ML23283A238
| ML23283A238 | |
| Person / Time | |
|---|---|
| Site: | 07201031, 07201015, 07201025, 07109235 |
| Issue date: | 12/07/2023 |
| From: | Shana Helton Division of Fuel Management |
| To: | Cole K NAC International |
| References | |
| EA-2023-069 | |
| Download: ML23283A238 (23) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 EA-2023-069 Kent Cole, President and Chief Executive Officer NAC International, Inc.
2 Sun Court, Suite 220 Peachtree Corners, GA 30092
SUBJECT:
NAC INTERNATIONAL, INC. - THE U.S. NUCLEAR REGULATORY COMMISSION INSPECTION REPORT NO. 721031/2023201
Dear Kent Cole:
This letter refers to the U.S. Nuclear Regulatory Commission (NRC) announced inspection at your NAC International, Inc. (NAC) corporate office in Norcross, Georgia during March 20-23, 2023. The inspection assessed the adequacy of NACs design activities for spent fuel storage casks regarding the applicable requirements of Title 10 of the Code of Federal Regulations (10 CFR) Part 72, Licensing Requirements for the Independent Storage of Spent Nuclear Fuel, High-level Radioactive Waste, and Reactor-related Greater Than Class C Waste.
The staff examined activities conducted under your NRC approved Quality Assurance program to determine whether NAC implemented the requirements associated with the Commissions rules and regulations and with the conditions of applicable certificates of compliance.
The inspection consisted of an examination of selected procedures and representative records, observations of activities, as applicable, and interviews with personnel. The NRC inspection team discussed the preliminary results of this inspection with you and other NAC representatives on March 23, 2023, and May 24, 2023. The team conducted a final telephonic exit meeting on November 3, 2023, with the Vice President of Quality, Joyce Hamman to discuss the options presented in this letter and when to expect the enclosed inspection report.
Based on the information reviewed during the inspection, the team identified two apparent violations that are being considered for escalated enforcement action in accordance with the NRC Enforcement Policy. The NRC's website includes the current Enforcement Policy at http://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html.
The apparent violations involve: (1) NACs failure to establish adequate design control measures for verifying or checking the adequacy of design by methods such as design reviews or simplified calculational methods, as required by 10 CFR 72.146(b), Design control; and (2)
NACs failure to submit a written report to the NRC within 30 days of discovery of a design or fabrication deficiency, for any spent fuel storage cask which has been delivered to a licensee, when the design or fabrication deficiency affects the ability of structures, systems, and components important to safety to perform their intended safety function as required by 10 CFR 72.242(d)(4), Recordkeeping and Reports. Enclosures 1 and 2 include the apparent violations and associated inspection report. The team discussed the circumstances surrounding these apparent violations, the significance of the issues, and the need for lasting and effective corrective action with members of your staff at the previously mentioned meetings.
December 7, 2023
K. Cole 2
Before the NRC makes its enforcement decision, we are providing you an opportunity to:
(1) respond in writing to the apparent violations addressed in this inspection report within 30 days of the date of this letter, (2) request to participate in a Pre-decisional Enforcement Conference (PEC), or (3) request to participate in an Alternative Dispute Resolution (ADR) mediation session. These options are discussed further in subsequent paragraphs in this letter.
If you choose to provide a written response, it should be clearly marked as a Response to Apparent Violations in NRC Inspection Report 07201031/2023-201; EA-2023-069 and should include for each apparent violation: (1) the reason for the apparent violation or, if contested, the basis for disputing the apparent violation; (2) the corrective steps that have been taken and the results achieved; (3) the corrective steps that will be taken; and (4) the date when full compliance will be achieved. Your response may reference or include previously docketed correspondence if the correspondence adequately addresses the required response.
Additionally, your response should be sent to the U.S. Nuclear Regulatory Commission, ATTN:
Document Control Desk, Washington, DC 20555-0001, within 30 days of the date of this letter.
If an adequate response is not received within the time specified or an extension of time has not been granted by the NRC, the NRC will proceed with its enforcement decision or schedule a PEC.
If you choose to request a PEC, the conference will afford you the opportunity to provide your perspective on these matters and any other information that you believe the NRC should take into consideration before making an enforcement decision. The decision to hold a PEC does not mean that the NRC has determined that a violation has occurred or that enforcement action will be taken. The topics discussed during the conference may include information to determine whether the violations occurred, information to determine the significance of the violations, information related to the identification of the violations, information related to the identification of a violation, and information related to any corrective actions taken or planned. The conference will include an opportunity for you to provide your perspective on these matters and any other information that you believe the NRC should take into consideration in making an enforcement decision.
The information should include for each apparent violation: (1) the reason for the apparent violation or, if contested, the basis for disputing the apparent violation; (2) the corrective steps that have been taken and the results achieved; (3) the corrective steps that will be taken; and (4) the date when full compliance will be achieved. This information may reference or include previously docketed correspondence. In presenting any corrective actions, you should be aware that the promptness and comprehensiveness of the actions will be considered in assessing any civil penalty for the apparent violation. The guidance in the enclosed (Enclosure 3) excerpt from the NRC Information Notice 96-28, "Suggested Guidance Relating to Development and Implementation of Corrective Action," may be helpful in assessing adequate corrective actions.
Following the PEC, you will be advised by separate correspondence of the results of our deliberations on this matter. If a PEC is held, it will be open for public observation and the NRC may issue a press release to announce the time and date of the conference.
In lieu of a PEC, you may request ADR with the NRC to resolve these issues. ADR is a general term encompassing various techniques for resolving conflicts using a neutral third party. The technique that the NRC process employs is mediation. Mediation is a voluntary, informal process in which a trained neutral third party (the mediator) works with parties to help them reach resolution. The Institute on Conflict Resolution (ICR) at Cornell University has agreed to facilitate the NRC's program as a neutral third party. If the parties agree to use ADR, they select
K. Cole 3
a mutually agreeable neutral mediator from ICR, who has no stake in the outcome and no power to make decisions. Mediation gives parties an opportunity to discuss issues, clear up misunderstandings, be creative, find areas of agreement, and reach a final resolution of the issues.
Additional information concerning the NRC's ADR program can be obtained at http://www.nrc.gov/about-nrc/regulatory/enforcement/adr.html, as well as the NRC brochure NUREG/BR-0317, Enforcement Alternative Dispute Resolution Program, Revision 2 (Agencywide Documents Access and Management System [ADAMS] Accession No. ML18122A101). Please contact the Institute on Conflict Resolution at 877-733-9415 within 10 days of the date of this letter if you are interested in pursuing resolution of this issue through ADR.
If you choose to pursue ADR, the ADR will be closed to the public; however, the NRC may issue a meeting notice and/or press release to announce the time and date of this closed mediation.
In addition, if the mediation is successful, the NRC typically issues a Confirmatory Order to document the agreement. The Confirmatory Order is typically publicly available.
If you decide to participate in a PEC or pursue ADR, please contact Aida Rivera-Varona, Chief, Inspection and Oversight Branch, via email at Aida.Rivera-Varona@nrc.gov within 10 days of the date of this letter. A PEC should be held within 30 days of the date of this letter and an ADR mediation session within 45 days of the date of this letter. If you do not contact us regarding your participation in either a PEC or ADR within the time specified above and the NRC has not granted an extension of the contact time, we will make an enforcement decision based on available information.
In addition, please be advised that the number and characterization of apparent violations described in the enclosures may change because of further NRC review. You will be advised by separate correspondence of the results of our deliberations on this matter.
In accordance with 10 CFR 2.390 of the NRC's "Rules of Practice," a copy of this letter, its enclosure(s), and your response, if you choose to provide one, will be made available electronically for public inspection in the NRC Public Document Room or from the NRCs ADAMS accessible from the NRC website at http://www.nrc.gov/reading-rm/adams.html. To the extent possible, your response should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the Public without redaction.
Any information forwarded to the NRC should be clearly labeled on the first page with the case reference number: EA-2023-069, and should be sent to the NRCs Document Control Center (Ref: 10 CFR 30.6 Communications, http://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html., with a copy mailed to, Shana Helton, Director, Division of Fuel Management, Office of Nuclear Material Safety and Safeguards, Two White Flint North, 11545 Rockville Pike, Rockville, MD 20852-2738.
K. Cole 4
Should you have any questions, please contact Aida Rivera-Varona, via email at Aida.Rivera-Varona@nrc.gov.
Sincerely, Shana Helton, Director Division of Fuel Management Office of Nuclear Material Safety and Safeguards Docket No. 72-1031
Enclosures:
- 1. Apparent Violations Being Considered for Escalated Enforcement
- 2. Inspection Report 07201031/2023-201
- 3. The U.S. Nuclear Regulatory Commission Information Notice 96-28 Howell, Linda signing on behalf of Helton, Shana on 12/07/23
ML23283A238 *via email OFFICE NMSS/DFM NMSS/DFM NMSS/DFM NMSS/MSST NMSS/DFM NAME MDavis JGoodridge for WWheatley ARivera-Varona RSun LHowell DATE 10/10/2023 10/13/2023 11/15/2023 11/15/2023 11/22/2023 OFFICE OE OGC NMSS/DFM NAME DJones RCarpenter LHowell for SHelton DATE 12/05/2023 12/07/2023 12/07/2023 APPARENT VIOLATIONS BEING CONSIDERED FOR ESCALATED ENFORCEMENT Apparent Violation A:
Title 10 of the Code of Federal Regulations (10 CFR) Part 72.146 (b), Design Control, requires, in part, that design control measures must provide for verifying or checking the adequacy of design by methods such as design reviews, alternate or simplified calculational methods, or by a suitable testing program.
From September 2007 through March 2023, NAC International, Inc. (NAC) failed to establish adequate design control measures for verifying or checking the adequacy of design by methods such as design reviews or simplified calculational methods. Specifically, NAC failed to provide adequate design control measures for verifying input parameters to a finite element analysis used in a fuel rod structural calculation for their storage and transportation systems (i.e., NAC-UMS, MAGASTOR, NAC-STC and MAGNATRAN). NACs computational model calculation 71160-2025 had a value of 0.215 inches for a fuel rod diameter when the value should have been 0.431 inches. This error resulted in the stress demands on the fuel rod being reported as half of its actual value and once corrected the safety margin was negative, which indicated that the stresses induced in the fuel rod cladding exceeded the NRC approved design bases values.
Apparent Violation B:
The 10 CFR 72.242(d), Record Keeping and Reports requires, in part, that each certificate holder shall submit a written report to the NRC within 30 days of discovery of a design or fabrication deficiency, for any spent fuel storage cask which has been delivered to a licensee, when the design or fabrication deficiency affects the ability of structures, systems, and components important to safety to perform their intended safety function.
Contrary to the above, from March 29, 2022 to March 10, 2023, NAC failed to submit a written report to the NRC within 30 days of discovery of a design or fabrication deficiency, for any spent fuel storage cask which has been delivered to a licensee, when the design or fabrication deficiency affects the ability of structures, systems, and components important to safety to perform their intended safety function. Specifically, NAC failed to submit a written report to the NRC within 30 days of discovery of a design error in a fuel rod structural calculation for normal and accident conditions that exceeded design bases limits; this design error impacted the NAC-UMS and MAGNASTOR storage systems which had been delivered to general licensees (i.e., Palo Verde, McGuire, Catawba, Zion, Kewaunee, and Three Mile Island). NAC discovered the design deficiency in calculation 71160-2025 on March 29, 2022, which adversely impacted the licensees computation for bending stresses on fuel rod cladding (i.e., negative margins). Eventually, NAC submitted the required report to the NRC on March 10, 2023, and updated the report on March 28, 2023 (Agencywide Documents Access and Management System Accession No. ML23069A215 and ML23087A062), this was approximately 11 months after NAC identified the issue.
U.S. NUCLEAR REGULATORY COMMISSION Office of Nuclear Material Safety and Safeguards Division of Fuel Management Docket:
721031 Report.:
721031/2023201 Enterprise Identifier: I2023201-0017 Certificate Holder:
NAC International, Incorporated Facility:
2 Sun Court Suite 200 Location:
Peachtree Corners, Georgia Inspection Dates:
March 20, - August 3, 2023 Inspection Team:
Marlone Davis, Senior Transportation and Storage Safety Inspector, Team Leader Matt Learn, Senior Transportation and Storage Safety Inspector Jeremy Tapp, Transportation and Storage Safety Inspector Nathan Audia, Reactor Inspector Patrick Koch, Technical Structural Reviewer Approved By:
Aida Rivera-Varona, Branch Chief Inspection and Oversight Branch Division of Fuel Management Office of Nuclear Material Safety and Safeguards
2 U.S. NUCLEAR REGULATORY COMMISSION Office of Nuclear Material Safety and Safeguards Division of Fuel Management EXECUTIVE
SUMMARY
NAC International, Inc.
NRC Inspection Report 721031/2023201 On March 20, 2023, through March 23, 2023, the U.S. Nuclear Regulatory Commission (NRC) conducted an announced onsite team inspection at the NAC International, Inc. (NAC) corporate office in Norcross, Georgia. The inspection team continued the inspection activities with an in-office review while the team waited for NAC to complete a root cause analysis and update calculations for a design deficiency that led to some of their storage and transportation systems (i.e., NAC-UMS, MAGNASTOR, NAC-STC, and MAGNATRAN, respectively) exceeding design limits for stress demands on fuel rod cladding. The team discussed the preliminary results of this inspection on March 23, 2023, and May 24, 2023. The team conducted a final telephonic exit meeting on November 3, 2023.
The purpose of the inspection was to verify and assess NACs implementation and compliance with Title 10 of the Code of Federal Regulations (10 CFR) Part 72, Licensing Requirements for the Independent Storage of Spent Nuclear Fuel, High-level Radioactive Waste, and Reactor-related Greater Than Class C Waste, for the design, modification, procurement, and design changes of their dry cask storage systems. The team assessed NACs quality related activities based on examination of permanent quality records and other supporting documentation under their NRC approved quality assurance program (QAP). The team also reviewed 10 CFR 72.48 evaluations and screenings performed since the last corporate inspection and followed-up on a traditional enforcement notice of violation (EA-20-066).
Based on the results of this inspection, the NRC inspection team assessed that NACs implementation of their QAP failed to comply with certain NRC requirements, design control, and reporting of design deficiencies to the NRC in a timely matter. This led to the inspection teams identification of two apparent violations that are being considered for escalated enforcement action in accordance with the NRC Enforcement Policy and Manual. The apparent violations related to design control measures and reporting requirements are further described in the applicable sections of this inspection report.
Quality Assurance Program The team determined that NAC had adequate QAP controls. The team determined that NAC conducts activities with a quality assurance organization that has independent responsibilities and uses a graded approach to quality in accordance with their NRC approved quality assurance manual and implementing quality procedures (section 1.1).
Nonconformance and Corrective Action Programs The team determined that the licensee effectively implemented its nonconformance and corrective action control programs and has adequate procedures in place to ensure compliance with applicable regulations and quality assurance requirements. However, as a part of the review of a design deficiency issue and NACs self-identification report process, the team identified an apparent violation because NAC failed to submit a
3 written report to the NRC within 30 days of discovery of a design deficiency in accordance with 10 CFR 72.242(d) (section 1.2).
Document Control The team determined that NAC has adequate controls in place to ensure that personnel identify, control, and maintain quality records in accordance with applicable regulations and quality assurance requirements (section 1.3)
Audits The team determined that NAC has an adequate audit program in place to schedule audits, develop an audit plan and evaluate applicable elements of their quality program.
The team determined that NAC appropriately identified issues and implemented corrective actions, as applicable in a time frame commensurate with their safety significance when auditors identify findings or observations during internal and external audits (section 1.4).
Design Control The team determined that NAC has established an effective method for tracking, evaluating, and dispositioning changes or modifications to the Dry Cask Storage Systems (DCSS) component design. However, the team identified an apparent violation related to NACs failure to verify the adequacy of design inputs for fuel rod cladding stress analysis following a non-mechanistic tip-over accident (section 1.5).
Follow-up on Traditional Enforcement Action (EA-20-066)
The team determined that NAC implemented adequate corrective actions for the root cause analysis associated with an escalated traditional enforcement violation (EA-20-066) (section 1.6).
4 REPORT DETAILS 1.0 Inspection Procedure (IP) 60851 Design Control of Independent Spent Fuel Storage Installation (ISFSI) Components 1.1 Quality Assurance Program 1.1.1 Inspection Scope The team reviewed NACs quality assurance (QA) manual and various implementing quality procedures (QPs) to assess the effectiveness of their QAP implementation. The team conducted reviews of NACs quality manual, policies, and procedures, to determine whether NAC adequately controlled and implemented activities under their NRC approved QAP and quality activities subject to 10 CFR Part 72 regulations. The team reviewed procedures to verify if NAC clearly defined and documented the quality program authorities and responsibilities and that the quality assurance organization functioned as an independent group.
The team also reviewed procedures for the use of a graded approached for identifying Important-to-Safety (ITS) components and whether NAC applied this graded level of quality to procurement documents. The team reviewed the following documents:
91150-Q-01, Quality Assurance Program Manual, Revision 9 QP 7-3, Graded Quality Categories, Revision 9 The team also reviewed procedures and documents regarding training, qualification, and certification of personnel involved in quality activities. The team reviewed training records of a random selection of employees in quality related positions to determine if they received the required QA indoctrination and QAP revision training. The team reviewed the following QP 2-1, Quality Assurance Orientation and Training, Revision 5 to verify training of NAC personnel.
1.1.2 Observation and Findings The team assessed that NAC has an adequate QAP with implementing QPs in place that are effective in conducting activities in accordance with their Dry Cask Storage Systems (DCSSs) certificates of compliance. The team verified that NAC clearly defined and documented the QAP authorities and responsibilities, and the quality assurance organization functioned as an independent group.
The team assessed that for the training records reviewed and selected that each staff member completed the required training and attained the applicable qualifications to perform their duties. Additionally, the team verified NACs QA procedures included a graded approach for identifying ITS components for their DCSS components.
There were no findings of significance identified.
5 1.1.3 Conclusions The team determined that NAC had adequate QA controls in place. The team also determined that NAC conducts activities with an organization that is independent of schedule and pressure and with a graded approach in accordance with their NRC approved QAP.
1.2 Nonconforming and Corrective Actions Control Programs 1.2.1 Inspection Scope Nonconforming Control Program The team reviewed selected records and interviewed personnel to verify that NAC effectively implemented a nonconformance control program in accordance with their NRC approved QAP, and the requirements of 10 CFR Parts 21 and 72. Specifically, the team reviewed the following QPs:
QP 15-1, "Control of Nonconforming Items," Revision 12 QP 15-2, "Vendor Nonconformance reports," Revision 11 QP 16-2, Potential Significant Deficiencies and Defects and Regulatory Reporting, Revision 10 The team selected several nonconformance reports (NCRs) to verify that NAC dispositioned the NCRs in a timely manner. The team reviewed NCRs since the previous inspection and concentrated on issues involving ITS structures, systems, and components. The team reviewed these NCRs to evaluate if the disposition was appropriate, adequately performed as necessary, and properly closed out in accordance with approved procedures. The team focused the review on use-as-is and repair dispositions because generally these NCRs require a technical justification or engineering evaluation generally dispositioned with 10 CFR 72.48 requirements.
The team also discussed the nonconformance controls with the NAC staff and reviewed a sample of vendor nonconformance reports (VNCRs). The team sampled VNCRs since the last inspection which consisted of a variety of component types and suppliers that included a mix of use-as-is and repair component dispositions. Further, the team reviewed program controls related to 10 CFR Part 21 such as internal postings, supplier notifications, and reporting processes.
Corrective Action Control Program The team reviewed selected records and interviewed personnel to verify that NAC effectively implemented their corrective action program (CAP). Specifically, the team reviewed NAC's policies and the following approved implementing procedures that govern the CAP for NAC to verify compliance with applicable requirements to 10 CFR Part 72:
QP 16-1, "Corrective Action Reports," Revision 7
6 QP 16-2, Potential Significant Deficiencies and Defects and Regulatory Reporting, Revision 10 SP-404, "Performance of Root Cause Analysis," Revision 1 The team discussed the CAP controls with the NAC staff and reviewed a sample of corrective action reports (CARs) and finding reports (FRs) for appropriate disposition.
The team evaluated whether NAC completed CARs and FRs for identified deficiencies in a technically sound and timely manner.
As part of the sample of CARs and FRs, the team reviewed an FR generated because of a violation that the NRC previously identified regarding a failure to request prior NRC review and approval before making changes to the American Concrete Institute (ACI)-318 requirements described in the FSAR and technical specifications for the MAGNASTOR cask system. The team reviewed a CAR regarding an issue with incorrect fuel rod dimensions NAC used in thermal models for the NAC-UMS and MAGNASTOR systems for pressurized water reactors that produced unconservative results. The team also reviewed a few cause analyses and verified that the CARs provided a connection to the 10 CFR Part 21 program. The team sampled CARs and FRs since 2020.
1.2.2 Observation and Findings On March 29, 2022, NAC discovered a design deficiency that resulted in some storage and transportation systems (i.e., NAC-UMS, MAGNASTOR, NAC-STC, and MAGNATRAN) exceeding their design limits for fuel cladding stresses.
The team noted that NAC did not capture this issue in their formal CAP when engineering personnel initially identified this issue; instead, on March 29, 2022, NAC entered the calculation error in a self-identification report (SIR) in accordance with a standard practice procedure. The team identified that this design deficiency remained in their SIR system until February 28, 2023, when it was entered into their formal QA corrective action process for resolution. Subsequently, NAC submitted the required report to the NRC on March 10, 2023, and updated the report on March 28, 2023 (Agencywide Documents Access and Management System Accession Nos.
ML23069A215 and ML23087A062,), which was approximately 11 months after NAC identified the design deficiency. The team determined this was an apparent violation of the NRC requirements.
Specifically, 10 CFR 72.242, Record Keeping and Reports requires, in part, that each certificate holder shall submit a written report to the NRC within 30 days of discovery of a design or fabrication deficiency, for any spent fuel storage cask which has been delivered to a licensee, when the design or fabrication deficiency affects the ability of structures, systems, and components important to safety to perform their intended safety function.
From March 29, 2022, to March 10, 2023, NAC failed to submit a written report to the NRC within 30 days of discovery of a design or fabrication deficiency, for any spent fuel storage cask which has been delivered to a licensee, when the design or fabrication deficiency affects the ability of structures, systems, and components important to safety to perform their intended safety function. Specifically, NAC failed to submit a written report to the NRC within 30 days of discovery of a design error in a fuel rod structural calculation for normal and accident conditions that impacted the NAC-UMS and MAGNASTOR storage systems; this design error which exceeded design bases limits,
7 impacted the NAC-UMS and MAGNASTOR storage systems which had been delivered to general licensees (i.e., Palo Verde, McGuire, Catawba, Zion, Kewaunee, and Three Mile Island). NAC discovered the design deficiency in calculation 71160-2025 on March 29, 2022, which adversely impacted the licensees computation for bending stresses on fuel cladding (i.e., negative margins). NAC initiated a corrective action report number 23-01 and notified the NRC in accordance with 10 CFR 72.242, Recordkeeping and reports. During the reportability and root cause determination, NAC evaluated the safety consequences and implication of this issue.
1.2.3 Conclusions Overall, the team determined that the licensee effectively implemented its nonconformance and corrective action control programs and has adequate procedures in place to ensure compliance with applicable regulations and QA requirements.
However, as a part of the review of a design deficiency issue and NAC SIR process, the team identified an apparent violation because NAC failed to submit a written report to the NRC within 30 days of discovery of a design deficiency.
1.3 Document Control 1.3.1 Inspection Scope The team reviewed NACs documentation and quality records control program and associated QPs to assess the effectiveness of controls established for the development, review, approval, issuance, use, and revision of quality documents. The team also reviewed the tracking verification, and storage of quality records. The team reviewed the following QA manual section and quality procedure documents associated with document control and records to verify proper implementation:
QP 4-1, Procurement. Revision 15 QP 5-3, Preparation and Control of Procedures, Instructions, and Drawings, Revision 7 QP 6-1, Controlled Document Distribution, Revision 9 QP 17-1, Identification, Transmittal, Storage and Maintenance of Quality Assurance Records, Revision 16 QP 17-2, Electronic Records Maintenance and Storage, Revision 5 The team also interviewed QA personnel regarding documentation and record controls.
1.3.2 Observation and Findings The team assessed that NAC has adequate controls for documents and quality records as described in approved QPs. The team verified that NAC stored records in two separate locations and that digital records are kept in accordance with QPs that meet regulatory requirements and guidance.
There were no findings of significance identified.
8 1.3.3 Conclusions Overall, the team determined that NAC has adequate controls in place to ensure that personnel identified, controlled, and maintained quality records.
1.4 Audits 1.4.1 Inspection Scope The team reviewed NACs internal and external audit program and associated QPs to assess the effectiveness of controls established for the scheduling, planning, and performance of audits. The team reviewed the qualifications, training records, and annual evaluations for NAC lead auditors to determine if they met the procedure requirements. The team reviewed the following quality procedure documents associated with internal and external audits to verify that NAC properly implemented the audit program controls:
QP 18-1, Qualification and Certification of Quality Assurance Audit Personnel, Revision 5 QP 18-2, Audits, Surveys, and Corrective Actions Revision 11 QP 7-1, Control of Purchased Items and Services, Revision 13 The team reviewed a sample of audit schedules since 2020 to verify that NAC audited all 18 QAP criteria, as applicable, each year. The team reviewed and assessed several of the internal audits completed since the last corporate inspection to determine if NAC identified deficiencies, and whether NAC adequately addressed these deficiencies within their FR system. The team reviewed the current procedure for the qualification of audit personnel and reviewed the lead auditor qualification and annual proficiency evaluation forms.
The team also reviewed an external audit related to a supplier who supplied ITS Category A vendor supplied equipment and materials. The team also reviewed the audit results to determine if NAC identified deficiencies and entered those into the FR system.
1.4.2 Observation and Findings The team assessed that NAC had internal and external audit implementing procedures in place and used them effectively. The team assessed that the audits were all very thorough and all the findings reviewed in the reports had FR numbers associated with them. The audit reports also included observations and FRs written for previous findings that the NAC audit team closed. The team noted that that the lead auditor qualifications and annual proficiency evaluation forms were well documented and there were no issues with the records.
In addition, the team assessed that the supplier audit reports used the correct forms and were adequately filled out by NAC. The team noted that the documentation contained an audit plan, audit checklists, plus external FRs.
There were no findings of significance identified.
9 1.4.3 Conclusions The team determined that NAC has an adequate audit program in place to schedule, develop an audit plan and evaluate applicable elements of their quality program. The team determined that NAC appropriately identified issues and implemented corrective actions, as applicable in a time frame commensurate with their safety significance when auditors identify findings or observations during internal and external audits.
1.5 Design Control 1.5.1 Inspection Scope The team reviewed selected records and interviewed personnel to evaluate NACs design control and change processes. The team reviewed QP 3-1, Control of Design Inputs, Revision 6, and QP-3-2, Preparation and Checking of Design Calculations, Revision 16 to determine if the overall design control process contained adequate guidance and that NAC followed the design procedure for the sample of design documents reviewed. The team focused its review on a sample of NACs design activities associated with their DCSSs.
The team also reviewed NACs quality procedure related to the implementation instructions for 10 CFR 72.48 evaluations, which include applicability and screening reviews. Specifically, the team reviewed QP 3-8, 10 CFR 72.48 Determinations for Changes to NAC Dry Storage Cask Systems, Revision 9 and a list of screenings and evaluations performed by NAC to meet regulatory requirements associated with 10 CFR 72.48 regulations. The team selected a representative sample of screenings and evaluations based on the criteria in IMC 2690, appendix E for the potential impact on safety since the last inspection in 2020.
The team selected a sample of approximately thirty-two 10 CFR 72.48 screenings (12) and evaluations (20) to verify that NAC appropriately concluded for screenings that NAC personnel determined that the change screened out during the screening process or needed a full evaluation in accordance NAC approved QPs, or that evaluations did not require prior NRC review and approval in accordance with NRC requirements.
1.5.2 Observation and Findings On March 29, 2022, NAC discovered a design deficiency for the NAC-UMS and MAGNASTOR dry cask storage systems and the NAC Storable Transport Cask (STC) and MAGNATRAN transportation systems. Specifically, NAC identified an error in one of the input parameters used to calculate the bending stress on a fuel rod following a concrete cask non-mechanistic tip-over accident and a transportation drop condition.
NAC specified the wrong fuel rod outer diameter in a finite element analysis (ANSYS).
The inputted value for the height real constant in the ANSYS code was only 50 percent of the correct value. Consequently, when NAC used the correct value, it doubled the computed bending stresses and resulted in negative margin thus exceeding the NRC approved design basis limits for accident conditions described in the storage and transportation systems final safety analysis reports. NAC discovered this issue during their review of a new calculation to support an amendment for the NAC-STC and determined through a review of other calculations that this design deficiency existed since September of 2007.
10 NAC identified the error in five calculations, two calculations were in process at the time:
(1) 423-2020 Rev. 0, "PWR High Burnup Fuel Rod 30-ft Side Drop and Fatigue Evaluation for NAC-STC" and (2) 70000.31-2170 Rev. 0, "OPTIMUS-XL SRDC Configuration HAC Fuel Rod Analysis," as well as three completed calculations dating back to August 2007; the other three had already been approved (3) 71160-2139 Rev. 0, "Pressure Water Reactor (PWR) and Boling Water Reactor (BWR) Fuel Fatigue Evaluation for MAGNATRAN," (4) 71160-2025 Rev. 1, "Fuel Assembly Structural Evaluation, NEWGEN," and (5) EA790-2520 Rev. 0, "BWR Fuel Assembly Structural Evaluation, UMS".
The resultant analyses are presented in UMS FSAR Sections 11.2.16.1 (PWR) and 11.2.16.2 (BWR) and MAGNASTOR FSAR Section 3.8.4 as bounding evaluations for the lateral accelerations experienced by the fuel during a non-mechanistic tip-over event.
The side drop 60 grams (g) uniform lateral acceleration applied in these evaluations bounded the maximum accelerations reported for the tip-over event of 26.6g and 33.4g at the top of the basket for MAGNASTOR and UMS, respectively. Both the MAGNASTOR FSAR and UMS FSAR provide evaluations which determine that the loaded systems on the ISFSI pad do not tip-over within licensed conditions. It is also important to note that the analyses performed are on fuel assemblies with up to 60 inches of unsupported fuel rod length (fuel grid loss). This analysis provides the basis for treating assemblies with partially damaged grid straps (corners missing, side damage, etc.) as undamaged and not requiring canning in damaged fuel cans.
The transport 30 foot drop fuel analyses for MAGNATRAN and UMS were also affected, as corrections to the model resulted in negative margins. The team determined this design control issue was an apparent violation of NRC requirements.
Specifically, 10 CFR 72.146 (b), Design Control, requires, in part, that design control measures must provide for verifying or checking the adequacy of design by methods such as design reviews, alternate or simplified calculational methods, or by a suitable testing program.
From September 2007 through March 2023, NAC International, Inc. (NAC) failed to establish adequate design control measures for verifying or checking the adequacy of design by methods such as design reviews or simplified calculational methods.
Specifically, NAC failed to provide design control measures for adequately verifying input parameters to a finite element analysis used in a fuel rod structural calculation for their storage and transportation systems (i.e., NAC-UMS, MAGASTOR, NAC-STC and MAGNATRAN). For example, NAC used a value of 0.215 inches for one of the fuel rod diameters in their computational model calculation 71160-2025, when the value should have been 0.431 inches. This error resulted in the stress demands on the fuel rod being reported as half of its actual value and once corrected the safety margin was negative, which indicated that the stresses induced in the fuel rod cladding exceeded the NRC approved design bases values.
1.5.3 Conclusions The team determined that NAC has established an effective method for tracking, evaluating, and dispositioning changes or modifications to the DCSS component design.
However, the team identified an apparent violation related to NACs failure to verify the
11 adequacy of design inputs for fuel rod cladding stresses analysis following a non-mechanistic tip-over accident.
1.6 Follow-up on Traditional Enforcement Action (EA-20-66) 1.6.1 Inspection Scope The team reviewed the root cause analysis (CAR 21-01) associated with the traditional enforcement Severity Level III violation (EA-20-66). The team reviewed NACs extent of condition and extent of cause evaluations to verify that the root cause analysis had sufficient breadth. The team reviewed the corrective actions NAC took to address the identified causes and evaluated NACs effectiveness of those actions. The team also held discussions with NAC personnel to ensure that the root and contributing causes, as well as any contribution of safety culture components, were understood and that corrective actions taken were appropriate to address the causes and preclude repetition.
1.6.2 Observation and Findings The team assessed that NAC provided adequate corrective actions for the escalated traditional enforcement violation. The team verified that NAC performed a root cause evaluation that focused on the causal factors, extent of condition, and extent of cause, as necessary. The team noted that NAC updated programs and provided training to necessary personnel.
There were no findings of significance identified.
1.6.3 Conclusions The team determined that NAC implemented adequate corrective actions for the root cause analysis associated with the escalated traditional enforcement violation.
2.0 Meetings On March 20, 2023, the NRC inspection team discussed the scope of the inspection during an entrance meeting with Kent Cole and other members of the NAC staff. On March 23, 2023, the NRC inspection team discussed the preliminary results and observations during an onsite debrief meeting with the NAC staff. The team continued the inspection activities with an in-office review while the team waited for NAC to provide additional information. Once the team received the additional information and completed their review, the team discussed the preliminary results of the inspection with George Carver and other NAC representatives on May 24, 2023. The team conducted a final telephonic exit meeting on November 3, 2023, with the Vice President of Quality, Joyce Hamman, to discuss the options presented in this letter and when to expect the enclosed inspection report.
NRC INFORMATION NOTICE 96-28 UNITED STATES NUCLEAR REGULATORY COMMISSION OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS WASHINGTON, D.C. 20555 May 1, 1996 NRC INFORMATION NOTICE 96-28:
SUGGESTED GUIDANCE RELATING TO DEVELOPMENT AND IMPLEMENTATION OF CORRECTIVE ACTION Addressees All material and fuel cycle licensees.
Purpose The U.S. Nuclear Regulatory Commission (NRC) is issuing this information notice to provide addressees with guidance relating to development and implementation of corrective actions that should be considered after identification of violation(s) of the NRC requirements. It is expected that recipients will review this information for applicability to their facilities and consider actions, as appropriate, to avoid similar problems. However, suggestions contained in this information notice are not new NRC requirements; therefore, no specific action or written response is required.
Background
On June 30, 1995, the NRC revised its Enforcement Policy, to clarify the enforcement program's focus by, in part, emphasizing the importance of identifying problems before events occur, and of taking prompt, comprehensive corrective action when problems are identified. Consistent with the revised Enforcement Policy, the NRC encourages and expects identification and prompt, comprehensive correction of violations.
In many cases, licensees who identify and promptly correct non-recurring Severity Level IV violations, without the NRC involvement, will not be subject to formal enforcement action. Such violations will be characterized as "non-cited" violations as provided in Section VI.A of the Enforcement Policy. Minor violations are not subject to formal enforcement action.
Nevertheless, the root cause(s) of minor violations must be identified, and appropriate corrective action must be taken to prevent recurrence.
If violations of more than a minor concern are identified by the NRC during an inspection, licensees will be subject to a Notice of Violation and may need to provide a written response,
2 as required by Title 10 of the Code of Federal Regulations (10 CFR) Part 2.201, addressing the causes of the violations and corrective actions taken to prevent recurrence.
In some cases, such violations are documented on Form 591 (for materials licensees) which constitutes a notice of violation that requires corrective action but does not require a written response. If a significant violation is involved, a Pre-decisional Enforcement Conference (PEC) may be held to discuss those actions.
The quality of a licensee's root cause analysis and plans for corrective actions may affect the NRC's decision regarding both the need to hold a PEC with the licensee and the level of sanction proposed or imposed.
Discussion Comprehensive corrective action is required for all violations. In most cases, the NRC does not propose imposition of a civil penalty where the licensee promptly identifies and comprehensively corrects violations. However, a Severity Level III violation will almost always result in a civil penalty if a licensee does not take prompt and comprehensive corrective actions to address the violation.
It is important for licensees, upon identification of a violation, to take the necessary corrective action to address the noncompliant condition and to prevent recurrence of the violation and the occurrence of similar violations. Prompt comprehensive action to improve safety is not only in the public interest but is also in the interest of licensees and their employees. In addition, it will lessen the likelihood of receiving a civil penalty. Comprehensive corrective action cannot be developed without a full understanding of the root causes of the violation.
Therefore, to assist licensees, the NRC staff has prepared the following guidance, that may be used for developing and implementing corrective action. Corrective action should be appropriately comprehensive to not only prevent recurrence of the violation at issue, but also to prevent occurrence of similar violations. The guidance should help in focusing corrective actions broadly to the general area of concern rather than narrowly to the specific violations.
The actions that need to be taken are dependent on the facts and circumstances of the particular case.
The corrective action process should involve the following three steps:
1.
Conduct a complete and thorough review of the circumstances that led to the violation. Typically, such reviews include:
Interviews with individuals who are either directly or indirectly involved in the violation, including management personnel and those responsible for training or procedure development/guidance. Particular attention should be paid to lines of communication between supervisors and workers.
Tours and observations of the area where the violation occurred, particularly when those reviewing the incident do not have day-to-day contact with the operation under review. During the tour, individuals should look for items that may have contributed to the violation as well as those items that may result in future violations. Reenactments (without use of radiation sources, if they were involved in the original incident) may be warranted to better understand what actually occurred.
3 Review of programs, procedures, audits, and records that relate directly or indirectly to the violation. The program should be reviewed to ensure that its overall objectives and requirements are clearly stated and implemented.
Procedures should be reviewed to determine whether they are complete, logical, understandable, and meet their objectives (i.e., they should ensure compliance with the current requirements). Records should be reviewed to determine whether there is sufficient documentation of necessary tasks to provide a record that can be audited and to determine whether similar violations have occurred previously. Particular attention should be paid to training and qualification records of individuals involved with the violation.
2.
Identify the root cause of the violation.
Corrective action is not comprehensive unless it addresses the root cause(s) of the violation. It is essential, therefore, that the root cause(s) of a violation be identified so that appropriate action can be taken to prevent further noncompliance in this area, as well as other potentially affected areas. Violations typically have direct and indirect cause(s). As each cause is identified, ask what other factors could have contributed to the cause. When it is no longer possible to identify other contributing factors, the root causes probably have been identified. For example, the direct cause of a violation may be a failure to follow procedures; the indirect causes may be inadequate training, lack of attention to detail, and inadequate time to carry out an activity. These factors may have been caused by a lack of staff resources that, in turn, are indicative of lack of management support. Each of these factors must be addressed before corrective action is considered to be comprehensive.
3.
Take prompt and comprehensive corrective action that will address the immediate concerns and prevent recurrence of the violation.
It is important to take immediate corrective action to address the specific findings of the violation. For example, if the violation was issued because radioactive material was found in an unrestricted area, immediate corrective action must be taken to place the material under licensee control in authorized locations. After the immediate safety concerns have been addressed, timely action must be taken to prevent future recurrence of the violation. Corrective action is sufficiently comprehensive when corrective action is broad enough to reasonably prevent recurrence of the specific violation as well as prevent similar violations.
In evaluating the root causes of a violation and developing effective corrective action, consider the following:
1.
Has management been informed of the violation(s)?
2.
Have the programmatic implications of the cited violation(s) and the potential presence of similar weaknesses in other program areas been considered in formulating corrective actions so that both areas are adequately addressed?
3.
Have precursor events been considered and factored into the corrective actions?
4.
In the event of loss of radioactive material, should security of radioactive material be enhanced? Has your staff been adequately trained on the applicable requirements?
5.
Should personnel be re-tested to determine whether re-training should be emphasized for a given area? Is testing adequate to ensure understanding of requirements and procedures?
6.
Has your staff been notified of the violation and of the applicable corrective action?
4 7.
Are audits sufficiently detailed and frequently performed? Should the frequency of periodic audits be increased?
8.
Is there a need for retaining an independent technical consultant to audit the area of concern or revise your procedures?
9.
Are the procedures consistent with current NRC requirements, should they be clarified, or should new procedures be developed?
10.
Is a system in place for keeping abreast of new or modified the NRC requirements?
11.
Does your staff appreciate the need to consider safety in approaching daily assignments?
12.
Are resources adequate to perform, and maintain control over, the licensed activities? Has the radiation safety officer been provided sufficient time and resources to perform his or her oversight duties?
13.
Have work hours affected the employees' ability to safely perform the job?
14.
Should organizational changes be made (e.g., changing the reporting relationship of the radiation safety officer to provide increased independence)?
15.
Are management and the radiation safety officer adequately involved in oversight and implementation of the licensed activities? Do supervisors adequately observe new employees and difficult, unique, or new operations?
16.
Has management established a work environment that encourages employees to raise safety and compliance concerns?
17.
Has management placed a premium on production over compliance and safety?
Does management demonstrate a commitment to compliance and safety?
18.
Has management communicated its expectations for safety and compliance?
19.
Is there a published discipline policy for safety violations, and are employees aware of it? Is it being followed?
Attachment ATTACHMENT 1.
ENTRANCE/EXIT MEETING ATTENDEES AND INDIVIDUALS INTERVIEWED Name Title Affiliation Entrance Debrief Debrief Exit Marlone Davis Team Leader NRC X
X X
X Matthew Learn Sr Safety Inspector NRC X
Jeremy Tapp Safety Inspector NRC X
X Nathan Audia Reactor Inspector NRC X
X Patrick Kock Structural Engineer NRC X
X Kent Cole President & CEO NAC X
X George Carver Vice President Engineering &
Support Services NAC X
X X
Brad Greene Vice President Quality NAC X
X X
Joyce Hamman Vice President Quality NAC X
X Leigh Trostel
- Director, Procurement &
Contracts NAC X
X Doug Jacobs VP Storage Projects NAC X
X X
Heath Baldner Director of Licensing NAC X
X X
David M.
X X
Holger Pfeifer Director Engineering NAC X
X X
X Sam Shock Fabrication Manager NAC X
X Kelly Sickafoose DCRM (Via MS Teams)
NAC X
Eric Shewbridge Project Manager (Via MS Teams)
NAC X
2.
INSPECTION PROCEDURES (IP) and GUIDANCE DOCUMENTS USED IP 60851 Design Control of Independent Spent Fuel Storage Installation (ISFSI)
Components IP 60857 Review of Title 10 of the Code of Federal Regulations Part 72.48 Evaluations NUREG/CR6314 Quality Assurance Inspections for Shipping and Storage Containers NUREG/CR6407 Classification of Transportation Packaging and Dry Spent Fuel Storage System Components According to Importance to Safety
2 3.
LIST OF ITEMS OPENED, CLOSED, AND DISCUSSED Item Number Status Type Description 721031/2023201-01 Open AV Failure to Establish Adequate Design Control 721031/2023201-02 Open AV Failure to Submit a Written Report to the NRC within 30 Days 4.
LIST OF ACRONYMS USED ADAMS Agencywide Documents Access and Management System ASME American Society of Mechanical Engineers AV Apparent Violation BWR Boiling Water Reactor CAP Corrective Action Program CAR Corrective Action Report CFR Code of Federal Regulations CoC Certificate of Compliance DCSS Dry Cask Storage System FSAR Final Safety Analysis Report FR Finding Report IMC Inspection Manual Chapter IP Inspection Procedure ISFSI Independent Spent Fuel Storage Installation ITS Important to Safety NAC NAC International, Incorporate NCR Nonconformance Report NCV Non-Cited Violation NEI Nuclear Energy Institute NRC Nuclear Regulatory Commission PWR Pressurized Water Reactor QA Quality Assurance QAM Quality Assurance Manual QP Quality Procedure SIR Self-Identification Report STC Storable Transport Cask VNCR Vendor Nonconformance Report VP Vice President 5.
DOCUMENTS REVIEWED Certificate holder documents reviewed during the inspection were specifically identified in the Report Details above.