ML23151A566

PRM-050-062 - 60FR47716 - Petition of the Nuclear Energy Institute to Amend Regulations Re NRC Quality Assurance Programs at Nuclear Power Plants

ML23151A566
Person / Time
Issue date:	09/14/1995
From:	Hoyle J NRC/SECY
To:
References
PRM-050-062, 60FR47716
Download: ML23151A566 (1)

Text

ADAMS Template: SECY-067 DOCUMENT DATE: 09/14/1995 I

TITLE: PRM-050-062 - 60FR47716 - PETITION OF THE NUCLEAR ENERGY INSTITUTE TO AMEND REGULATIONS RE NRC QUAl,ITY ASSURANCE PROGRAMS AT NUCLEAR POWER PLANTS CASE

REFERENCE:

PRM-050-062 60FR47716 KEYWORD: RULEMAK.JNG COMMENTS Document Sensitiv.ity: Non-sensitive - SUNSI Review Complete

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PETITION OF Tiffi NUCLEAR ENERGY INSTITUIE TO AME 60FR47716 PRM-050-062 IMENTNO DOCDATE DKTDATE NAME REPRESENT DOCDESC1

/

06/08/1995 06/19/1995 LTR FM WilLIAM RASIN, N RUIBMAKING RE QUALITY NUCLEAR POWER PLANTS 09/07/1995 09/07/1995 10/06/1995 10/10/1995 ANONYMOUS CO SELF 2 10/15/1995 10/18/1995 MARVIN I. LEWIS SEIF 3 11/01/_1995 11/06/1995 FAWN SHIU.lNGL SELF 4 11/03/1995 11/09/1995 CHARI.ENE F. JO SELF 5 11/08/1995 11/13/1995 GEORGES. IBOM DUQUESNE LIGHT 11/11/1995 11/17/1995 LTR FM CHARI.ENE P. JOH 11/3/95 COMMBNI'S (NO. 4)

Thursday,December14,2000 Page 1 of3

~MENTNO DOCDATE DKTDATE NAME REPRESENT DOCDESC1 6 11/27/1995 11m11995 W.H. BOHLKE FLORIDA POWER &

7 11/20/1995 11/27/1995 ANONYMOUS CO SFLF 8 l l/'1:7/1995 11/28/1995 GARY 0. BENES COMMONWEAL1H

• 9 11/28/1995 11/29/1995 A.C. PASSWATER UNIONEIBCIRIC 11/28/1995 11/29/1995 1HOMAS E. TIPTO NUCIBAR ENERGY 11 11/28/1995 11/29/1995 JERROLD G. DEW ENTERGY OPERATI .

12 11/28/1995 11/30/1995 C. LANCE TERRY, TU ELECTRIC 13 11/28/1995 12"04/1995 LYNNE S. GOOD DEI'ROIT EDISON 14 11/28/1995 12/04/1995 R.E. ROGAN CAROLINA POWER 15 11/28/1995 12/04/1995 MARYP. SINCLAI DONTWASTEMIC Thursday, December 14, 2000 Page2 of3

IMENTNO DOCDATE DKTDATE NAME REPRESENT DOCDESC1 16 11/28/1995 12/04/1995 RICHARD F. PHA IUJNOIS POWER C 17 11/28/1995 12/07/1995 WILLlAM L SIB ARIZONA PUBLICS 11/30/2000 12/01/2000 LTR. TO R. BEEDLE, NEI F INDICATING TIIB wmIDRA CONCERNING A PETITION Thursday, December 14, 2000 Page3 of3

DOCKET NO. PRN-050-062

{60FR47716)

In the Matter of PETITION OF THE NUCLEAR ENERGY INSTITUTE TO AMEND NRC REGULATIONS RE QUALITY ASSURANCE PROGRAMS AT NUCLEAR POWER PLANTS DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT I '

06/19/95 06/08/95 LTR FM WILLIAM RASIN, NEI, SUBMITTING PETITION FOR RULEMAKING RE QUALITY ASSURANCE PROGRAMS AT NUCLEAR POWER PLANTS 09/07/95 09/07/95 FEDERAL REGISTER NOTICE - RECEIPT OF PETITION FOR RULEMAKING 10/10/95 10/06/95 COMMENT OF ANONYMOUS COMMENTER { 1) 10/18/95 10/15/95 COMMENT OF MARVIN I. LEWIS { 2) 11/06/95 11/01/95 COMMENT OF FAWN SHILLINGLAW { 3) 11/09/95 11/03/95 COMMENT OF CHARLENE F. JOHNSTON { 4) 11/13/95 11/08/95 COMMENT OF DUQUESNE LIGHT CO {GEORGES. THOMAS) { 5) 11/17 /95

• 11/11/95 LTR FM CHARLENE F. JOHNSTON SUPPLEMENTING HER 11/3/95 COMMENTS {NO. 4) 11/27/95 11/27 /95 COMMENT OF FLORIDA POWER & LIGHT CO {W.H. BOHLKE) { 6) 11/27/95 11/20/95 COMMENT OF ANONYMOUS COMMENTER ( 7) 11/28/95 11/27 /95 COMMENT OF COMMONWEALTH EDISON CO {GARY 6. BENES) { 8) 11/29/95 11/28/95 COMMENT OF UNION ELECTRIC {A.C. PASSWATER) { 9) 11/29/95 11/28/95 COMMENT OF NUCLEAR ENERGY INSTITUTE

{THOMAS E. TIPTON) { 10) 11/29/95 11/28/95 COMMENT OF ENTERGY OPERATIONS, INC

{JERROLD G. DEWEASE) { 11)

- 11/30/95 11/28/95 COMMENT OF TU ELECTRIC

{C. LANCE TERRY, GROUP VP, NUCLEAR) { 12) 12/04/95 11/28/95 COMMENT OF DETROIT EDISON {LYNNE S. GOODMAN) { 13)

DOCKET NO. PRM-050-062 (60FR47716)

DATE DATE OF TITLE OR DOCKETED DOCUMENT DESCRIPTION OF DOCUMENT 12/04/95 11/28/95 COMMENT OF CAROLINA POWER l LIGHT CO (R.E. ROGAN) ( 14) 12/04/95 11/28/95 COMMENT OF DON'T WASTE MICHIGAN (MARY P. SINCLAIR, CO-CHAIR) ( 15) 12/04/95 11/28/95 COMMENT OF ILLINOIS POWER CO (RICHARD F. PHARES) ( 16) 12/07/95 11/28/95 COMMENT OF ARIZONA PUBLIC SERVICE CO (WILLIAN L. STEWART, EXEC VP-NUCLEAR) ( 17)

UNITED STATES

. NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 November 30, 2000 u

Mr. Ralph Beedle Nuclear Energy Institute 1776 I Street, NW Washington, DC 20006-3708

Dear Mr. Beedle:

I am responding to the petition for rulemaking that the Nuclear Energy Institute (NEI) submitted to the Nuclear Regulatory Commission (NRC) by a letter from Mr. Phillip Bayne, dated June 8, 1995. The petition was docketed by the Commission on June 19, 1995, and assigned Docket No. PRM-50-62. The petition requested that the NRC amend 10 CFR 50.54(a) to change the criteria that nuclear power plant licensees are required to use to permit changes to their quality assurance (QA) programs without prior NRC approval. According to the proposal, changes involvir,g unreviewed safety questions would require NRC approval prior to implementation.

On September 14, 1995 (60 FR 47716), the NRC announced the receipt of your petition in a Federal Register Notice and provided an opportun ity for public comment. Seventeen comment letters were received plus one comment letter that supplemented one of the original letters. Of the 18 letters submitted, 11 were sent by nuclear power plant licensees and NEI, all supporting the proposed change in the regulations. The remainder of the public comments came from individual concerned citizens, all of whom expressed opposition to the relaxation of regulatory control of changes. The Commission has considered the merits of NEl's petition, and the public comments supporting and opposing it, and has previously accepted the petition in part, with regard to the need to broaden the scope of unilaterally permitted QA program changes.

The NRC published a direct final rule that amended 10 CFR 50.54(a) to allow licensees to make changes to selected aspects of their QA programs without prior NRC approval, as previously required. The direct final rule became effective on April 26, 1999. The NRC now permits a licensee to make the following changes unilaterally, provided that they continue to meet the requirements in Appendix B to 10 CFR Part 50 and 10 CFR 50.34(b)(6)(ii):

1. The use of a QA standard approved by the NRC that is more recent than the QA standard in a licensee's current QA program at the time of the change;

2. The use of a quality assurance alternative or ex{;eption approved by an NRC safety evaluation, provided that the bases of the NRC approval are applicable to a licensee's facility;

3. The use of generic organizational position titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific titles;

4. The use of generic organizational charts to indicate functional relationships, authorities, and responsibilities, or, alternately, the use of descriptive text;

5. The elimination of quality assurance program information that duplicates language in quality assurance regulatory guides and quality assurance standards to which a licensee is committed; and

6. Organizational revisions that ensure that persons and organizations performing QA functions continue to have the requisite authority and organizational freedom, including sufficient independence from cost and schedule considerations, when those concerns are in conflict with safety considerations.

The goal of this rulemaking effort was to provide relief to licensees by eliminating the need for discussions between the industry and the NRC staff on changes that previously would have constituted reductions in commitment that need prior staff approval, but which are of minor safety significance.

On June 7, 2000, the staff conducted a public workshop to solicit feedback on the implementation of the revision to 10 CFR 50.54(a) and to gather information to determine the need for and feasibility of developing a voluntary alternative rule based on the NEI petition.

Workshop participants acknowledged the significant burden reduction already achieved through the 1999 revision to 10 CFR 50.54(a). As a result of the discussions at the workshop, NEI concluded, and the NRC agreed, that a separate rulemaking on 10 CFR 50.54(a) is not needed. NE! noted that a separate rulemaking on 10 CFR 50.54(a) is not needed since QA special treatment requirements are being addressed under the NRC's Risk-Informing Part 50, Option 2 initiative. By letter dated August 15, 2000 (Accession No. ML003755305), NEI documented its belief that it is not necessary to pursue further changes to 10 CFR 50.54(a) related to its petition. By letter to NEI dated September 5, 2000, the staff confirmed NEl's intent to withdraw the remainder of the 1995 petition. Consequently, the Commission is completing action on your petition. For a more detailed discussion on the NRC's reasoning in this matter please see the enclosed Federal Register Notice.

Sincerely,

~v~-~

Annette L. Vietti-Cook

Enclosure:

Federal Register Notice

[7590-01 -PJ NUCLEAR REGULATORY COMMISSION PRM-50-62 10 CFR Part 50 Changes to Quality Assurance Programs; Withdrawal of Remaining Issues Concerning a Petition for Rulemaking AGENCY: Nuclear Regulatory Commission.

ACTION: Petition for rulemaking: Withdrawal.

SUMMARY

The Nuclear Regulatory Commission (NRG) is terminating its plans to develop a voluntary option alternative to its regulations to allow licensees to make unilateral changes to their quality assurance (QA) program descriptions. This action is being taken because the petitioner, the Nuclear Energy Institute (NEI), has withdrawn the remaining issues raised in its petition for rulemaking submitted on June 8, 1995 (Docket No. PRM-50-62). NEl's action is related in part to a revision dated February 23, 1999, to the Commi.ssion's regulations that was implemented in response to the petition and provided the industry with a reduction of unnecessary regulatory burden. The effect of this action is that further revisions to the Commission's quality assurance regulations are not being developed.

ADDRESSES: Copies of the petition for rulemaking, the public comments received on the notice of receipt of the petition (60 FR 47716; September 14, 1995), NRC's response to the petitioner, public comments received on the direct final rule (64 FR 9029; February 23, 1999},

NRC's response to comments received on the direct final rule partially granting the petition (64 FR 42823; August 6, 1999), the Petitioner's letter (Accession No. ML003755305), stating that it is not necessary to pursue further changes, and NRC's confirmation letter (Accession No.

ML003747685), pertaining to the withdrawal of the petition are available for public inspection or copying for a fee in the NRG Public Document Room (PDR), One White Flint North, Room 0-1 F21, 11555 Rockville Pike, Rockville, Maryland 20852. These documents are also available for perusal at the NRC's rulemaking website http://ruleforum.llnl.gov. Questions or comments regarding this website should be directed to Carol A. Gallagher at 301-415-5905 or CAG@NRC.GOV.

- FOR FURTHER INFORMATION CONTACT: Michael T. Bugg, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone 301-415-3221, e-mail mtb@nrc.gov.

SUPPLEMENTARY INFORMATION:

BACKGROUND By letter dated June 8, 1995, NEI petitioned the NRG to amend its regulations controlling changes to nuclear power plant licensee QA programs. The petition was received by the Commission on June 19, 1995,. and assigned Docket No. PRM-50-62. The petitioner requested that the NRG modify 10 CFR 50.54(a) to permit a nuclear power plant licensee to make a broader range of changes to its QA programs without prior NRG approval. At the time of the petition submittal, 10 CFR 50.54(a)(3) allowed d licensee to" ... make a change to a previously accepted quality assurance program description included or referenced in the Safety Analysis Report, provided the change does not reduce the commitments in the program description previously accepted by the NRG." NEI requested that the Commission amend this requirement to allow a licensee to" ... make a change to a previously accepted quality assurance program description included or referenced in its Safety Analysis Report without prior Commission approval unless the proposed change involves a change in the technical specifications incorporated in the license or involves an unreviewed safety question," consistent with the criteria of 10 CFR 50.59. 1\ccording to NEl's proposal, changes involving unreviewed safety questions (USQs) would require NRC approval beforE~ implementation._

THE PETITION NEI stated that 10 CFR 50.54(a) is sometimes interpreted by the NRC as requiring NRC approval for any changes in the QA program, regardless of the safety significance associated

- with the change. As a consequence, there are often prolonged and sometimes unnecessary regulatory debates about the correct interpretation of the term "reduction in commitment." NEI presented the following examples of changes that it believed could be made without the need for prior NRC approval but that have been viewed as "reductio~s in commitment," requiring prior NRC approval:

1. Changes in the level of approval of administrative, implementation, or policy procedures, regardless of the safety significance;

2. Changes in the company organization as it is described in a licensee's original quality e, plan;

3. Changes in frequency for audit, review, or surveillance activities that have minimal, if any, safety significance;

4. Adoption of a more recent national standard that may, or may not, have been I

endorsed by the NRC staff, that results in a different implementation methodology, yet fulfills the same function and achieves the same objective as the original standard described in the QA program description through the use of enhanced technology or other developments; and

5. Adoption of quality processes different or more effective and efficient than those described in a licensee's original quality plan based on the safety significance and past operating performance.

(

NEI estimated that NRC review and approval of these types of changes cost the industry in excess of $1 million per year. In addition, NEI asserted that licensees occasionally were hesitant to pursue QA program improvements because of the resources requir_~d for NRC approval, even though the ultimate result would be improvements in efficiency, quality, or safety.

NEI also noted that the NRC's main purpose for the current requirement in 10 CFR 50.54(a) (which was adopted in 1983) was to preclude licensees from making certain changes

- to QA programs without prior NRC approval because, in the past, some QA progra~s had been changed and no-longer*conformed to NRC re*gulations. NEI claimed that its proposed approach in PRM-50-62 would still address the NRC's concerns because QA program changes would continue to be reported periodically to the NRC as required by 10 CFR 50.71 (0) as program updates, and changes that involve a USO or cause a change to the technical specifications would be submitted to the NRC for approval before they are implemented. The petitioner reiterated that this is the same process used for change control for many other aspects of the facility design and operation, and should be used for QA programs as well. NEI further stated

- that the proposed amendment would improve the consistency of the regulatory process and would result in increased safety of commercial nuclear power plants through more efficient use of NRC and industry resources.

COMMENTS RECEIVED ON THE PETITION On September 14, 1995 (60 FR 47716), the NRC published a notice of receipt of the NEI petition for rulemaking and provided an opportunity for public comment. The document requested that public comment on eight specific questions on critical regulatory aspects of the NEI petition. Seventeen comment letters were received, plus one comment letter that supplemented one of the original letters.

Eleven of the public comment letters were sent by nuclear power plant licensees and NEI; all supported the proposed change in the regulations. The six non-NEl/non-licensee letters were sent by individual concerned citizens (two are currently employed in the nuclear field); all expressed opposition to the relaxation of current requirements that address changes in QA programs. All of the comment letters addressed issues raised in the petition, particularly the appropriateness of using the 10 CFR 50.59 criteria for QA program changes.

COMMISSION DECISION The Commission agreed with NEI that the 10 CFR 50.54{a) criteria under which a licensee was allowed to make unilateral QA program changes was too stringent because it prevented a licensea from making QA program changes of minor safety significance without first obtaining NRC approval. The Commission decided that new criteria should be adopted to broaden the scope of changes that could be made by a licensee without prior NRC approval.

Therefore, the Commission accepted the petition in part and issued a direct final rule (64 FR 9029; February 23, 1999) that revised 10 CFR 50.54(a) to allow a licensee to make additional

- changes to selected elements of its QA program without having to obtain prior NRC approval.

As of April 26, 1999, a licensee is permitted to make the following types of unilateral changes to its QA programs:

1. The use of a quality assurance standard approved by the NRC that is more recent than the QA standard in a licensee's current QA program at the time of the change;

2. The use of a quality assurance alternative or exception previously approved by an NRC safety evaluation, provided that the bases of the NRC approval are applicable to a licensee's facility;

3. The use of generic organizational position titles that clearly denote the position function, supplemented as necessary by descriptive text, rather than specific titles;

4. The use of generic organizational charts to indicate functional relationships, authorities, and responsibilities, or, alternately, the use of descriptive text;

5. The elimination of quality assurance program information that duplicates language in quality assurance regulatory guides and quality assurance standards to which a licensee is committed; and

6. Organizational revisions that ensure that persons and organizations performing QA functions continue to have the requisite authority and organizational freedom, including sufficient independence from cost and schedule considerations, when these concerns are in conflict with safety considerations.

Licensees shall continue to conform to the requirements in Appendix B to 10 CFR Part 50 and 10 CFR 50.34(b)(6)(ii) and to notify the NRC of these changes as required by 10 CFR 50. 71 (e). The direct final rule provided immediate relief to licensees by clearly defining six categories of QA program changes that do not require NRC approval prior to implementation. On June 7, 2000, the NRC staff conducted a public workshop to solicit feedback on the implementation of the revision to 10 CFR 50.54(a) and to gather information to

- determine the need for and feasibility of developing a voluntary alternative rule based on the NEI petition. Workshop participants acknowledged the significant burden reduction already achieved through the 1999 revision to 10 CFR 50.54(a). As a result of the discussions at the workshop, NEI concluded, and the NRC agreed, that a separate rulemaking on 10 CFR 50.54(a) is not needed at this time. By letter dated August 15, 2000 (Accession No. ML003755305), NEI documented its belief that "it is not necessary to pursue" further changes to 10 CFR 50.54(a) related to its petition. By letter to NEI dated September 5, 2000, the NRC staff confirmed NEl's intent to withdraw the remainder of the 1995 petition.

In the direct final rule published on February 23, 1999 (64 FR 9029), the NRC noted that comple_t1on of the NEI petition should be accomplished in two stages. The first stage was the r'

immediate burden relief of partially granting the NEI petition through the direct final rule. The second stage proposed was a follow-on rulemaking action in which criteria would have been developed for determining other areas in which unilateral changes could be made by licensees without prior NRC approval that would not negatively impact on the effectiveness of the licensee's QA program. However, given the petitioner's belief that it is not necessary to pursue further changes and based upon feedback from a public workshop on the implementation of the direct final rule, the NRG has decided not to pursue the previously planned second rulemaking.

For these reasons, the NRG finds that all outstanding issues relating to PRM-50-62 are resolved. This completes NRG action on PRM-50-62.

Dated at Rockville, Maryland, this 3oth day of November, 2000.

For the Nuclear Regulatory Commission.

W.. ~-~

Annette L. Vietti-Cook, Secretary of the Commission.

DOCKETED IJ NRC Arizona Public Service PALO VERDE NUCLEAR GENERATING STATION 5801 S. WINTERSBURG ROAD TONOPAH, ARIZONA 85354-7529 *95 O[C -7 P3 :20 WILLIAM L. STEWART 102-03558-WLS/ AKK/ACR EXECUTIVE VICE PRESIDENT NUCLEAR November 28, 1995 0F Fl2:: u-=- St. 1~Rr *1ti.R (

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BRA~Crl Mr. John C. Hoyle Secretary of the Commission Attention: Docketing and Service Branch DOCKET NUMBER U. S. Nuclear Regulatory Commission PEnTION RULE .:. :,PR_M~ ~*

Washington, DC 20555-0001 (_(oDF~~11\b)@

Subject:

Palo Verde Nuclear Generating Station (PVNGS}

Units 1, 2, and 3 Docket Nos. STN 50-528/529/530 Comments on Petition for 10CFR50.54 Rulemaking (60 Federal Register 47716)

On September 14, 1995, the Nuclear Regulatory Commission (NRC) requested public comment on a petition for rulemaking filed by the Nuclear Energy Institute (NEI) on behalf of the nuclear power industry. The notice in the Federal Register pertained to proposed changes to 10CFR50.54 which would achieve more consistency in the regulations by making 50 .54 more like 10CFR50.59.

Arizona Public Service Company (APS) participated in activities that resulted in NEI submitting the petition. APS is an active member of the Append ix B Working Group.

The Appendix B Working Group initiated the NEl's activities that focused on the need for changes in 50.54. The Appendix B Working Group provided oversight, fostered comments, and contributed guidance as NEI drafted the petition.

APS endorses the industry petition and the response to the petition provided by NEI.

Of specific interest to APS is that the proposed rule focuses both utility and regulatory resources on changes which have the greatest potential to impact safety. The petition proposes a change wh ich eliminates the use of a poorly defined "reduction in commitment" philosophy to determine the need for NRC review of proposed changes prior to implementation. Instead, the petition provides a method wh ich ensures the NRC is periodically informed of changes to a licensee's QA Program , that safety significant changes receive appropriate evaluation , and that those changes that have the potential to degrade safety (i.e., unreviewed safety questions as determined using existing 10 CFR 50.59 regulation and industry guidance) will receive the appropriate level of NRC review and approval prior to implementation.

Acknowledged by card 'DEC 1 4 1995 _

.............~

U.S. NUCLEAR REGULMORY COMMISSIOt-.

DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Poslmffl Date ~ a.._,_______ _ __

Coples Received _____._ _ _ __ __

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Mr. John C. Hoyle U.S. Nuclear Regulatory Commission Comments on Petition for 10CFR50.54 Rulemaking Page2 The petition also interfaces well with recently endorsed guidelines related to management of NRC commitments which allow for licensees to evaluate and modify commitments using criteria that eliminates unnecessary regulatory interface, yet provides for periodic notification of changes to commitments so that appropriate regulatory oversight can be applied. Provisions to add a "reduction in effectiveness clause" or other NRC guidance, as implied in the Federal Registrar "Specific Areas for Public Comment" items 4, 5, 6, and 7, would not address the root cause of the problems experienced in implementing the regulation , nor would they support our mutual goals of improving consistency and efficiency of the regulatory process.

NEI has included in the industry response suggested additional guidance which is intended to supplement the NSAC-125 guidance for 50.59 Evaluations. This additional guidance is based on the NRC's comment that "... NSAC-125 deals principally with evaluating changes associated with nuclear plant equipment and not programmatic controls. " The NRC should recognize that many 50.59 Screenings and Evaluations involve proposed procedure changes. Procedure changes can and often do require research of programmatic commitments that may be found in the Safety Analysis Report or other Licensing Basis documents. Therefore, based on the fact that programmatic changes have been made using 50.59 since it became a regulation , APS believes that application of a similar process for quality assurance program changes could be done without additional programmatic guidance. The addition of a guidance document would detract from the goal of consistency in the change process.

Should you have any questions, please contact Ms. Angie Krainik at (602) 393-5421 .

Sincerely, WLS/AKK/ACR/rv cc: W. H. Rasin - NEI

Illinois Power Company DOCKETED Clinton Power Station P.O. Box678 USNRC Clinton, IL 61727 Tel 217 935-8881 ILLIN915 . . ? U-602521 P8WER 95 DEC -4 A11 .S Ll0-95(11 - 28 )LP 8G.120 November 28, l ~ ~FIC i:. OF SECRETAR Y oocKE r wG .~ sL* v1cE BR A:1Ch Docket No. 50-461 DOCKET NUMBER Secretary PETITION RULE PAM ,5<::> - ~

U.S. Nuclear Regulatory Commission (koFe.1.\-"17 HoJ(7;'\

Attention: Docketing and Service Branch Washington, D.C. 20555

~

Subject:

Illinois Power's (IP's) Comments on the Nuclear Energy Institute (NEI) Petition for Rulemaking

Dear Sir:

Federal Register, Volume 60, No. 178, Pages 47716 through 47719 discusses a Petition for Rulemaking submitted by Nuclear Energy Institute (NEI) to request that the NRC amend certain portions of 10CFR50.54(a) related to quality assurance programs at commercial nuclear power plants. NEI has developed and is submitting a response to the Federal Register notice on behalf of the nuclear power industry. Illinois Power (IP) has reviewed the original petition and strongly endorses the concepts and recommended guidance contained therein.

In recent time, IP has experienced significant delays in implementing cost beneficial and process improving changes to the quality assurance program description (QAPD) that did not affect quality and had minimal or no safety significance. The delays were a result of having to submit the changes and await NRC approval prior to implementation of changes. IP has had extended reviews due to unavailable NRC resources and challenges to changes where "reductions in commitment" were postulated by the NRC. Further, IP has had concern, at times, in determining when prior NRC approval was required for QAPD changes. The concern was a result of the lack of clear guidance for interpreting the 10CFR50.54(a) term "reduction in commitment" which is the sole criteria for evaluating the need for NRC approval prior to implementing a QAPD change. In some cases, NRC has used cost reduction as the measurement for "reduction in commitment."

These difficulties have lead to prolonged. interaction with the NRC regarding changes that are ultimately approved and have minimal or no safety significance. Since the intent of the regulation is to ensure that changes do not diminish the .scope of a QAPD program thereby increasing the risk to the public health and safety, these experiences demonstrate an inefficient use of IP and NRC resources.

Acknowfedged by card"J.P!.£..!...L.-199t:-. .

U.S. NUCLEAR REGULATORY COMMISSIOt.

DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statlsticl Postmark Date -1)µ.,.\lµd.

ir,.; ;i~1,.1;3\~s....._ _ __

Coples Received_,__1_ __ __

Add'! Copies Rep

U-602521 Page2 The NEI proposal to amplify the existing 10CFR50.59 processes to evaluate changes to QAPDs improves the emphasis on safety, provides regulatory consistency and meets the intent of I0CFR50.54(a). Regulatory consistency is enhanced by applying to QAPD changes the 50.59 process already being used to evaluate changes to other portions of the safety analysis report (SAR). The NEI proposal retains the existing requirement to inform the NRC periodically of all changes to the QAPD. Using the proposed amplified 50.59 process will ensure that NRC approval is obtained prior to implementation of changes presenting a potential to degrade safety or result in a change to the Technical Specifications.

The NEI proposal provides licensees with the flexibility to improve their quality programs while continuing to satisfy the intent of the regulation in assuring safety. IP endorses the NEI proposal and recommends that the NRC approve it.

Sincerely yours, Director, Licensing JSP/csm

DOCKETED USNRC 5711 Summerset Dr.

Midland, MI 48640

• 95 DEC -4 Al 1 :SSov. 28, 1995 Secretary U.S. Nuclear Regulatory Corrmi" !(j~rr :=- ~E -~ [ 1/,i~Y DOCKET NUMBER Washington, D. C . 20 55 5 DOCKETIN:; &. s -*;:n ll' f 8F/J. 'n 1; PET1T10N RULE PRM so -bo\

Dear Sir:

(Cd'.:>FR-1.\-771~ @

These comments are submitted in response to the petition for rulemaking submitted by the Nuclear Energy Institute on behalf of the nuclear industry, and docketed by the Commission at Docket No.

PRM-50-62.

Most citizens who are keeping watch on developments in the nuclear power plant area have quite a different perspective of what is happening there compared to that of the nuclear industry and the Nuclear Energy Institute (NEI). Far from seeing a need for relaxation of the quality assurance procedures that the NEI is seeking, we see that the NRC is deficient in its oversight in very critical ways.

Furthermore, this lack of adequate oversight will inevitably lead to much greater costs for the utilities who will have to take expensive corrective action in the future--to say nothing of the jeopardy to public health and safety that this lack of oversight brings with it.

We can only describe a few of these types of instances as a part

- of these comments.

1) The whole process of the "generic" licensing of dry cask storage at reactor sites has clearly been done to accommodate the nuclear industry and not to protect public health and safety,--which should be the primary goal of the NRC. Key leaders have pointed out the weaknesses in that process which, nevertheless, continues.

For example, Valdus Adamkus, Administrator for Region 5 of the EPA, wrote of his concerns about the placement of high level nuclear waste in dry casks on the shores of Lake Michigan at Palisades and on Prairie Island at the headwaters of the Mississippi.

Since this was done without any environmental impact statement, he considered this a major risk to the drinking water of millions of people. His letter was responded to by Robert Bernero, who was then director of Nuclear Materials Safety and Safeguards. As a major architect of "generic" licensing, Bernero explained that that an

U.S. NUCLEAR REGULATORY COMMISSIOt-.

DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY Of THE COMMISSION Oocument Statistics Postmark Date #,. ._.,__;:1--- - -

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environmental impact statement had been drawn for the construction of the reactor at the site, and that thus adequate studies had been made.

However, Dr. Ross Landsman, NRC's soils expert, went to view the Palisades site in Feb., '94, after many appeals were made questioning the placing of nuclear waste in untested concrete casks on what was characterized by the Michigan Dept. of Natural Resources as a "high risk erosion-critical sand dunes area".

Landsman was critical of using the environmental impact statement for the Palisades reactor as adequate for the dry cask storage project on that site. He pointed out that the reactor sits on an 8ft. concrete base on bedrock, while the casks are on a 3 ft. concrete pad on loose sands with no connection to bedrock. He said the NRC's "current ideology" could lead to "catastrophic consequences".

More recently, Carl Paperiello, the new director of NMSS, has reiterated similar concerns. In his document, Dry Cask Storage Action Plan, July 28, 1995, stated, "The effects of the postulated earthquake based on the earthquake ground motion used for the plant design-basis SSE is valid for storage casks without further analysis only if the foundation conditions for the cask pad are the same as that for the plant. p. 7 (Emphasis added)

At the Palisades plant, the NRC did not review the plans for unloading the VSC-24 cask prior to certifying the cask for loading. A workable plan for unloading a cask is a condition for certifying a cask. When Cask no. 4 was found to have a defective weld, Consumers Power Co., the utility, said it would unload the cask and place the waste in the spent fuel pool. This statement was made in Aug., '94, but to date the utility has not been able to unload the cask.

It has identified serious problems in the process that were not anticipated initially. Without being required by the NRC to resolve them, the utility continued to load 9 more casks. A complete document of the unloading procedures was requested by the NRC last fall. This document was submitted to the NRC on June 2, 1995.

However, it still indicated parts of the unloading procedure are subject to further evaluation.

No cask that has been certified by the NRC has, as yet, been unloaded. It raises the question about whether anyone knows bow to do this. Yet these casks will last only a fraction of the time that the high level waste within them will be highly toxic--for centuries.

And the NRC is allowing them to be placed on all the nation's fresh water supplies with no EIS, and no public input.

Here again, Carl Paperiello in his July 28, '95 Action Plan has echoed his concerns about the adequacy of the unloading procedures for dry casks. He says, "The unloading procedures tend to be simplistic. This has resulted in neglecting to consider contingencies and assumptions on failed fuel, air sampling techniques, disassembly requirements, design problems, and radiation protection requirements." (p. 10).

In what should have been a wake-up call for the NEI, Charles Haughney, associate director of the spent fuel storage project office, gave an address before the NEI and utility management personnel.

He explained that the many fabricators of the cask who are hired by the vendor do not have adequate quality assurance programs and that the NRC does not have an adequate oversight staff to assure regulatory compliance.

In summary, Haughney told utility managers, "Assume if anything can go wrong, it will go wrong. Murphy's phantom is hugging every cask, whether it is loaded or it's sitting on a pad."

These examples show that the NRC should not have its quality assurance program weakened in any way. On the contrary, it badly needs to have it strengthened.

If the petition of the NEI is granted it can result in licensees changing their programs in unacceptable ways. This can only result in costly efforts to correct changes later on and possibly have a grave adverse impact on the public before they are corrected.

The NRC should continue to use various documents such as the Standard Review Plan, Regulatory Guides, etc. to define acceptable QA programs.

I appreciate the opportunity to submit these comments.

Yours sincerely, Don't Waste Michigan

DOCK ETED CP&L USNRC Carolina Power & Light Company *95 OEC -4 A1 1 :56 PO Box 1551 A11 Fayetteville Street Mall Raleigh NC 27602 OF FICE OF s;~ C;~ ~ TARY OOCK ETl~' 3 .... S::. R* 'i C':

Nov ~~ ~ d 1995 FILE: X-X-1075 SERIAL: NL&RAS-95-077 X-X-0990 DOCKET NUMBER 1 Mr. John C. Hoyle PEITTION RULE ~RM ~ Q -~

Secretary (.\oO~""t"77\~ @

U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 Attention: Docketing and Service Branch

Subject:

NEI 10 CFR 50.54(a) Petition for Rulemaking - Response to NRC Request for Additional Information and Comment (60 FR 47716, September 14, 1995)

Dear Mr. Hoyle:

Carolina Power & Light Company (CP&L) appreciates the opportunity to comment on the subject Nuclear Energy Institute (NEI) petition and fully supports the industry position submitted by NEI.

CP&L believes that this rule change would improve the regulatory process through a more efficient use of agency and industry resources, and thus, contribute to the safe, reliable operation of our nuclear power plants.

Please contact Mr. Fred Emerson at (919) 546-7573 with any questions about the CP&L position on this matter.

Sincerely, f~

Manager Nuclear Licensing and Regulatory Affairs FAE/air cc: Mr. M. D. Bradley Mr. J. P. Cowan Mr. S. D. Floyd (NEI)

Mr. L. E. Jones Mr. F. A. Emerson Ms. P. N. Morales (DEC 1 4 1995 Acknowtedged bv eanf ....-~.....-*-*-~

(n:\nsd\nls\nria\2402nria)

U.S. NUCLEAR REGIJLA TORY COMMIS$10t-.

DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics P011mar1c Date _,\~\\~A:-8+\q"""s..._

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DOCKETED Detroit Fermi2 6400 North Dixie Highway USNRC Edison Newport, Michigan 48166 (313) 586-4000

• 95 OEC -4 p3:10 Nuclear Operations OF FICE OF S ~cR i: TARY DOC KE TI NG & ~ . :]~V ICE BRANCH DOCKET NUMBER PETITION RULE PRM SD- le,?.

( (oOFR..'-\77 lloJ f\3' November 28, 1995 ~

NRC-95-0131 Secretary, U.S. Nuclear Regulatory Commission Washington, D. C. 20555 Attn: Docketing and Services Branch

References:

1) Fermi 2 NRC Docket No. 50-341 NRC License No. NPF-43

2) Federal Register, Vol. 60, No. 178, pages. 47716-47719, dated September 14, 1995

Subject:

Comments on Petition for Rulemaking Regarding Changes to Quality Assurance Pro~

Detroit Edison agrees with the petitioner that changes are needed in the process for Quality Assurance (QA) Program revisions. The current process is sometimes unnecessarily burdensome for minor changes. Changes should be made so that licensee and NRC resources can be better used on activities related to the health and safety of the public. However, rather than review future QA Program changes using the criteria in 10CFR50.59, as proposed by the petition, Detroit Edison believes a decrease in program effectiveness criteria should be used to screen future changes requiring NRC prior review. These criteria would be similar to those used for Security Plan changes, but adapted to be applicable to QA Programs. Such criteria can be better directed to issues of concern for QA Program changes than the criteria contained in 10CFR50.59. The NEI examples provided to the NRC could be easily adapted to a decrease in program effectiveness criteria.

U.S. NUCLEAR REGULA IOHY COM1i,SSiU1, DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmark Date 1,) a~ \9 S:::

Coples ReceivPd_-+-- - -- - -

. 0

USNRC November 28, 1995 NRC-95-0131 Page2 If there are any questions, please contact me at (313) 5 86-4097.

Sincerely, Lynne S. Goodman Director, Nuclear Licensing cc: T. G. Colburn M. J. Jordan H. J. Miller A. Vegel NEI

- -- Log # TXX-95296 File # ~~glo DOCKETED USN C

• 95 NOV 30 P2 :38 Ref# PRM-50-62 1UELECTRIC k CF OF SEC RE TA.RY 8t 1

November 28, f.9 Gt\,E-Tl*ir- (' ~r:r-u r-

!'Hl ('t ... L I \ Y 1I,.

C. Lance Terry BRA~~Ch Group Vic" p,.,,;J.,nt, Nucl..ar DOCKET NUMBER Mr. John Hoyle PETITION RULE PRM 50-'5a Secretary, U. S. Nuclear Regulatory Commiss i on Attn: Docketing and Service Branch Washington, DC 20555-0001

("=CR2. 1.-\7 7 \ le;

SUBJECT:

COMANCHE PEAK STEAM ELECTRIC STATION (CPSES)

REQUEST FOR PUBLIC COMMENT ON NUCLEAR ENERGY INSTITUTE (NEI) 10 CFR 50.54(a) PETITION REF : 1) Federal Reg i ster. Volume 60 - 47716 dated September 14, 1995

2) Nuc l ear Energy Institute (NEI) letter from Mr. Thomas A. Tipton dated November 28, 1995 to Secretary, Nuclear Regulatory Commission in response to 60 FR 47716 Gentlemen:

Per reference 1, Nuclear Regulatory Commission (NRC) requested publ i c comment on the subject rulemaking pet i tion filed by NEI. The petition requests NRC to amend i ts regulation regarding quality assurance (QA) programs to permit nuclear power plant licensees to change the quality program referred/described in the Safety Analysis Report (SAR) without prior NRC approval if an eva l uation determines that the changes do not present a potential to degrade safety or do not resu lt in a change to the pl ant Techn i cal Specifications (TS).

Reference 2 provided the NEI response to the NRC addressing the specific eight NRC issues in the federal register notice. Based on TU Electric's review of the proposed amendment to 10 CFR 50.54(a) contained i n the NEI petition, we find the proposed wording and changes to be appropriate and responsive to licensee needs.

Regulatory acceptance of the proposed changes in the subject petition would improve the consistency in QA program changes submi tted for NRC approval , by eliminating the ambiguity in the existing wording of 10 CFR 50.54(a). It should be noted that words such as "decrease in QA program effect i veness" are also vague and open to interpretation and offer litt l e or no real relief to a licensee. The proposed changes in the subject pet iti on util i ze a recognized NRC process (10 CFR 50 . 59) to eval uate changes t o QA programs for i mpact on sa fety , which was t he intended purpose of the i ni tial ru l emaking in 1983. The proposed changes satisfy the orig i nal intent of t he regulation and eli minate differences

. DEC 1 4 1995 1 Acknowledged by card ..................."............

Energy Plaza 1601 Bryan Street Dallas, Texas 75201-3411

U.S. NUCLEAR REGULATORY COMMISSIO~

OOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmartc Date ....1~,jia=.....s4-j9...,,~...___ _ __

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TXX -95296 Page 2 of 2 in opinion between licensees and the NRC Staff . These changes would encourage licensees to focus on ways to further improve their quality programs wi thout the resource uncertai nt ies of the current change process and also enable licensees to focus attention/resources to safety significant matters, enhancing public health and safety .

Sincerely ,

C. L. Terry By:~rJl!___

D. R. Woodl an Docket Licensing Manager JMK/jmk c - Mr . T. E. Tipton , NEI

-=:-- ENTERGY DOCKETED US~RC Entergy Operations, Inc.

P.O. Box 31995 Jackson, MS 39286-1995 Tel 601 368 5760 Fax 601 368 5768 Jerrold G. Dewease

'9'5 OEC 4 A1 1 :56 Vic President Operations Support November 28, 1995 DOCKET NUMBER Mr. John C. Hoyle, Secretary PETITION RULE PRM 5 A- !o~

Office of the Secretary (<oD~l-\-,1 \lo) r.7\

U.S. Nuclear Regulatory Commission ~

Washington, DC 20555-0001 ATTN: Docketing and Service Branch

Subject:

NEI 10 CFR 50.54(a) Petition for Rulemaking- Response to NRC Request for Additional Information and Comment CNRO-95/00022

Dear Mr. Hoyle:

On September 14, 1995, the Nuclear Regulatory Commission published in the Federal Register (60 Fed. Reg. 47716) a request for additional information and comment on a 10 CFR 50.54(a) petition for rulemaking initiated by the Nuclear Energy Institute (NEI).

NEI, in interaction with and in behalf of the nuclear utility industry, is submitting a detailed response to the published request.

Entergy Operations, Inc. has reviewed and concurs with the NEI response. Please consider this to be our formal endorsement of the NEI submittal.

Sincerely, cc: (See next page)

-NOV 3 0 1gg5~*

Acta1cJwledged by card .......................... ......,

U.S. NUCLEAR REGULATORY COMMISSIOr,.

DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY Of THE COMMISSION Document Statistics PosmiarttDate \~\9S' ( ~ \\\"2~)

Copies Received _ __.___ _ _ __

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?f>=r.=i . 1~ .,.,,J

NEI 50.54(a) Petition for Rulemaking November 28, 1995 CNRO-95/00022 Page 2 of2 cc: Mr. R. P. Barkhurst Mr. J. L. Blount Mr. R. W. Bishop Mr. L. J. Callan Mr. J. L. Colvin Mr. C.R. Hutchinson Mr. G. Kalman Mr. H. W. Keiser Mr. J. R. McGaha Mr. R. B. McGehee Mr. P. W. O'Connor Mr. C. P. Patel Mr. N. S. Reynolds Mr. D. L. Wigginton Mr. J. W. Yelverton Central File (GGNS)

DCC (ANO)

Records Center (WF-3)

SDC (RBS)

Corporate File [2]

DOCKETED US RC NUCLEA R ENERGY INS TI T U TE

• 95 NO' 29 A10 :Q2 Thomas E. Tipton VICE PRESIDENT OPERATIONS & ENGINEERING November 28, 1995 Mr. John C. Hoyle Secretary DOCKET NUMBER U.S. Nuclear Regulatory Commission PETITION RULE PRM 50*'8S Washington, D.C. 20555-0001 ( G:oFR 4 1 7 1~ @

ATTENTION: Docketing and Services Branch

SUBJECT:

NEI 10 CFR 50.54(a) Petition for Rulemaking- Response to NRC Request for Additional Information and Comment (60 Fed. Reg. 47716 - September 14, 1995)

Dear Mr. Hoyle:

These comments are submitted on behalf of the nuclear energy industry by the Nuclear Energy Institute (NEI) 1 in response to the subject Federal Register notice of the NEI petition on 10 CFR 50.54(a) and the request for additional information and comment on eight specific issues described in the notice.

General Comment:

(1) In the eight issues described in the Federal Register notice, comments were requested on suggested alternatives to the petition. The industry has significant reservations regarding two of these suggested alternatives.

(a) The use of a "departure from commitment" standard as the threshold for requesting NRC approval prior to implementation. The industry believes that the adoption of such a threshold would be a regressive step in regard to the protection of public health and safety. Licensee and 1 NEI is the organization responsible for establishing unified nuclear industry policy on matters affecting the nuclear energy industry, including regulatory aspects of generic operational and technical issues. NEI's members include all utilities licensed to operate commercial nuclear power plants in the United States, nuclear power plant designers, major architect /engineering firms, fuel fabrication facilities, materials licensees, and other organizations and individuals involved in the nuclear energy issue.

UIOV 3 o 1995 Acknowledged by card .."""'"""..---*-

1776 I STREET, NW SUITE 400 WASHINGTON, DC 20006-3708 PHONE 202 739 8107 FAX 202 785 1898

U.S. NUCLEAR REGULATORY C0t.! 1~1SSl0t--.

OOCKETING & SER ICE SECTION OFFICE OF THE SECRETARY Of THE COMMISSION Doalnent Statisties Pollbnart Date -~-=.._____

Coples Received__.__ _ _ _ __

Aden Copies Reproduced ---- - . - - --

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Mr. John C. Hoyle November 28, 1995 Page 2 NRC management would be required to address all matters described in a licensee's quality assurance program description, whether or not there is a nexus to safety. This has the potential of diverting licensee and NRC attention and resources from safety-significant matters, increasing the probability of not identifying a safety-significant issue.

(b) Separate change process and mechanism for review and audit functions is suggested in Issue 3. The industry believes that such a measure would further decrease the coherency and consistency of the regulatory process that was a recommendation in the NRC's 1993 Regulatory Review Group Report. The process of implementing the regulations would become more complex, increasing the potential for confusion, misunderstanding and misinterpretation. There would be two different change processes for matters described in the same licensee-controlled document, the quality assurance program description, implementing a common NRC regulation, 10 CFR 50 Appendix B.

In both these instances, the licensee and NRC Rdmiuistrative and regulatory burden would be increased without any corresponding increase in safety. Such a change would be contrary to the recent Administration and Congressional initiatives for improving the federal regulatory process, and contrary to the recommendations in the 1993 NRC Regulatory Review Group Report. Enclosure 1 provides additional amplification on these two issues, and on the other issues described in the Federal Register notice.

(2) The notice suggested that the petition had not addressed the impact or provided the rationale for deleting 10 CFR 50.4(b)(7)(i) from the NRC regulations. The NEI petition submitted on June 8, 1995, included the following statement:

"10 CFR 50.4(b)(7), Quality aB§Urance related submittals. (i) :

This paragraph has been deleted. There is no reason for requiring a separate administrative reporting requirement for changes to the quality assurance program description included or referenced in the Safety Analysis Report. Administrative reporting requirements for changes to the facility, its programs, procedures, tests or experiments that are described in the Safety Analysis Report should be treated in a

Mr. John C. Hoyle November 28, 1995 Page 8 consistent manner. The administJ:ation of the regulatory process should be as efficient and as consistent as possible through the optimization of the f!dministrative process.

Sub-paragraph (ii) of 10 CFR 50.4(b)(7) is not amended because the requirement is unique to nonlicensees (i.e., architect/engineers, NSSS suppliers, fuel suppliers, constructors, etc.)."

Section 10 CFR 50.4(b)(6) addresses written communication requirements associated with updating a licensee's Final Safety Analysis Report. A licensee's quality assurance program description is included or referenced in its (Final) Safety Analysis Report (SAR). The petition proposes a change process for a licensee's quality assurance program description based on the same change process as for other matters, inclucting programs, described in a licensee's SAR. There is no reason to have different change mechanisms, or different reporting requirements, for matters described or referenced in a licensee's SAR.

A common set of update and reporting requirements for all matters described in a licensee's SAR would improve regulatory coherency, consistency and efficiency.

The petition requires a licensee to inform the NRC of changes made to its quality assurance program description during the periodic updates of its SAR. The impact of deleting the Section 50.4(b)(7)(i) requirement is that it will improve the regulations. The estimated cost savings associated with the deletion of the Section 50.4(b)(7)(i) requirement are included in the estimates provided in the petition, and amplified in the industry responses to the eight issues described in the Federal Register notice. provides NEfs response to the request for input and additional comment. A draft industry guideline with examples to assist licensees in implementing and interpreting the petition is included as part of the NEI response to the Federal Register notice. Naturally, the guideline would not be issued until the rule is finalized and NRC comments have been addressed.

NEI would be pleased to discuss with the NRC staff the NEI response to the request for additional information and comment on the 10 CFR 50.54(a) petition, and the draft guideline, with the intent of improving the regulatory process and interface associated with changes to a licensee's quality assurance program descriptions.

Mr. John C. Hoyle November 28, 1995 Page4 If you have any questions or comments, please contact St.eve Floyd (202) 739-8078 or Adrian Heym.er (202) 739-8094 of the NEI staff.

TET/ljw Enclosures c: Mr. WiJ1iam T. Russell (Director, NRR, NRC)

Ms. Karen D. Cyr (General Counsel, NRC)

Enclosure 1 Response to NRC Reguests for Comment on NEl's Petition on 10 CFR 50,54Ca}

Issue 1: 10 CFR 50.54(a) was issued on January 10, 1983, to correct instances where licensees had changed their programs that resulted in some unacceptable programs without informing the NRC. What assurances exist to prevent a similar situation from recurring if the petition and the revised threshold for reporting QA program changes is adopted? Is it necessary that such situations be prevented from occurring by adoption of a regulatory approval system?

Comment As stated in the NEI petition, the original concern of the Commission which prompted the issuance of 10 CFR 50.54(a) in 1983 is still being addressed. The NRC had become concerned that some licensees were making changes to their quality assurance programs that were unacceptable and could increase the risk to the public health and safety.

"...... some licensees have been changing their quality programs without informing the Commission. In a few cases this has resulted in QA programs which were not acceptable to the NRC staff and which did not conform to all aspects of the NRC regulations. The primary concern with the current situation is that unreported changes to the QA program might diminish the scope of the program permitting significant deficiencies to arise in the design, fabrication, construction, or operation of the facility. This could increase the risk to the public health and safety" (48 Fed. Reg. 1026, January 10, 1983).

The Commission's main concern was that changes could be occurring that presented the potential to degrade public health and safety. The language in the regulation addressed the potential safety degradation issue by linking it to a reduction in commitment as described in the quality assurance program description previously accepted by the Commission. Since its issuance in 1983, there has been significant, and often unnecessary, regulatory and intra-industry discussion on the interpretation of Section 50.54(a) with respect to the term, "... does not reduce the commitments ...", even for matters that have no, or minimal safety significance.

In contrast, the use of the Section 50.59 change process for matters described or referenced in the SAR has been relatively free from the debates that are sometimes associated with Section 50.54(a) changes. Licensees routinely use the Section 50.59 criteria to evaluate equipment and non-hardware related changes to procedures and programs described in the SAR. In general, the implementation of the Section 1

50.59 change process has been successful and acceptable from a regulatory perspective.

The NEI petition builds on the experiences of the past twelve years in attempting to interpret and implement the regulation from a perspective of its impact on public health and safety. The petition addresses the concerns described in the Statements of Consideration for the original rule in a more effective and efficient manner by providing a greater emphasis and focus on safety. The petition basis is a well proven regulatory process, the Section 50.59 process. It requires a licensee to inform the NRC of all changes to its quality assurance program description, included or referenced in its Safety Analysis Report. In addition, for changes that present a potential to de.grade safety, as determined by an evaluation against the criteria described in the petition (as amplified in the guideline attachment to these comments), or that result in a change to the Technical Specifications, the petition requires a licensee to seek NRC approval prior to implementation. Such requirements still ensure that the concerns which caused the Commission to issue the initial rule in 1983 do not recur.

Currently, when considering changes to its quality assurance program, a licensee is uncertain of the resource burden associated with processing and implementing the change, even for simple changes that have no, or minim~ safety significance. This uncertainty is because of the variance in interpretations on the term "reduction in commitment". Such uncertainties discourage licensees from pursuing more significant improvements to their quality assurance program descriptions that could benefit public health and safety.

The industry recognizes the importance of an effective and efficient quality assurance program in respect to safety. Further, experiences in the global non-nuclear industries, as well as the U.S. nuclear sector adequately demonstrate the importance of effective quality programs in the commercial marketplace. In general, facilities with good quality programs and practices have good safety assessment reports, high capacity factors and low operating costs. It is not in a licensee's interest to implement changes that only are focused on improving efficiency and productivity, and not on improving quality. In a competitive generating marketplace, there is significant financial incentive for licensees to have superior quality programs that assure safety and economic performance.

The only difference in the proposed petition and the existing regulation is that the petition appropriately places emphasis on safety rather than a reduction in commitment. The petition provides added impetus for licensees to pursue improvements to their quality programs and eliminates the uncertainty over resources associated with implementing improvements to their quality assurance programs. As such, the petition, when implemented, would enable licensee and NRC attention and resources to be more appropriately focused on safety significant matters, enhancing the protection of public health and safety.

2

Issue 2: Traditionally, the NRC staff has used a variety of documents such as the NRC Standard Review Plan, NRC Regulatory Guides, and associated industry consensus standards to delineate what QA program elements are necessary to meet Appendix B. Should these standards continue to be used to define acceptable QA programs? Should a licensee QA program change that constitutes a departure from a commitment to comply with a specific regulatory position be considered of sufficient importance that the NRC should be notified in advance of implementation? How would such changes be evaluated under the petitioner's proposed criterion?

Comment The NRC regulations provide for the protection of public health and safety. The NRC's quality assurance regulations, when implemented, provide reasonable assurance that the pertinent safety functions will be satisfactorily accomplished, thus assuring the protection of public health and safety.

The NRC Standard Review Plan, regulatory guides and the associated industry consensus standards are general guidance on approaches to satisfy the NRC regulations. It is acknowledged that other implementation methodologies and practices also can satisfy the regulations. Licensees must meet the requirements of Appendix B regardless of implementation strategy. The focus of licensee reviews and submittals, NRC reviews, and regulatory interactions should be on safety and satisfying the regulations, not a departure from an existing regulatory commitment, or on a departure from an NRC accepted industry standard or generic guidance document in an area that may be of no, or minimal safety significance.

When assessing any change, a licensee's first and most important task is to assure safety. As a result, the petition places emphasis on the safety implications of a change. It ensures that the NRC is informed of all changes to a licensee's quality assurance program description, with NRC approval being required prior to implementation for changes that could have implications to safety (ie., present an unreviewed safety question or result in a change to the Technical Specifications incorporated in a license).

The benefits of making a change in accordance with an NRC accepted industry standard or guidance document are associated with implementation resources and the management of the regulatory interface. In the case of implementing NRC accepted industry standards or guidance documents, the regulatory costs (both industry and NRC) should bP. minimal, because the standard or plan has already been reviewed and endorsed. The decision on whether to adopt an NRC accepted industry standard or guidance document, or the degree to which that standard or 3

guidance is implemented, are predominantly economic and ease of implementation decisions. Naturally this assumes that the alternative approach accomplishes the same function, output, or result from a safety perspective.

Licensees should be afforded the regulatory flexibility to deviate from existing guidance to improve their quality programs, without prior NRC approval providing they continue to meet the regulations. Such a regime will encourage licensees to seek ways to further improve their programs without the resource uncertainties of the current change process.

Since its issuance in 1983, the industry and the NRC staff have struggled to reach a consistent understanding on the term "provided the change does not reduce the commitments". There have been numerous instances of rigid interpretation by the industry and the NRC staff that have throttled the drive for improvement in quality programs or safety (see response to Issue 1).

A "departure from commitment" threshold for seeking NRC approval prior to implementation is inappropriate. Its adoption would be a regressive step with respect to the protection of public health and safety. It increases the potential for distracting licensee and NRC management attention from matters of safety significance as they are obligated to address all matters described in a licensee's quality assurance program description, even for those where there is no nexus to safety.

Recently, the industry and the NRC reached a general understanding on a process for licensees to use in managing licensee commitments to the NRC. In this process, potential safety impact is the determining factor in seeking prior NRC review and approval. The change process for regulatory commitments should be consistent, no matter the topic, whether associated with design, operations, or quality assurance.

Such an approach, as defined in the industry Guideline for Managing NRG Commitments, enhances regulatory coherence and provides an appropriate and consistent focus on matters that could impact the protection of public health and safety. The important regulatory measure is whether safety is impacted, not whether there has been a departure from, or reduction in, a regulatory commitment.

The petition places a different emphasis on the change process than currently prescribed in Section 50.54(a). The emphasis is similar to that used in the process for managing NRC commitments and for performing Section 50.59 changes, one of safety and meeting the regulations, not a reduction in commitment. It focuses on the differences in the program description element being changed, as it relates to safety. A licensee determines whether the differences in the program description result in a decrease in public health and safety, as measured by potential equipment malfunctions and general qualitative or quantitative risk evaluations 4

that are assessed to be beyond those analyzed in its Safety Analysis Report, or result in a change to the Technical Specifications incorporated in its license. The process is described in the attached draft guideline.

Issue 3: The NRC has allowed licensees to relocate administrative controls for review and audit functions from the Technical Specifications.

Examples include details on safety review committees, audits, and technical review functions. These have been relocated to the QA program based on the existing change control provisions in

§ 50.54(a). Would it be appropriate for activities such as safety review committees, independent technical review groups, and audits to be controlled so that only licensee changes exceeding the threshold of an unreviewed safety question (USQ) be reported to the NRC for pre-review before implementation? What kind of changes to a licensee's QA program would constitute a USQ?

Assuming that the USQ should/could be applied, does not the use of§ 50.59 effectively negate the administrative and regulatory advantage of removing this information from Technical Specifications (because both Technical Specification changes and USQs are subject to an opportunity for hearing)? ~f the revised QA change control mechanism is adopted, should aspects of the review and audit functions remain in the QA program or be relocated elsewhere to ensure appropriate NRC review of changes prior to implementation?

Comment The 1993 NRC Regulatory Review Group Report emphasized the need for consistency and coherence in the NRC regulations and identified 10 CFR 50.54(a) as an example of incoherency and inconsistency in the regulations and their implementation. For a number of licensees, the adminii,trative controls for review and audit functions are described in their SAR, and in some cases these controls are duplicated in the Technical Specifications of their licenses.

Through the Technical Specification Improvement Program, the NRC allowed licensees to relocate these administrative controls from the Technical Specifications to ".... other licensee documents for which changes to those provisions are adequately controlled by other regulatory requirements" (NRC Letter to Owners' Groups Chqirpersons, dated October 25, 1993). As such, the NRC is assured that a licensee's change process for these Eidroinistrative controls will continue to ensure that safety is maintained at a level that provides for the protection of public health and safety. The NRC reaffirmed its position in a letter to the Owners' Groups Chairpersons on January 17, 1995, 5

"The Owners' Groups submitted proposed changes to the standard technical specifications (STS), .... by relocating many of the provisions to licensee-controlled documents, in accordance with the letter from W. Russell dated October 25, 1993. Several of the provisions previously included in the administrative controls would be allowed to be relocated to licensee-controlled documents, such as the Quality Assurance Program (QAP) ...".

Licensees routinely use the criteria of Section 50.59 to evaluate non-hardware related changes to procedures and programs described in the SAR. Some licensees may wish to include these controls in their quality assurance programs; others may wish to simplify the process and keep them in existing SAR sections, for which there is a satisfactory and well proven regulatory change process, the Section 50.59 process. In either case, changes are subject to regulatory controls that assure the protection of public health and safety.

The QA program is the only SAR described program not evaluated under Section 50.59. The petition remedies this inconsistency.

The petition requires licensees to inform the NRC staff of all changes to its quality assurance program description, and for changes that have the potential to degrade safety, (i.e., present an unreviewed safety question, seek NRC approval prior to implementation). The proposed change process, when approved by the Commission, would become a regulatory controlled change process that improves the focus on safety. As such, the process would be consistent with the understanding reached in the Technical Specification Improvement Program interactions.

The Section 50.54(a) petition improves the coherence and consistency of the NRC's regulations and their implementation. It provides for a similar change process to the Section 50.59 change process. The Section 50.59 process has been proven over time, with the NRC staff being notified of changes to matters described in the SAR, and with the requirement for an NRC approval prior to implementation for changes that present an unreviewed safety question, or result in a change to the Technical Specifications. Also, the amendment is consistent with the concepts and understandings recently discussed in the regulatory interactions on managing NRC commitments, one of focusing on safety.

The 1993 NRC Regulatory Review Group Report recommended an approach similar to Section 50.59 for managing licensee commitments to the NRC. Such an approach would be based on an evaluation of whether an unreviewed safety question is involved. The industry's Guideline for Managing NRC Commitments reflects such an methodology. The NEI petition is consistent with the approach and concepts described in the industry's Guideline for Managing NRC Commitments. There should be no distinction in the method or focus for assessing a change to a commitment, be it a QA commitment or any other commitment. It should be 6

associated with the potential to degrade safety, i.e., present an unreviewed safety question.

Since the issuance of 10 CFR 50.59 in 197 4, there have been only a few instances of licensees requesting approval for changes that involve unreviewed safety questions.

In general, licensees withdraw changes that involve an unreviewed safety question, or amend the change so that it no longer presents an unreviewed safety question before making the decision to proceed with implementation. Should a licensee decide to proceed with a change that involves an unreviewed safety question, then in accordance with the requirements of Section 50.59, the change is processed as a license amendment per the requirements of 10 CFR 50.90. In such cases, there is an opportunity for a hearing. The potential for a hearing under Section 50.59 is not increased until the licensee decides to pursue a change through a license amendment, per the requirements of Section 50.90.

Experience with implementing the Section 50.59 process indicate that the benefits of a more predictable and stable regulatory environment, the resulting improvements in the efficiency of managing the regulatory interface, and the benefits of increased regulatory flexibility significantly outweigh any burden associated with the opportunity for a hearing for changes that constitute an unreviewed safety question, or require a change to the Technical Specifications.

Regulatory consistency and efficiency would be increased by reducing the number of different types of change processes for similar regulatory practices, regulations and matters described in the SAR. Review and audit functions are fundamental components of any quality assurance program. More importantly, for a particular regulation, viz., 10 CFR 50, Appendix B, there should be one change control process.

To invoke a different change process for different elements within an existing program or regulation, e.g., the quality assurance program (10 CFR 50, Appendix B), adds unnecessary complexity to the regulatory process, increasing the potential for confusion and misinterpretation. It will result in a fragmented regulatory process, increased regulatory inconsistency and incoherency, and reduced regulatory predictability and stability.

The adoption of a different change mechanism for review and audit functions would be a regressive regulatory step, increasing the administrative and regulatory burden on licensees and the NRC. As such, the proposal to introduce a different change mechanism for review and audit functions would be contrary to the recent Administration and Congressional initiatives for improving the regulations.

The attached guidance document for implementing the petition provides examples of changes that could constitute an unreviewed safety question.

7

Issue 4: Are there alternative thresholds for determining whether a licensee must submit their QA program changes for advance review in lieu of the USQ threshold? Provide a technical and/or policy explanation as to why this or any other threshold would be more appropriate.

Comment Alternative thresholds for determining when a licensee should submit changes to its quality assurance program description for NRC review and approval prior to implementation include: (1) the adoption of the same standard as described in Sections 50.54(p) and (q), one of decreased effectiveness, and (2) the deletion of Section 50.54(a), with the change process for quality assurance program commitments being incorporated into the process described in the industry's Guideline for Managing NRG Commitments.

Industry discussions, NRC briefings and the NRC 1993 Regulatory Review Group Report have emphasized the need for increased consistency in the regulatory process. These comments reinforce the need for simplifying the regulations by reducing the number of change processes for specific regulations, or matters described in the SAR, to a single process.

The threshold for the proposed change process described the NEI petition includes an element that relates to assessing the impact of a decrease in program effectiveness with respect to safety (also see comments on Issue 5 and the attached guidance document). The petition proposes a threshold for seeking NRC approval prior to implementation as being an unreviewed safety question, or a change to the Technical Specifications. Such a process is consistent with the process developed for managing NRC commitments and the Section 50.59 change process.

The change process for matters described in the SAR (the Section 50.59 process) is understood and well established. A consistent change process should be used for all matters described in the SAR, with the focus for seeking NRC approval prior to implementation being one of possible safety degradation. The use of different change processes for different subjects described in the SAR (i.e., QA program description) unnecessarily complicates regulatory regime. Such complexities present the potential for distracting and diverting licensee and NRC attention and resources from matters of safety significance that could present the potential for degrading public health and safety.

The NRC is notified of changes made pursuant to the Section 50.59 process, with NRC approval being required for changes that involve a change to the Technical Specifications or an unreviewed safety question. Its implementation process is 8

documented in established industry guidance documents that are generally acceptable to the NRC. The process is understood by the industry and the NRC, and has been proven over time.

The industry believes that the optimum approach for making changes to a licensee's quality assurance program description is through a process that is similar to Section 50.59. Such a change builds on a well proven process, improves the consistency and coherency of the regulations, enhances regulatory predictability and improves safety. Additional draft guidance with examples has been developed to assist licensees in implementing programmatic changes, and is attached to these comments.

Issue 5: The NRC Regulatory Review Group (RRG) examined change

• control mechanisms in § 50.54 for control of licensee plans and programs (quality assurance, security, and emergency preparedness). The RRG recommended that licensees should have greater flexibility to make changes in their programs without having to receive prior NRC approval. Currently, QA program changes that "reduce the commitments in the program" are submitted for NRC staff review before implementation.

Similarly, security plan changes that "decrease the effectiveness" are submitted for staff review before implementation. Should the staff consider a revision to § 50.54(a) to set the threshold for reporting QA program changes for NRC pre-review that constitute a decrease in effectiveness? Would a "decrease in effectiveness" standard in § 50.54(a) provide a sufficiently flexible and technically reasonable criteria for licensees to report QA program changes to the staff before implementation?

Comment As described in the comments on Issue 4, above, the industry discussed a "decrease in effectiveness" option during its deliberations on the petition prior to its submittal. The industry's conclusions are documented in the petition: the optimum change process for amending a licensee's quality assurance program description is a process modeled on the Section 50.59 process.

For a "decrease in effectiveness" threshold to be effective, the following criteria are essential:

(1) Does the changed quality assurance program description meet the requirements described in 10 CFR 50, Append.ix B, consistent with the importance to safety?

(2) Does this change contradict any regulatory requirement?

9

(3) Would this change result in a change to the function(s) described in a licensee's quality assurance program description that would impact the ability of the safety significant stnictures, systems and components to satisfactorily perform their safety functions, or inhibit licensee personnel from making a safety determination?

(4) Does this change any licensee commitment to an extent that safety is potentially degraded?

In assessing the above criteria, a licensee would focus on whether the proposed change could cause a decrease in program effectiveness with respect to safety; i.e.,

does the change produce an unreviewed safety question. These are the same issues that are evaluated when considering a change to the SAR using the Section 50.59 process, and the same issues as described in the industry's Guideline for Managing

• NRC Commitments. As such, the implementation process should be the same as for the Section 50.59 process; the process described in the proposed petition, and the associated guideline (Attachment 1). However, these criteria and the associated implementation regime are significantly different to those established for assessing a "decrease in effectiveness" threshold for requiring NRC approval that was recently established by NRC Generic Letter 95-08 dated October 31, 1995, 10 CFR 50.54(p) Process for Changes to Security Plans without prior NRC Approval.

In 1994 and 1995 the NRC staff and industry discussed the development of a change process for a licensee's security plan based on Section 50.59 concepts. The industry concluded that a security plan, while ultimately associated with plant safety, is focused on the prevention of unwanted substances and personnel from entering the facility and ta.king actions that could result in an event that ultimately endangers public health and safety. In addition, the security plan is not included as part of a licensee's SAR. As such, it was considered that the use of a Section 50.59 process would not be appropriate.

NRC Generic Letter 95-08 provides a clarification of the term "decrease in effectiveness" as used in Section 50.54(p) in the form of two screening criteria: (1) a change in any of the three security plans is deemed not to decrease the effectiveness of the plan if the change does not decrease the ability of the onsite physical protection system and security organization, as described in paragraphs (b) through (h) of 10 CFR 73.55, or equivalent measures approved under 10 CFR 73.55(a), to protect with high assurance against design basis threat as stated in 10 CFR 73.l(a);

and (2) a change that increases the effectiveness of any plan.

In addition to the above criteria, the generic letter includes three questions to assess the impact on the effectiveness of a security plan. (1) Does this change delete or contradict any regulatory requirement? (2) Would the change decrease the overall level of security system performance as described in paragraphs (b) through (h) of 10 CFR 73.55 to protect with the objective of high assurance against the 10

design basis threat of radiological sabotage as stated in 10 CFR 73.l(a)? (3) For any licensee that has NRC approved security plan commitments of 10 CFR 73.55(b) through (h): does this change decrease the overall level of security system performance needed to protect with the objective of high assurance against the design basis threat of radiological sabotage as stated in 10 CFR 73.l(a)?

The purpose of 10 CFR 50, Appendix B is to provide reasonable assurance that safety related SSCs will satisfactorily perform their intended safety functions. The criteria of Section 50.59 are directly applicable to this purpose. The EP and security regulations are not directly related to ensuring that the safety related functions of the plant are satisfactorily accomplished. Therefore, it could be appropriate to have different criteria, ie., a "decrease in effectiveness" criteria for the EP and security regulations .

• As indicated in the preceding paragraphs, the imposition of a "decrease in effectiveness" threshold for QA program description changes would result in three different interpretations for the same term in a single NRC regulation (10 CFR 50.54). It would introduce additional complexity and incoherency into the regulations by establishing yet another, different interpretation of a term that is already used in Section 50.54 for security and emergency preparedness. As such, the imposition of such a term for QA increases the Rdministrative and regulatory burden on the licensee and NRC staff. The imposition of such a threshold would further reduce the coherency and consistency of the regulations in an area that was identified in the 1993 NRC Regulatory Review Group Report as being an example of incoherency and inconsistency in the regulations.

A "decrease in effectiveness" threshold increases the potential for the diversion of resources from matters of safety significance to matters of regulatory, administrative significance. Such a regime would increase the potential for degrading the protection of the public health and safety.

Currently, there are Congressional and Adrninisi:t'ation initiatives to improve the efficiency of federal regulations and their implementation. In addition, the industry is striving to improve productivity as it faces the increasing competitive demands of the electrical generation marketplace. With these ongoing initiatives, it is important to increase the focus of regulatory activities on matters that have safety significance. In such a changing and dynamic environment, it is important that licensee and NRC staff not become distracted by protracted discussions on matters that have minim~ or no safety significance, increasing the potential for not properly focusing on, and identifying issues of, significant safety significance.

The change process described in the industry's petition provides a licensee with increased, yet bounded, regulatory flexibility that will engender further licensee initiated improvements to quality assurance program descriptions. As such, the petition is consistent with another recommendation in the 1993 NRC Regulatory 11

Review Group Report for increased licensee flexibility in regard to making changes to its quality assurance program description without the need for NRC approval prior to implementation for matters that do not present an unreviewed safety question or change the Technical Specifications.

Issue 6; Should the NRC staff consider retaining the current language of

§ 50.54(a) and to define explicit guidance or identify examples on what types of QA program changes would be considered to "reduce the commitments in the program"? By developing this guidance could sufficient flexibility be afforded to licensees to make changes in their QA program without having to undergo a pre-review by the staff?

Comment The purpose of the NRC regulations is to provide adequate protection of public health and safety. The focus of implementing the regulations should be on safety, not on whether the change reduces a commitment which may have no nexus to safety.

As stated in the petition, since the issuance of 10 CFR 50.54(a) in 1983, licensees and the NRC have struggled over the interpretation of the term "provided the change does not reduce commitments". There have been numerous instances of rigid interpretation of the regulation by industry and NRC staff for changes that have no nexus to safety. The regulation needs to be changed to eliminate ambiguity, uncertainty and inconsistency of the current regime for implementing Section 50.54(a) (also see responses to Issue 1 and Issue 2).

The development of additional NRC guidance would not address the root cause of the problems experienced over the past twelve years in implementing the regulation. The recommendations of the 1993 NRC Regulatory Review Group Report, and the Congressional and Administration initiatives to improve the efficiency and effectiveness of the federal regulations, support the intent of the industry's petition: the introduction of a regulation that would improve the consistency, efficiency and effectiveness of regulatory process, improving productivity, yet ensuring the maintenance of public health and safety.

The term "provided the change does not reduce commitments" continues to result in misinterpretation, miscommunication, and misunderstandings. It increases the unpredictability in the regulatory regime, thereby reducing regulatory efficiency and effectiveness. The industry experiences over the past twelve years indicate that the regulation needs to be amended to refocus licensee and NRC attention on matters of safety significance.

12

Issue 7: The petition proposes to apply a § 50.59 process to evaluate QA program changes to determine the necessity for pre-review by the staff. Industry guidance for § 50.59 exists within NSAC-125 "Guidelines for§ 50.59 Safety Evaluations." NSAC-125 appears to contain little relevant guidance that would be helpful for determining whether QA programmatic changes would constitute a USQ that requires NRC pre-review of the change. In particular, Section 4.2 of NSAC-125 deals principally with evaluating changes associated with nuclear plant equipment and not programmatic controls. Is existing guidance for processing 10 CFR 50.59 evaluations sufficient for evaluating QA program changes? What factors or aspects of the existing industry guidance would need to be supplemented? What types of QA program changes would be necessary to report to the NRC if the current § 50.59 criteria were applied to QA program changes? What are examples of QA program changes that should be considered as meeting the USQ threshold?

Comment The petition proposes the use of a 50.59 type change process. The general concepts and implementation of such an approach are described in established industry guidance documents. The NRC staff has acknowledged that licensees implement Section 50.59 requirements in an acceptable manner. Attached to these comments is additional guidance that, when read in conjunction with the established industry guidance on implementing Section 50.59 safety evaluations, will further assist a licensee in assessing and implementing programmatic changes using a Section 50.59 type process. The guidance also includes examples of changes that would be sent to the NRC for review and approval prior to implementation.

Additionally, Section 50.59 applies to changes to the facility, programs and procedures, as described in the SAR. Licensees routinely use the criteria of Section 50.59 to evaluate non-hardware related changes to procedures and programs. The QA program is the only SAR described program not evaluated under Section 50.59.

The petition remedies this inconsistency.

The petition proposes that all changes to a licensee's quality assurance program description are reported to the NRC. For changes that would result in a Technical Specification change or present an unreviewed safety question, as defined in the attached guidance document, the proposed change is submitted to the NRC for approval prior to implementation.

13

Issue 8: Would the protection of public health and safety be enhanced if the petition were granted, and if so, in what way? What licensee and NRC costs would be reduced, or increased, if the petition were granted?

Comment The petition, when implemented, will improve the focus of licensee and NRC attention and resources on matters that present the potential for degrading safety, rather than on a myriad of issues that are associated with a reduction in commitment, yet have no, or minimal safety significance. As such, the protection of public health and safety will be improved by increasing licensee and NRC attention and resources on matters of safety significance.

The majority of changes to a licensee's quality assurance program description are administrative. In general, under the change process described in the petition, and as amplified in the attached draft guideline, the cost of making changes to a licensee's quality assurance program description would be reduced. It is acknowledged that even under the proposed change process described in the petition there are implementation costs. Yet, because the majority of changes would be classified as administrative, or be assessed as achieving the same intent as the existing program description, in a more effective and efficient manner (see ), the savings in licensee and NRC resources utilized in processing changes could be significant.

In preparation of the petition, cost benefit estimates on implementing the change process described in the petition were developed and compared with the estimated costs of the current process. There was significant variance in the estimated savings that were, in general, approximations based on the resources expended in implementing Section 50.54(a) changes over the past five years. The estimated savings ranged from $3,000/unit/year, to $45,000/unit/year, which translate into industry wide savings of between $330,000/year to $4.9 million/year.

It should be noted that not all licensees capture costs in the same manner. In several instances, licensee management costs associated with specific regulatory or licensing interactions were not included because these licensees do not use unique accounting entries for specific regulatory interactions. In other cases, estimates were made on the licensee management costs and included in the estimates used in the petition. Naturally, these estimates only reflect the savings from implementing the new change process.

None of the cost estimates included NRC costs. The industry believes that the NRC resource burden would also be reduced through the approval of the petition. The NRC resource burden for assessing changes to a licensee's quality assurance 14

program would be reduced because of a decrease in the number of licensee subm.ittals for NRC approval prior to implementation. The reduction in NRC resources would increase the estimated savings for processing changes to licensees' quality assurance program descriptions because of the 100% licensee fee recovery structure for NRC expenditures.

It is acknowledged that there are costs associated with processing a change per the process described in the petition. These implementation costs increase as a licensee proceeds through the process. NEI estimates that the costs associated with processing a change that involves NRC review and approval prior to implementation, would be at least equivalent to the costs associated with the existing change process. As such, the potential economic burden and degree of uncertainty with pursuing such changes that require NRC approval prior to implementation is a significant and additional disincentive to proposing changes that involve an unreviewed safety question or Technical Specification change.

As a result, a licensee would only pursue a change involving an unreviewed safety question if there were substantial and quantifiable benefits. A review of Section 50.59 changes indicate that only under exceptional circumstances, and only where there are significant and quantifiable benefits, do licensees pursue changes that require NRC review and approval prior to implementation, i.e., pursue changes that involve an unreviewed safety question.

If the industry's petition is granted, it will result in a more consistent, effective and efficient change process for a licensee's quality assurance program description. The change will encourage and promote a better focus of licensee and NRC resources on matters of safety significance instead of utilizing regulatory resources on matters that have minim~ or no safety implications. The cost effectiveness of the regulatory regime from a safety perspective will be improved.

15

DRAFT to Enclosure 1 ofNEI Comment Letter on 10 CFR 50.54(a) Petition NEI-XX-YY GUIDELINE FOR QUALITY ASSURANCE PROGRAM DESCRIPTION CHANGES PER 10 CFR 50.54(a)

DRAFT GUIDANCE FOR IMPLEMENTING CHANGES TO QUALITY ASSURANCE PROGRAM DESCRIPTIONS PER 10 CFR 50.54(a}

TABLE OF CONTENTS Section Title Page

1.0 INTRODUCTION

1

• 2.0 3.0

3.1 BACKGROUND

GUIDANCE Screening Criteria 1

2 3.2 Quality Program Element Description 3.3 Safety Evaluation 3.4 Commitment Change Determination

4.0 CONCLUSION

9 Appendix A EXAMPLES OF CHANGES THAT WOULD RESULT IN A TECHNICAL SPECIFICATION CHANGE OR AN UNREVIEWED SAFETY

- QUESTION I

DRAFT

1.0 INTRODUCTION

This document is designed to provide additional guidance :to a licensee effecting a change to its quality assurance program description included or referenced in its Safety Analysis Report (SAR) per the requirements of 10 CFR 50.54(a).

This guidance should be read in conjunction with NSAC-125, Guidelines for 10 CFR, 50.59 Safety Evaluations, because of the similarity between the requirements of the two change processes: evaluating whether a proposed change involves an unreviewed safety question or a change to the Technical Specifications.

This document provides additional clarification to assist licensees in making the correct interpretation for changes that are of a programmatic nature associated

• with quality assurance. Examples to assist in interpretation and implementation are provided in Appendix A In the past some licensees have experienced difficulties in using the Section 50.59 criteria to evaluate non-hardware related changes to procedures and programs that are described in the SAR. This guidance is designed to provide some additional insights to assist licensees in making Rimilar programmatic changes associated with quality assurance. Some licensees may determine that their current Section 50.59 implementation regime for procedural and programmatic changes to matters described in the SAR is satisfactory. In such cases, those licensees might make the determination not to adopt this guideline.

2.0 BACKGROUND

In 1983, the NRC issued a new regulation, 10 CFR 50.54(a), governing changes to a licensee's quality program description included or referenced in its SAR. The regulation was introduced as a result of a concern that licensees were not informing the NRC of changes to their quality assurance program descriptions that presented a potential to impact safety. The rule permitted a licensee to make changes to its quality assurance program description included or referenced in its SAR, providing the change did not reduce the commitments in the program description previously accepted by the NRC.

In 1993, the NRC performed a regulatory review of power reactor regulations and related programs, processes and practices with special attention focused on the feasibility of substituting performance-based regulatory requirements and guidance for the prescriptive requirements and guidance of that time. The NRC Regulatory Review Group Report, dated August 1993, concluded that the regulatory burden on licensees could be reduced if each licensee were held to a consistent set of requirements provided by the NRC's regulations. The NRC report identified specific examples of inconsistency and incoherence in the regulations and in 1

DRAFT associated Rdministrative requirements. The regulatory change process for a licensee's quality assurance program description, 10 CFR 50.54(a), was given as an example.

The Nuclear Energy lnstitute's Appendix B Working Group recommended the submittal of a petition to amend Section 50.54(a) in 1994, to provide for a consistent change proceSB for matters described or referenced in the SAR. Specifically, the working group recommended a process, similar to the proven change process for 10 CFR 50.59, for establishing a threshold for seeking prior NRC approval for changes to a licensee's quality program description. The working group advised that such a change would improve regulatory consistency, efficiency and predictability, emphasizing that a single change process for changes to the facility, its procedures, tests or experiments, or other matters described in the SAR would

• reduce the burden on licensees and the NRC staff. The working group maintained that the threshold for seeking prior NRC approval should be one of safety significance, not reduction in commitment.

In June 1995, NEI submitted a petition to amend Section 50.54(a). The petition proposed changing the regulation to:

(a) Require a licensee to implement a quality assurance program pursuant to 10 CFR 50.34(b)(6)(ii);

(b) Provide a licensee the flexibility to make changes to its quality aSBurance program description, providing the change does not result in a change to its Technical Specifications or involve an unreviewed safety question; and (c) Inform the NRC staff of the change as part of a licensee's standard SAR reporting and revision update requirements.

3.0 GUIDANCE This guidance on changes to a licensee's quality program description, included or referenced in its SAR, supplements the guidance given in established industry guidance documents (NSAC-125) for changes to the facility and procedures that are described in the SAR, or to tests and experiments that are not described in the SAR.

The revised change process focuses licensee and regulatory attention and resources on matters of safety significance affected by a proposed change to a licensee's quality assurance program description. Further, it requires the NRC to be informed of a change as part of the routine SAR reporting and update requirements, unless the change involves an unreviewed safety question or a change to the Technical Specifications.

2

DRAFT Change Process for Implementing 10 CFR 50.54(a)

QA Program Description Change NO NO

• nt I0CFR50.54 (a)(3)

Do not make change,

& perform element comparison or alternatively evaluation seek NRC approval IO CFR 50.54(a,)(2)(1)

Perform safety evaluation -

safety significance of reduced effectiveness 10 CFR 50 54(a)(2)(i,)

Implement change &

notifyNRC in routine report Interact with NRC If NOV respome < 2yn old Figure t 3

DRAFT The revised 10 CFR 50.54(a) permits a licensee to make a change to its quality assurance program description without prior NRC approval providing the change does not involve a change to the Technical Specifications or an unreviewed safety question. Fundamentally, through Section 50.54(a) [as amended], a licensee has the flexibility to make a change to its quality assurance program description without prior NRC approval, providing that a determination can be made that the revised quality measures, e.g., inspections, tests, corrective action, etc., described in the revised quality program description, still provide reasonable assurance that the safety function(s) will be*performed. A licensee needs to provide the rationale for assuring the analyzed safety considerations prior to implementing the change are not being reduced, or that the change does not create a new safety concern.

Naturally, a licensee's quality program description must still meet the requirements of 10 CFR 50, Appendix B.

• In addition to the evaluation described in this document, a licensee needs to be aware of the safety considerations and purpose of the quality program description approved in the original licensing proceedings, or in the regulatory interactions in response to the NRC's 1983 Section 50.54(a) requirements. It is important to ensure that the original intent of the quality aBSurance program description is not inadvertently degraded to an extent beyond that analyzed in the SAR through incremental changes.

The overall change process is depicted in figure 1.

3.1 Screening Criteria Before evaluating the change to determine if an unreviewed safety question (USQ) exists, there are several questions to be answered. These are:

(a) Is a change being made to the quality program description, described or referenced in the SAR?

(b) Is the change of an fldroinistrative nature?

An Rdministrative change is one that meets the following criteria:

(i) Editorial corrections (e.g., textual ambiguities, typographical errors, grammatical errors, formatting errors);

(ii) Changes in organizational position titles, descriptions, and/or reporting relationships; (iii) Organizational realignment, wherein the overall scope of activities is unchanged; (iv) Relocation of requirements from one licensing basis document to another, (e.g., specific reporting requirements may require NRC notification); and 4

DRAFT (v) Renewal, updating or clarification of regularory approved documents reproduced or referenced in the quality assurance program description (e.g., updates t,o later approved AS:ME Code editions) that have been generically approved by the NRC staff.

If the change is administrative, the change may be made and implemented without further evaluation, with a report being forwarded to the NRC as part of the normal SAR or annual update, or at shorter intervals as prescribed by each licensee.

(c) Does the revised quality program description continue t,o comply with 10 CFR 50, Appendix B?

• (d) Does the change result in a revision to the Technical Specifications?

If the change results in a change to the Technical Specifications, a licensee would either withdraw the change or seek prior NRC approval through the process prescribed by 10 CFR 50.90.

3.2 Quality Program Element Comparison Does the revised program description perform the same activities and achieve the same purpose (function) as the existing program description?

A comparison of the proposed program against the current program is performed.

To accomplish this activity a licensee performs the following three step process:

(a) Defines the safety function or intent of the program description or activity that is being changed.

(b) Defines the safety function or intent of the program or activity in the new quality program element program description.

(c) Compares the differences between the two program descriptions to determine if the same safety function is being performed, or the same safety objective accomplished.

In performing the three step process described above, the following guidance should assist licensees:

The intent (purpose or objective), the desired output (result, conclusion or product), and task (activity) from a safety perspective for the existing and proposed elements should be described. If the element is not specifically described in the revised program because another element envelopes and 5

DRAFT accomplishes the original function; the activity, intent, desired output and task of the pertinent element from a safety perspective should be noted.

Once the safety functions of the existing and revised quality program elements have been established, they can be compared, and any differences with respect to safety can be identified. In performing the comparison, the following questions may be of assistance:

• Is the same task, from a safety perspective being accomplished?

• Is the same intent with respect to safety being achieved as that described in the existing quality program description?

• Is the same result or output, with respect to safety, being achieved as described in the existing quality assurance program description?

Is the program less complex (fewer steps) than the existing?

Are software programs or databases involved? If so is the same database or program (revision) being used?

Example: Transfer of the quality assurance department's responsibilities to the line organizations with the introduction of a line assessment coordinator/director whose responsibilities include, the coordination of multi-disciplined reviews of identified areas of weaknesses, and resolving professional differences of opinion between the line assessment and work sections.

Current function: The purpose and activities (the safety function) of the quality assurance department is to conduct independent reviews to confirm that the defined and established quality controls and measures are being implemented correctly, to identify defects and deficiencies, and to ascertain that identified defects and deficiencies are addressed through the licensee's corrective action program.

New function: A departmental (line) assessment coordinator ensures the same activities are performed by line personnel, as currently performed by the QA department personnel, providing the personnel are not performing the work. Each department is responsible for providing personnel, as necessary, to support detailed group reviews of identified areas of weakness, or concern. As appropriate and necessary, differences in professional opinion are resolved by the department assessment section leader/coordinator, the site assessment director/coordinator, or the senior executive responsible for safety. The personnel qualifications for implementing the tasks would continue as for the exiting element consistent with the safety significance and complexity of the task.

6

DRAFT

Conclusion:

From a safety perspective, the current activities, or work functions continued to be performed, and the original intent and purpose of the quality program description continue to be fulfilled:

hence, a safety evaluation is not required. Th~ change can be made following the assessment of the notice of violation step.

Defining the safety significance of the program description or its associated activities that are being changed focuses attention on the safety considerations related to the proposed change. In addition, the comparison will assist a licensee in making the correct safety determination (see Section 3.3), when addressing the standard questions associated with safety evaluations.

If the initial comparison review, described above, determines that the safety function of the existing program is not changed, then the licensee proceeds to the final step described in Section 3.4. The basis for the conclusions of this evaluation should be documented and held in the licensee's files for a period of five years.

If the safety functions (intent, output, and task) are not the same as that of the existing quality assurance program description, a safety evaluation, as described in Section 3.3, is performed.

3.3 Safety Evaluation The objective of the safety evaluation is to determine whether the change would result in any reduction in program adequacy that has safety significance. The evaluation determines whether the proposed revised program description challenges or changes the safety function of the existing quality assurance program description to an extent that is significant, and that might be detrimental to the protection of public health and safety. The safety evaluation determines the impact on safety, in terms of plant (equipment and personnel) performance and overall risk.

The program comparison performed in Section 3.2 is used in answering the seven safety evaluation questions. Primarily, a licensee uses the output from Section 3.2 to determine whether the differences in the quality assurance program description established in Section 3.2 potentially impact a safety function or activity described in the SAR? If the answer is yes, a determination is made as to whether the impact is beyond that analyzed in the SAR?

7

DRAFT The discussion section on the seven questions (the same as the questions described in NSAC-125, Section 3) is intended to provide further amplification and guidance for addressing programmatic changes to the SAR. In regard to quality assurance program description changes, it is important to note that such changes have the potential to impact more than one activity, system or component. The following aspects relating to quality assurance activities should be taken into consideration:

Q.1. May the proposed activity increase the probability of occurrence of an accident previously evaluated in the SAR?

If the answer is yes, an evaluation on whether the change would increase the probability of an accident needs to be considered. Licensees have established methods for detennining whether the probability of an accident is increased to an extent that is beyond the accidents analyzed in the SAR. If the probability of an accident has been increased to an extent that impacts the safety analyses described in the SAR then an unreviewed safety question is involved.

Q.2. May the proposed activity increase the consequences of an accident previously evaluated in the SAR?

In this question, the licensee makes the same determination as for normal 50.59 evaluations; a determination on whether the dose consequences of any analyzed accident are affected to an extent beyond that analyzed in the SAR, for changes to the quality assurance program description that could impact a mitigative safety function.

Q.3. May the proposed activity increase the probability of occurrence of a malfunction of equipment important to safety previously evaluated in the SAR?

Using the results from the program comparison in Section 3.2, a determination is made on whether the performance of a structure, system or component (SSC) is degraded to an extent that it impacts the safety function of those SSCs? If the answer is yes, the licensee determines whether the impact on the safety functions are significant to affect the safety analyses beyond those described in the SAR. The important aspect is associated with the probability of a malfunction being increased to an extent that could impact the events previously analyzed in the SAR Q.4. May the proposed activity increase the consequences of a malfunction of equipment important to safety previously evaluated in the SAR?

Could the revised program result in an impact on plant SSCs that degrades safety beyond that analyzed in the SAR? If the answer is yes, a 8

DRAFI' determination of the dose consequences of the malfunction must be performed. If the dose consequences exceed the limits described in the SAR, or other licensing documents, the change is considered as presenting an unreviewed safety question.

Q.5. May the proposed activity create the possibility of an accident of a different type than any previously evaluated in the SAR?

The issues in this question are Rimilar t,o those being addressed in question (I) from a quality assurance program description change consideration and no additional guidance beyond that already discussed in this supplement or in NSAC-125 is necessary.

Q.6. May the proposed activity create the possibility of a different type of malfunction of equipment important to safety than previously evaluated in the SAR?

If the evaluation indicates that a different type of malfunction will occur, are the consequences of the malfunction bounded by the SAR analyses? The probability of the accident or event being assessed should be similar to. the probability of the accidents and events described in the SAR, i.e., considered to be as credible as the accidents described in the SAR (see NSAC-125 for additional information).

Q.7. Does the proposed activity reduce the margin of safety as defined in the basis for Technical Specifications?

No additional clarification is required beyond the guidance given in the NSAC-125.

3.4 Commitment Change Determination The final step is to assess whether the proposed revision changes any licensing commitments made as a result of a notice of violation within the last two years. If the answer is yes, the change can still be processed. However, the NRC staff should be notified as soon as possible and the rationale for changing the commitment made in response to the report or violation should be prepared.

This final step is to assure a degree of consistency between the process for managing NRC commitments and the change process for making changes to a licensee's quality assurance program description.

9

DRAFI'

4.0 CONCLUSION

On completion of the change process, a licensee should have confidence that its quality assurance program description retains the appropriate quality controls and measures that provide reasonable assurance that the applicable (safety related) structures, systems and components will satisfactorily perform their intended safety functions. If this assurance would be degraded through a quality assurance program description change to an extent that impacted public health and safety beyond that analyzed in the SAR, the change should be withdrawn, or NRC approval should be requested prior to implementation.

10

DRAFT APPENDIXA Guideline for Quality Assurance Pr01qam Description Chana:es per 10 CFR 5Q.54(a)

EXAMPLES Introduction The differences in levels of regulatory commitments as a result of licensing and enforcement activities can result in varying interpretations, and can influence a licensee's decision on whether a change to the quality assurance program description is needed, whether NRC approval should occur prior to implementation, or whether the change can be implemented prior to NRC notification.

Currently, some licensees may have the regulatory flexibility to implement a change described in this Appendix without performing the evaluations described in this guidance document. Other licensees may decide not to implement a change because of specific regulatory interactions, licensee specific nuances in design or operational philosophy, or unique licensing conditions.

The following examples are designed to assist licensees in understanding the process described in the main document by providing additional clarification by way of example.

Examples of changes that would result in a licensee seeking NRC approval prior to implementation.

The changes in this section assume that a licensee has not graded its quality programs into high and low safety significance categories, or does not distinguish between high and low safety significance for design considerations. These changes are associated with changes to quality programs for safety-related structures, systems and components.

A. F,limination of design authority reviews of safety-related equipment modifications Basis: In the current regulatory environment, a safety evaluation using the Section 50.59 criteria would conclude that the change involves an unreviewed safety question. Having defined the purpose and intent of the design authority reviews of modification packages, and how the change would impact the safety functions of one or more systems, the responses to the questions described in the main document, Q.1 through Q.5 would be yes.

In the current organizational structure, design engineering (design authority) is the organization that has the technically qualified personnel and possesses the design 1

DRAFT basis information to evaluate the safety impact of modifications. Such evaluations ensure that the specific, and sometimes design unique, conditions associated with design basis operational, transient, or accident conditions are addressed. Through such a process there is reasonable assurance that the plant (structures, systems and components) remains capable of satisfactorily performing its intended safety functions. To eliminate such a review could significantly increase the probability of occurrence of the matters that would present an unreviewed safety question: an increase in probability of the consequences or occurrence of an accident or malfunction, or an increase the possibility of a different type malfunction or accident, or a reduction in the margin of safety defined in the basis for the technical specifications.

B. Deletion of design engineering/authority review of completed modification packages prior to final acceptance into operation. (Maintenance/craft (contractor) group responsible for final engineering approval of completed modification package (field changes implemented) prior to acceptance for service).

Basis: Having defined the purpose and intent of the design authority review of completed modification packages, the safety evaluations from Q. l, Q.3, Q.6 or Q. 7 would be evaluated as presenting an unreviewed safety question for such a programmatic change.

The design authority may place specific work (craft) requirements, inspection and acceptance criteria, or tolerances in modification packages and procedures because of concerns over a potential design weakness, or reductions in operational safety margins. These design requirements may be more restrictive and severe than the requirements of the construction codes, guidance given in the industry consensus standards, or in the standard licensee's craft procedures and work instructions.

These additional installation requirements are imposed to assure that the design basis is not degraded.

If in the course of installation, such additional instructions are changed, or deleted because they are in excess of code, or standard work instructions the designer assumptions may be impacted and the margin of safety impacted through such activities. Without a design authority review of changes, the safety analyses described in the licensee's SAR may be impacted, or the safety margins reduced to an extent that is unacceptable and beyond the conditions and criteria described in the SAR.

Example: The piping configuration requirements for a pump suction line may be critical from NPSH considerations. A change in bend radius, or reduction in pipe length prior to the impeller suction inlet resulting from a construction interference may invalidate the design basis performance characteristics of the pump during a plant transient or event.

2

DRAFT C. Deletion of component and vendor documAntation verification for structures.

systems and components of high reliability.

Basis: Even if a determination was made that the change continued to comply with the requirements of Appendix B, this change would result in an unreviewed safety question during performance of a safety evaluation using the Section 50.59 criteria.

Also, having defined the purpose of the vendor/component receipt inspection process, the safety evaluation described in the main document would result in an unreviewed safety question from answering questions Q. l through Q.6.

The purpose of inspection/verification on receipt is to identify deficiencies that indicate a component has not met the requirements of the procurement order, and

• may not meet the requirements for its intended safety application. In the majority of instances, high reliability components from manufacturers do not have deficiencies, and when they occur they are often associated with documentation, rather than hardware deficiencies. However, some instances have occurred where components are rejected or require some work before being utilized. In addition, test deficiencies sometimes go undetected during manufacture, and deficiencies do occur in high reliable components. Such deficiencies could impact the safety analysis assumptions that form the basis for the scenarios, resulting in an adverse impact on SAR assumptions and supporting analyses.

D. Appointment of line managers (engineering. maintenance. health physics.

and design) as the final authority for the resolution of safety concerns within their area of responsibility.

Basis: Having defined the purpose and intent of the company, site, or plant senior nuclear officer having the fu:ml. authority for the resolution of safety issues, the safety evaluation described in the main body of the guideline would, as a rninirn1rm result in Q.3, Q.4, Q.6 or Q. 7 being assessed as an unreviewed safety question.

In addition, for some licensees, such a change may require a change to their Technical Specifications incorporated in their licenses, and as such, NRC approval would be required.

A licensee's Technical Specifications or quality assurance program description sometimes state that the final authority for the resolution of safety issues resides with the company, plant, or site senior nuclear officer (executive). Operational, design, health physics and maintenance safety issues often require input from one or more of the other line organizations, e.g., operations sometimes need input from design, and health physics; design often needs input from maintenance and operations.

3

DRAFT In general, line managers reach a consensus on the correct course of action.

However, instances do occur where there are differences in professional opinion or advice on the correct course of action. These differences of opinion are sometimes a result of differences in experience, knowledge, or qualifications, and occasionally are exacerbated by operational pressures. When such differences in professional opinion occur and cannot be reconciled, the company senior nuclear officer is tasked with resolving safety issues to ensure the appropriate and correct action is taken.

E. Elimination of the audit function based on plant reliability and licensee self assessment activities,

~ : This would be inconsistent with the requirements of 10 CFR 50, Appendix B, Criterion XVIII. In addition, some licensees may be required to address the issue

• through a change to their Technical Specifications incorporated in their license. In both instances, NRC approval would be required prior to implementation.

F. A programmatic change in software validation and jnetrument calibration of Regulatory Guide 1.97 instrumentation and indication in the control room based on modifications to other infilJ11mAntation.

Basis: A general programmatic reduction in instrument calibration or software validation requirements that are primarily based on the presence of other, more resilient, commercial equipment, instruments or indication in the control room that is not qualified or categorized as Regulatory Guide 1.97 equipment, the evaluations of Q. l, Q.3, Q.4, Q.6, or Q. 7 would result in an unreviewed safety question.

Note: For a specific change, based on a partial, or full system upgrade, the evaluations may indicate that the change does not present an unreviewed safety question.

The purpose and intent of the calibration is to ensure that the instrumentation is accurately providing the correct information, and does not result in an unsafe condition during normal, transient conditions, or cause inappropriate operator or automatic initiation based on control room indication. Likewise, software validation ensures that there are no errors in the software program that would impact safety through in inaccurate information, false alarm annunciation, or result in the initiation of incorrect automatic or manual sequences.

Operators react to indications and alarms as directed by operating procedures. Reg.

Guide 1.97 instrumentation and software programs are designed, developed, installed, tested, calibrated and maintained in a manner that provides reasonable assurance and indication that the plant is being operated within its design basis.

The operator actions (manual or automatic) are initiated at the correct time and in the correct sequence based on indication or annunciation from this set of instrumentation and indication. Incorrect operator response, even during normal 4

DRAFT operations can rapidly lead to operations that are inconsistent with the plant's design basis, or the safety analyses described in the SAR.

2. Examples of changes that would be implemented by a licensee with NRC notification through the standard SAR update process.

The changes in this section assume that a licensees has not graded its quality program into high and low safety significance categories, or does not distinguish between high and low safety significance for design considerations. These changes are related to the quality program practices for safety related structures, systems and components.

A. Change specific qualification standards {experience and education) for line or section supervisors to one based on licensee management's assessment of the candidates abilities to perform the duties. responsibilities and tasks.

Basis: The qualifications for line or section supervisors should be based on licensee management's assessment of the candidate's competency in fulfilling the duties and responsibilities required by the position. The selection process should be based on the candidate's education, experience, and performance, and assessed abilities to undertake the tasks demanded by the position.

The activity, (the supervision of activities, personnel, and safety) is still being performed. Plant performance or safety is not degraded. The change is not administrative, does not result in a Technical Specification change, and the requirements of Appendix B are still satisfied. The activity, the selection and performance of the duties of the line supervisor are still being performed, and will be assessed on a continuous basis through the personnel appraisal process.

B. Transfer of receipt inspection activity and oversight from the QA department to the line organization.

Basis: The change is considered Rdministrative (organizational realignment) and the prescribed activity, duties and functions are still being performed.

The activity is still being performed, and the verification of the equipment is independent of the supplier. In addition, it may be more appropriate for the line organization to perform the receipt inspection activity, and track and monitor any identified deficiencies. A licensee's nonconformance and corrective action programs assure that deficiencies are corrected and that defective material and equipment are not installed.

The interface with the supplier's organization is maintained through the appropriate department tasked with the supplier interface. Such interactions may be through the project, line, or assessment/QA departments.

5

DRAFT C. CbapgP. offsite review committee reporting relationship for Site #1 from Executive Vice-President - Power Supply to Senior Site Manager - Site #2.

Basis: This is an Bdministrative change. The offsite review committee is described in the quality assurance program description and its activities continue to be performed. The activity (function) is still being performed and there is no impact on safety or plant operations.

D. Utilize associate company personnel and programs to perform support services (design, quality asse88ment. P:fliPiur:. ID@intenance. etc .. ) for nuclear operations.

Basis: . The associate companies have quality programs sufficient to meet the requirements of 10 CFR 50, Appendix B. The change is administrative. The licensee remains responsible for operations and activities that are performed in accordance with the requirements of the NRC regulations, including 10 CFR 50, Appendix B, and the conditions of the license. There is no impact on safety, beyond that described in the licensee's SAR E. Create a new department on-site to perform plant modjfications.

Basis: Change is Bdministrative. Design control, installation, testing, and maintenance activities are still performed in accordance with the licensee's quality assurance program description consistent with safety significance. Design basis information is still available to the personnel performing design modifications and the senior site/plant manager ~mains responsible for safety.

F. Create a matrix-type organjzation that allows for maintenance personnel to perform QC inspections of work performed by other maintenance personnel.

Basis: Personnel performing inspections are qualified per indUBtry, company, or licensee standards. Compliance with the prescribed standards in regard to independence of inspectors and organizations is ensured by a matrix reporting relationship to the assessment/inspection coordinator or assessment section supervisor within that department (maintenance department). Plant maintenance and inspection activities continue to be performed in accordance with plant procedures. There is no detrimental impact on plant safety significant activities, or on the safety analyses described in the SAR.

6

1901 Chouteau Avenue Post Office Box 149 St. Louts, Missouri 63166 314-621-3222 Docl<r:TEo Nov 2 9 1995 DOCl<ETJNG &

SERVICE 8RANc1-1 SEOY-NAC UNION ELECTRIC November 27, 1995

~)2' 6

Mr. John Hoyle ULNRC-03296 Secretary U.S. Nuclear Regulatory Commission DOCKET NUMBER Washington, DC 20555-00 01 PETITION RULE PRM 59 - E?I Attn: Docketing and Services Branch ( (ooF R.. "i-77 I lo) G)

Dear Mr. Hoyle:

Solicitation of Public Comments on NEI Petition on 10CPRS0.54(a) , Quality Assurance Program Changes ,

60 Federal Register 47716. September 14, 1995 Union Electric herewith submits comments to the proposed rule changes to 10CFR50.54(a), 60 Federal Register 47716, dated September 14, 1995.

Union Electric support s the petition in its entirety. We agree with the petitioner in that the current 50.54(a) has been appl ied too s tringently. The result has been unnecessary regulatory interactions on QA program changes involving no reduction in nuclear safety or the level of quality assurance. A change to 50.54(a) is clearly needed. The proposed change provides a process for evaluating QA program changes similar to the tried and proven 50.59 process. The result will be an evaluation that properly focuses on the effect of changes on nuclear safety.

Regarding the specific issues for which the NRC requested comments, Union Electric offers the following:

1. The proposed rule assures that unacceptable program changes wi l l not be made by providing for a review of impact on safety. By def i nition, then, unacceptable changes are those that involve an unreviewed safety question. Such changes cannot be made without NRC approval.

2. The Standard Review Plan, Regulatory Guides, and consensus standards provide guidance for acceptable methods to meet Appendix B. Alternative approaches are acceptable as long as Appendix Bis met. The petition provides an effective mechanism to implement acceptable alternative program controls while maintaining focus on safety. ,.DEC 1 4 1995

• Acfmowfedged by card ..................~.. ~:::=~

U.S. NUCLEAR REGULATORY COMMISSl*J~

OOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Postmanc Date 1,~ ( i?Rca\J ~ f e ~ ~ \\ ~q)

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3. Review and audit functions should remain in the QA program.

4. The unreviewed safety question threshold is the most appropriate reporting threshold.

5. A "decrease in effectiveness" threshold would create another subjective threshold with similar problems as the current 50.5 4 (a} language. Such a threshold would neces s itate more regulatory interactions. The 50.59 process is tried and true, and creates a clear, defined threshold.

6. No. Again, the 50.59 process is well understood and has a defined threshold.

7. The industry, through NEI , will develop guidance for evaluating QA program changes under the proposed rule.

8. Yes. Protection of the public will be enhanced by allowing licensees to make program changes that better focus on safety performance. By reducing the regulatory burden on changes that do not impact safety we will be able to provide more attention on areas important to safety.

We appreciate the opportunity to comment on this issue. Please contact us if you have any questions regarding this letter.

Very truly yours, A. C. Passwater Manager, Licensing & Fuels WBM/ s l d

cc: T. A. Baxter, Esq.

Shaw, Pittman, Potts & Trowbridge 2300 N. Street, N.W.

Washington, D.C. 20037 M. H. Fletcher Professional Nuclear Consul ting, Inc.

19041 Raines Drive Derwood, MD 20855-2432 L. Joe Callan Regional Administrator U.S. Nuclear Reg ulatory Commission Region IV 611 Ryan Plaza Drive Suite 400 Arlington, TX 76011-8064 Senior Resident Inspector Callaway Resid ent Office U.S. Regulatory Commi ssion RR#l Steedman, MO 65077 Kristine M. Thomas (2)

Office of Nuclear Reactor Regulation U.S. Nuclear Regulatory Commission 1 White Flint, North, Mail Stop 13E16 11555 Rockville Pike Rockville, MD 20852-2738 Manager, Electric Department Missouri Public Service Commission P.O. Box 360 J efferson City, MO 65102

Commonwealth Edison Company 1400 Opus Place Downers Grove, IL 6051 5 DOCKE ED U 'RC November 27, 1995 Secretary

,, 28 PJ :49 ComEd U. S. Nuclear Regulatory Commissio@FFiC~ OF SECRET~R ~

Washington D C 20555-0001 DOCKET! -G ~ SE?';! f

' . . BRA~CH DOCKET NUMBER ATIN: Docketing and Service Branch PETITION RULE PRM SQ -la?\

Subject:

Commonwealth Edison Company ( <oo FR.'-\ 7, \ G_)

Comments on Petition for Rulemaking Ci) 10 CFR 50.54(a) changes (Docket No. PRM-50-62)

Reference:

60 FR 4 7716 dated September 14, 1995

Dear Mr. Secretary:

Commonwealth Edison Company (ComEd) is submitting the following comments in response to a petition for rulemaking filed by the Nuclear Energy Institute (NEI) on behalf of the nuclear power industry. The petition is dated June 8, 1995, and was docketed as PRM-50-62 on June 19, 1995. The petitioner requests that the NRC amend its regulations in 10 CFR 50.54(a) to permit licensees to make certain changes to their quality assurance programs without prior approval from the NRC.

ComEd fully supports the subject petition. If enacted, the revised rule will enhance a licensees ability to allocate resources to important safety matters. The overall safety of a nuclear plant will be improved as resources are appropriately and effectively focused on competing safety risks.

ComEd appreciates the opportunity to comment on this matter, and would welcome any further interaction deemed necessary by the staff.

0:ze~ g~

Nuclear Licensing Administrator A Unicom Company

J.S. NUl.-'l.EAR REGULATORY COMMISSIOt-.

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• 95 OV 27 A1 1 :09 November 20, 1995 Secretary OFF ICE 0..- SECRETARY U.S.NRC OOCKE I 3 & ~:ER 1 ,CE Washington, D. C. 20555-0001 ~r{A CH Attention: Docketing and Services Branch DOCKET NUMBER

Subject:

Proposed NEI Amendment to 50.54 (a)

PETITION RULE PRM 59-~

l\cOfR.~11 \~ 6)

To Whom It May Concern:

The purpose of this letter is to provide official input into proposed NEI petitions to change the QA Rule and the provisions established in 50.54(a) which as I understand must reach your office by November 28, 1995.

The proposed NEI amendment would allow licensees to make a change to their QA programs without prior NRC approval if the change does not require a change to the technical specification. While this proposed amendment sounds convenient and logical, it provides for too much latitude in the licensee' s QA program which I do not believe the industry is ready for at this time. While it is recognized that the industry is changing and the competition is growing greater everyday and we must change with it, it is also recognized by many of the middle management employees (worker bee' s) in the nuclear industry that the change is occurring to rapidly without appropriate consideration for other situations. The upper management of this industry is changing things so rapidly that I believe it is getting out of control. Based on a NRC Regulatory Review document that your organization created sometime ago, many of the utilities are taking off in a completely different direction. The emphasis is now being placed on the issue associated with what a commi1rnent is, and what a commitment is not. It would appear that many of the utilities appear to be using this Regulatory Review document for many of the changes being made under the 50.54 (a) process using these guidelines as if they are already federal regulations. The term commitment is truly being taken out of context for the mere convenience of changing important QA program commitments. Many of the changes being made today affect the USAR and the commitments established in many of the licensee documents such as the commitments to Regulatory Guides and ANSI standards which are important elements of an effective QA Program. The ultimate affect of these important regulatory commitments is an effective and strong QA program. The deliberate and methodical demise of these important requirements is an ineffective QA program which is ultimately an accident looking for a place to happen.

In the past, changes to a QA Program were made with prior NRC approval if the change was considered to be a reduction in a commitment. However, in the manner that utilities are now making these changes, changes are occurring without prior NRC approval because some utilities have managed to convince themselves that if the change does not have a direct correlation to "safety" in some way, then the cltange cannot be a reduction in a commitment and can be implemented immediately, without NRC approval or knowledge prior to the change taking affect. While I recognize that some changes can and should be made based on logic and safety concerns, I do not believe this process should be allowed to continue as if wholesale changes are the menu of the day. Within the context of QA Program changes, and using the new rationale as a basis, I doubt seriously that any change to any QA Program would ever have a direct impact on a safety issue since the QA Program is generally a program statement and does not in and of itself represent anything other than general program requirements. In the.se *type cases, you wou!d-never have what would truly be considered a "reduction in commitment" which would ever require NRC approval prior to implementation.

Acmowledged by card~ -

U.S. NUCLEAR REGULATORY COMMISSIO~

DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Docunent Statistics Postmark Date u\~95 ~ 0 *95. \..~')

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Page 2 of2 I personally believe that one of the primary driving forces behind these changes is a convenient method of eliminating jobs and destroying families. The less regulation the industry has, the fewer the people it needs to run the plants. The safety culture is rapidly being replaced in this industry by the bottom dollar. That dollar sign drives everything we do in this industry. There are many examples in this industry to drive home the point, some of these examples will be shown here.

Graded QA Program, elimination ofTS audit frequencies based on performance monitoring programs, elimination of in line QA reviews in such areas as procurement document control, design reviews, nonconformance reviews, supplier annual evaluations, audit program requirements, elimination of effective verification of corrective action programs, elimination of supplier QA manual reviews, and the list goes on.

It is my understanding that only recently Entergy Operations submitted a 50.54 (a) to NRC Region IV eliminating the TS audit frequencies based on a performance indicator program. It is also my understanding that these type changes occurred when the utility is not fully ready to implement the new program nor have an effective performance indicator program in place to make these changes. It is also my understanding that Entergy Operations, Inc. submitted this change for information and did not ask for prior NRC prior to making this change. Another example of the bold new way some of these utilities are taking on this issue.

It almost appears that some utilities are challenging the NRC just to see how much they can get away with before the NRC stops some of these changes from occurring.

As a concerned employee of a nuclear utility, I am sincerely worried about the direction and future that some of these organizations are taking regarding the changes. This proposed change to the 50.54 (a) process is only one of many examples. Downsmng, right-sizing, re-engineering are the order of the day.

These changes are affecting morale throughout the industry and I believe the industry is heading in the wrong direction. It may not happen today or tomorrow, but there will come a day in the not too distant future when these rapid changes eliminating important elements of an effective QA program will have a devastating affect on this entire industry. And you, the NRC will be the bad guy for letting it happen. In this era of downsizing and cost cutting, it is also recognized that your organization must also reduce its size and let the utility do more self assessments and police there own organization. In this guise, I believe the NRC is carrying it to far. The analogy I can use in this change process is like crossing a railroad track with a train bearing down on you at 80 miles an hour. Right at the last minute, you floor the car and get out of the way. Saved again! However, one day the car will stall, you will sustain a direct hit and you and your car will be destroyed. This industry is a ticking ti.me bomb! Its ti.me to get back your control.

I highly recommend that you review this letter with the highest authority and consider the contents of this letter. It is ti.me to shore up the dike and rethink the direction this industry is heading in. Perhaps you need to recalibrate your thinking and go back and look at some of these issues. This kinder and gentler NRC is refreshing, but let's not take it too far.

In conclusion, please carefully consider this proposed NEI change to the 50.54 (a) process. And you might should consider policing up the industry and review some of the past changes that are occurring in this area.

I never thought I would live to see the day when I would welcome strong NRC enforcement and overview, but the day has come. I guess if I had to pinpoint a day when I wanted the NRC back in our yard again it was when the day of GRADED QA PROGRAMS came to be. I never believed in my lifetime I would see the day when a safety related component in a safety related system would be characterized as unimportant and treated in less of a manner than other safety related items. This is classic deregulation in its finest hour!

A concerned citizen and employee of the nuclear industry who for obvious reasons shall remain anonymous!

cc: Shirley Jackson NRC Chairman

Florida Power & Light Company, P.O. Box 14000, Juno Beach, FL 33408-0420 DOCK ETED US ~RC

• 95 DEC -4 Al 1 :56 0FFICE Or- .J Er_ PF fAR yN QV 2 ? 1995 00C KET IN~ I St.R 1nCf L-95-319 BRAHCH Mr. J.C. Hoyle, Secretary DOCKET NUMBER U. S. Nuclear Regulatory Commission PETITION RULE PAM 59- bo\

Washington, DC 20555-0001 ((£,Fl<-'-\i 711,,'5 © Attn: Docketing and Services Branch

Subject:

Nuclear E11ergy Institute; Receipt of a Petition for Rulemaking 60 FR 47716 Request for Comments On September 14, 1995, the Nuclear Regulatory Commission published for public comment, "Nuclear Energy Institute; Receipt of a Petition for Rulemaking." The Nuclear Energy Institute (NEI) petition requests that the NRC amend its regulations regarding quality assurance programs to permit nuclear power plant licensees to change their quality program described or referenced in a license's Safety Analysis Report (SAR) without prior NRC approval under specified conditions.

Florida Power & Light (FPL), a licensed operator of two nuclear power plant units in Dade County, Florida and two units in St. Lucie County, Florida, endorses the comments and recommendations that are being provided by NEI on behalf of the nuclear industry.

We appreciate this opportunity to comment.

Very truly yours, W. H. Bohlke Vice President Nuclear Engineering and Licensing WHB/spt

'M1V s_o__iggs_

Acknowledged bv eard .. ""'""'"""""""""

an FPL Group company

U.S. NUCLEAH i-u:G:.;LAIORY COMMISSIOI\.

DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics POSlmark Date 11\~\9<: ls?b,10.0 ,d,27)

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DOCKETED USN RC November 11 , 1995

• 95 0 17 A11 :OS 11 OFFICE CF S[: ~E LAn Y OOCKE Tl::G <~ :~*RVI CF Mr. John C. Hoyle, Secretary BRt1, 't,h U.S. Nuclear Regulatory Commission Washington, D. C. 20555 Mr. Hoyle:

Please accept this letter (as a additional comments to the letter submitted on 11 95) on the petition for rulemaking by NEI regarding quality assurance. This petition seem to be an attempt to reduce the Nuclear Regulatory Commission's role as regulatory authority body regarding nuclear safety issues.

NEI is requesting that the licensee have control over changes in the quality assurance programs except those changes that involve unreviewed safety questions (USQ) or technical specifications (TS). What is lacking in this petition is exactly who is making the decisions as to what is an USQ or change in TS - the licensee apparently.

If the licensee has the authority to change the QA and decide what is an USQ or change in TS, the only role left to the NRC is to accept the changes. Unless the QA is controlled by the NRC, there will be no controls on the licensee determining what they choose as an USQ or TS changes and then QA requirements.

If the above petition were to be approved, the licensee can decide what changes they choose to make and then tailor the QA to accept the change - leaving the NRC out of the process. The petitioner states that "if an analysis of a proposed change to the quality assurance program indicates that any unreviewed safety questions may be involved, a licensee would either decide not to institute the change or submit the change for NRC approval before implementation. Again, the licensee can make the decision as to what is an USQ and change the QA accordingly. If the licensee deems a certain issue to not be an USQ or change in TS, the issue may be changed and goes unreviewed by NRC. A specific example of this very matter is at the heart of the DSC controversy at Davis Besse. This request for rulemaking certainly seems tailored to fit the change that the licensee's [Centerior Energy] contractor [Vectra] made to the shell thickness of the casks (a reduction of thickness as a result of weld seam grinding). If the licensee has the authority by the Code to change the QA requirements and al.so has the right to be the determiner as to what is a change in margin of safety, then in effect the licensee has changed the original requirements which were approved by the NRC (SAR and SER) and is not required to submit this change to the NRC for oversight and approval. There is no doubt that this would afford the licensee the authorization to make unlimited changes in the original NRC approved-documents with essentially no regulatory overview by the NRC.

U.S. NUCL AR REG lATORY C::JMM SSIOt-.

DOCKET G & S 9VICE SECTION O~FICf OF THE= SECRETARY OF T, _ CO I.\IISSION Postmark Da1 Cop~s Re ,

Add'! Cop 1es R

This petition demands that the NRC give up its regulatory authority when it comes to quality assurance. Please consider this issue carefully. Unless there is an avenue for the NRC to control exactly what is determined to be an USQ involving a change in the margin of safety, NRC must to refuse to grant this petition for rulemaking as written .

Sincerely,

/!::::h:off-~

3417 Darlington Rd.

Toledo , Ohio 43606

Duquesne Lig1t Company Beaver Valley Power Station P.O. Box 4 Shippingport, PA 15077-0004 DOCKETED (412) 393-5206 (412) 643-8069 FAX USNRC GEORGES. THOMAS Division Vice President Nuclear Services Nuclear Power Division No vembe r '°Fn ~fu (lF SEC RE r RY

'O'O C'KITfHG & :ERVICE Secretary, U.S. Nuclear Regulatory Commission BHA CH Attention: Docketing and Services Branch Washington, DC 20555-0001 5o-6G\

((ooFR-477 l<ci)

Subject:

10 CFR Part 50 Petition for Rulemaking (Docket No. PRM-50-62)

Duquesne Light Company (DLC) is responsible for the operation of Beaver Valley Power Station Units 1 and 2. DLC is submitting the following comments on the 10 CPR Part 50 petition for rulemaking which was filed by the Nuclear Energy Institute (NEI) on behalf of the nuclear power industry. The petitioner requested that the Nuclear Regulator Commission (NRC) amend its regulations regarding quality assurance programs to permit nuclear power plant licensees to change their quality program( s) described or referenced in a Safety Analysis Report (SAR) without prior NRC approval under specified conditions.

DLC endorses the petition for rulemaking. The inability of licensee's to adjust quality assurance program descriptions and commitments without prior NRC approval is an administrative burden on licensees and can distract licensees and the NRC from more significant safety matters. DLC believes that the proposed amendment would improve regulatory consistency by instituting the same type of change process for the quality assurance program described or referenced in t.lie SAR as that delineated in 10 CPR Part 50.59. The proposed amendment will allow the attention and resources of the NRC and industry to be more appropriately and effectively focused on issues that could have an adverse effect on health and safety.

Thank you for the opportunity to comment on this issue. If you have any questions on this submittal, please contact Mr. K. L. Ostrowski, Manager, Quality Services Unit, (412) 393-7775.

Sincerely,

~5~~ George S. Thomas rrmv i 6 1995 .

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November 3, 1995 DOCKETED us~rnc Mr. John C. Hoyle, Secretary DOCKET NUMBER *95 NOV -9 P12 :QQ U.S. Nuclear Regulatory Commission PETITION RULE PRM !SQ- ~

Washington, D. C. 20555 (icor-"R."t-771(pJ OFF ICE or SEC RE. ,-/,RY OOC KE Tlt'G SE.h VICE Mr. Hoyle: BRANCH Please consider this letter as a formal comment on the petition for rulemaking by NEI regarding quality assurance. This petition seem to be an attempt to reduce the Nuclear Regulatory Commission's role as regulatory authority body regarding nuclear safety issues.

NEI is requesting that the licensee have control over changes in the quality assurance programs except those changes that involve unreviewed safety questions (USQ) or technical specifications (TS) . What is lacking in this petition is exactly who is making the decisions as to what is an USQ or change in TS - the licensee apparently.

The nuclear industry already has too much of the decision making ability concerning safety. It certainly seems that the utility can making changes, and then after the fact notify the NRC to accept the change or change the regulations to fit their concerns. If the licensee has the authority to change the QA and decide what is an USQ or change in TS, the only role left to the NRC is to accept the changes. Unless the QA is controlled by the NRC, there will be no controls on the licensee determining what they choose as an USQ or TS changes and then QA requirements.

If the above petition were to be approved, the licensee can decide what changes they choose to make and then tailor the QA to accept the change - leaving the NRC out of the process. The petitioner states that "if an analysis of a proposed change to the quality assurance program indicates that any unreviewed safety questions may be involved, a licensee would either decide not to institute the change or submit the change for NRC approval before implementation. Again, the licensee can make the decision as to what is an USQ and TS and change the QA accordingly.

I feel very uncomfortable with the NRC giving up any of its regulatory authority when it comes to quality assurance. Please consider this issue carefully. Unless there is an avenue for the NRC to control what is determined to be an USQ or TS involving a change in the margin or safety, I urge the NRC to refuse to grant this petition for rulemaking as written.

Sincerely,

~- ~~

Charlene F. Johnston 3417 Darlington Rd.

Toledo, Ohio 43606

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'6 1995

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U.S. NUCLEAR EGULA OR 'COMM! $10~

DOCKEl I G & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMl3SlON Postmark DJ~ \~~=~~----

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DOCKET NUMBER PETITION RULi.. .:. :PR~M::....:=~.,.. DOCKETED

((o()F~-477\0 USNRC

• 95 OCT 18 P3 :36 Marvin I. lewis 3133 Fairfield Street Philadelphia, PA 191~6 OFFICE OF ECRETAR Y (215)676 1291 DOC KE TING t,._ S(:RY!C E BRA~CH In the matter of

1. Health f-ff~cts Valuation, Letter from T. S. Kress, Chairman ACRS, to Jame~ R. Taylor, EDD NRC, dated Sept. 13, 1995.

2. Nuc- l e;,ir f-nprgy Institute petitions NRC for "reduct ion j n commitment" Federal Register Notice dated Sept. 14, 1995.

3. Petition for Rulemaking to AmPnd 10 CFR ~0.48 from W. Rasin, NEI, to J.C. Hoyl ~ , Secretary NRC, datect Feb. 2, 1995.

4. NHC considers one time~ year Automatic extension of rertain materials license~. NUREG/BR 0032 Vol 15 No. 33 News Releases dated September 1~, 1995.

~- NHC Staff asks public comment on proposal to reduce amount of operational data reported by nuclear power plant licensees.

NURf-G/RR 0032 Vol. 15 No. 31, dated September 1, 1995.

6. Compatibility with the International Atomic Energy Agency, Final Rule, FR dated Sept. ?8, 1995 at Page 50248, and Regulations on the Transport ation of Radioactive Material published in thP Fed~ral Register Sept. 28, 1995.

?. fhree related NUREGs were issued together for comment in Auyus.t 1995:

NURf-G l50~ ~Nonparametric-Statistical Methodology for the Design and Analysis of Final Status Decommissioning Surveys.

NLIRH:i l~06 Measurement Methods for Radiological Surveys ***

NIJRF.:G 1:307 Minimum Detectable Concentrations with Typical Radiation Survey Instruments ***

Dear Commis~ioners:

This c-omment letter contains comments on an entire group of recent rulemaking!:i "lnd other actions for which the NRC hai,;.

invited or allowed comment. I chose this unusual style for several specific reasons. The most important reason for which I cho~e this styl~ is to demonstrate a pattern in the recent rulemaking~ and other actions which places the public in a very unsaf~ rpgulatory milieu.

1. He"llth Effects Valuation:

Pr@sPntly thP NRC Staff is reronsidering the ancient

$1000 /person rem avoided health effects valuation used in the HOC~ and Flsewhere. $1000/person rem avoided c-alcul ates into a human life being worth about $1.5 million dollars. The ACRS has

~ugg~sted that $3 million/human life would he more consi stent with the valuation of human life in other Federal agencies. The Staff has s.uggested reducing the valuation of human life by discounting the $1000/person rem. This attitude on the Staff's and NHC's part to di~count human life is part of the NRC's an*oydnt, deficient attitude toward safety (ACRS Letter to James laylor dated 7-20-95.)

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2. NEI Petitions for "Reduction In Commitment."

What an amazing concept! Hey, if the nurlear industry makes a contrnct and if they don't want to fulfill that contract, they Lan give thtc*msPlves a "reduction in commitment." I wish that I could give myself d "reduction in commitment" from my mortgage by

~elf determination.

This is a rompletely parallel situation:

1. The nuclear induc;try makes a commitment,

2. llie NRC "would permit a licensPe (nuclear industry) to rhange (r~duction in commitment) its quality control program if it could

~how by analysis (esoteric. paperwork) that the change does nnt involv~ an unreview~d safety question (Safety questions remain after they are rev i ewe>d ! ) "

Aqain the public safety ic; subjected to an arrogant, deticiE:>nt attitudP, but this time the attitude arises from the nuclear industry in petitioning for these changes.

3. lhe lhermolag Debacle continues:

A fire retarddnt material failed to provide fire protection again and ag~in in testing. One person went to jail, finPs were levied, and the ThermoLag remains in place performing most t.lefic.iEmtly. The rPsult is the nuclear industry petitions for a "r~duction in commitment" and other relief thru rulemaking of 10 Cf-R ~0.48.

Ag<<in, the nuclear industry shows its arrogant, defic.ient attitude where safety is concerned.

4. f-orget safety; just change the rules.

With 10 CFR 30, 40, and 70, the NRC plans to extend li~enses tor~ years. Many small users bring their records up to date and do ~c;sential mdintenance at license renewal time like many peuple change th~ir ~mnkP alarm batteries on their birthday~.*

Smnll users need the shock of filling out a license and paying a f~e to gPt their attention on their radioactive sources. This is one ~mall way that the NRC c;hows its arrogant, deficient attitude toward !:,afety.

~- lhrow away the data before somehody finds it.

fhe NRC is proposing to reduce the amount of operational data reportPd liy nuc.:lear plant licPn~ees. TMI #2 would have liked this rulu. Think how little of the shoddy workmanship and arrogant attitude would have bePn reJ")orted during the acrident if the licensees dirl not have to report his operational data.

With nuclear plants aging, deficiencies will he hidden by this rule. Error~ of judgement and sins of commission need never rPach the light ot ciay. By reducing the amount of ciata reported sufficiently, the dying need never know where the radiation which rau~Pd their canr~r came.

3.

6. Lowe,t common denominator: domestic and foreign.

• 1he Uruguay Round of GATT requirc>s, 11 E:ach memhe>r $hall e>nsure the c:onformity ot* its laws, regulation,; and adminic;trative procedure~ with it& ot,ligations as provided in the annexed Agr~c:1ments. 11 (GATT WTO Marrakesh, Morrocco, dated 4/15/94.)

lhe AnnPxed Agr~em~nt~ are tens of thousands of pages. The NRC r~spomied to these annexed Agreements by a rule which r,romote& thP triln!:.portation by air of plutonium and oth1:>r radionuclides. The NRC again preo;ents it'.:i arrogant, deficient attitude toward !:'>afety L,y promoting the air transportation of plutonium and othP.r rarHonuclides while the country is in the throes of a 11 unahomer 11 scare>.

7. The Devil is in the details.

CommissionPr ~- Gail Deplanque said in a ~pPech on November 29, 1~94, 11 The Devil i~ in the details. 11 The Commis'.:iioner ic; correct. By manipulating dPtails as described in NUR~Gs 150~,

1506, dnd 1507 ~n investigator could come up with any int@rpretatinn which he wished. The recent Thermal ag criminal Cd~e again*t a fhermoLag principle demonstrated that manipulation of tPchnical data is impossible for a jury of good citizens to overcome.

lt1P samP might he ~aid for NRC staff or just ahout anyone.

Our Nation ha* entered an era of technology where a half dozen reprobates can derail a train with crowbars, where a 11 unahumer 11 can kill for two decades, where a former foe sells lioml.J gradE' matPrial on the black market. The NRr. must wake up to the r~alities of today and understand that its primary agenda is haf~ty in&tead of licPnsing at any co&t.

Suggestion, reque,t, plea for help.

Stop producinCJ more and more radioactive wastes. We will have>

c1 lot of Wd-;t<? .ano lose uur Country. Stop production now.

lf thE:.> NRt: is really ~Prious ahout safE:.>ty, call me at 215 676 1291 and I will show you how to increase safety.

Respectfully suhmittt?d,

~~,/~~

10-15-95

occ* E ; *u.Ji ~

PETIT! ULE PRM ~ DOCKETED PRM 50-62 l.,'-b ~~77 \c;) (D US NRC Response to the NEI petition to modify the 10 CFR 50.54 {a) .~ qlij(fi'trt A change a quality assurance commitment.

1. The definition of what constitutes a reduction in thepffl~~0f 9~ ~YARY assurance convnitment may need some further definition so f1DUK *S sg R.VICE predictable process for arriving at a decision. The unrev1ewe ~~~

question standard of 50.59 is not suited for that task. The 50 .o9 standard was created to evaluate changes to the plant {whether certain equipment or the procedural need for certain functions of equipment is required) and evaluates such changes using quantitative terms such as "probability" and "margin". The quality assurance reduction in commitment standard decides, in more qualitative 10 CFR Part 50 Appendix B terms such as "adequate confidence", the question of whether a required piece of equipment will perform satisfactorily.

Depending on how one wants to interpret the "mays" of the 50.59 standard either all or no changes to the quality assurance program would be unresolved safety questions.

2. The use of 10 CFR 50.59 should not be expanded to quality assurance requirements because the NRC and the nuclear power industry have yet to agree on the extent of changes that can be made using 50.59 on issues already covered by the regulation. An industry document exists {NSAC-125) which is used to implement 50.59. In various papers in 1990-2, the NRC directed its staff to work with the industry to come to an understanding on 50.59 and endorse the resulting guidance. In a March 1993 paper the NRC staff told the NRC that they still had differences with the industry guidance. Now 2 1/2 years later those differences apparently have not been addressed. With differences still unresolved, why should more decisions be subject to a regulation which is not applied in the same manner by the NRC staff and industry?

U.S. N:JG.::. * . ,,., ._,.., 10R COMMISSIO~

DOCKETING & SERVICE SECTION OFFICE OF THE SECRETARY OF THE COMMISSION Document Statistics Copies Rece1ved_~ - - - - - -

Add'1 Copies Reproduced _ ..s_ _ _ __

Special Distribution :d.a ,,.,,.. . ~ e,

October 10, 1995 Note to: Mike Lesar, PDR, RIDS The attached comment in PRM-50-62 was received by Docketing and Service with no signature of the sender and no return address. It is being treated as an anonymous comment.

Jeanne Shoemaker, SECY

ooc~~o-PJ US RC NUCLEAR REGULATORY COMMISSION 10 CFR Part 50 *95 SEP -7 PS :12

[Docket No. PRM-50-62]

OFFICE OF S~CRET/.1.RY Nuclear Energy Institute; DOC KE TING 8;_ SERVICE Receipt of a Pet ition for Rulemaking BRAW:H DOCKET NUMBER AGENCY: Nuclear Regulatory Commission. PETITION RULE PRM ~

( loor--R.. 4'17 \ 0

- ACTION: Petition for rulemaking; Notice of receipt.

SUMMARY

The Nuclear Regulatory Commission (NRC) has received and requests public comment on a petition for rulemaking filed by the Nuclear Energy Institute (NEI) on behalf of the nuclear power industry. The petition has been docketed by the Commission and assigned Docket No. PRM-50-62. The petitioner requests that the NRC amend its regulations regarding quality assurance programs to permit nuclear power plant licensees to change their

- quality program described or referenced in a licensee's Safety Analysis Report (SAR) without prior NRC approval under specified conditions. The petitioner believes that this amendment would improve the regulatory process and increase the safety of commercial nuclear power plants through a more efficient use of agency and industry resources.

~~ ~~) \9q~

DATE: Submit comments by ( ~ays after Qate ef puelicatieR).

• Comments received after this date will be cons idered if it is practical to do so, but assurance of consideration cannot be given except to those comments received on or before this date.

2 ADDRESSES: For a copy of the petition, write: Rules Review Section, Rules Review and Directives Branch, Division of Freedom of Information and Publications Services, Office of .Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

Submit comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Attention: Docketing and Services Branch.

Deliver comments to 11555 Rockville Pike, Rockville, Maryland, between 7:45 am and 4:15 pm on Federal workdays.

Electronic Access Comments may be submitted through the Internet by addressing electronic mail to INTERNET:SECY@NRC.GOV. Comments may also be submitted electronically, in either ASCII text or WordPerfect format (version 5.1 or later), by calling the NRC Electronic Rulemaking Bulletin Board (BBS) on FEDWORLD.

The BBS is an electronic information system operated by the National Technical Information Service of the Department of Commerce. The purpose of

~ this bulletin board BBS is to facilitate public participation in the NRC regulatory process, particularly rulemakings. With publication of this notice, proposed rulemakings and appropriate supporting documents will be available for review and comment on the BBS. These same documents are also available for review and comment at the NRC's Public Document Room, 2120 L Street, N.W. (Lower Level), Washington, DC. The BBS may be accessed using a persondl computer, a modem, and one of the commonly available communications software packages, or directly via Internet.

3 The NRC rulemaking bulletin board (rulemaking subsystem) on FEDWORLD can be accessed directly by using a personal computer and modem, dialing the toll free number at 1-800-303-9672. Communication software parameters should be set as follows: parity to none, data bits to 8, and stop bits to I (N,8,1).

Using ANSI or VT-100 terminal emulation, the NRC rulemaking subsystem can then be accessed by selecting the "Rules Menu" option from the "NRC Main Menu."

For further information about options available for NRC at FEDWORLD consult the RHelp/Information Center" from the "NRC Main Menu." Users will find the "FEOWORLD Online User's Guides" particularly helpful. Many NRC sl'bsystems and databases also have a "Help/Information Center" option that is tailored to the particular subsystem.

The NRC subsystem on FEDWORLD also can be accessed by a direct dial phone number for the main FEDWORLD BBS at 703-321-3339; or by using Telnet via Internet: fedworld.gov. Using the 703 number to contact FEDWORLD, the NRC subsystem will be accessed from the main FEDWORLD menu by selecting the 11 Regulatory, Government Administration and State Systems," then selecting "Regulatory Information Mall." At that point, a menu will be displayed that has the option "U.S. Nuclear Regulatory Conrnission" that will take you to the NRC Online main menu. The NRC Online area also can be accessed directly by typing "/go nrc at a FEDWORLD colTflland line.

11 If you access NRC from FEDWORLD's main menu, then you may return to FEDWORLD by selecting the "Return to FEOWORLOR option from the NRC Online Main Menu. However, if you access NRC at FEDWORLD by using NRC's toll-free number, then you will have full access to all NRC systems, but you will not have access to the main FEDWORLD system.

4 If you contact FEDWORLD using Telnet, you will see the NRC area and menus, including the "Rules Menu." Although you will be able to download documents and 1eave messages; you wi 11 not be ab 1e to-write comments or up 1oad files. If you contact FEDWORLD using File Transfer Program (FTP), all files can be accessed and downloaded, but uploads are not allowed, and all you will see is. a list of files without descriptions (normal Gopher look). An index file listing all files within a subdirectory, with descriptions, is available.

There is a 15-minute time limit for FTP access.

Although FEDWORLD also can be accessed through the World Wide Web as well, like FTP, that mode only provides access for downloading files, and does not display the NRC "Rules Menu."

For more information on NRC bulletin boards call Mr. Arthur Davis, Office of Information Resources Management, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 415-5780; e-mail AXD3@nrc.gov.

FOR FURTHER INFORMATION CONTACT:

Michael T. Lesar, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Telephone:

301-415-7163 or Toll Free: 800-368-5642.

SUPPLEMENTARY INFORMATION:

The Petitioner The petitioner is the Nuclear Energy Institute {NEI). NEI represents that it is responsible for establishing unified nuclear industry positions o.n matters affecting the nuclear energy industry, including the regulatory

5 aspects of generic operational and technical issues. NEI's members include all utilities licensed to operate tolTITlercial nuclear power plants in the United States, nuclear power plant designers, major architect/engineering firms, fuel fabrication facilities, nuclear materials licensees, and other organizations and individuals involved in the nuclear energy industry.

Background

The NRC received an NEI petition for rulemaking on June 12, 1995. The petition is dated June 8, 1995, and was docketed as PRM-50-62 on June 19, 1995. The petitioner requests that the NRC amend its regulations in 10 CFR 50.54(a) to permit licensees to make certain changes to their quality assurance programs without prior approval from the NRC. The petitioner believes that this will change the quality assurance process consistent with the change process for other matters described in the SAR.

Discussion of the Petition The petition states that the current§ 50.54(a) allows NRC licensees to

.change their quality assurance programs as long as any prior commitment in that program is not reduced. The petitioner believes that if a corrmitment is to be reduced, a licensee needs NRC approval prior to implementation. The petitioner believes that this requirement is sometimes interpreted by the NRC as requiring NRC prior approval for any changes tn the quality program, no matter the degree of safety significance. The petitioner believes that prolonged and sometimes unnecessary regulatory interactions often occur centered on the correct interpretation of the term "reduction in corrmi tment. "'

The petitioner cites the following examples of topics that have been the subject of concern in the past:

6

• Changes in the level of approval of administrative, implementation or policy procedures, regardless of the safety s.i gn i ficance.

• Changes in the company organization as it is described in the licensee's original quality plan.

• Changes to audit, review or surveillance frequencies that have minimal, if any, safety significance.

• Adoption of a more recent national standard that may, or may not, have been endorsed by the NRC staff that results in a different implementation methodology, yet fulfills the same function and achieves the same objective as the original standard described in the quality program description through the use of enhanced technology or other developments.

• Adoption of different, more effective and efficient quality processes than those described in a licensee's original quality plant based on the safety significance and past operating performance.

The petitioner believes that the current provisions of§ 50.54(a}

related to the quality assurance program change process are inconsistent with the requirements associated with other changes to the SAR {see§ 50.59).

7 The petitioner believes that a licensee's inability to adjust its quality assurance program descriptions and commitments without prior NRC approval is a significant administrative burden on a licensee and can distract a licensee and the NRC from more significant safety matters. The petitioner also believes that the proposed amendment would improve regulatory consistency by instituting the same type of change process for the quality assurance program described or referenced in the SAR (i.e., a change process similar to the process delineated in§ 50.59). The petitioner believes that the proposed amendment ensures that the attention and resources of NRC and industry would be more appropriately and effectively focused on issues that could have an adverse effect on public health and safety.

The petitioner further believes that the proposed amendment is consistent with the overall objectives of the 1993 Report of the National Performance Review, conducted by the Vice President of the United States, and the 1995 congressional initiatives on improving Federal regulations. In conjunction with phase two of the NRC's national performance review study, a

, review of current NRC regulations has been performed to identify regulations that are obsolete, unnecessarily burdensome, too prescriptive, or that overlap or duplicate other regulations.

The petitioner states that the NRC's Regulatory Review Group (RRG), in its review of power reactor regulations and related processes, programs, and practices, identified specific examples of inconsistency and incoherence in the current regulations and their associated administrative requirements. The RRG also provided recorrnnendations for improvement. The petitioner states that, in some of the areas reviewed by the RRG, licensees are responsible for controlling specific activities that are very similar in nature to the quality

8 assurance process; however, these other activities are subject to different regulatory constraints, reporting, and record retention requirements.

The petitioner cites the following*examples that the regulatory review group provided in its report of August 1993:

• Changes that can be made by a licensee to a facility or procedures without prior NRC approval if the change does not require a change to the Technical Specifications or involve an unreviewed safety question ....

Changes that can only be made to a license's quality assurance program described or referenced in the SAR without prior NRC approval if they do not reduce conunitments in the program description previously accepted by the NRC, even if the changes do not affect the Technical Specifications, involve unreviewed safety questions, or have any adverse safety significance ....

• Varying record retention and reporting frequencies for activities of a similar nature, such as those associated with quality assurance* and changes to the SAR.

The petitioner agrees with the NRC's RRG finding that there is no reason for these inconsistencies in the NRC's regulations. The petitioner believes that regulatory effectiveness would be improved, the burden on licensees and the NRC reduced, and regulatory coherence enhanced if there were a consistent change process for changes to the facility, its procedures, tests and experiments, or other matters as described in the SAR.

The petitioner states that in the development of a more efficient and effective quality regime, it is important that licensees not be discouraged by an unnecessary administrative burden of seeking prior NRC approval when a

9 change 1s of no regulatory significance {i.e., does not result in non-compliance with the NRC's regulations, a change to the technical specifications, or an unreviewed safety question). The petitioner also states that in an evolving technological environment, each licensee should be allowed the opportunity to respond to improvements in technology, industry operating experiences, and new operational or technical information by making changes to its quality assurance program that do not degrade protection of the public health and safety without the need for administrative and managerial regulatory interactions.

The petitioner states that the proposed amendment does not introduce a new type of change process. The petitioner believes that the proposed amendment is based on a well~tried and proven process for making changes to a facility, its procedures, tests, or activities that are described or referenced in the SAR. *compliance with the regulations to ensure proper control of a facility and the quality program associated with the protection*

of public health and safety is still provided by the adoption of a change process that is similar to the established§ 50.59 process.

Section 50.59, Changes, tests and experiments, allows the holder of a license authorizing operation of a production or utilization facility to (i) make changes in the facility as described in the SAR, (ii) make changes in the procedures as described in the SAR, and {iii) conduct tests or experiments not described in the SAR, without prior Commission approval, unless the proposed changes, test$, or experiments, involve a change in the technical specifications incorporated into the license or an unreviewed safety question.

The petitioner believes that its proposed amendment would allow the licensee to have the authority to change its quality program if analysis, as

10 described 1n § 50.59, demonstrates that a proposed change does not involve an unreviewed safety question or change the technical specifications. The petitioner states that the analysis to~support this determination would be consistent with that required to support other types of changes to an SAR; therefore, it would be based on the well-proven and established industry guidance.

The petitioner believes that if the analysis of a proposed change to the quality assurance program indicates that any unreviewed safety questions may be involved, a licensee would either decide not to institute the change or submit the change for NRC approval before implementation. For changes involving an unreviewed safety question, the complete change, including the safety evaluation, would be submitted in accordance with the requirements of

§ 50.90.

The petitioner states that the proposed amendment would maintain the requirements of§ 50.4, requiring licensees to submit a report containing a summary description of the changes to the quality assurance program described

.or referenced in the SAR. The petitioner states that the report would be submitted annually, or along with the FSAR updates as required by

§ 50.7l(e), or at shorter intervals as determined by each licensee. The petitioner states that licensees would maintain records of the changes as facility records for 5 years, a period that is consistent with other similar NRC regulations (e.g. § 50.59).

The NEI did not address the impact of removing§ 50.4(b)(7)(i) from the Colllllission's regulations or why NEI believes the deletion is necessary.

The petitioner's suggested amendment would require that only a sunrnary, not a detailed safety evaluation, be submitted to the NRC for changes that do

11 not involve a Technical Specification change or an unreviewed safety question.

The petitioner believes that this is consistent with the requirements of similar regulations (§ 50.59). The petitioner also believes that th~ proposed amendment would require that licensees maintain records of these evaluations until the termination of the license.

The petitioner has provided supplemental analyses to facilitate the NRC's consideration of the effect of the proposed action on the environment and small business entities, as well as the paperwork burden on all entities that would be affected by the change. NEI also included analyses to assist NRC in its consideration of the need for a regulatory analysis or application of the backfit rule to this rulemaking.

The NRC is soliciting public comment on NEI's petition requesting the changes to regulations in 10 CFR Part 50 as discussed below.

The Petitioner's Proposed Amendment The petitioner recommends the following amendments to 10 CFR Part 50.

§ 50.4 [Amended]

1. In§ 50.4, paragraph (b)(7){i) and the designation for paragraph (b)(7)(ii) are removed.

2. In§ 50.54, paragraph {a) is revised to read as follows:

§ 50.54 Conditions of licenses.

(a){l) Each nuclear power plant or fuel reprocessing plant licensee shall implement a quality assurance program pursuant to§ 50.34{b){6)(ii) of this part, as described or referenced in its Safety Analysis Report.

(2) Each licensee described in paragraph (a){l) of this section may make a change to a previously accepted quality assurance program description

12 included or referenced in its Safety Analysis Report without prior Cofl1Tlission approval unless the proposed change involves a change to the technical specifications incorporated in the license or involves an unrev.iewed safety question.

(i) A change shall be deemed to involve an unreviewed safety question

{A) if the probability of occurrence or the consequences of an accident or malfunction of equipment important to safety previously evaluated in a licensee's Safety Analysis Report may be increased; or (B) if a possibility for an accident or malfunction of a different type than any previously evaluated in a licensee's Safety Analysis Report may be created; or (C) if the margin of safety as defined in the basis for any technical specification is reduced.

{ii) When changes are made to a previously accepted quality assurance program description, a licensee shall submit, as specified in§ 50.4, a report containing a brief description of the change, including a summary of the safety evaluation of each change. The report may be submitted annually, or

~along with FSAR updates as required by§ 50.71(e), or at shorter intervals as determined by each licensee.

(iii) Records of changes to the quality assurance program shall be maintained as facility records for five years.

(3) For changes to the quality assurance program description that involve an unreviewed safety question, licensees shall submit the proposed change to the NRC for approval before impl~mentation. The licensee shall submit the application to amend the quality assurance program pursuant to the requirements of§ 50.90.

13 (4) For changes that involve a change to the technical specifications, a licensee shall submit an application for a license amendment pursuant to

§ 50.90.

Specific Areas for Public Comment In addition to commenting on the petition for rulemaking (petition)

• presented above, the NRC staff is soliciting specific conments on the issues presented below. Because the NRC staff has not yet developed its positions on the petition, it is soliciting these comments to obtain information that it may consider in developing future rulemakings that provide procedures for licensees to make changes to its quality assurance program.

1. 10 CFR 50.54(a) was issued on January 10, 1983, to correct instances where licensees had changed their programs that resulted in some unacceptable programs without informing the NRC. What assurances exist to prevent a similar situation from recurring if the petition and the revised threshold for reporting QA program changes is adopted? Is it necessary that such situations be prevented from occurring by adoption of a regulatory approval system?

2. Traditionally, the NRC staff has used a variety of documents such as the NRC Standard Review Plan, NRC Regulatory Guides, and associated industry consensus standards to delineate what QA program elements are necessary to meet Appendix B. Should these standards continue to be used to define acceptable QA programs? Should a licensee QA program change that constitutes a departure from a commitment to comply with a specific

14 regulatory position be considered of sufficient importance that the NRC should be notified in advance of implementation? How would such changes be evaluated under the petitioner's proposed criterion?

3. The NRC has allowed licensees to relocate administrative controls for review and audit functions from the technical specifications. Examples include details on safety review committees, audits, and technical

• review functions. These have been relocated to the QA program based on the existing change control provisions in§ 50.54(a). Would it be appropriate for activities such as safety review convnittees, independent technical review groups, and audits to be controlled so that only licensee changes exceeding the threshold of an unreviewed safety question (USQ) be reported to the NRC for pre-review before implementation? What kind of changes to a licensee's QA program would constitute a USQ? Assuming that the USQ should/could be applied, does not the use of§ 50.59 effectively negate the administrative and regulatory advantage of removing this information from technical specifications (because both technical specification changes and USQs are subject to an opportunity for hearing)? If the revised QA change control mechanism is adopted should aspects of the review and audit functions remain in the QA program or be relocated elsewhere to ensure appropriate NRC review of changes prior to implementation?

15 4., Are there alternative thresholds for determining whether a licensee must submit their QA program changes for advance review in lieu of the USQ threshold? Provide a technical -and/or policy explanation as to why this or any other threshold would be more appropriate.

5. The NRC Regulatory Review Group (RRG) examined change control mechanisms in§ 50.54 for control of licensee plans and programs (quality assurance, security, and emergency preparedness). The RRG recommended that licensees should have greater flexibility to make changes in their programs without having to receive prior NRC approval. Currently, QA program changes that "reduce the commitments in the program" are submitted for NRC staff review before implementation. Similarly, security plan changes that "decrease the effectiveness" are submitted for staff review before implementation. Should the staff consider a revision to§ 50.54(a) to set the threshold for reporting QA program changes for NRC pre-review that constitute a decrease in effectiveness?

Would a "decrease in effectiveness" standard in§ 50.54(a) provide a sufficiently flexible and technically reasonable criteria for licensees to report QA program changes to the staff before implementation?

6. Should the NRC staff consider retaining the current language of

§ 50.54(a) and to define explicit guidance or identify examples on what types of QA program changes would be considered to "reduce the co11111itments in the program"? By developing this guidance could sufficient flexibility be afforded to licensees to make changes in their QA program without having to undergo a pre-review by the staff?

16

7. The petition proposes to apply a§ 50.59 process to evaluate QA program changes to determine the necessity for pre-review by the staff.

Industry guidance for§ 50.59 exists within NSAC-125 "Guidelines for

§ 50.59 Safety Evaluations." NSAC-125 appears to contain little relevant guidance that would be helpful for determining whether QA progranvnatic changes would constitute a USQ that requires NRC pre-review of the change. In particular, Section 4.2 of NSAC-125 deals principally

• with evaluating changes associated with nuclear plant equipment and not programmatic controls. Is existing guidance for processing 10 CFR 50.59 evaluations sufficient for evaluating QA program changes? What factors or aspects of the existing industry guidance would need to be supplemented? What types of QA program changes would be necessary to report to the NRC if the current§ 50.59 criteria were applied to QA program changes? What are examples of QA program changes that should be considered as meeting the USQ threshold?

8. Would protection of the public health and safety be enhanced if the petition were granted, and if so, in what way? What licensee and NRC costs would be reduced, or increased, if the petition were granted?

Dated at Rockville, Maryland, this 7th day of September, 1995.

For the Nuclear Regulatory Commission.

G_

I NUCLEAR ENERGY IN STITUTE William H. Rasin VICE PRESIDENT ,

TECHNICAL/REGULATORY June 8, 1995 DOCKET NUMBER Mr. John C. Hoyle PETITION RULE _PR_M_ _~

Secretary of the Commission (CoOFR..'i--7'1 I1/2)

U.S. Nuclear Regulatory Commission Washington DC 20555

Dear Mr. Hoyle:

The Nuclear Energy Institute (NEI), on behalf of the nuclear energy industry, hereby submits a Petition for Rulemaking pursuant to 10 CFR 2.800 et seq. The Petition for Rulemaking requests that the U.S. Nuclear Regulatory Commission amend certain aspects of 10 CFR 50.54(a) that are related to quality programs at commercial nuclear power plants.

NEI would be pleased to discuss this petition and to respond to any questions NRC personnel may have regarding its content or application.

Sincerely,

~_;-

William H. Rasin WHR/jes Enclosures 1776 I STREET , NW SUITE 400 WASHINGTON , DC 20006-3708 PHONE 202 739 8088 FAX 202 . 785 1 898

Postmar1t Date UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION In the Matter of a )

Proposed Rulemaking ) Docket No.

Regarding Amendments to )

10 CFR Part 50.54(a) )

PETITION FOR RULEMAKING

SUMMARY

This petition for rulemaking is submitted pursuant to 10 CFR 2.802 by the Nuclear Energy Institute (NEI) on behalf of the nuclear energy industry. Petitioners request that the U.S. Nuclear Regulatory Commission ("NRC"), following notice and opportunity for comment, amend certain portions of the regulations contained in 10 CFR 50.54 to improve the effectiveness and efficiency of the regulations pertaining to licensee initiated changes to their quality programs. This petition is the first of several petitions being considered *by NEI to improve the consistency of the regulatory change process associated with matters that are described or referenced in a Safety Analysis Report (SAR).

Currently, 10 CFR 50.54(a) allows licensees to make changes to a previously accepted quality assurance program description included or referenced in a SAR without prior NRC approval, provided that the change does not reduce the commitments in the program description previously accepted by the NRC. Changes to the quality assurance program description that reduce commitments must receive NRC approval prior to implementation.

This proposed amendment would permit a licensee to change its quality program as described or referenced in the SAR, without prior NRC approv~ providing the change does not involve an unreviewed safety question, or result in a change to the Technical Specifications incorporated in its license. This will :p:iake the process for changing the quality assurance program consistent with the change process for other matters described in the SAR. *-

The proposed change is commensurate with the recommendations of the 1993 Report of the National Performance Review conducted by the Vice President of the United States and the 1995 Congressional initiatives currently under consideration to improve the general regulatory regime. The proposed change will significantly 1

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improve the regulatory process and increase the safety of commercial nuclear power plants through a more efficient use of agency and industry resources by improving the focus on matters that have safety significance while reducing unnecessary burdens on licensee and NRC staffs.

In addition to setting forth the information required under 10 CFR 2.802(c) for a petition for rulemaking, NEI has provided supplemental analyses to facilitate the NRC's consideration of the effect of the proposed action on the environment, small business entities, and the paperwork burden on those entities that would be affected by the change. Further, because the NRC must consider whether a regulatory analysis must be performed as well as whether 10 CFR 50.109 (the Backfit rule) applies to this rulemaking, NEI also has included its analysis of those subjects (see the Appendix, Supplementary Analyses in Support of the Petition for Rulemaking).

STATEl\IBNT OF PETITIONER'S INTEREST NEI is responsible for establishing unified nuclear industry policy on matters affecting the nuclear energy industry, including the regulatory aspects of generic operational and technical issues. NEfs members include all utilities licensed to operate commercial nuclear power plants in the United States, nuclear plant designers, major architect/engineering firms, fuel fabrication facilities, nuclear materials licensees, and other organizations and individuals involved in the nuclear energy industry. NEI is an "interested person" within the meaning of 10 CFR 2.802.

STATEl\IBNT IN SUPPORT OF THE PETITION A. Background There have been a number of studies and surveys in recent years to identify areas of excessive regulatory burden that have no, or marginal, safety significance. In addition, these studies have recommended areas for further investigation and

. included proposals for improving the effectiveness of the NRC regulations.

In 1992, the NRC reported in the Federal Register that it had been assessing NRC regulations that had no significant safety benefit and imposed large burdens on licensees. A summary of the initial NRC conclusions was published for public comment on February 4, 1992 (57 Fed. Reg. 4166). The subsequent public comments were summarized in the announcement of a public workshop to discuss the NRC program for Elimination of Requirements Marginal to Safety (57 Fed. Reg. 55156, November 24, 1992). In that announcement, the NRC stated its commitment to reducing unnecessary regulatory burdens so as to improve 'the* focus and effectiveness of its regulations. This commitment was commensurate with the 2

intent of the February 1992 request from the President of the United States for federal agencies to conduct a special review of existing federal regulations. The NRC's 1992 study identified performance-based quality assurance as a concept that warranted further study. In addition, the public comments suggested further analysis would be appropriate in the area of the quality assurance criteria contained in 10 CFR Part 50, Appendix B, to assess the potential for burden reduction that would have no impact on safety.

On January 4, 1993, the Executive Director of Operations, NRC, established a Regulatory Review Group to conduct a review of power reactor regulations and related processes, programs, and practices with special attention placed on the feasibility of substituting performance-based requirements and guidance for the existing prescriptive requirements and guidance. Subsequently, the NRC Regulatory Review Group identified specific examples of inconsistency and incoherence in the current regulations and their associated 11droinistrative requirements, and provided recommendations for improvement. In some of these areas, licensees are responsible for controlling specific activities that are very similar in nature, but are the subject of different regulatory constraints, reporting, and record retention requirements. Examples provided in the Regulatory Review Group Report, dated August 1993, included:

• Changes that can be made by a licensee to a facility or procedures without prior NRC approval if the change does not require a change to the Technical Specifications or involve an unreviewed safety question (i.e., 10 CFR 50.59).

• Changes that can only be made to a licensee's quality assurance program described or referenced in the SAR without prior NRC approval if they do not reduce commitments in the program description previously accepted by the NRC, even if the changes do not affect the Technical Specifications, involve unreviewed safety questions, or have any adverse safety significance (i.e., 10 CFR 50.54(a)).

• Varying record retention and reporting frequencies for activities of a similar nature, such as those associated with quality assurance and changes to the SAR.

NEI concurs with the NRC Regulatory Review Group Report that there is no reason for such inconsistencies in the NRC regulations. Regulatory effectiveness would be improved, the burden on licensees and the NRC reduced, and regulatory coherence enhanced if there were a consistent change process for changes to the facility, its procedures, tests and experiments, or other matters as described in the SAR.

Further, in the NRC staff briefing of the Commission on January 24, 1994, on the Regulatory Review Group Report Implementation Plan, the need for a consistent approach for dealing with regulatory commitments was acknowledged. As such, the 3

NRC and industry have been developing a method of addressing the issue of commitments and their associated change process that is based on a determination of safety significance. However, because the quality assurance program change process is specifically addressed in the regulations through Section 50.54(a), it has not been included in that activity.

Currently, under Section 50.54(a) a licensee has the flexibility to change commitments in the quality assurance program as long as any prior commitment in that program is not reduced. If a commitment is to be reduced, a licensee needs NRC approval prior to implementation. This requirement is sometimes interpreted by the NRC as requiring NRC prior approval for any changes in the quality program, no matter the degree of safety significance. Prolonged and sometimes unnecessary regulatory interactions often occur centered on the correct interpretation of the term "reduction in commitment." In this regard, examples of topics that have been the subject of concern in the past include:

• Changes in the level of approval of administrative, implementation or policy procedures, regardless of the safety significance.

• Changes in the company organization as it is described in the licensee's original quality plan.

• Changes to audit, review or surveillance frequencies that have minimal, if any, safety significance.

• Adoption of a more recent national standard that may, or may not, have been endorsed by the NRC staff that results in a different implementation methodology, yet fulfills the same function and achieves the same objective as the original standard described in the quality program description through the use of enhanced technology or other developments.

• Adoption of different, more effective and efficient quality processes than those described in a licensee's original quality plan based on the safety significance and past operating performance.

Based on preliminary estimates from a cross section of industry representatives on the NEI Appendix B Working Group, the cost to the industry (excluding NRC costs and fees) of these activities is in excess of one million dollars per year. More importantly, on occasions licensees are hesitant to pursue quality program improvements that may be interpreted by the NRC as a reduction in commitment.

Such hesitancy is caused by the potential resource burden associated with regulatory interactions on changes to a licensee's quality program where matters might be interpreted as a reduction in commitment, even though the ultimate result would be an improvement in efficiency, quality, and/or safety.

4

Under Section 50.59, a licensee's ability to make changes in the facility described in its SAR is technically sound and procedurally pragmatic, allowing the licensee the latitude to make a change without prior NRC approval unless the change results in a change to the Technical Specifications, or involves an unreviewed safety question.

The method developed for addressing and managing regulatory commitments that is being proven through pilot implementation projects with several licensees is based on the safety significance of the proposed change, not on a reduction in commitment. In the process both for managing commitments and changes to the SAR under Section 50.59, the focus is appropriately on those changes that have safety significance. However, regarding quality assurance programs, the threshold for seeking prior NRC approval is associated with the interpretation of what constitutes a reduction in a licensee's "commitment" rather than its safety significance.

Further, the provisions of Section 50.54(a) describing the change process for a licensee's quality program description included or referenced in the SAR are inconsistent with the requirements associated with other changes to the SAR. A licensee's inability to adjust its quality program descriptions and commitments without prior NRC approval is a significant administrative burden on a licensee and can distract licensee and NRC attention from more safety significant matters.

The proposed amendment would improve regulatory consistency by instituting the same type of change process for the quality assurance program described or referenced in the SAR as for other matters described in the SAR (i.e., a change process delineated similar to Section 50.59). The result would assure that industry and NRC attention and resources are more appropriately and effectively focused on issues that could have an adverse impact on public health and safety.

B. Proposed Change to 10 CFR 50.54 (a)

The main purpose of the Section 50.54(a) requirement introduced in 1983 was described in the Statements of Consideration for the original rule:

"...... some licensees have been changing their quality programs without informing the Commission. In a few cases this has resulted in QA programs which were not acceptable to the NRC staff and which did not conform to all aspects of the NRC regulations. The primary concern with the current situation is that unreported changes to the QA program might diminish the scope of the program permitting significant deficiencies to arise in the design, fabrication, construction, or operation of the facility. This could increase the risk to the public health and safety" (48 Fed. Reg. 1026, January 10,'1983).

The Commission's main concerns wer~ associated with the potential impact on safety and the need to keep the Commission apprised accordingly of changes to the accepted quality assurance program. However, the standard for determining the need for NRC staff prior review and approval, the application of the "reduction in 5

commitment" standard has, on occasions, presented a significant potential for diverting licensee and NRC staff attention -and resources from more safety significant matters.

This petition still addresses the Commission's concerns that prompted the original Section 50.54(a) rule in 1983. Changes will continue to be reported and changes that present the potential for an unreviewed safety question will be formally submitted to the NRC staff for approval prior to implementation. Applying a Section 50.59 type process to quality assurance matters described or referenced in the SAR still meets the Commission's original objective. This would provide enhanced regulatory consistency, improves the emphasis on safety, and maintains the reporting requirement for changes to the accepted quality assurance program.

The NRC Regulatory Review Group Report concluded that the regulatory burden on licensees could be reduced if each licensee was to be held to a consistent set of requirements provided by the NRC's regulations. The Regulatory Review Group Report recommended changes in specific regulations to improve the consistency and effectiveness of the body of NRC regulations and the efficiency of their implementation. The proposed amendment to Section 50.54(a) is consistent with the recommendations of the Regulatory Review Group and the other NRC initiatives to improve the effectiveness of its regulations, in that it will improve regulatory efficiency, consistency, and predictability.

Additionally, the proposed change is consistent with the overall objectives of the 1993 National Performance Review conducted by the Vice President of the United States, and with the 1995 Congressional initiatives on improving federal regulations. In conjunction with phase two of the NRC's National Performance Review Study, a review of current regulations is being performed to identify regulations that are obsolete, unnecessarily burdensome, or too prescriptive, or that overlap or duplicate other regulations. This petition is consistent with the aims of the NRC phased implementation of the National Performance Review. This petition will improve the efficiency of the regulatory quality regime, and enable licensee and NRC staff to improve their focus on safety significant issues which could ultimately result in enhanced public health and safety.

A longstanding goal of the Commission has been to improve regulatory predictability and stability, while protecting public health and safety. The Commission discussions and actions associated with licensing reform and regulation for advanced reactors, predominantly that associated with the adoption and implementation of 10 CFR Part 52, Early Site Permits; Standard Design Certifications; and Combiried Licenses for Nuclear Power Reactors, reflect a significant advancement towards such a goal. The proposed amendment continues the progression towards the goal of a more predictable and effective regulatory environment.

6

Each level of the hierarchical regulatory structure should have a change mechanism that would allow the NRC staff to review licensees' actions at a level consistent with the safety significance of the action. Such an approach is exemplified by the Section 50.59 change process for the SAR and the two tier approach for implementing 10 CFR Part 52. The Section 50.59 change proceBB has proven to be an effective process that has reduced an unwarranted burden on licensees and N'RC staff for matters that are not of safety significance. The change process for all elements of the Safety Analysis Report should be consistent, no matter the subject. NRC involvement and prior approval should be consistent, and linked to matters affecting the protection of public health and safety. And just because a change would affect the quality assurance program should not cause its importance to be elevated out of context with its safety significance.

In the development of a more efficient and effective quality regime, it is important that licensees not be discouraged by an unneceBBary 11dministrative burden of seeking prior NRC approval when a change is of no regulatory significance (i.e.,

does not result in non-compliance with the NRC's regulations, a change to the Technical Specifications, or an unreviewed safety question). Further, in an evolving technological environment, each licensee should be allowed the opportunity to respond to improvements in technology, industry operating experiences, and new operational or technical information by ma.king changes to the quality program that do not degrade public health and safety without the need for 11dministrative and managerial regulatory interactions.

The proposed amendment to Section 50.54(a) does not introduce a new type of change process. The proposed use of a Section 50.59 type change process in this context is based on a well tried and proven process for making changes to a facility, l' its procedures, tests, or activities that are described or referenced in its SAR.

Compliance with the regulations to assure proper control of the facility and quality program associated with the protection of public health and safety is still provided by the adoption of a change proceBB that is similar to the established Section 50.59 process.

Under the proposed rule, a licensee would have the authority to change its quality program if a Section 50.59 type analysis demonstrates that a proposed change does not involve an unreviewed safety question or change the Technical Specifications.

The analysis to support such a determination would be consistent with that required to support other types of changes to a SAR. It would be based on the well proven and established industry guidance that has been used to perform Section 50.59 type evaluations.

If the analysis of a proposed change to the quality program indicates that an unreviewed safety question may be involved, a licensee would either decide not to institute the change, or submit the change for NRC approval before 7

implementation. For changes involving an unreviewed safety question, the complete change, including the safety evaluation, would be submitted in accordap.ce with the requirements of 10 CFR 50.90.

• Licensees.would still be required to submit, as specified in 10 CFR 50.4, a report containing a summary description of the changes to the quality assurance program described or referenced in the SAR. The report would be submitted annually, or along with the FSAR updates as required by Section 50.71(e), or at shorter intervals as determined by each licensee. Licensees would maintain records of the changes, as facility records for five years, a period that is consistent with other similar NRC regulations (e.g., Section 50.59).

The proposed petition would require that only a summary, not a detailed safety evaluation, be submitted to the NRC for changes that do not involve an unreviewed safety question. This is consistent with the requirements of similar regulations (e.g. Section 50.59). A licensee would maintain records of such evaluations until the termination of the license.

C. Other Affected NRC Regulations 10 CFR 50.4(b)(7), Quality assurance related submittals (i):

This paragraph has been deleted. There is no reason for requiring a separate administrative reporting requirement for changes to the quality assurance program description included or referenced in the Safety Analysis Report. Administrative reporting requirements for changes to the facility, its programs, procedures, tests or experiments that are described in the Safety Analysis Report should be treated in a consistent manner. The administration of the regulatory process should be as efficient and as consistent as possible through the optimization of the administrative process.

Sub-paragraph (ii) of 10 CFR 50.4(b)(7) is not amended because the requirement is unique to nonlicensees (ie., architect/engineers, NSSS suppliers, fuel suppliers, constructors, etc.).

10 CFR 50.55(f), Conditions of constrnction permits:

This petition does not propose any changes to 10 CFR 50.55(f) because of the current regulatory discussions on implementing Subpart C of 10 CFR Part 52, Combined Licenses (combined construction permit and operating license). These discussions encompass the new regulatory process associated with licensing and constructing new power plants. It is more appropriate for changes to NRC regulations associated with initial construction activities to be developed as a result of these discussions. More importantly, 10 CFR Part 52 invokes several new 8

regulatory concepts, and to assure consistency and reduce the potential for unnecessarily impacting the development of the new regulatory regime for licensing new facilities, changes to Section 50.55(:f) are not proposed.

D. Conclusion For the reasons stated herein, 10 CFR 50.54(a) should be amended to permit a licensee to make a change to its quality program description that is included or referenced in its SAR without prior NRC approval, provided that the change does not involve a change in the Technical Specifications incorporated in the license, or pose an unreviewed safety question. Such a change to Section 50.54(a) would represent a significant step towards improving the efficiency, effectiveness, predictability, stability, and consistency of regulations governing nuclear power plants, and would enhance public heath and safety by assuring that licensee and NRC resources are better focused on matters that could impact public health and safety.

9

PROPOSED CHANGES TO 10 CFR Part 50.54(a) 10 CFR 50.54(a) is revised in its entirety to read as follows:

(a)(l) Each nuclear power plant or fuel reprocessing plant licensee shall imple:rµent a quality assurance program pursuant to§ 50.34(b)(6)(ii) of this part, as described or referenced in its Safety Analysis Report.

(2) Each licensee described in paragraph (a)(l) of this section may e- make a change to a previously accepted quality assurance program description included or referenced in its Safety Analysis Report without prior Commission approval unless the proposed change involves a change to the Technical Specifications incorporated in the license or involves an unreviewed safety question.

(i) A change shall be deemed to involve an unreviewed safety question (A) if the probability of occurrence or the consequences of an accident or malfunction of equipment important to safety previously evaluated in a licensee's Safety Analysis Report may be increased; or (B) if a possibility for an accident or malfunction of a different type than any previously evaluated in a licensee's Safety Analysis Report may be created; or (C) if the margin of safety as defined in the basis for any technical specification is reduced.

(ii) When changes are made to a previously accepted quality assurance program description, a licensee shall submit, as specified in

§ 50.4, a report containing a brief description of the change, including a summary of the safety evaluation of each change. The report may be submitted annually, or along with FSAR updates as required by§ 50. 71(e),

or at shorter intervals as determined by each licensee.

(iii) Records of changes to the quality assurance program shall be maintained as facility records for five years.

10

(3) For changes to the quality assurance program description that involve an unreviewed safety question, licensees shall submit the proposed change to the NRC for approval prior to implementation. The licensee shall submit the application to amend the quality program pursuant to the requirements of§ 50.90.

(4) For changes that involve a change to the Technical Specifications, a licensee shall submit an application for a license

• amendment pursuant to § 50.90.

PROPOSED CHANGES TO OTHER REGULATIONS 10 CFR 50.4(b)(7)(i) is deleted.

11

.APPENDIX SUPPLEMENTARY ANALYSES IN SUPPORT OF THE PETITION FOR RULEMAKING INTRODUCTION Pursuant to 10 CFR 2.802, a petition for rulemaking must set out the problem for which petitioners seek redress, the proposed solution, and the substantive basis for the proposed solution. In turn, the NRC must evaluate the procedural and substantive merit of the proposed action against the dictates of the Atomic Energy Act and evaluate the ramifications of the proposed action against several statutes in

• addition to the Atomic Energy Act. Specifically, the other statutes that must be addressed are the National Environmental Policy Act, the Paperwork Reduction Act, and the Regulatory Flexibility Act. Also, the NRC must draft a Regulatory Analysis if certain criteria are met, and it must determine whether 10 CFR 50.109 is applicable, and if so, an additional evaluation must be conducted.

Petitioner submits the following information to assist the NRC in conducting those analyses.

THE NATIONAL ENVIRONMENTAL POLICY ACT These proposed regulations are the type of action described in categorical exclusion 10 CFR 51.22(c)(3). Therefore, neither an environmental assessment nor an environmental impact statement is necessary for these proposed amendments.

THE PAPERWORK REDUCTION ACT The objective of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.) is to ensure that the Office of Management and Budget has the opportunity to review and approve regulatory actions that create an increased burden on the public due to additional information collection requirements imposed by the federal government.

This statute does not apply to the instant rulemaking.

The proposed rule amends the change process and the reporting requirements for changes to a licensee's quality program description that is included or referenced in a licensee's Safety Analysis Report.

The amendment makes the reporting requirements consistent with the procedures for other SAR changes. This amendment will reduce the administrative burden on the NRC as well as on licensees, which are the only entities affected by the proposed amendment.

1

REGULATORY ANALYSIS Under certain circumstances, the NRC is required to perform a Regulatory Analysis. The purpose of the analysis is to assure that the NRC obtains adequate information regarding the need for, and consequences of, a proposed regulatory action and that the NRC appropriately considers costs and benefits of alternative regulatory actions. A Regulatory Analysis must be prepared if it is determined that the proposed action contemplated by the rule will likely result in any of the following: (1) an annual effect on the economy of $100,000,000 or more in direct or indirect costs; (2) a significant impact on health, safety, or the environment; or (3) a substantial increase in the cost to NRC licensees, permit holders or applicants, to federal, state or local governments, and geographic regions. Also, preparation of an analysis may be required by the Commission or the Executive Director of Operations. Analyzing each of the criteria in turn, the following discussion supports a conclusion that the NRC is not required to perform a Regulatory Analysis of the proposed amendment to 10 CFR 50.54(a).

First, the proposed change to Section 50.54(a) will not have an annual effect on the economy of $100,000,000 or more in direct or indirect costs. To the contrary, the proposal will reduce industry and NRC costs of f!droinistering and implementing the NRC regulations. Provisional industry estimates from a cross section of the industry indicate savings in excess of one million dollars per year.

Second, there will be no adverse impact on health, safety or the environment. As noted infra, the proposed amendment to 10 CFR 50.54(a) has four objectives: (1) to improve the consistency in the body of regulations by having a consistent change process for items described or referenced in the SAR; (2) to better focus industry and NRC attention and resources on matters that have safety significance such that the protection of public health and safety would be enhanced; (3) to improve the effectiveness and efficiency of NRC regulations; and (4) to reduce unnecessary effort and burden on licensees in implementing NRC regulations.

The achievement of these objectives does not reduce the margin of safety or otherwise degrade public health and safety. Compliance with the regulations to assure proper control of facility and program changes is still provided by basing the change process on the well established and proven process described in 10 CFR 50.59. In addition, licensee and NRC i:idroinistrative tasks will be reduced, enabling NRC and industry to focus on more safety-significant matters that have a potential impact on public health and safety. The proposed change process will enable licensees to more efficiently assess the impact of new information and circumstances, and implement appropriate changes while ensuring that public health and safety are not adversely affected.

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Third, the proposed changes will not lead to any, much less a substantial, increase in the cost to NRC licensees, permit holders, or applicants; state or local governments; or geographic regions. To the contrary, the current restraints and controls impose an unnecessary burden, often resulting in the consumption of significant licensee and NRC resources to address matters that have minimal safety significance and that present no challenge to public health and safety. Recent industry surveys conclude that approximately 30 percent of industry management time is associated with regulatory interactions, as opposed to plant or personnel management matters. Improvements in efficiency, effectiveness and productivity are being encouraged and pursued through several industry and government (Presidential, Congressional, and agency) initiatives. Through these initiatives, unnecessary activities are being identified and eliminated. The current change process for quality assurance programs, as described by Section 50.54(a), meets the criteria for inclusion in these initiatives to improve the effectiveness and efficiency of the regulatory process. This petition is consistent with these initiatives for improving the federal regulatory process and with the NRC's phased approach for implementing such activities initiated on March 9, 1995.

The NRC Regulatory Review Group and the industry independently have determined that Section 50.54(a) should be amended to improve the consistency in the body of NRC regulations and to improve the effectiveness and efficiency in the implementation of those regulations. Also, such a change would enable licensee and NRC staff to better focus their attention on matters of safety significance that could impact public health and safety rather than specific administrative issues.

THE BACKFIT RULE The proposed rule amends the process that licensees would use to implement changes to the quality assurance program described or referenced in a licensee's Safety Analysis Report. The proposed amendment would bring consistency to the change process for matters described or referenced in a licensee's Safety Analysis Report. The proposed amendment would not impose additional, more stringent requirements on 10 CFR Part 50 licensees. Rather, it will allow licensees to reduce costs through the deletion of submittals for NRC approval of changes to the quality assurance program description that have no safety significance. Accordingly, the proposed rule would not constitute a backfit as defined in 10 CFR 50.109 and the Commission is not required to prepare a backfit analysis.

REGULATORY FLEXIBILITY ACT In accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)), this rule will not, if promulgated, have a significant economic impact on a substantial number of small entities. This proposed rule affects only the licensing and operation of nuclear power plants. The companies that own these plants do not fall within the scope of the definition of "small entities" set forth in the Regulatory 3

Flexibility Act, or the Small Business Size Standards set out in the regulations issued by the Small Business Administration at 13 CFR Part 121.

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