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* Identify exceptions to the development approval process for a RIS, and | * Identify exceptions to the development approval process for a RIS, and | ||
* Clarify the concurrence and distribution provisions for a RIS. | * Clarify the concurrence and distribution provisions for a RIS. | ||
TABLE OF CONTENTS I. POLICY..............................................................................................................................2 II. OBJECTIVES ....................................................................................................................3 III. ORGANIZATIONAL RESPONSIBILITIES AND DELEGATIONS OF AUTHORITY ........... 3 A. Commission..................................................................................................................3 | TABLE OF CONTENTS I. POLICY..............................................................................................................................2 II. OBJECTIVES ....................................................................................................................3 III. ORGANIZATIONAL RESPONSIBILITIES AND DELEGATIONS OF AUTHORITY ........... 3 A. Commission..................................................................................................................3 For updates or revisions to policies contained in this MD that were published after the MD was signed, please see the Yellow Announcement to Management Directive index (YA-to-MD index). | ||
For updates or revisions to policies contained in this MD that were published after the MD was signed, please see the Yellow Announcement to Management Directive index (YA-to-MD index). | |||
MD 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015 B. Executive Director for Operations (EDO) ......................................................................3 C. Office of the General Counsel (OGC) ...........................................................................4 D. Director, Office of Nuclear Reactor Regulation (NRR) ..................................................4 E. Director, Office of New Reactors (NRO), and Director, Office of Nuclear Material Safety and Safeguards (NMSS) ......................................................................5 F. Director, Office of Nuclear Security and Incident Response (NSIR) ..............................5 G. Director, Office of Nuclear Regulatory Research (RES) ................................................6 H. Chief Information Officer (CIO) .....................................................................................6 I. Director, Office of Enforcement (OE) ............................................................................6 J. Committee to Review Generic Requirements (CRGR)..................................................6 K. Advisory Committee on Reactor Safeguards (ACRS) ...................................................6 L. Advisory Committee on the Medical Uses of Isotopes (ACMUI)....................................6 M. Director, Division of Policy and Rulemaking (DPR), Office of Nuclear Reactor Regulation (NRR) ............................................................................................6 N. Director, Division of Construction Inspection and Operational Programs (DCIP), Office of New Reactors (NRO) .........................................................................7 IV. PROPOSING GENERIC COMMUNICATIONS OR CHANGES TO THE NRC GENERIC COMMUNICATIONS PROGRAM .....................................................................7 V. APPLICABILITY ................................................................................................................7 VI. DIRECTIVE HANDBOOK ..................................................................................................7 VII. REFERENCES ...................................................................................................................8 I. POLICY It is the policy of the U.S. Nuclear Regulatory Commission to have an effective generic communications program for communicating with the nuclear industry on matters having generic applicability. These communications may include issues of safety, security, safeguards, and environmental significance. Some generic communications request information that may reveal issues regarding compliance with NRC rules and regulations or the licensing basis. They may also address a broad spectrum of matters on which the NRC finds it appropriate to inform the industry, and matters on which the NRC may request voluntary industry cooperation and participation. The NRC Generic Communications Program implements the NRCs objective of openness by providing opportunities for early stakeholder input, as appropriate. The need to obtain public input on draft generic communications is balanced against the need for NRC staff to exercise its regulatory and safety responsibilities without undue administrative burden, as well as the need to protect classified, safeguards, and sensitive information. | MD 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015 B. Executive Director for Operations (EDO) ......................................................................3 C. Office of the General Counsel (OGC) ...........................................................................4 D. Director, Office of Nuclear Reactor Regulation (NRR) ..................................................4 E. Director, Office of New Reactors (NRO), and Director, Office of Nuclear Material Safety and Safeguards (NMSS) ......................................................................5 F. Director, Office of Nuclear Security and Incident Response (NSIR) ..............................5 G. Director, Office of Nuclear Regulatory Research (RES) ................................................6 H. Chief Information Officer (CIO) .....................................................................................6 I. Director, Office of Enforcement (OE) ............................................................................6 J. Committee to Review Generic Requirements (CRGR)..................................................6 K. Advisory Committee on Reactor Safeguards (ACRS) ...................................................6 L. Advisory Committee on the Medical Uses of Isotopes (ACMUI)....................................6 M. Director, Division of Policy and Rulemaking (DPR), Office of Nuclear Reactor Regulation (NRR) ............................................................................................6 N. Director, Division of Construction Inspection and Operational Programs (DCIP), Office of New Reactors (NRO) .........................................................................7 IV. PROPOSING GENERIC COMMUNICATIONS OR CHANGES TO THE NRC GENERIC COMMUNICATIONS PROGRAM .....................................................................7 V. APPLICABILITY ................................................................................................................7 VI. DIRECTIVE HANDBOOK ..................................................................................................7 VII. REFERENCES ...................................................................................................................8 I. POLICY It is the policy of the U.S. Nuclear Regulatory Commission to have an effective generic communications program for communicating with the nuclear industry on matters having generic applicability. These communications may include issues of safety, security, safeguards, and environmental significance. Some generic communications request information that may reveal issues regarding compliance with NRC rules and regulations or the licensing basis. They may also address a broad spectrum of matters on which the NRC finds it appropriate to inform the industry, and matters on which the NRC may request voluntary industry cooperation and participation. The NRC Generic Communications Program implements the NRCs objective of openness by providing opportunities for early stakeholder input, as appropriate. The need to obtain public input on draft generic communications is balanced against the need for NRC staff to exercise its regulatory and safety responsibilities without undue administrative burden, as well as the need to protect classified, safeguards, and sensitive information. | ||
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* Identify exceptions to the development approval process for a RIS, and | * Identify exceptions to the development approval process for a RIS, and | ||
* Clarify the concurrence and distribution provisions for a RIS. | * Clarify the concurrence and distribution provisions for a RIS. | ||
TABLE OF CONTENTS I. INTRODUCTION ................................................................................................................2 II. ORGANIZATIONAL RESPONSIBILITIES BY OFFICE .....................................................5 A. Generic Communications Coordinator (Office of Nuclear Material Safety and Safeguards (NMSS), Office of New Reactors (NRO), Office of | TABLE OF CONTENTS I. INTRODUCTION ................................................................................................................2 II. ORGANIZATIONAL RESPONSIBILITIES BY OFFICE .....................................................5 A. Generic Communications Coordinator (Office of Nuclear Material Safety and Safeguards (NMSS), Office of New Reactors (NRO), Office of For updates or revisions to policies contained in this MD that were published after the MD was signed, please see the Yellow Announcement to Management Directive index (YA-to-MD index). | ||
For updates or revisions to policies contained in this MD that were published after the MD was signed, please see the Yellow Announcement to Management Directive index (YA-to-MD index). | |||
DH 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015 Nuclear Reactor Regulation (NRR), Office of Nuclear Security and Incident Response (NSIR) ............................................................................................5 B. Generic Communications Support, Office of Administration (ADM)...............................5 III. OVERVIEW OF THE NRC GENERIC COMMUNICATIONS PROGRAM ...........................6 A. Types of Generic Communications and Their Application .............................................6 B. Approval for Development of Generic Communications ................................................9 IV. GENERIC COMMUNICATIONS LIFECYCLE ..................................................................12 A. Preparation of a Bulletin .............................................................................................12 B. Preparation of a Generic Letter...................................................................................13 C. Preparation of a Regulatory Issue Summary ..............................................................15 D. Preparation of an Information Assessment Team Advisory ......................................... 17 E. Preparation of a Security Advisory ..............................................................................17 F. Preparation of an Information Notice ..........................................................................18 G. Considerations Common to the Preparation of Bulletins, Generic Letters, and Regulatory Issue Summaries ..................................................................19 H. Issuance of Generic Communications ........................................................................19 I. Closeout of Generic Communications (Bulletins and Generic Letters) ........................ 20 J. Effectiveness Review of Generic Communications .....................................................21 I. INTRODUCTION A. The U.S. Nuclear Regulatory Commission communicates with the nuclear industry on matters of generic applicability through its generic communications program. Generic communications are the NRCs primary method of communicating to stakeholders on a common need or resolution approach to an issue. They allow the NRC to communicate and share industry experiences and send information to specific classes of licensees and interested stakeholders. Generic communications may also suggest methods for meeting regulatory requirements on which licensees may voluntarily act or the generic communication may communicate related technical information or other issues of significance to stakeholders. | DH 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015 Nuclear Reactor Regulation (NRR), Office of Nuclear Security and Incident Response (NSIR) ............................................................................................5 B. Generic Communications Support, Office of Administration (ADM)...............................5 III. OVERVIEW OF THE NRC GENERIC COMMUNICATIONS PROGRAM ...........................6 A. Types of Generic Communications and Their Application .............................................6 B. Approval for Development of Generic Communications ................................................9 IV. GENERIC COMMUNICATIONS LIFECYCLE ..................................................................12 A. Preparation of a Bulletin .............................................................................................12 B. Preparation of a Generic Letter...................................................................................13 C. Preparation of a Regulatory Issue Summary ..............................................................15 D. Preparation of an Information Assessment Team Advisory ......................................... 17 E. Preparation of a Security Advisory ..............................................................................17 F. Preparation of an Information Notice ..........................................................................18 G. Considerations Common to the Preparation of Bulletins, Generic Letters, and Regulatory Issue Summaries ..................................................................19 H. Issuance of Generic Communications ........................................................................19 I. Closeout of Generic Communications (Bulletins and Generic Letters) ........................ 20 J. Effectiveness Review of Generic Communications .....................................................21 I. INTRODUCTION A. The U.S. Nuclear Regulatory Commission communicates with the nuclear industry on matters of generic applicability through its generic communications program. Generic communications are the NRCs primary method of communicating to stakeholders on a common need or resolution approach to an issue. They allow the NRC to communicate and share industry experiences and send information to specific classes of licensees and interested stakeholders. Generic communications may also suggest methods for meeting regulatory requirements on which licensees may voluntarily act or the generic communication may communicate related technical information or other issues of significance to stakeholders. |
Latest revision as of 10:51, 3 February 2020
ML18073A213 | |
Person / Time | |
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Issue date: | 12/09/2015 |
From: | Office of Nuclear Reactor Regulation |
To: | |
References | |
DT-17-169 MD 8.18 | |
Download: ML18073A213 (30) | |
Text
U.S. NUCLEAR REGULATORY COMMISSION MANAGEMENT DIRECTIVE (MD)
MD 8.18 NRC GENERIC COMMUNICATIONS DT-17-169 PROGRAM Volume 8: Licensee Oversight Programs Approved By: William M. Dean, Director Office of Nuclear Reactor Regulation Date Approved: December 9, 2015 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 Policy and Rulemaking Contact Name: Tanya Mensah 301-415-3610 EXECUTIVE
SUMMARY
Management Directive (MD) 8.18 establishes the roles and responsibilities of various offices for implementation of the NRC Generic Communications Program. It also provides guidance for U.S. Nuclear Regulatory Commission staff to prepare and issue each type of generic communication product. MD 8.18 is being revised to
- Update agency-level guidance on the NRC Generic Communications Program,
- Reference a desk guide that replaces the Office of Nuclear Reactor Regulation office instruction,
- Include a reference to the Federal Register notice template library on SharePoint,
- Eliminate the informal review of a Regulatory Issue Summary (RIS) by the Committee to Review Generic Requirements before the public comment period,
- Identify exceptions to the development approval process for a RIS, and
- Clarify the concurrence and distribution provisions for a RIS.
TABLE OF CONTENTS I. POLICY..............................................................................................................................2 II. OBJECTIVES ....................................................................................................................3 III. ORGANIZATIONAL RESPONSIBILITIES AND DELEGATIONS OF AUTHORITY ........... 3 A. Commission..................................................................................................................3 For updates or revisions to policies contained in this MD that were published after the MD was signed, please see the Yellow Announcement to Management Directive index (YA-to-MD index).
MD 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015 B. Executive Director for Operations (EDO) ......................................................................3 C. Office of the General Counsel (OGC) ...........................................................................4 D. Director, Office of Nuclear Reactor Regulation (NRR) ..................................................4 E. Director, Office of New Reactors (NRO), and Director, Office of Nuclear Material Safety and Safeguards (NMSS) ......................................................................5 F. Director, Office of Nuclear Security and Incident Response (NSIR) ..............................5 G. Director, Office of Nuclear Regulatory Research (RES) ................................................6 H. Chief Information Officer (CIO) .....................................................................................6 I. Director, Office of Enforcement (OE) ............................................................................6 J. Committee to Review Generic Requirements (CRGR)..................................................6 K. Advisory Committee on Reactor Safeguards (ACRS) ...................................................6 L. Advisory Committee on the Medical Uses of Isotopes (ACMUI)....................................6 M. Director, Division of Policy and Rulemaking (DPR), Office of Nuclear Reactor Regulation (NRR) ............................................................................................6 N. Director, Division of Construction Inspection and Operational Programs (DCIP), Office of New Reactors (NRO) .........................................................................7 IV. PROPOSING GENERIC COMMUNICATIONS OR CHANGES TO THE NRC GENERIC COMMUNICATIONS PROGRAM .....................................................................7 V. APPLICABILITY ................................................................................................................7 VI. DIRECTIVE HANDBOOK ..................................................................................................7 VII. REFERENCES ...................................................................................................................8 I. POLICY It is the policy of the U.S. Nuclear Regulatory Commission to have an effective generic communications program for communicating with the nuclear industry on matters having generic applicability. These communications may include issues of safety, security, safeguards, and environmental significance. Some generic communications request information that may reveal issues regarding compliance with NRC rules and regulations or the licensing basis. They may also address a broad spectrum of matters on which the NRC finds it appropriate to inform the industry, and matters on which the NRC may request voluntary industry cooperation and participation. The NRC Generic Communications Program implements the NRCs objective of openness by providing opportunities for early stakeholder input, as appropriate. The need to obtain public input on draft generic communications is balanced against the need for NRC staff to exercise its regulatory and safety responsibilities without undue administrative burden, as well as the need to protect classified, safeguards, and sensitive information.
For the latest version of any NRC directive or handbook, see the online MD Catalog. 2
MD 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015 II. OBJECTIVES Define the purpose of each generic communication product:
- 1. Bulletin (BL),
- 2. Generic Letter (GL),
- 3. Regulatory Issue Summary (RIS),
- 4. Security Advisory (SA),
- 5. Information Assessment Team Advisory (IATA), and
- 6. Information Notice (IN).
Describe the process for preparing each generic communication product.
Establish staff and organizational responsibilities for implementing the NRC Generic Communications Program.
Require appropriate organizational and management-level support for a proposed generic communication.
III. ORGANIZATIONAL RESPONSIBILITIES AND DELEGATIONS OF AUTHORITY A. Commission
- 1. Reviews Office of the Secretary (SECY) information papers from the Executive Director for Operations (EDO) informing the Commission of the staffs intent to issue a BL or a GL.
- 2. Retains the option to take action on any proposed generic communication.
B. Executive Director for Operations (EDO)
- 1. Ensures that generic communication products are made publicly available to the extent practicable and consistent with information security requirements.
- 2. Notifies the Commission by a SECY information paper of the staffs intent to issue a BL or a GL.
- 3. Ensures that arrangements are made for any requested formal or informal Commission briefing.
- 4. Ensures that any Commission comments on generic communications are satisfactorily resolved.
- 5. Provides direction and program oversight for the NRC Generic Communications Program.
For the latest version of any NRC directive or handbook, see the online MD Catalog. 3
MD 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015
- 6. Authorizes the issuance of IATAs and informs the Commission of staffs intent to issue an IATA.
C. Office of the General Counsel (OGC)
- 1. Provides comments and a statement of no legal objection to the Office of Nuclear Reactor Regulation (NRR) and the Office of New Reactors (NRO) on generic communications that address nuclear reactor issues, including all BLs, GLs, and RISs, and on notifications to the Commission pertaining to the staffs intent to issue a BL or a GL.
- 2. Provides comments and a statement of no legal objection to the Office of Nuclear Security and Incident Response (NSIR) on SAs.
- 3. Provides comments and a statement of no legal objection to the Office of Nuclear Material Safety and Safeguards (NMSS) on generic communications that address materials and fuel cycle issues, including all BLs, GLs, and RISs; and on notifications to the Commission pertaining to the staffs intent to issue a BL or a GL; and on Federal Register notices related to generic communications.
- 4. Provides advice to NRC program offices on the rule status of generic communications (including BLs, GLs, and RISs) under the Congressional Review Act (CRA) of 1996. Specifically, OGC identifies if BLs, GLs, and RISs, under review are rules that must follow the CRA process.
D. Director, Office of Nuclear Reactor Regulation (NRR)
- 1. Establishes written procedures on the criteria, responsibilities, and guidance for the preparation, issuance, and followup of NRC generic communications.
- 2. Serves as the agency focal point for the administration of the NRC Generic Communications Program.
- 3. Provides managerial and procedural control of the NRC Generic Communications Program to promote consistency, effective recordkeeping, and to maintain the scope and integrity of the generic communications process.
- 4. Ensures that the impact of generic communications on other NRC offices and programs is considered and evaluated.
- 5. Provides agency oversight through the Division of Policy and Rulemaking (DPR),
NRR (focal point for the NRC Generic Communications Program), for ensuring the implementation of the NRC Generic Communications Program.
- 6. Evaluates the effectiveness of the NRC Generic Communications Program under NRRs purview.
- 7. Maintains an agencywide tracking system for generic communications.
For the latest version of any NRC directive or handbook, see the online MD Catalog. 4
MD 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015
- 8. Establishes the technical and legal adequacy of its generic communication products by ensuring that these products are appropriately reviewed and vetted with internal and external stakeholders.
- 9. Obtains technical input from the program offices (NRO and NMSS) and, as appropriate, the Office of Nuclear Regulatory Research (RES) and NSIR.
E. Director, Office of New Reactors (NRO), and Director, Office of Nuclear Material Safety and Safeguards (NMSS)
- 1. Coordinate through NRR to ensure the consistent implementation of the NRC Generic Communications Program.
- 2. Establish written procedures for its office on the criteria, responsibilities, coordination, and guidance for the preparation, issuance, and followup of NRC generic communications or uses NRR guidance.
- 3. Evaluate the effectiveness of the NRC Generic Communications Program under the offices purview.
- 4. Establish the technical and legal adequacy of its generic communication products by ensuring that these products are appropriately reviewed and vetted with internal and external stakeholders.
- 6. For NMSS only, the office director appoints the generic communications coordinator.
F. Director, Office of Nuclear Security and Incident Response (NSIR)
- 1. Ensures NSIR coordinates with NRR to ensure the consistent implementation of the NRC Generic Communications Program.
- 2. Establishes NSIR internal written procedures on the criteria, responsibilities, coordination, and guidance for the preparation, issuance, and followup of NRC generic communications.
- 3. Coordinates with the licensing program offices, as appropriate, to obtain concurrence on the issuance of security-related generic communications that affect licensees and applicants within the respective offices programmatic responsibility.
- 4. Coordinates with the licensing program offices, as appropriate, to ensure that the issuance and dissemination of security-related generic communications that affect licensees and applicants is conducted by the respective NRC program office.
- 5. Evaluates the effectiveness of the NRC Generic Communications Program under NSIRs purview.
For the latest version of any NRC directive or handbook, see the online MD Catalog. 5
MD 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015
- 6. Establishes the technical and legal adequacy of its generic communication products by ensuring that these products are appropriately reviewed and vetted with internal and external stakeholders.
- 7. Obtains technical input from RES, as appropriate.
G. Director, Office of Nuclear Regulatory Research (RES)
Provides input to the licensing program offices on the technical basis for generic communications, and concurrence where appropriate.
H. Chief Information Officer (CIO)
Assists NRC program offices on the implementation of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et. seq.) and the Government Paperwork Elimination Act of 1998 (44 U.S.C. Sec. 3504n) for all outgoing BLs, GLs, and RISs, as appropriate.
I. Director, Office of Enforcement (OE)
- 1. Advises NRC program offices on the enforcement implications for outgoing generic communications (BLs, GLs, and RISs).
- 2. Coordinates and issues enforcement discretion, as appropriate.
J. Committee to Review Generic Requirements (CRGR)
Reviews new or revised generic communications in accordance with the responsibilities outlined in the Committee to Review Generic Requirements (CRGR) Charter.
K. Advisory Committee on Reactor Safeguards (ACRS)
Staff may provide ACRS an opportunity to request a briefing for all BLs, GLs, and RISs (only those for which the CRGR has requested a formal briefing).
L. Advisory Committee on the Medical Uses of Isotopes (ACMUI)
Staff may provide ACMUI an opportunity to comment on generic communications affecting the medical community, where appropriate.
M. Director, Division of Policy and Rulemaking (DPR), Office of Nuclear Reactor Regulation (NRR)
- 1. Upon obtaining requisite approvals, signs and issues BLs, GLs, RIS, and INs.
- 2. Concurs on SAs and IATAs, if applicable.
For the latest version of any NRC directive or handbook, see the online MD Catalog. 6
MD 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015 N. Director, Division of Construction Inspection and Operational Programs (DCIP),
Office of New Reactors (NRO)
- 1. Appoints the NRO Generic Communications Coordinator.
- 2. Reviews and signs generic communications addressed to all holders of and applicants for a power reactor early site permit, combined license, standard design approval, or manufacturing license under Part 52 of Title 10 of the Code of Federal Regulations, Licenses, Certifications, and Approvals for Nuclear Power Plants, as well as all applicants for a standard design certification, including such applicants after initial issuance of a design certification rule.
IV. PROPOSING GENERIC COMMUNICATIONS OR CHANGES TO THE NRC GENERIC COMMUNICATIONS PROGRAM A. Any NRC office or region may propose a generic communication on an issue within its technical or regulatory purview.
B. If the subject matter of a generic communication pertains to issues within the purview of multiple licensing program offices, a joint communication will be signed by the applicable offices (the preferred approach). If the generic communication affects reactor licensees or applicants, the procedures of NRR that govern generic communications take precedence.
C. NRR facilitates the preparation, issuance, and dissemination of generic communications, except advisories prepared by NSIR. The licensing program offices will facilitate the issuance and dissemination of security-related generic communications to their respective licensed facilities.
D. Any individual, NRC office, other Government agency, licensee, certificate holder, or member of the public may recommend changes in the NRC Generic Communications Program, including the regulatory and procedural aspects of the process.
Recommendations should be made to the Director, NRR.
V. APPLICABILITY The policy and guidance of this directive and handbook apply to all NRC employees.
VI. DIRECTIVE HANDBOOK Handbook 8.18 provides criteria for the use of each generic communication type, guidance on obtaining approval for a proposed generic communication, and guidance on its preparation, issuance, distribution, and followup.
For the latest version of any NRC directive or handbook, see the online MD Catalog. 7
MD 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015 VII. REFERENCES Code of Federal Regulations Title 10, Energy.
Part 40, Domestic Licensing of Source Material.
Part 50, Domestic Licensing of Production and Utilization Facilities.
Part 52, Licenses, Certifications, and Approvals for Nuclear Power Plants.
Part 70, Domestic Licensing of Special Nuclear Material.
Part 71, Packaging and Transportation of Radioactive 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.
Part 76, Certification of Gaseous Diffusion Plants.
Part 110, Export and Import of Nuclear Equipment and Material.
Nuclear Regulatory Commission Charter of the Committee to Review Generic Requirements, Rev. 8, March 2011 (ML110620618).
Federal Register Notice Template Library on SharePoint:
http://fusion.nrc.gov/adm/team/DAS/RADB/rt/Templates/default.aspx.
Generic Communications Templates available at the Federal Register Notice Template Library on SharePoint:
http://fusion.nrc.gov/adm/team/DAS/RADB/rt/Templates/Lists/gctemp/AllItems.aspx.
Generic Communications Coordinators, available at http://fusion.nrc.gov/nrr/team/dpr/pgcb/Lists/Generic%20Communications%20Coordinat ors/AllItems.aspx.
Generic Communications (PGCB) Desktop Guide, available at http://fusion.nrc.gov/nrr/team/dpr/pgcb/Lists/Generic%20Communications%20Guidance/
AllItems.aspx.
Closed Bulletins and Generic Letters (agency tracking Web site), available at http://fusion.nrc.gov/nrr/team/dpr/pgcb/Lists/ClosedGC/AllItems.aspx.
Inspection Manual Chapter 0040 (IMC 0040), Preparing, Revising, and Issuing Documents for NRC Inspection Manual, available at http://www.nrc.gov/reading-rm/doc-collections/insp-manual/manual-chapter/.
For the latest version of any NRC directive or handbook, see the online MD Catalog. 8
MD 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015 Inspection Manual Chapter 0730, Generic Communications Regarding Materials and Fuel Cycle Issues, available at http://www.nrc.gov/reading-rm/doc-collections/insp-manual/manual-chapter/.
NRC Generic Communications Web site available at http://www.nrc.gov/reading-rm/doc-collections/gen-comm/.
NRC Regulatory Issue Summary 99-01, Revisions to the Generic Communications Program, dated October 4, 1999, available at http://www.nrc.gov/reading-rm/doc-collections/gen-comm/reg-issues/1999/.
NSIR Office Procedure COM-215, Generic Communications, available at http://nsir.nrc.gov/ppd/officeprocedures.htm.
Office of Administrations Internal Web site (guidance on technical editing):
http://www.internal.nrc.gov/ADM/techedit/techedit.html.
SECY-99-143, Revisions to Generic Communication Program, dated May 26, 1999, available at http://www.nrc.gov/reading-rm/doc-collections/commission/secys/1999/.
SECY-01-0121, Industry Initiatives in the Regulatory Process, dated July 5, 2001, available at http://www.nrc.gov/reading-rm/doc-collections/commission/secys/2001/.
Staff Requirements Memorandum on SECY-01-0121, Industry Initiatives in the Regulatory Process, dated August 2, 2001, available at http://www.nrc.gov/reading-rm/doc-collections/commission/srm/2001/2001-0121srm.pdf.
Management Directive 3.54, NRC Collections of Information and Reports Management.
United States Code Atomic Energy Act of 1954, Section 182a, as amended (42 U.S.C. 2011 et seq.).
Congressional Review Act of 1996 (5 U.S.C. 801-808).
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
Government Paperwork Elimination Act of 1998 (44 U.S.C. Sec. 3504n).
For the latest version of any NRC directive or handbook, see the online MD Catalog. 9
U.S. NUCLEAR REGULATORY COMMISSION DIRECTIVE HANDBOOK (DH)
DH 8.18 NRC GENERIC COMMUNICATIONS DT-17-169 PROGRAM Volume 8: Licensee Oversight Programs Approved By: William M. Dean, Director Office of Nuclear Reactor Regulation Date Approved: December 9, 2015 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 Policy and Rulemaking Contact Name: Tanya Mensah 301-415-3610 EXECUTIVE
SUMMARY
Management Directive (MD) 8.18 establishes the roles and responsibilities of various offices for implementation of the NRC Generic Communications Program. It also provides guidance for U.S. Nuclear Regulatory Commission staff to prepare and issue each type of generic communication product. MD 8.18 is being revised to
- Update agency-level guidance on the NRC Generic Communications Program,
- Reference a desk guide that replaces the Office of Nuclear Reactor Regulation office instruction,
- Include a reference to the Federal Register notice template library on SharePoint,
- Eliminate the informal review of a Regulatory Issue Summary (RIS) by the Committee to Review Generic Requirements before the public comment period,
- Identify exceptions to the development approval process for a RIS, and
- Clarify the concurrence and distribution provisions for a RIS.
TABLE OF CONTENTS I. INTRODUCTION ................................................................................................................2 II. ORGANIZATIONAL RESPONSIBILITIES BY OFFICE .....................................................5 A. Generic Communications Coordinator (Office of Nuclear Material Safety and Safeguards (NMSS), Office of New Reactors (NRO), Office of For updates or revisions to policies contained in this MD that were published after the MD was signed, please see the Yellow Announcement to Management Directive index (YA-to-MD index).
DH 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015 Nuclear Reactor Regulation (NRR), Office of Nuclear Security and Incident Response (NSIR) ............................................................................................5 B. Generic Communications Support, Office of Administration (ADM)...............................5 III. OVERVIEW OF THE NRC GENERIC COMMUNICATIONS PROGRAM ...........................6 A. Types of Generic Communications and Their Application .............................................6 B. Approval for Development of Generic Communications ................................................9 IV. GENERIC COMMUNICATIONS LIFECYCLE ..................................................................12 A. Preparation of a Bulletin .............................................................................................12 B. Preparation of a Generic Letter...................................................................................13 C. Preparation of a Regulatory Issue Summary ..............................................................15 D. Preparation of an Information Assessment Team Advisory ......................................... 17 E. Preparation of a Security Advisory ..............................................................................17 F. Preparation of an Information Notice ..........................................................................18 G. Considerations Common to the Preparation of Bulletins, Generic Letters, and Regulatory Issue Summaries ..................................................................19 H. Issuance of Generic Communications ........................................................................19 I. Closeout of Generic Communications (Bulletins and Generic Letters) ........................ 20 J. Effectiveness Review of Generic Communications .....................................................21 I. INTRODUCTION A. The U.S. Nuclear Regulatory Commission communicates with the nuclear industry on matters of generic applicability through its generic communications program. Generic communications are the NRCs primary method of communicating to stakeholders on a common need or resolution approach to an issue. They allow the NRC to communicate and share industry experiences and send information to specific classes of licensees and interested stakeholders. Generic communications may also suggest methods for meeting regulatory requirements on which licensees may voluntarily act or the generic communication may communicate related technical information or other issues of significance to stakeholders.
B. The Office of Nuclear Reactor Regulation (NRR) has primary oversight responsibility for implementing the NRC Generic Communications Program and for ensuring the appropriate application of generic communications. Any NRC office or region may propose a generic communication on an issue within its purview. The type of generic communication issued is determined during NRC evaluations of the nuclear industry and regulatory activities. All staff should consult with the generic communications coordinator for their office when considering the potential development of any generic communications.
For the latest version of any NRC directive or handbook, see the online MD Catalog. 2
DH 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015 C. In general, the NRC considers the following as external stakeholders:
- 1. Licensees,
- 2. Vendors,
- 3. Consulting companies,
- 4. Other Federal agencies,
- 5. State and local governments,
- 6. Federally-recognized Indian Tribes,
- 7. The general public, and
- 8. Any other individual or group that may be directly or indirectly impacted by the NRCs decisions in the specific area of consideration as an external stakeholder.
D. An internal stakeholder includes any cognizant NRC management or staff that has functional responsibility or knowledge of the subject matter involved or should be informed of the generic communication. Hereafter, external and internal stakeholders are referred to as stakeholders. The appropriate NRC organizations responsible for developing a generic communication will ensure that coordination with stakeholders occurs early and, as appropriate, during the development of the generic communication.
E. There are six types of generic communications:
- 1. Bulletin (BL),
- 2. Generic Letter (GL),
- 3. Regulatory Issue Summary (RIS),
- 4. Security Advisory (SA),
- 5. information Assessment Team Advisory (IATA), and
- 6. Information Notice (IN).
F. Once signed, a generic communication is placed in the Agencywide Documents Access and Management System (ADAMS) as an official NRC record. NRR disseminates the generic communication electronically to generic communications list server subscribers and requests posting to the NRC external Web site, as appropriate. (See the NRC Generic Communications Web site for instructions on how to subscribe to the list server.) The affected NRC program offices for the generic communication coordinate any direct mailings to their respective licensees through the generic communications coordinator for their office.
For the latest version of any NRC directive or handbook, see the online MD Catalog. 3
DH 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015 G. All generic communication development will:
- 1. Require that staff obtain early management acknowledgment of emergent generic issues.
- 2. Require that staff consider interacting with stakeholders, whenever possible, when evaluating an issue.
- 3. Provide clear justification for the selected generic communication.
- 4. Restrict the use of Section 50.54(f) of Title 10 of the Code of Federal Regulations (10 CFR), Conditions of Licenses, to only those matters in which the NRC has been unable to obtain needed information through other means.
- 5. Develop, in reasonable detail, an evaluation of whether the staff position underlying the generic communication is a new or different staff position in the context of the backfit rule (10 CFR 50.109).
H. All matters addressed by the staff that could lead to a generic communication will follow a similar process from inception to closeout. The basic steps of the process include
- 1. Issue identification;
- 2. Office endorsement of the issue;
- 3. Interaction with stakeholders, as appropriate;
- 4. Office approval to proceed with a generic communication;
- 5. Office determination of public notification of a sensitive generic communication,
- 6. Preparation of the generic communication;
- 7. Submittal of appropriate generic communication to the Commission for information, if applicable;
- 8. Issuance of the generic communication after resolving any Commission comments, if applicable;
- 9. Issuance of an Executive Director for Operations (EDO) Daily Note that a generic communication has been issued, and;
- 10. Documentation of the results and staff followup to support the closure of the generic communication.
For the latest version of any NRC directive or handbook, see the online MD Catalog. 4
DH 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015 II. ORGANIZATIONAL RESPONSIBILITIES BY OFFICE A. Generic Communications Coordinator (Office of Nuclear Material Safety and Safeguards (NMSS), Office of New Reactors (NRO), Office of Nuclear Reactor Regulation (NRR), Office of Nuclear Security and Incident Response (NSIR)
- 1. Coordinates interoffice review for generic communications.
- 2. Acts as the focal point for the concurrence and signature of generic communications for his or her office (see current list of Generic Communications Coordinators, available at http://fusion.nrc.gov/nrr/team/dpr/pgcb/default.aspx).
- 3. Coordinates requests for his or her program office to distribute NSIR SAs and IATAs directly to licensees.
- 4. Coordinates for his or her program office, to provide current licensee contact information and periodic status updates to the Headquarters Operations Center, at the request of NSIR.
B. Generic Communications Support, Office of Administration (ADM)
- 1. Develops and maintains templates for Federal Register notices, which are available in the Federal Register Notice (FRN) template library on SharePoint at http://fusion.nrc.gov/adm/team/DAS/RADB/rt/Templates/default.aspx.
- 2. Generic communications templates are available at http://fusion.nrc.gov/adm/team/DAS/RADB/rt/Templates/Lists/gctemp/AllItems.aspx.
- 3. Provides technical editing for (a) Generic communications when submitted to QTE.Resource@nrc.gov, and (a) FRNs related to generic communications through the Rules, Announcements, and Directives Branch (RADB). FRN templates for generic communications are available at http://fusion.nrc.gov/adm/team/DAS/RADB/rt/Templates/Lists/gctemp/AllItems.aspx.
A draft of the Federal Register notice should be submitted to the FRN early review box at FRN_ReviewRequest@nrc.gov to ensure that the notice is written in plain language and meets NRC and Office of the Federal Register publication requirements.
- 4. Arranges through RADB, publication of FRNs related to generic communications.
- 5. Receives, dockets, and directs initial distribution of all public comments received on FRNs related to generic communications.
- 6. Facilitates submittal of any generic communication determined to be a rule under the Congressional Review Act to the Office of Management and Budget (OMB).
For the latest version of any NRC directive or handbook, see the online MD Catalog. 5
DH 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015 III. OVERVIEW OF THE NRC GENERIC COMMUNICATIONS PROGRAM A. Types of Generic Communications and Their Application
- 1. Bulletin (a) A BL is used to request licensee actions and/or information to address significant issues regarding matters of safety, security, safeguards, or environmental significance that also have great urgency. A BL requires a written response. The compensatory actions requested should be commensurate with the urgency of the issue being addressed.
(b) To the extent that circumstances permit, NRC staff will interact with the stakeholders on the issue being addressed.
(c) A BL may (i) Request actions be taken.
(ii) Request information be provided.
(iii) Request analyses be performed and submitted by a specified time.
(iv) Request new or revised commitments that are based on analyses performed and on proposed corrective actions.
(v) Require a response from affected licensees.
(d) A BL may NOT request long-term actions or require actions or commitments.
- 2. Generic Letter (a) A GL addresses either an emergent or routine technical issue with generic applicability for which NRC staff and stakeholders have interacted. A GL may also be issued without extensive prior interaction between the NRC and stakeholders when the NRC has determined a risk-significant compliance matter should be brought promptly to the attention of licensees.
(b) A GL may request information and/or compensatory actions and require a written response from licensees regarding matters of safety, security, safeguards, or environmental significance.
(c) A GL may (i) Request actions be taken.
(ii) Request information be provided.
(iii) Request analyses be performed and submitted by a specified time.
(iv) Request new or revised commitments that are based on analyses performed and on proposed corrective actions.
For the latest version of any NRC directive or handbook, see the online MD Catalog. 6
DH 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015 (v) Request that addressees report the completion of actions by letter with or without prior NRC approval of the actions.
(vi) Require a response from affected licensees.
(d) A GL may NOT request long-term actions or require actions or commitments.
- 3. Regulatory Issue Summary (a) A RIS is used to communicate with stakeholders on a broad range of matters.
(b) A RIS may (i) Communicate previous NRC endorsement of an industry-developed resolution of a matter on which the staff has interacted with the industry.
(ii) Communicate previous NRC endorsement of industry guidance on technical or regulatory matters.
(iii) Provide the status of staff interaction with the nuclear industry on a matter.
(iv) Request the voluntary participation of the nuclear industry in staff-sponsored pilot programs.
(v) Inform the nuclear industry of previously established opportunities for regulatory relief.
(vi) Communicate and/or clarify staff technical or policy positions on regulatory matters that have not been communicated or are not broadly understood by the nuclear industry.
(vii) Provide guidance to applicants and licensees on the scope and detail of information that should be provided in license applications to facilitate staff review.
(viii) Communicate any of the following: administrative procedure changes in the implementation of regulations or staff positions; the issuance and availability of regulatory documents (topical reports, NUREG-type documents, regulatory guides; memoranda documenting the closeout of generic safety issues); and changes in NRC internal procedures and organization.
(ix) Request the voluntary submittal of information which will assist the NRC in the performance of its functions.
(c) A RIS may NOT (i) Provide guidance for the implementation of rules and regulations, (ii) Provide guidance to NRC staff on regulatory or technical matters, (iii) Require a response, commitments, or action, or For the latest version of any NRC directive or handbook, see the online MD Catalog. 7
DH 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015 (iv) Be used in lieu of other established agency products.
- 4. Information Assessment Team Advisory (a) An IATA issued by NSIR provides urgent, time-sensitive, threat-related information to specified licensees.
(b) An IATA is used whenever the U.S. Attorney General or the Secretary of the Department of Homeland Security makes a change in the National Terrorism Advisory System (NTAS) level. The NRC will issue a corresponding IATA elevating security at licensee facilities.
(c) An IATA may (i) Suggest or request that recipients execute certain voluntary precautionary or protective actions, (ii) Inform licensees when the Federal Bureau of Investigation issues a terrorism-related threat advisory or alert that is considered relevant to NRC licensees.
(iii) Inform licensees when a significant act of domestic terrorism, or other malevolent act, has occurred.
(iv) Inform licensees when the NRC becomes aware of intelligence information regarding statements or actions taken by foreign persons or by terrorist organizations, or other threat-related information, relating to NRC-licensed facilities or activities.
(d) An IATA may NOT request information or require commitments or actions.
- 5. Security Advisory (a) An SA issued by NSIR communicates emergent, timely, operational or situational awareness threat-related information directly relating to the security and common defense of national infrastructure under NRCs cognizance. An SA is operational in nature and is issued in response to an urgent situation or recently identified vulnerability. The nuclear industry is expected to review the information for applicability to its facilities or operations and consider actions, as appropriate, to correct or prevent similar issues.
(b) An SA may (i) Communicate timely information regarding an emergent security vulnerability that may affect a whole class or several classes of licensees.
(ii) Communicate situational awareness, threat-related information that may affect a whole class or several classes of licensees.
(iii) Provide licensees additional information following notification by an IATA that the NTAS threat level has been raised.
For the latest version of any NRC directive or handbook, see the online MD Catalog. 8
DH 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015 (iv) Notify affected licensees of national special security events.
(v) Recommend voluntary compensatory measures and actions for urgent, security-related issues.
(c) An SA may NOT (i) Convey or imply new requirements or new interpretations of existing requirements or guidance, (ii) Require information from or action by addressees, (iii) Be used in lieu of other generic communication products, or (iv) Provide guidance for the implementation of rules and regulations.
- 6. Information Notice (a) An IN communicates recently identified operating experience to the nuclear industry. The results of recently completed research that may affect addressees may also be communicated in an IN. Addressees are expected to review the information for applicability to their facilities or operations and consider actions, as appropriate, to avoid similar problems.
(b) An IN may NOT (i) Convey or imply requirements, (ii) Transmit interpretations of regulations, or (iii) Request information or action from addressees.
B. Approval for Development of Generic Communications
- 1. Bulletins and Generic Letters (a) Development approval for a BL or a GL will be at the office director level within NRR, NRO, NSIR, and/or NMSS. These offices have direct responsibility for licensing, licensee project management, and communications with potential generic communication addressees.
(b) The organization proposing the BL or the GL will coordinate its consideration through NRR, to ensure the consistent implementation of the NRC Generic Communications Program.
(c) Whenever a BL or a GL is considered for development, the organization responsible for the issue will present its case to the respective office director that the issuance of a generic communication is warranted, and shall obtain the requisite management approval to commit resources to prepare the BL or the GL. The responsible organization will also present a closure strategy for a BL or For the latest version of any NRC directive or handbook, see the online MD Catalog. 9
DH 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015 a GL to the office leadership team. The closeout plan will be developed before the issuance of a BL or a GL.
(d) The organization proposing the BL or the GL will assess the merits of the issue and alternative resolution strategies. The discussion of alternative resolution strategies will include, as appropriate, the following aspects:
(i) Staff plans, if any, to interact with stakeholders to reach consensus on the scope of the emergent issue, its safety and risk significance, and its regulatory basis.
(ii) Staff plans to promptly prepare a BL or a GL without extensive, formal interaction with stakeholders on the basis of the safety and risk significance of the emergent issue and its urgency.
(e) The organization proposing the BL or the GL will prepare a summary analysis of the issue. In the case of a BL requiring immediate action by the licensing office, the Committee to Review Generic Requirements (CRGR) review may occur after, rather than before, issuance. The staff will ordinarily prepare the documented evaluation before the BL or the GL is issued. However, if immediate issuance of the BL or the GL is needed to protect public health and safety, then the staff may prepare the documented evaluation after the issuance of the BL or the GL, consistent with 10 CFR 50.109(a)(6), and the CRGR charter. The CRGR Chairman shall be notified by the program office director originating immediately effective BLs and GLs. Use of this provision should normally be reserved for circumstances that pose an immediate or imminent threat to adequate protection of the public health and safety.
(f) For issues within the purview of NRR or NRO, the analysis should be based on Appendix C of the CRGR Charter.
(g) For issues within the purview of NMSS, Appendix C of the CRGR Charter may be used, to the degree applicable, or some other suitable approach may be used, to support decisionmaking.
(h) The organization proposing the BL or the GL will address the need for a temporary instruction (TI) for the conduct of verification inspections to aid in the subsequent closeout of a BL and a GL. A TI is primarily used as a one-time inspection of a significant generic safety issue, but may also be used as a one-time collection of information under certain circumstances. An assessment of the short- and long-term actions necessary to close out the BL or the GL will also be presented. Guidance on the preparation of a TI is contained in Inspection Manual Chapter 0040 (IMC 0040), Preparing, Revising, and Issuing Documents for NRC Inspection Manual.
For the latest version of any NRC directive or handbook, see the online MD Catalog. 10
DH 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015
- 2. Regulatory Issue Summary (a) Typically, development approval for a RIS will be at the leadership team/division director level (i.e., NRR leadership team) of the lead technical organization.
Leadership team/division director level approval is not required in the following cases (i.e., only the approval of the cognizant branch chief and the generic communications branch chief is required):
(i) When the staff plans to issue a revision to a generic communication that has been superseded by other guidance (e.g., issuing a RIS to inform stakeholders of the NRCs withdrawal of an outdated generic communication).
(ii) When the staff plans to issue a RIS as followup to a BL or a GL that was already approved (e.g., issuing a RIS to inform stakeholders that an interim enforcement policy has been issued to support closure of a BL or a GL).
(iii) A purely administrative or routinely issued RIS that involves NRC voluntary information requests (e.g., licensed operator examination schedules or updating of information for incident response electronic libraries).
(b) The organization proposing the RIS will coordinate its consideration through NRR/DPR, to ensure the consistent implementation of the NRC Generic Communications Program.
(c) The organization proposing the RIS will present its case to its respective office leadership team/cognizant division director that the issuance of the RIS is warranted and obtain the requisite management approval to commit resources to prepare the RIS. If the RIS also applies to licensees outside the lead organizations area of regulatory authority, the technical leads are responsible for including a senior management representative (or designee) from the other office(s) in any leadership team briefings.
- 3. Information Assessment Team Advisory Development approval for an IATA will be made at the division director level in NSIR.
- 4. Security Advisory (a) Development approval of an SA will be made at the division director level in NSIR.
(b) The organization proposing the SA will coordinate its consideration through NRR, to ensure the consistent implementation of the NRC Generic Communications Program.
- 5. Information Notice (a) Development approval for an IN will be at the branch chief level.
For the latest version of any NRC directive or handbook, see the online MD Catalog. 11
DH 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015 (b) The organization proposing the IN will coordinate its consideration through NRR, to ensure the consistent implementation of the NRC Generic Communications Program.
(c) An IN communicates recently identified operational information. Since an IN does not impose new requirements or interpretations and does not request information or action, formal office management review and endorsement are not needed.
(d) The CRGR does not review an IN since it is informational.
IV. GENERIC COMMUNICATIONS LIFECYCLE The basic steps involved in the lifecycle of each type of generic communication are presented below.
A. Preparation of a Bulletin
- 1. Senior Office Management Review and Approval A staff proposal to issue a BL must be reviewed and approved by senior office management (i.e., office director level). NRC staff may recommend the issuance of a BL if a safety or security-significant issue is identified that also has great urgency.
- 2. Preparation and Coordination (a) The organization responsible for the technical issue (lead technical organization) will prepare the BL and coordinate its development through NRR. A BL will be submitted for technical editing to QTE.Resource@nrc.gov to ensure clear and accurate communication. Additional guidance on technical editing is provided on the ADM internal Web site at http://www.internal.nrc.gov/ADM/techedit/techedit.html.
(b) As an option, in preparation for the CRGR formal review, the staff may request a CRGR informal review, if they deem it necessary to address any concerns raised by NRC stakeholders or staff members regarding backfitting, before the issuance of the BL.
- 3. Review by the CRGR (a) The lead technical organization will prepare a CRGR information package. The information package consists of the basis for the proposed issuance; a transmittal memorandum and several attachments, including the draft BL, Appendix C of the CRGR Charter, and relevant background material.
(b) A CRGR review is required for BL issuance. For a BL requiring immediate action, refer to the discussion in Section III.B.1(e) of this handbook.
For the latest version of any NRC directive or handbook, see the online MD Catalog. 12
DH 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015
- 4. Advisory Committee Notification (a) The lead technical organization will inform the cognizant advisory committee (Advisory Committee on Reactor Safeguards (ACRS), or the Advisory Committee on the Medical Uses of Isotopes (ACMUI)) of the intended action. The advisory committee should be given the opportunity to request a briefing.
(b) The advisory committee review is not required for BL issuance. However, a BL briefing may be completed after issuance.
- 5. Commission Information Paper The lead technical organization will prepare an information paper informing the Commission of the staffs intent to issue the BL. A BL may be issued without Commission notification, with the subsequent information paper review coming afterwards.
- 6. Issuance Upon obtaining requisite approvals, the cognizant generic communications division director will sign and issue the BL. The BL will also be published in the Federal Register. FRN templates for generic communications are available at http://fusion.nrc.gov/adm/team/DAS/RADB/rt/Templates/Lists/gctemp/AllItems.aspx.
A draft of the FRN should be submitted to the FRN early review box at FRN_ReviewRequest@nrc.gov to ensure that the notice is written in plain language and meets NRC and Office of the Federal Register publication requirements.
B. Preparation of a Generic Letter
- 1. Senior Office Management Review and Approval A staff proposal to issue a GL must be reviewed and approved by senior office management (i.e., office director level). NRC staff may recommend the issuance of a GL to resolve an issue on which the NRC staff has interacted with the stakeholders, or to identify a risk-significant emergent issue without extensive prior interaction.
- 2. Preparation and Coordination (a) The lead technical organization will prepare the GL and coordinate its development through NRR. GLs will be submitted for technical editing to QTE.Resource@nrc.gov to ensure clear and accurate communication. Additional guidance on technical editing is provided on ADMs internal Web site at http://www.internal.nrc.gov/ADM/techedit/techedit.html.
(b) As an option, in preparation for the CRGR formal review, the staff may request a CRGR informal review, if they deem it necessary to address any concerns raised by NRC stakeholders or staff members regarding backfitting, before the issuance of the draft GL for comment in the Federal Register. The lead technical organization will prepare a CRGR information package, if applicable. The For the latest version of any NRC directive or handbook, see the online MD Catalog. 13
DH 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015 information package consists of the basis for the proposed issuance; a transmittal memorandum and several attachments, including the draft GL, Appendix C of the CRGR Charter; and relevant background material. For GLs requiring immediate action, refer to the discussion in Section III.B.1(e) of this handbook.
- 3. Initial Advisory Committee Notification (a) The lead technical organization will inform the cognizant advisory committee (the ACRS or the ACMUI) of the intended action. The advisory committee should be given the opportunity to request a briefing, or as appropriate, provide comments.
(b) The staff may request a waiver of the initial advisory committee review before obtaining public comments. The advisory committee, on its own prerogative, may choose to grant or deny this waiver request.
- 4. Public Comment and Comment Resolution (a) When the lead office completes required internal reviews and management approvals, the proposed GL will be published in the Federal Register for a 60-day initial comment period.
(b) FRN templates for generic communications are available at http://fusion.nrc.gov/adm/team/DAS/RADB/rt/Templates/Lists/gctemp/AllItems.as px. A draft of the FRN should be submitted to the FRN early review box at FRN_ReviewRequest@nrc.gov to ensure that the notice is written in plain language and meets NRC and Office of the Federal Register publication requirements.
(c) The FRN solicits public comment on the technical and the value/impact aspects of the proposed GL. The lead technical organization should hold a public meeting on the proposed GL during the public comment period to allow interested parties to discuss relevant issues. The need for a meeting will be based on the complexity of the issues that are involved and the level of interest shown by stakeholders. The lead technical organization will resolve the public comments and revise the proposed GL, as appropriate.
- 5. CRGR Review (a) The lead technical organization prepares the information package that is submitted to the CRGR, if applicable. The information package consists of (i) A transmittal memorandum; (ii) The revised GL to reflect relevant public comments; For the latest version of any NRC directive or handbook, see the online MD Catalog. 14
DH 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015 (iii) The documentation of the comment letters received and the staffs resolution of each relevant comment (or group of similar or related comments);
Appendix C of the CRGR Charter, including a simplified value impact analysis; and (iv) Relevant background material.
(b) CRGR endorsement following the public comment period is a prerequisite to finalizing the GL for issuance.
- 6. Final Advisory Committee Notification The lead technical organization will inform the cognizant advisory committee (the ACRS or the ACMUI) of the intended action to issue a GL. The lead technical organization will provide the advisory committee with a copy of the final CRGR information package. The advisory committee should be given the opportunity to request a briefing.
- 7. Commission Information Paper Before issuing the GL, the lead technical organization will prepare an information paper informing the Commission of the staffs intent to issue the GL. A GL may not be issued without Commission notification.
- 8. Issuance Upon obtaining requisite approvals, the cognizant generic communications division director will sign and issue the GL. The final GL will be published in the Federal Register, as appropriate.
C. Preparation of a Regulatory Issue Summary
- 1. Management Review and Approval The office leadership team (i.e., division director level), as discussed above, must review and approve any staff proposal to develop a RIS.
- 2. Preparation and Coordination (a) The lead technical organization will prepare the RIS and coordinate its development through NRR. A RIS will be submitted for technical editing at QTE.Resource@nrc.gov to ensure clear and accurate communication. Additional guidance on technical editing is provided on ADMs internal Web site at http://www.internal.nrc.gov/ADM/techedit/techedit.html.
(b) As an option, the staff may request a CRGR informal review before public comment, if they deem it necessary to address any concerns raised by NRC stakeholders or staff members regarding backfitting, before the issuance of the draft RIS.
For the latest version of any NRC directive or handbook, see the online MD Catalog. 15
DH 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015
- 3. Public Comment and Comment Resolution (a) The NRC will normally seek public comment for any RIS that deals with a controversial topic or has potentially significant impacts. The lead technical organization will coordinate with NRR, DPR, to determine whether the draft RIS should be published for comment in the Federal Register.
(b) Upon completion of required reviews and management approvals, the proposed RIS will be published in the Federal Register for comment. While the public will be given at least 30 days to comment, which may be extended upon request from a member of the public, a 60-day initial comment period is preferred.
(c) FRN templates for generic communications are available at http://fusion.nrc.gov/adm/team/DAS/RADB/rt/Templates/Lists/gctemp/AllItems.as px. A draft of the FRNs should be submitted to the FRN early review box at FRN_ReviewRequest@nrc.gov to ensure that the notice is written in plain language and meets NRC and Office of the Federal Register publication requirements.
(d) The lead office will request public comment on the technical and the value/impact aspects of the proposed RIS. The lead technical organization will coordinate with NRR, to determine the need for a public meeting. The need for a meeting will be based on the complexity of the issues that are involved and the level of interest shown by the industry or the public. The lead technical organization will resolve the public comments and revise the proposed RIS, as appropriate.
- 4. Informal or Formal CRGR Review (a) In accordance with the CRGR Charter, the staff will request an informal review by the CRGR. The CRGR staff will review the document to confirm that it does not contain language that could give the appearance of backfit. The staff will ensure that a document sent to the CRGR for review will be in its final concurred state.
The division director or deputy of the technical division that has the lead or functional responsibility for the issue that is the subject of the generic communication should have reviewed and concurred in the final proposed document before it is submitted for CRGR review. This satisfies the CRGR charter criterion that the document be in its final concurred state. Following the CRGR endorsement, there should not be any substantial changes to the document. If substantial changes or backfit-related changes occur, the staff will resubmit the document to the CRGR in redline/strikeout format.
(b) If the CRGR, at its discretion, requests a formal review of a RIS, the lead technical organization responsible for the technical issue and preparation of the RIS (lead technical organization) will prepare a CRGR information package using the requirements listed in Appendix C of the CRGR Charter. The information package consists of the basis for the proposed issuance, a transmittal memorandum, the proposed RIS, a documented evaluation, and relevant For the latest version of any NRC directive or handbook, see the online MD Catalog. 16
DH 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015 background material. NRC staff may not proceed with development of the RIS until the conclusion of the CRGR formal review or notice that a formal review will not be conducted.
(c) The CRGR Chairman may request an informal briefing from the lead technical organization for clarification of key issues. The lead technical organization will support this briefing and ensure resolution of any comments or issues. This meeting may result in a formal review to comprise the full CRGR membership.
- 5. Issuance Upon obtaining requisite approvals, the cognizant generic communications division director will sign and issue the RIS. If the draft RIS was issued for public comment in the Federal Register, the final RIS will also be published in the Federal Register.
D. Preparation of an Information Assessment Team Advisory
- 1. Management Review and Approval NSIR management (e.g., division director) must review and approve any staff proposal to issue an IATA.
- 2. Preparation and Coordination (a) Because of the critical, urgent nature of an IATA, NSIR should attempt to coordinate with NRR, NRO, NMSS, and regional offices, as applicable. However, if the time-sensitive nature of the information does not allow for staff coordination, NSIR will issue the IATA and provide the directors of NRR, NRO, and NMSS, and the regional administrators, as applicable, a copy of the IATA upon issuance.
(b) The EDO authorizes the issuance of each IATA and informs the Commission of the staffs intent to issue an IATA, before it is issued.
- 3. Issuance An IATA must be prepared for NSIR management (e.g., office director) or designees signature. Upon obtaining requisite approvals, the NSIR office director or designee will sign and issue the IATA. An IATA that contains urgent, time sensitive, threat-related information requiring expedited processing will be issued and disseminated to applicable NRC-licensed facilities by the NRC Headquarters Operations Center. An IATA that does not require expedited processing will be issued and disseminated to the affected NRC-licensed facilities by each NRC program office, as appropriate.
E. Preparation of a Security Advisory
- 1. Management Review and Approval NSIR management (e.g., division director) must review and approve any staff proposal to issue an SA.
For the latest version of any NRC directive or handbook, see the online MD Catalog. 17
DH 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015
- 2. Preparation and Coordination The lead technical organization will prepare the SA and coordinate its development and issuance through the NSIR Generic Communications Coordinator. The NSIR Generic Communications Coordinator will coordinate the SA through NRR, NRO, and NMSS, and through the regional offices, as appropriate.
- 3. Review, Approval, and Issuance (a) NSIR will obtain concurrences from the appropriate licensing division director and the directors of NRR, NRO, and NMSS, as applicable, for SAs.
(b) The cognizant division director of NSIR authorizes the issuance of each SA and informs the EDO and the Commission of the staffs intent to issue an SA, before it is issued.
(c) NSIR will coordinate the issuance of an SA to affected licensees for dissemination with the NRR, NRO, and NMSS generic communications coordinator using methods appropriate for the highest level of controlled information contained in the SA. To the extent practicable, a publicly available summary of the SA will be placed in ADAMS.
F. Preparation of an Information Notice
- 1. Management Review and Approval The technical branch chief and the generic communications branch chief in NRR must review and approve any staff proposal to issue an IN.
- 2. Preparation and Coordination The lead technical organization will prepare the IN and coordinate its development through NRR. An IN will be submitted for technical editing to QTE.Resource@nrc.gov to ensure clear and accurate communication. Additional guidance on technical editing is provided on ADMs internal Web site at http://www.internal.nrc.gov/ADM/techedit/techedit.html.
- 3. Review, Approval, and Issuance (a) NRR, NMSS, NSIR, and NRO will ensure that proposals to prepare an IN meet the requirements of this management directive (MD). A program-specific IN will be issued by the licensing program office. An IN that affects multiple licensing offices should be jointly issued.
(b) Upon obtaining requisite approvals, the cognizant generic communications division director will sign and issue the IN.
For the latest version of any NRC directive or handbook, see the online MD Catalog. 18
DH 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015 G. Considerations Common to the Preparation of Bulletins, Generic Letters, and Regulatory Issue Summaries
- 1. Office of Enforcement (OE)
(a) OE will review all BLs, GLs, and RISs to evaluate the implications of positions taken in these documents for consistency with existing enforcement guidance and practice.
(b) OE also develops and authorizes enforcement discretion.
- 2. OMB Clearance for Information Collections (a) Under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.), an agency may not collect identical information from ten or more respondents unless it first obtains approval from the OMB.
(b) The NRC has established generic clearances to be used by all NRC program offices when issuing generic communications as described in MD 3.54, NRC Collections of Information and Reports Management.
(c) Information collections issued under a generic clearance must include a Paperwork Reduction Act statement and Public Protection Notice, as described in MD 3.54.
- 3. Applicability of the Congressional Review Act of 1996 The Congressional Review Act (CRA) of 1996 (5 U.S.C. 801-808) requires Federal agencies to provide Congress with an opportunity to review agency rules. The definition of rule is broad enough to capture many NRC generic actions, including generic communications. Each program office is responsible for developing an internal procedure for complying with the CRA. The NRC staff should consult with the Office of the General Counsel to determine the rule status of a generic communication under the CRA. The office should submit their CRA summary to ADM for transmittal to OMB.
- 4. Applicability of the Government Paperwork Elimination Act The Government Paperwork Elimination Act requires all Federal agencies to provide individuals or entities the option to submit, maintain, or disclose signatures and other information electronically and encourages Federal Government use of a range of electronic signature alternatives. Each program office will determine when and how the use of electronic signatures is appropriate, and/or practical.
H. Issuance of Generic Communications
- 1. Management and procedural control over the process for the issuance and distribution of NRC generic communications resides with NRR, who will assist program offices, and NSIR, in issuing a generic communication.
For the latest version of any NRC directive or handbook, see the online MD Catalog. 19
DH 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015
- 2. NRO and NMSS may issue and distribute generic communications within their purview independently from NRR; however, these offices are expected to adhere to the guidance in this MD and to coordinate with NRR, in doing so.
- 3. NSIR issues and coordinates the distribution of SAs and IATAs through the NRR, NRO, and NMSS generic communications coordinators.
I. Closeout of Generic Communications (Bulletins and Generic Letters)
The lead technical organization will coordinate activities leading to the closeout of the generic communication in accordance with the following guidelines.
- 1. Ensure that a consistent approach is used to closeout licensees or that different approaches are justified. Prepare guidance on the strategy that will be used to closeout the generic communication, including evaluating addressee replies, conducting site inspections or other followup actions, reviewing inspection reports and other summary reports prepared by the regions, and preparing closeout reports.
- 2. Include an assessment of additional inspector training requirements and NRC inspection resources required for any proposed use of inspection resources. The responsible program organization will concur with this guidance before the use of inspection resources is directed.
- 3. Maintain a record of the closeout status of the affected addressees. Provide this information, as appropriate, to NRR, for inclusion in the agencywide tracking system, at http://fusion.nrc.gov/nrr/team/dpr/pgcb/Lists/ClosedGC/AllItems.aspx.
- 4. Assess the need to develop a task action plan to manage closeout activities and keep relevant NRC staff informed.
- 5. Ensure that NRC staff evaluations of licensee responses to generic communications are documented in sufficient detail for stakeholders to understand the basis for the closeout.
- 6. Ensure that documents related to the closeout of the generic communication (e.g., addressee responses, NRC staff evaluations, inspection reports) are made publicly available, consistent with agency policies on the release of information to the public (see Sensitive Unclassified Non-Safeguards Information (SUNSI) Handling Requirements, available at http://www.internal.nrc.gov/sunsi/index.html). In situations where an NRC staff document contains nonpublic (e.g., SUNSI, Safeguards Information, or classified) information, consider developing a redacted version or separate document that can be made publicly available.
For the latest version of any NRC directive or handbook, see the online MD Catalog. 20
DH 8.18 NRC GENERIC COMMUNICATIONS PROGRAM Date Approved: 12/9/2015 J. Effectiveness Review of Generic Communications
- 1. BLs and GLs The lead technical organization will conduct an effectiveness review of the BL or the GL upon closeout. This review will (a) Evaluate the generic communications focus in communicating the safety or security concern, the adequacy of the request for information and/or actions, the adequacy of addressee response to the generic communication, and whether the generic communication was sufficient to provide a basis for regulatory decisionmaking.
(b) Provide the effectiveness evaluation to the respective deputy office director and NRR. Enter the final effectiveness evaluation into ADAMS.
For the latest version of any NRC directive or handbook, see the online MD Catalog. 21