ULNRC-06275, Response to Request for Additional Information (RA) Related to Operating Quality Assurance Manual (Oqam), Revision 31, Oqam Change Notice 15-002

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Response to Request for Additional Information (RA) Related to Operating Quality Assurance Manual (Oqam), Revision 31, Oqam Change Notice 15-002
ML16014A026
Person / Time
Site: Callaway  Ameren icon.png
Issue date: 01/12/2016
From: Diya F
Ameren Missouri, Union Electric Co
To:
Document Control Desk, Office of Nuclear Material Safety and Safeguards, Office of Nuclear Reactor Regulation
References
ULNRC-06275
Download: ML16014A026 (10)
v • d • e


Text

Fadi M. Diya Senior Vice President

~rt. and Chief Nuclear Officer Ameren Missouri

'WAmeren Callaway Energy Center T 573.676.6411 F 573.676.4056 MISSOURI fdiya@ameren.com January 12, 2016 ULNRC-06275 U.S. Nuclear Regulatory Commission Attn: Document Control Desk Washington, DC 20555-0001 10 CFR 50.54(a)

Ladies and Gentlemen:

DOCKET NUMBER 50-483 and 72-1045 CALLAWAY PLANT UNIT 1 UNION ELECTRIC CO.

RENEWED FACILITY OPERATING LICENSE NPF-30 RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION (RAI)

RELATED TO OPERATING QUALITY ASSURANCE MANUAL (OQAM) REVISION 31.1 OQAM CHANGE NOTICE 15-002 By letter dated October 7, 2015 (ADAMS Accession No. ML15280A446) Ameren Missouri submitted a proposed QA program revision for NRC approval pursuant to 10 CFR 50.54(a). The intent of the change is to incorporate a program alternative to the QA program for Callaway Plant consistent with the change generically addressed in the NRC's Safety Evaluation for Technical Report NEI 14-05, "Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services," Revision 1 (ADAMS Accession No. ML14322A535),

dated February 9, 2015. During its review, the NRC staff determined that a request for additional information (RAI) was needed to complete its review. Pursuant to electronic correspondence dated December 1, 2015 and a clarification teleconference on December 8, 2015, the NRC electronically transmitted an RAI to Ameren Missouri on December 14, 2015, and requested that a response be provided by January 14, 2016.

The response to the RAI is provided in the Attachment to this letter.

This letter contains no new commitments. For questions concerning this letter, please contact Earl Mayhorn at 314-605-9701.

                                                                                                                                                                                                                    • Junction CC & Hwy 0 .............
                                                                                                                                                                                                                    • PO Box 620, MC CA-460 Fulton, MD 65251 AmerenMissouri.com .............

ULNRC-06275 January12, 2016 Page2 I declare under penalty of perjury that the foregoing is true and correct.

  • cerely, F. M. Diya Senior Vice President and Chief Nuclear Officer Executed on: t/l '2. { l ~

JPK Attachment Response to Request for Additional Information (RAI) for QA Plan Change-NEI 14-0SA

ULNRC-06275 January12, 2016 Page 3 cc: Mr. Marc L. Dapas Regional Administrator U.S. Nuclear Regulatory Commission Region IV 1600 East Lamar Boulevard Arlington, TX 76011-4511 Director Division of Spent Fuel Management Office ofNuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 Senior Resident Inspector Callaway Resident Office U.S. Nuclear Regulatory Commission 8201 NRC Road Steedman, MO 65077 Mr. L. John Klos Project Manager, Callaway Plant Office ofNuclear Reactor Regulation U.S. Nuclear Regulatory Commission Mail Stop 08H4 Washington, DC 20555-0001

ULNRC-06275 January 12, 2016 Page4 Index and send hardcopy to QA File A160.0761 Hardcopy:

Certrec Corporation 6100 Western Place, Suite 1050 Fort Worth, TX 76107 (Certrec receives ALL attachments as long as they are non-safeguards and may be publicly disclosed.)

Electronic distribution for the following can be made via QA Program ULNRC Distribution:

F. M. Diya D. W. Neterer T. E. Herrmann M.A. McLachlan B. L. Cox L. H. Kanuckel S. A. Maglio T. B. Elwood Corporate Communications NSRB Secretary STARS Regulatory Affairs Mr. John O'Neill (Pillsbury Winthrop Shaw Pittman LLP)

Missouri Public Service Commission

Attachment to ULNRC-06275 Response to Request for Additional Information (RAI) for QA Plan Change- NEI 14-0SA 5 Pages

Attachment to ULNRC-06275 Page 1 RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION FOR QA PLAN CHANGE- NEI14-05A CALLAWAY PLANT, UNIT 1 DOCKET NO. 50-483 AND 72-1045 1.0 SCOPE By letter dated October 7, 2015, Agencywide Documents and Access and Management System (ADAMS) Accession Number ML15280A446, Ameren Missouri submitted a QA program document which the licensee stated could be considered a reduction in commitment. The change intends to incorporate a QA program alternative, approved by the Nuclear Regulatory Commission's (NRC's) Safety Evaluation, for Technical Report NEI 14-05, "Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services," Revision 1 (ADAMS No.

ML14322A535), dated February 9, 2015.

The NRC staff reviewed the submittal and determined that a request for additional information (RAJ) was needed to complete its review. The draft question was sent via electronic transmission on December 1, 2015 and a clarification call was held with the licensee on December 8, 2015. The RAJ was submitted to licensee and a response was requested by January 14, 2016.

The NRC's RAJ is provided in Section 3.0 of this attachment, and Callaway's response is provided in Section 4.0.

2.0 REGULATORY BASIS Items and services used in safety-related applications at U.S. commercial nuclear power plants are designated as basic components and are required to be provided in accordance with Appendix B to 10 CFR Part 50, which includes requirements for calibration and testing associated with basic components. The predominant criteria of Appendix B to 10 CFR Part 50 that are related to the use of accreditation in lieu of performing commercial-grade surveys for procurement of laboratory calibration and test services are Criteria 1, 4, 7, and 12.

3.0 REQUEST FOR ADDITIONAL INFORMATION Question 1.0 Section 4 of NEI 14-05, "Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services," Revision 1, states, in part, a Template for describing the use of the ILAC process in lieu of a commercial grade survey in a Purchaser's QA Program is provided in Appendix A. Although a Purchaser is not required to use the Template in Appendix A, all of the actions and steps described in Appendix A need to be included in the Purchaser's QA Program.

Attachment to ULNRC-06275 Page2 The first four paragraphs in Appendix A state:

Commercial Grade items (items not originally designed or manufactured as a basic component) are subject to a Commercial Grade Dedication process as defined and authorized by Engineering in accordance with procedures that meet the requirements of the U.S. NRC, before such items are approved for safety-related applications.

Commercial Grade Dedication also applies to a commercial grade service that is associated with basic component hardware, design certification, design approval, or information in support of an early site permit application under 10 CFR Part 52, whether these services are performed by the component supplier or others (e.g., safety-related design, analysis, inspection, testing, or fabrication that is associated with a basic component).

Procedures are established to describe the responsibilities for Engineering to perform a technical evaluation, select applicable critical characteristics, and determine an appropriate dedication method for acceptance. Procedures are also established to enhance the detection of counterfeit and fraudulent items and to minimize the likelihood of the introduction of such items in safety-related applications.

[Purchaser] may utilize commercial grade items or services in its supply of basic components in a manner consistent with the guidance in [Generic Letter (GL) 89-02, "Actions to Improve the Detection of Counterfeit and Fraudulently Marked Products." GL 89-02 documents the NRC's conditional endorsement of EPRI NP-5652, "Guideline for the Utilization of Commercial grade Items in Nuclear Safety Related Applications (NCIG-07)."]

[Purchaser] utilizes a commercial grade dedication process consistent with Generic Letter 89-02 and 10CFR21, for the supply of basic components. When a commercial grade item is modified, inspected, and/or tested to demonstrate compliance to requirements more restrictive than the manufacturer's original specifications such item is uniquely identified as different from the commercial grade (off-the-shelf) item and traceable to documents that record the difference.

Request The proposed change to the Callaway Plant Unit 1 OQAM does not address the above requirements of Appendix A. Please provide clarification on how Callaway Unit 1 incorporates these requirements of Appendix A in its Quality Assurance Program.

Attachment to ULNRC-06275 Page 3 4.0 RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION Callaway Energy Center Administrative and Departmental procedures implement the Quality Assurance Program requirements described in the four paragraphs discussed in the RAI.

The following table provides a description of how Callaway accomplishes the requirements of each paragraph.

Paragraph(s) How Callaway Meets the Paragraph(s)

1. Commercial Grade items (items not While the Ameren Operating Quality originally designed or manufactured as a Assurance Manual does not specifically basic component) are subject to a include verbiage addressing the first two Commercial Grade Dedication process as paragraphs of the Template in Appendix A defined and authorized by Engineering in of NEI14-05A, Callaway Energy Center accordance with procedures that meet the (CEC) has developed administrative and requirements of the U.S. NRC, before implementing procedures that address the such items are approved for safety-related commercial grade dedication process.

applications. Commercial Grade Procedure APA-ZZ-00400, "Procurement Dedication also applies to a commercial of Parts, Supplies Materials and Services,"

grade service that is associated with basic indicates that the Manager, Supply Chain component hardware, design certification, Operations Nuclear is responsible for design approval, or information in support determining when commercial grade items of an early site permit application under 10 may be evaluated for use in safety-related CFR Part 52, whether these services are applications and establishes critical performed by the component supplier or characteristics for verification and others (e.g., safety-related design, selection of tests and inspections for analysis, inspection, testing, or fabrication dedication of commercial grade items that is associated with a basic procured as like-for-like replacements.

component). Specifically, the Procurement/Materials Engineering Group reports directly to the

2. Procedures are established to describe Manager, Supply Chain Operations the responsibilities for Engineering to Nuclear and is responsible for performing perform a technical evaluation, select technical evaluations in accordance with applicable critical characteristics, and Procedure WEP-ZZ-00001, "Commercial determine an appropriate dedication Grade Evaluation," APA-ZZ-00430, "Parts method for acceptance. Procedures are Classification," and the Electric Power also established to enhance the detection Research Institute (EPRI) Commercial of counterfeit and fraudulent items and to Grade Dedication Guidelines. The minimize the likelihood of the introduction process requires the identification of a of such items in safety-related commercial item's safety function, applications. consideration of credible failure modes, selection of critical characteristics for verification, and identification of the acceptance method(s).

Attachment to ULNRC-06275 Page4 Paragraph(s) How Callaway Meets the Paragraph(s)

The EPRI Commercial Grade Dedication Guidelines were developed by EPRI in conjunction with licensees. The NRC conditionally endorsed this guidance in NRC Generic Letter 89-02, "Actions to Improve the Detection of Counterfeit and Fraudulently marked Products." Generic Letter 89-02 did not specify any additional commercial grade dedication guidance but rather specified the conditions for use of the EPRI guidance. While CEC procedures do not specifically reference Generic Letter 89-02, procedures do address the NRC conditional use of EPRI commercial grade dedication guidance including specifying that Method 4 can only be used in conjunction with one or more of Methods 1, 2 & 3 and specifying that when Method 2 is used, the supplier must have a documented QA program.

The EPRI commercial grade dedication guidance factors in the understanding that counterfeit and fraudulent items would be detected through the selection and verification of the appropriate identification attributes and physical and performance critical characteristics of commercial grade items undergoing dedication. Additionally, CEC Procure QCP-ZZ-03003, "Material Receipt Inspection," provides additional guidance on the detection of counterfeit, fraudulent and suspect items.

3. [Purchaser] may utilize commercial The third paragraph of the Template in grade items or services in its supply of Appendix A of NEI 14-05A is primarily basic components in a manner consistent intended for suppliers of basic with the guidance in [Generic Letter (GL) components. The statement acknowledges 89-02, "Actions to Improve the Detection of that a basic component could include Counterfeit and Fraudulently Marked commercial parts and subcomponents or Products." GL 89-02 documents the commercial services in support of the NRC's conditional endorsement of EPRI basic component, and these parts, NP-5652, "Guideline for the Utilization of subcomponents, or services may require Commercial grade Items in Nuclear Safety dedication if they perform a safety function Related Applications (NCIG-07)."] within the parent component. Ameren is

Attachment to ULNRC-06275 Page 5 Paragraph(s) How Callaway Meets the Paragraph(s) not a supplier of basic components.

Therefore, this item is not required to be specifically addressed in the CEC OQAM and plant procedures.

4. [Purchaser] utilizes a commercial grade The CEC commercial grade dedication dedication process consistent with Generic program is based on EPRI Guidelines Letter 89-02 and 10CFR21, for the supply which were conditionally endorsed by NRC of basic components. When a commercial Generic Letter 89-02. It is recognized that grade item is modified, inspected, and/or the basic requirements, including the tested to demonstrate compliance to definitions of key terms, for dedication are requirements more restrictive than the specified in 10 CFR Part 21. CEC manufacturer's original specifications such procedures APA-ZZ-00400 and WEP-ZZ-item is uniquely identified as different from 00001 address these basic requirements the commercial grade (off-the-shelf) item of the commercial grade dedication and traceable to documents that record process. The process does not allow the the difference. procurement of alternative parts that are not identical replacements unless they are approved through an equivalency evaluation in accordance with APA-ZZ-00604, "Request for Resolution."

Changes to parts are not typically performed. However, changes would be treated under the CEC design change process and APA-ZZ-00604 which requires an equivalency evaluation. Any additional testing would be documented in the dedication test/inspection documentation in accordance with WEP-ZZ-00001 and QCP-ZZ-03003.

Fadi M. Diya Senior Vice President

~rt. and Chief Nuclear Officer Ameren Missouri

'WAmeren Callaway Energy Center T 573.676.6411 F 573.676.4056 MISSOURI fdiya@ameren.com January 12, 2016 ULNRC-06275 U.S. Nuclear Regulatory Commission Attn: Document Control Desk Washington, DC 20555-0001 10 CFR 50.54(a)

Ladies and Gentlemen:

DOCKET NUMBER 50-483 and 72-1045 CALLAWAY PLANT UNIT 1 UNION ELECTRIC CO.

RENEWED FACILITY OPERATING LICENSE NPF-30 RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION (RAI)

RELATED TO OPERATING QUALITY ASSURANCE MANUAL (OQAM) REVISION 31.1 OQAM CHANGE NOTICE 15-002 By letter dated October 7, 2015 (ADAMS Accession No. ML15280A446) Ameren Missouri submitted a proposed QA program revision for NRC approval pursuant to 10 CFR 50.54(a). The intent of the change is to incorporate a program alternative to the QA program for Callaway Plant consistent with the change generically addressed in the NRC's Safety Evaluation for Technical Report NEI 14-05, "Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services," Revision 1 (ADAMS Accession No. ML14322A535),

dated February 9, 2015. During its review, the NRC staff determined that a request for additional information (RAI) was needed to complete its review. Pursuant to electronic correspondence dated December 1, 2015 and a clarification teleconference on December 8, 2015, the NRC electronically transmitted an RAI to Ameren Missouri on December 14, 2015, and requested that a response be provided by January 14, 2016.

The response to the RAI is provided in the Attachment to this letter.

This letter contains no new commitments. For questions concerning this letter, please contact Earl Mayhorn at 314-605-9701.

                                                                                                                                                                                                                    • Junction CC & Hwy 0 .............
                                                                                                                                                                                                                    • PO Box 620, MC CA-460 Fulton, MD 65251 AmerenMissouri.com .............

ULNRC-06275 January12, 2016 Page2 I declare under penalty of perjury that the foregoing is true and correct.

  • cerely, F. M. Diya Senior Vice President and Chief Nuclear Officer Executed on: t/l '2. { l ~

JPK Attachment Response to Request for Additional Information (RAI) for QA Plan Change-NEI 14-0SA

ULNRC-06275 January12, 2016 Page 3 cc: Mr. Marc L. Dapas Regional Administrator U.S. Nuclear Regulatory Commission Region IV 1600 East Lamar Boulevard Arlington, TX 76011-4511 Director Division of Spent Fuel Management Office ofNuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 Senior Resident Inspector Callaway Resident Office U.S. Nuclear Regulatory Commission 8201 NRC Road Steedman, MO 65077 Mr. L. John Klos Project Manager, Callaway Plant Office ofNuclear Reactor Regulation U.S. Nuclear Regulatory Commission Mail Stop 08H4 Washington, DC 20555-0001

ULNRC-06275 January 12, 2016 Page4 Index and send hardcopy to QA File A160.0761 Hardcopy:

Certrec Corporation 6100 Western Place, Suite 1050 Fort Worth, TX 76107 (Certrec receives ALL attachments as long as they are non-safeguards and may be publicly disclosed.)

Electronic distribution for the following can be made via QA Program ULNRC Distribution:

F. M. Diya D. W. Neterer T. E. Herrmann M.A. McLachlan B. L. Cox L. H. Kanuckel S. A. Maglio T. B. Elwood Corporate Communications NSRB Secretary STARS Regulatory Affairs Mr. John O'Neill (Pillsbury Winthrop Shaw Pittman LLP)

Missouri Public Service Commission

Attachment to ULNRC-06275 Response to Request for Additional Information (RAI) for QA Plan Change- NEI 14-0SA 5 Pages

Attachment to ULNRC-06275 Page 1 RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION FOR QA PLAN CHANGE- NEI14-05A CALLAWAY PLANT, UNIT 1 DOCKET NO. 50-483 AND 72-1045 1.0 SCOPE By letter dated October 7, 2015, Agencywide Documents and Access and Management System (ADAMS) Accession Number ML15280A446, Ameren Missouri submitted a QA program document which the licensee stated could be considered a reduction in commitment. The change intends to incorporate a QA program alternative, approved by the Nuclear Regulatory Commission's (NRC's) Safety Evaluation, for Technical Report NEI 14-05, "Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services," Revision 1 (ADAMS No.

ML14322A535), dated February 9, 2015.

The NRC staff reviewed the submittal and determined that a request for additional information (RAJ) was needed to complete its review. The draft question was sent via electronic transmission on December 1, 2015 and a clarification call was held with the licensee on December 8, 2015. The RAJ was submitted to licensee and a response was requested by January 14, 2016.

The NRC's RAJ is provided in Section 3.0 of this attachment, and Callaway's response is provided in Section 4.0.

2.0 REGULATORY BASIS Items and services used in safety-related applications at U.S. commercial nuclear power plants are designated as basic components and are required to be provided in accordance with Appendix B to 10 CFR Part 50, which includes requirements for calibration and testing associated with basic components. The predominant criteria of Appendix B to 10 CFR Part 50 that are related to the use of accreditation in lieu of performing commercial-grade surveys for procurement of laboratory calibration and test services are Criteria 1, 4, 7, and 12.

3.0 REQUEST FOR ADDITIONAL INFORMATION Question 1.0 Section 4 of NEI 14-05, "Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services," Revision 1, states, in part, a Template for describing the use of the ILAC process in lieu of a commercial grade survey in a Purchaser's QA Program is provided in Appendix A. Although a Purchaser is not required to use the Template in Appendix A, all of the actions and steps described in Appendix A need to be included in the Purchaser's QA Program.

Attachment to ULNRC-06275 Page2 The first four paragraphs in Appendix A state:

Commercial Grade items (items not originally designed or manufactured as a basic component) are subject to a Commercial Grade Dedication process as defined and authorized by Engineering in accordance with procedures that meet the requirements of the U.S. NRC, before such items are approved for safety-related applications.

Commercial Grade Dedication also applies to a commercial grade service that is associated with basic component hardware, design certification, design approval, or information in support of an early site permit application under 10 CFR Part 52, whether these services are performed by the component supplier or others (e.g., safety-related design, analysis, inspection, testing, or fabrication that is associated with a basic component).

Procedures are established to describe the responsibilities for Engineering to perform a technical evaluation, select applicable critical characteristics, and determine an appropriate dedication method for acceptance. Procedures are also established to enhance the detection of counterfeit and fraudulent items and to minimize the likelihood of the introduction of such items in safety-related applications.

[Purchaser] may utilize commercial grade items or services in its supply of basic components in a manner consistent with the guidance in [Generic Letter (GL) 89-02, "Actions to Improve the Detection of Counterfeit and Fraudulently Marked Products." GL 89-02 documents the NRC's conditional endorsement of EPRI NP-5652, "Guideline for the Utilization of Commercial grade Items in Nuclear Safety Related Applications (NCIG-07)."]

[Purchaser] utilizes a commercial grade dedication process consistent with Generic Letter 89-02 and 10CFR21, for the supply of basic components. When a commercial grade item is modified, inspected, and/or tested to demonstrate compliance to requirements more restrictive than the manufacturer's original specifications such item is uniquely identified as different from the commercial grade (off-the-shelf) item and traceable to documents that record the difference.

Request The proposed change to the Callaway Plant Unit 1 OQAM does not address the above requirements of Appendix A. Please provide clarification on how Callaway Unit 1 incorporates these requirements of Appendix A in its Quality Assurance Program.

Attachment to ULNRC-06275 Page 3 4.0 RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION Callaway Energy Center Administrative and Departmental procedures implement the Quality Assurance Program requirements described in the four paragraphs discussed in the RAI.

The following table provides a description of how Callaway accomplishes the requirements of each paragraph.

Paragraph(s) How Callaway Meets the Paragraph(s)

1. Commercial Grade items (items not While the Ameren Operating Quality originally designed or manufactured as a Assurance Manual does not specifically basic component) are subject to a include verbiage addressing the first two Commercial Grade Dedication process as paragraphs of the Template in Appendix A defined and authorized by Engineering in of NEI14-05A, Callaway Energy Center accordance with procedures that meet the (CEC) has developed administrative and requirements of the U.S. NRC, before implementing procedures that address the such items are approved for safety-related commercial grade dedication process.

applications. Commercial Grade Procedure APA-ZZ-00400, "Procurement Dedication also applies to a commercial of Parts, Supplies Materials and Services,"

grade service that is associated with basic indicates that the Manager, Supply Chain component hardware, design certification, Operations Nuclear is responsible for design approval, or information in support determining when commercial grade items of an early site permit application under 10 may be evaluated for use in safety-related CFR Part 52, whether these services are applications and establishes critical performed by the component supplier or characteristics for verification and others (e.g., safety-related design, selection of tests and inspections for analysis, inspection, testing, or fabrication dedication of commercial grade items that is associated with a basic procured as like-for-like replacements.

component). Specifically, the Procurement/Materials Engineering Group reports directly to the

2. Procedures are established to describe Manager, Supply Chain Operations the responsibilities for Engineering to Nuclear and is responsible for performing perform a technical evaluation, select technical evaluations in accordance with applicable critical characteristics, and Procedure WEP-ZZ-00001, "Commercial determine an appropriate dedication Grade Evaluation," APA-ZZ-00430, "Parts method for acceptance. Procedures are Classification," and the Electric Power also established to enhance the detection Research Institute (EPRI) Commercial of counterfeit and fraudulent items and to Grade Dedication Guidelines. The minimize the likelihood of the introduction process requires the identification of a of such items in safety-related commercial item's safety function, applications. consideration of credible failure modes, selection of critical characteristics for verification, and identification of the acceptance method(s).

Attachment to ULNRC-06275 Page4 Paragraph(s) How Callaway Meets the Paragraph(s)

The EPRI Commercial Grade Dedication Guidelines were developed by EPRI in conjunction with licensees. The NRC conditionally endorsed this guidance in NRC Generic Letter 89-02, "Actions to Improve the Detection of Counterfeit and Fraudulently marked Products." Generic Letter 89-02 did not specify any additional commercial grade dedication guidance but rather specified the conditions for use of the EPRI guidance. While CEC procedures do not specifically reference Generic Letter 89-02, procedures do address the NRC conditional use of EPRI commercial grade dedication guidance including specifying that Method 4 can only be used in conjunction with one or more of Methods 1, 2 & 3 and specifying that when Method 2 is used, the supplier must have a documented QA program.

The EPRI commercial grade dedication guidance factors in the understanding that counterfeit and fraudulent items would be detected through the selection and verification of the appropriate identification attributes and physical and performance critical characteristics of commercial grade items undergoing dedication. Additionally, CEC Procure QCP-ZZ-03003, "Material Receipt Inspection," provides additional guidance on the detection of counterfeit, fraudulent and suspect items.

3. [Purchaser] may utilize commercial The third paragraph of the Template in grade items or services in its supply of Appendix A of NEI 14-05A is primarily basic components in a manner consistent intended for suppliers of basic with the guidance in [Generic Letter (GL) components. The statement acknowledges 89-02, "Actions to Improve the Detection of that a basic component could include Counterfeit and Fraudulently Marked commercial parts and subcomponents or Products." GL 89-02 documents the commercial services in support of the NRC's conditional endorsement of EPRI basic component, and these parts, NP-5652, "Guideline for the Utilization of subcomponents, or services may require Commercial grade Items in Nuclear Safety dedication if they perform a safety function Related Applications (NCIG-07)."] within the parent component. Ameren is

Attachment to ULNRC-06275 Page 5 Paragraph(s) How Callaway Meets the Paragraph(s) not a supplier of basic components.

Therefore, this item is not required to be specifically addressed in the CEC OQAM and plant procedures.

4. [Purchaser] utilizes a commercial grade The CEC commercial grade dedication dedication process consistent with Generic program is based on EPRI Guidelines Letter 89-02 and 10CFR21, for the supply which were conditionally endorsed by NRC of basic components. When a commercial Generic Letter 89-02. It is recognized that grade item is modified, inspected, and/or the basic requirements, including the tested to demonstrate compliance to definitions of key terms, for dedication are requirements more restrictive than the specified in 10 CFR Part 21. CEC manufacturer's original specifications such procedures APA-ZZ-00400 and WEP-ZZ-item is uniquely identified as different from 00001 address these basic requirements the commercial grade (off-the-shelf) item of the commercial grade dedication and traceable to documents that record process. The process does not allow the the difference. procurement of alternative parts that are not identical replacements unless they are approved through an equivalency evaluation in accordance with APA-ZZ-00604, "Request for Resolution."

Changes to parts are not typically performed. However, changes would be treated under the CEC design change process and APA-ZZ-00604 which requires an equivalency evaluation. Any additional testing would be documented in the dedication test/inspection documentation in accordance with WEP-ZZ-00001 and QCP-ZZ-03003.

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