backfitting and forward fitting decisions publicly available, consistent with applicable requirements and guidance.

10.9. Ensure appropriate training is available to the regional staff and ensures that the regional staff performance is in accordance with regulations and current agency guidelines and policiesNUREG-1409.

11.10. Designate a regional POC who will be responsible for any specific backfitting and forward fitting activities (generic and facility-specific) as needed, including the coordination and resolution of any backfitting and forward fitting questions or concerns from the staff as they relate to the responsibilities of the respective region.

The regional POC also ensures that the associated regional staff is proficient in a training program relevant to backfitting activities and agency information collection processes.

D. Office of the General Counsel (OGC)

1. Identifies potential backfitting and forward fitting actions.

2. Advises staff about whether staffs actions meet the applicable definitions of backfit.

3. Advises staff about how whether staffs actions are congruent with issue finality provisions in 10 CFR Part 52.

4. Provides legal advice and assistance during backfitting identification, justification, imposition, and licensee appeal processes.

4.5. Provides legal advice and assistance during forward fitting identification, justification, imposition, and licensee appeal processes.

For the latest version of any NRC directive or handbook, see the online MD Catalog. 8

MD 8.4 MANAGEMENT OF BACKFITTING, FORWARD Date Approved: XX/XX/XXXX FITTING, ISSUE FINALITY, AND INFORMATION COLLECTIONREQUESTS

6. Provides legal advice and assistance for developing backfitting training in accordance withregarding backfitting requirements and agency implementation.

7. Provides legal advice and assistance for information collections.

5.8. Maintains a backfitting/forward fitting Community of Practice with office POCs, including a backfitting/forward fitting site.

E. Committee To Review Generic Requirements (CRGR)

1. Monitors the overall effectiveness of the NRCs generic backfitting and forward fitting management process, including the effectiveness of administrative controls for facility-specific backfitting and forward fitting. Maintains a Charter that describes the roles, responsibilities, and procedures of the CRGR in accordance with applicable regulations.

2. Selects a sample of proposed backfitting and forward fitting actions for audit under 10 CFR Part 50, 10 CFR Part 52, 10 CFR Part 70, 10 CFR Part 72 and 10 CFR Part 76, consistent with its Charter and ensures the actions are justified in accordance with regulations, guidance, and agency policies.

3. Reviews potential facility- specific backfits and forward fits as requested by program office directorsprogram ODs and RAs.

4. Uses its discretion in deciding whether any review should require a formal staff presentation to the CRGR.

5. Periodically assesses the effectiveness of the NRCs backfitting process implementation as part of its regulatory effectiveness responsibility and provides a report to the EDO.

6.5. Ensures consistency among the offices and regions in implementing the provisions of the NRCs backfitting rules and policies and forward fitting policies. The CRGR review focuses on the adequacy of backfitting and forward fitting implementation, interoffice coordination for processing backfitting and forward fitting actions, and staff training.

For the latest version of any NRC directive or handbook, see the online MD Catalog. 9

MD 8.4 MANAGEMENT OF BACKFITTING, FORWARD Date Approved: XX/XX/XXXX FITTING, ISSUE FINALITY, AND INFORMATION COLLECTIONREQUESTS 7.6. Verifies that the responsible staff4 promptly enters backfitting and forward fitting decisions into the Agencywide Documents Access and Management System (ADAMS), and makes them publicly available, consistent with applicable requirements and guidance.

8.7. Periodically meets with stakeholders to gain stakeholder views and advise the EDO when modifications to the backfitting and forward fitting processes should be considered.

9.8. Participates in Backfitting Review Panels at the request of the EDO.

10.9. Coordinates with the Office of the Chief Human Capital Officer (OCHCO), OGC, RES, NSIR, OE, the regions, and program offices to ensure that Human Resources Training and Development (HRTD) provides appropriate training for the NRC staff and that individual office procedures and guidance appropriately reflect the requirements of this MD and other applicable guidance.

F. Director, Office of Nuclear Regulatory Research (RES)

1. Identifies potential backfitting and forward fitting actions.

2. Supports the offices and regions by implementing pertinent CRGR recommendations, EDO decisions, staff lessons -learned, and Commission directives for enhancing the NRCs backfitting program.

3. Provides administrative support for routine CRGR activities.

3.4. Ensures appropriate training is available to the RES staff.

4. Maintains a backfitting Community of Practice with office POCs, including a backfitting SharePoint site.

G. Director, Office of Enforcement (OE)

1. Defines and implements appropriate administrative controls to support the office and regional staffs in processing compliance backfits that involve enforcement discretion.

4 The office or the region that initiated the backfitting action supports the program office (the Office of Nuclear Reactor Regulation (NRR), the Office of Nuclear Material Safety and Safeguards (NMSS),

or the Office of New Reactors (NRO)) that has the obligation to impose the backfit. The program office is solely responsible for generic backfitting actions. Regions are responsible for facility-specific backfitting actions arising from inspection, and program offices are responsible for facility-specific backfitting actions arising from licensing or other headquarters actions.

For the latest version of any NRC directive or handbook, see the online MD Catalog. 10

MD 8.4 MANAGEMENT OF BACKFITTING, FORWARD Date Approved: XX/XX/XXXX FITTING, ISSUE FINALITY, AND INFORMATION COLLECTIONREQUESTS

2. If an Order, a notice of violation, or enforcement discretion is necessary in relation to a backfitting action, consults with OGC and the responsible office(s) and region(s),

on the backfitting action and advises on its imposition, including supporting interactions with licensees to establish a schedule for implementing the compliance backfit, as applicable.

Ensures appropriate training is providedavailable available to the OE staff and ensures OE staff performance is in accordance with NUREG-1409, Backfitting Guidelines. with current agency policy and guidelines and policies.

3. Designates an office-level POC to coordinate and resolve backfitting questions or concerns from the staff as they relate to the responsibilities of OE.

H. Director, Office of Nuclear Security and Incident Response (NSIR)

1. Identifies any potential security-related or emergency preparedness-related backfitting or forward fitting actions.5

2. Coordinates all security-related backfitting with the program offices and the regional offices.

3.2. Designates an NSIR manager (division director or higher) who coordinates with the program offices and OGC to request that the program office propose backfitting or forward fitting actions on nuclear power reactor and nuclear materials licensees facilities that pertain to the common defense and security or emergency preparedness.

4.3. Ensures consistency of security and emergency preparedness inspection procedures with regulations and current agency guidelines and policies, and NUREG-1409.

5.4. Consults, coordinates with, and provides support to program ODs, as appropriatenecessary, to resolve issues with security-related backfitting and forward fitting actions. The Director, NSIR, must supports the program ODs and RAs, as appropriate, in processing security-related backfits and forward fits, including the resolution of licensee backfit appeals.6 5

Throughout this MD, security-related and emergency preparedness-related backfitting may be referred to as security or security-related backfitting.

6 The program OD for the affected facilities imposes facility-specific backfitting actions and forwards licensee appeals on security-related backfitting to the NSIR OD. The NSIR OD will decide on the appeal and coordinate with the program OD. If a licensee refuses to implement an imposed backfitting action, the appropriate program office must issue an Order.

For the latest version of any NRC directive or handbook, see the online MD Catalog. 11

MD 8.4 MANAGEMENT OF BACKFITTING, FORWARD Date Approved: XX/XX/XXXX FITTING, ISSUE FINALITY, AND INFORMATION COLLECTIONREQUESTS 6.5. Ensures appropriate training is available to the NSIR staff and ensures that the NSIR staff performance is in accordance with current agency guidelines and policiesNUREG-1409.

7.6. Designates an office-level POC to coordinate and resolve backfitting and forward fitting questions or concerns from staff as they relate to the responsibilities of NSIR.

8.7. Makes backfitting decisions publicly available, consistent with applicable requirements and guidance.

I. Chief Human Capital Officer (CHCO)

1. Develops, maintains, and updates, in consultation with the CRGR and OGC and in coordination with other offices and regions, a backfitting training program for the NRC staff, including generic and facility-specific backfitting training modules and refresher courses.

2. Consults and coordinates with the appropriate contact in the Office of the Chief Information Officer to maintain backfitting training modules online.

J. Chief Information Officer (CIO)

1. Maintains a repository for backfitting and forward fitting records in ADAMS.

2. Advises the offices and regions on implementing administrative controls to ensure backfitting and forward fitting information is maintained in accordance with Federal and agency recordkeeping requirements.

3. Consults on the agency review of information collections requests to ensure compliance with the Paperwork Reduction Act.

IV. APPLICABILITY The policy in this directive and handbook applies to all NRC employees.

V. DIRECTIVE HANDBOOK For effective regulation of NRC-licensed facilities, it is important crucial that the backfitting and forward fitting processes be well-defined, that staff members clearly understand their obligation for responsibly implementing all aspects of the backfitting program, and that managers ensure staff performance is in accordance with this MD. Handbook 8.4 explains the components of the NRC backfitting and forward fitting management programs. NUREG-1409 provides guidance to the staff implementing backfitting regulations.

For the latest version of any NRC directive or handbook, see the online MD Catalog. 12

MD 8.4 MANAGEMENT OF BACKFITTING, FORWARD Date Approved: XX/XX/XXXX FITTING, ISSUE FINALITY, AND INFORMATION COLLECTIONREQUESTS VI. REFERENCES Code of Federal Regulations 10 CFR 26.39, Review Process for Fitness-For-Duty Policy Violations.

10 CFR Part 2, Agency Rules of Practice and Procedure.

10 CFR 2.202, Orders.

10 CFR 2.204, Demand for Information.

10 CFR Part 50, Domestic Licensing of Production and Utilization Facilities.

10 CFR 50.2, Definitions.

10 CFR 50.12, Specific Exemptions.

10 CFR 50.49, Environmental Qualification of Electrical Equipment Important to Safety for Nuclear Power Plants.

10 CFR 50.54, Conditions of Licenses.

10 CFR 50.55a, Codes and Standards.

10 CFR 50.59, Changes, Tests, and Experiments.

10 CFR 50.71, Maintenance of Records; Making of Reports.

10 CFR 50.72, Immediate Notification Requirements for Operating Nuclear Power Reactors.

10 CFR 50.73, License Event Report System.

10 CFR 50.109, Backfitting.

10 CFR Part 52, Licenses, Certifications, and Approvals for Nuclear Power Plants.

10 CFR 52.7, Specific Exemptions.

10 CFR 52.31, Criteria for Renewal.

10 CFR 52.39, Finality of Early Site Permit Determinations.

10 CFR 52.59, Criteria for Renewal.

10 CFR 52.63, Finality of Standard Design Certifications.

10 CFR 52.83, Finality of Referenced NRC Approvals; Partial Initial Decision on Site Suitability.

10 CFR 52.98, Finality of Combined Licenses; Information Requests.

For the latest version of any NRC directive or handbook, see the online MD Catalog. 13

MD 8.4 MANAGEMENT OF BACKFITTING, FORWARD Date Approved: XX/XX/XXXX FITTING, ISSUE FINALITY, AND INFORMATION COLLECTIONREQUESTS 10 CFR 52.145, Finality of Standard Design Approvals; Information Requests.

10 CFR 52.171, Finality of Manufacturing Licenses; Information Requests.

10 CFR 52.179, Criteria for Renewal.

10 CFR Part 54, Requirements for Renewal of Operating Licenses for Nuclear Power Plants.

10 CFR 54.30, Matters Not Subject to a Renewal Review.

10 CFR Part 70, Domestic Licensing of Special Nuclear Material.

10 CFR Part 70, Subpart B, Exemptions.

10 CFR 70.22, Contents of Applications.

10 CFR 70.76, Backfitting.

10 CFR Part 72, Licensing Requirements for the Independent Storage of Spent Nuclear Fuel, High-Level Radioactive Waste, and Reactor-Related Greater Than Class C Waste.

10 CFR 72.7, Specific Exemptions.

10 CFR 72.62, Backfitting.

10 CFR Part 76, Certification of Gaseous Diffusion Plants.

10 CFR 76.23, Specific Exemptions.

10 CFR 76.76, Backfitting.

Nuclear Regulatory Commission Documents Charter of the Committee To Review Generic Requirements.

Letter to Ellen Ginsberg from Stephen Burns discussing applicability of the Backfit Rule to NRC interpretive guidance, July 14, 2010 (ADAMS Accession No. ML101960180).

Memorandum to Edwin Hackett from Andrew Averbach, Summary of COMSECY-16-0020, Recommendation on Revision of Guidance Concerning Consideration of Cost and Applicability of Compliance Exception to Backfit Rule, December 20, 2016 (ADAMS Accession No. ML16355A258).

Memorandum to James M. Taylor and William C. Parler from Samuel J. Chilk, SECY-93-086, Backfit Considerations, June 30, 1993 (ADAMS Accession No. ML003760758).

For the latest version of any NRC directive or handbook, see the online MD Catalog. 14

MD 8.4 MANAGEMENT OF BACKFITTING, FORWARD Date Approved: XX/XX/XXXX FITTING, ISSUE FINALITY, AND INFORMATION COLLECTIONREQUESTS Memorandum from Luis A. Reyes, Executive Director for Operations, NRR to Those on the Attached List, Implementation of an ADAMS-Based Record Access System for Facility-Specific Backfits, February 22, 2006 (ADAMS Accession No. ML052720147).

NUREG-0910, NRC Comprehensive Records Disposition Schedule.

NUREG-1409, Backfitting Guidelines.

NUREG/BR-0058, Revision 45, Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission, and all Appendices.

Revision of Backfitting Process for Power Reactors, 50 FR 38097 (September 20, 1985)

(https://s3.amazonaws.com/archives.federalregister.gov/issue_slice/1985/9/20/3809 7-38114.pdf#page=1).

SECY-99-063, The Use by Industry of Voluntary Initiatives in the Regulatory Process, dated March 2, 1999 (ADAMS Accession No. ML992810068).

Staff Requirements Memorandum, COMSECY-16-0020, Staff Requirements

- COMSECY-16-0020 - Revision of Guidance Concerning Consideration of Cost and Applicability of Compliance Exception to Backfit Rule, November 29, 2016 (ADAMS Accession No. ML16334A462).

Staff Requirements Memorandum, SECY-98-185, Staff Requirements -- SECY 185 -- Proposed Rulemaking, Revised Requirements for the Domestic Licensing of Special Nuclear Material, December 1, 1998 (ADAMS Accession No. ML991880012).

Staff Requirements Memorandum, SECY-14-0087, Staff Requirements SECY 0087-Qualitative Consideration of Factors in the Development of Regulatory Analyses and Backfit Analyses, dated March 4, 2015 (ADAMS Accession No. ML15063A568).

Use of Probabilistic Risk Assessment Methods in Nuclear Regulatory Activities; Final Policy Statement, 60 FR 42622, August 16, 1995.

United States Code Administrative Procedure Act, Pub. L.79-404(5 U.S.C. 551 et seq).

Atomic Energy Act of 1954, as amended (42 U.S.C. 2011 et seq.).

Energy Reorganization Act of 1974, as amended (42 U.S.C. 5801 et seq.).

Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

For the latest version of any NRC directive or handbook, see the online MD Catalog. 15

MD 8.4 MANAGEMENT OF BACKFITTING, FORWARD Date Approved: XX/XX/XXXX FITTING, ISSUE FINALITY, AND INFORMATION COLLECTIONREQUESTS United States Supreme Court Decision Michigan v. Environmental Protection Agency, 135 S. Ct. 2699 (2015).

For the latest version of any NRC directive or handbook, see the online MD Catalog. 16