Regulatory Guide 1.187: Difference between revisions

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{{Adams
{{Adams
| number = ML19204A176
| number = ML003759710
| issue date = 07/23/2019
| issue date = 11/30/2000
| title = Public Meeting Summary, June 25, 2019
| title = Guidance for Implementation of 10 CFR 50.59, Changes, Tests, and Experiments
| author name = Govan T
| author name =  
| author affiliation = NRC/NRR/DIRS/IRGB
| author affiliation = NRC/RES
| addressee name = Mckenna P
| addressee name =  
| addressee affiliation = NRC/NRR/DIRS/IRGB
| addressee affiliation =  
| docket =  
| docket =  
| license number =  
| license number =  
| contact person = Govan T, 415-6197, NRR/DIRS
| contact person = McKenna E
| case reference number = NEI 96-07, RG-1.187, Rev 2
| case reference number = DG-1095
| document type = Meeting Summary, Memoranda
| document report number = RG-1.187
| page count = 6
| document type = Regulatory Guide
| page count = 7
}}
}}
{{#Wiki_filter:UNITED STATES
{{#Wiki_filter:U.S. NUCLEAR REGULATORY COMMISSION                                                             November 2000
                            NUCLEAR REGULATORY COMMISSION
                                    REGULATORY
                                      WASHINGTON, D.C. 20555-0001 July 23, 2019 MEMORANDUM TO:            Philip J. McKenna, Chief ROP Support and Generic Communication Branch Division of Inspection and Regional Support Office of Nuclear Reactor Regulation FROM:                    Tekia V. Govan, Project Manager /RA/
                                    GUIDE
                          ROP Support and Generic Communication Branch Division of Inspection and Regional Support Office of Nuclear Reactor Regulation SUBJECT:                  SUMMARY OF THE PUBLIC MEETING ON THE DRAFT
                                      OFFICE OF NUCLEAR REGULATORY RESEARCH
                          REGULATORY GUIDE 1.187, REVISION 2, THAT ENDORSES
                                                  REGULATORY GUIDE 1.187 (Draft was issued as DG-1095)
                          NUCLEAR ENERGY INSTITUTE 96-07, APPENDIX D, HELD ON
                    GUIDANCE FO
                          JUNE 25, 2019 On June 25, 2019, the U.S. Nuclear Regulatory Commission (NRC) staff held a Category 2 public meeting with the Nuclear Energy Institute (NEI) to discuss the usability of NEI
96-07, Appendix D, Supplemental Guidance for Application of 10 CFR 50.59 to Digital Modifications (Agencywide Documents Access and Management System (ADAMS) Accession No. ML18338A389), as endorsed by draft Regulatory Guide (RG) 1.187, Revision 2, Guidance for Implementation of 10 CFR 50.59, Changes, Tests, and Experiments (ADAMS Accession No. ML19045A435).
Background The NRC staff issued for public comment draft RG 1.187, Revision 2, that will provide guidance on complying with the requirements of Title 10 of the Code of Federal Regulations (10 CFR)
Section 50.59 when performing a digital instrumentation and controls (digital I&C) modification.


Specifically, NEI 96-07, Appendix D, Revision 0, was submitted to the NRC on November 30, 2018. As discussed in Section C of RG 1.187, the staff endorses NEI 96-07 and finds that it provides an acceptable approach for the application of 10 CFR 50.59 guidance when conducting digital I&C modifications, with certain exceptions and clarifications. Draft RG 1.187, Revision 2, was issued for public comment to facilitate the Commissions direction in the Staff Requirements Memorandum (SRM)  SECY-16-0070, Staff Requirements  SECY-16-0070  Integrated Strategy to Modernize the Nuclear Regulatory Commissions Digital Instrumentation and Control Regulatory Infrastructure (ADAMS
==R. IMPLEMENTATION==
Accession No. ML16299A157). The NRC staff has engaged the public, NEI, and industry representatives to improve the guidance for applying 10 CFR 50.59 to digital I&C-related CONTACT: Tekia V. Govan, NRR/DIRS
OF 10 CFR 50.59, CHANGES, TESTS, AND EXPERIMENTS
              (301) 415-6197


P. McKenna                                          2 design modifications as part of a broader effort to modernize the regulatory infrastructure for digital I&C. This meeting, on June 25, 2019, serves as an additional opportunity to engage the public and the nuclear industry prior to the close of the public comment period on the draft RG
==A. INTRODUCTION==
1.187, Revision 2, on July 15, 2019.
In 10 CFR Part 50, Domestic Licensing of Production and Utilization Facilities, Section
  50.59, Changes, Tests and Experiments, contains requirements for the process by which licensees may make changes to their facilities and procedures as described in the safety analysis report, without prior NRC approval, under certain conditions. The rule was promulgated in 1962 and revised in 1968.


Meeting Summary The NRC and industry management made brief opening remarks, and introductions were made by all in attendance. The NRC staff stated the objective of the meeting which was to conduct table-top exercises of digital I&C upgrades in which applying NEI 96-07, Appendix D, Criterion 6 guidance was met. During this meeting, NEI presented four examples and NRC presented three examples (ADAMS Accession Nos. ML19176A070 and ML19170A329), respectively related to NEI 96-07, Appendix D, Criterion 6 guidance. All the examples were presented with a starting point where it could not be demonstrated that a common cause failure across multiple trains was sufficiently low through a qualitative assessment as described in regulatory issue summary 2002-22, Supplement 1. The examples were only discussed against 10 CFR 50.59, Criterion 6, which is applicable to modifications that create a possibility for a malfunction of an
As a result of lessons learned from operating experience and other initiatives related to control of conformance of facilities with their final safety analysis report (FSAR) descriptions, the NRC
[structure, system, and component (SSC)] important to safety with a different result than any previously evaluated in the final safety analysis report (as updated). The NRC staff has taken an exception in draft RG 1.187, Revision 2, against the documentation of NEI 96-07, Appendix D, Criterion 6, Section 4.3.6.
  determined that additional action was necessary to provide clarity and consistency in implementation of the rule. The staff recommended specific actions in SECY-97-205, Integration and Evaluation of Results from Recent Lessons-Learned Reviews,1 dated September 10, 1997. In a staff requirements memorandum dated March 24, 1998,1 the Commission directed the staff to initiate rulemaking to revise the requirements of 10 CFR 50.59 to clarify the requirements and to allow changes involving only minimal increases in probability or consequences to be made without prior NRC approval.


During the table-top exercises the NRC staff and NEI generally came to the same conclusion as to whether the digital I&C modification in the exercise could be performed under 10 CFR 50.59 or if a license amendment request (LAR) would be required.
The proposed rule was published for comment in October 1998. Following consideration of public comments, on October 4, 1999 (64 FR 53582), the NRC issued a final revision to
  10 CFR 50.59 that becomes effective 90 days after approval of regulatory guidance, which is
      1 Copies are available for inspection or copying for a fee from the NRC Public Document Room at 11555 Rockville MD; the PDRs mailing address is Mail Stop PDR, Washington, DC 20555; telephone (301) 415-4737 or (800)397-4209; fax (301)415-
      3548; email <PDR@NRC.GOV>.
Regulatory guides are issued to describe and make available to the public such information as methods acceptable to the NRC staff for implementing specific parts of the NRCs regulations, techniques used by the staff in evaluating specific problems or postulated accidents, and data needed by the NRC staff in its review of applications for permits and licenses. Regulatory guides are not substitutes for regulations, and compliance with them is not required. Methods and solutions different from those set out in the guides will be acceptable if they provide a basis for the findings requisite to the issuance or continuance of a permit or license by the Commission.


The major take ways from the meeting were:
This guide was issued after consideration of comments received from the public. Comments and suggestions for improvements in these guides are encouraged at all times, and guides will be revised, as appropriate, to accommodate comments and to reflect new information or experience. Written comments may be submitted to the Rules and Directives Branch, ADM, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.
          *  NEI clarified that the safety analysis in NEI 96-07, Appendix D is not exclusive to updated final safety analysis report (UFSAR), Chapter 15, Accident Analysis. NEI
            stated that the term safety analysis applies to any portion of the UFSAR where a safety analysis is performed.


*  Some of the digital modification examples provided by NEI demonstrated that a different interpretation of the current wording in the draft RG 1.187, Revision 2, could result in a licensee submitting a LAR when it is not required.
Regulatory guides are issued in ten broad divisions: 1, Power Reactors; 2, Research and Test Reactors; 3, Fuels and Materials Facilities; 4, Environmental and Siting;
5, Materials and Plant Protection; 6, Products; 7, Transportation; 8, Occupational Health; 9, Antitrust and Financial Review; and 10, General.


*  NEI and NRC staff agreed that working through the examples using NEI 96-07, Appendix D guidance should produce the same result as using the current guidance in NEI 96-07 base document.
Single copies of regulatory guides (which may be reproduced) may be obtained free of charge by writing the Distribution Services Section, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by fax to (301)415-2289, or by email to DISTRIBUTION@NRC.GOV. Electronic copies of this guide are available on the internet at NRCs home page at <WWW.NRC.GOV> in the Reference Library under Regulatory Guides. This guide is also in the Electronic Reading Room at NRCs home page, along with other recently issued guides, Accession Number ML003759710.


*  NEI and NRC staff agreed with the definition of Malfunction of an SSC Important to Safety in NEI 96-07. There was discussion on what a different result meant in the regulation under 10 CFR 50.59, Criterion 6. Specifically, it was discussed where a modification should be evaluated by the malfunction different result or the safety analysis different result. The NEI 96-07 base document discusses malfunction different result, but NEI 96-07, Appendix D now discusses the safety analysis different result. There was action taken by NEI to evaluate the difference in terminology between the NEI 96-07 base document and NEI 96-07, Appendix D.
contained in this Regulatory Guide 1.187. The text of the revised rule is contained in Appendix A
to this regulatory guide for convenience.


*  NEI agreed that they needed to revise the wording in NEI 96-07, Appendix D,
The information collections contained in this regulatory guide are covered by the requirements of 10 CFR Part 50, which were approved by the Office of Management and Budget, approval number 3150-0011. If a means used to impose an information collection does not display a currently valid OMB control number, the NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.
            Section 4.3.6, steps 1 through 4 and to clarify the step 6 wording as it relates to safety analysis have become invalid due to their basic assumptions no longer being


P. McKenna                                      3 valid. Based on the current reading of Section 4.3.6, step 6, the NRC staff concluded that modifications could result in the need for a LAR.
==B. DISCUSSION==
OBJECTIVE
          The objectives of 10 CFR 50.59 are to ensure that licensees (1) evaluate proposed changes to their facilities for their effects on the licensing basis of the plant, as described in the FSAR, and
(2) obtain prior NRC approval for changes that meet specified criteria as having a potential impact upon the basis for issuance of the operating license. This regulatory guide, through its endorsement of a guideline document for licensees, provides guidance on complying with the revised requirements of 10 CFR 50.59.


The NRC staff did not make any decisions or took any agency positions during this meeting.
DEVELOPMENT OF INDUSTRY GUIDELINE, NEI 96-07 Following publication of the revised rule, the Nuclear Energy Institute (NEI) submitted a guidance document for the implementation of 10 CFR 50.59 and requested NRC endorsement through a regulatory guide. Following a series of meetings between NEI and the NRC, a revised version of the guidance document was submitted by NEI on February 22, 200


The enclosure provides the attendance list for this meeting.
===0. The NRC===
published for public comment a Draft Regulatory Guide, DG-1095, which endorsed, with certain clarifications, Revision 1 of NEI 96-07. As part of their comments in response to the draft guide, NEI proposed revisions to NEI 96-07 to respond to the issues raised by the NRC staff in its draft guide. Subsequently, NEI submitted a revised version of NEI 96-07, dated November 2000, for endorsement.


Conclusion The meeting concluded with NEI stating that they will be able to meet the deadline for public comment period on draft RG 1.187, Revision 2, that closed on July 15, 2019. NEI stated that they will have recommended changes to NEI 96-07, Appendix D that will be included as a part their comment response including additional examples that clarify the discussion held during this meeting. The NRC staff stated that with the additional guidance and examples that are expected to be submitted as a part of NEIs public comment, there will be a need for another public comment period and potentially another public meeting to discuss these latest revisions to the NEI guidance.
==C. REGULATORY POSITION==
1.       NEI 96-07 Revision 1 of NEI 96-07, Guidelines for 10 CFR 50.59 Evaluations,2 dated November
2000, provides methods that are acceptable to the NRC staff for complying with the provisions of
10 CFR 50.59.


Enclosure:
2 Copies of NEI 96-07 are available through NRCs web site, <WWW.NRC.GOV> through NRCs Electronic Reading Room, under Accession Number ML003771157. Copies are available for inspection or copying for a fee from the NRC Public Document Room at 11555 Rockville Pike, Rockville, MD; the PDRs mailing address is Washington, DC 20555; telephone
  As stated
(301)415-4737 or (800)397-4209; fax (301 415-3548; email <PDR@NRC.GOV>.
                                                          1.187-2


ML19204A176                      concurred via e-mail*
2.      OTHER DOCUMENTS REFERENCED IN NEI 96-07 Revision 1 of NEI 96-07 references other documents, but NRCs endorsement of Revision
OFFICE NRR/DIRS/IRGB* NRR/DIRS/IRGB* NRR/DIRS/IRGB* NRR/DIRS/IRGB*
1 should not be considered an endorsement of the referenced documents.
NAME      TGovan          IBetts          PMcKenna      TGovan DATE      07/23/2019      07/23/2019      07/23/2019    07/23/2019


LIST OF ATTENDEES
3.      USE OF EXAMPLES IN NEI 96-07 Revision 1 of NEI 96-07 includes examples to supplement the guidance. While appropriate for illustrating and reinforcing the guidance in Revision 1 of NEI 96-07, the NRCs endorsement of Revision 1 should not be considered a determination that the examples are applicable for all licensees. A licensee should ensure that an example is applicable to its particular circumstances before implementing the guidance as described in an example.
    SUMMARY OF THE PUBLIC MEETING ON THE DRAFT REGULATORY GUIDE 1.187, REVISION 2 THAT ENDORSES NUCLEAR ENERGY INSTITUTE 96-07, APPENDIX D, HELD
                              ON JUNE 25, 2019 June 25, 2019, 1:00 PM to 4:30 PM
                          NRC One White Flint North
                            11555 Rockville Pike O-11B04 Rockville, MD
ATTENDEE                                        ORGANIZATION
1. Rossnyev Alvarado                            NRC
2. Pete LeBlond                                  LeBlond and Associates
3. Kate Austgen                                  NEI
4. Phil Couture                                  Entergy
5. Thomas Thornton                              Entergy
6. Steve Burd                                    Entergy
7. Ron Jarrett                                  TVA
8. Raymond Herb                                  Southern Nuclear
9. Steven Arndt                                  NRC
10. Tim Reed                                    NRC
11. Maxine Segarnick                            NRC
12. Kayla Gamin                                  NRC
13. Paul Kallan                                  NRC
14. Jana Bergman                                Curtiss-Wright
15. Steve Geier                                  NEI
16. Steve Vaughn                                NEI
17. Shakur Walker                                NRC
18. Bob Weisman                                  NRC
19. Phil McKenna                                NRC
20. Tara Inverso                                NRC
21. Greg Bowman                                  NRC
22. Mirela Gavrilas                              NRC
23. Deanna Zhang                                NRC
24. Neil Archambo                                Duke Energy
25. Norbert Carte                                NRC
26. Eric Benner                                  NRC
27. Michael Waters                              NRC
28. Dave Beaulieu                                NRC
29. Wendell Morton                              NRC
30. Tekia Govan                                  NRC
                                                                        Enclosure


P. McKenna                      -2- Participated via conference line
4.     GUIDANCE FOR FSAR SUPPLEMENTS FOR LICENSE RENEWAL
31. Matthew Shakur                  Westinghouse
        The guidance in Revision 1 of NEI 96-07 and in this regulatory guide is applicable to information added to the FSAR in accordance with 10 CFR 54.21(d), that is, for summary descriptions of the programs and activities for managing the effects of aging and the evaluation of time-limited aging analyses.
32. Joe Holonich                    NRC
 
33. Donald Chase                    Curtiss Wright
5.      APPLICABILITY TO NON-POWER REACTORS
34. Ken Lowery                      Southern Nuclear
        While most of the examples and specific discussion focus on power reactors, the guidance contained in Revision 1 of NEI 96-07 is also applicable to evaluations performed by licensees for non-power reactors. Certain of the provisions in the guidance that discuss the relationship of other regulatory requirements to 10 CFR 50.59 may not be fully applicable to non-power reactors because of differences in those other requirements. For example, non-power reactors are not subject to 10 CFR 50.65, and thus, the guidance concerning use of risk assessments for temporary alterations associated with maintenance in lieu of 10 CFR 50.59 reviews would not be applicable.
35. Gordon Clefton                  Idaho National Lab
 
36. Bob Neuendorf                    DC Cook NPP
6.      APPLICABILITY TO 10 CFR 72.48 EVALUATIONS
37. Megan Nydegger                  NIST
        The guidance contained in Revision 1 of NEI 96-07 is also generally applicable to evaluations performed by licensees of independent spent fuel storage facilities (ISFSIs) or spent fuel storage cask design certificate holders for implementation of the revised 10 CFR 72.48. The NRC plans to issue guidance that would endorse (with comment if needed) a companion industry guidance document that has adjustments to the examples and other specific aspects as they pertain to 10 CFR 72.48.
38. David Madsen                    Pacific Gas and Electric
 
39. Larry Nicholson                 Certrec
7.      APPLICABILITY OF PAST NRC COMMUNICATIONS
40. Rob Burg                        EPM
        The NRC has issued a number of communications such as Generic Letters or Bulletins that discussed or referred to 10 CFR 50.59. In considering whether the information in those documents remains applicable, it should be noted that those documents were based on the rule requirements that existed at the time of issuance. To the extent that the discussion therein relates to specific aspects of the rule, such as evaluation criteria that have been revised, these past documents may no
41. Charles Brown                    NRC
                                                1.187-3
42. Randy Strader                    NIST
 
43. Michael Sortwell                DC Cook NPP}}
longer be fully consistent and the new rule requirements would prevail. The status is unchanged of other parts of these documents that are not affected by the revisions to the rule.
 
===8. USE OF OTHER METHODS===
        To meet the requirements of 10 CFR 50.59, licensees may use methods other than those set forth in Revision 1 of NEI 96-07. The NRC will determine the acceptability of other methods on a case-by-case basis.
 
==D. IMPLEMENTATION==
The purpose of this section is to provide information to licensees and applicants regarding the NRC staffs plans for using this regulatory guide.
 
Except in those cases in which a licensee proposes an acceptable alternative method for complying with the specified portions of the NRCs regulations, the methods described in this guide will be used in the evaluation of licensee compliance with the requirements of
10 CFR 50.59.
 
1.187-4
 
APPENDIX A
                                    TEXT OF 10 CFR 50.59
&sect; 50.59 Changes, Tests, and Experiments.
 
(a) Definitions for the purposes of this section:
        (1) Change means a modification or addition to, or removal from, the facility or procedures that affects a design function, method of performing or controlling the function, or an evaluation that demonstrates that intended functions will be accomplished.
 
(2) Departure from a method of evaluation described in the FSAR (as updated) used in establishing the design bases or in the safety analyses means (i) changing any of the elements of the method described in the FSAR (as updated) unless the results of the analysis are conservative or essentially the same; or (ii) changing from a method described in the FSAR to another method unless that method has been approved by NRC for the intended application.
 
(3) Facility as described in the final safety analysis report (as updated) means:
                (i) The structures, systems, and components (SSC) that are described in the final safety analysis report (FSAR) (as updated),
                (ii) The design and performance requirements for such SSCs described in the FSAR
                (as updated), and (iii) The evaluations or methods of evaluation included in the FSAR (as updated)
                for such SSCs which demonstrate that their intended function(s) will be accomplished.
 
(4) Final Safety Analysis Report (as updated) means the Final Safety Analysis Report (or Final Hazards Summary Report) submitted in accordance with &sect; 50.34, as amended and supplemented, and as updated per the requirements of &sect; 50.71(e) or &sect; 50.71(f), as applicable.
 
(5) Procedures as described in the final safety analysis report (as updated) means those procedures that contain information described in the FSAR (as updated) such as how structures, systems, and components are operated and controlled (including assumed operator actions and response times).
        (6) Tests or experiments not described in the final safety analysis report (as updated)
means any activity where any structure, system, or component is utilized or controlled in a manner which is either:
                (i) Outside the reference bounds of the design bases as described in the final safety analysis report (as updated) or (ii) Inconsistent with the analyses or descriptions in the final safety analysis report (as updated).
(b) Applicability. This section applies to each holder of a license authorizing operation of a production or utilization facility, including the holder of a license authorizing operation of a nuclear power reactor that has submitted the certification of permanent cessation of operations required under &sect; 50.82(a)(1) or a reactor licensee whose license has been amended to allow possession but not operation of the facility.
 
(c)(1) A licensee may make changes in the facility as described in the final safety analysis report (as updated), make changes in the procedures as described in the final safety analysis report (as
                                                1.187-A-1
 
updated), and conduct tests or experiments not described in the final safety analysis report (as updated) without obtaining a license amendment pursuant to &sect; 50.90 only if:
                (i) A change to the technical specifications incorporated in the license is not required, and (ii) The change, test, or experiment does not meet any of the criteria in paragraph (c)(2) of this section.
 
(2) A licensee shall obtain a license amendment pursuant to &sect; 50.90 prior to implementing a proposed change, test, or experiment if the change, test, or experiment would:
                (i) Result in more than a minimal increase in the frequency of occurrence of an accident previously evaluated in the final safety analysis report (as updated);
                (ii) Result in more than a minimal increase in the likelihood of occurrence of a malfunction of a structure, system, or component (SSC) important to safety previously evaluated in the final safety analysis report (as updated);
                (iii) Result in more than a minimal increase in the consequences of an accident previously evaluated in the final safety analysis report (as updated);
                (iv) Result in more than a minimal increase in the consequences of a malfunction of an SSC important to safety previously evaluated in the final safety analysis report (as updated);
                (v) Create a possibility for an accident of a different type than any previously evaluated in the final safety analysis report (as updated);
                  (vi) Create a possibility for a malfunction of an SSC important to safety with a different result than any previously evaluated in the final safety analysis report (as updated);
                 (vii)Result in a design basis limit for a fission product barrier as described in the FSAR (as updated) being exceeded or altered; or (viii) Result in a departure from a method of evaluation described in the FSAR (as updated) used in establishing the design bases or in the safety analyses
        (3) In implementing this paragraph, the FSAR (as updated) is considered to include FSAR
changes resulting from evaluations performed pursuant to this section and analyses performed pursuant to &sect; 50.90 since submittal of the last update of the final safety analysis report pursuant to
&sect; 50.71 of this part.
 
(4) The provisions in this section do not apply to changes to the facility or procedures when the applicable regulations establish more specific criteria for accomplishing such changes.
 
(d)(1)The licensee shall maintain records of changes in the facility, of changes in procedures, and of tests and experiments made pursuant to paragraph (c) of this section. These records must include a written evaluation which provides the bases for the determination that the change, test or experiment does not require a license amendment pursuant to paragraph (c)(2) of this section.
 
(2) The licensee shall submit, as specified in &sect; 50.4, a report containing a brief description of any changes, tests, and experiments, including a summary of the evaluation of each. A report must be submitted at intervals not to exceed 24 months.
 
(3) The records of changes in the facility must be maintained until the termination of a license issued pursuant to this part or the termination of a license issued pursuant to 10 CFR Part
54, whichever is later. Records of changes in procedures and records of tests and experiments must be maintained for a period of 5 years.
 
1.187-A-2
 
VALUE/IMPACT STATEMENT
      A separate Value/Impact Statement was not prepared for this regulatory guide. The Value/Impact Statement that was prepared as part of the Regulatory Analysis for the rulemaking in May 1999 is still applicable. Copies of the Regulatory Analysis are available for inspection or copying for a fee in the NRCs Public Document Room at 11555 Rockville Pike, Rockville, MD,
Washington, DC, as part of SECY-99-130, dated May 12, 1999. The PDR may be reached by telephone at (301)415-4737 or fax at (301)415-3548.
 
ADAMS Accession Number of Regulatory Guide 1.187:
ML003759710
ADAMS Accession Number of Revision 1 of NEI 96-07:
ML003771157}}


{{RG-Nav}}
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Revision as of 05:11, 24 November 2019

Guidance for Implementation of 10 CFR 50.59, Changes, Tests, and Experiments
ML003759710
Person / Time
Issue date: 11/30/2000
From:
Office of Nuclear Regulatory Research
To:
McKenna E
References
DG-1095 RG-1.187
Download: ML003759710 (7)


U.S. NUCLEAR REGULATORY COMMISSION November 2000

REGULATORY

GUIDE

OFFICE OF NUCLEAR REGULATORY RESEARCH

REGULATORY GUIDE 1.187 (Draft was issued as DG-1095)

GUIDANCE FO

R. IMPLEMENTATION

OF 10 CFR 50.59, CHANGES, TESTS, AND EXPERIMENTS

A. INTRODUCTION

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

50.59, Changes, Tests and Experiments, contains requirements for the process by which licensees may make changes to their facilities and procedures as described in the safety analysis report, without prior NRC approval, under certain conditions. The rule was promulgated in 1962 and revised in 1968.

As a result of lessons learned from operating experience and other initiatives related to control of conformance of facilities with their final safety analysis report (FSAR) descriptions, the NRC

determined that additional action was necessary to provide clarity and consistency in implementation of the rule. The staff recommended specific actions in SECY-97-205, Integration and Evaluation of Results from Recent Lessons-Learned Reviews,1 dated September 10, 1997. In a staff requirements memorandum dated March 24, 1998,1 the Commission directed the staff to initiate rulemaking to revise the requirements of 10 CFR 50.59 to clarify the requirements and to allow changes involving only minimal increases in probability or consequences to be made without prior NRC approval.

The proposed rule was published for comment in October 1998. Following consideration of public comments, on October 4, 1999 (64 FR 53582), the NRC issued a final revision to

10 CFR 50.59 that becomes effective 90 days after approval of regulatory guidance, which is

1 Copies are available for inspection or copying for a fee from the NRC Public Document Room at 11555 Rockville MD; the PDRs mailing address is Mail Stop PDR, Washington, DC 20555; telephone (301) 415-4737 or (800)397-4209; fax (301)415-

3548; email <PDR@NRC.GOV>.

Regulatory guides are issued to describe and make available to the public such information as methods acceptable to the NRC staff for implementing specific parts of the NRCs regulations, techniques used by the staff in evaluating specific problems or postulated accidents, and data needed by the NRC staff in its review of applications for permits and licenses. Regulatory guides are not substitutes for regulations, and compliance with them is not required. Methods and solutions different from those set out in the guides will be acceptable if they provide a basis for the findings requisite to the issuance or continuance of a permit or license by the Commission.

This guide was issued after consideration of comments received from the public. Comments and suggestions for improvements in these guides are encouraged at all times, and guides will be revised, as appropriate, to accommodate comments and to reflect new information or experience. Written comments may be submitted to the Rules and Directives Branch, ADM, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

Regulatory guides are issued in ten broad divisions: 1, Power Reactors; 2, Research and Test Reactors; 3, Fuels and Materials Facilities; 4, Environmental and Siting;

5, Materials and Plant Protection; 6, Products; 7, Transportation; 8, Occupational Health; 9, Antitrust and Financial Review; and 10, General.

Single copies of regulatory guides (which may be reproduced) may be obtained free of charge by writing the Distribution Services Section, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by fax to (301)415-2289, or by email to DISTRIBUTION@NRC.GOV. Electronic copies of this guide are available on the internet at NRCs home page at <WWW.NRC.GOV> in the Reference Library under Regulatory Guides. This guide is also in the Electronic Reading Room at NRCs home page, along with other recently issued guides, Accession Number ML003759710.

contained in this Regulatory Guide 1.187. The text of the revised rule is contained in Appendix A

to this regulatory guide for convenience.

The information collections contained in this regulatory guide are covered by the requirements of 10 CFR Part 50, which were approved by the Office of Management and Budget, approval number 3150-0011. If a means used to impose an information collection does not display a currently valid OMB control number, the NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.

B. DISCUSSION

OBJECTIVE

The objectives of 10 CFR 50.59 are to ensure that licensees (1) evaluate proposed changes to their facilities for their effects on the licensing basis of the plant, as described in the FSAR, and

(2) obtain prior NRC approval for changes that meet specified criteria as having a potential impact upon the basis for issuance of the operating license. This regulatory guide, through its endorsement of a guideline document for licensees, provides guidance on complying with the revised requirements of 10 CFR 50.59.

DEVELOPMENT OF INDUSTRY GUIDELINE, NEI 96-07 Following publication of the revised rule, the Nuclear Energy Institute (NEI) submitted a guidance document for the implementation of 10 CFR 50.59 and requested NRC endorsement through a regulatory guide. Following a series of meetings between NEI and the NRC, a revised version of the guidance document was submitted by NEI on February 22, 200

0. The NRC

published for public comment a Draft Regulatory Guide, DG-1095, which endorsed, with certain clarifications, Revision 1 of NEI 96-07. As part of their comments in response to the draft guide, NEI proposed revisions to NEI 96-07 to respond to the issues raised by the NRC staff in its draft guide. Subsequently, NEI submitted a revised version of NEI 96-07, dated November 2000, for endorsement.

C. REGULATORY POSITION

1. NEI 96-07 Revision 1 of NEI 96-07, Guidelines for 10 CFR 50.59 Evaluations,2 dated November

2000, provides methods that are acceptable to the NRC staff for complying with the provisions of

10 CFR 50.59.

2 Copies of NEI 96-07 are available through NRCs web site, <WWW.NRC.GOV> through NRCs Electronic Reading Room, under Accession Number ML003771157. Copies are available for inspection or copying for a fee from the NRC Public Document Room at 11555 Rockville Pike, Rockville, MD; the PDRs mailing address is Washington, DC 20555; telephone

(301)415-4737 or (800)397-4209; fax (301 415-3548; email <PDR@NRC.GOV>.

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2. OTHER DOCUMENTS REFERENCED IN NEI 96-07 Revision 1 of NEI 96-07 references other documents, but NRCs endorsement of Revision

1 should not be considered an endorsement of the referenced documents.

3. USE OF EXAMPLES IN NEI 96-07 Revision 1 of NEI 96-07 includes examples to supplement the guidance. While appropriate for illustrating and reinforcing the guidance in Revision 1 of NEI 96-07, the NRCs endorsement of Revision 1 should not be considered a determination that the examples are applicable for all licensees. A licensee should ensure that an example is applicable to its particular circumstances before implementing the guidance as described in an example.

4. GUIDANCE FOR FSAR SUPPLEMENTS FOR LICENSE RENEWAL

The guidance in Revision 1 of NEI 96-07 and in this regulatory guide is applicable to information added to the FSAR in accordance with 10 CFR 54.21(d), that is, for summary descriptions of the programs and activities for managing the effects of aging and the evaluation of time-limited aging analyses.

5. APPLICABILITY TO NON-POWER REACTORS

While most of the examples and specific discussion focus on power reactors, the guidance contained in Revision 1 of NEI 96-07 is also applicable to evaluations performed by licensees for non-power reactors. Certain of the provisions in the guidance that discuss the relationship of other regulatory requirements to 10 CFR 50.59 may not be fully applicable to non-power reactors because of differences in those other requirements. For example, non-power reactors are not subject to 10 CFR 50.65, and thus, the guidance concerning use of risk assessments for temporary alterations associated with maintenance in lieu of 10 CFR 50.59 reviews would not be applicable.

6. APPLICABILITY TO 10 CFR 72.48 EVALUATIONS

The guidance contained in Revision 1 of NEI 96-07 is also generally applicable to evaluations performed by licensees of independent spent fuel storage facilities (ISFSIs) or spent fuel storage cask design certificate holders for implementation of the revised 10 CFR 72.48. The NRC plans to issue guidance that would endorse (with comment if needed) a companion industry guidance document that has adjustments to the examples and other specific aspects as they pertain to 10 CFR 72.48.

7. APPLICABILITY OF PAST NRC COMMUNICATIONS

The NRC has issued a number of communications such as Generic Letters or Bulletins that discussed or referred to 10 CFR 50.59. In considering whether the information in those documents remains applicable, it should be noted that those documents were based on the rule requirements that existed at the time of issuance. To the extent that the discussion therein relates to specific aspects of the rule, such as evaluation criteria that have been revised, these past documents may no

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longer be fully consistent and the new rule requirements would prevail. The status is unchanged of other parts of these documents that are not affected by the revisions to the rule.

8. USE OF OTHER METHODS

To meet the requirements of 10 CFR 50.59, licensees may use methods other than those set forth in Revision 1 of NEI 96-07. The NRC will determine the acceptability of other methods on a case-by-case basis.

D. IMPLEMENTATION

The purpose of this section is to provide information to licensees and applicants regarding the NRC staffs plans for using this regulatory guide.

Except in those cases in which a licensee proposes an acceptable alternative method for complying with the specified portions of the NRCs regulations, the methods described in this guide will be used in the evaluation of licensee compliance with the requirements of

10 CFR 50.59.

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APPENDIX A

TEXT OF 10 CFR 50.59

§ 50.59 Changes, Tests, and Experiments.

(a) Definitions for the purposes of this section:

(1) Change means a modification or addition to, or removal from, the facility or procedures that affects a design function, method of performing or controlling the function, or an evaluation that demonstrates that intended functions will be accomplished.

(2) Departure from a method of evaluation described in the FSAR (as updated) used in establishing the design bases or in the safety analyses means (i) changing any of the elements of the method described in the FSAR (as updated) unless the results of the analysis are conservative or essentially the same; or (ii) changing from a method described in the FSAR to another method unless that method has been approved by NRC for the intended application.

(3) Facility as described in the final safety analysis report (as updated) means:

(i) The structures, systems, and components (SSC) that are described in the final safety analysis report (FSAR) (as updated),

(ii) The design and performance requirements for such SSCs described in the FSAR

(as updated), and (iii) The evaluations or methods of evaluation included in the FSAR (as updated)

for such SSCs which demonstrate that their intended function(s) will be accomplished.

(4) Final Safety Analysis Report (as updated) means the Final Safety Analysis Report (or Final Hazards Summary Report) submitted in accordance with § 50.34, as amended and supplemented, and as updated per the requirements of § 50.71(e) or § 50.71(f), as applicable.

(5) Procedures as described in the final safety analysis report (as updated) means those procedures that contain information described in the FSAR (as updated) such as how structures, systems, and components are operated and controlled (including assumed operator actions and response times).

(6) Tests or experiments not described in the final safety analysis report (as updated)

means any activity where any structure, system, or component is utilized or controlled in a manner which is either:

(i) Outside the reference bounds of the design bases as described in the final safety analysis report (as updated) or (ii) Inconsistent with the analyses or descriptions in the final safety analysis report (as updated).

(b) Applicability. This section applies to each holder of a license authorizing operation of a production or utilization facility, including the holder of a license authorizing operation of a nuclear power reactor that has submitted the certification of permanent cessation of operations required under § 50.82(a)(1) or a reactor licensee whose license has been amended to allow possession but not operation of the facility.

(c)(1) A licensee may make changes in the facility as described in the final safety analysis report (as updated), make changes in the procedures as described in the final safety analysis report (as

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updated), and conduct tests or experiments not described in the final safety analysis report (as updated) without obtaining a license amendment pursuant to § 50.90 only if:

(i) A change to the technical specifications incorporated in the license is not required, and (ii) The change, test, or experiment does not meet any of the criteria in paragraph (c)(2) of this section.

(2) A licensee shall obtain a license amendment pursuant to § 50.90 prior to implementing a proposed change, test, or experiment if the change, test, or experiment would:

(i) Result in more than a minimal increase in the frequency of occurrence of an accident previously evaluated in the final safety analysis report (as updated);

(ii) Result in more than a minimal increase in the likelihood of occurrence of a malfunction of a structure, system, or component (SSC) important to safety previously evaluated in the final safety analysis report (as updated);

(iii) Result in more than a minimal increase in the consequences of an accident previously evaluated in the final safety analysis report (as updated);

(iv) Result in more than a minimal increase in the consequences of a malfunction of an SSC important to safety previously evaluated in the final safety analysis report (as updated);

(v) Create a possibility for an accident of a different type than any previously evaluated in the final safety analysis report (as updated);

(vi) Create a possibility for a malfunction of an SSC important to safety with a different result than any previously evaluated in the final safety analysis report (as updated);

(vii)Result in a design basis limit for a fission product barrier as described in the FSAR (as updated) being exceeded or altered; or (viii) Result in a departure from a method of evaluation described in the FSAR (as updated) used in establishing the design bases or in the safety analyses

(3) In implementing this paragraph, the FSAR (as updated) is considered to include FSAR

changes resulting from evaluations performed pursuant to this section and analyses performed pursuant to § 50.90 since submittal of the last update of the final safety analysis report pursuant to

§ 50.71 of this part.

(4) The provisions in this section do not apply to changes to the facility or procedures when the applicable regulations establish more specific criteria for accomplishing such changes.

(d)(1)The licensee shall maintain records of changes in the facility, of changes in procedures, and of tests and experiments made pursuant to paragraph (c) of this section. These records must include a written evaluation which provides the bases for the determination that the change, test or experiment does not require a license amendment pursuant to paragraph (c)(2) of this section.

(2) The licensee shall submit, as specified in § 50.4, a report containing a brief description of any changes, tests, and experiments, including a summary of the evaluation of each. A report must be submitted at intervals not to exceed 24 months.

(3) The records of changes in the facility must be maintained until the termination of a license issued pursuant to this part or the termination of a license issued pursuant to 10 CFR Part 54, whichever is later. Records of changes in procedures and records of tests and experiments must be maintained for a period of 5 years.

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VALUE/IMPACT STATEMENT

A separate Value/Impact Statement was not prepared for this regulatory guide. The Value/Impact Statement that was prepared as part of the Regulatory Analysis for the rulemaking in May 1999 is still applicable. Copies of the Regulatory Analysis are available for inspection or copying for a fee in the NRCs Public Document Room at 11555 Rockville Pike, Rockville, MD,

Washington, DC, as part of SECY-99-130, dated May 12, 1999. The PDR may be reached by telephone at (301)415-4737 or fax at (301)415-3548.

ADAMS Accession Number of Regulatory Guide 1.187:

ML003759710

ADAMS Accession Number of Revision 1 of NEI 96-07:

ML003771157