View source for RA-18-068, Response to Request for Additional Information (RAI) Regarding Request for Approval of Decommissioning Quality Assurance Program, Revision 0 for Oyster Creek Nuclear Generating Station

{{Adams
| number = ML18157A227
| issue date = 06/06/2018
| title = Response to Request for Additional Information (RAI) Regarding Request for Approval of Decommissioning Quality Assurance Program, Revision 0 for Oyster Creek Nuclear Generating Station
| author name = Gallagher M
| author affiliation = Exelon Generation Co, LLC
| addressee name = 
| addressee affiliation = NRC/Document Control Desk, NRC/NMSS, NRC/NRR
| docket = 05000219, 07200015
| license number = DPR-016
| contact person = 
| case reference number = RA-18-068
| document type = Letter type:RA, Response to Request for Additional Information (RAI)
| page count = 11
| project = 
| stage = Response to RAI
}}

=Text=
{{#Wiki_filter:Michael P. Gallagher Exelon Nuclear Exelon Generation                                                  Vice President License Renewal and Decommissioning 200 Exelon Way Kennett Square, PA 19348 610 765 5958 Office 610 765 5658 Fax www.exeloncorp.com m1chaelp.gallagher@exeloncorp com 10 CFR 50.54(a)(4)
RA-18-068 June 6, 2018 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555-0001 Oyster Creek Nuclear Generating Station Renewed Facility Operating License No. DPR-16 NRC Docket Nos. 50-219 and 72-15

==Subject:==
Response to Request for Additional Information (RAI) Regarding Request for Approval of Decommissioning Quality Assurance Program, Revision O for Oyster Creek Nuclear Generating Station

==Reference:==
: 1)   Letter from Michael P. Gallagher, (Exelon Generation Company, LLC) to U.S. Nuclear Regulatory Commission - "Request for Approval of Decommissioning Quality Assurance Program, Revision 0 for Oyster Creek Nuclear Generating Station," dated November 30, 2017 (ML17334A798)
: 2)   U.S. Nuclear Regulatory Commission Electronic Mail Request to David Helker, et al., (Exelon Generation Company, LLC) - Draft RAI for Oyster Creek DQAP (EPID: L-2017-LLQ-003), dated May 4, 2018
: 3)   U.S. Nuclear Regulatory Commission Electronic Mail Request to David Helker (Exelon Generation Company, LLC) - RAls - Oyster Creek -
Request Approval of the Decommissioning Quality Assurance Program (EPID: L-2017-LLQ-0003), dated May 15, 2018 (ML18135A073)
By letter dated November 30, 2017 (Reference 1), Exelon Generation Company, LLC (Exelon) submitted a proposed Decommissioning Quality Assurance Program (DQAP) for U.S. Nuclear Regulatory Commission (NRC) review and approval in preparation for the transition of the Oyster Creek Nuclear Generating Station (OCNGS) to a permanent defueled condition.
Subsequently, in an electronic mail request dated May 4, 2018 (Reference 2), the NRC issued a draft Request for Additional Information (RAI) indicating that it had reviewed the information submitted in the Reference 1 letter and that additional clarifying information was needed to support its continued review. The draft RAI in Reference 2 was further discussed during a teleconference between Exelon and NRC representatives held on May 14, 2018. As a result of the discussions, it was determined that no modification to the draft RAI was needed and the

U.S. Nuclear Regulatory Commission Response to Request for Additional Information Docket Nos. 50-219 and 72-15 June 6, 2018 Page 2 NRC subsequently issued a formal RAI via electronic mail on May 15, 2018 (Reference 3), and requested a response within 30 days of the date of this electronic mail message.
Accordingly, Attachment 1 of this letter provides Exelon's responses to the NRC's RAI in support of this DQAP request. Attachment 2 provides the clean copy of the DQAP pages. The DQAP pages being submitted in this letter supersede in entirety those pages previously submitted in Reference 1 .
There are no regulatory commitments contained in this submittal.
If you have any questions concerning this submittal, please contact Paul Bonnett at (610) 765-5264.
Respectfully, Michael P. Gallagher Vice President, License Renewal & Decommissioning Exelon Generation Company, LLC :     Response to NRC's Request for Additional Information :     Clean Replacement Pages - Decommissioning Quality Assurance Program (DQAP) cc:    w/Attachments Regional Administrator - NRC Region I NRC Senior Resident Inspector - Oyster Creek Nuclear Generating Station NRC Project Manager, NRA - Oyster Creek Nuclear Generating Station Director, Bureau of Nuclear Engineering - New Jersey Department of Environmental Protection Mayor of Lacey Township, Forked River, NJ

U.S. Nuclear Regulatory Commission Response to Request for Additional Information Docket Nos. 50-219 and 72-15 June 6, 2018 Page 3 bee: w/o Attachments Senior Vice President Mid-Atlantic Operations Site Vice President - Oyster Creek Nuclear Generating Station Plant Manager - Oyster Creek Nuclear Generating Station Director, Operations - Oyster Creek Nuclear Generating Station Director, Training - Oyster Creek Nuclear Generating Station wlAttachments Senior Manager, Decommissioning - Cantera Site Decommissioning Director - Oyster Creek Nuclear Generating Station Regulatory Assurance Manager - Oyster Creek Nuclear Generating Station Manager, Licensing and Regulatory Affairs - KSA Director, Emergency Preparedness - Cantara Records Management - KSA Commitment Tracking Coordinator - East

Attachment 1 Response to NRC's Request for Additional Information Response to Request for Additional Information Docket Nos. 50-219 and 72-15 Page A1-1 of A1-3

==SUMMARY==

By letter dated November 30, 2017 (Reference 1), Exelon Generation Company, LLC (Exelon) submitted a proposed Decommissioning Quality Assurance Program (DQAP) for U.S. Nuclear Regulatory Commission (NRC) review and approval in preparation for the transition of the Oyster Creek Nuclear Generating Station (OCNGS) to a permanent defueled condition.
Subsequently, in an electronic mail request dated May 4, 2018 (Reference 2), the NRC issued a draft Request for Additional Information (RAI) indicating that it had reviewed the information submitted in the Reference 1 letter and that additional clarifying information was needed to support its continued review. The draft RAI in Reference 2 was further discussed during a teleconference between Exelon and NRC representatives held on May 14, 2018. As a result of the discussions, it was determined that no modification to the draft RAI was needed and the NRC subsequently issued a formal RAI via electronic mail on May 15, 2018 (Reference 3), and requested a response within 30 days of the date of this electronic mail message.
Accordingly, this attachment provides Exelon's responses to the NRC's RAI in support of this DQAP request. Attachment 2 provides the clean copy of the DQAP pages. The DQAP pages being submitted in this letter supersede in entirety those pages previously submitted in Reference 1.
RESPONSE TO RAI QUESTIONS RAl-OC-1 Title 10 of the Code of Federal Regulations (10 CFR), Part 50, Appendix B, Criterion XVIII "Audits," requires, in part, that audits shall be performed in accordance with written procedures or check lists by appropriate trained personnel not having direct responsibilities in the areas being audited .
Exelon DQAP Section 1, "Organization," and Section 18, "Audits," does not clearly articulate how personnel within the Nuclear Oversight (NOS) organization will only conduct audits in areas within the scope of the DQAP with no direct responsibilities.
Clarify how the DQAP meets the above requirement.
Exelon's Response to RAl-OC-1:
Section 1.2.1 describes the management position responsible for Nuclear Oversight. That description requires Nuclear Oversight personnel reporting to that management position to have sufficient authority and organizational freedom to identify any quality problems and to verify implementation of corrective actions. The wording also requires Nuclear Oversight personnel to have direct access to appropriate levels of management necessary to perform their function independent from cost and schedule. While Exelon believes that this adequately defines the independence of the Nuclear Oversight personnel, Exelon would propose to clarify and reinforce this information with the following additional wording in Section 18.1 highlighted in bold italics below:
18.1. Measures shall be established for a system of planned and documented audits in order to verify compliance with all aspects of the DQAP, and determine the effective implementation of programs covered by the DQAP. Internal and supplier audits are conducted in accordance with written procedures or checklists. Audit personnel shall not have direct responsibilities in the areas to be audited.
Response to Request for Additional Information Docket Nos. 50-219 and 72-15 Page A1-2 of A1-3 RAl-OC-2 The regulation 10 CFR Part 50, Appendix B, Criterion XII, "Control of Measuring and Test Equipment [M&TE]," requires measures to be established to assure that tools, gages, instruments, and other measuring and testing devices used in activities affecting quality are properly controlled, calibrated, and adjusted at specified periods to maintain accuracy within necessary limits. Criterion XV, "Nonconforming Materials, Parts, or Components," requires, in part, that procedures be established, as appropriate, for the identification, documentation, segregation, disposition, and notification to affected organizations of nonconforming parts or components.
NUREG-1536, "Standard Review Plan for Spent Fuel Dry Storage Systems at a General License Facility," Revision 1, Chapter 14, "Quality Assurance Evaluation," Section 14.5.12.e, "Control of Measuring and Test Equipment," requires measures to document the assessment of the validity of previous inspections when M&TE equipment is found out of calibration and take control of the out of calibration equipment.
Exelon DQAP Section 12, "Control of Measuring and Test Equipment," does not clearly articulate how gages and instruments within the DQAP M&TE program will be documented and assessed for potential extent of condition issues after an out-of-calibration condition is identified.
Specifically, use of out-of-calibration M&TE could result in a nonconforming condition of components in which the M&TE was previously used for maintenance or testing of important to safety components. Therefore, procedures should be in place to identify and evaluate the potential for such nonconforming conditions.
Clarify how the DQAP meets the above requirement.
Exelon's Response to RAl-OC-2:
Section 12. 7 requires, in part, that out-of-calibration M&TE be processed in accordance with approved procedures. Exelon's standard governance for processing M&TE found out-of-calibration includes guidance for evaluation of components in which work was previously performed with the suspect equipment consistent with American Society of Mechanical Engineers (ASME) standard NQA-1, "Quality Assurance Requirements for Nuclear Facility Applications,"
and other industry standards.
To clarify this requirement in the DQAP document, Exelon would propose adding the following additional wording in Section 12.7 highlighted in bold italics below:
: 12. 7    M& TE which is found to be damaged, out-of-calibration or for which accuracy is suspect, shall be tagged and segregated and processed in accordance with approved procedures.
When M& TE is found to be out-of-tolerance, an evaluation is made of its previous uses to determine corrective action.
RAl-OC-3 The regulation 10 CFR Part 50, Appendix B, Criterion II, "Quality Assurance Program," requires, in part, a regular review of the status and adequacy of the quality assurance (QA) program.
NUREG-1757, "Decommissioning Plans: Process for Material Licensees," Vol. 1, Revision 2, Section 17.6.2, "Quality Assurance Program," requires, in part, a description of how management (above or outside the QA organization) regularly assess the scope, status, adequacy, and compliance of the QA program.
Response to Request for Additional Information Docket Nos. 50-219 and 72-15 Page A1-3 of A1-3 Exelon DQAP Section 2, "Quality Assurance Program," removes the requirement of Independent Reviews per American National Standards Institute (ANSI) N18.7-1976.
Clarify how the DQAP meets the above requirement.
Exelon's Response to RAl-OC-3:
Exelon is not committing to meet the requirements of ANS-3.2, ANSI N18.7-1976 or subsequent revisions of the standard. This standard is clearly written to address Administrative Controls and QA for the Operational Phase of Nuclear Power Plants. The Operational Phase is defined in Section 2 of the document as the period of time during which the principal activity is associated with normal operation of the plant. The phase ends with plant decommissioning. The Exelon DQAP reflects the requirements of NQA-1, Basic Requirement 2, in that it requires management of organizations implementing the QA program to regularly assess the adequacy for that part of the program for which they are responsible and assure effective implementation. In addition, the DQAP reflects requirements of NQA-1, Basic Requirement 18, for planned and scheduled audits to verify compliance with all aspects of the QA Program.
To clarify this requirement in the DQAP document, Exelon would propose adding the following additional wording in Appendix D, General Administrative Requirements, highlighted in bold italics below:
Appendix D General Administrative Requirements D.5. Safety Review Committee D.5.1. The Safety Review Committee (SRC) serves the CNO as an on-site review body that performs procedure and program reviews for decommissioning activities and ISFSI operation as necessary on matters of Nuclear Safety. Details regarding the membership, quorum, agenda, and meeting schedule are contained in implementing procedures.

==REFERENCES:==
: 1)       Letter from Michael P. Gallagher, (Exelon Generation Company, LLC) to U.S. Nuclear Regulatory Commission - "Request for Approval of Decommissioning Quality Assurance Program, Revision O for Oyster Creek Nuclear Generating Station," dated November 30, 2017 (ML17334A798)
: 2)       U.S. Nuclear Regulatory Commission Electronic Mail Request to David Helker, et al.,
(Exelon Generation Company, LLC) - Draft RAI for Oyster Creek DQAP (EPID: L-2017-LLQ-003), dated May 4, 2018
: 3)       U.S. Nuclear Regulatory Commission Electronic Mail Request to David Helker (Exelon Generation Company, LLC) - RAls - Oyster Creek - Request Approval of the Decommissioning Quality Assurance Program (EPID: L-2017-LLQ-0003), dated May 15, 2018 (ML18135A073)

Attachment 2 Clean Replacement Pages - Decommissioning Quality Assurance Program (DQAP)

12.6. Calibration reference standards shall be based on nationally recognized standards or accepted values of natural physical constants. Where national standards do not exist, the basis for the calibration shall be documented.
Special calibration and control measures are not required when normal commercial practices provide adequate accuracy (e.g., rulers, tape measures, levels, and other such devices).
: 12. 7. M&TE which is found to be damaged, out-of-calibration or for which accuracy is suspect, shall be tagged and segregated and processed in accordance with approved procedures. When M&TE is found to be out-of-tolerance, an evaluation is made of its previous uses to determine corrective action.
Page 25 of 41
: 18. AUDITS 18.1 . Measures shall be established for a system of planned and documented audits in order to verify compliance with all aspects of the DQAP, and determine the effective implementation of programs covered by the DQAP.
Internal and supplier audits are conducted in accordance with written procedures or checklists. Audit personnel shall not have direct responsibilities in the areas to be audited.
18.2. The internal audit program is conducted on a performance driven frequency that is commensurate with the status and importance of the activity to be completed but does not exceed 24-months, unless otherwise required by regulation. Audits may be extended beyond their originally scheduled due date based on the following criteria:
A. Audits shall be performed at the intervals designated and the schedules are based on the month in which the audit starts.
: 8. A maximum extension not to exceed 25 percent of the audit interval is allowed unless restricted by regulation .
C. When an audit interval extension greater than one month is used, the next audit for that particular audit area is scheduled from the original anniversary month rather than from the month of the extended audit.
D. Item 8 applies to supplier audits and evaluations except that a total combined interval for any three (3) consecutive inspection or audit intervals does not exceed 3.25 times the specified inspection or audit interval.
18.3. Audit scheduling, preparation, personnel selection, personnel qualification, performance, reporting, response, follow-up, and records management for audits are performed in accordance with written procedures. Audit scopes and schedules are based upon the status of work progress, activities being performed, regulatory requirements, and/or experience with the organization being audited. An audit schedule shall be maintained, reviewed, and revised as necessary at least annually, to ensure that programs receive necessary audits to support regulatory compliance.
Page 31 of 41

Appendix D Page 2 of 2 GENERAL ADMINISTRATIVE REQUIREMENTS D.3. Services D.3.1. The Company procures services from qualified suppliers. It is not necessary that these suppliers have a quality assurance program approved by the licensee, however, suppliers should provide a quality assurance program that includes the quality assurance program elements presented in Regulatory Guide 4.15, Quality Assurance for Radiological Monitoring Programs (Normal Operations) - Effluent Streams and the Environment, and routinely provide program data summaries sufficiently detailed to permit evaluation of the program for the following areas:
* Meteorology.
* Offsite Dose Calculation Manual.
* Radiological environmental monitoring.
D.4. License Renewal D.4.1. Consistent with the requirements of 10 CFR 54.21 (a)(3), the Company implements the requirements of DQAP Section 1 through 18 for aging management activities related to safety related SSCs as described by licensing documents for those systems that remain active.
D.4.2. Additionally, to manage the aging effects of non-safety related SSCs that were determined to be within the scope of License Renewal, the Company implements the administrative controls, corrective actions and confirmation processes described in DQAP Sections 6, 16 and the applicable requirements of this appendix.
D.5. Safety Review Committee D.5.1. The Safety Review Committee (SAC) serves the CNO as an on-site review body that performs procedure and program reviews for decommissioning activities and ISFSI operation as necessary on matters of Nuclear Safety.
Details regarding the membership, quorum, agenda, and meeting schedule are contained in implementing procedures.
Page 39 of 41}}