ML20004F460
| ML20004F460 | |
| Person / Time | |
|---|---|
| Issue date: | 06/11/1981 |
| From: | NRC COMMISSION (OCM) |
| To: | |
| References | |
| REF-10CFR9.7 SECY-81-316, NUDOCS 8106180389 | |
| Download: ML20004F460 (10) | |
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UNITED STATES OF AMERICA 2
NUCLEAR REGULATORY COMMISSION 3
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AFFIRMATION / DISCUSSION SESSIbN 8/ ~31 6
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PUBLIC NEETING 9
to Nuclear Requistory Commission I
11 Room 1130 12 1717 H Stree t, N.
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Washington, D. C.
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Thursday, June 11, 1981 14
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15 The Commission zet, pursuant to notice, at 16 4:05 p.m.
17 PHESENTs 18
_ JOSEPH H. HENDRIE, Chairman of the Commission 19 PETER A. BRADFORD, Commissioner JOHN F. AREARNE, Commissioner 20 ALSO PRESENTS l
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S. CHILK 22
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CHAIBMAN HEND3II:
That created such a zone of 3 silence I think we can go ahead.
4 (Laughter.)
5 MR. CHILK The first affirmation is81-316, i
6 Reporting of Changes to Quality Assurance Programs in which 7 the Commission is being asked to approve a notice of 8 pro;osed rulemaking which would require licensees to
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9 implement approved quality assurance programs and report 10 certain changes.
11
.The Commission has unanimously approved the 12 document with the modification suggested by Commissioner 13 Ahearne.
L 14 There is an unresolved issue here with regard to 15 the length of the comment period.
The staff has suqqested a 16 60-day comment period.
Commissioner Bradfo rd has 17 recommended a 30-d ay comment period.
18 COMMISSIONE3 3RADF03D:
The staff originally l
19 suggessted it be immediately ef f ective.
That was the only t
20 reason I suggested 30 days.
21 MR. CHILK The paper said 60..
There seems to be l
22 diverging views on whether it be 60 or 30.
T 23 COMMISSIONER AHEARNE:
I went with 50.
i 24 EH. CHILK Cctais sione r Gilinsky, who is not i
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25 here, went with 30.
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CHAIRHAN HENDRIE:
We are split on-the time.
I 2 guess I would pref er to stick with 50 on the basis that that-3 is where the staff ultimately shook themselves down and I i
4 don 't know what 30 seans ---
5 C05MISSIONE3 AHEARNE:
My reason really has 6 nothing to do with the staff proposing.
It is just that it 7 always takes so long to analyze any comments that come 8 back.
When we go to t'te short comment period it seems to me 9 tha t there are more comments tha t come in right at the end 10 or af ter.
i 11 The 30 days seemed to me more saying well we have 12 now met the for-consent aspect of it, but I think 60 is 13 about the shortest that even is reasonable.
Otherwise, ve 14 zight as well leave it immediately effective.
i
'S COMMISSIONES BRADFORD:
Gee, when I think of all 18 of the things we have put out for comment that spring on a 17 15, 20 and 30-da.y leash ---
18 C3H5ISSIONER AHEARNE:
Let me go back and find 19 that item.
I 20 COEMISSIONER BRADFORD:
You may have been opposed f
21 to putting it cat for comment.
22 (Laughter.)
23 COE3ISSIONE3 AHEASNs:
That is righ t.
i 24 COMMISSIONES BRADFORD:
Well, it is not an end of 25 the world proposition.
I will offer 70u 45.
(laughter.)
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400 VIRLNIA AVE S.W, WASHINGTCN. 3.C. 20024 (202) 554-2345 l
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1 CHAIRMAN HENDRIE:
I think we have got his moving,
. 2 John.
Let's see if we can.
Why don't you come on up to 60.
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CO3HISSIONER BRADFORDs Sold.
4 ER. CHILK4 Will you please affirm your vote.
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5 (Chorus of Ayes.)
6 CHAIRMAN HENDRIE:
So ordered at 60 days.
I 7
ER. CH1LI:
The second is81-220 which is a 8 Cesaission Review of ALAB-603, St. Lucie.
9 Ihe latest status at least known in our effice is 10 tha t the revised memo dated on the 21st was agreed to by the
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r 11 Chairman and Commissioners Bradford and Ahearne.
f 12 Commissioner Ahearne provided additional views and 13 Commissioner Gilinksy provided, separate views.
Commissioner 14 Bradford then suggested a changed opinion.
i" 15 CHAIRMAN HENDRIE:
We have agreed to go back to l
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16 the latest t
17 HR. BICKWIT:
If you are going to discuss it, our
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18 recommendation would be to close the seeting.
19 CHAIR 5AN HENDRIE4 I hadn't been planning to do t
20 t ha t.
21 COHNISSIONER BRADFORD4 I don't think you are 22 going to discuss it, Joe.
I think you cre just going to i
1 23 descriDe it.
24 CHAIRMAN HENDRIE:
I am not going to discuss the i
25 serits of the proposition.
I am trying to identify the l
ALDERSoN REPORTING CCMPANY. INC.
f 400 VIRGINIA AVE., S.W., WASHINGTCN. D.C. 20024 (202) 554 2345 f
5 1 draft for a certain amount of discussion.
2 ER. BICKWIT:
If you are net planning to discuss 3 it, our recommendation would not be to close it.
4 (Ladghter.)
5 CHAIRMAN HENDRIE.
It sure is good to have a t
6 counsel talk once more.
7 (Laughter.)
i 8
That lastest draft, I could probably put my hand 9 on, was your write-up.
Peter and I decided to go back and
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10 stand together on that one.
John concurs in the 11 Commission's opinion and has a few line additional comment.
12 Vic has his own comments.
13 As I see it standing at this meeting then there 14 are three Cosaissioners present and able to vote Aye on that 15 last draf t you prepared.
We recognire John's additional 16 remarks.
Vic would not vote for tha t one anyway but would 17 have his own comments.
18 COMMISSIONER 3RADFORD:
Has he been asked whether 19 he has any objection to our voting?
t 20
- 53. CHILKs He has none.
21 COMMISSIONER BRADFORD He has no objection to our r
22 voting?
23
- 13. CHILKs No.
24 CHAIR 3AN HE3 DRIES I thought that was kind of 25 where we can to before when you and I were having the last l
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I 1 round of discussion.
2 Sam, I think on the basis I have outlined you can i
3 go ahead and ask us.
4 MR. CHILKa Would you please affirm your vote.
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(Chorus of Ayes.)
6 CHAIRMAN HENDRIIs Good.
Th a t is it.
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249.
There was a vote to ---
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8
- 53. CHILKa That is the fire protection.
9 CH AIRMAN HENDRIE:
--- deny the petition on the 10 stay of a final rule on fire protection.
There was a vote f
11 to deny yesterday.
Ihree Commissioners have now agreed on 12 the text of the order.
I have agreed to go with it, so 13 there is a majority text.
14 COMMISSIONER BRADFORD:
Does that need a separate 15 affirmance?
16 CHAIRMAN HENDHIE It doesn't need a vote that I 17 know of.
18
- 13. BICKWIT My unlerstanding was tha t you voted 19 to deny and that the order would follow.
In that case it 20 would not need a separate vote.
21 CHAIRMAN HENDRIE:
We now have three Commissioners 22 who have agreed on a text which will be the majority 23 opinion.
24 Your separate cCaments say you would deny but for 25 teasons framed in another way that vi.11 aerompany it.
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-.1 soon as we can churn that out why that can be made public.
2 Anything else?
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- 33. CHILK No, sir.
4 CHAIRMAN HENDRIE:
Good.
Thank you very much.
5
('Ahereupon, at tas10, the affirmation session 6 concluded.)
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AFFIRMATION / DISCUSSION SESSION Cate cf Prcceeci.g:
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t MJ@if I gw f May 19,1981 SECY-81-316 RULEMAKING ISSUE (Affirmation)
For:
The Commissioners From:
William J. Dircks, Executive Director for Operations
Subject:
REPORTING OF CHANGES TO QUALITY ASSURANCE PROGRAMS Purcose:
To obtain Commission approval of a notice of proposed rulemaking which would require licensees to implement the approved quality assurance program and to report certain changes to their quality assurance programs which affect the program description approved by the NRC.
i Category:
This paper covers a minor policy question.
Issue:
Whether licensees, including permit holders for construction of nuclear power plants, should be required to implement the approved quality assurance program and to notify NRC of certain changes to their quality assurance (QA) programs which affect the description of the program included in the Safety Analysis Report as approved by the NRC.
These changes would be sucmitted to the NRC Regional Offices for evaluation; however, policy issues or unusual issues would in turn be referred by IE to NRR for detailed review and evaluation.
Discussion:
The QA requirements of 10 CFR Part 50 are one of the cornerstones of the Commission's " defense-in-depth" concept for ensuring safe operation of nuclear power plants.
Because of the importance of the QA program as a management tool to attain objectives impor-tant to nuclear safety, the NRC staff conducts reviews during the licensing process to ensure that the QA program described in the Safety Analysis Report (SAR) satisfies 10 CFR 50, Appendix B,
" Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants." Following acceptance by the staff, the.
QA program becomes a principal basis for inspection and appli-t cable enforcement to ensure that the permit holder or licensee complies with all NRC quality assurance requirements for protect-ing the public health and safety.
Contact:
5.0. Richa dson, RES 443-5987 J.A. Norberg, RES hC 443-5863 h
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'Ths Commissioners l
l Ar, indicated in paragraph (a)(7) of 10 CFR S 50.34, " Contents of r.pplications; technical information," the Preliminary Safety Analysis Report (PSAR) must include "a description of the quality l
assurance program to be applied to the design, fabrication, con-struction, and testing of the structures, systems, and components Similarly, 9 50.34(b)(6)(ii) requires that of the facility."
the Final Safety Analysis Report (FSAR) describe " managerial and administrative controls to be used to assure safe operation" and that it " include a discussion of how the applicable requirements
[
of Ap'endix B [ Quality Assurance Criteria] will be satisfied."
It is clear that the QA program described in the SAR report is i
meant to represent the QA program actually being applied in prac-Consistent with this intent, the staff included a position tice.
in Revision 1 of the Standard Review Plan (Enclosure "A," Item 1) which provides that substantive changes to the QA program descrip-tion in the PSAR be submitted to NRC for review.
The review procedures in effect since issuance of Revision 1 of the Standard Review Plan in early 1980 apply to new applications for i
co struct1on permits and operating licenses.
However, they are not icient because all permit holders and all operating plant I
sulicensees for which construction permits or operating license applications were reviewed prior to 1980 have not been required to make such commitments, nor is such a commitment, once mace, subject e full range of enforcement options.
This lack of enforcement e exists because current regulations do not specificali re uirement that changes to the QA program which aff ct cl de on of the,QA program in the SAR be submitted to the p
NRC for review.
Additionally, there is no explicit requirement i
that the approved quality assurance program be implemented as a l
condition of the construction permit or license.,
Past and current problems with some licensees, a number of which have been discussed with individual Commissioners and on occasion
[
with the full Commission in session, have highlighted a need for i
requiring licensees to report substantive QA program changes to the i
A major concern is that an unreported relaxation of the QA NRC.
l program from the program description in the SAR and accepted by the NRC could seriously diminish the effectiveness of the program and permit significant deficiencies to arise in the design, fabrication, i
construction or operation of the nuclear facility and could result in increased risk to the public health and safety, if these def t-t In some cases, the licensee has l
ciencies remained uncorrected.
revised the QA program without informing NRC of the change and then proceeded to revise affected procedures in accordance with that This resulted in use of a " relaxed" QA program without change.
(See Enclosure "A," Item 2 for examples of such NRC awareness.
cases currently under review by IE and NRR.)
-In one case involving an operational plant, (see Enclosure "A",
l Item 2) IE discovered that the licensee used i 50.59, " Changes, j
tests and experiments," to justify that a QA program change did i
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Y not have to be submitted to the NRC since it did not represent an unreviewed safety question.
Section 50.71(e), " Maintenance of records, making of reports," promulgated by the Commission (45 FR 30614) on May 9; 1980, which requires periodic updating of the FSARs, will partially alleviate the situation; however, the initial updated FSARs are not due until July 1982.
Further-more, the FSARs only have to be updated annually and construction permit holders are exempt from updating.
The publication of this rule will cause a minor resource impact on the industry which we estimate to be about one person-day per QA program description change.
Additionally, we estimate that the impact on the NRC to review each change to be one person-day and that each utility would submit approximately two such changes per year.
Recommendation:
That the Commission:
1.
Accrove a.
Publication of the notice of proposed rulemaking (Enclo-sure B) to amend !s 50.54 and 50.55.
b.
The staff's conclusions set forth in Enclosure 0, which provides the analysis _ called for by the Periodic and Systematic Review of the Regulations.
The criteria used were derived from Executive Order 12044 which was res-cinded on February 17, 1981 by Executive Order 12291 (see memorandum from Bickwit to the Commission, February 27, 1981).
This approach is proposed as an interim procedure until the staff can make recommenda-tions and the Commission decides what to do in response to Executive Order 12291.
2.
In order to satisfy the requirements of the Regulatory Flexi-bility Act 5 U.S.C. 605(b) certify that this rule, if promul-gated, will not have a significant economic impact on a sub-stantial number of small entities.
This proposed rule affects only the licensing and operation of nuclear pcwer plants.
Publication cf a Federal Register Notice on this finding and the basis upon which the finding was made will follow.
I 3.
Note:
a.
That pursuant to Section 51.5(d) of Part 51 of the l
Commission's regulations neither an environmental impact statement nor a negative declaration need be prepared in connection with the amendment since the amendment is nonsubstantive and insignificant from the l
l standpoint of environmental impact.
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immissioners 4
b.
That the Subcommittee on Nuclear Regulation of the Senate Committee on Environment and Public Works, the Subcommittee on Energy and the Environment of the House Committee on Interior and Insular Affairs, the 'Sub-committee on Energy and Power of the House Committee on Interstate and Foreign Commerce, and the Subcommittee on Environment, Energy and Natural Resources of the House Committee on Government Operations will be informed.
That a letter wi11 be sent to each construction permit c.
holder and to each licensee affected by the rule inform-ing them of the requirements of the rule.
d.
The information collection requirements in this proposed rule will be submitted to the Office of Management and Budget as part of the general clearance for 10 CFR 50.
)
ling:
Recommend affirmation at an open meeting.
[ s. b d
William J. Dircks Executive Director for Operations ures:
Backgrot.nd Information Related to QA Program Changes
, Federal Register Notice of Proposed Rulemaking
/alue/ Impact Assessment Analysis with Respect to Review of Regulations Comissioners' coments or consent should be provided directly to the Office of the Secretary by c.c.b. Thursday, June 4,1981.
Comission Staff Office coments, if any, should be submitted to the Comissioners NLT May 28, 1981, with an information copy to the Office of the Secretary.
If the paper is of such a nature that it requires additional time for analytical review and comment, the Comissioners and the Secretariat should be apprised of when coments may be expected.
This paper is tentatively scheduled for affirmation at an open meeting during the week of June 8, 1981. Please refer to the appropriate Weekly Comission Schedule, when published, for a specific date and time.
OISTRIBUTION Comissioners Comission Staff Offices Exec Dir for Operations l
ACRS ASL'3P 5;cretariat I
ENCLOSURE "A" O
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B CKGROUND INFORMATION RELATED TO QA PROGRAM CHANGES 1.
Since early 1980 the Standard Review Plan (SRP) has contained a provision whereby the applicant (and each holder of an NRC-approved QA Topical Report; is requested to coamit to the following staff position:
9
"(17.1.II)2B2. Provisions are included for notifying NRC of changes (1) for review and acceptance in the accepted des-cription of the QA Program as presented or referenced in the SAR or SSAR prior to implementation, and (2) in organizational elements within 30 days after announcement.
(Note:
editorial changes or personnel reassignments of a non-substantive nature do not require NRC notification.)"
The above provision of the SRP was not made retroactive to cover existing 7
CP holders and licensees, thus creating a double standard whereby some licensees are committed to report QA Program changes while others are not.
2.
A limited sampling of IE inspectio. experience reflected in docketed
[
inspection reports shows cases where licensees have made substantive changes to their QA Progrim without notifying the NRC.
Examples are:
a.
At the Hatch facility, Georgia Power & Light Company unilaterally revised its QA Program -commitments to ANSI N45.2.3, " Housekeeping During the Construction Phase of Nuclear Power Plants," and ANSI 45.2.12, " Requirements for Auditing of Quality Assurance 1
Enclosure "A"
Programs for Nuclear Power Plants." The licensee's basis for not notifying the NRC was that the matter did not comprise an i
unreviewed safety question per 10 CFR 50.59.
b.
At the Shearon Harris facility, Carolina Power & Light Company changed its QA Program commitments with regard to organization such that the potential existed for quality control inspectors to perform audits of their own, previously completed inspection activities.
Action has been taken or is in process to resolve the above as a result of IE identification of the problems.
3.
There have been a number of cases where licensees have been ineffective in implementing their QA Program commitments as presented in the SAR.
Some of these have resulted in the issuance of NRC Orders as well as requirements for the licensees to make substantial changes to their QA
~
Programs as part of the required corrective action:.
These examples illustrate the importance of changes to the quality assurance program and the importance of NRC awareness and evaluacion of such changes.
Examples are:
a.
The Soutn Texas Project of Houston Lighting and Power Ccmpany.
In its response to NRC's Show Cause Order, the licensee included a number of major changes to its quality assurance program which it considered necessary.
2 Enclosure "A"
b.
The Marble Hill Project of Public Service of Indiana.
In response to NRC's Order Confirming Suspension of Construction, the licensee made major changes to its quality assurance program.
c.
In an inspection of TVA nuclear activities, NRC inspectors deter-mined that, contrary to SAR commitments, quality assurance person-nel did not have sufficient organizational freedom and TVA manage-ment was not giving adequate support to quality assurance.
In its response to these findings, TVA made substantial changes to its QA Program including elevating the organizational reporting i
level of quality assurance personnel.
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3 Enclosure "A"
. 4 C
6 ENCLOSURE asa e
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.[7590-01]
NUCLEAR REGULATORY CCMMISSION 10 CFR Part 50 Reporting of Changes to the Quality Assurance Program AGENCY:
Nuclear Regulatory Commission ACTION:
Proposed Rule
SUMMARY
The Nuclear Regulatory Commission is proposing to amend its regulations to require holders of nuclear power plant construction permits and holders of operating licenses to implement the approved quality assur-ance pregram and to inform the Commission in writing of certain quality assurance program changes which affect the description of the quality assurance program included in their Safety Analysis Report and accepted by the Commission, within 30 days of making any such change.
The amend-ments will provide greater assurance that quality assurance programs approved by the Commission do not have their effectiveness reduced by subsequent changes.
DATES:
Comments should be submitted on or before (60 days after publica-tion).
Comments received after this date will be considered if it is practical to do so; but assurance of consideration cannot be given except as to comments received on or before that date.
ADDRESSES: Written comments should be submitted to the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.
Attention:
Occketing and Service Branch.
a 1
Enclosure "B"
'[7590-01]
+
r FOR FURTHER INFORMATION CONTACT:
Steven D. Richardson, Office of Nuclear Regulatory Research, U.S. Nuclea-Regulatory Commission, Washington, D.C.
t 20555, telephone 301-443-5987.
SUPPLEMENTARY INFORMATION:
The quality assurance (QA) requirements of I
10 CFR Part 50, " Domestic Licensing of Production and Utilization Facil-I ities," are one of the cornerstones of the Commission's " defense-in-depth" concept for ensuring safe operation of nuclear power plants.
Because of the importance of the QA program as a management tool to attain objectives important to nuclear safety, the NRC staff conducts extensive reviews during the licensing process to ensure that the appli-cant's QA program description satisfies 10 CFR 50, Appendix B, " Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants."
Following acceptance by the.1RC staff, the QA program description is tnen used as a principal inspection and enforcement tool in ensuring that the permit holder or licensee is in compliance with all NRC quality assurance requirements for protecting the public health and safety.
i' As indicatad in paragraph (a)(7) of 10 CFR 5 50.34, " Contents of appli-cations, technical information," the Preliminary Safety Analysis Report (PSAR) must include "a description of the quality assurance program to be f
' applied to the design, fabrication, construction, and testing of the struc-l tures, systems, and ccmponents of the facility." Similarly, 5 50.34(b)(6)(ii) t requires that the Final Safety Analysis Report (FSAR) describe " managerial and administrative controls to be used to assure safe cperation" and that it " include a discussion of how the applicable requirements of Appendix B
[ Quality Assurance Criteria] will be satisfied." The QA programs described in the safety analysis reports are intended to represent the QA programs actually being applied in practice.
2 Enclosure "B"
-[7590-01]
Because existing regulations do not specifically include a require-ment that changes to the accepted QA program be reported to the Commis-sion, some licensees have been changing the QA program without informing t
the Commission.
In several cases, this has resulted in QA programs which were not acceptable to the NRC staff anc which did not conform to all I
i aspects of the NRC regulations.
The primary corcern with the current i
situation is that unreported changes to the QA program which could affect the QA program description finally approved by the NRC might diminish the l
effectiveness of the program permitting significant deficiencies to arise in the design, fabrication, construction or operation of the facility.
This could result in increased risk to :he public health and safety.
The propo ed amendments would require that construction permit holders i
and licensees implement the approved quality assurance program, provide
[
a current description of the program, evaluate all changes to the approved l
i program and, for certain changes that meet the criteria in the rule i
submit the evaluation to the NRC for review.
REGULATORY FLEXIBILITY ACT CERTIFICATION I
In accordance with the Regulatory Flexibility Act of 1980, 5 U.S.C.
605(b), the Commission hereby certifies that this rule will not, if promul-6 gated, 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 i
within the scope of the definition of "small entities" set forth in the Regulatory Flexibility Act or the small Business Size Standards set out in regulations issued by the Small Business Administration at 13 CFR 1
Part 121.
3 Enclosure "B" l
[7590-01]
Accordingly, notice is hareby given that, pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and sections 552 and 553 of title 5 of the United States Code, the following amendment to 10 CFR Part 50 is contemplated.
PART 50 - DOMESTIC LICENSING OF PRODUCTION AND UTILIZATION FACILITIES 1.
Section 50.54 of 10 CFR Part 50 is revised by adding a new para-graph (a) to read as follows:
5 50.54 Conditions of licenses.
A A
A A
R (a)(1)
Each licensee shall implement the quality assurance program described or referenced in the Safety Analysis Report and modified by changes thereto.
(2) Each licensee shall submit to the appropriate NRC Regional Office within 90 days of the affective date of this regulation the current description of the quality assurance program unless the description pre-viously approved has not been changed.
(3) After the effective date of thi.s rule,_the licensee may make changes to a previously submitted quality assurance program description, i
provided the change does not decrease the effectiveness of the program such that the revised program no longer meets the criteria of Appendix 3 of 10 CFR Part 50.
Prior to making any change to a previously submitted QA program description, the licensee shall prepare a written evaluation identifying the change, the reason for the enange, and the basis for con-cluding that the change satisfies the criteria of Appendix 3 of 10 CFR n
4 Enclosure "B" 1
[7590-01]
i Part 50.
A copy of this evaluation shall be maintained at the facility for three years.
(4) For changes made to the quality assurance program affecting the program description incit:ded in the Safety Analysis Report which (i) change or affect the authority, independence, or management reporting levels previously established for organi;:ations or persons performing quality assurance functions; or (ii) change or affect the controls pre-viously established over activities affecting the quality of the nuclear pcwer plant structures, systems, and components, the evaluation described in paragraph (3) shall be submitted within 30 days of making any such change to the appropriate NRC Regional office shown in Appendix 0 of Part 20 of this chapter, with one ccpy sent to the Resident Inspector and one copy sent to the Chief of the Document Management Branch, TIDC, ADM, U.S.
Nuclear Regulatory Commission, Washington, D.C. 20555.
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2.
Sei: tion 50.55 of 10 c.FR Part 50 is revised by adding a new paragraph (f) to read as folicws:
6 50.55 Conditions of construction permits.
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(f)(1) Each construction permit holder shall implement the quality assurance program described or referenced in the Safety Analysis Report and modified by changes thereto.
(2) Each permit holder shall submit to the~ appropriate NRC Regional office within 90 days of the effective date of this regulation the current description of the quality assurance program unless the description pre-viously approved has not been changed.
(3) After the effective date of this rule, the permit holder may make changes to a previously submitted cuality assurance program description, 5
Enclosure "B"
[7590-01]
provided the change does not decreasa the effectiveness of the program such that the revised program'no longer meets the criteria of Appendix'8 i
f of 10 CFR Part 50.
Prior to making any change to a previously submitted QA program description, the permit holder shall prepara a written evaluation f
identifying the change, the reason for the change, and the basis for con-cluding that the change satisfies the criteria of Appendix B of 10 CFR Part 50.
A copy of this evaluation shall be maintained at the facility for j
three years.
(4) For changes made to the quality assurance program affecting the program description included in the Safety Analysis Report which (i) change i
or affect the authority, independence, or management reporting levels i
previously established for organizations or persons performing quality assurance functions; or (ii) change or affect the controls previously
[
established over activities affecting the quality of the nuclear power i
plant structures, syszems, and components, the evaluation described in I
paragraph (3) shall be submitted within 30 days of making any such change l
to the appropriate NRC Regional office shown in Appendix 0 of Part 20 of 7
i this chapter, with one copy sent to the Resident Inspector and one copy I
sent to the Chief of the Document Management Branch, TIDC, ADM, U.S.
Nuclear Regulatory Commission, Washington, D.C.
20555.
a a
a (Secs. 103, 104, 161o., Pub. L.83-703, 68 Stat. 936, 937, 948; Sec. 201, as amended, Pub. L.93-438, 88 Stat. 1242 (42 U.S.C. 2133, 2134, 2201(o),
I 5841)).
Dated at Washington, D.C. the day of 1981.
f For the Nuclear Regulatory Com. mission.
Samuel J. Chilk i
Secretary of the Commission 6
Enc?isure "B"
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I o-j VALUE/ IMPACT ASSESSMENT Revision to 10 CFR.Part 50 Regarding Reporting of Changes to Quality Assurance Programs 1.
PROPOSED ACTION 1.1 Descriotion The proposed action is to initiate rulemaking to revise 10 CFR Part 50, Section 50.54, " Conditions of licenses" and Section 50.55, " Condition of con-struction permits" to require licensees and construction permit hciders, respec-tively, to implement the approved quality assurance program ar i to identify to the Commission certain changes made to their quality assurance programs which affect the quality assurance program. descriptions included in their Safety Analysis Report (SAR).
- 1. 2 Need for Procosed Action The quality assurance requirements of 10 CFR Part 50 are one of the cornerstones of the NRC defense-in-depth concept for quality construction and safe operation of nuclear power plants.
Due to the importance of the quality assurance program as a management tool to attain objectives important to nuclear safety, the NRC staff conducts extensive reviews during the licensing process to assure that the applicant's QA Program satisfies 10 CFR 50, Appendix B, " Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants." With staff acceptance, the applicant's QA Program is then used as a principal inspection and enforce-ment tool in ensuring that the applicant / licensee is in compliance with all NRC requirements important to assuring public health and safety.
Current rules are not specific on whether or not a licensee is required to notify the NRC of changes to the QA Program previously accepted by the staff.
Additionally, current regulations do not explicitly require. licensees or permit holders to implement the approved program.
However, as discussed under 10 CFR 50.34, it is intended that the QA Program cescribed in the SAR, and not unreviewed l
-changes thereto, be acolied to the design, fabrication, cor.struction and testing l
1 Enclosure "C"
e of structures, systems, and components of the facility.
Consistent with this intent, the staff included criteria in the 1979 revision of the Standard Review Plan (Enclosure A, Item 1) that changes to the accepted QA Program description referenced or presented in the SAR be submitted to NRC for review and approval prior to implementation.
The review procedures in effect since 1979 apply to new license applica-tices.and the annual review of topical reports.
However, they are not suffi-cient in that those utilities licensed prior to 1979 have not been required to make such commitments, nor is such a commitment, once made, subject to the
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l full range of enforcement options.
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This lack of a commitment exists because current regulations do not
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specifically include a requirement that changes to the QA Program described in the SAR be submitted to the NRC for review and approval prior to implementation.
[
A major concern is that an unreviewed relaxation of the QA Program des-cribed in the SAR could diminish the effectiveness of the QA program and permit I
significant deficiencies to arise in the design, fabrication, construction or operation of the nuclear facility.
1.3 Value/Imoact of Procosed Action 1.3.1 NRC
.Value - The proposed action will provide a positive regulatory basis from which the NRC can be kept aware of and evaluate changes to licensees' quality assurance programs.
Current regulations are unclear in this regard.
Impact - The proposed action will represent on a case-by-case basis an increase in the review of and follow up action with respect to changes to
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licensees' quality assurance programs.
It is estimated that staff resources f
of approximately one person-day per change report will be required and that each utility will submit approximately two such changes per year.
j 1.3.2 Other Government Acencies Not applicaole unless the government agency is an applicant or a licensee, 1
such as TVA.
l 2
dnclosure."C" l
1.3.3 Industry value - The proposed action will clarify the NRC staff position regarding the types of changes to licensees' and applicants' quality assurance programs that can be made without informing the NRC.
Impact - It is estimated that approximately one person-day per quality
^
assurance program change will be required.
It is also estimated that each utility will submit to the NRC reports of two changes per year.
1.3.4 Public Value - Unreported changes to licensees' and applicants' quality assurance programs that could diminish the effectiveness of the quality assurance program would be minimized thus increasing plant safety and reliability.
f Imaact - No impact on the public is foreseen.
1.3.5 Workers (Relative to ALARA)
Not applicable.
1.4 Decision on Procosed Action Requirements should be provided in 10 CFR Part 50 to require that appli-i cants and licensees implement the approved quality assurance program and inform the NRC of changes to their quality assurance programs.
2.
ALTERNATIVE APPROACHES
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Although alternative methods for obtaining information on ch'anges to licensee or construction permit holder quality assurance programs are available (such as by means of a Regulatory Guide), rulemaking has been adopted in order to impose a specific, enforceable requirement for reporting such information.,
3.
STATUTORY CONSIDERATION This rulemaking would fall under the Commission's authority under the Atomic Energy Act to impose requisita safety requirements on licensees and i
permit hoiders under sections 103 and 104 of the Act, and require appropriate repotts under section 161o.
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3 Enclosurs "C"
4.
NEED FOR NEPA ASSESSMENT The proposed action is not a major action, as-defined by 10 CFR Part 51.5(a)(10), and does not require an environmental impact assessment.
5.
RELATIONSHIP TO OTHER EXISTING OR PROPOSED REGULATIONS OR POLICIES No conflicts or overlaps with requirements promulgated by other agencies are foreseen.
t 6.
SUMMARY
AND CONCLUSIONS r
A revision to 10 CFR Part 50 should be prepared to require that construc-
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tion permit holders and licensees implement the approved quality assurance program and inform the NRC of changes to their quality assurance programs.
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ANALYSIS WITil RESPECT TO PERIODIC SYSTEMAIIC REVIEW 0F HEGULATIONS (1MI ACIl0N PLAN TASK IV.G.2)
SUBJECT:
Reporting of Changes to Quality Assurance Programs Criteria for Periodic and Systematic Review of Regulat. ions' NRC Compliance 1.
The proposed regulat. ions are needed.
The need for ! M proposed regulation are discussed in the Value/ Impact Assessment. prepared in connection with the ruiemaking (Enclosure C).
.)
2.
1he direct and indirect effects of the The direct. alid indirect effects of this rulemaking were regulations have been adequately considered.
considered in the Value/ Impact Analysis prepared in connec-Lion with the proposed rule.
(See Enclosures C).
1 3.
Alternative approaches have been considered Although alternal.ive methods for obtaining information on and the least burdensome of the acceptable changes to licensee and certruction permit holder quality alternatives has been chosen.
assurance programs are available (such as by means of a Regulatory Guide), rulemaking has been adopted in order to l
I impose a specific, enforceable requirement. for reporting i
such informat. ion.
4.
Public conmients have been considered and an Ihe proposed revisions are being issued for public cos;.nent.
j adequate response has been prepared.
1 S.
The regulation is written in plain English an<' is The proposed amendments have been reviewed and edited for i
understandable to those who must. comply with it.
tho spes.ific purpose of ensuring that the regulation is l
clear and can be understood by persons who are required l
to comply with it..
4 1
Enclosure D
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SUBJECT:
Reporting of Changes to Quality Assurance Programs Criteria for Periodic and Systematic Review of Regulations NRC Compliance 6.
An estimate has been made of the new reporting Such an estimate has been included in the Value/ Impact burdens or recordkeeping requirements necessary Assessment prepared in connection with the rulemaking for compliance with the regulation.
(Enclosure C).
7.
The name, address, and telephone number of a The Federal Register notice promulgating the rule contains knowledgeable agency official is included in the name, address, and telephone number of a knowledge-the publication.
able agency cfficial.
8.
A plan for evaluating the regulation after This regulation will be reviewed.in the second cycle of its issuance has been developed.
NRC's periodic and systematic review process (1986-1991).
j 2
Enclosure D i
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- P TRANSMITTAL TO:
g Document Control Desk,
-d 016 Phillips ADVANCED COPY TO:
C The Public Document Room h
DATE:
June 12, 1981 3
Attached are the PDR copies of a Commission meeting transcript /s/ and related meeting document /s/.
They are being forwarded for entry on the Daily Access 2.on List and elacement in the Public Document Room.
No P
other distribution is requested or required.
Existing "M
DCS identification numbers are listed on the individual documents wherever possible.
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Transcript-of:
Affirmation / Discussion Session 81-22, g
June 11, 1981.
(1 copy) o
- 4 a.
SECY Paper - Rulemaking Issue. SECY-81-316 dated May 19, 1981 from W.
Dircks to the Commissioners, Subj:
Rep ^rting of Changes to Quality Assurance Programs.
(1 copy) p s
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