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See also: [[see also::IR 05000397/1989021]]


=Text=
=Text=
{{#Wiki_filter:f., pg.,~ELERATED
{{#Wiki_filter:f., pg.,~ELERATED Dl BUTION DEMONS ON SYFI'E}rl REGULAT INFORMATION DISTRIBUTION STEM (RIDS), ACCESSION NBR:9002260288 DOC.DATE: 90/02/16 NOTARIZED:
Dl BUTION DEMONS ON SYFI'E}rl REGULAT INFORMATION
YES FACIL:50-397 WPPSS Nuclear Project, Unit 2, Washington Public Powe AUTH.NAME AUTHOR AFFILIATION BOUCHEY,G.D.
DISTRIBUTION
Washington Public Power Supply System RECIP.NAME RECIPIENT AFFILIATION LIEBERMAN,J.
STEM (RIDS), ACCESSION NBR:9002260288
Ofc of Enforcement (Post 870413)
DOC.DATE: 90/02/16 NOTARIZED:
 
YES FACIL:50-397
==SUBJECT:==
WPPSS Nuclear Project, Unit 2, Washington
Responds to NRC 891221 notice of violation s propsed imposition of civil penalty.DISTRIBUTION CODE: IE14D COPIES RECEIVED:LTR ENCL SIZE: TITLE: Enforcement Action Non-2.790-Licensee Response NOTES: DOCKET 05000397 RECIPIENT ID CODE/NAME PD5 LA SAMWORTH,R INTERNAL: AEOD/DOA DEDRO NRR/PMAS/ILRB12 OE, DIR REG FILE 02 RGN2/DRSS/EPRPB EXTERNAL:.
Public Powe AUTH.NAME AUTHOR AFFILIATION
'LPDR," ,':NSIC;COPIES LTTR ENCL 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 RECIPIENT ID CODE/NAME PD5 PD AEOD/DSP/TPAB NRR/DOEA/OEAB11 NUD~S~S ACT~~ILE RGNS FILE 03 NRC PDR COPIES LTTR ENCL 1 1 1 1 D S'i S h NCtXE K)ALL"RIDS" RECIPIENIS:
BOUCHEY,G.D.
Washington
Public Power Supply System RECIP.NAME
RECIPIENT AFFILIATION
LIEBERMAN,J.
Ofc of Enforcement (Post 870413)SUBJECT: Responds to NRC 891221 notice of violation s propsed imposition
of civil penalty.DISTRIBUTION
CODE: IE14D COPIES RECEIVED:LTR
ENCL SIZE: TITLE: Enforcement
Action Non-2.790-Licensee
Response NOTES: DOCKET 05000397 RECIPIENT ID CODE/NAME PD5 LA SAMWORTH,R
INTERNAL: AEOD/DOA DEDRO NRR/PMAS/ILRB12
OE, DIR REG FILE 02 RGN2/DRSS/EPRPB
EXTERNAL:.
'LPDR," ,':NSIC;COPIES LTTR ENCL 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 RECIPIENT ID CODE/NAME PD5 PD AEOD/DSP/TPAB
NRR/DOEA/OEAB11
NUD~S~S ACT~~ILE RGNS FILE 03 NRC PDR COPIES LTTR ENCL 1 1 1 1 D S'i S h NCtXE K)ALL"RIDS" RECIPIENIS:
PLEASE HELP US TO REDUCE HASTE.'GNI'ACT
PLEASE HELP US TO REDUCE HASTE.'GNI'ACT
'IHE DOCUMEPZ CXKQL DESK, ROCN Pl-37 (EXT.20079)%0 ELBQHRm YOUR NAME PBCH DISTRIBUXXQN
'IHE DOCUMEPZ CXKQL DESK, ROCN Pl-37 (EXT.20079)%0 ELBQHRm YOUR NAME PBCH DISTRIBUXXQN LISTS FOR DOVlMEMZS Y0U DONiT NEED!TOTAL NUMBER OF COPIES REQUIRED: LTTR 17 ENCL 17  
LISTS FOR DOVlMEMZS Y0U DONiT NEED!TOTAL NUMBER OF COPIES REQUIRED: LTTR 17 ENCL 17  
 
WASHINGTON PUBLIC POWER SUPPLY SYSTEM P.O.Box 968~3000 George Washington Way~Richland, Washington 99352 February 16, 1990 Docket No.50-397 License No.NPF-21 EA 89-130 G02-90-028 Mr.James Lieberman Director, Office of Enforcement U.S.Nuclear Regulatory Commission Attn: Document Control Desk Washington, DC 20555  
WASHINGTON
 
PUBLIC POWER SUPPLY SYSTEM P.O.Box 968~3000 George Washington
==Dear Mr.Lieberman:==
Way~Richland, Washington
 
99352 February 16, 1990 Docket No.50-397 License No.NPF-21 EA 89-130 G02-90-028
==Subject:==
Mr.James Lieberman Director, Office of Enforcement
RESPONSE TO NOTICE OF VIOLATION AND PROPOSED IMPOSITION Of CIVIL PENALTY-EA 89-130  
U.S.Nuclear Regulatory
 
Commission
==Reference:==
Attn: Document Control Desk Washington, DC 20555 Dear Mr.Lieberman:
 
Subject: RESPONSE TO NOTICE OF VIOLATION AND PROPOSED IMPOSITION
1)Letter, J.B.Martin (NRC)to G.C.Sorensen (Supply System), Notice of Violation and Proposed Imposition of Civil Penalty, dated December 21, 1989.2)Letter, G.C.Sorensen (Supply System)to J.Lieberman (NRC), Extension of Response Time for EA 89-130, dated December 29, 1989.3)Letter, G.D.Bouchey (Supply System)to J.Lieberman (NRC), Request for Further Extension of Response Time for EA 89-130, dated February 6, 1990.Pursuant to 10 CFR 2'01 and 2.205, the Supply System is submitting its response to the Notice of Violation and Proposed Imposition of Civil Penalty (Ref.1).Because the NOV and proposed civil penalty was received just prior to the Christmas holidays, the Supply System requested, and was granted, a 30 day extension to the response time for this NOV (Ref.2).In preparing our response to the NOV and proposed civil penalty, Freedom of Information Act Requests were made for records related to prior NRC inspections related to our procurement process.Because we have not yet received a response to these FOIA requests, an additional extention of time was requested on February 6, 1990.In a telephone conversation of February 15, 1990, with Mr.Ed Baker, Deputy Director, Office of Enforcement, we were advised that this request was denied (February 13 letter from Mr.Lieberman).
Of CIVIL PENALTY-EA 89-130 Reference:
He noted that the denial letter did provide us the opportunity to supplement our response at a later date based on information received in response to our FOIA requests.Accordingly, we reserve the right to supplement this response pending receipt of the FOIA response.Ž900226 ADOCK 0+0003 pre  
1)Letter, J.B.Martin (NRC)to G.C.Sorensen (Supply System), Notice of Violation and Proposed Imposition
 
of Civil Penalty, dated December 21, 1989.2)Letter, G.C.Sorensen (Supply System)to J.Lieberman (NRC), Extension of Response Time for EA 89-130, dated December 29, 1989.3)Letter, G.D.Bouchey (Supply System)to J.Lieberman (NRC), Request for Further Extension of Response Time for EA 89-130, dated February 6, 1990.Pursuant to 10 CFR 2'01 and 2.205, the Supply System is submitting
Mr.James Lieberman Page 2 February 16, 1990 RESPONSE TO NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY-EA 89-130 Attachment I to this letter provides our response to the Notice of Violation in accordance with 10 CFR 2.201.Attachment II provides our response to the proposed civil penalty in accordance with 10 CFR 2.205 and provides reasons why'the penalty should not be imposed and requests remission of the penalty.As discussed in the attached response, it is the Supply System's position that NRC guidance on commercial grade procurement has been an evolving standard.Our programs have met the guidance available at any given point in time.Our reevaluations of past commercial grade procurements have confirmed that our process has resulted in items installed in the plant which are capable of meeting their intended function.The NRC inspection of items identified in the NOV has also confirmed that those items are"acceptable for the function intended" (Ref.1, pg.2).The attachments provide new information not previously provided as well as amplification and clarification of information supplied verbally in the enforcement conference and management meeting.In particular, details related to the backfit issues have not been previously discussed and provide information not evaluated by the staff in issuing the NOV and proposed civil penalty.Based on the lack of any safety significant finding, the backfit considerations, and the new information provided herein, we believe there is sufficient justification for the NRC to reclassify this issue and provide remission of the civil penalty.Should you have any questions regarding our response, please contact me~Very truly yours, G.D.Bouchey, Dir Licensing&Assurance (MD 280)cc: Mr.C.J.Bosted, Resident NRC Inspector (901A)Mr.J.B.Martin, Region V NRC Mr.N.S.Reynolds, Bishop, Cook, Purcell&Reynolds Mr.R.B.Samworth, NRC Mr.D.L.Williams, BPA (399)
its response to the Notice of Violation and Proposed Imposition
of Civil Penalty (Ref.1).Because the NOV and proposed civil penalty was received just prior to the Christmas holidays, the Supply System requested, and was granted, a 30 day extension to the response time for this NOV (Ref.2).In preparing our response to the NOV and proposed civil penalty, Freedom of Information
Act Requests were made for records related to prior NRC inspections
related to our procurement
process.Because we have not yet received a response to these FOIA requests, an additional
extention of time was requested on February 6, 1990.In a telephone conversation
of February 15, 1990, with Mr.Ed Baker, Deputy Director, Office of Enforcement, we were advised that this request was denied (February 13 letter from Mr.Lieberman).
He noted that the denial letter did provide us the opportunity
to supplement
our response at a later date based on information
received in response to our FOIA requests.Accordingly, we reserve the right to supplement
this response pending receipt of the FOIA response.Ž900226 ADOCK 0+0003 pre  
Mr.James Lieberman Page 2 February 16, 1990 RESPONSE TO NOTICE OF VIOLATION AND PROPOSED IMPOSITION
OF CIVIL PENALTY-EA 89-130 Attachment
I to this letter provides our response to the Notice of Violation in accordance
with 10 CFR 2.201.Attachment
II provides our response to the proposed civil penalty in accordance
with 10 CFR 2.205 and provides reasons why'the penalty should not be imposed and requests remission of the penalty.As discussed in the attached response, it is the Supply System's position that NRC guidance on commercial
grade procurement
has been an evolving standard.Our programs have met the guidance available at any given point in time.Our reevaluations
of past commercial
grade procurements
have confirmed that our process has resulted in items installed in the plant which are capable of meeting their intended function.The NRC inspection
of items identified
in the NOV has also confirmed that those items are"acceptable
for the function intended" (Ref.1, pg.2).The attachments
provide new information
not previously
provided as well as amplification
and clarification
of information
supplied verbally in the enforcement
conference
and management
meeting.In particular, details related to the backfit issues have not been previously
discussed and provide information
not evaluated by the staff in issuing the NOV and proposed civil penalty.Based on the lack of any safety significant
finding, the backfit considerations, and the new information
provided herein, we believe there is sufficient
justification
for the NRC to reclassify
this issue and provide remission of the civil penalty.Should you have any questions regarding our response, please contact me~Very truly yours, G.D.Bouchey, Dir Licensing&Assurance (MD 280)cc: Mr.C.J.Bosted, Resident NRC Inspector (901A)Mr.J.B.Martin, Region V NRC Mr.N.S.Reynolds, Bishop, Cook, Purcell&Reynolds Mr.R.B.Samworth, NRC Mr.D.L.Williams, BPA (399)  
STATE OF WASHINGTON)
STATE OF WASHINGTON)
COUNTY OF BENTON)Subject: RESPONSE TO NOTICE OF VIOLATION'ND PROPOSED IMPOSITION
COUNTY OF BENTON)
OF CIVIL PENALTY-EA'9-130 I, G.D.Bouchey, being duly sworn, subscribe to and say that I am the Director, Licensing and Assurance, for the WASHINGTON
 
PUBLIC POWER SUPPLY SYSTEM, the applicant herein;that I have full authority to execute this oath;that I have reviewed the foregoing;
==Subject:==
and that to the best of my knowledge, information, and belief the statements
RESPONSE TO NOTICE OF VIOLATION'ND PROPOSED IMPOSITION OF CIVIL PENALTY-EA'9-130 I, G.D.Bouchey, being duly sworn, subscribe to and say that I am the Director, Licensing and Assurance, for the WASHINGTON PUBLIC POWER SUPPLY SYSTEM, the applicant herein;that I have full authority to execute this oath;that I have reviewed the foregoing; and that to the best of my knowledge, information, and belief the statements made in it are true.DATE 1990 G.D.Bouchey, Director Licensing and Assu On this day personally appeared before me G.D.Bouchey, to me known to be the individual who executed the foregoing instrument, and acknowledged that he signed the same as his free act and deed for the uses and purposes herein mentioned.
made in it are true.DATE 1990 G.D.Bouchey, Director Licensing and Assu On this day personally
GIVEN under my hand and seal this Qd (lay of p~us 1990.Notary ub sc sn and the STATE OF WASHINGTON Residing at My commission expires 7 14 91 I tf I~4 P,~c 4 P ATTACHMENT I Washington Public Power Supply System (NRC Inspection Report Nos.50-397/89-21, 50-397/89-22, and 50-397/89-28)
appeared before me G.D.Bouchey, to me known to be the individual
REPLY TO THE NOTICE OF VIOLATION (EA 89-130)I.Introduction Pursuant to 10 C.F.R.Section 2.201, Washington Public Power Supply System (Supply System)hereby submits its reply to the Nuclear Regulatory Commission's (NRC)Notice of Violation and Proposed Imposition of a Civil Penalty issued on December 21, 1989.Consistent with the Supply System's letter (No.G02-89-233) to Mr.James Lieberman, dated December 28, 1989, we are submitting this response on or before the due date of February 20, 1990.II.Restatement of the Alle ed Violation During the Nuclear Regulatory Commission (NRC)inspections conducted between March 27 and September 14, 1989, violations of NRC requirements were identified.
who executed the foregoing instrument, and acknowledged
In accordance with the"General Statement of Policy and Procedures for NRC Enforcement Actions," 10 C.F.R.Part 2, Appendix C (1989)the following violation was identified:
that he signed the same as his free act and deed for the uses and purposes herein mentioned.
10 C.F.R.Part 50, Appendix B, Criterion III,"Design Control," requires, in part, that measures shall be established to assure that applicable regulatory requirements and the design basis are correctly translated into specifications, drawings, procedures, and instructions.
GIVEN under my hand and seal this Qd (lay of p~us 1990.Notary ub sc sn and the STATE OF WASHINGTON
These measures shall include provisions to assure that appropriate quality standards are specified and included in design documents and that deviations from such standards are controlled.
Residing at My commission
Measures shall also be established for the selection and review for suitability of application of materials, parts, equipment, and processes that are essential to the safety-related functions of the structures, systems, and components.
expires 7 14 91  
Contrary to the above, the licensee failed to establish and implement adequate measures to assure that quality standards are specified and included in design documents, and for the selection and review for suitability of application of materials, parts, and equipment that are essential to the safety-related functions of systems and components.
I tf I~4 P,~c 4 P  
Specifically, the following examples of items purchased commercial grade that were either installed or available for installation in safety-related systems for which an adequate evaluation for suitability of application had not been performed:
ATTACHMENT
1.Evaluation 668 dedicated a commercial grade Potter-Brumfield MDR type control circuit relay for use in the safety-relate'd emergency diesel generator"Loss of Power" control circuit.The evaluation did not specify appropriate quality standards nor otherwise assure that the replacement component was selected and reviewed for suitability of application in its safety-related function.The evaluation was primarily based upon advertised specifications that I the licensee failed to verify either through audits of the manufacturing process or through identification of critical characteristics that must be inspected or tested.Consequently, the component was installed in a safety-related application on Hay 17, 1988, without assurance that design seismic requirements were met.Evaluation 1179 dedicated Anchor-Darling valve parts purchased commercial grade for use in the safety-related high pressure core spray system.The evaluation did not specify quality standards, such as fabrication under appropriate aspects of the vendor's approved guality Assurance Program, or identify the replacement parts'ritical characteristics that must otherwise be inspected or tested to assure suitability for application prior to the components'nstallation per Haintenance Work Request dated April 11, 1988.Standard Procurement Policy No.6, dated June 30, 1987, dedicated commercial grade fuses for installation in safety-related electrical systems.The policy did not specify appropriate quality standards nor assure that critical characteristics were identified for inspection or testing.The policy was inadequate in that it was based in part on: (1)the licensee's understanding of the manufacturing process for which no audits of the manufacturer were performed or required to be performed by the licensee, (2)Underwriters Laboratory (UL)activities which UL advised are not sufficient to derive any statistical inference with regard to product quality, and (3)functional compliance demonstrated by inspection and installation tests that did not cover the expected range of component operating conditions.
I Washington
A pressure switch was purchased commercial grade under Purchase Order (PO)89583 and installed on July 20, 1987 in a safety-related application in the control circuitry for the emergency diesel generator starting air compressor.
Public Power Supply System (NRC Inspection
The licensee failed to either (1)properly audit the vendor's manufacturing process or (2)specify and conduct appropriate inspections or testing to assure that critical characteristics of the components were suitable for their intended safety-related application.
Report Nos.50-397/89-21, 50-397/89-22, and 50-397/89-28)
Hetallic 0-rings were purchased commercial grade under PO 90163 and were installed in the discharge flange assembly of RHR relief valve RHR-RV-IB, during the 1988 refueling outage (April-June, 1988).The PO required a Certified Haterial Test Report (CHTR)from the vendor to assure appropriate quality standards.
REPLY TO THE NOTICE OF VIOLATION (EA 89-130)I.Introduction
However, the licensee Failed to either assure the validity of the CHTR through an audit of the vendor, or specify inspections or tests to verify the critical characteristics of the O-rings.Various General Electric relays were purchased under PO 94920 from North Coast Electric as replacement parts for safety-related applications.
Pursuant to 10 C.F.R.Section 2.201, Washington
As of Hay 26, 1989, the licensee's evaluation J process performed to dedicate these components was inadequate in that the licensee dedicated the components for use in safety-related applications prior to (1)auditing the suppliers of the components and (2)conducting tests to assure that the components would perform in accordance with applicable critical characteristics.
Public Power Supply System (Supply System)hereby submits its reply to the Nuclear Regulatory
7.A York (Division of Borg-Warner) chiller shaft was purchased under PO 20173.As of Hay 26, 1989, the licensee failed to either perform an audit of the vendor's manufacturing process or evaluate the critical characteristics and specify any inspection or testing necessary to assure the adequacy of the component for its intended safety-related application.
Commission's (NRC)Notice of Violation and Proposed Imposition
8.A pump shaft was purchased as commercial grade from Ingersoll-Rand under PO 70808 for use as a spare part for emergency cooling water pumps.As of Hay 26, 1989, the licensee failed to either (1)audit the vendor's manufacturing process or (2)specify inspections or tests to assure that the component's critical characteristics were suitable for its intended safety-related application.
of a Civil Penalty issued on December 21, 1989.Consistent
9.Pressure gauges were purchased from Paramount Supply for various safety-related applications under PO 83283 in 1986.The licensee failed to either conduct or verify that an appropriate audit of the vendor's manufacturing process was conducted until another utility performed a February 1989 audit.This is a severity Level III Violation (Supplement I).Civil Penalty-$50,000.III.Su l S stem Position The Supply System respectfully denies the alleged violation.
with the Supply System's letter (No.G02-89-233)
As will be discussed below, the Supply System submits that its commercial grade item (CGI)procurement program has complied with NRC requirements and available guidance.Further, our process has resulted in the installation in the plant of commercial grade items which are fully capable of performing their intended safety function.The NRC examination of the 10 items addressed in the NOV has confirmed that items already installed in the plant are"acceptable for the function intended" (Ref.1, pg.2).The enforcement action seeks to impose new staff positions in the review of past procurements and, as such, represents an inappropriate backfit.Furthermore, as discussed in the Supply System's separate answer to the proposed civil penalty (Attachment II), even if the items cited in the enforcement action represented a violation, they would not individually or collectively rise to the level of escalated enforcement and, therefore, any civil penalty that may be considered should be fully mitigated.  
to Mr.James Lieberman, dated December 28, 1989, we are submitting
~~q I IV.Res onse to the Alle ed Violation A.Backfittin Im lications 1.The Violation Is Not Supported By Existin Re ulator Re uirements The Supply System respectfully.submits that the NOV is not supported by regulatory requirements or guidance existing at the time of the procurements involved.The enforcement action in fact represents a new Staff position for WNP-2 which is inconsistent with prior NRC acceptance of our CGI procurement and dedication practices.
this response on or before the due date of February 20, 1990.II.Restatement
of the Alle ed Violation During the Nuclear Regulatory
Commission (NRC)inspections
conducted between March 27 and September 14, 1989, violations
of NRC requirements
were identified.
In accordance
with the"General Statement of Policy and Procedures
for NRC Enforcement
Actions," 10 C.F.R.Part 2, Appendix C (1989)the following violation was identified:
10 C.F.R.Part 50, Appendix B, Criterion III,"Design Control," requires, in part, that measures shall be established
to assure that applicable
regulatory
requirements
and the design basis are correctly translated
into specifications, drawings, procedures, and instructions.
These measures shall include provisions
to assure that appropriate
quality standards are specified and included in design documents and that deviations
from such standards are controlled.
Measures shall also be established
for the selection and review for suitability
of application
of materials, parts, equipment, and processes that are essential to the safety-related
functions of the structures, systems, and components.
Contrary to the above, the licensee failed to establish and implement adequate measures to assure that quality standards are specified and included in design documents, and for the selection and review for suitability
of application
of materials, parts, and equipment that are essential to the safety-related
functions of systems and components.
Specifically, the following examples of items purchased commercial
grade that were either installed or available for installation
in safety-related
systems for which an adequate evaluation
for suitability
of application
had not been performed:
1.Evaluation
668 dedicated a commercial
grade Potter-Brumfield
MDR type control circuit relay for use in the safety-relate'd
emergency diesel generator"Loss of Power" control circuit.The evaluation
did not specify appropriate
quality standards nor otherwise assure that the replacement
component was selected and reviewed for suitability
of application
in its safety-related
function.The evaluation
was primarily based upon advertised
specifications
that  
I  
-2-the licensee failed to verify either through audits of the manufacturing
process or through identification
of critical characteristics
that must be inspected or tested.Consequently, the component was installed in a safety-related
application
on Hay 17, 1988, without assurance that design seismic requirements
were met.Evaluation
1179 dedicated Anchor-Darling
valve parts purchased commercial
grade for use in the safety-related
high pressure core spray system.The evaluation
did not specify quality standards, such as fabrication
under appropriate
aspects of the vendor's approved guality Assurance Program, or identify the replacement
parts'ritical
characteristics
that must otherwise be inspected or tested to assure suitability
for application
prior to the components'nstallation
per Haintenance
Work Request dated April 11, 1988.Standard Procurement
Policy No.6, dated June 30, 1987, dedicated commercial
grade fuses for installation
in safety-related
electrical
systems.The policy did not specify appropriate
quality standards nor assure that critical characteristics
were identified
for inspection
or testing.The policy was inadequate
in that it was based in part on: (1)the licensee's
understanding
of the manufacturing
process for which no audits of the manufacturer
were performed or required to be performed by the licensee, (2)Underwriters
Laboratory (UL)activities
which UL advised are not sufficient
to derive any statistical
inference with regard to product quality, and (3)functional
compliance
demonstrated
by inspection
and installation
tests that did not cover the expected range of component operating conditions.
A pressure switch was purchased commercial
grade under Purchase Order (PO)89583 and installed on July 20, 1987 in a safety-related application
in the control circuitry for the emergency diesel generator starting air compressor.
The licensee failed to either (1)properly audit the vendor's manufacturing
process or (2)specify and conduct appropriate
inspections
or testing to assure that critical characteristics
of the components
were suitable for their intended safety-related
application.
Hetallic 0-rings were purchased commercial
grade under PO 90163 and were installed in the discharge flange assembly of RHR relief valve RHR-RV-IB, during the 1988 refueling outage (April-June, 1988).The PO required a Certified Haterial Test Report (CHTR)from the vendor to assure appropriate
quality standards.
However, the licensee Failed to either assure the validity of the CHTR through an audit of the vendor, or specify inspections
or tests to verify the critical characteristics
of the O-rings.Various General Electric relays were purchased under PO 94920 from North Coast Electric as replacement
parts for safety-related
applications.
As of Hay 26, 1989, the licensee's
evaluation  
J  
-3-process performed to dedicate these components
was inadequate
in that the licensee dedicated the components
for use in safety-related applications
prior to (1)auditing the suppliers of the components
and (2)conducting
tests to assure that the components
would perform in accordance
with applicable
critical characteristics.
7.A York (Division of Borg-Warner)
chiller shaft was purchased under PO 20173.As of Hay 26, 1989, the licensee failed to either perform an audit of the vendor's manufacturing
process or evaluate the critical characteristics
and specify any inspection
or testing necessary to assure the adequacy of the component for its intended safety-related
application.
8.A pump shaft was purchased as commercial
grade from Ingersoll-Rand
under PO 70808 for use as a spare part for emergency cooling water pumps.As of Hay 26, 1989, the licensee failed to either (1)audit the vendor's manufacturing
process or (2)specify inspections
or tests to assure that the component's
critical characteristics
were suitable for its intended safety-related
application.
9.Pressure gauges were purchased from Paramount Supply for various safety-related
applications
under PO 83283 in 1986.The licensee failed to either conduct or verify that an appropriate
audit of the vendor's manufacturing
process was conducted until another utility performed a February 1989 audit.This is a severity Level III Violation (Supplement
I).Civil Penalty-$50,000.III.Su l S stem Position The Supply System respectfully
denies the alleged violation.
As will be discussed below, the Supply System submits that its commercial
grade item (CGI)procurement
program has complied with NRC requirements
and available guidance.Further, our process has resulted in the installation
in the plant of commercial
grade items which are fully capable of performing
their intended safety function.The NRC examination
of the 10 items addressed in the NOV has confirmed that items already installed in the plant are"acceptable
for the function intended" (Ref.1, pg.2).The enforcement
action seeks to impose new staff positions in the review of past procurements
and, as such, represents
an inappropriate
backfit.Furthermore, as discussed in the Supply System's separate answer to the proposed civil penalty (Attachment
II), even if the items cited in the enforcement
action represented
a violation, they would not individually
or collectively
rise to the level of escalated enforcement
and, therefore, any civil penalty that may be considered
should be fully mitigated.  
~~q I  
IV.Res onse to the Alle ed Violation A.Backfittin
Im lications 1.The Violation Is Not Supported By Existin Re ulator Re uirements The Supply System respectfully.submits that the NOV is not supported by regulatory
requirements
or guidance existing at the time of the procurements
involved.The enforcement
action in fact represents
a new Staff position for WNP-2 which is inconsistent
with prior NRC acceptance
of our CGI procurement
and dedication
practices.
We believe, therefore, that the NOV should be withdrawn.
We believe, therefore, that the NOV should be withdrawn.
As a matter of fundamental
As a matter of fundamental fairness, enforcement should not be taken without prior notice of the NRC Staff's requirements.
fairness, enforcement
If the enforcement action is not withdrawn, or at a minimum reduced to the level of non-escalated enforcement, we respectfully request that the NOV be reviewed as a backfit pursuant to 10 C.F.R.Section 50.109 before being imposed.a.The NRC Has Previously Approved The Supply S stem's CGI Procurement and Dedication Practices The Supply System believes that its past CGI procurement activities are not only consistent with the guidance and standards available at the time of its dedications in 1987 and 1988, but that the NRC has, on certain occasions, already approved these activities.
should not be taken without prior notice of the NRC Staff's requirements.
The following discussion will review these positions.
If the enforcement
As will be demonstrated below, the Supply System believes the alleged violation represents a plant-specific backfit and, thus, is an inappropriate basis for enforcement action.To begin with, the Supply System has consistently maintained a CGI procurement program that is adequate to ensure the proper suitability of items installed or available for installation in safety-related applications.
action is not withdrawn, or at a minimum reduced to the level of non-escalated
The Supply System's program is generally consistent with those of other licensees which we understand have been found acceptable by the NRC.Specifically, the Supply System first issued its procedure, PPH 1.3.13, for material procurement, which included replacement and spare parts, in 1976.The procedure indicated, inter alia that the technical requirements for the purchase request were to be specified consistent with ANSI 45.2.13 and the procedure also provided for an engineering review.The earliest revisions of PPH 1.3.13 did not explicitly focus on commercial grade or"off-the-shelf" items.However, in Revision 2, dated April 20, 1978, the Supply System did discuss commercial quality purchases.
enforcement, we respectfully
Revision 2 (at p.1.3.13-4)indicated that CGIs may be purchased"when it has been determined by engineering that a commercially available item will enable a component or system to perform its safety-related function." The Supply System continued to upgrade its CGI program.For example, in Revision 7, dated Hay 28, 1982 (at p.1.3.13-4), the Supply System indicated that"critical characteristics" shall be identified.
request that the NOV be reviewed as a backfit pursuant to 10 C.F.R.Section 50.109 before being imposed.a.The NRC Has Previously
In 1986, 5
Approved The Supply S stem's CGI Procurement
the Supply System significantly upgraded its CGI procurement process by implementing PPH 1.3.39, dated Hay 13, 1986,"Plant Technical Procurement Review." This procedure provided detailed guidance for the reviews being performed by the Plant Technical organization.
and Dedication
PPH 1.3.39 has been revised several times to provide further program enhancements and is in compliance with recently issued EPRI guidelines.
Practices The Supply System believes that its past CGI procurement
In summary, since the issuance of its initial procurement procedures, the Supply System has included program controls consistent with contemporaneous NRC requirements and available industry guidance.Horeover, the consistent requirement for specification of technical criteria and engineering involvement demonstrates that the Supply System's CGI purchases were made in accordance with the"suitability" requirement of Appendix B, Criterion III.In addition to the Supply System's acceptable program as described above, the NRC has on prior occasions reviewed and approved the Supply System's CGI procurement practices.
activities
The first instance of this occurred in early 1982.Specifically, in the Harch 1982 Safety Evaluation Report (SER), the NRC staff reviewed the Supply System's CGI procurement practices pursuant to Section 17.1, Item 7B4 of the Standard Review Plan (SRP).This part of Revision 2 to the SRP appears to be the first time that NRC specifically addressed CGIs.Section 17.1, Item 784 of the SRP states that: For commercial
are not only consistent
'off-the-shelf'tems where specific quality assurance controls appropriate for nuclear applications cannot be imposed in a practicable manner, special quality verification requirements shall be established and described to provide the necessary assurance of an acceptable item by the purchaser.
with the guidance and standards available at the time of its dedications
The Staff's SER (at pp.17-1 to 17-2)reviewed the Supply System's procurement controls and noted that the Supply System's gA program did not contain these additional controls for the application of"off-the-shelf" items.Notwithstanding, the SER stated that"[b]ecause the staff does not consider these controls to be of such importance as to require their implementation for WNP-2, adequate quality assurance program controls exist without these additional items." Therefore, at the time of licensing the NRC had reviewed and approved the Supply System's procurement controls in this area.The next clear instance where the NRC reviewed the Supply System's CGI procurement practices occurred between late 1984 and early 1985.As Inspection Report No.50-397/84-38 (at p.2)indicates, the NRC Staff reviewed procurement"documents to ascertain that the licensee had developed and implemented a gA program relating to the control of procurement activities that was in conformance with regulatory requirements, commitments in the application, and industry guides and standards." In particular, the staff reviewed Administrative Procedure PPH 1.3.13, the Supply System's CGI dedication procedure along with several CGI procurements.
in 1987 and 1988, but that the NRC has, on certain occasions, already approved these activities.
This 1" II F N inspection report demonstrates the acceptability of the Supply System's CGI procurement practices as of 1985.More importantly, however, Inspection Report No.50-397/84-38 also demonstrates the acceptability of the Supply System's CGI procurement program in 1987 and 1988, during which the NRC alleges inadequate CGI dedications occurred.Specifically, when a comparison is made between PPH 1.3.13 (as in effect during 1984-1985) and 1.3.39 (as in effect in 1987-1988), the only changes made were improvements.
The following discussion
Thus, if the NRC accepted the Supply System's CGI program under PPH 1.3.13 during 1984-1985, then our program under the improved procedures has to be acceptable.
will review these positions.
It should be noted that there have been other specific instances of prior Staff review.For example, in 1984 the NRC Staff reviewed the Supply System's procedure for controlling vendor information and found no violations or deviations.
As will be demonstrated
See Inspection Report No.50-397/84-26, dated November 2, 1984, at pp.9-10.More recently, in 1987, the NRC staff reviewed the Supply System's response to NRC Bulletin 87-02 which involved concerns about fasteners, including commercial grade fasteners.
below, the Supply System believes the alleged violation represents
NRC's review found no violations or deviations.
a plant-specific
See Inspection Report No.50-397/87-30, dated January 15, 1988, at pp.8-9.In addition to the NRC's past procurement reviews discussed above, there have been recent inspections where the staff has evaluated the Supply System's CGI procurement practices.
backfit and, thus, is an inappropriate
During the Safety System Functional Inspection conducted in August 1987, the Supply System was requested by the NRC to provide representative samples of CGI dedications for review.See Affidavit of Steven H.Peck, Kenneth R.Wise, and J.Michael Curren (attached hereto).Four packages were provided to the NRC.Significantly one of the packages reviewed at that time by the NRC was Evaluation 668 relating to Potter-Brumfield relays.This same dedication package was cited in the NOV as one of the examples of inadequate dedication (See NOV at 1).As explained in the attached affidavits, the four dedication packages were selected on the basis that they were not clear cut cases, but rather were examples of more complex cases where it was not clear what actions were sufficient for dedication.
basis for enforcement
It was felt that, if the NRC found these packages acceptable, the Supply System would have a much better understanding of what technical requirements were necessary for the dedication process.The NRC was also provided a copy of PPH 1.3.39.In meetings with Supply System personnel (including a meeting on August 26, 1987)the NRC inspectors discussed their review of the dedication packages as well as a design change package which included installation of a commercial grade switch in the ADS system.The inspectors did not identify any significant concerns with the packages reviewed and indicated general acceptance of the Supply System's dedication process.A minor concern was raised regarding one of the dedications, but no concerns were identified with the other three, which included Evaluation 668.
action.To begin with, the Supply System has consistently
1 I E See Affidavit of Hessrs.Peck, Wise, and Curren at p.4.Similarly, during an inspection of the emergency diesel generator system in August and September 1988, an NRC inspector asked to review Evaluation 301, the CGI dedication package for a Viking pump associated with the diesel generator.
maintained
See Affidavit of Hessrs.Peck, Wise, and Curren at p.5.The inspector reviewed the Evaluation as part of his examination of maintenance practices.
a CGI procurement
He discussed with Supply System personnel a question as to how seismic qualification was maintained and was provided a satisfactory explanation.
program that is adequate to ensure the proper suitability
Supply System personnel also generally described the dedication process for the inspector.
of items installed or available for installation
The inspector identified no further questions or concerns with the package or the dedication process.See Affidavit of Hessrs.Peck, Wise, and Curren at p.5.Based on this inFormation, it is apparent that our CGI dedication process has been previously reviewed and accepted by the NRC.Certainly, in the past reviews, the NRC has not brought to our attention any significant concerns with the CGI procurement and dedication process, despite the opportunity to do so.It is the Supply System's firm belief, therefore, that the NOV represents a change in the NRC Staff position.In these circumstances, enforcement action is inappropriate.
in safety-related
b.The Staff Position Reflected In The NOV Is Not Su orted B Existin NRC Re uirements Part 50, Appendix B establishes general guality Assurance requirements for safety-related structures, systems and components.
applications.
It does not explicitly address CGI procurement and dedication.
The Supply System's program is generally consistent
Criterion III,"Design Control," contains a broad provision which states that"[m]easures shall also be established for the selection and review for suitability of application of materials, parts, equipment, and processes that are essential to the safety-related functions of the structures, systems and components." This provision, which the NRC cites as the basis for the violation, is not further defined in Appendix B or in the rulemaking history.Criterion III also does not address CGI procurement programs.I/There has been little, if any, previous guidance on the meaning of Criterion III.The provision quoted above relative to selection and review for suitability of parts is not specifically discussed in any relevant industry or NRC guidance documents.
with those of other licensees which we understand
have been found acceptable
by the NRC.Specifically, the Supply System first issued its procedure, PPH 1.3.13, for material procurement, which included replacement
and spare parts, in 1976.The procedure indicated, inter alia that the technical requirements
for the purchase request were to be specified consistent
with ANSI 45.2.13 and the procedure also provided for an engineering
review.The earliest revisions of PPH 1.3.13 did not explicitly
focus on commercial
grade or"off-the-shelf" items.However, in Revision 2, dated April 20, 1978, the Supply System did discuss commercial
quality purchases.
Revision 2 (at p.1.3.13-4)indicated that CGIs may be purchased"when it has been determined
by engineering
that a commercially
available item will enable a component or system to perform its safety-related
function." The Supply System continued to upgrade its CGI program.For example, in Revision 7, dated Hay 28, 1982 (at p.1.3.13-4), the Supply System indicated that"critical characteristics" shall be identified.
In 1986,  
5  
the Supply System significantly
upgraded its CGI procurement
process by implementing
PPH 1.3.39, dated Hay 13, 1986,"Plant Technical Procurement
Review." This procedure provided detailed guidance for the reviews being performed by the Plant Technical organization.
PPH 1.3.39 has been revised several times to provide further program enhancements
and is in compliance
with recently issued EPRI guidelines.
In summary, since the issuance of its initial procurement
procedures, the Supply System has included program controls consistent
with contemporaneous
NRC requirements
and available industry guidance.Horeover, the consistent
requirement
for specification
of technical criteria and engineering
involvement
demonstrates
that the Supply System's CGI purchases were made in accordance
with the"suitability" requirement
of Appendix B, Criterion III.In addition to the Supply System's acceptable
program as described above, the NRC has on prior occasions reviewed and approved the Supply System's CGI procurement
practices.
The first instance of this occurred in early 1982.Specifically, in the Harch 1982 Safety Evaluation
Report (SER), the NRC staff reviewed the Supply System's CGI procurement
practices pursuant to Section 17.1, Item 7B4 of the Standard Review Plan (SRP).This part of Revision 2 to the SRP appears to be the first time that NRC specifically
addressed CGIs.Section 17.1, Item 784 of the SRP states that: For commercial
'off-the-shelf'tems
where specific quality assurance controls appropriate
for nuclear applications
cannot be imposed in a practicable
manner, special quality verification
requirements
shall be established
and described to provide the necessary assurance of an acceptable
item by the purchaser.
The Staff's SER (at pp.17-1 to 17-2)reviewed the Supply System's procurement
controls and noted that the Supply System's gA program did not contain these additional
controls for the application
of"off-the-shelf" items.Notwithstanding, the SER stated that"[b]ecause
the staff does not consider these controls to be of such importance
as to require their implementation
for WNP-2, adequate quality assurance program controls exist without these additional
items." Therefore, at the time of licensing the NRC had reviewed and approved the Supply System's procurement
controls in this area.The next clear instance where the NRC reviewed the Supply System's CGI procurement
practices occurred between late 1984 and early 1985.As Inspection
Report No.50-397/84-38 (at p.2)indicates, the NRC Staff reviewed procurement"documents
to ascertain that the licensee had developed and implemented
a gA program relating to the control of procurement
activities
that was in conformance
with regulatory
requirements, commitments
in the application, and industry guides and standards." In particular, the staff reviewed Administrative
Procedure PPH 1.3.13, the Supply System's CGI dedication
procedure along with several CGI procurements.
This  
1" II F N  
-6-inspection
report demonstrates
the acceptability
of the Supply System's CGI procurement
practices as of 1985.More importantly, however, Inspection
Report No.50-397/84-38
also demonstrates
the acceptability
of the Supply System's CGI procurement
program in 1987 and 1988, during which the NRC alleges inadequate
CGI dedications
occurred.Specifically, when a comparison
is made between PPH 1.3.13 (as in effect during 1984-1985)
and 1.3.39 (as in effect in 1987-1988), the only changes made were improvements.
Thus, if the NRC accepted the Supply System's CGI program under PPH 1.3.13 during 1984-1985, then our program under the improved procedures
has to be acceptable.
It should be noted that there have been other specific instances of prior Staff review.For example, in 1984 the NRC Staff reviewed the Supply System's procedure for controlling
vendor information
and found no violations
or deviations.
See Inspection
Report No.50-397/84-26, dated November 2, 1984, at pp.9-10.More recently, in 1987, the NRC staff reviewed the Supply System's response to NRC Bulletin 87-02 which involved concerns about fasteners, including commercial
grade fasteners.
NRC's review found no violations
or deviations.
See Inspection
Report No.50-397/87-30, dated January 15, 1988, at pp.8-9.In addition to the NRC's past procurement
reviews discussed above, there have been recent inspections
where the staff has evaluated the Supply System's CGI procurement
practices.
During the Safety System Functional
Inspection
conducted in August 1987, the Supply System was requested by the NRC to provide representative
samples of CGI dedications
for review.See Affidavit of Steven H.Peck, Kenneth R.Wise, and J.Michael Curren (attached hereto).Four packages were provided to the NRC.Significantly
one of the packages reviewed at that time by the NRC was Evaluation
668 relating to Potter-Brumfield
relays.This same dedication
package was cited in the NOV as one of the examples of inadequate
dedication (See NOV at 1).As explained in the attached affidavits, the four dedication
packages were selected on the basis that they were not clear cut cases, but rather were examples of more complex cases where it was not clear what actions were sufficient
for dedication.
It was felt that, if the NRC found these packages acceptable, the Supply System would have a much better understanding
of what technical requirements
were necessary for the dedication
process.The NRC was also provided a copy of PPH 1.3.39.In meetings with Supply System personnel (including
a meeting on August 26, 1987)the NRC inspectors
discussed their review of the dedication
packages as well as a design change package which included installation
of a commercial
grade switch in the ADS system.The inspectors
did not identify any significant
concerns with the packages reviewed and indicated general acceptance
of the Supply System's dedication
process.A minor concern was raised regarding one of the dedications, but no concerns were identified
with the other three, which included Evaluation
668.  
1 I E  
-7-See Affidavit of Hessrs.Peck, Wise, and Curren at p.4.Similarly, during an inspection
of the emergency diesel generator system in August and September 1988, an NRC inspector asked to review Evaluation
301, the CGI dedication
package for a Viking pump associated
with the diesel generator.
See Affidavit of Hessrs.Peck, Wise, and Curren at p.5.The inspector reviewed the Evaluation
as part of his examination
of maintenance
practices.
He discussed with Supply System personnel a question as to how seismic qualification
was maintained
and was provided a satisfactory
explanation.
Supply System personnel also generally described the dedication
process for the inspector.
The inspector identified
no further questions or concerns with the package or the dedication
process.See Affidavit of Hessrs.Peck, Wise, and Curren at p.5.Based on this inFormation, it is apparent that our CGI dedication
process has been previously
reviewed and accepted by the NRC.Certainly, in the past reviews, the NRC has not brought to our attention any significant
concerns with the CGI procurement
and dedication
process, despite the opportunity
to do so.It is the Supply System's firm belief, therefore, that the NOV represents
a change in the NRC Staff position.In these circumstances, enforcement
action is inappropriate.
b.The Staff Position Reflected In The NOV Is Not Su orted B Existin NRC Re uirements Part 50, Appendix B establishes
general guality Assurance requirements
for safety-related
structures, systems and components.
It does not explicitly
address CGI procurement
and dedication.
Criterion III,"Design Control," contains a broad provision which states that"[m]easures
shall also be established
for the selection and review for suitability
of application
of materials, parts, equipment, and processes that are essential to the safety-related functions of the structures, systems and components." This provision, which the NRC cites as the basis for the violation, is not further defined in Appendix B or in the rulemaking
history.Criterion III also does not address CGI procurement
programs.I/There has been little, if any, previous guidance on the meaning of Criterion III.The provision quoted above relative to selection and review for suitability
of parts is not specifically
discussed in any relevant industry or NRC guidance documents.
Significantly, even the current NRC's Standard Review Plan (SRP)fails to provide any guidance on the meaning of this provision.
Significantly, even the current NRC's Standard Review Plan (SRP)fails to provide any guidance on the meaning of this provision.
SRP Section 17.1.3,"Design Control," is silent regarding the"suitability
SRP Section 17.1.3,"Design Control," is silent regarding the"suitability of application" provision, and the related guidance in acceptance criterion 3A of SRP Section 17.1 merely states that design control activities should address"compatibility of materials." 1 See 35 Fed.Reg.10498 (1970), which noted that this provision was added to the proposed rule published in 1969, but did not further explain its purpose.
of application" provision, and the related guidance in acceptance
f I The broad provisions of Appendix B have been somewhat clarified in various industry guidelines.
criterion 3A of SRP Section 17.1 merely states that design control activities
should address"compatibility
of materials." 1 See 35 Fed.Reg.10498 (1970), which noted that this provision was added to the proposed rule published in 1969, but did not further explain its purpose.  
f I  
-8-The broad provisions
of Appendix B have been somewhat clarified in various industry guidelines.
The primary guidance document since the mid-1970s has been ANSI N18.7, to which the Supply System is committed for its gA program.ANSI N18.7 provides general guidance on gA for procurement.2/
The primary guidance document since the mid-1970s has been ANSI N18.7, to which the Supply System is committed for its gA program.ANSI N18.7 provides general guidance on gA for procurement.2/
The NRC endorsed ANSI N18.7-1976
The NRC endorsed ANSI N18.7-1976 in Regulatory Guide 1.33, Rev.2, published in February 1978, as an adequate basis for complying with the requirements of Appendix B.ANSI N18.7 addresses commercial grade items only very briefly,3/
in Regulatory
and does not discuss"dedication" of CGIs for safety-related use.ANSI N45.2.13-1976, which was endorsed by the NRC in Regulatory Guide 1.123, Rev.1, published in July 1977, provides more specific guidance on OA for procurement of items and services.4/
Guide 1.33, Rev.2, published in February 1978, as an adequate basis for complying with the requirements
The standard, however, does not explicitly address commercial grade procurement and dedication.
of Appendix B.ANSI N18.7 addresses commercial
Horeover, neither ANSI N18.7-1976 nor ANSI N45.2.13-1976 provides specific guidance on the"suitability of application" provision of Appendix B, Criterion III.The term"commercial grade item" finds its only regulatory definition in 10 C.F.R.Part 21.CGI was nowhere explicitly mentioned in NRC regulations until the first revision to 10 C.F.R.Part 21 in 1978 (43 Fed.Reg.48621 (1978)), when the following definition appeared: "Commercial grade item" means an item that is (1)not subject to design or specification requirements that are unique to facilities or activities licensed pursuant to Parts 30, 40, 50, 60, 61, 70, 71, or 72 of this chapter and (2)used in applications other than facilities or activities licensed pursuant to parts 30, 40, 50, 60, 61, 70, 71, or 72 of this chapter and (3)to be ordered from the manufacturer or supplier on the basis of specifications set forth in the manufacturer's published product description (for example a catalog).Section 21.3(c-l)also contains a reference to"dedication" of a CGI in order to denote the point in time when Part 21 reporting obligations attach.Part 21, then, clearly contemplates that licensees may make commercial grade purchases and"dedicate" the items to safety-related applications.
grade items only very briefly,3/
Certainly, nothing in Part 21--the only regulation specifically addressing the subject of CGI procurement and dedication
and does not discuss"dedication" of CGIs for safety-related
--supports the Staff position reflected in the NOV.2/ANSI N18.7,"Administrative Controls and guality Assurance for the Operational Phase of Nuclear Power Plants." 3/See Section 5.2.13.4/ANSI N45.2.13,"guality Assurance Requirements for Control of Procurement of Items and Services for Nuclear Power Plants."  
use.ANSI N45.2.13-1976, which was endorsed by the NRC in Regulatory
'I r It can be seen, therefore, that no significant guidance exists as to the nature of activit'ies that licensees are expected to undertake to satisfy Appendix B, Criterion III, the specific regulatory provision cited as the basis for the violation.
Guide 1.123, Rev.1, published in July 1977, provides more specific guidance on OA for procurement
Indeed, as the NRC's own Inspection Procedure 38703 (at p.2)on CGI procurement (issued in June 1988)states,"consistent criteria for determining an item's suitability for its intended application have not been clearly established." It follows that, even as of mid-1988, licensees have been free to implement programs that in their reasoned judgment meet the intent of the requirement.
of items and services.4/
For this reason, enforcement action that would establish specific new procedural and documentation requirements is inappropriate.
The standard, however, does not explicitly
As a matter of fair notice and sound policy, the Supply System submits that new requirements to upgrade CGI review procedures and documentation should be applied (and enfdrced)only prospectively.
address commercial
The Supply System is well aware that beginning in 1988, as a result of fraudulent and counterfeit equipment problems which were detected by licensee procurement programs in effect at the time, the NRC for the first time published detailed guidance on CGI procurement and dedication.
grade procurement
Specifically, Generic Letter 89-02,"Actions to Improve the Detection of Counterfeit and Fraudulently Harketed Products," issued Harch 21, 1989, conditionally endorsed the industry initiatives of NCIG-07 related to licensees'edication processes.
and dedication.
While the Generic Letter stated that the guidelines of NCIG-07, as modified by the Generic Letter, established methods satisfying"existing" requirements of Appendix B, the Staff did not explain the legal basis for this conclusion.
Horeover, neither ANSI N18.7-1976
We believe that the intent of NCIG-07 was to legitimately and prospectively upgrade procurement programs;not to provide an enforcement basis for past procurements.
nor ANSI N45.2.13-1976
Significantly, on Harch 16, 1989, the NRC published an Advance Notice of Proposed Rulemaking (54 Fed.Reg.9229)on procurement practices, specifically including commercial grade item dedication.
provides specific guidance on the"suitability
The Commission noted that it was reconsidering the adequacy of current regulations in this area.guestions posed in the ANPR strongly suggest that the Commission did not believe that existing regulations require the extensive verification tests assumed in the present NOV against the Supply System.For example, the Commission asked: How should products...be inspected to verify that all critical characteristics are satisfied?
of application" provision of Appendix B, Criterion III.The term"commercial
Should all upgrade inspections be restricted to inspections and tests or should they include, on a sample basis, destructive inspections and tests to verify chemical and physical characteristics? How should inspections verify all critical characteristics (for example, chemistry, physical properties, dimensions, special processes, etc.)?5/Had the Commission believed that these actions were already mandated by existing regulations (as the NOV assumes), there would have been no need to pose these questions.
grade item" finds its only regulatory
The only conclusion that can be drawn is that the Commission did not believe these requirements were within the contemplation of the current regulations (or at least current interpretations of those r'egulations).
definition
B.Clarification to the Notice of Violation and Su ortin Ins ection Re orts The cover letter dated December 21, 1989, transmitting the Notice of Violation states (at p.2)that"A fundamental flaw in your procurement program appears to be the failure to adequately identify each commercial grade item's critical characteristics that must be inspected or tested to verify its suitability for use in a safety-related application.
in 10 C.F.R.Part 21.CGI was nowhere explicitly
This failure conflicts with the requirement to implement ANSI 18.7 specified in your FSAR as the method chosen to comply with 10 C.F.R.Part 30, Appendix B." ANSI N18.7 does not specifically address"critical characteristics." It does require that an appropriate"engineering evaluation shall be conducted by qualified individuals to establish the requirements and controls.This evaluation shall ensure that interfaces, interchangeability, safety, fit, and function are not adversely affected...The results of this evaluation shall be documented." The Supply System's process has required an evaluation by qualified individuals as well as meeting other requirements of ANSI N18.7.The staff requirement that each critical characteristic be inspected or tested differs from the guidance provided in the EPRI"Guideline for the Utilization of Commercial Grade Items in Nuclear Safety-Related Application (NCIG-07)," which states that"...only certain of these[critical characteristics]
mentioned in NRC regulations
must be verified to provide reasonable assurance that the item specified is the item received." This difference in interpretation is currently an item of discussion between the NRC and NUHARC.C.Conclusion In summary, it can be seen from the above that the Supply System's CGI procurement and dedication practices have been previously reviewed and accepted by the NRC.Further, this has been an area in which no explicit guidance existed until industry publication of NCIG-07.NRC regulations do not contain explicit standards and requirements for CGI procurement and dedication.
until the first revision to 10 C.F.R.Part 21 in 1978 (43 Fed.Reg.48621 (1978)), when the following definition
Under these circumstances, enforcement action is wholly inappropriate.
appeared: "Commercial
The Supply System therefore respectfully requests that the Notice of Violation be withdrawn.
grade item" means an item that is (1)not subject to design or specification
5/54 Fed.Reg.at 9232 (guestions 2.1.4, 2.1.7, and 2.1.9).
requirements
T J~, We must also observe that the NRC's reliance on new standards to review past procurement activity, as is implied by Generic Letter 89-02 and Inspection Procedure 38703 (both of which rely on NCIG-07 criteria), could greatly discourage industry self-improvement.
that are unique to facilities
For this additional reason, enforcement action would not be in the public interest.V.Procurement Pro ram Enhancements As discussed above, the Supply System believes that it has conducted its procurement activities in accordance with the standards and guidance that existed at the time the items cited in the NOV were dedicated arid that the programs in place have resulted in equipment installed in the plant capable of performing its intended safety function.Nevertheless, in an effort to fully ensure the NRC and ourselves that no significant deficiencies exist in our past procurement activities, the Supply System has taken the following steps: l.A verification of the 10 CGIs evaluated by the NRC was conducted.
or activities
Utilizing NCIG-07 methodology, information was established which demonstrates that each item is capable of performing its intended safety function.This information was reported to the NRC at the November 20, 1989, management meeting.In addition, our findings were reviewed and are supported by our contractor, Cygna Energy Services.The NRC has also found that those items installed in the plant are capable of performing their intended function.2.A verification of an additional sample of 50 CGIs was conducted by Cygna Energy Services.The purpose of this evaluation was to expand the sample size beyond the initial 10 CGIs to achieve a statistically valid sample of our entire CGI population.
licensed pursuant to Parts 30, 40, 50, 60, 61, 70, 71, or 72 of this chapter and (2)used in applications
As with the initial 10 items, NCIG-07 methodology was used to evaluate the technical adequacy of our past procurement activities.
other than facilities
Although the procurement packages for the 50 CGIs reviewed did not meet the documentation"requirements" specified under today's guidance (i.e., NCIG-07), Cygna Energy Services determined that the Supply System's CGI dedication process was technically sound and that each item was capable of performing its intended safety function.These findings combined with those for the initial 10 items provide significant evidence that there is reasonable assurance that the Supply System's entire population of CGIs can perform their intended safety function when called upon.3.The Supply System is conducting an internal reverification review of an additional 60 CGIs to provide further assurance of the quality of our past procurement activities.
or activities
This sample will focus on items purchased prior to 1985.Although Supply System personnel are performing the review, individuals not involved in the previous reviews are being used to obtain an independent assessment.
licensed pursuant to parts 30, 40, 50, 60, 61, 70, 71, or 72 of this chapter and (3)to be ordered from the manufacturer
This work is being performed by the Nuclear Safety Assurance Group. 4.Another important action is our ongoing process of evaluating all reorders of CGIs currently installed in the plant or in storage.Whenever a reorder is requested, we will review the past procurement process to determine whether any deficiencies existed.NCIG-07 criteria will be applied to the review process.If a hardware concern is identified, we will conduct the appropriate generic reviews and take prompt and comprehensive action, as necessary.
or supplier on the basis of specifications
In conclusion, the Supply System believes that it has taken and is taking prompt and comprehensive program enhancements to ensure the continued adequacy of our CGI dedication practices.
set forth in the manufacturer's
We believe that our additional sampling efforts will further demonstrate the technical quality of our past procurement activities.
published product description (for example a catalog).Section 21.3(c-l)also contains a reference to"dedication" of a CGI in order to denote the point in time when Part 21 reporting obligations
Furthermore, our ongoing efforts should ensure that we meet or exceed the industry initiative to conform all future CGI purchases to NCIG-07 standards.
attach.Part 21, then, clearly contemplates
Our commercial grade dedication program was upgraded in 1986 and subsequent enhancements have been made since that time to bring the program into conformance with NCIG-07 in accordance with the NUMARC initiative on this issue.
that licensees may make commercial
ATTACHMENT II I.Introduction Washington Public Power Supply System (NRC Inspection Report Nos.50-397/89-21, 50-397/89-22, and 50-397/89-28)
grade purchases and"dedicate" the items to safety-related
ANSWER TO THE NOTICE OF VIOLATION (EA 89-130)Pursuant to 10 C.F.R.Section 2.205, Washington Public Power Supply System (Supply System)hereby submits its Answer to the Nuclear Regulatory Commission's (NRC)Notice of Violation and Proposed Imposition of a Civil Penalty issued on December 21, 1989.Consistent with the Supply System's letter (No.G02-89-233) to Hr.James Lieberman, dated December 28, 1989, we are submitting this answer on or before the due date of February 20, 1990.II.Su 1 S stem Position The Supply System believes that the discussion provided in the Reply to the Notice of Violation (Attachment I)identifies more than sufficient facts to support the conclusion that enforcement action is wholly unwarranted.
applications.
Certainly, nothing in Part 21--the only regulation
specifically
addressing
the subject of CGI procurement
and dedication
--supports the Staff position reflected in the NOV.2/ANSI N18.7,"Administrative
Controls and guality Assurance for the Operational
Phase of Nuclear Power Plants." 3/See Section 5.2.13.4/ANSI N45.2.13,"guality Assurance Requirements
for Control of Procurement
of Items and Services for Nuclear Power Plants."  
'I r  
It can be seen, therefore, that no significant
guidance exists as to the nature of activit'ies
that licensees are expected to undertake to satisfy Appendix B, Criterion III, the specific regulatory
provision cited as the basis for the violation.
Indeed, as the NRC's own Inspection
Procedure 38703 (at p.2)on CGI procurement (issued in June 1988)states,"consistent
criteria for determining
an item's suitability
for its intended application
have not been clearly established." It follows that, even as of mid-1988, licensees have been free to implement programs that in their reasoned judgment meet the intent of the requirement.
For this reason, enforcement
action that would establish specific new procedural
and documentation
requirements
is inappropriate.
As a matter of fair notice and sound policy, the Supply System submits that new requirements
to upgrade CGI review procedures
and documentation
should be applied (and enfdrced)only prospectively.
The Supply System is well aware that beginning in 1988, as a result of fraudulent
and counterfeit
equipment problems which were detected by licensee procurement
programs in effect at the time, the NRC for the first time published detailed guidance on CGI procurement
and dedication.
Specifically, Generic Letter 89-02,"Actions to Improve the Detection of Counterfeit
and Fraudulently
Harketed Products," issued Harch 21, 1989, conditionally
endorsed the industry initiatives
of NCIG-07 related to licensees'edication
processes.
While the Generic Letter stated that the guidelines
of NCIG-07, as modified by the Generic Letter, established
methods satisfying"existing" requirements
of Appendix B, the Staff did not explain the legal basis for this conclusion.
We believe that the intent of NCIG-07 was to legitimately
and prospectively
upgrade procurement
programs;not to provide an enforcement
basis for past procurements.
Significantly, on Harch 16, 1989, the NRC published an Advance Notice of Proposed Rulemaking
(54 Fed.Reg.9229)on procurement
practices, specifically
including commercial
grade item dedication.
The Commission
noted that it was reconsidering
the adequacy of current regulations
in this area.guestions posed in the ANPR strongly suggest that the Commission
did not believe that existing regulations
require the extensive verification
tests assumed in the present NOV against the Supply System.For example, the Commission
asked: How should products...be inspected to verify that all critical characteristics
are satisfied?
Should all upgrade inspections
be restricted
to inspections
and tests or should they include, on a sample basis, destructive
inspections
and tests to verify chemical and physical characteristics?  
-10-How should inspections
verify all critical characteristics (for example, chemistry, physical properties, dimensions, special processes, etc.)?5/Had the Commission
believed that these actions were already mandated by existing regulations (as the NOV assumes), there would have been no need to pose these questions.
The only conclusion
that can be drawn is that the Commission
did not believe these requirements
were within the contemplation
of the current regulations (or at least current interpretations
of those r'egulations).
B.Clarification
to the Notice of Violation and Su ortin Ins ection Re orts The cover letter dated December 21, 1989, transmitting
the Notice of Violation states (at p.2)that"A fundamental
flaw in your procurement
program appears to be the failure to adequately
identify each commercial
grade item's critical characteristics
that must be inspected or tested to verify its suitability
for use in a safety-related
application.
This failure conflicts with the requirement
to implement ANSI 18.7 specified in your FSAR as the method chosen to comply with 10 C.F.R.Part 30, Appendix B." ANSI N18.7 does not specifically
address"critical characteristics." It does require that an appropriate"engineering
evaluation
shall be conducted by qualified individuals
to establish the requirements
and controls.This evaluation
shall ensure that interfaces, interchangeability, safety, fit, and function are not adversely affected...The results of this evaluation
shall be documented." The Supply System's process has required an evaluation
by qualified individuals
as well as meeting other requirements
of ANSI N18.7.The staff requirement
that each critical characteristic
be inspected or tested differs from the guidance provided in the EPRI"Guideline
for the Utilization
of Commercial
Grade Items in Nuclear Safety-Related
Application (NCIG-07)," which states that"...only certain of these[critical characteristics]
must be verified to provide reasonable
assurance that the item specified is the item received." This difference
in interpretation
is currently an item of discussion
between the NRC and NUHARC.C.Conclusion
In summary, it can be seen from the above that the Supply System's CGI procurement
and dedication
practices have been previously
reviewed and accepted by the NRC.Further, this has been an area in which no explicit guidance existed until industry publication
of NCIG-07.NRC regulations
do not contain explicit standards and requirements
for CGI procurement
and dedication.
Under these circumstances, enforcement
action is wholly inappropriate.
The Supply System therefore respectfully
requests that the Notice of Violation be withdrawn.
5/54 Fed.Reg.at 9232 (guestions
2.1.4, 2.1.7, and 2.1.9).  
T J~,  
-11-We must also observe that the NRC's reliance on new standards to review past procurement
activity, as is implied by Generic Letter 89-02 and Inspection
Procedure 38703 (both of which rely on NCIG-07 criteria), could greatly discourage
industry self-improvement.
For this additional
reason, enforcement
action would not be in the public interest.V.Procurement
Pro ram Enhancements
As discussed above, the Supply System believes that it has conducted its procurement
activities
in accordance
with the standards and guidance that existed at the time the items cited in the NOV were dedicated arid that the programs in place have resulted in equipment installed in the plant capable of performing
its intended safety function.Nevertheless, in an effort to fully ensure the NRC and ourselves that no significant
deficiencies
exist in our past procurement
activities, the Supply System has taken the following steps: l.A verification
of the 10 CGIs evaluated by the NRC was conducted.
Utilizing NCIG-07 methodology, information
was established
which demonstrates
that each item is capable of performing
its intended safety function.This information
was reported to the NRC at the November 20, 1989, management
meeting.In addition, our findings were reviewed and are supported by our contractor, Cygna Energy Services.The NRC has also found that those items installed in the plant are capable of performing
their intended function.2.A verification
of an additional
sample of 50 CGIs was conducted by Cygna Energy Services.The purpose of this evaluation
was to expand the sample size beyond the initial 10 CGIs to achieve a statistically
valid sample of our entire CGI population.
As with the initial 10 items, NCIG-07 methodology
was used to evaluate the technical adequacy of our past procurement
activities.
Although the procurement
packages for the 50 CGIs reviewed did not meet the documentation"requirements" specified under today's guidance (i.e., NCIG-07), Cygna Energy Services determined
that the Supply System's CGI dedication
process was technically
sound and that each item was capable of performing
its intended safety function.These findings combined with those for the initial 10 items provide significant
evidence that there is reasonable
assurance that the Supply System's entire population
of CGIs can perform their intended safety function when called upon.3.The Supply System is conducting
an internal reverification
review of an additional
60 CGIs to provide further assurance of the quality of our past procurement
activities.
This sample will focus on items purchased prior to 1985.Although Supply System personnel are performing
the review, individuals
not involved in the previous reviews are being used to obtain an independent
assessment.
This work is being performed by the Nuclear Safety Assurance Group.  
-12-4.Another important action is our ongoing process of evaluating
all reorders of CGIs currently installed in the plant or in storage.Whenever a reorder is requested, we will review the past procurement
process to determine whether any deficiencies
existed.NCIG-07 criteria will be applied to the review process.If a hardware concern is identified, we will conduct the appropriate
generic reviews and take prompt and comprehensive
action, as necessary.
In conclusion, the Supply System believes that it has taken and is taking prompt and comprehensive
program enhancements
to ensure the continued adequacy of our CGI dedication
practices.
We believe that our additional
sampling efforts will further demonstrate
the technical quality of our past procurement
activities.
Furthermore, our ongoing efforts should ensure that we meet or exceed the industry initiative
to conform all future CGI purchases to NCIG-07 standards.
Our commercial
grade dedication
program was upgraded in 1986 and subsequent
enhancements
have been made since that time to bring the program into conformance
with NCIG-07 in accordance
with the NUMARC initiative
on this issue.  
ATTACHMENT
II I.Introduction
Washington
Public Power Supply System (NRC Inspection
Report Nos.50-397/89-21, 50-397/89-22, and 50-397/89-28)
ANSWER TO THE NOTICE OF VIOLATION (EA 89-130)Pursuant to 10 C.F.R.Section 2.205, Washington
Public Power Supply System (Supply System)hereby submits its Answer to the Nuclear Regulatory
Commission's (NRC)Notice of Violation and Proposed Imposition
of a Civil Penalty issued on December 21, 1989.Consistent
with the Supply System's letter (No.G02-89-233)
to Hr.James Lieberman, dated December 28, 1989, we are submitting
this answer on or before the due date of February 20, 1990.II.Su 1 S stem Position The Supply System believes that the discussion
provided in the Reply to the Notice of Violation (Attachment
I)identifies
more than sufficient
facts to support the conclusion
that enforcement
action is wholly unwarranted.
However, as discussed below, the Supply System believes that, even if the NRC disagrees with this position, the alleged violation rises at most to the level of a Severity Level IV or V violation.
However, as discussed below, the Supply System believes that, even if the NRC disagrees with this position, the alleged violation rises at most to the level of a Severity Level IV or V violation.
Therefore, no civil penalty is warranted.
Therefore, no civil penalty is warranted.
Notwithstanding
Notwithstanding the above, the discussion below also offers facts to support the conclusion that the Enforcement Policy adjustment factors properly provide for full mitigation of the proposed civil penalty.III.Severit Level Determination A.NRC Did Not Identif Hardware 0 erabilit Concerns The NRC has indicated on several occasions that it did not have concerns about the operability of the installed items cited in the Notice of Violation (NOV).This position is supported by the NOV (at p.2)where the Staff states that during a"follow-up inspection of items already installed[NRC]found the items to be acceptable for the function intended." Therefore, the cited concerns can have no actual safety significance.
the above, the discussion
The NOV (at p.2)indicates that the Supply System's CGI procurement activities during 1987 and 1988 demonstrated"the underlying programmatic problem of[not]adequately identifying critical'haracteristics of commercial grade items and[not]properly verifying their adequacy." This apparently, to the NRC Staff, represents a regulatory concern.While the Supply System can accept that its (and many licensees')
below also offers facts to support the conclusion
CGI procurement programs may need to be improved to reflect increasing emphasis on this concern, it cannot accept that the problems identified rise to the level of a significant regulatory concern.The examples cited represent only minor procedural or documentation problems.Perhaps even more importantly, as discussed in the Reply to the NOV, NRC's enforcement action appears to be viewing yesterday's procurements in light of today's sensitivities.
that the Enforcement
In this light, the examples should not be held out as a significant regulatory concern.
Policy adjustment
I , I C Further support for the Supply System's position on Severity Level can be found in the NRC's Enforcement Policy (53 Fed.Reg.40019, 40023 (October 13, 1988)).The Enforcement Policy states that"the severity of a violation will be characterized at the level best suited to the significance of the particular violation." Thus, the Enforcement Policy establishes a hierarchy of significance in its Supplements I through VIII.Each Supplement is"designed to illustrate the significance which NRC places on a particular type of violation of NRC requirements" (53 Fed.Reg.at 40023).It-is noteworthy that, in the Severity Level I through III categories for Supplement I of the Enforcement Policy, the examples refer specifically to systems"not being able to perform[their]intended function[s]" (53 Fed.Reg.at 40030).This same concept, however, is not used for the Severity Level IV or V categories.
factors properly provide for full mitigation
Therefore, because the NOV explicitly states that all of the items cited are"acceptable for the function intended," it logically follows that the significance of these items does not rise above Severity Level IV or V.In addition to the above, the Supply System has demonstrated the lack of safety significant deficiencies in its commercial grade item (CGI)procurements other than those cited in the NOV.Specifically, during the November 20, 1989 management meeting, the Supply System presented findings concerning a reverification sample for its CGI population totalling approximately 9700.The sample size was 50 items plus the 10 items reviewed by the NRC.The findings show no CGIs which are not capable of performing their intended safety function.1/Therefore, based on this sample, the Supply System believes there is at least a 95 percent confidence level that reasonable assurance exists that all CGIs procured and installed (or available for installation) in safety related applications can perform their intended safety function.2/
of the proposed civil penalty.III.Severit Level Determination
These results clearly do not indicate a program that is a"significant regulatory concern." With regard to NRC's assertion that a"programmatic problem" exists, there are several other pertinent points that should be considered.
A.NRC Did Not Identif Hardware 0 erabilit Concerns The NRC has indicated on several occasions that it did not have concerns about the operability
First, as discussed above, the items cited in the NOV represent, at most, minor procedural or documentation concerns.When the dedication of the cited items is viewed in light of the guidance and standards available at the time, it is clear that the Supply System exercised effective controls to ensure safe operation of its nuclear facility.Therefore, a"programmatic problem" only exists in the Staff's view, if at all, because the Supply System's past activities are being evaluated against recently issued guidance.1/See NRC Meeting Report No.50-397/89-36 (December 8, 1989)at p.3;see also Cygna Energy Services,"Commercial Grade Dedication Project for Washington Public Power Supply System Contract No.C-30298" (August 14, 1989).2/The NRC as well as various federal courts have accepted the use of the 95 percent confidence standard to demonstrate that specific sampling data is valid.See~e..Commonwealth Edison Co.LBP-84-41, 20 NRC 1203 (1984), aff'd ALAB-793, 20 NRC 1591 (1984)(involved the issue of adequacy of a reinspection program concerning BA/BC activities at Byron);see also Schaill b Kross v.Ti ecanoe Count School Cor.864 F.2d 1309 (7th Cir.1989).
of the installed items cited in the Notice of Violation (NOV).This position is supported by the NOV (at p.2)where the Staff states that during a"follow-up
Second, the Supply System has not been subject to prior escalated enforcement action in the procurement area.Further, the non-escalated actions that have occurred are few in number, isolated in nature and do not relate directly to the concerns addressed in the NOV.In addition, as discussed in the Reply to the NOV, NRC has previously evaluated the Supply System's procurement activities without finding significant concerns.Thus, our enforcement history coupled with the lack of safety significance of the concerns demonstrates that there is no programmatic problem.In summary, based on the NRC's independent evaluation and the Supply System's reverification efforts, including its sampling efforts, it may be reasonably concluded that the items cited in the NOV do not represent safety significant concerns.Furthermore, when all of the facts and circumstances surrounding the NOV are considered, as is the purpose of the Enforcement Policy, it may also be reasonably concluded that there was no programmatic problem which could rise to a level of regulatory significance that would warrant escalated enforcement action.In fact, even applying today's standards, the Supply System's past procurement activities represent, at most, low severity level procedural or documentation violations.
inspection
B.Prior Enforcement Precedent In 1989, a number of NRC inspections concentrating on CGI procurement activities took place.In each case, the inspection reports indicated that the utilities involved allegedly failed to ensure the"suitability" of CGIs installed in safety-related applications.
of items already installed[NRC]found the items to be acceptable
The NRC's findings have generally involved concerns such as inadequate verification of critical characteristics and inadequate determination of safety function.In several cases, the inspections have resulted in the issuance of escalated enforcement actions (e.g., EA 89-16 and EA 89-135).On the other hand, a recent NRC team inspection which identified similar concerns as those listed above resulted in no escalated enforcement action (EA 89-43).As distinguished from the two cases previously referenced, the utility involved in EA 89-43 performed a reverification effort which demonstrated there was reasonable assurance that CGIs installed in safety-related applications could perform their intended safety functions.
for the function intended." Therefore, the cited concerns can have no actual safety significance.
Consequently, the NRC determined that the CGIs reviewed were not of indeterminate quality or defective.
The NOV (at p.2)indicates that the Supply System's CGI procurement
The NRC thus concluded that escalated enforcement action was not warranted and cited the utility for minor documentation concerns.In the case of the Supply System's alleged CGI procurement violations, the only deficiencies which exist, if in fact there are any, involve mere procedural or documentation concerns.This position is supported by NRC's finding of no actual safety significance as well as by the Supply System's reverification results.As we discussed with you at the November 20, 1989 management meeting, our reverification effort used NCIG-07 type methodology.
activities
The results demonstrate that there is no safety significance to the NRC's concerns and that there is reasonable assurance that CGIs installed (or available for installation) in safety-related applications can perform their intended safety function.
during 1987 and 1988 demonstrated"the underlying
E h 1 The Supply System's reverification results are very similar to those presented by the utility involved in EA 89-43.While the Supply System acknowledges that its documentation could have been improved by today's standards, we maintain, that our CGI procurement efforts were consistent with the limited regulations and guidance available to industry at the time.In addition, because our reverification efforts demonstrate reasonable assurance of adequate suitability, no escalated enforcement is warranted.
programmatic
This position is consistent with NRC's prior enforcement precedent.
problem of[not]adequately
C.A lication of Enforcement Discretion The Enforcement Policy states that the NRC must exercise judgement and discretion in determining the severity levels of the violations and the appropriate enforcement sanctions, including the decision to issue a Notice of Violation, or to propose or impose a civil penalty and the amount of such penalty, after considering the general principles of this statement of policy and the technical significance of the violations and the surrounding circumstances.
identifying
53 Fed.Reg.at 40029.We believe that in light of (I)the purposes of the Policy, (2)the significance of the violations, and (3)the surrounding circumstances, enforcement discretion is appropriate in this case.The Supply System believes that in this case escalated enforcement is neither appropriate nor necessary to achieve the purposes of the Policy.The Policy states four principal purposes: (I)Ensuring compliance with NRC regulations and license conditions; (2)Obtaining prompt correction of violations and adverse quality conditions which may affect safety;(3)Deterring future violations and occurrences of conditions adverse to quality;and (4)Encouraging improvement of licensee and vendor performance, and by example, that of industry, including the prompt identification and reporting of potential safety problems.53 Fed.Reg.40022.With regard to item (I), the Supply System is well aware of the need for compliance with NRC regulations.
critical'haracteristics
The NRC Staff has consistently recognized in its Systematic Assessment of Licensee Performance evaluations that, overall, the Supply System has a well established safety culture, a tradition of technical competence, and a long-standing reputation for proactive programs.In fact, the NRC acknowledged our"overall good performance" in the NOV (at p.2).With regard to items (2)and (3), the Supply System has already implemented procurement program enhancements which will further ensure that violations or conditions adverse to quality do not occur in the future (See Attachment I, Section V, supra).
of commercial
0 A With respect to the completeness and effectiveness of this action, it is noteworthy to reemphasize that the positive findings of our reverification effort (i.e., concerning the 60 items)are supported by the former Chairman of the NCIG-07 Task Group, Nr.William E.Craig, who can best provide the proper interpretation and application of this EPRI guidance document.Finally, concerning item (4), escalated enforcement action and/or a civil penalty is not necessary to encourage the Supply System's improvement.
grade items and[not]properly verifying their adequacy." This apparently, to the NRC Staff, represents
As we noted during the June 28, 1989 enforcement conference and during the November 20, 1989 management meeting, the Supply System has been proactive in the CGI procurement area.We have had a number of our personnel actively involved in industry developments in this area, such as NCIG-07 and NCIG-11.In addition, since mid-1986, the Supply System has implemented a number of significant procurement program enhancements to meet or exceed the evolving expectations of the NRC Staff.This demonstrates that the Supply System has been actively and effectively pursuing the stated goals of the Enforcement Policy.Concerning the second element of enforcement discretion i.e., technical significance of the violations, the Supply System believes that the demonstrated lack of safety significance shows escalated enforcement is unwarranted.
a regulatory
As previously discussed, the NRC agrees that there is no actual safety significance to the cited examples.Furthermore, even if violations exist, they rise only to the level of Severity Level IV or V procedural or documentation violations, as viewed under today's guidance.Finally, concerning the last element of discretion, i.e., evaluation of the"surrounding circumstances," the Supply System believes that escalated enforcement action, and for that matter any enforcement action, is unwarranted because the NRC has apparently not considered all of the information relevant to the NOV.In particular, the NOV indicates that various Supply System actions which were presented at the November 20, 1989 management meeting"have not yet been inspected." Principal among these actions is the reverification effort by Cygna Energy Services.Thus, the issuance of the NOV appears to be premature and does not appear to comport with the above stated requirements of the Enforcement Policy.In addition, it should be noted that the failure by an agency to consider the full extent of the"surrounding circumstances" is an improper exercise of its discretion.
concern.While the Supply System can accept that its (and many licensees')
Specifically, the Eighth Circuit has held that: An administrative agency's exercise of its discretion cannot be'unreasoned or arbitrary.'ourts reviewing discretionary agency action must evaluate, among other things, the agency's treatment of the evidence.The agency must have observed the necessary procedural requirements including the consideration of all relevant facts available in the administrative record as a whole.3/3 Choi v.United States I.N.S.798 F.2d 1189, 1191 (8th Cir.1986)(emphasis supplied)(citations omitted).  
CGI procurement
'I I 0 r A h In conclusion, for all of the reasons stated above, the NRC should exercise enforcement discretion in this case.IV.A lication of Enforcement Polic Ad'ustment Factors With respect to the application of the Enforcement Policy Adjustment Factors, 10 C.F.R.Part 2, Appendix C, Section V.B, the NOV states (at p.2)that the"escalation and mitigation factors of the Enforcement Policy were considered." The Supply System believes that the NRC did not properly apply the Enforcement Policy with regard to: (1)past performance and (2)corrective actions.A.Past Performance The Enforcement Policy, at Section V.B.3, states that:[when evaluating past performance,]
programs may need to be improved to reflect increasing
consideration will be given to, among other things, the effectiveness of previous corrective action for similar problems, overall performance such as Systematic Assessment of Licensee Performance (SALP)evaluations for power reactors, and prior performance including Severity Level IV and V violations in the area of concern.53 Fed.Reg.at 40025.Using these factors the Policy allows reduction of a proposed civil penalty"by as much as 100%." The NOV (at p.2), however, indicates that the NRC believes only 50 percent mitigation is warranted for the Supply System's"prior overall good performance." 4 The NOV is silent as to how the NRC Staff determined that 50 percent mitigation was the appropriate amount.In this regard, the NRC should consider the fact that the Supply System has had no escalated enforcement in the procurement area nor have there been any low level violations relevant to the issues raised in the NOV.In addition, the NRC Staff should consider the Supply System's proactive involvement with the CGI dedication issue.As previously discussed, Supply System personnel have been, and still are, actively involved in various industry groups (e.g., NCIG-07)concerning the procurement area.Moreover, as our discussion in the reply indicates, the NRC Staff has evaluated the Supply System's CGI procurement activities in the past and found them to be acceptable.
emphasis on this concern, it cannot accept that the problems identified
Therefore, based on the above information, it is reasonable that the Supply System should receive additional mitigation for its long-standing good performance regarding the CGI procurement issue and for its overall good performance. B.Corrective Actions The Enforcement Policy, at Section V.B.2, states that: the promptness and extent to which the licensee takes corrective action, including actions to prevent recurrence, may result in up to a 50%increase or decrease in the base civil penalty.53 Fed.Reg.at 40025 (emphasis supplied).
rise to the level of a significant
The NOV (at p.2)indicates that the NRC determined the Supply System's post-inspection actions to be"inadequate." Specifically, the NOV (at p.2)states that"your corrective actions for these violations failed to fully address the need to properly evaluate and specify the critical characteristics required for proper dedication of commercial grade items." Consequently, the NRC escalated the base civil penalty by 50 percent.The Supply System believes that the NRC misapplied the corrective actions factor.As discussed previously, the NRC guidance available at the time the cited items were dedicated was minimal.Thus, we believe that the kind of"upgrades" or"corrective actions" that the NRC Staff is apparently expecting exceed those required at the time of dedication.
regulatory
Notwithstanding, and as also discussed previously, the Supply System did initiate prompt enhancements to our CGI procurement program.Part of this effort included the reverification of the items cited in the NOV as well as an additional sample of CGIs.The results of this reverification effort demonstrated no safety significance or operability concern.In addition, our reverification effort used as its principal basis the NCIG-07 methodology.
concern.The examples cited represent only minor procedural
According to our contractor, who is very familiar with the interpretation of NCIG-07, there is reasonable assurance that the CGIs reviewed can perform their intended safety related function when called upon.Based on this information, the Supply System believes that it did take adequate corrective action.The"corrective actions" which the Staff believes should have been taken are the very issues at the heart of the NOV, e.g., the proper evaluation and specification of critical characteristics.
or documentation
Thus, the Supply System believes that requiring actions beyond those required by NCIG-07, the NRC's current guidance concerning CGI dedication, is an improper application of the Enforcement Policy.Therefore, because we have demonstrated that our past CGI procurements are consistent with the NCIG-07 methodology, the NRC should not escalate the base civil penalty.In addition to the above position, the Supply System also believes that the NRC did not allow sufficient credit for the program enhancements described in Section V of our Reply to the NOV.Me believe that when viewed together with the Supply System's proactive efforts in the CGI dedication area (both past and present)the NRC Staff has ample support for full mitigation of the proposed base civil penalty. V.Conclusion The Supply System believes that the NRC has more than sufficient evidence to support full mitigation of the proposed base civil penalty.This position is firmly supported by (1)the backfitting issues discussed in the reply to the NOV, (2)the demonstrated lack of safety significance, (3)the prior, enforcement precedent, (4)the enforcement discretion concept and (5)an appropriate application of the Enforcement Policy adjustment factors.
problems.Perhaps even more importantly, as discussed in the Reply to the NOV, NRC's enforcement
UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION AFFIDAVIT OF STEVEN H.PECK KENNETH R.WISE AND J.MICHAEL CURREN I.Introduction I, Steven H.Peck, being first duly sworn, depose and state as follows: I am employed by Washington Public Power Supply System (" Supply System")as Manager of Spare Parts Engineering.
action appears to be viewing yesterday's
I have held that position since August 1989.I am responsible for performing the technical evaluations to establish procurement requirements, including the dedication requirements for items purchased commercial grade.Prior to holding my current position, I was Supervisor, Materials Support Engineering (August 1988 to August 1989)and Lead for the Spare Parts Program (July 1986 to August 1988), In those positions my technical responsibilities over procurement were the same as they are today.I, Kenneth R.Wise, being first duly sworn, depose and state as follows: I am employed by the Supply System as Manager of Equipment Engineering.
procurements
I have held that position since October 28, 1989.Prior to holding my current position, I was Supervisor of Electrical Equipment Engineering (September 17, 1988 to October 1989).From 1983 until September 16, 1988, I was Technical Program Leader, Electrical Equipment Engineering.
in light of today's sensitivities.
In that position, my responsibilities included reviewing dedication packages for electrical equipment commercial grade item purchases.
In this light, the examples should not be held out as a significant
Hy review focused on ensuring that adequate commercial grade dedication requirements were established.
regulatory
I, J.Michael Curren, being first duly sworn, depose and state as follows: I am employed by the Supply System as Senior Equipment Engineer, Equipment Engineering Group.I have held that position since July 1986.Hy responsibilities from June 1985 to August 1989 included involvement in the commercial grade dedication process in order to ensure maintenance of equipment qualification and operability.
concern.  
These responsibilities included dedication activities for commercial grade items procured for use in safety-related applications.
I , I C  
This affidavit is provided to support the Supply System's response to the Nuclear Regulatory Commission (NRC)Notice of Violation and Proposed Imposition of Civil Penalty (EA 89-130)related to commercial grade item ("CGI")procurement.
-2-Further support for the Supply System's position on Severity Level can be found in the NRC's Enforcement
In this affidavit, we describe certain recent instances in which the NRC has reviewed the Supply System's CGI dedication practices.
Policy (53 Fed.Reg.40019, 40023 (October 13, 1988)).The Enforcement
Section II below describes the NRC's review of the CGI dedication process in connection with the 1987 Safety System Functional Inspection (SSFI).Section III discusses an NRC review of CGI dedication practices during the 1988 inspection of the emergency diesel generator system.Throughout this affidavit, we describe the facts based on the direct knowledge of each of us.For any statements where the particular facts are not personally known by all the affiants, we indicate by name which of the affiants has.direct knowledge of the facts described.
Policy states that"the severity of a violation will be characterized
at the level best suited to the significance
of the particular
violation." Thus, the Enforcement
Policy establishes
a hierarchy of significance
in its Supplements
I through VIII.Each Supplement
is"designed to illustrate
the significance
which NRC places on a particular
type of violation of NRC requirements" (53 Fed.Reg.at 40023).It-is noteworthy
that, in the Severity Level I through III categories
for Supplement
I of the Enforcement
Policy, the examples refer specifically
to systems"not being able to perform[their]intended function[s]" (53 Fed.Reg.at 40030).This same concept, however, is not used for the Severity Level IV or V categories.
Therefore, because the NOV explicitly
states that all of the items cited are"acceptable
for the function intended," it logically follows that the significance
of these items does not rise above Severity Level IV or V.In addition to the above, the Supply System has demonstrated
the lack of safety significant
deficiencies
in its commercial
grade item (CGI)procurements
other than those cited in the NOV.Specifically, during the November 20, 1989 management
meeting, the Supply System presented findings concerning
a reverification
sample for its CGI population
totalling approximately
9700.The sample size was 50 items plus the 10 items reviewed by the NRC.The findings show no CGIs which are not capable of performing
their intended safety function.1/Therefore, based on this sample, the Supply System believes there is at least a 95 percent confidence
level that reasonable
assurance exists that all CGIs procured and installed (or available for installation)
in safety related applications
can perform their intended safety function.2/
These results clearly do not indicate a program that is a"significant
regulatory
concern." With regard to NRC's assertion that a"programmatic
problem" exists, there are several other pertinent points that should be considered.
First, as discussed above, the items cited in the NOV represent, at most, minor procedural
or documentation
concerns.When the dedication
of the cited items is viewed in light of the guidance and standards available at the time, it is clear that the Supply System exercised effective controls to ensure safe operation of its nuclear facility.Therefore, a"programmatic
problem" only exists in the Staff's view, if at all, because the Supply System's past activities
are being evaluated against recently issued guidance.1/See NRC Meeting Report No.50-397/89-36 (December 8, 1989)at p.3;see also Cygna Energy Services,"Commercial
Grade Dedication
Project for Washington
Public Power Supply System Contract No.C-30298" (August 14, 1989).2/The NRC as well as various federal courts have accepted the use of the 95 percent confidence
standard to demonstrate
that specific sampling data is valid.See~e..Commonwealth
Edison Co.LBP-84-41, 20 NRC 1203 (1984), aff'd ALAB-793, 20 NRC 1591 (1984)(involved the issue of adequacy of a reinspection
program concerning
BA/BC activities
at Byron);see also Schaill b Kross v.Ti ecanoe Count School Cor.864 F.2d 1309 (7th Cir.1989).  
Second, the Supply System has not been subject to prior escalated enforcement
action in the procurement
area.Further, the non-escalated
actions that have occurred are few in number, isolated in nature and do not relate directly to the concerns addressed in the NOV.In addition, as discussed in the Reply to the NOV, NRC has previously
evaluated the Supply System's procurement
activities
without finding significant
concerns.Thus, our enforcement
history coupled with the lack of safety significance
of the concerns demonstrates
that there is no programmatic
problem.In summary, based on the NRC's independent
evaluation
and the Supply System's reverification
efforts, including its sampling efforts, it may be reasonably
concluded that the items cited in the NOV do not represent safety significant
concerns.Furthermore, when all of the facts and circumstances
surrounding
the NOV are considered, as is the purpose of the Enforcement
Policy, it may also be reasonably
concluded that there was no programmatic
problem which could rise to a level of regulatory
significance
that would warrant escalated enforcement
action.In fact, even applying today's standards, the Supply System's past procurement
activities
represent, at most, low severity level procedural
or documentation
violations.
B.Prior Enforcement
Precedent In 1989, a number of NRC inspections
concentrating
on CGI procurement
activities
took place.In each case, the inspection
reports indicated that the utilities involved allegedly failed to ensure the"suitability" of CGIs installed in safety-related
applications.
The NRC's findings have generally involved concerns such as inadequate
verification
of critical characteristics
and inadequate
determination
of safety function.In several cases, the inspections
have resulted in the issuance of escalated enforcement
actions (e.g., EA 89-16 and EA 89-135).On the other hand, a recent NRC team inspection
which identified
similar concerns as those listed above resulted in no escalated enforcement
action (EA 89-43).As distinguished
from the two cases previously
referenced, the utility involved in EA 89-43 performed a reverification
effort which demonstrated
there was reasonable
assurance that CGIs installed in safety-related
applications
could perform their intended safety functions.
Consequently, the NRC determined
that the CGIs reviewed were not of indeterminate
quality or defective.
The NRC thus concluded that escalated enforcement
action was not warranted and cited the utility for minor documentation
concerns.In the case of the Supply System's alleged CGI procurement
violations, the only deficiencies
which exist, if in fact there are any, involve mere procedural
or documentation
concerns.This position is supported by NRC's finding of no actual safety significance
as well as by the Supply System's reverification
results.As we discussed with you at the November 20, 1989 management
meeting, our reverification
effort used NCIG-07 type methodology.
The results demonstrate
that there is no safety significance
to the NRC's concerns and that there is reasonable
assurance that CGIs installed (or available for installation)
in safety-related
applications
can perform their intended safety function.  
E h 1  
The Supply System's reverification
results are very similar to those presented by the utility involved in EA 89-43.While the Supply System acknowledges
that its documentation
could have been improved by today's standards, we maintain, that our CGI procurement
efforts were consistent
with the limited regulations
and guidance available to industry at the time.In addition, because our reverification
efforts demonstrate
reasonable
assurance of adequate suitability, no escalated enforcement
is warranted.
This position is consistent
with NRC's prior enforcement
precedent.
C.A lication of Enforcement
Discretion
The Enforcement
Policy states that the NRC must exercise judgement and discretion
in determining
the severity levels of the violations
and the appropriate
enforcement
sanctions, including the decision to issue a Notice of Violation, or to propose or impose a civil penalty and the amount of such penalty, after considering
the general principles
of this statement of policy and the technical significance
of the violations
and the surrounding
circumstances.
53 Fed.Reg.at 40029.We believe that in light of (I)the purposes of the Policy, (2)the significance
of the violations, and (3)the surrounding
circumstances, enforcement
discretion
is appropriate
in this case.The Supply System believes that in this case escalated enforcement
is neither appropriate
nor necessary to achieve the purposes of the Policy.The Policy states four principal purposes: (I)Ensuring compliance
with NRC regulations
and license conditions;
(2)Obtaining prompt correction
of violations
and adverse quality conditions
which may affect safety;(3)Deterring future violations
and occurrences
of conditions
adverse to quality;and (4)Encouraging
improvement
of licensee and vendor performance, and by example, that of industry, including the prompt identification
and reporting of potential safety problems.53 Fed.Reg.40022.With regard to item (I), the Supply System is well aware of the need for compliance
with NRC regulations.
The NRC Staff has consistently
recognized
in its Systematic
Assessment
of Licensee Performance
evaluations
that, overall, the Supply System has a well established
safety culture, a tradition of technical competence, and a long-standing
reputation
for proactive programs.In fact, the NRC acknowledged
our"overall good performance" in the NOV (at p.2).With regard to items (2)and (3), the Supply System has already implemented
procurement
program enhancements
which will further ensure that violations
or conditions
adverse to quality do not occur in the future (See Attachment
I, Section V, supra).  
0 A  
With respect to the completeness
and effectiveness
of this action, it is noteworthy
to reemphasize
that the positive findings of our reverification
effort (i.e., concerning
the 60 items)are supported by the former Chairman of the NCIG-07 Task Group, Nr.William E.Craig, who can best provide the proper interpretation
and application
of this EPRI guidance document.Finally, concerning
item (4), escalated enforcement
action and/or a civil penalty is not necessary to encourage the Supply System's improvement.
As we noted during the June 28, 1989 enforcement
conference
and during the November 20, 1989 management
meeting, the Supply System has been proactive in the CGI procurement
area.We have had a number of our personnel actively involved in industry developments
in this area, such as NCIG-07 and NCIG-11.In addition, since mid-1986, the Supply System has implemented
a number of significant
procurement
program enhancements
to meet or exceed the evolving expectations
of the NRC Staff.This demonstrates
that the Supply System has been actively and effectively
pursuing the stated goals of the Enforcement
Policy.Concerning
the second element of enforcement
discretion
i.e., technical significance
of the violations, the Supply System believes that the demonstrated
lack of safety significance
shows escalated enforcement
is unwarranted.
As previously
discussed, the NRC agrees that there is no actual safety significance
to the cited examples.Furthermore, even if violations
exist, they rise only to the level of Severity Level IV or V procedural
or documentation
violations, as viewed under today's guidance.Finally, concerning
the last element of discretion, i.e., evaluation
of the"surrounding
circumstances," the Supply System believes that escalated enforcement
action, and for that matter any enforcement
action, is unwarranted
because the NRC has apparently
not considered
all of the information
relevant to the NOV.In particular, the NOV indicates that various Supply System actions which were presented at the November 20, 1989 management
meeting"have not yet been inspected." Principal among these actions is the reverification
effort by Cygna Energy Services.Thus, the issuance of the NOV appears to be premature and does not appear to comport with the above stated requirements
of the Enforcement
Policy.In addition, it should be noted that the failure by an agency to consider the full extent of the"surrounding
circumstances" is an improper exercise of its discretion.
Specifically, the Eighth Circuit has held that: An administrative
agency's exercise of its discretion
cannot be'unreasoned
or arbitrary.'ourts
reviewing discretionary
agency action must evaluate, among other things, the agency's treatment of the evidence.The agency must have observed the necessary procedural
requirements
including the consideration
of all relevant facts available in the administrative
record as a whole.3/3 Choi v.United States I.N.S.798 F.2d 1189, 1191 (8th Cir.1986)(emphasis
supplied)(citations
omitted).  
'I I 0 r A h  
-6-In conclusion, for all of the reasons stated above, the NRC should exercise enforcement
discretion
in this case.IV.A lication of Enforcement
Polic Ad'ustment Factors With respect to the application
of the Enforcement
Policy Adjustment
Factors, 10 C.F.R.Part 2, Appendix C, Section V.B, the NOV states (at p.2)that the"escalation
and mitigation
factors of the Enforcement
Policy were considered." The Supply System believes that the NRC did not properly apply the Enforcement
Policy with regard to: (1)past performance
and (2)corrective
actions.A.Past Performance
The Enforcement
Policy, at Section V.B.3, states that:[when evaluating
past performance,]
consideration
will be given to, among other things, the effectiveness
of previous corrective
action for similar problems, overall performance
such as Systematic
Assessment
of Licensee Performance (SALP)evaluations
for power reactors, and prior performance
including Severity Level IV and V violations
in the area of concern.53 Fed.Reg.at 40025.Using these factors the Policy allows reduction of a proposed civil penalty"by as much as 100%." The NOV (at p.2), however, indicates that the NRC believes only 50 percent mitigation
is warranted for the Supply System's"prior overall good performance." 4 The NOV is silent as to how the NRC Staff determined
that 50 percent mitigation
was the appropriate
amount.In this regard, the NRC should consider the fact that the Supply System has had no escalated enforcement
in the procurement
area nor have there been any low level violations
relevant to the issues raised in the NOV.In addition, the NRC Staff should consider the Supply System's proactive involvement
with the CGI dedication
issue.As previously
discussed, Supply System personnel have been, and still are, actively involved in various industry groups (e.g., NCIG-07)concerning
the procurement
area.Moreover, as our discussion
in the reply indicates, the NRC Staff has evaluated the Supply System's CGI procurement
activities
in the past and found them to be acceptable.
Therefore, based on the above information, it is reasonable
that the Supply System should receive additional
mitigation
for its long-standing
good performance
regarding the CGI procurement
issue and for its overall good performance.  
-7-B.Corrective
Actions The Enforcement
Policy, at Section V.B.2, states that: the promptness
and extent to which the licensee takes corrective
action, including actions to prevent recurrence, may result in up to a 50%increase or decrease in the base civil penalty.53 Fed.Reg.at 40025 (emphasis supplied).
The NOV (at p.2)indicates that the NRC determined
the Supply System's post-inspection
actions to be"inadequate." Specifically, the NOV (at p.2)states that"your corrective
actions for these violations
failed to fully address the need to properly evaluate and specify the critical characteristics
required for proper dedication
of commercial
grade items." Consequently, the NRC escalated the base civil penalty by 50 percent.The Supply System believes that the NRC misapplied
the corrective
actions factor.As discussed previously, the NRC guidance available at the time the cited items were dedicated was minimal.Thus, we believe that the kind of"upgrades" or"corrective
actions" that the NRC Staff is apparently
expecting exceed those required at the time of dedication.
Notwithstanding, and as also discussed previously, the Supply System did initiate prompt enhancements
to our CGI procurement
program.Part of this effort included the reverification
of the items cited in the NOV as well as an additional
sample of CGIs.The results of this reverification
effort demonstrated
no safety significance
or operability
concern.In addition, our reverification
effort used as its principal basis the NCIG-07 methodology.
According to our contractor, who is very familiar with the interpretation
of NCIG-07, there is reasonable
assurance that the CGIs reviewed can perform their intended safety related function when called upon.Based on this information, the Supply System believes that it did take adequate corrective
action.The"corrective
actions" which the Staff believes should have been taken are the very issues at the heart of the NOV, e.g., the proper evaluation
and specification
of critical characteristics.
Thus, the Supply System believes that requiring actions beyond those required by NCIG-07, the NRC's current guidance concerning
CGI dedication, is an improper application
of the Enforcement
Policy.Therefore, because we have demonstrated
that our past CGI procurements
are consistent
with the NCIG-07 methodology, the NRC should not escalate the base civil penalty.In addition to the above position, the Supply System also believes that the NRC did not allow sufficient
credit for the program enhancements
described in Section V of our Reply to the NOV.Me believe that when viewed together with the Supply System's proactive efforts in the CGI dedication
area (both past and present)the NRC Staff has ample support for full mitigation
of the proposed base civil penalty.  
-8-V.Conclusion
The Supply System believes that the NRC has more than sufficient
evidence to support full mitigation
of the proposed base civil penalty.This position is firmly supported by (1)the backfitting
issues discussed in the reply to the NOV, (2)the demonstrated
lack of safety significance, (3)the prior, enforcement
precedent, (4)the enforcement
discretion
concept and (5)an appropriate
application
of the Enforcement
Policy adjustment
factors.  
UNITED STATES OF AMERICA NUCLEAR REGULATORY
COMMISSION
AFFIDAVIT OF STEVEN H.PECK KENNETH R.WISE AND J.MICHAEL CURREN I.Introduction
I, Steven H.Peck, being first duly sworn, depose and state as follows: I am employed by Washington
Public Power Supply System (" Supply System")as Manager of Spare Parts Engineering.
I have held that position since August 1989.I am responsible
for performing
the technical evaluations
to establish procurement
requirements, including the dedication
requirements
for items purchased commercial
grade.Prior to holding my current position, I was Supervisor, Materials Support Engineering (August 1988 to August 1989)and Lead for the Spare Parts Program (July 1986 to August 1988), In those positions my technical responsibilities
over procurement
were the same as they are today.I, Kenneth R.Wise, being first duly sworn, depose and state as follows: I am employed by the Supply System as Manager of Equipment Engineering.
I have held that position since October 28, 1989.Prior to holding my current position, I was Supervisor
of Electrical
Equipment Engineering (September
17, 1988 to October 1989).From 1983 until September 16, 1988, I was Technical Program Leader, Electrical
Equipment Engineering.
In that position, my responsibilities
included reviewing dedication
packages for electrical
equipment commercial
grade item purchases.
Hy review focused on ensuring that adequate commercial
grade dedication
requirements
were established.
I, J.Michael Curren, being first duly sworn, depose and state as follows: I am employed by the Supply System as Senior Equipment Engineer, Equipment Engineering
Group.I have held that position since July 1986.Hy responsibilities
from June 1985 to August 1989 included involvement
in the commercial
grade dedication
process in order to ensure maintenance
of equipment qualification
and operability.
These responsibilities
included dedication
activities
for commercial
grade items procured for use in safety-related applications.
This affidavit is provided to support the Supply System's response to the Nuclear Regulatory
Commission (NRC)Notice of Violation and Proposed Imposition
of Civil Penalty (EA 89-130)related to commercial
grade item ("CGI")procurement.
In this affidavit, we describe certain recent instances in which the NRC has reviewed the Supply System's CGI dedication
practices.  
Section II below describes the NRC's review of the CGI dedication
process in connection
with the 1987 Safety System Functional
Inspection (SSFI).Section III discusses an NRC review of CGI dedication
practices during the 1988 inspection
of the emergency diesel generator system.Throughout
this affidavit, we describe the facts based on the direct knowledge of each of us.For any statements
where the particular
facts are not personally
known by all the affiants, we indicate by name which of the affiants has.direct knowledge of the facts described.
It should be noted that only Hr.Peck has direct knowledge of the facts discussed in Section III of this affidavit.
It should be noted that only Hr.Peck has direct knowledge of the facts discussed in Section III of this affidavit.
Accordingly, Messrs.Wise and Curren do not join in Section III below.II.1987 Safet S stem Functional
Accordingly, Messrs.Wise and Curren do not join in Section III below.II.1987 Safet S stem Functional Ins ection The 1987 SSFI focused on the AC and DC electrical distribution systems, the standby service water system, and the automatic depressurization system.Early in the course of the SSFI, on August 3 or 4, 1987, NRC Inspector L.Stanley asked to see representative examples of commercial grade item dedications.
Ins ection The 1987 SSFI focused on the AC and DC electrical
Hr.Curren was assigned the task of assembling the dedication packages for Hr.Stanley's review.Hr.Curren conservatively selected four CGI dedications which he considered difficult cases or"gray area" situations.
distribution
That is to say, these dedications were not simple cases, but rather were more difficult in the sense that the technical requirements for dedication were not clear-cut.
systems, the standby service water system, and the automatic depressurization
Hr.Curren recalls discussing the approach of selecting"gray area" cases with J.E.Rhoads, then the Supply System's Manager, Equipment Engineering.
system.Early in the course of the SSFI, on August 3 or 4, 1987, NRC Inspector L.Stanley asked to see representative
Hr.Peck also met with Mr.Curren on August 4, 1987, to get the package pulled together for review at the meeting with the NRC the following day, The Supply System considered this a conservative approach and anticipated that NRC review of these more difficult dedications would provide useful direction to the Supply System's CGI dedication program.If these particular dedications were acceptable to the NRC, then the Supply System would have a better understanding of the actions which the NRC felt were necessary for proper dedication.
examples of commercial
Hr.Wise recalls that this approach was discussed with the NRC inspectors at the time-with Hr.Stanley and possibly with Hr.Wagner as well-and that the NRC agreed that this was an acceptable approach.The four specific evaluations selected for review by the NRC were as follows: 1.Evaluation 668, concerning Potter-Brumfield type HDR control circuit relays.
grade item dedications.
r I Af'I r, 2.Evaluation 419, concerning a pulse preamplifier to be purchased from General Electric.3.Evaluation 377, concerning Square D temperature switches.4.Engineering specification 15122 Rev.0, which originated P.O.088173, involving procurement of air pressure regulators (originally PPH 1.3.39 Evaluation 44)./1 It should be noted that Evaluation 668 was one of the examples of allegedly inadequate dedications
Hr.Curren was assigned the task of assembling
'cited by the NRC in the recent Notice of Violation (EA 89-130).Hr.Curren's notes from the time (Exhibit A)originally showed Evaluation "668" as"688." This was clearly an error in transcription, since'valuation 668 was the only dedication of Potter-Brumfield relays in the relevant time period, and we understand that the NRC's records show that the dedication of Potter-Brumfield relays was one of the packages examined during the SSFI.(Evaluation 688 related to stainless steel staples, an item not reviewed by the NRC~)On August 5, 1987, NRC Inspector Stanley met with us to discuss the dedication process.See Exhibit B hereto (Hr.Wise's memorandum to file reporting on this meeting).During this meeting, we explained the dedication process to the inspector by walking through the four dedication packages selected.According to Hr.Wise's record of this meeting (Exhibit B), the inspector"seemed to understand the examples and what had been done." The inspector was provided copies of the four evaluation files.The inspector was also furnished a copy of procedure PPH 1.3.39, issued July 30, 1986.The evaluation packages provided to the NRC at that time reflected generally the same level of detail as those reviewed in the 1989 inspection leading to the NOV.Nore specifically, the packages contained information such as Form 4,"Commercial Grade Dedication," and Form 5,"Equipment gualification Evaluation." Various revisions have been made to these packages as additional purchases took place.However, the dedication method reflected in those packages was the same as that used until our program>>as recently upgraded to NCIG-07.1/Appended to this affidavit as Exhibit A are copies of handwritten summaries of these evaluation packages prepared by Hr.Curren at, the time of the NRC inspection.
the dedication
These summaries were prepared in order to provide a brief description of the dedications for use by Supply System personnel in discussing these examples with the NRC.Originals of these summaries were retained by Mr.Curren in his personal subject files and were retrieved for purposes of preparing this affidavit.
packages for Hr.Stanley's review.Hr.Curren conservatively
In retrieving those files, Hr.Curren noticed the error in the use of the title Evaluation "688" rather than"668" (see'text)and made a pen-and-ink change on the original to correct the error.
selected four CGI dedications
V Vf Towards the end of the SSFI, on the morning of August 26, 1987, the NRC inspector requested a meeting to discuss CGI dedication.
which he considered
Both NRC inspectors Stanley and Wagner attended this meeting with us.See Exhibit 8'Mr.Wise's memorandum to file on this meeting).This meeting was a follow-up to discuss, among other things, the NRC's examination of the four evaluation files which had previously been provided.As reflected in Exhibit C, the NRC initially questioned whether CGI dedications were being used too frequently, since the dedication package numbers were in the 700s.We explained that not all the numbers necessarily reflected CGI dedications; quality Class 1 and nonsafety-related evaluations were included as well.The inspectors seemed to understand this and were satisfied.
difficult cases or"gray area" situations.
Of the four dedication packages the NRC reviewed, Mr.Stanley expressed only a minor concern with one of them (Evaluation 419).This related to reliability testing requirements for components purchased through General Electric.The inspectors discussed this issue briefly and did not indicate that this was a significant concern.It is noteworthy that the NRC's Inspection Report 87-19 on the SSFI did not note any deviations or weaknesses in the area of procurement.
That is to say, these dedications
During the meeting, the NRC also discussed with us a Design Change Package (DCP)which they had examined.This package, DCP 85-0073-0A, had been used for installation of a commercial grade switch in the Automatic Depressurization System (See Exhibit C).Mr.Stanley asked for the documentation on the dedication of this device.According to Mr.Wise's records, the inspector later that day was provided a copy of the procurement file on this item which included the memorandum defining the required vendor certification, the Purchase Requisition, the Purchase Order, and the vendor's certification.
were not simple cases, but rather were more difficult in the sense that the technical requirements
for dedication
were not clear-cut.
Hr.Curren recalls discussing
the approach of selecting"gray area" cases with J.E.Rhoads, then the Supply System's Manager, Equipment Engineering.
Hr.Peck also met with Mr.Curren on August 4, 1987, to get the package pulled together for review at the meeting with the NRC the following day, The Supply System considered
this a conservative
approach and anticipated
that NRC review of these more difficult dedications
would provide useful direction to the Supply System's CGI dedication
program.If these particular
dedications
were acceptable
to the NRC, then the Supply System would have a better understanding
of the actions which the NRC felt were necessary for proper dedication.
Hr.Wise recalls that this approach was discussed with the NRC inspectors
at the time-with Hr.Stanley and possibly with Hr.Wagner as well-and that the NRC agreed that this was an acceptable
approach.The four specific evaluations
selected for review by the NRC were as follows: 1.Evaluation
668, concerning
Potter-Brumfield
type HDR control circuit relays.  
r I Af'I r,  
-3-2.Evaluation
419, concerning
a pulse preamplifier
to be purchased from General Electric.3.Evaluation
377, concerning
Square D temperature
switches.4.Engineering
specification
15122 Rev.0, which originated
P.O.088173, involving procurement
of air pressure regulators (originally
PPH 1.3.39 Evaluation
44)./1 It should be noted that Evaluation
668 was one of the examples of allegedly inadequate
dedications
'cited by the NRC in the recent Notice of Violation (EA 89-130).Hr.Curren's notes from the time (Exhibit A)originally
showed Evaluation
"668" as"688." This was clearly an error in transcription, since'valuation
668 was the only dedication
of Potter-Brumfield relays in the relevant time period, and we understand
that the NRC's records show that the dedication
of Potter-Brumfield
relays was one of the packages examined during the SSFI.(Evaluation
688 related to stainless steel staples, an item not reviewed by the NRC~)On August 5, 1987, NRC Inspector Stanley met with us to discuss the dedication
process.See Exhibit B hereto (Hr.Wise's memorandum
to file reporting on this meeting).During this meeting, we explained the dedication
process to the inspector by walking through the four dedication
packages selected.According to Hr.Wise's record of this meeting (Exhibit B), the inspector"seemed to understand
the examples and what had been done." The inspector was provided copies of the four evaluation
files.The inspector was also furnished a copy of procedure PPH 1.3.39, issued July 30, 1986.The evaluation
packages provided to the NRC at that time reflected generally the same level of detail as those reviewed in the 1989 inspection
leading to the NOV.Nore specifically, the packages contained information
such as Form 4,"Commercial
Grade Dedication," and Form 5,"Equipment
gualification
Evaluation." Various revisions have been made to these packages as additional
purchases took place.However, the dedication
method reflected in those packages was the same as that used until our program>>as recently upgraded to NCIG-07.1/Appended to this affidavit as Exhibit A are copies of handwritten
summaries of these evaluation
packages prepared by Hr.Curren at, the time of the NRC inspection.
These summaries were prepared in order to provide a brief description
of the dedications
for use by Supply System personnel in discussing
these examples with the NRC.Originals of these summaries were retained by Mr.Curren in his personal subject files and were retrieved for purposes of preparing this affidavit.
In retrieving
those files, Hr.Curren noticed the error in the use of the title Evaluation
"688" rather than"668" (see'text)and made a pen-and-ink
change on the original to correct the error.  
V Vf  
Towards the end of the SSFI, on the morning of August 26, 1987, the NRC inspector requested a meeting to discuss CGI dedication.
Both NRC inspectors
Stanley and Wagner attended this meeting with us.See Exhibit 8'Mr.Wise's memorandum
to file on this meeting).This meeting was a follow-up to discuss, among other things, the NRC's examination
of the four evaluation
files which had previously
been provided.As reflected in Exhibit C, the NRC initially questioned
whether CGI dedications
were being used too frequently, since the dedication
package numbers were in the 700s.We explained that not all the numbers necessarily
reflected CGI dedications;
quality Class 1 and nonsafety-related
evaluations
were included as well.The inspectors
seemed to understand
this and were satisfied.
Of the four dedication
packages the NRC reviewed, Mr.Stanley expressed only a minor concern with one of them (Evaluation
419).This related to reliability
testing requirements
for components
purchased through General Electric.The inspectors
discussed this issue briefly and did not indicate that this was a significant
concern.It is noteworthy
that the NRC's Inspection
Report 87-19 on the SSFI did not note any deviations
or weaknesses
in the area of procurement.
During the meeting, the NRC also discussed with us a Design Change Package (DCP)which they had examined.This package, DCP 85-0073-0A, had been used for installation
of a commercial
grade switch in the Automatic Depressurization
System (See Exhibit C).Mr.Stanley asked for the documentation
on the dedication
of this device.According to Mr.Wise's records, the inspector later that day was provided a copy of the procurement
file on this item which included the memorandum
defining the required vendor certification, the Purchase Requisition, the Purchase Order, and the vendor's certification.
The inspector was fully satisfied and no remaining issues were identified.
The inspector was fully satisfied and no remaining issues were identified.
See Exhibit C.The overall impression
See Exhibit C.The overall impression we formed from the NRC's review during the SSFI was that the four CGI dedication packages reviewed, which were relatively more difficult examples, were acceptable to the NRC (See Exhibit C).As a result of the NRC's review, the Supply System thereafter was more comfortable with respect to the technical requirements for proper dedication.
we formed from the NRC's review during the SSFI was that the four CGI dedication
In short, we felt that the NRC had confirmed the acceptability of our CGI procurement and dedication process, and that our program was adequate.Certainly the NRC brought no significant problems to our attention.
packages reviewed, which were relatively
1 0 t P~ III.1988 Diesel Generator Ins ection 2 From August 22, 1988 to September 2, 1988, the NRC conducted a special, announced inspection of the Emergency Diesel Generator (EDG)system and the Nuclear Steam Supply.Shutoff System.In connection with reviewing maintenance practices on the EDGs, the NRC identified concerns with certain components.
more difficult examples, were acceptable
As part of this review, on August 23, 1988, an NRC inspector asked to see Evaluation 301, concerning dedication of a Viking pump, Model FH456M.See Exhibit D (Mr.Peck's log entry for this date).This procurement was selected for review because the pump in question had previously been replaced on the EDG system.I recall that the inspector identified himself as an NRC contractor, and most probably was Mr.B.L.Collins, who is listed in Inspection Report 88-24 as an NRC contractor who assisted in conducting the inspection.
to the NRC (See Exhibit C).As a result of the NRC's review, the Supply System thereafter
I provided Evaluation 301 to the inspector and also provided him a verbal explanation of how our CGI procurement and dedication process worked.My understanding was that the inspector wanted to review Evaluation 301 to make sure that we had performed a proper dedication when replacing the pump on the EDG system.His only concern after reviewing the dedication package related to how we had maintained seismic qualification during the dedication process.I explained that this had been a like-for-like replacement and that the seismic qualification of the original pump applied to the replacement.
was more comfortable
with respect to the technical requirements
for proper dedication.
In short, we felt that the NRC had confirmed the acceptability
of our CGI procurement
and dedication
process, and that our program was adequate.Certainly the NRC brought no significant
problems to our attention.  
1 0 t P~  
-5-III.1988 Diesel Generator Ins ection 2 From August 22, 1988 to September 2, 1988, the NRC conducted a special, announced inspection
of the Emergency Diesel Generator (EDG)system and the Nuclear Steam Supply.Shutoff System.In connection
with reviewing maintenance
practices on the EDGs, the NRC identified
concerns with certain components.
As part of this review, on August 23, 1988, an NRC inspector asked to see Evaluation
301, concerning
dedication
of a Viking pump, Model FH456M.See Exhibit D (Mr.Peck's log entry for this date).This procurement
was selected for review because the pump in question had previously
been replaced on the EDG system.I recall that the inspector identified
himself as an NRC contractor, and most probably was Mr.B.L.Collins, who is listed in Inspection
Report 88-24 as an NRC contractor
who assisted in conducting
the inspection.
I provided Evaluation
301 to the inspector and also provided him a verbal explanation
of how our CGI procurement
and dedication
process worked.My understanding
was that the inspector wanted to review Evaluation
301 to make sure that we had performed a proper dedication
when replacing the pump on the EDG system.His only concern after reviewing the dedication
package related to how we had maintained
seismic qualification
during the dedication
process.I explained that this had been a like-for-like
replacement
and that the seismic qualification
of the original pump applied to the replacement.
The inspector accepted this explanation.
The inspector accepted this explanation.
The inspector appeared to accept the adequacy of Evaluation
The inspector appeared to accept the adequacy of Evaluation 301.Except for the question regarding seismic qualification, he did not raise any questions or concerns with that package or our process in general.The inspection report did not identify any deviations or weaknesses in this regard.During the EDG inspection, the inspector also took the opportunity to ask whether we were aware that the NRC in that time frame (second half of 1988)was beginning to focus more on commercial grade item procurement and dedication.
301.Except for the question regarding seismic qualification, he did not raise any questions or concerns with that package or our process in general.The inspection
I informed him that we were aware of the NRC's increasing focus on the subject.In fact, at the time, the Supply System was actively involved in the EPRI committee addressing this issue.2/As noted above, Messrs.Wise and Curren had no significant involvement in facts discussed in this section of the affidavit, and accordingly do not join in this section.  
report did not identify any deviations
 
or weaknesses
The foregoing information is true and correct to the best of my knowledge.
in this regard.During the EDG inspection, the inspector also took the opportunity
Steven H.Pec Subscribed and sworn to before me this~/+day of February 1990.Notary u lic for the o nty of Benton, State of Washington Ny commission expires 7///f The foregoing information is true and correct to the best of my knowledge.
to ask whether we were aware that the NRC in that time frame (second half of 1988)was beginning to focus more on commercial
Kenneth R.Wise Subscribed and sworn to before me this jj i hay of February 1990.Notary Public for the County of Benton, State of Washington Hy commission expires The foregoing information is true and correct to the best of my knowledge.
grade item procurement
J.Michael Curren Subscribed and sworn to before me this~2 day of February 1990.Notary Public for the ounty of Benton, State of Washington Ny commission expires 1 I EXHIBIT A t,  
and dedication.
I informed him that we were aware of the NRC's increasing
focus on the subject.In fact, at the time, the Supply System was actively involved in the EPRI committee addressing
this issue.2/As noted above, Messrs.Wise and Curren had no significant
involvement
in facts discussed in this section of the affidavit, and accordingly
do not join in this section.  
The foregoing information
is true and correct to the best of my knowledge.
Steven H.Pec Subscribed
and sworn to before me this~/+day of February 1990.Notary u lic for the o nty of Benton, State of Washington
Ny commission
expires 7///f The foregoing information
is true and correct to the best of my knowledge.
Kenneth R.Wise Subscribed
and sworn to before me this jj i hay of February 1990.Notary Public for the County of Benton, State of Washington
Hy commission
expires The foregoing information
is true and correct to the best of my knowledge.
J.Michael Curren Subscribed
and sworn to before me this~2 day of February 1990.Notary Public for the ounty of Benton, State of Washington
Ny commission
expires  
1 I  
EXHIBIT A  
t,  
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I MduPAKuf@~Pg~pb@y/ski,@82,, O'6 MI/g52z PIZ8dvt262, COQIA'AMIAI
..CM c@G6Caf~WQ M I P 6PIU 5,~Q p/<v~4~Cou&P~/%~dime r~<W<~A>PL.~WC LE>Mrtrs"/le~-Sss~fizL!.p~~P~)cy L,A~~M~V'hlg g&40IPLS~o g~sfi~C Qp4 i~A7<o~gp'W R/k pOAJFW(5, R~~~l 4<&~l~d.fg 4.~W/W5 pl M p~g<.P~di2 kL6AJc 4P b~g VV'J~-C6Ai(~~4 GJE VP~~~t''Fl p~La/~a~s, f4.AA4s gp...~~+Qo~~~~Fa,4w, Pu,l~.p~Q$,,.p 4u6P i<gf~>~~4~~18dW a<g}P@.~~&f1~$nEu~s wiiiC 9o uA'Lk~<~@z-~V)VLOHPrV~+<<(Q ULllLI kC AVLG~.W~~~pM~I'74 dMctg..P Re..., ILUTE c~..AR 74.u,ggo c<u f~5~Lemfug~G~M~~~i++
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kL6AJc 4P b~g VV'J~-C6Ai(~~4 GJE VP~~~t''Fl p~La/~a~s, f4.AA4s gp...~~+Qo~~~~Fa,4w, Pu,l~.p~Q$,,.p 4u6P i<gf~>~~4~~18dW a<g}P@.~~&f1~$nEu~s wiiiC 9o uA'Lk~<~@z-~V)VLOHPrV~+<<(Q ULllLI kC AVLG~.W~~~pM~I'74 dMctg..P Re..., ILUTE c~..AR 74.u,ggo c<u f~5~Lemfug~G~M~~~i++  
hing t'1 lG4 CM~$aae,u~C.>V/AALU pill/g, p~+P p Lt C RV cow two 4geuf&iu QOV5ls'tA d p>~~<~M<0 u+s WLgPu P~>R~m covP~r4w>c'au'twL-,~~~~s.Qg~JI lQ)~tggl4ll M/Ky&8 dtC;fLQ~JQs+mM-C I gy.pg g~~Q 6 u p LL~J Uu8wdz pg(g gg,/4is waS g~c~~Q~(,~fuj N~L'&LA A~S, AI4cgsi s ma~Qhk~~gpLicjj f~u.j&Ho~6iCNLc ku.+LLY~C~7~&
hing t'1 lG4 CM~$aae,u~C.>V/AALU pill/g, p~+P p Lt C RV cow two 4geuf&iu QOV5ls'tA d p>~~<~M<0 u+s WLgPu P~>R~m covP~r4w>c'au'twL-,~~~~s.Qg~JI lQ)~tggl4ll M/Ky&8 dtC;fLQ~JQs+mM-C I gy.pg g~~Q 6 u p LL~J Uu8wdz pg(g gg,/4is waS g~c~~Q~(,~fuj N~L'&LA A~S, AI4cgsi s ma~Qhk~~gpLicjj f~u.j&Ho~6iCNLc ku.+LLY~C~7~&
QQwl,c W~8ca FA I~u 4LlLQ lg~~W~)-~4M'6 u age lV 5 LUg~tu~u.L p kg)~Q i~TS+WC kezcui'fQ Cycv~,"G'~gfL./MAL~ALh i'Ag.~S.~L-<Q+~ED l~'TER C4G4~w4~r)c~~L~~~e~~m~, m~eM (u, iMQLF~(-khan Qo S'~ni<Lu@rly
QQwl,c W~8ca FA I~u 4LlLQ lg~~W~)-~4M'6 u age lV 5 LUg~tu~u.L p kg)~Q i~TS+WC kezcui'fQ Cycv~,"G'~gfL./MAL~ALh i'Ag.~S.~L-<Q+~ED l~'TER C4G4~w4~r)c~~L~~~e~~m~, m~eM (u, iMQLF~(-khan Qo S'~ni<Lu@rly kkighegU 7'.,
kkighegU 7'.,  
T4 Mu~fLlp~Of f~<+gQ'f/+$f'WLID+T<0 d/5'mu(Q~k G8)"7 pz.7~p~~cUss 4,vi6cou3 F~~~40t~lg~uYQ(US o~a.~>>l 4c M teem CL+"(u (oQ~G4'AL]nr CVPpX 2 gr itcilp.g g p j(~G~ct~M'.p lace~@we go~ea~~gg,g~S~u$~Q go....~few~../~..I<gP.<4-..UJO.S.c 4,LU P~AL uVL-Q KJ Po g~, wu b k+8@v l~~Qg pF~tU~>~-b'al j 4~~.)I 2)/l 5yAu p 4&/l-8~~88~~~AlJ puAu6~uw XSVig<~p~~~m>A 8y~W Pip'Pd2-1mW~r~ifu~VA Sg a Pk./79'9'2 w g~(u~(gp~&~~~Po pQgg')y.Imeuw~o+P~~u~utAam gufo USA-PC U-.lC.I q~Q5g p8u=$gk uey gQ n luge+SgM, EQu<PW 5~Pca+.~w I'5'~.l<'+~4sbi~c A~w C pc 4'f4-Mq>>~~Cl Pi~+g M~P~8V~~/kll~sL Lg~s(,~M 8g l'~k~..>'L Qua L~gio~Po.l~/~u,f usa 5 8<@.<PFa..uo.i s->>~~f+4 ltd-[~<<~~~4'>g.[@ta~~Q.+C+Gag,~'~~~~Ty Wu,~cia.n.Jg a.s.5Q''eely(~g 6 gg 8 HA.u+gRWg g~cp~&g, su Co~~o~uC Co nQ u.Meow pic&p~~s goubA mt'<~2 4~~~u~W/~uF Qgj l Qa8~>>~g))b),<<A,)l~lu i u+Eu.G~i4icc$~
T4 Mu~fLlp~Of f~<+gQ'f/+$f'WLID+T<0
U 4 4'li EXHIBIT 8 4 e 4~I 4 AUGUST 5, 1987 NRC Reviewer: Mr.Stanley Supply System Staff: KR Mise S Peck, M Curren Mr.Stanley had a two part question concerning quality class and use of commercial grade equipment in safety-related applications.
d/5'mu(Q~k G8)"7 pz.7~p~~cUss 4,vi6cou3 F~~~40t~lg~uYQ(US o~a.~>>l 4c M teem CL+"(u (oQ~G4'AL]nr CVPpX 2 gr itcilp.g g p j(~G~ct~M'.p lace~@we go~ea~~gg,g~S~u$~Q go....~few~../~..I<gP.<4-..UJO.S.c 4,LU P~AL uVL-Q KJ Po g~, wu b k+8@v l~~Qg pF~tU~>~-b'al j  
Ne responded to the second half of the question and referred him to G.Brastad for the first half.Me explained our dedication process to him by walking through 4 examples, he borrowed the spares evaluation files for the four examples.He was given a copy of PPM 1.3.39.He seemed to understand the examples and what had been done.He is coming from an experience base at Sequoyah which used commercial equipment in safety related application without control.He requested an example or two of substitutions involving commercial grade equipment.
4~~.)I 2)/l  
Curren has the action to identify these by the last week of August.Stanley will not be here next week.
5yAu p 4&/l-8~~88~~~AlJ puAu6~uw XSVig<~p~~~m>A 8y~W Pip'Pd2-1mW~r~ifu~VA Sg a Pk./79'9'2 w g~(u~(gp~&~~~Po pQgg')y.Imeuw~o+P~~u~utAam gufo USA-PC U-.lC.I q~Q5g p8u=$gk uey gQ n luge+SgM, EQu<PW 5~Pca+.~w I'5'~.l<'+~4sbi~c A~w C pc 4'f4-Mq>>~~Cl Pi~+g M~P~8V~~/kll~sL Lg~s(,~M 8g l'~k~..>'L Qua L~gio~Po.l~/~u,f usa 5 8<@.<PFa..uo.i s->>~~f+4 ltd-[~<<~~~4'>g.[@ta~~Q.+C+Gag,~'~~~~Ty Wu,~cia.n.Jg
rl E I' AUGUST.6,$987 NRC Reviever: Yir.Stanley, Nr.wagner Supply System Staf: KF.'ise, N.Curren, S.Peck i"ir.Stanley requested a meetinq his morning to discu s dedica ion Cf COmrherCial grade equiPment tO safe y-I e aved use~ar ier)le had examined 4 par vs evaluation files which dedicated equipment.
a.s.5Q''eely(~g
He had formed tne impressiotl vha ve had been doing vhol esa~e deci.cation because of the package numbers of the packages he had reviewed.The number s werc up in the 700'5 and he had assumed hat-ll 700 werc corrtmercial gracie de''cation.They are n>ot but inc 1 Ude qUal i.y c 1 a55 one eval Ua ot't5 a5 w&1.Thi 5 was ew p al neet and Understood.
6 gg 8 HA.u+gRWg g~cp~&g, su Co~~o~uC Co nQ u.Meow pic&p~~s goubA mt'<~2 4~~~u~W/~uF Qgj l Qa8~>>~g))b),<<A,)l~lu i u+Eu.G~i4icc$~  
U 4 4'li  
EXHIBIT 8  
4 e 4~I 4  
AUGUST 5, 1987 NRC Reviewer: Mr.Stanley Supply System Staff: KR Mise S Peck, M Curren Mr.Stanley had a two part question concerning
quality class and use of commercial
grade equipment in safety-related
applications.
Ne responded to the second half of the question and referred him to G.Brastad for the first half.Me explained our dedication
process to him by walking through 4 examples, he borrowed the spares evaluation
files for the four examples.He was given a copy of PPM 1.3.39.He seemed to understand
the examples and what had been done.He is coming from an experience
base at Sequoyah which used commercial
equipment in safety related application
without control.He requested an example or two of substitutions
involving commercial
grade equipment.
Curren has the action to identify these by the last week of August.Stanley will not be here next week.  
rl E I'  
AUGUST.6,$987 NRC Reviever: Yir.Stanley, Nr.wagner Supply System Staf: KF.'ise, N.Curren, S.Peck i"ir.Stanley requested a meetinq his morning to discu s dedica ion Cf COmrherCial
grade equiPment tO safe y-I e aved use~ar ier)le had examined 4 par vs evaluation
files which dedicated equipment.
He had formed tne impressiotl
vha ve had been doing vhol esa~e deci.cation because of the package numbers of the packages he had reviewed.The number s werc up in the 700'5 and he had assumed hat-ll 700 werc corrtmercial
gracie de''cation.They are n>ot but inc 1 Ude qUal i.y c 1 a55 one eval Ua ot't5 a5 w&1.Thi 5 was ew p al neet and Understood.
0;the 4 packaqes he had no prob em wi"h~and Only a A>inar COnCern Vith vhe 4tht Which VaS eXp.aitled.
0;the 4 packaqes he had no prob em wi"h~and Only a A>inar COnCern Vith vhe 4tht Which VaS eXp.aitled.
He seeme~~C'cV>til: ar Ca W'>~>get'Iel al a Cept atlCC C>f v:le r i gOI O>Our process bu~vi=h an underly=ng
He seeme~~C'cV>til: ar Ca W'>~>get'Iel al a Cept atlCC C>f v:le r i gOI O>Our process bu~vi=h an underly=ng utleas'ness tha dedication vas being over u5ed i'ir Stanley had a port"-'n of DC.B5-0072-0A wh-'h inst ccn:met c a.grad=-switch for"iS-PNS-ADB'2A7 EI.He asked docui;Ie>t'av otl otl v>le c>edica lot: o i villus dev'e~aver was provided v-'-n~copy o-the pr-procurement file I de, l,>ltlg'ne requ're venaor cer.l rica'on, tne P.;, th-ile Yendc;s certi f ica'n.He vas fu y savisfiec and appear'v C>.<mal t'I i n'v'hi 5 area~al led a our he day memo all d"n v tie~Q 7>>o 1 ssue5 vne rn~~l t'I."Ig A<eev=ng CafnPOtlen v 1 ssuei'ti 5 i ssue wa5 acicil" e55ec.BI ast aa~re'b" i vy Was rai sed as a~1 a'eY" n ile dc.".y y Gc>t dc>tl V d e o EXHIBIT C ie<I(~I P t~~('0'e ,'Pw Aj 1=
utleas'ness
0~~~~~I H'OC rt 0~r r~K'4~~
tha dedication
r+
vas being over u5ed i'ir Stanley had a port"-'n of DC.B5-0072-0A
fXHIBIT D V ro l~L II%Ha,~c, I}}
wh-'h inst ccn:met c a.grad=-switch for"iS-PNS-ADB'2A7
EI.He asked docui;Ie>t'av otl otl v>le c>edica lot: o i villus dev'e~aver was provided v-'-n~copy o-the pr-procurement
file I de, l,>ltlg'ne requ're venaor cer.l rica'on, tne P.;, th-ile Yendc;s certi f ica'n.He vas fu y savisfiec and appear'v C>.<mal t'I i n'v'hi 5 area~al led a our he day memo all d"n v tie~Q 7>>o 1 ssue5 vne rn~~l t'I."Ig A<eev=ng CafnPOtlen
v 1 ssuei'ti 5 i ssue wa5 acicil" e55ec.BI ast aa~re'b" i vy Was rai sed as a~1 a'eY" n ile dc.".y y Gc>t dc>tl  
V d e o  
EXHIBIT C  
ie<I(~I P t~~('0'e ,'Pw Aj 1=  
0~~~~~I H'OC rt 0~r r~K'4~~  
r+  
fXHIBIT D  
V ro l~L II%Ha,~c, I
}}

Revision as of 13:12, 17 August 2019

Responds to Notice of Violation & Proposed Imposition of Civil Penalty Re Insp Repts 50-397/89-21,50-397/89-22 & 50-397/89-28.Violations Denied for Specified Reasons
ML17285B027
Person / Time
Site: Columbia Energy Northwest icon.png
Issue date: 02/16/1990
From: Bouchey G
WASHINGTON PUBLIC POWER SUPPLY SYSTEM
To: Lieberman J
NRC OFFICE OF ENFORCEMENT (OE)
References
EA-89-130, GO2-90-028, GO2-90-28, NUDOCS 9002260288
Download: ML17285B027 (75)


Text

f., pg.,~ELERATED Dl BUTION DEMONS ON SYFI'E}rl REGULAT INFORMATION DISTRIBUTION STEM (RIDS), ACCESSION NBR:9002260288 DOC.DATE: 90/02/16 NOTARIZED:

YES FACIL:50-397 WPPSS Nuclear Project, Unit 2, Washington Public Powe AUTH.NAME AUTHOR AFFILIATION BOUCHEY,G.D.

Washington Public Power Supply System RECIP.NAME RECIPIENT AFFILIATION LIEBERMAN,J.

Ofc of Enforcement (Post 870413)

SUBJECT:

Responds to NRC 891221 notice of violation s propsed imposition of civil penalty.DISTRIBUTION CODE: IE14D COPIES RECEIVED:LTR ENCL SIZE: TITLE: Enforcement Action Non-2.790-Licensee Response NOTES: DOCKET 05000397 RECIPIENT ID CODE/NAME PD5 LA SAMWORTH,R INTERNAL: AEOD/DOA DEDRO NRR/PMAS/ILRB12 OE, DIR REG FILE 02 RGN2/DRSS/EPRPB EXTERNAL:.

'LPDR," ,':NSIC;COPIES LTTR ENCL 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 RECIPIENT ID CODE/NAME PD5 PD AEOD/DSP/TPAB NRR/DOEA/OEAB11 NUD~S~S ACT~~ILE RGNS FILE 03 NRC PDR COPIES LTTR ENCL 1 1 1 1 D S'i S h NCtXE K)ALL"RIDS" RECIPIENIS:

PLEASE HELP US TO REDUCE HASTE.'GNI'ACT

'IHE DOCUMEPZ CXKQL DESK, ROCN Pl-37 (EXT.20079)%0 ELBQHRm YOUR NAME PBCH DISTRIBUXXQN LISTS FOR DOVlMEMZS Y0U DONiT NEED!TOTAL NUMBER OF COPIES REQUIRED: LTTR 17 ENCL 17

WASHINGTON PUBLIC POWER SUPPLY SYSTEM P.O.Box 968~3000 George Washington Way~Richland, Washington 99352 February 16, 1990 Docket No.50-397 License No.NPF-21 EA 89-130 G02-90-028 Mr.James Lieberman Director, Office of Enforcement U.S.Nuclear Regulatory Commission Attn: Document Control Desk Washington, DC 20555

Dear Mr.Lieberman:

Subject:

RESPONSE TO NOTICE OF VIOLATION AND PROPOSED IMPOSITION Of CIVIL PENALTY-EA 89-130

Reference:

1)Letter, J.B.Martin (NRC)to G.C.Sorensen (Supply System), Notice of Violation and Proposed Imposition of Civil Penalty, dated December 21, 1989.2)Letter, G.C.Sorensen (Supply System)to J.Lieberman (NRC), Extension of Response Time for EA 89-130, dated December 29, 1989.3)Letter, G.D.Bouchey (Supply System)to J.Lieberman (NRC), Request for Further Extension of Response Time for EA 89-130, dated February 6, 1990.Pursuant to 10 CFR 2'01 and 2.205, the Supply System is submitting its response to the Notice of Violation and Proposed Imposition of Civil Penalty (Ref.1).Because the NOV and proposed civil penalty was received just prior to the Christmas holidays, the Supply System requested, and was granted, a 30 day extension to the response time for this NOV (Ref.2).In preparing our response to the NOV and proposed civil penalty, Freedom of Information Act Requests were made for records related to prior NRC inspections related to our procurement process.Because we have not yet received a response to these FOIA requests, an additional extention of time was requested on February 6, 1990.In a telephone conversation of February 15, 1990, with Mr.Ed Baker, Deputy Director, Office of Enforcement, we were advised that this request was denied (February 13 letter from Mr.Lieberman).

He noted that the denial letter did provide us the opportunity to supplement our response at a later date based on information received in response to our FOIA requests.Accordingly, we reserve the right to supplement this response pending receipt of the FOIA response.Ž900226 ADOCK 0+0003 pre

Mr.James Lieberman Page 2 February 16, 1990 RESPONSE TO NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY-EA 89-130 Attachment I to this letter provides our response to the Notice of Violation in accordance with 10 CFR 2.201.Attachment II provides our response to the proposed civil penalty in accordance with 10 CFR 2.205 and provides reasons why'the penalty should not be imposed and requests remission of the penalty.As discussed in the attached response, it is the Supply System's position that NRC guidance on commercial grade procurement has been an evolving standard.Our programs have met the guidance available at any given point in time.Our reevaluations of past commercial grade procurements have confirmed that our process has resulted in items installed in the plant which are capable of meeting their intended function.The NRC inspection of items identified in the NOV has also confirmed that those items are"acceptable for the function intended" (Ref.1, pg.2).The attachments provide new information not previously provided as well as amplification and clarification of information supplied verbally in the enforcement conference and management meeting.In particular, details related to the backfit issues have not been previously discussed and provide information not evaluated by the staff in issuing the NOV and proposed civil penalty.Based on the lack of any safety significant finding, the backfit considerations, and the new information provided herein, we believe there is sufficient justification for the NRC to reclassify this issue and provide remission of the civil penalty.Should you have any questions regarding our response, please contact me~Very truly yours, G.D.Bouchey, Dir Licensing&Assurance (MD 280)cc: Mr.C.J.Bosted, Resident NRC Inspector (901A)Mr.J.B.Martin, Region V NRC Mr.N.S.Reynolds, Bishop, Cook, Purcell&Reynolds Mr.R.B.Samworth, NRC Mr.D.L.Williams, BPA (399)

STATE OF WASHINGTON)

COUNTY OF BENTON)

Subject:

RESPONSE TO NOTICE OF VIOLATION'ND PROPOSED IMPOSITION OF CIVIL PENALTY-EA'9-130 I, G.D.Bouchey, being duly sworn, subscribe to and say that I am the Director, Licensing and Assurance, for the WASHINGTON PUBLIC POWER SUPPLY SYSTEM, the applicant herein;that I have full authority to execute this oath;that I have reviewed the foregoing; and that to the best of my knowledge, information, and belief the statements made in it are true.DATE 1990 G.D.Bouchey, Director Licensing and Assu On this day personally appeared before me G.D.Bouchey, to me known to be the individual who executed the foregoing instrument, and acknowledged that he signed the same as his free act and deed for the uses and purposes herein mentioned.

GIVEN under my hand and seal this Qd (lay of p~us 1990.Notary ub sc sn and the STATE OF WASHINGTON Residing at My commission expires 7 14 91 I tf I~4 P,~c 4 P ATTACHMENT I Washington Public Power Supply System (NRC Inspection Report Nos.50-397/89-21, 50-397/89-22, and 50-397/89-28)

REPLY TO THE NOTICE OF VIOLATION (EA 89-130)I.Introduction Pursuant to 10 C.F.R.Section 2.201, Washington Public Power Supply System (Supply System)hereby submits its reply to the Nuclear Regulatory Commission's (NRC)Notice of Violation and Proposed Imposition of a Civil Penalty issued on December 21, 1989.Consistent with the Supply System's letter (No.G02-89-233) to Mr.James Lieberman, dated December 28, 1989, we are submitting this response on or before the due date of February 20, 1990.II.Restatement of the Alle ed Violation During the Nuclear Regulatory Commission (NRC)inspections conducted between March 27 and September 14, 1989, violations of NRC requirements were identified.

In accordance with the"General Statement of Policy and Procedures for NRC Enforcement Actions," 10 C.F.R.Part 2, Appendix C (1989)the following violation was identified:

10 C.F.R.Part 50, Appendix B, Criterion III,"Design Control," requires, in part, that measures shall be established to assure that applicable regulatory requirements and the design basis are correctly translated into specifications, drawings, procedures, and instructions.

These measures shall include provisions to assure that appropriate quality standards are specified and included in design documents and that deviations from such standards are controlled.

Measures shall also be established for the selection and review for suitability of application of materials, parts, equipment, and processes that are essential to the safety-related functions of the structures, systems, and components.

Contrary to the above, the licensee failed to establish and implement adequate measures to assure that quality standards are specified and included in design documents, and for the selection and review for suitability of application of materials, parts, and equipment that are essential to the safety-related functions of systems and components.

Specifically, the following examples of items purchased commercial grade that were either installed or available for installation in safety-related systems for which an adequate evaluation for suitability of application had not been performed:

1.Evaluation 668 dedicated a commercial grade Potter-Brumfield MDR type control circuit relay for use in the safety-relate'd emergency diesel generator"Loss of Power" control circuit.The evaluation did not specify appropriate quality standards nor otherwise assure that the replacement component was selected and reviewed for suitability of application in its safety-related function.The evaluation was primarily based upon advertised specifications that I the licensee failed to verify either through audits of the manufacturing process or through identification of critical characteristics that must be inspected or tested.Consequently, the component was installed in a safety-related application on Hay 17, 1988, without assurance that design seismic requirements were met.Evaluation 1179 dedicated Anchor-Darling valve parts purchased commercial grade for use in the safety-related high pressure core spray system.The evaluation did not specify quality standards, such as fabrication under appropriate aspects of the vendor's approved guality Assurance Program, or identify the replacement parts'ritical characteristics that must otherwise be inspected or tested to assure suitability for application prior to the components'nstallation per Haintenance Work Request dated April 11, 1988.Standard Procurement Policy No.6, dated June 30, 1987, dedicated commercial grade fuses for installation in safety-related electrical systems.The policy did not specify appropriate quality standards nor assure that critical characteristics were identified for inspection or testing.The policy was inadequate in that it was based in part on: (1)the licensee's understanding of the manufacturing process for which no audits of the manufacturer were performed or required to be performed by the licensee, (2)Underwriters Laboratory (UL)activities which UL advised are not sufficient to derive any statistical inference with regard to product quality, and (3)functional compliance demonstrated by inspection and installation tests that did not cover the expected range of component operating conditions.

A pressure switch was purchased commercial grade under Purchase Order (PO)89583 and installed on July 20, 1987 in a safety-related application in the control circuitry for the emergency diesel generator starting air compressor.

The licensee failed to either (1)properly audit the vendor's manufacturing process or (2)specify and conduct appropriate inspections or testing to assure that critical characteristics of the components were suitable for their intended safety-related application.

Hetallic 0-rings were purchased commercial grade under PO 90163 and were installed in the discharge flange assembly of RHR relief valve RHR-RV-IB, during the 1988 refueling outage (April-June, 1988).The PO required a Certified Haterial Test Report (CHTR)from the vendor to assure appropriate quality standards.

However, the licensee Failed to either assure the validity of the CHTR through an audit of the vendor, or specify inspections or tests to verify the critical characteristics of the O-rings.Various General Electric relays were purchased under PO 94920 from North Coast Electric as replacement parts for safety-related applications.

As of Hay 26, 1989, the licensee's evaluation J process performed to dedicate these components was inadequate in that the licensee dedicated the components for use in safety-related applications prior to (1)auditing the suppliers of the components and (2)conducting tests to assure that the components would perform in accordance with applicable critical characteristics.

7.A York (Division of Borg-Warner) chiller shaft was purchased under PO 20173.As of Hay 26, 1989, the licensee failed to either perform an audit of the vendor's manufacturing process or evaluate the critical characteristics and specify any inspection or testing necessary to assure the adequacy of the component for its intended safety-related application.

8.A pump shaft was purchased as commercial grade from Ingersoll-Rand under PO 70808 for use as a spare part for emergency cooling water pumps.As of Hay 26, 1989, the licensee failed to either (1)audit the vendor's manufacturing process or (2)specify inspections or tests to assure that the component's critical characteristics were suitable for its intended safety-related application.

9.Pressure gauges were purchased from Paramount Supply for various safety-related applications under PO 83283 in 1986.The licensee failed to either conduct or verify that an appropriate audit of the vendor's manufacturing process was conducted until another utility performed a February 1989 audit.This is a severity Level III Violation (Supplement I).Civil Penalty-$50,000.III.Su l S stem Position The Supply System respectfully denies the alleged violation.

As will be discussed below, the Supply System submits that its commercial grade item (CGI)procurement program has complied with NRC requirements and available guidance.Further, our process has resulted in the installation in the plant of commercial grade items which are fully capable of performing their intended safety function.The NRC examination of the 10 items addressed in the NOV has confirmed that items already installed in the plant are"acceptable for the function intended" (Ref.1, pg.2).The enforcement action seeks to impose new staff positions in the review of past procurements and, as such, represents an inappropriate backfit.Furthermore, as discussed in the Supply System's separate answer to the proposed civil penalty (Attachment II), even if the items cited in the enforcement action represented a violation, they would not individually or collectively rise to the level of escalated enforcement and, therefore, any civil penalty that may be considered should be fully mitigated.

~~q I IV.Res onse to the Alle ed Violation A.Backfittin Im lications 1.The Violation Is Not Supported By Existin Re ulator Re uirements The Supply System respectfully.submits that the NOV is not supported by regulatory requirements or guidance existing at the time of the procurements involved.The enforcement action in fact represents a new Staff position for WNP-2 which is inconsistent with prior NRC acceptance of our CGI procurement and dedication practices.

We believe, therefore, that the NOV should be withdrawn.

As a matter of fundamental fairness, enforcement should not be taken without prior notice of the NRC Staff's requirements.

If the enforcement action is not withdrawn, or at a minimum reduced to the level of non-escalated enforcement, we respectfully request that the NOV be reviewed as a backfit pursuant to 10 C.F.R.Section 50.109 before being imposed.a.The NRC Has Previously Approved The Supply S stem's CGI Procurement and Dedication Practices The Supply System believes that its past CGI procurement activities are not only consistent with the guidance and standards available at the time of its dedications in 1987 and 1988, but that the NRC has, on certain occasions, already approved these activities.

The following discussion will review these positions.

As will be demonstrated below, the Supply System believes the alleged violation represents a plant-specific backfit and, thus, is an inappropriate basis for enforcement action.To begin with, the Supply System has consistently maintained a CGI procurement program that is adequate to ensure the proper suitability of items installed or available for installation in safety-related applications.

The Supply System's program is generally consistent with those of other licensees which we understand have been found acceptable by the NRC.Specifically, the Supply System first issued its procedure, PPH 1.3.13, for material procurement, which included replacement and spare parts, in 1976.The procedure indicated, inter alia that the technical requirements for the purchase request were to be specified consistent with ANSI 45.2.13 and the procedure also provided for an engineering review.The earliest revisions of PPH 1.3.13 did not explicitly focus on commercial grade or"off-the-shelf" items.However, in Revision 2, dated April 20, 1978, the Supply System did discuss commercial quality purchases.

Revision 2 (at p.1.3.13-4)indicated that CGIs may be purchased"when it has been determined by engineering that a commercially available item will enable a component or system to perform its safety-related function." The Supply System continued to upgrade its CGI program.For example, in Revision 7, dated Hay 28, 1982 (at p.1.3.13-4), the Supply System indicated that"critical characteristics" shall be identified.

In 1986, 5

the Supply System significantly upgraded its CGI procurement process by implementing PPH 1.3.39, dated Hay 13, 1986,"Plant Technical Procurement Review." This procedure provided detailed guidance for the reviews being performed by the Plant Technical organization.

PPH 1.3.39 has been revised several times to provide further program enhancements and is in compliance with recently issued EPRI guidelines.

In summary, since the issuance of its initial procurement procedures, the Supply System has included program controls consistent with contemporaneous NRC requirements and available industry guidance.Horeover, the consistent requirement for specification of technical criteria and engineering involvement demonstrates that the Supply System's CGI purchases were made in accordance with the"suitability" requirement of Appendix B, Criterion III.In addition to the Supply System's acceptable program as described above, the NRC has on prior occasions reviewed and approved the Supply System's CGI procurement practices.

The first instance of this occurred in early 1982.Specifically, in the Harch 1982 Safety Evaluation Report (SER), the NRC staff reviewed the Supply System's CGI procurement practices pursuant to Section 17.1, Item 7B4 of the Standard Review Plan (SRP).This part of Revision 2 to the SRP appears to be the first time that NRC specifically addressed CGIs.Section 17.1, Item 784 of the SRP states that: For commercial

'off-the-shelf'tems where specific quality assurance controls appropriate for nuclear applications cannot be imposed in a practicable manner, special quality verification requirements shall be established and described to provide the necessary assurance of an acceptable item by the purchaser.

The Staff's SER (at pp.17-1 to 17-2)reviewed the Supply System's procurement controls and noted that the Supply System's gA program did not contain these additional controls for the application of"off-the-shelf" items.Notwithstanding, the SER stated that"[b]ecause the staff does not consider these controls to be of such importance as to require their implementation for WNP-2, adequate quality assurance program controls exist without these additional items." Therefore, at the time of licensing the NRC had reviewed and approved the Supply System's procurement controls in this area.The next clear instance where the NRC reviewed the Supply System's CGI procurement practices occurred between late 1984 and early 1985.As Inspection Report No.50-397/84-38 (at p.2)indicates, the NRC Staff reviewed procurement"documents to ascertain that the licensee had developed and implemented a gA program relating to the control of procurement activities that was in conformance with regulatory requirements, commitments in the application, and industry guides and standards." In particular, the staff reviewed Administrative Procedure PPH 1.3.13, the Supply System's CGI dedication procedure along with several CGI procurements.

This 1" II F N inspection report demonstrates the acceptability of the Supply System's CGI procurement practices as of 1985.More importantly, however, Inspection Report No.50-397/84-38 also demonstrates the acceptability of the Supply System's CGI procurement program in 1987 and 1988, during which the NRC alleges inadequate CGI dedications occurred.Specifically, when a comparison is made between PPH 1.3.13 (as in effect during 1984-1985) and 1.3.39 (as in effect in 1987-1988), the only changes made were improvements.

Thus, if the NRC accepted the Supply System's CGI program under PPH 1.3.13 during 1984-1985, then our program under the improved procedures has to be acceptable.

It should be noted that there have been other specific instances of prior Staff review.For example, in 1984 the NRC Staff reviewed the Supply System's procedure for controlling vendor information and found no violations or deviations.

See Inspection Report No.50-397/84-26, dated November 2, 1984, at pp.9-10.More recently, in 1987, the NRC staff reviewed the Supply System's response to NRC Bulletin 87-02 which involved concerns about fasteners, including commercial grade fasteners.

NRC's review found no violations or deviations.

See Inspection Report No.50-397/87-30, dated January 15, 1988, at pp.8-9.In addition to the NRC's past procurement reviews discussed above, there have been recent inspections where the staff has evaluated the Supply System's CGI procurement practices.

During the Safety System Functional Inspection conducted in August 1987, the Supply System was requested by the NRC to provide representative samples of CGI dedications for review.See Affidavit of Steven H.Peck, Kenneth R.Wise, and J.Michael Curren (attached hereto).Four packages were provided to the NRC.Significantly one of the packages reviewed at that time by the NRC was Evaluation 668 relating to Potter-Brumfield relays.This same dedication package was cited in the NOV as one of the examples of inadequate dedication (See NOV at 1).As explained in the attached affidavits, the four dedication packages were selected on the basis that they were not clear cut cases, but rather were examples of more complex cases where it was not clear what actions were sufficient for dedication.

It was felt that, if the NRC found these packages acceptable, the Supply System would have a much better understanding of what technical requirements were necessary for the dedication process.The NRC was also provided a copy of PPH 1.3.39.In meetings with Supply System personnel (including a meeting on August 26, 1987)the NRC inspectors discussed their review of the dedication packages as well as a design change package which included installation of a commercial grade switch in the ADS system.The inspectors did not identify any significant concerns with the packages reviewed and indicated general acceptance of the Supply System's dedication process.A minor concern was raised regarding one of the dedications, but no concerns were identified with the other three, which included Evaluation 668.

1 I E See Affidavit of Hessrs.Peck, Wise, and Curren at p.4.Similarly, during an inspection of the emergency diesel generator system in August and September 1988, an NRC inspector asked to review Evaluation 301, the CGI dedication package for a Viking pump associated with the diesel generator.

See Affidavit of Hessrs.Peck, Wise, and Curren at p.5.The inspector reviewed the Evaluation as part of his examination of maintenance practices.

He discussed with Supply System personnel a question as to how seismic qualification was maintained and was provided a satisfactory explanation.

Supply System personnel also generally described the dedication process for the inspector.

The inspector identified no further questions or concerns with the package or the dedication process.See Affidavit of Hessrs.Peck, Wise, and Curren at p.5.Based on this inFormation, it is apparent that our CGI dedication process has been previously reviewed and accepted by the NRC.Certainly, in the past reviews, the NRC has not brought to our attention any significant concerns with the CGI procurement and dedication process, despite the opportunity to do so.It is the Supply System's firm belief, therefore, that the NOV represents a change in the NRC Staff position.In these circumstances, enforcement action is inappropriate.

b.The Staff Position Reflected In The NOV Is Not Su orted B Existin NRC Re uirements Part 50, Appendix B establishes general guality Assurance requirements for safety-related structures, systems and components.

It does not explicitly address CGI procurement and dedication.

Criterion III,"Design Control," contains a broad provision which states that"[m]easures shall also be established for the selection and review for suitability of application of materials, parts, equipment, and processes that are essential to the safety-related functions of the structures, systems and components." This provision, which the NRC cites as the basis for the violation, is not further defined in Appendix B or in the rulemaking history.Criterion III also does not address CGI procurement programs.I/There has been little, if any, previous guidance on the meaning of Criterion III.The provision quoted above relative to selection and review for suitability of parts is not specifically discussed in any relevant industry or NRC guidance documents.

Significantly, even the current NRC's Standard Review Plan (SRP)fails to provide any guidance on the meaning of this provision.

SRP Section 17.1.3,"Design Control," is silent regarding the"suitability of application" provision, and the related guidance in acceptance criterion 3A of SRP Section 17.1 merely states that design control activities should address"compatibility of materials." 1 See 35 Fed.Reg.10498 (1970), which noted that this provision was added to the proposed rule published in 1969, but did not further explain its purpose.

f I The broad provisions of Appendix B have been somewhat clarified in various industry guidelines.

The primary guidance document since the mid-1970s has been ANSI N18.7, to which the Supply System is committed for its gA program.ANSI N18.7 provides general guidance on gA for procurement.2/

The NRC endorsed ANSI N18.7-1976 in Regulatory Guide 1.33, Rev.2, published in February 1978, as an adequate basis for complying with the requirements of Appendix B.ANSI N18.7 addresses commercial grade items only very briefly,3/

and does not discuss"dedication" of CGIs for safety-related use.ANSI N45.2.13-1976, which was endorsed by the NRC in Regulatory Guide 1.123, Rev.1, published in July 1977, provides more specific guidance on OA for procurement of items and services.4/

The standard, however, does not explicitly address commercial grade procurement and dedication.

Horeover, neither ANSI N18.7-1976 nor ANSI N45.2.13-1976 provides specific guidance on the"suitability of application" provision of Appendix B, Criterion III.The term"commercial grade item" finds its only regulatory definition in 10 C.F.R.Part 21.CGI was nowhere explicitly mentioned in NRC regulations until the first revision to 10 C.F.R.Part 21 in 1978 (43 Fed.Reg.48621 (1978)), when the following definition appeared: "Commercial grade item" means an item that is (1)not subject to design or specification requirements that are unique to facilities or activities licensed pursuant to Parts 30, 40, 50, 60, 61, 70, 71, or 72 of this chapter and (2)used in applications other than facilities or activities licensed pursuant to parts 30, 40, 50, 60, 61, 70, 71, or 72 of this chapter and (3)to be ordered from the manufacturer or supplier on the basis of specifications set forth in the manufacturer's published product description (for example a catalog).Section 21.3(c-l)also contains a reference to"dedication" of a CGI in order to denote the point in time when Part 21 reporting obligations attach.Part 21, then, clearly contemplates that licensees may make commercial grade purchases and"dedicate" the items to safety-related applications.

Certainly, nothing in Part 21--the only regulation specifically addressing the subject of CGI procurement and dedication

--supports the Staff position reflected in the NOV.2/ANSI N18.7,"Administrative Controls and guality Assurance for the Operational Phase of Nuclear Power Plants." 3/See Section 5.2.13.4/ANSI N45.2.13,"guality Assurance Requirements for Control of Procurement of Items and Services for Nuclear Power Plants."

'I r It can be seen, therefore, that no significant guidance exists as to the nature of activit'ies that licensees are expected to undertake to satisfy Appendix B, Criterion III, the specific regulatory provision cited as the basis for the violation.

Indeed, as the NRC's own Inspection Procedure 38703 (at p.2)on CGI procurement (issued in June 1988)states,"consistent criteria for determining an item's suitability for its intended application have not been clearly established." It follows that, even as of mid-1988, licensees have been free to implement programs that in their reasoned judgment meet the intent of the requirement.

For this reason, enforcement action that would establish specific new procedural and documentation requirements is inappropriate.

As a matter of fair notice and sound policy, the Supply System submits that new requirements to upgrade CGI review procedures and documentation should be applied (and enfdrced)only prospectively.

The Supply System is well aware that beginning in 1988, as a result of fraudulent and counterfeit equipment problems which were detected by licensee procurement programs in effect at the time, the NRC for the first time published detailed guidance on CGI procurement and dedication.

Specifically, Generic Letter 89-02,"Actions to Improve the Detection of Counterfeit and Fraudulently Harketed Products," issued Harch 21, 1989, conditionally endorsed the industry initiatives of NCIG-07 related to licensees'edication processes.

While the Generic Letter stated that the guidelines of NCIG-07, as modified by the Generic Letter, established methods satisfying"existing" requirements of Appendix B, the Staff did not explain the legal basis for this conclusion.

We believe that the intent of NCIG-07 was to legitimately and prospectively upgrade procurement programs;not to provide an enforcement basis for past procurements.

Significantly, on Harch 16, 1989, the NRC published an Advance Notice of Proposed Rulemaking (54 Fed.Reg.9229)on procurement practices, specifically including commercial grade item dedication.

The Commission noted that it was reconsidering the adequacy of current regulations in this area.guestions posed in the ANPR strongly suggest that the Commission did not believe that existing regulations require the extensive verification tests assumed in the present NOV against the Supply System.For example, the Commission asked: How should products...be inspected to verify that all critical characteristics are satisfied?

Should all upgrade inspections be restricted to inspections and tests or should they include, on a sample basis, destructive inspections and tests to verify chemical and physical characteristics? How should inspections verify all critical characteristics (for example, chemistry, physical properties, dimensions, special processes, etc.)?5/Had the Commission believed that these actions were already mandated by existing regulations (as the NOV assumes), there would have been no need to pose these questions.

The only conclusion that can be drawn is that the Commission did not believe these requirements were within the contemplation of the current regulations (or at least current interpretations of those r'egulations).

B.Clarification to the Notice of Violation and Su ortin Ins ection Re orts The cover letter dated December 21, 1989, transmitting the Notice of Violation states (at p.2)that"A fundamental flaw in your procurement program appears to be the failure to adequately identify each commercial grade item's critical characteristics that must be inspected or tested to verify its suitability for use in a safety-related application.

This failure conflicts with the requirement to implement ANSI 18.7 specified in your FSAR as the method chosen to comply with 10 C.F.R.Part 30, Appendix B." ANSI N18.7 does not specifically address"critical characteristics." It does require that an appropriate"engineering evaluation shall be conducted by qualified individuals to establish the requirements and controls.This evaluation shall ensure that interfaces, interchangeability, safety, fit, and function are not adversely affected...The results of this evaluation shall be documented." The Supply System's process has required an evaluation by qualified individuals as well as meeting other requirements of ANSI N18.7.The staff requirement that each critical characteristic be inspected or tested differs from the guidance provided in the EPRI"Guideline for the Utilization of Commercial Grade Items in Nuclear Safety-Related Application (NCIG-07)," which states that"...only certain of these[critical characteristics]

must be verified to provide reasonable assurance that the item specified is the item received." This difference in interpretation is currently an item of discussion between the NRC and NUHARC.C.Conclusion In summary, it can be seen from the above that the Supply System's CGI procurement and dedication practices have been previously reviewed and accepted by the NRC.Further, this has been an area in which no explicit guidance existed until industry publication of NCIG-07.NRC regulations do not contain explicit standards and requirements for CGI procurement and dedication.

Under these circumstances, enforcement action is wholly inappropriate.

The Supply System therefore respectfully requests that the Notice of Violation be withdrawn.

5/54 Fed.Reg.at 9232 (guestions 2.1.4, 2.1.7, and 2.1.9).

T J~, We must also observe that the NRC's reliance on new standards to review past procurement activity, as is implied by Generic Letter 89-02 and Inspection Procedure 38703 (both of which rely on NCIG-07 criteria), could greatly discourage industry self-improvement.

For this additional reason, enforcement action would not be in the public interest.V.Procurement Pro ram Enhancements As discussed above, the Supply System believes that it has conducted its procurement activities in accordance with the standards and guidance that existed at the time the items cited in the NOV were dedicated arid that the programs in place have resulted in equipment installed in the plant capable of performing its intended safety function.Nevertheless, in an effort to fully ensure the NRC and ourselves that no significant deficiencies exist in our past procurement activities, the Supply System has taken the following steps: l.A verification of the 10 CGIs evaluated by the NRC was conducted.

Utilizing NCIG-07 methodology, information was established which demonstrates that each item is capable of performing its intended safety function.This information was reported to the NRC at the November 20, 1989, management meeting.In addition, our findings were reviewed and are supported by our contractor, Cygna Energy Services.The NRC has also found that those items installed in the plant are capable of performing their intended function.2.A verification of an additional sample of 50 CGIs was conducted by Cygna Energy Services.The purpose of this evaluation was to expand the sample size beyond the initial 10 CGIs to achieve a statistically valid sample of our entire CGI population.

As with the initial 10 items, NCIG-07 methodology was used to evaluate the technical adequacy of our past procurement activities.

Although the procurement packages for the 50 CGIs reviewed did not meet the documentation"requirements" specified under today's guidance (i.e., NCIG-07), Cygna Energy Services determined that the Supply System's CGI dedication process was technically sound and that each item was capable of performing its intended safety function.These findings combined with those for the initial 10 items provide significant evidence that there is reasonable assurance that the Supply System's entire population of CGIs can perform their intended safety function when called upon.3.The Supply System is conducting an internal reverification review of an additional 60 CGIs to provide further assurance of the quality of our past procurement activities.

This sample will focus on items purchased prior to 1985.Although Supply System personnel are performing the review, individuals not involved in the previous reviews are being used to obtain an independent assessment.

This work is being performed by the Nuclear Safety Assurance Group. 4.Another important action is our ongoing process of evaluating all reorders of CGIs currently installed in the plant or in storage.Whenever a reorder is requested, we will review the past procurement process to determine whether any deficiencies existed.NCIG-07 criteria will be applied to the review process.If a hardware concern is identified, we will conduct the appropriate generic reviews and take prompt and comprehensive action, as necessary.

In conclusion, the Supply System believes that it has taken and is taking prompt and comprehensive program enhancements to ensure the continued adequacy of our CGI dedication practices.

We believe that our additional sampling efforts will further demonstrate the technical quality of our past procurement activities.

Furthermore, our ongoing efforts should ensure that we meet or exceed the industry initiative to conform all future CGI purchases to NCIG-07 standards.

Our commercial grade dedication program was upgraded in 1986 and subsequent enhancements have been made since that time to bring the program into conformance with NCIG-07 in accordance with the NUMARC initiative on this issue.

ATTACHMENT II I.Introduction Washington Public Power Supply System (NRC Inspection Report Nos.50-397/89-21, 50-397/89-22, and 50-397/89-28)

ANSWER TO THE NOTICE OF VIOLATION (EA 89-130)Pursuant to 10 C.F.R.Section 2.205, Washington Public Power Supply System (Supply System)hereby submits its Answer to the Nuclear Regulatory Commission's (NRC)Notice of Violation and Proposed Imposition of a Civil Penalty issued on December 21, 1989.Consistent with the Supply System's letter (No.G02-89-233) to Hr.James Lieberman, dated December 28, 1989, we are submitting this answer on or before the due date of February 20, 1990.II.Su 1 S stem Position The Supply System believes that the discussion provided in the Reply to the Notice of Violation (Attachment I)identifies more than sufficient facts to support the conclusion that enforcement action is wholly unwarranted.

However, as discussed below, the Supply System believes that, even if the NRC disagrees with this position, the alleged violation rises at most to the level of a Severity Level IV or V violation.

Therefore, no civil penalty is warranted.

Notwithstanding the above, the discussion below also offers facts to support the conclusion that the Enforcement Policy adjustment factors properly provide for full mitigation of the proposed civil penalty.III.Severit Level Determination A.NRC Did Not Identif Hardware 0 erabilit Concerns The NRC has indicated on several occasions that it did not have concerns about the operability of the installed items cited in the Notice of Violation (NOV).This position is supported by the NOV (at p.2)where the Staff states that during a"follow-up inspection of items already installed[NRC]found the items to be acceptable for the function intended." Therefore, the cited concerns can have no actual safety significance.

The NOV (at p.2)indicates that the Supply System's CGI procurement activities during 1987 and 1988 demonstrated"the underlying programmatic problem of[not]adequately identifying critical'haracteristics of commercial grade items and[not]properly verifying their adequacy." This apparently, to the NRC Staff, represents a regulatory concern.While the Supply System can accept that its (and many licensees')

CGI procurement programs may need to be improved to reflect increasing emphasis on this concern, it cannot accept that the problems identified rise to the level of a significant regulatory concern.The examples cited represent only minor procedural or documentation problems.Perhaps even more importantly, as discussed in the Reply to the NOV, NRC's enforcement action appears to be viewing yesterday's procurements in light of today's sensitivities.

In this light, the examples should not be held out as a significant regulatory concern.

I , I C Further support for the Supply System's position on Severity Level can be found in the NRC's Enforcement Policy (53 Fed.Reg.40019, 40023 (October 13, 1988)).The Enforcement Policy states that"the severity of a violation will be characterized at the level best suited to the significance of the particular violation." Thus, the Enforcement Policy establishes a hierarchy of significance in its Supplements I through VIII.Each Supplement is"designed to illustrate the significance which NRC places on a particular type of violation of NRC requirements" (53 Fed.Reg.at 40023).It-is noteworthy that, in the Severity Level I through III categories for Supplement I of the Enforcement Policy, the examples refer specifically to systems"not being able to perform[their]intended function[s]" (53 Fed.Reg.at 40030).This same concept, however, is not used for the Severity Level IV or V categories.

Therefore, because the NOV explicitly states that all of the items cited are"acceptable for the function intended," it logically follows that the significance of these items does not rise above Severity Level IV or V.In addition to the above, the Supply System has demonstrated the lack of safety significant deficiencies in its commercial grade item (CGI)procurements other than those cited in the NOV.Specifically, during the November 20, 1989 management meeting, the Supply System presented findings concerning a reverification sample for its CGI population totalling approximately 9700.The sample size was 50 items plus the 10 items reviewed by the NRC.The findings show no CGIs which are not capable of performing their intended safety function.1/Therefore, based on this sample, the Supply System believes there is at least a 95 percent confidence level that reasonable assurance exists that all CGIs procured and installed (or available for installation) in safety related applications can perform their intended safety function.2/

These results clearly do not indicate a program that is a"significant regulatory concern." With regard to NRC's assertion that a"programmatic problem" exists, there are several other pertinent points that should be considered.

First, as discussed above, the items cited in the NOV represent, at most, minor procedural or documentation concerns.When the dedication of the cited items is viewed in light of the guidance and standards available at the time, it is clear that the Supply System exercised effective controls to ensure safe operation of its nuclear facility.Therefore, a"programmatic problem" only exists in the Staff's view, if at all, because the Supply System's past activities are being evaluated against recently issued guidance.1/See NRC Meeting Report No.50-397/89-36 (December 8, 1989)at p.3;see also Cygna Energy Services,"Commercial Grade Dedication Project for Washington Public Power Supply System Contract No.C-30298" (August 14, 1989).2/The NRC as well as various federal courts have accepted the use of the 95 percent confidence standard to demonstrate that specific sampling data is valid.See~e..Commonwealth Edison Co.LBP-84-41, 20 NRC 1203 (1984), aff'd ALAB-793, 20 NRC 1591 (1984)(involved the issue of adequacy of a reinspection program concerning BA/BC activities at Byron);see also Schaill b Kross v.Ti ecanoe Count School Cor.864 F.2d 1309 (7th Cir.1989).

Second, the Supply System has not been subject to prior escalated enforcement action in the procurement area.Further, the non-escalated actions that have occurred are few in number, isolated in nature and do not relate directly to the concerns addressed in the NOV.In addition, as discussed in the Reply to the NOV, NRC has previously evaluated the Supply System's procurement activities without finding significant concerns.Thus, our enforcement history coupled with the lack of safety significance of the concerns demonstrates that there is no programmatic problem.In summary, based on the NRC's independent evaluation and the Supply System's reverification efforts, including its sampling efforts, it may be reasonably concluded that the items cited in the NOV do not represent safety significant concerns.Furthermore, when all of the facts and circumstances surrounding the NOV are considered, as is the purpose of the Enforcement Policy, it may also be reasonably concluded that there was no programmatic problem which could rise to a level of regulatory significance that would warrant escalated enforcement action.In fact, even applying today's standards, the Supply System's past procurement activities represent, at most, low severity level procedural or documentation violations.

B.Prior Enforcement Precedent In 1989, a number of NRC inspections concentrating on CGI procurement activities took place.In each case, the inspection reports indicated that the utilities involved allegedly failed to ensure the"suitability" of CGIs installed in safety-related applications.

The NRC's findings have generally involved concerns such as inadequate verification of critical characteristics and inadequate determination of safety function.In several cases, the inspections have resulted in the issuance of escalated enforcement actions (e.g., EA 89-16 and EA 89-135).On the other hand, a recent NRC team inspection which identified similar concerns as those listed above resulted in no escalated enforcement action (EA 89-43).As distinguished from the two cases previously referenced, the utility involved in EA 89-43 performed a reverification effort which demonstrated there was reasonable assurance that CGIs installed in safety-related applications could perform their intended safety functions.

Consequently, the NRC determined that the CGIs reviewed were not of indeterminate quality or defective.

The NRC thus concluded that escalated enforcement action was not warranted and cited the utility for minor documentation concerns.In the case of the Supply System's alleged CGI procurement violations, the only deficiencies which exist, if in fact there are any, involve mere procedural or documentation concerns.This position is supported by NRC's finding of no actual safety significance as well as by the Supply System's reverification results.As we discussed with you at the November 20, 1989 management meeting, our reverification effort used NCIG-07 type methodology.

The results demonstrate that there is no safety significance to the NRC's concerns and that there is reasonable assurance that CGIs installed (or available for installation) in safety-related applications can perform their intended safety function.

E h 1 The Supply System's reverification results are very similar to those presented by the utility involved in EA 89-43.While the Supply System acknowledges that its documentation could have been improved by today's standards, we maintain, that our CGI procurement efforts were consistent with the limited regulations and guidance available to industry at the time.In addition, because our reverification efforts demonstrate reasonable assurance of adequate suitability, no escalated enforcement is warranted.

This position is consistent with NRC's prior enforcement precedent.

C.A lication of Enforcement Discretion The Enforcement Policy states that the NRC must exercise judgement and discretion in determining the severity levels of the violations and the appropriate enforcement sanctions, including the decision to issue a Notice of Violation, or to propose or impose a civil penalty and the amount of such penalty, after considering the general principles of this statement of policy and the technical significance of the violations and the surrounding circumstances.

53 Fed.Reg.at 40029.We believe that in light of (I)the purposes of the Policy, (2)the significance of the violations, and (3)the surrounding circumstances, enforcement discretion is appropriate in this case.The Supply System believes that in this case escalated enforcement is neither appropriate nor necessary to achieve the purposes of the Policy.The Policy states four principal purposes: (I)Ensuring compliance with NRC regulations and license conditions; (2)Obtaining prompt correction of violations and adverse quality conditions which may affect safety;(3)Deterring future violations and occurrences of conditions adverse to quality;and (4)Encouraging improvement of licensee and vendor performance, and by example, that of industry, including the prompt identification and reporting of potential safety problems.53 Fed.Reg.40022.With regard to item (I), the Supply System is well aware of the need for compliance with NRC regulations.

The NRC Staff has consistently recognized in its Systematic Assessment of Licensee Performance evaluations that, overall, the Supply System has a well established safety culture, a tradition of technical competence, and a long-standing reputation for proactive programs.In fact, the NRC acknowledged our"overall good performance" in the NOV (at p.2).With regard to items (2)and (3), the Supply System has already implemented procurement program enhancements which will further ensure that violations or conditions adverse to quality do not occur in the future (See Attachment I,Section V, supra).

0 A With respect to the completeness and effectiveness of this action, it is noteworthy to reemphasize that the positive findings of our reverification effort (i.e., concerning the 60 items)are supported by the former Chairman of the NCIG-07 Task Group, Nr.William E.Craig, who can best provide the proper interpretation and application of this EPRI guidance document.Finally, concerning item (4), escalated enforcement action and/or a civil penalty is not necessary to encourage the Supply System's improvement.

As we noted during the June 28, 1989 enforcement conference and during the November 20, 1989 management meeting, the Supply System has been proactive in the CGI procurement area.We have had a number of our personnel actively involved in industry developments in this area, such as NCIG-07 and NCIG-11.In addition, since mid-1986, the Supply System has implemented a number of significant procurement program enhancements to meet or exceed the evolving expectations of the NRC Staff.This demonstrates that the Supply System has been actively and effectively pursuing the stated goals of the Enforcement Policy.Concerning the second element of enforcement discretion i.e., technical significance of the violations, the Supply System believes that the demonstrated lack of safety significance shows escalated enforcement is unwarranted.

As previously discussed, the NRC agrees that there is no actual safety significance to the cited examples.Furthermore, even if violations exist, they rise only to the level of Severity Level IV or V procedural or documentation violations, as viewed under today's guidance.Finally, concerning the last element of discretion, i.e., evaluation of the"surrounding circumstances," the Supply System believes that escalated enforcement action, and for that matter any enforcement action, is unwarranted because the NRC has apparently not considered all of the information relevant to the NOV.In particular, the NOV indicates that various Supply System actions which were presented at the November 20, 1989 management meeting"have not yet been inspected." Principal among these actions is the reverification effort by Cygna Energy Services.Thus, the issuance of the NOV appears to be premature and does not appear to comport with the above stated requirements of the Enforcement Policy.In addition, it should be noted that the failure by an agency to consider the full extent of the"surrounding circumstances" is an improper exercise of its discretion.

Specifically, the Eighth Circuit has held that: An administrative agency's exercise of its discretion cannot be'unreasoned or arbitrary.'ourts reviewing discretionary agency action must evaluate, among other things, the agency's treatment of the evidence.The agency must have observed the necessary procedural requirements including the consideration of all relevant facts available in the administrative record as a whole.3/3 Choi v.United States I.N.S.798 F.2d 1189, 1191 (8th Cir.1986)(emphasis supplied)(citations omitted).

'I I 0 r A h In conclusion, for all of the reasons stated above, the NRC should exercise enforcement discretion in this case.IV.A lication of Enforcement Polic Ad'ustment Factors With respect to the application of the Enforcement Policy Adjustment Factors, 10 C.F.R.Part 2, Appendix C, Section V.B, the NOV states (at p.2)that the"escalation and mitigation factors of the Enforcement Policy were considered." The Supply System believes that the NRC did not properly apply the Enforcement Policy with regard to: (1)past performance and (2)corrective actions.A.Past Performance The Enforcement Policy, at Section V.B.3, states that:[when evaluating past performance,]

consideration will be given to, among other things, the effectiveness of previous corrective action for similar problems, overall performance such as Systematic Assessment of Licensee Performance (SALP)evaluations for power reactors, and prior performance including Severity Level IV and V violations in the area of concern.53 Fed.Reg.at 40025.Using these factors the Policy allows reduction of a proposed civil penalty"by as much as 100%." The NOV (at p.2), however, indicates that the NRC believes only 50 percent mitigation is warranted for the Supply System's"prior overall good performance." 4 The NOV is silent as to how the NRC Staff determined that 50 percent mitigation was the appropriate amount.In this regard, the NRC should consider the fact that the Supply System has had no escalated enforcement in the procurement area nor have there been any low level violations relevant to the issues raised in the NOV.In addition, the NRC Staff should consider the Supply System's proactive involvement with the CGI dedication issue.As previously discussed, Supply System personnel have been, and still are, actively involved in various industry groups (e.g., NCIG-07)concerning the procurement area.Moreover, as our discussion in the reply indicates, the NRC Staff has evaluated the Supply System's CGI procurement activities in the past and found them to be acceptable.

Therefore, based on the above information, it is reasonable that the Supply System should receive additional mitigation for its long-standing good performance regarding the CGI procurement issue and for its overall good performance. B.Corrective Actions The Enforcement Policy, at Section V.B.2, states that: the promptness and extent to which the licensee takes corrective action, including actions to prevent recurrence, may result in up to a 50%increase or decrease in the base civil penalty.53 Fed.Reg.at 40025 (emphasis supplied).

The NOV (at p.2)indicates that the NRC determined the Supply System's post-inspection actions to be"inadequate." Specifically, the NOV (at p.2)states that"your corrective actions for these violations failed to fully address the need to properly evaluate and specify the critical characteristics required for proper dedication of commercial grade items." Consequently, the NRC escalated the base civil penalty by 50 percent.The Supply System believes that the NRC misapplied the corrective actions factor.As discussed previously, the NRC guidance available at the time the cited items were dedicated was minimal.Thus, we believe that the kind of"upgrades" or"corrective actions" that the NRC Staff is apparently expecting exceed those required at the time of dedication.

Notwithstanding, and as also discussed previously, the Supply System did initiate prompt enhancements to our CGI procurement program.Part of this effort included the reverification of the items cited in the NOV as well as an additional sample of CGIs.The results of this reverification effort demonstrated no safety significance or operability concern.In addition, our reverification effort used as its principal basis the NCIG-07 methodology.

According to our contractor, who is very familiar with the interpretation of NCIG-07, there is reasonable assurance that the CGIs reviewed can perform their intended safety related function when called upon.Based on this information, the Supply System believes that it did take adequate corrective action.The"corrective actions" which the Staff believes should have been taken are the very issues at the heart of the NOV, e.g., the proper evaluation and specification of critical characteristics.

Thus, the Supply System believes that requiring actions beyond those required by NCIG-07, the NRC's current guidance concerning CGI dedication, is an improper application of the Enforcement Policy.Therefore, because we have demonstrated that our past CGI procurements are consistent with the NCIG-07 methodology, the NRC should not escalate the base civil penalty.In addition to the above position, the Supply System also believes that the NRC did not allow sufficient credit for the program enhancements described in Section V of our Reply to the NOV.Me believe that when viewed together with the Supply System's proactive efforts in the CGI dedication area (both past and present)the NRC Staff has ample support for full mitigation of the proposed base civil penalty. V.Conclusion The Supply System believes that the NRC has more than sufficient evidence to support full mitigation of the proposed base civil penalty.This position is firmly supported by (1)the backfitting issues discussed in the reply to the NOV, (2)the demonstrated lack of safety significance, (3)the prior, enforcement precedent, (4)the enforcement discretion concept and (5)an appropriate application of the Enforcement Policy adjustment factors.

UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION AFFIDAVIT OF STEVEN H.PECK KENNETH R.WISE AND J.MICHAEL CURREN I.Introduction I, Steven H.Peck, being first duly sworn, depose and state as follows: I am employed by Washington Public Power Supply System (" Supply System")as Manager of Spare Parts Engineering.

I have held that position since August 1989.I am responsible for performing the technical evaluations to establish procurement requirements, including the dedication requirements for items purchased commercial grade.Prior to holding my current position, I was Supervisor, Materials Support Engineering (August 1988 to August 1989)and Lead for the Spare Parts Program (July 1986 to August 1988), In those positions my technical responsibilities over procurement were the same as they are today.I, Kenneth R.Wise, being first duly sworn, depose and state as follows: I am employed by the Supply System as Manager of Equipment Engineering.

I have held that position since October 28, 1989.Prior to holding my current position, I was Supervisor of Electrical Equipment Engineering (September 17, 1988 to October 1989).From 1983 until September 16, 1988, I was Technical Program Leader, Electrical Equipment Engineering.

In that position, my responsibilities included reviewing dedication packages for electrical equipment commercial grade item purchases.

Hy review focused on ensuring that adequate commercial grade dedication requirements were established.

I, J.Michael Curren, being first duly sworn, depose and state as follows: I am employed by the Supply System as Senior Equipment Engineer, Equipment Engineering Group.I have held that position since July 1986.Hy responsibilities from June 1985 to August 1989 included involvement in the commercial grade dedication process in order to ensure maintenance of equipment qualification and operability.

These responsibilities included dedication activities for commercial grade items procured for use in safety-related applications.

This affidavit is provided to support the Supply System's response to the Nuclear Regulatory Commission (NRC)Notice of Violation and Proposed Imposition of Civil Penalty (EA 89-130)related to commercial grade item ("CGI")procurement.

In this affidavit, we describe certain recent instances in which the NRC has reviewed the Supply System's CGI dedication practices.

Section II below describes the NRC's review of the CGI dedication process in connection with the 1987 Safety System Functional Inspection (SSFI).Section III discusses an NRC review of CGI dedication practices during the 1988 inspection of the emergency diesel generator system.Throughout this affidavit, we describe the facts based on the direct knowledge of each of us.For any statements where the particular facts are not personally known by all the affiants, we indicate by name which of the affiants has.direct knowledge of the facts described.

It should be noted that only Hr.Peck has direct knowledge of the facts discussed in Section III of this affidavit.

Accordingly, Messrs.Wise and Curren do not join in Section III below.II.1987 Safet S stem Functional Ins ection The 1987 SSFI focused on the AC and DC electrical distribution systems, the standby service water system, and the automatic depressurization system.Early in the course of the SSFI, on August 3 or 4, 1987, NRC Inspector L.Stanley asked to see representative examples of commercial grade item dedications.

Hr.Curren was assigned the task of assembling the dedication packages for Hr.Stanley's review.Hr.Curren conservatively selected four CGI dedications which he considered difficult cases or"gray area" situations.

That is to say, these dedications were not simple cases, but rather were more difficult in the sense that the technical requirements for dedication were not clear-cut.

Hr.Curren recalls discussing the approach of selecting"gray area" cases with J.E.Rhoads, then the Supply System's Manager, Equipment Engineering.

Hr.Peck also met with Mr.Curren on August 4, 1987, to get the package pulled together for review at the meeting with the NRC the following day, The Supply System considered this a conservative approach and anticipated that NRC review of these more difficult dedications would provide useful direction to the Supply System's CGI dedication program.If these particular dedications were acceptable to the NRC, then the Supply System would have a better understanding of the actions which the NRC felt were necessary for proper dedication.

Hr.Wise recalls that this approach was discussed with the NRC inspectors at the time-with Hr.Stanley and possibly with Hr.Wagner as well-and that the NRC agreed that this was an acceptable approach.The four specific evaluations selected for review by the NRC were as follows: 1.Evaluation 668, concerning Potter-Brumfield type HDR control circuit relays.

r I Af'I r, 2.Evaluation 419, concerning a pulse preamplifier to be purchased from General Electric.3.Evaluation 377, concerning Square D temperature switches.4.Engineering specification 15122 Rev.0, which originated P.O.088173, involving procurement of air pressure regulators (originally PPH 1.3.39 Evaluation 44)./1 It should be noted that Evaluation 668 was one of the examples of allegedly inadequate dedications

'cited by the NRC in the recent Notice of Violation (EA 89-130).Hr.Curren's notes from the time (Exhibit A)originally showed Evaluation "668" as"688." This was clearly an error in transcription, since'valuation 668 was the only dedication of Potter-Brumfield relays in the relevant time period, and we understand that the NRC's records show that the dedication of Potter-Brumfield relays was one of the packages examined during the SSFI.(Evaluation 688 related to stainless steel staples, an item not reviewed by the NRC~)On August 5, 1987, NRC Inspector Stanley met with us to discuss the dedication process.See Exhibit B hereto (Hr.Wise's memorandum to file reporting on this meeting).During this meeting, we explained the dedication process to the inspector by walking through the four dedication packages selected.According to Hr.Wise's record of this meeting (Exhibit B), the inspector"seemed to understand the examples and what had been done." The inspector was provided copies of the four evaluation files.The inspector was also furnished a copy of procedure PPH 1.3.39, issued July 30, 1986.The evaluation packages provided to the NRC at that time reflected generally the same level of detail as those reviewed in the 1989 inspection leading to the NOV.Nore specifically, the packages contained information such as Form 4,"Commercial Grade Dedication," and Form 5,"Equipment gualification Evaluation." Various revisions have been made to these packages as additional purchases took place.However, the dedication method reflected in those packages was the same as that used until our program>>as recently upgraded to NCIG-07.1/Appended to this affidavit as Exhibit A are copies of handwritten summaries of these evaluation packages prepared by Hr.Curren at, the time of the NRC inspection.

These summaries were prepared in order to provide a brief description of the dedications for use by Supply System personnel in discussing these examples with the NRC.Originals of these summaries were retained by Mr.Curren in his personal subject files and were retrieved for purposes of preparing this affidavit.

In retrieving those files, Hr.Curren noticed the error in the use of the title Evaluation "688" rather than"668" (see'text)and made a pen-and-ink change on the original to correct the error.

V Vf Towards the end of the SSFI, on the morning of August 26, 1987, the NRC inspector requested a meeting to discuss CGI dedication.

Both NRC inspectors Stanley and Wagner attended this meeting with us.See Exhibit 8'Mr.Wise's memorandum to file on this meeting).This meeting was a follow-up to discuss, among other things, the NRC's examination of the four evaluation files which had previously been provided.As reflected in Exhibit C, the NRC initially questioned whether CGI dedications were being used too frequently, since the dedication package numbers were in the 700s.We explained that not all the numbers necessarily reflected CGI dedications; quality Class 1 and nonsafety-related evaluations were included as well.The inspectors seemed to understand this and were satisfied.

Of the four dedication packages the NRC reviewed, Mr.Stanley expressed only a minor concern with one of them (Evaluation 419).This related to reliability testing requirements for components purchased through General Electric.The inspectors discussed this issue briefly and did not indicate that this was a significant concern.It is noteworthy that the NRC's Inspection Report 87-19 on the SSFI did not note any deviations or weaknesses in the area of procurement.

During the meeting, the NRC also discussed with us a Design Change Package (DCP)which they had examined.This package, DCP 85-0073-0A, had been used for installation of a commercial grade switch in the Automatic Depressurization System (See Exhibit C).Mr.Stanley asked for the documentation on the dedication of this device.According to Mr.Wise's records, the inspector later that day was provided a copy of the procurement file on this item which included the memorandum defining the required vendor certification, the Purchase Requisition, the Purchase Order, and the vendor's certification.

The inspector was fully satisfied and no remaining issues were identified.

See Exhibit C.The overall impression we formed from the NRC's review during the SSFI was that the four CGI dedication packages reviewed, which were relatively more difficult examples, were acceptable to the NRC (See Exhibit C).As a result of the NRC's review, the Supply System thereafter was more comfortable with respect to the technical requirements for proper dedication.

In short, we felt that the NRC had confirmed the acceptability of our CGI procurement and dedication process, and that our program was adequate.Certainly the NRC brought no significant problems to our attention.

1 0 t P~ III.1988 Diesel Generator Ins ection 2 From August 22, 1988 to September 2, 1988, the NRC conducted a special, announced inspection of the Emergency Diesel Generator (EDG)system and the Nuclear Steam Supply.Shutoff System.In connection with reviewing maintenance practices on the EDGs, the NRC identified concerns with certain components.

As part of this review, on August 23, 1988, an NRC inspector asked to see Evaluation 301, concerning dedication of a Viking pump, Model FH456M.See Exhibit D (Mr.Peck's log entry for this date).This procurement was selected for review because the pump in question had previously been replaced on the EDG system.I recall that the inspector identified himself as an NRC contractor, and most probably was Mr.B.L.Collins, who is listed in Inspection Report 88-24 as an NRC contractor who assisted in conducting the inspection.

I provided Evaluation 301 to the inspector and also provided him a verbal explanation of how our CGI procurement and dedication process worked.My understanding was that the inspector wanted to review Evaluation 301 to make sure that we had performed a proper dedication when replacing the pump on the EDG system.His only concern after reviewing the dedication package related to how we had maintained seismic qualification during the dedication process.I explained that this had been a like-for-like replacement and that the seismic qualification of the original pump applied to the replacement.

The inspector accepted this explanation.

The inspector appeared to accept the adequacy of Evaluation 301.Except for the question regarding seismic qualification, he did not raise any questions or concerns with that package or our process in general.The inspection report did not identify any deviations or weaknesses in this regard.During the EDG inspection, the inspector also took the opportunity to ask whether we were aware that the NRC in that time frame (second half of 1988)was beginning to focus more on commercial grade item procurement and dedication.

I informed him that we were aware of the NRC's increasing focus on the subject.In fact, at the time, the Supply System was actively involved in the EPRI committee addressing this issue.2/As noted above, Messrs.Wise and Curren had no significant involvement in facts discussed in this section of the affidavit, and accordingly do not join in this section.

The foregoing information is true and correct to the best of my knowledge.

Steven H.Pec Subscribed and sworn to before me this~/+day of February 1990.Notary u lic for the o nty of Benton, State of Washington Ny commission expires 7///f The foregoing information is true and correct to the best of my knowledge.

Kenneth R.Wise Subscribed and sworn to before me this jj i hay of February 1990.Notary Public for the County of Benton, State of Washington Hy commission expires The foregoing information is true and correct to the best of my knowledge.

J.Michael Curren Subscribed and sworn to before me this~2 day of February 1990.Notary Public for the ounty of Benton, State of Washington Ny commission expires 1 I EXHIBIT A t,

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U 4 4'li EXHIBIT 8 4 e 4~I 4 AUGUST 5, 1987 NRC Reviewer: Mr.Stanley Supply System Staff: KR Mise S Peck, M Curren Mr.Stanley had a two part question concerning quality class and use of commercial grade equipment in safety-related applications.

Ne responded to the second half of the question and referred him to G.Brastad for the first half.Me explained our dedication process to him by walking through 4 examples, he borrowed the spares evaluation files for the four examples.He was given a copy of PPM 1.3.39.He seemed to understand the examples and what had been done.He is coming from an experience base at Sequoyah which used commercial equipment in safety related application without control.He requested an example or two of substitutions involving commercial grade equipment.

Curren has the action to identify these by the last week of August.Stanley will not be here next week.

rl E I' AUGUST.6,$987 NRC Reviever: Yir.Stanley, Nr.wagner Supply System Staf: KF.'ise, N.Curren, S.Peck i"ir.Stanley requested a meetinq his morning to discu s dedica ion Cf COmrherCial grade equiPment tO safe y-I e aved use~ar ier)le had examined 4 par vs evaluation files which dedicated equipment.

He had formed tne impressiotl vha ve had been doing vhol esa~e deci.cation because of the package numbers of the packages he had reviewed.The number s werc up in the 700'5 and he had assumed hat-ll 700 werc corrtmercial gracie decation.They are n>ot but inc 1 Ude qUal i.y c 1 a55 one eval Ua ot't5 a5 w&1.Thi 5 was ew p al neet and Understood.

0;the 4 packaqes he had no prob em wi"h~and Only a A>inar COnCern Vith vhe 4tht Which VaS eXp.aitled.

He seeme~~C'cV>til: ar Ca W'>~>get'Iel al a Cept atlCC C>f v:le r i gOI O>Our process bu~vi=h an underly=ng utleas'ness tha dedication vas being over u5ed i'ir Stanley had a port"-'n of DC.B5-0072-0A wh-'h inst ccn:met c a.grad=-switch for"iS-PNS-ADB'2A7 EI.He asked docui;Ie>t'av otl otl v>le c>edica lot: o i villus dev'e~aver was provided v-'-n~copy o-the pr-procurement file I de, l,>ltlg'ne requ're venaor cer.l rica'on, tne P.;, th-ile Yendc;s certi f ica'n.He vas fu y savisfiec and appear'v C>.<mal t'I i n'v'hi 5 area~al led a our he day memo all d"n v tie~Q 7>>o 1 ssue5 vne rn~~l t'I."Ig A<eev=ng CafnPOtlen v 1 ssuei'ti 5 i ssue wa5 acicil" e55ec.BI ast aa~re'b" i vy Was rai sed as a~1 a'eY" n ile dc.".y y Gc>t dc>tl V d e o EXHIBIT C ie<I(~I P t~~('0'e ,'Pw Aj 1=

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