ML24029A048: Difference between revisions

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FY 2023 PART 72 INSPECTION VIOLATIONS
FY 2023 PART 72 INSPECTION VIOLATIONS


Type           Licensee/     Description                           Applicable     Category Certificate of                                       Regulation Compliance (CoC) Holder SL IV -       Holtec         Holtec failed to adequately implement Title 10 of the Procedural non-cited     International a procedure for an activity affecting Code of         Adherence violation     (Holtec)       quality. Specifically, procedure, HSP- Federal (NCV)                         477, revision 4, Digital Radiographic Regulations Weld Examination, specified that     (10 CFR) deliquification, dissolution, and     Section adjustment (DDA) calibration (pixel   72.150 mapping) be performed at the           Instructions, commencement of an inspection         Procedures, period and not more than 24 hours as   and Drawings required, instead, Holtec performed the DDA calibrations at 2-week intervals.
Type Licensee/ Description Applicable Category Certificate of Regulation Compliance (CoC) Holder SL IV - Holtec Holtec failed to adequately implement Title 10 of the Procedural non-cited International a procedure for an activity affecting Code of Adherence violation (Holtec) quality. Specifically, procedure, HSP-Federal (NCV) 477, revision 4, Digital Radiographic Regulations Weld Examination, specified that (10 CFR) deliquification, dissolution, and Section adjustment (DDA) calibration (pixel 72.150 mapping) be performed at the Instructions, commencement of an inspection Procedures, period and not more than 24 hours as and Drawings required, instead, Holtec performed the DDA calibrations at 2-week intervals.
SL IV -       Orano TN       Inadequate Supplier Audits             10 CFR         Procedural NCV           Americas LLC   TN Americas (TN) quality procedures   72.150         Adequacy Hitachi Zozen did not provide sufficient guidance to Instructions, perform a licensing review for all     Procedures, applicable situations. Specifically,   and Drawings material nonconformances that are not controlled under the TN Quality Assurance Program Description Manual and do not receive a supplier nonconformance are not required to have an associated licensing review conducted under the TN quality program. A licensing review would determine if TN needed additional licensing actions such as the U.S.
SL IV - Orano TN Inadequate Supplier Audits 10 CFR Procedural NCV Americas LLC TN Americas (TN) quality procedures 72.150 Adequacy Hitachi Zozen did not provide sufficient guidance to Instructions, perform a licensing review for all Procedures, applicable situations. Specifically, and Drawings material nonconformances that are not controlled under the TN Quality Assurance Program Description Manual and do not receive a supplier nonconformance are not required to have an associated licensing review conducted under the TN quality program. A licensing review would determine if TN needed additional licensing actions such as the U.S.
Nuclear Regulatory Commission (NRC) approval or an exemption to the regulations to accept the nonconformance to an approved NRC license.
Nuclear Regulatory Commission (NRC) approval or an exemption to the regulations to accept the nonconformance to an approved NRC license.


Enclosure 2 SL IV -       Northern       Inadequate quality procedure for       10 CFR           Procedural NCV           States Power   guidance in conducting a Root Cause     72.150           Adequacy Company         Analysis (RCA) SeAH Besteel             Instructions, NSPM           Corporation (SBCs) corrective action   Procedures, SeAH Besteel   procedure SB-D-7255A did not provide   and Drawings sufficient guidance to perform an RCA required by Step 5.3.3 to determine the corrective action necessary to preclude repetition. Specifically, no RCA process is documented in SB-D-7255A or another quality procedure in the SBC quality assurance program (QAP).
Enclosure 2 SL IV - Northern Inadequate quality procedure for 10 CFR Procedural NCV States Power guidance in conducting a Root Cause 72.150 Adequacy Company Analysis (RCA) SeAH Besteel Instructions, NSPM Corporation (SBCs) corrective action Procedures, SeAH Besteel procedure SB-D-7255A did not provide and Drawings sufficient guidance to perform an RCA required by Step 5.3.3 to determine the corrective action necessary to preclude repetition. Specifically, no RCA process is documented in SB-D-7255A or another quality procedure in the SBC quality assurance program (QAP).
SL IV - NCV   Westinghouse   Failure to perform adequate corrective 10 CFR           Corrective Electric       actions for a condition adverse to     72.172           Action Company         quality. Failed to perform adequate     Corrective corrective action to address a         Action Corrective Action Program (CAP) issue report. Specifically, Westinghouse failed to perform an adequate extent of condition evaluation for the existing and in service Fuel Solutions DCSS to determine if there were any adverse effects due to the input file error identified for the SENTRY project.
SL IV - NCV Westinghouse Failure to perform adequate corrective 10 CFR Corrective Electric actions for a condition adverse to 72.172 Action Company quality. Failed to perform adequate Corrective corrective action to address a Action Corrective Action Program (CAP) issue report. Specifically, Westinghouse failed to perform an adequate extent of condition evaluation for the existing and in service Fuel Solutions DCSS to determine if there were any adverse effects due to the input file error identified for the SENTRY project.


SL IV -       Holtec         As required by 10 CFR                   10 CFR 72.48     Design Notice of                     72.48(c)(2)(viii), Changes, tests, and Changes,         Changes Violation                     experiments, Holtec failed to obtain   Tests, and (NOV)                         CoC amendments pursuant to 10 CFR       Experiments 72.244 prior to implementing proposed design changes to multi-purpose canister (MPC) continuous basket shims (CBS) for four spent fuel cask designs (i.e., MPC 68M-CBS, MPC 32M-CBS, MPC 89-CBS, and MPC 37-CBS basket variants) that resulted in a departure from the method of evaluations described in the HI-STORM 100 and HI-STORM Flood/Wind (FW) Final Safety Analysis Reports (FSAR) (updated) used in establishing the design bases;
SL IV - Holtec As required by 10 CFR 10 CFR 72.48 Design Notice of 72.48(c)(2)(viii), Changes, tests, and Changes, Changes Violation experiments, Holtec failed to obtain Tests, and (NOV) CoC amendments pursuant to 10 CFR Experiments 72.244 prior to implementing proposed design changes to multi-purpose canister (MPC) continuous basket shims (CBS) for four spent fuel cask designs (i.e., MPC 68M-CBS, MPC 32M-CBS, MPC 89-CBS, and MPC 37-CBS basket variants) that resulted in a departure from the method of evaluations described in the HI-STORM 100 and HI-STORM Flood/Wind (FW) Final Safety Analysis Reports (FSAR) (updated) used in establishing the design bases;


The certificate holder Holtec International failed to obtain a CoC amendment pursuant to 10 CFR Section 72.244, prior to implementing proposed changes that would result in a departure from a method of
The certificate holder Holtec International failed to obtain a CoC amendment pursuant to 10 CFR Section 72.244, prior to implementing proposed changes that would result in a departure from a method of
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2 evaluation (MOE) described in the FSAR used in establishing the design bases or in the safety analyses.
2 evaluation (MOE) described in the FSAR used in establishing the design bases or in the safety analyses.
Specifically, from November 6, 2020, to July 19, 2021, Holtec made design changes to four multi-purpose canister (MPC) fuel baskets from the standard MPC 68M, 32M, 89, and 37 baskets to the MPC 68M-continuous basket shims (CBS), MPC 32M-CBS, MPC 89-CBS, and MPC 37-CBS basket variants that resulted in a departure from methods of evaluation described in the FSARs (as updated) used in establishing the design bases and failed to submit CoC amendment applications prior to implementing the changes.
Specifically, from November 6, 2020, to July 19, 2021, Holtec made design changes to four multi-purpose canister (MPC) fuel baskets from the standard MPC 68M, 32M, 89, and 37 baskets to the MPC 68M-continuous basket shims (CBS), MPC 32M-CBS, MPC 89-CBS, and MPC 37-CBS basket variants that resulted in a departure from methods of evaluation described in the FSARs (as updated) used in establishing the design bases and failed to submit CoC amendment applications prior to implementing the changes.
SL IV - NOV   Holtec         As required by 10 CFR 72.48(d)(1),     10 CFR 72.48     Design Changes, tests, and experiments,     Changes,         Changes Holtec failed to maintain records of   Tests, and changes that included written           Experiments evaluations that provided an adequate bases for the determination that changing to the MPC CBS basket variants did not require CoC amendments pursuant to 10 CFR 72.48(c)(2).
SL IV - NOV Holtec As required by 10 CFR 72.48(d)(1), 10 CFR 72.48 Design Changes, tests, and experiments, Changes, Changes Holtec failed to maintain records of Tests, and changes that included written Experiments evaluations that provided an adequate bases for the determination that changing to the MPC CBS basket variants did not require CoC amendments pursuant to 10 CFR 72.48(c)(2).


Holtec failed to maintain records of changes in the spent fuel storage cask design made pursuant to paragraph (c) of 10 CFR 72.48 that included a written evaluation which provided the bases for the determination that the change does not require a CoC amendment pursuant to 10 CFR 72.48(c)(2). Specifically, for the MPC 68M-CBS, MPC 32M-CBS, MPC 89-CBS, and MPC 37-CBS variants, as of February 17, 2021, July 19, 2021, May 13, 2020, and November 6, 2020, Holtecs written evaluations failed to provide an adequate bases for the determination that incorporation of the CBS design fuel basket variants did not require a CoC amendment. Holtec did not clearly and thoroughly discuss the impacts on departures from elements of the MOEs described in the FSARs for the original design (all-welded stainless steel fuel basket) that were affected by the changes to the CBS design fuel basket variants (MPC 68M-CBS, MPC 32M-CBS, MPC 89-CBS, and MPC 37-CBS). The
Holtec failed to maintain records of changes in the spent fuel storage cask design made pursuant to paragraph (c) of 10 CFR 72.48 that included a written evaluation which provided the bases for the determination that the change does not require a CoC amendment pursuant to 10 CFR 72.48(c)(2). Specifically, for the MPC 68M-CBS, MPC 32M-CBS, MPC 89-CBS, and MPC 37-CBS variants, as of February 17, 2021, July 19, 2021, May 13, 2020, and November 6, 2020, Holtecs written evaluations failed to provide an adequate bases for the determination that incorporation of the CBS design fuel basket variants did not require a CoC amendment. Holtec did not clearly and thoroughly discuss the impacts on departures from elements of the MOEs described in the FSARs for the original design (all-welded stainless steel fuel basket) that were affected by the changes to the CBS design fuel basket variants (MPC 68M-CBS, MPC 32M-CBS, MPC 89-CBS, and MPC 37-CBS). The


3 impacted elements included the demonstration of the design criteria of the fuel basket; mathematical model associated with material performance and tip-over analysis; calculational framework on connections between fuel basket and shims; use of revised version of software; new assumptions, etc.
3 impacted elements included the demonstration of the design criteria of the fuel basket; mathematical model associated with material performance and tip-over analysis; calculational framework on connections between fuel basket and shims; use of revised version of software; new assumptions, etc.
SL IV - NOV   Holtec         As required by 10 CFR 72.146(c),         10 CFR           Design Design control, Holtec failed to       72.146           Changes subject design changes for the MPC       Design Control 68M-CBS, MPC 32M-CBS, MPC 89-CBS, and MPC 37-CBS basket variants to design control measures commensurate with those applied to the original design.
SL IV - NOV Holtec As required by 10 CFR 72.146(c), 10 CFR Design Design control, Holtec failed to 72.146 Changes subject design changes for the MPC Design Control 68M-CBS, MPC 32M-CBS, MPC 89-CBS, and MPC 37-CBS basket variants to design control measures commensurate with those applied to the original design.


Holtec failed to subject design changes, including field changes, to design control measures commensurate with those applied to the original basket design. Specifically, in four examples prior to February 17, 2021, July 19, 2021, May 13, 2020, and November 6, 2020, Holtec failed to subject design changes from the MPC 68M, 32M, 89, and 37 standard basket designs to the MPC 68M-CBS, 32M-CBS, 89-CBS, and 37-CBS basket variants to design control measures commensurate with those applied to the original design, and made changes in the conditions specified in the license that required prior NRC approval. Holtec failed to perform adequate tip-over calculations and to model the basket shim bolts for the four CBS basket variants. In addition, material strength assumptions were different, the deflection design criteria of the fuel baskets were not demonstrated, and thermal expansion interference was not calculated in the CBS baskets.
Holtec failed to subject design changes, including field changes, to design control measures commensurate with those applied to the original basket design. Specifically, in four examples prior to February 17, 2021, July 19, 2021, May 13, 2020, and November 6, 2020, Holtec failed to subject design changes from the MPC 68M, 32M, 89, and 37 standard basket designs to the MPC 68M-CBS, 32M-CBS, 89-CBS, and 37-CBS basket variants to design control measures commensurate with those applied to the original design, and made changes in the conditions specified in the license that required prior NRC approval. Holtec failed to perform adequate tip-over calculations and to model the basket shim bolts for the four CBS basket variants. In addition, material strength assumptions were different, the deflection design criteria of the fuel baskets were not demonstrated, and thermal expansion interference was not calculated in the CBS baskets.


4 Apparent       NAC             NAC failed to submit a written report to 10 CFR           Reporting Violation     International   the NRC within 30 days of discovery of 72.242(d)
4 Apparent NAC NAC failed to submit a written report to 10 CFR Reporting Violation International the NRC within 30 days of discovery of 72.242(d)
(NAC)           a design or fabrication deficiency, for Recordkeeping any spent fuel storage cask which has   and Reports 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.
(NAC) a design or fabrication deficiency, for Recordkeeping any spent fuel storage cask which has and Reports 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 which had been delivered to general licensees (i.e., Palo Verde, McGuire, Catawba, Zion, Kewaunee, and Three Mile Island) when the design deficiency exceed the design limits.
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 which had been delivered to general licensees (i.e., Palo Verde, McGuire, Catawba, Zion, Kewaunee, and Three Mile Island) when the design deficiency exceed the design limits.
NAC discovered a design deficiency in calculation 71160-2025 on March 29, 2022, that adversely impacted the licensees computation for bending stresses (i.e., negative margins).
NAC discovered a design deficiency in calculation 71160-2025 on March 29, 2022, that adversely impacted the licensees computation for bending stresses (i.e., negative margins).
Eventually, NAC submitted the required report to the NRC on March 11, 2023, and updated the report on March 28, 2023 (ML23087A062), this was approximately 11 months after NAC identified the issue.
Eventually, NAC submitted the required report to the NRC on March 11, 2023, and updated the report on March 28, 2023 (ML23087A062), this was approximately 11 months after NAC identified the issue.
SL IV - NCV   Seabrook         Improper Removal of Quality Control     10 CFR           Procedural Station         Hold Points from Dry Cask Storage       72.140           Adherence NextEra         Procedures.                             Quality Energy           The inspectors identified a Severity   Assurance Seabrook,       Level IV non-cited violation of         Requirements LLC             NextEra's Quality Assurance Manual when the licensee failed to obtain permission from either the Quality Control Level III Inspector or Nuclear Assurance and Assessment Manager prior to removing quality control hold points as specified in the dry cask storage operations procedure.
SL IV - NCV Seabrook Improper Removal of Quality Control 10 CFR Procedural Station Hold Points from Dry Cask Storage 72.140 Adherence NextEra Procedures. Quality Energy The inspectors identified a Severity Assurance Seabrook, Level IV non-cited violation of Requirements LLC NextEra's Quality Assurance Manual when the licensee failed to obtain permission from either the Quality Control Level III Inspector or Nuclear Assurance and Assessment Manager prior to removing quality control hold points as specified in the dry cask storage operations procedure.


5 SL IV - NCV   Indian Point     Failure to Verify HI-LIFT Crane         10 CFR           Design DECOM           Component Seismic Qualification         72.146           Changes One the NRC identified Severity Level   Design Control IV NCV of 10 CFR 72.146 is documented because design control measures did not ensure that appropriate quality standards were specified and included in design documents associated with the HI-LIFT crane structure. Specifically, Holtec Decommissioning International failed to ensure suitability of the crane swing arm hydraulic system counterbalance valves during postulated seismic conditions, which are essential to the function of the HI-LIFT crane and therefore important to safety. Holtec Decommissioning International entered the issue into its CAP as IR-IP3-01202 and completed actions to seismically qualify the valves.
5 SL IV - NCV Indian Point Failure to Verify HI-LIFT Crane 10 CFR Design DECOM Component Seismic Qualification 72.146 Changes One the NRC identified Severity Level Design Control IV NCV of 10 CFR 72.146 is documented because design control measures did not ensure that appropriate quality standards were specified and included in design documents associated with the HI-LIFT crane structure. Specifically, Holtec Decommissioning International failed to ensure suitability of the crane swing arm hydraulic system counterbalance valves during postulated seismic conditions, which are essential to the function of the HI-LIFT crane and therefore important to safety. Holtec Decommissioning International entered the issue into its CAP as IR-IP3-01202 and completed actions to seismically qualify the valves.
SL IV - NCV   Perry Nuclear   Zero Profile Transporter               10 CFR 72.48     Design Power Plant     The inspectors identified a Severity   Changes,         Changes FirstEnergy     Level IV NCV of 10 CFR 72.48(d)(1),     Tests, and Nuclear         Changes, Tests, and Experiments,     Experiments Operating Co. for the licensees failure to provide a written evaluation describing the basis for determining that the change to the design of the Holtec HI-STORM FW system did not require a license amendment. Specifically, while implementing the HI-STORM FW system, the licensees calculational verification of the Zero Profile Transporter did not adhere to the design requirements resulting in two changes that could result in uncontrolled movements of the HI-STORM FW overpack during transport potentially impacting the shielding function of the overpack.
SL IV - NCV Perry Nuclear Zero Profile Transporter 10 CFR 72.48 Design Power Plant The inspectors identified a Severity Changes, Changes FirstEnergy Level IV NCV of 10 CFR 72.48(d)(1), Tests, and Nuclear Changes, Tests, and Experiments, Experiments Operating Co. for the licensees failure to provide a written evaluation describing the basis for determining that the change to the design of the Holtec HI-STORM FW system did not require a license amendment. Specifically, while implementing the HI-STORM FW system, the licensees calculational verification of the Zero Profile Transporter did not adhere to the design requirements resulting in two changes that could result in uncontrolled movements of the HI-STORM FW overpack during transport potentially impacting the shielding function of the overpack.


6 Enforcement   Perry Nuclear   Tornado Hazards Protection at           10 CFR           Tornado Discretion     Power Plant     Independent Spent Fuel Storage         72.212(b)       Hazards Installations (ISFSI)                   Conditions of Upon issuance of the U.S. NRC           CoC Enforcement Guidance Memorandum (EGM) 22-001 (ML22087A496), dated April 15, 2022, the licensee performed an assessment of all outdoor dry cask storage activities that are not explicitly analyzed for tornado hazards in the cask licensing basis. One configuration was identified by the licensee when a loaded Holtec HI-STORM FW storage overpack is brought out of the fuel building without a lid installed. This configuration is not explicitly analyzed in the HI-STORM FW FSAR. The 10 CFR Section72.212 (b)(6), states, in part, that "the general licensee must:...
6 Enforcement Perry Nuclear Tornado Hazards Protection at 10 CFR Tornado Discretion Power Plant Independent Spent Fuel Storage 72.212(b) Hazards Installations (ISFSI) Conditions of Upon issuance of the U.S. NRC CoC Enforcement Guidance Memorandum (EGM) 22-001 (ML22087A496), dated April 15, 2022, the licensee performed an assessment of all outdoor dry cask storage activities that are not explicitly analyzed for tornado hazards in the cask licensing basis. One configuration was identified by the licensee when a loaded Holtec HI-STORM FW storage overpack is brought out of the fuel building without a lid installed. This configuration is not explicitly analyzed in the HI-STORM FW FSAR. The 10 CFR Section72.212 (b)(6), states, in part, that "the general licensee must:...
review the Safety Analysis Report (SAR) referenced in the CoC
review the Safety Analysis Report (SAR) referenced in the CoC
[Certificate of Compliance] or amended CoC and the related NRC SAR, prior to use of the general license, to determine whether or not the reactor site parameters, including analyses of earthquake intensity and tornado missiles, are enveloped by the cask design bases considered in these reports. The results of this review must be documented in the evaluation made in paragraph (b)(5) of this section."
[Certificate of Compliance] or amended CoC and the related NRC SAR, prior to use of the general license, to determine whether or not the reactor site parameters, including analyses of earthquake intensity and tornado missiles, are enveloped by the cask design bases considered in these reports. The results of this review must be documented in the evaluation made in paragraph (b)(5) of this section."
Tornado hazards are evaluated in the Holtec HI-STORM FW FSAR section 2.2.3.e, "Environmental Phenomena and Accident Condition Design Criteria," and section 12.2.6.2, "Tornado Analysis." These sections of the FSAR do not include an analysis for tornado hazards with the storage overpack lid removed.
Tornado hazards are evaluated in the Holtec HI-STORM FW FSAR section 2.2.3.e, "Environmental Phenomena and Accident Condition Design Criteria," and section 12.2.6.2, "Tornado Analysis." These sections of the FSAR do not include an analysis for tornado hazards with the storage overpack lid removed.


7 Enforcement   Waterford       Tornado Hazards Protection at ISFSI     10 CFR           Tornado Discretion     Steam           Upon issuance of the U.S. NRC           72.212(b)       Hazards Electric       Enforcement Guidance Memorandum         Conditions of Station         (EGM) 22-001 (ML22087A496), dated       CoC Entergy         April 15, 2022, the licensee performed Operations     an assessment of all outdoor dry cask Inc.           storage activities that were not explicitly analyzed for tornado hazards in the system's FSAR. Two configurations were identified by the licensee where transport activities did not have a related tornado wind and hazard analysis consistent with the cask's design basis requirements.
7 Enforcement Waterford Tornado Hazards Protection at ISFSI 10 CFR Tornado Discretion Steam Upon issuance of the U.S. NRC 72.212(b) Hazards Electric Enforcement Guidance Memorandum Conditions of Station (EGM) 22-001 (ML22087A496), dated CoC Entergy April 15, 2022, the licensee performed Operations an assessment of all outdoor dry cask Inc. storage activities that were not explicitly analyzed for tornado hazards in the system's FSAR. Two configurations were identified by the licensee where transport activities did not have a related tornado wind and hazard analysis consistent with the cask's design basis requirements.
These situations occurred during outside operations when the HI-STORM FW overpack was on the low-profile transporter and when the Vertical Cask Transporter carried the overpack using the HI-STORM FW lifting brackets.
These situations occurred during outside operations when the HI-STORM FW overpack was on the low-profile transporter and when the Vertical Cask Transporter carried the overpack using the HI-STORM FW lifting brackets.


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8 FY 2023 PART 71 INSPECTION VIOLATIONS
8 FY 2023 PART 71 INSPECTION VIOLATIONS


Type     Licensee/               Description                           Applicable     Category CoC Holder                                                     Regulation
Type Licensee/ Description Applicable Category CoC Holder Regulation


SL IV -   Best Theratronics Ltd. Failure to perform audits in         10 CFR         Audits NCV                               accordance with QAP                   71.137 The certificate holder (Best         Audits Theratonics Limited [BTL]) did not carry out a comprehensive system of planned and periodic audits to verify compliance with all aspects of the quality assurance program that determined the effectiveness of the program.
SL IV - Best Theratronics Ltd. Failure to perform audits in 10 CFR Audits NCV accordance with QAP 71.137 The certificate holder (Best Audits Theratonics Limited [BTL]) did not carry out a comprehensive system of planned and periodic audits to verify compliance with all aspects of the quality assurance program that determined the effectiveness of the program.
Additionally, BTL did not perform the audits in accordance with written procedures. Specifically, BTL missed performing audits and did not complete audits as scheduled in accordance with written procedures.
Additionally, BTL did not perform the audits in accordance with written procedures. Specifically, BTL missed performing audits and did not complete audits as scheduled in accordance with written procedures.


SL IV -   Industrial Nuclear Co. Failure to promptly correct           10 CFR         Procedural NCV       (INC)                   conditions adverse to quality         71.133         Adequacy INC failed to assure that conditions Instructions, adverse to quality were promptly     Procedures, corrected. Specifically, INC, failed to and Drawings promptly correct a condition adverse to quality when actions applicable to CAR 21-005 had not been performed to identify or implement corrective actions to bring Quality Procedure (QP) 7.1 into compliance since August 2021.
SL IV - Industrial Nuclear Co. Failure to promptly correct 10 CFR Procedural NCV (INC) conditions adverse to quality 71.133 Adequacy INC failed to assure that conditions Instructions, adverse to quality were promptly Procedures, corrected. Specifically, INC, failed to and Drawings promptly correct a condition adverse to quality when actions applicable to CAR 21-005 had not been performed to identify or implement corrective actions to bring Quality Procedure (QP) 7.1 into compliance since August 2021.


SL IV -   NAC International       Failure to notify prior to           10 CFR 71.93   Reporting NOV                               fabrication                           Inspections NAC did not notify the NRC, in       and Tests accordance with 10 CFR 71.1, 45 days in advance of starting fabrication of the first packaging under a CoC. Specifically, NAC missed opportunities to notify the NRC of fabrication activities prior to completion of the first packaging for use in the United States under the CoC Docket No. 71-9390. This paragraph applies to the OPTIMUS-L transportation packaging because it has a maximum normal operating pressure more than 103kPa. The NAC self-identified the violation and
SL IV - NAC International Failure to notify prior to 10 CFR 71.93 Reporting NOV fabrication Inspections NAC did not notify the NRC, in and Tests accordance with 10 CFR 71.1, 45 days in advance of starting fabrication of the first packaging under a CoC. Specifically, NAC missed opportunities to notify the NRC of fabrication activities prior to completion of the first packaging for use in the United States under the CoC Docket No. 71-9390. This paragraph applies to the OPTIMUS-L transportation packaging because it has a maximum normal operating pressure more than 103kPa. The NAC self-identified the violation and


9 performed a root cause analysis to determine the cause of the violation.
9 performed a root cause analysis to determine the cause of the violation.


SL IV -   NAC International       Failure to establish control of       10 CFR           M&TE NCV                               measuring and test equipment           71.125           Control NAC did not establish measures to     Control of assure that tools, gauges,             Measuring instruments, and other measuring       and Test and testing devices used in activities Equipment affecting quality are properly controlled, calibrated, and adjusted at specified times to maintain accuracy within necessary limits.
SL IV - NAC International Failure to establish control of 10 CFR M&TE NCV measuring and test equipment 71.125 Control NAC did not establish measures to Control of assure that tools, gauges, Measuring instruments, and other measuring and Test and testing devices used in activities Equipment affecting quality are properly controlled, calibrated, and adjusted at specified times to maintain accuracy within necessary limits.
Specifically, NAC oversight of fabrication activities at Joseph Oat Corporation did not establish measures to assure that the step-wedge film strip used in interpreting film of the CCV shell weld was within the 12-month calibration /
Specifically, NAC oversight of fabrication activities at Joseph Oat Corporation did not establish measures to assure that the step-wedge film strip used in interpreting film of the CCV shell weld was within the 12-month calibration /
replacement period as required in section 2.3 of SP-1508, revision 3 to maintain accuracy within the necessary limits. At the time when the team discovered this issue, the step-wedge film strip had not been retested and called into question the results of previous tests including radiograph of the CCV shell weld.
replacement period as required in section 2.3 of SP-1508, revision 3 to maintain accuracy within the necessary limits. At the time when the team discovered this issue, the step-wedge film strip had not been retested and called into question the results of previous tests including radiograph of the CCV shell weld.


10 SL IV - Nordion                 Failure to submit a change to         10 CFR         Quality NCV                               QAP that reduced commitments         71.106         Assurance Nordion did not submit a description Changes to of proposed changes to its NRC-       Quality approved QAP that reduced             Assurance commitments in the program           Program description as approved by the NRC and implemented those changes before receiving NRC approval.
10 SL IV - Nordion Failure to submit a change to 10 CFR Quality NCV QAP that reduced commitments 71.106 Assurance Nordion did not submit a description Changes to of proposed changes to its NRC-Quality approved QAP that reduced Assurance commitments in the program Program description as approved by the NRC and implemented those changes before receiving NRC approval.
Specifically, Nordion reduced its commitments for audits, and specific sections that do not reflect the current practice in the quality program description such as inspection, testing, and operating status as approved by the NRC and implemented those changes before receiving prior NRC approval.
Specifically, Nordion reduced its commitments for audits, and specific sections that do not reflect the current practice in the quality program description such as inspection, testing, and operating status as approved by the NRC and implemented those changes before receiving prior NRC approval.


SL IV - Source Production &     Failure to adequately store           10 CFR         Procedural NCV     Equipment Co.           records per procedure                 71.111         Adherence (SPEC)                   SPEC did not follow the filing and   Instructions, storage section of Quality Standard   Procedures, Procedure Manual section 17.0 and     and Drawings quality records were lost due to Hurricane Ida. Specifically, some quality records were not filed in storage devices/areas free from environmental threats as required.
SL IV - Source Production & Failure to adequately store 10 CFR Procedural NCV Equipment Co. records per procedure 71.111 Adherence (SPEC) SPEC did not follow the filing and Instructions, storage section of Quality Standard Procedures, Procedure Manual section 17.0 and and Drawings quality records were lost due to Hurricane Ida. Specifically, some quality records were not filed in storage devices/areas free from environmental threats as required.


SL IV - SPEC                     Failure to properly classify and     10 CFR         Design NCV                               justify sealed source capsule         71.107         Changes quality category                     Package SPEC failed to establish measures     Design to assure that appropriate quality   Control standards were specified and included in design documents.
SL IV - SPEC Failure to properly classify and 10 CFR Design NCV justify sealed source capsule 71.107 Changes quality category Package SPEC failed to establish measures Design to assure that appropriate quality Control standards were specified and included in design documents.
Measures were also not established for the selection and review for suitability of application of materials, parts, equipment, and processes that are essential to the functions of the materials, parts, and components of the packaging that are important-to-safety.
Measures were also not established for the selection and review for suitability of application of materials, parts, equipment, and processes that are essential to the functions of the materials, parts, and components of the packaging that are important-to-safety.


Line 93: Line 93:
The sealed source capsule was not properly classified as ITS Category A to ensure all required procurement controls are applied.
The sealed source capsule was not properly classified as ITS Category A to ensure all required procurement controls are applied.


SL IV - ROBATEL                 Failure to evaluate an adverse         10 CFR         Corrective NCV     TECHNOLOGIES (RT)       condition for appropriate             71.133         Action corrective actions                     Corrective Specifically, RTs QAPD Section 16,   Action Corrective Action, requires that conditions adverse to quality (e.g.,
SL IV - ROBATEL Failure to evaluate an adverse 10 CFR Corrective NCV TECHNOLOGIES (RT) condition for appropriate 71.133 Action corrective actions Corrective Specifically, RTs QAPD Section 16, Action Corrective Action, requires that conditions adverse to quality (e.g.,
deficiencies, deviations, defective material) be documented in corrective action reports (CARs) to evaluate the cause and actions of significant conditions adverse to quality (SCAQ) to prevent recurrence. Contrary to this, although the weld deficiency was repaired, RT failed to disposition the condition (significant vs adverse) and if required, evaluate the cause and actions to prevent recurrence.
deficiencies, deviations, defective material) be documented in corrective action reports (CARs) to evaluate the cause and actions of significant conditions adverse to quality (SCAQ) to prevent recurrence. Contrary to this, although the weld deficiency was repaired, RT failed to disposition the condition (significant vs adverse) and if required, evaluate the cause and actions to prevent recurrence.


12 SL IV - ROBATEL                 Failure to comply with               10 CFR         Procedural NCV     TECHNOLOGIES             procurement control procedure         71.111         Adherence The team reviewed RTs PO No.         Instructions, 185, dated 05/21/2021, issued to     Procedures, NFT-EPD, LLC for performance of       and Drawings annual cask maintenance services for RT-100 cask nos. 1, 2, 3, and 4 in accordance with the RT-100 SAR and RT procedures. The team noted, PO No. 185, invoked a restriction that procedures and personnel used on cask maintenance work to be reviewed and approved by RT, prior to the work being performed. Further, RTs procurement control QP (No.
12 SL IV - ROBATEL Failure to comply with 10 CFR Procedural NCV TECHNOLOGIES procurement control procedure 71.111 Adherence The team reviewed RTs PO No. Instructions, 185, dated 05/21/2021, issued to Procedures, NFT-EPD, LLC for performance of and Drawings annual cask maintenance services for RT-100 cask nos. 1, 2, 3, and 4 in accordance with the RT-100 SAR and RT procedures. The team noted, PO No. 185, invoked a restriction that procedures and personnel used on cask maintenance work to be reviewed and approved by RT, prior to the work being performed. Further, RTs procurement control QP (No.
QP-04-01) requires RT supplier documentation approval. Contrary to these requirements, RTs review, and approval of certain cask maintenance EPD examination procedures were not documented.
QP-04-01) requires RT supplier documentation approval. Contrary to these requirements, RTs review, and approval of certain cask maintenance EPD examination procedures were not documented.
In addition, documentation of qualification and certification of nondestructive examination Level III personnel performing review and approval of helium leak testing procedure (No.
In addition, documentation of qualification and certification of nondestructive examination Level III personnel performing review and approval of helium leak testing procedure (No.
2013-015-PR-CB-003) utilized during RT-100 casks annual maintenance was not apparent. The team determined that this was a violation of the NRC requirements.
2013-015-PR-CB-003) utilized during RT-100 casks annual maintenance was not apparent. The team determined that this was a violation of the NRC requirements.


SL IV - Nuclear Fuel Services   Failure to have adequate             10 CFR         Procedural NCV                               packaging inspection procedures       71.111         Adequacy Nuclear Fuel Services (NFS) failed   Instructions, to prescribe activities affecting     Procedures, quality by documented instructions,   and Drawings procedures, or drawings of a type appropriate to the circumstances and include appropriate quantitative or qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished. Specifically, NFS failed to include in the LR package loading procedure Standard Operating Procedure 409-SEC 45, revision 18, all the required operational pre-shipment inspections for visible flaws
SL IV - Nuclear Fuel Services Failure to have adequate 10 CFR Procedural NCV packaging inspection procedures 71.111 Adequacy Nuclear Fuel Services (NFS) failed Instructions, to prescribe activities affecting Procedures, quality by documented instructions, and Drawings procedures, or drawings of a type appropriate to the circumstances and include appropriate quantitative or qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished. Specifically, NFS failed to include in the LR package loading procedure Standard Operating Procedure 409-SEC 45, revision 18, all the required operational pre-shipment inspections for visible flaws


13 including corrosion, actions in the case of identifying corrosion, and actions for shackle securing or removal as required by the LR package SAR, revision 9, chapter 7.
13 including corrosion, actions in the case of identifying corrosion, and actions for shackle securing or removal as required by the LR package SAR, revision 9, chapter 7.


SL IV -   Nuclear Fuel Services   Failure to perform independent         10 CFR         Audits NCV                               internal audits                         71.137 NFS failed to perform internal audits   Audits of all applicable areas with auditors not having direct responsibilities in the areas being audited.
SL IV - Nuclear Fuel Services Failure to perform independent 10 CFR Audits NCV internal audits 71.137 NFS failed to perform internal audits Audits of all applicable areas with auditors not having direct responsibilities in the areas being audited.
Specifically, NFS failed to perform independent audits of the vendor qualification, receipt inspection, and internal audit areas.
Specifically, NFS failed to perform independent audits of the vendor qualification, receipt inspection, and internal audit areas.


14 FY 2023 PART 71.95 Reports
14 FY 2023 PART 71.95 Reports


Docket     Package Model No.       Description                           Report       Reporting No.                                                                       Date         Requirement
Docket Package Model No. Description Report Reporting No. Date Requirement


07109291   CoC #9291 Liqui-Rad     Westinghouse Electric Company         1/06/2023   71.95(a)(3) -
07109291 CoC #9291 Liqui-Rad Westinghouse Electric Company 1/06/2023 71.95(a)(3) -
Transport Package       determined that conditions of                     Conditions of (model LR-230)         approval in CoC No. 9291 for the                   approval in Liqui-Rad Transport Unit Package                   the Certificate (model LR-230) were not followed                   of during a shipment on November 9,                   Compliance 2022. This package is used to                     were not transport low-enriched uranyl                     observed in nitrate solutions for repurposing.                 making a Upon receipt of heeled packages at                 shipment.
Transport Package determined that conditions of Conditions of (model LR-230) approval in CoC No. 9291 for the approval in Liqui-Rad Transport Unit Package the Certificate (model LR-230) were not followed of during a shipment on November 9, Compliance 2022. This package is used to were not transport low-enriched uranyl observed in nitrate solutions for repurposing. making a Upon receipt of heeled packages at shipment.
a customer site, the primary lid port             71.95(b) -
a customer site, the primary lid port 71.95(b) -
plug bolt was determined to have                   Conditions in not been properly installed prior to               the Certificate shipment from Westinghouse. The                   of bolt was found uninstalled, sitting               Compliance inside the boundary of the outer lid               were not and outside containment. The                       followed supplier reported this issue to                   during a Westinghouse on November 14,                       shipment.
plug bolt was determined to have Conditions in not been properly installed prior to the Certificate shipment from Westinghouse. The of bolt was found uninstalled, sitting Compliance inside the boundary of the outer lid were not and outside containment. The followed supplier reported this issue to during a Westinghouse on November 14, shipment.
2022. The error likely occurred as a result of imprecise operation and maintenance requirements that led to a human error of missed installment and verification of the bolt. Procedures were modified to add a verification step to ensure installation and torque tightness of the bolt. No known release of contents occurred.
2022. The error likely occurred as a result of imprecise operation and maintenance requirements that led to a human error of missed installment and verification of the bolt. Procedures were modified to add a verification step to ensure installation and torque tightness of the bolt. No known release of contents occurred.


07109291   CoC #9291 Liqui-Rad     The NFS reported that conditions     5/22/2023   71.95(a)(3) -
07109291 CoC #9291 Liqui-Rad The NFS reported that conditions 5/22/2023 71.95(a)(3) -
Transport Package       of approval in CoC No. 9291 for the               Conditions of (model LR-230)         Liqui-Rad Transport Unit Package                   approval in (model LR-230) were not followed                   the Certificate during shipments. This package is                 of used to transport up to 230 gallons               Compliance of low-enriched uranyl nitrate                     were not solution. During an NRC                           observed in Transportation Quality Assurance                   making a Inspection on March 28, 2023,                     shipment.
Transport Package of approval in CoC No. 9291 for the Conditions of (model LR-230) Liqui-Rad Transport Unit Package approval in (model LR-230) were not followed the Certificate during shipments. This package is of used to transport up to 230 gallons Compliance of low-enriched uranyl nitrate were not solution. During an NRC observed in Transportation Quality Assurance making a Inspection on March 28, 2023, shipment.
corrosion was identified on exterior               71.95(b) -
corrosion was identified on exterior 71.95(b) -
surfaces of a LR-230 container that               Conditions in was being prepared for loading.                   the Certificate Subsequent inspection of a loaded                 of LR-230 trailer indicated similar                   Compliance corrosion on multiple containers.                 were not The corrosion was most significant                 followed
surfaces of a LR-230 container that Conditions in was being prepared for loading. the Certificate Subsequent inspection of a loaded of LR-230 trailer indicated similar Compliance corrosion on multiple containers. were not The corrosion was most significant followed


15 on the carbon steel bracing for the               during a packages and on exterior surfaces                 shipment.
15 on the carbon steel bracing for the during a packages and on exterior surfaces shipment.
surrounding the equipment data plates. The corrosion along the carbon steel bracing plates could be described as pitting and blistering. The SAR stated that the package should not be used if corrosion is discovered on the exterior surface. The NFS operating procedure did not specifically include corrosion on the preload inspection checklist. As a result, packages were shipped with corrosion present. NFS has shipped LR-230 trailers for many years, with approximately two to three shipments per week to Westinghouse Corporation. NFS immediately stopped shipments of the loaded LR-230 trailers pending resolution with the package owner (Westinghouse Electric Corporation) and Certificate Holder (Orano TN Americas). The NFS evaluated the safety significance of this issue as low. The NFS sought information needed to determine operability for continued use until the packages could be repaired or refurbished. The NFS planned to modify their procedures to capture all applicable inspection criteria, especially corrosion.
surrounding the equipment data plates. The corrosion along the carbon steel bracing plates could be described as pitting and blistering. The SAR stated that the package should not be used if corrosion is discovered on the exterior surface. The NFS operating procedure did not specifically include corrosion on the preload inspection checklist. As a result, packages were shipped with corrosion present. NFS has shipped LR-230 trailers for many years, with approximately two to three shipments per week to Westinghouse Corporation. NFS immediately stopped shipments of the loaded LR-230 trailers pending resolution with the package owner (Westinghouse Electric Corporation) and Certificate Holder (Orano TN Americas). The NFS evaluated the safety significance of this issue as low. The NFS sought information needed to determine operability for continued use until the packages could be repaired or refurbished. The NFS planned to modify their procedures to capture all applicable inspection criteria, especially corrosion.


16 FY 2023 PART 72.242 Reports
16 FY 2023 PART 72.242 Reports


Docket     Cask Type             Description                         Report Date     Reporting No.                                                                                   Requirement
Docket Cask Type Description Report Date Reporting No. Requirement


07201004   NUHOMS 61 BTH         In early November, Orano TN         11/30/2022     72.242(d)
07201004 NUHOMS 61 BTH In early November, Orano TN 11/30/2022 72.242(d)
Type 2 DSC           Americas identified fabrication issues during operation activities.
Type 2 DSC Americas identified fabrication issues during operation activities.
The 72.242 submitted to the NRC is a proprietary document.
The 72.242 submitted to the NRC is a proprietary document.


07201015   NAC-UMS and           NAC has internally identified a     3/10/2023       72.242(d) 07201031   MAGNASTOR dry         licensing basis deficiency for the cask storage         NAC-UMS and MAGNASTOR dry systems               cask storage systems. Specifically, a parameter used in the computation of bending stress in the finite element model used to structurally evaluate a fuel rod under the non-mechanistic tip-over accident condition was incorrectly specified resulting in the non-conservative calculation of stresses. More specifically, the calculation uses an ANSYS 2-dimensional elastic beam element, BEAM3, to represent a single fuel rod. The BEAM3 element requires the input of various real constants that define physical properties of the element such as cross-sectional area, area moment of inertia, and height. The height real constant is used by ANSYS in the computation of bending stress in the element and is defined in ANSYS documentation to be the total height of the beam (i.e., rod outer diameter in this case). The input code in question incorrectly set the height real constant using a parameter equal to the outer radius of the rod, which is half of the correct value. Use of the correct value effectively doubles the computed bending stress.
07201015 NAC-UMS and NAC has internally identified a 3/10/2023 72.242(d) 07201031 MAGNASTOR dry licensing basis deficiency for the cask storage NAC-UMS and MAGNASTOR dry systems cask storage systems. Specifically, a parameter used in the computation of bending stress in the finite element model used to structurally evaluate a fuel rod under the non-mechanistic tip-over accident condition was incorrectly specified resulting in the non-conservative calculation of stresses. More specifically, the calculation uses an ANSYS 2-dimensional elastic beam element, BEAM3, to represent a single fuel rod. The BEAM3 element requires the input of various real constants that define physical properties of the element such as cross-sectional area, area moment of inertia, and height. The height real constant is used by ANSYS in the computation of bending stress in the element and is defined in ANSYS documentation to be the total height of the beam (i.e., rod outer diameter in this case). The input code in question incorrectly set the height real constant using a parameter equal to the outer radius of the rod, which is half of the correct value. Use of the correct value effectively doubles the computed bending stress.


NAC has completed an impact to safety evaluation and determined there is no Impact to Safety or concerns relative to the ability of
NAC has completed an impact to safety evaluation and determined there is no Impact to Safety or concerns relative to the ability of

Latest revision as of 20:35, 5 October 2024

Enclosure 2 - Fiscal Year 2023 Summary of Inspection Violations and Reports Under Title 10 of the Code of Federal Regulations Part 71 and 72
ML24029A048
Person / Time
Issue date: 03/20/2024
From:
NRC/NMSS/DFM/IOB
To:
Division of Fuel Management
Shared Package
ML24029A045 List:
References
Download: ML24029A048 (18)
v • d • e


Text

Fiscal Year 2023 Summary of Inspection Violations and Reports Under Title 10 of the Code of Federal Regulations Part 71 and 72

FY 2023 PART 72 INSPECTION VIOLATIONS

Type Licensee/ Description Applicable Category Certificate of Regulation Compliance (CoC) Holder SL IV - Holtec Holtec failed to adequately implement Title 10 of the Procedural non-cited International a procedure for an activity affecting Code of Adherence violation (Holtec) quality. Specifically, procedure, HSP-Federal (NCV) 477, revision 4, Digital Radiographic Regulations Weld Examination, specified that (10 CFR) deliquification, dissolution, and Section adjustment (DDA) calibration (pixel 72.150 mapping) be performed at the Instructions, commencement of an inspection Procedures, period and not more than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> as and Drawings required, instead, Holtec performed the DDA calibrations at 2-week intervals.

SL IV - Orano TN Inadequate Supplier Audits 10 CFR Procedural NCV Americas LLC TN Americas (TN) quality procedures 72.150 Adequacy Hitachi Zozen did not provide sufficient guidance to Instructions, perform a licensing review for all Procedures, applicable situations. Specifically, and Drawings material nonconformances that are not controlled under the TN Quality Assurance Program Description Manual and do not receive a supplier nonconformance are not required to have an associated licensing review conducted under the TN quality program. A licensing review would determine if TN needed additional licensing actions such as the U.S.

Nuclear Regulatory Commission (NRC) approval or an exemption to the regulations to accept the nonconformance to an approved NRC license.

Enclosure 2 SL IV - Northern Inadequate quality procedure for 10 CFR Procedural NCV States Power guidance in conducting a Root Cause 72.150 Adequacy Company Analysis (RCA) SeAH Besteel Instructions, NSPM Corporation (SBCs) corrective action Procedures, SeAH Besteel procedure SB-D-7255A did not provide and Drawings sufficient guidance to perform an RCA required by Step 5.3.3 to determine the corrective action necessary to preclude repetition. Specifically, no RCA process is documented in SB-D-7255A or another quality procedure in the SBC quality assurance program (QAP).

SL IV - NCV Westinghouse Failure to perform adequate corrective 10 CFR Corrective Electric actions for a condition adverse to 72.172 Action Company quality. Failed to perform adequate Corrective corrective action to address a Action Corrective Action Program (CAP) issue report. Specifically, Westinghouse failed to perform an adequate extent of condition evaluation for the existing and in service Fuel Solutions DCSS to determine if there were any adverse effects due to the input file error identified for the SENTRY project.

SL IV - Holtec As required by 10 CFR 10 CFR 72.48 Design Notice of 72.48(c)(2)(viii), Changes, tests, and Changes, Changes Violation experiments, Holtec failed to obtain Tests, and (NOV) CoC amendments pursuant to 10 CFR Experiments 72.244 prior to implementing proposed design changes to multi-purpose canister (MPC) continuous basket shims (CBS) for four spent fuel cask designs (i.e., MPC 68M-CBS, MPC 32M-CBS, MPC 89-CBS, and MPC 37-CBS basket variants) that resulted in a departure from the method of evaluations described in the HI-STORM 100 and HI-STORM Flood/Wind (FW) Final Safety Analysis Reports (FSAR) (updated) used in establishing the design bases;

The certificate holder Holtec International failed to obtain a CoC amendment pursuant to 10 CFR Section 72.244, prior to implementing proposed changes that would result in a departure from a method of

2 evaluation (MOE) described in the FSAR used in establishing the design bases or in the safety analyses.

Specifically, from November 6, 2020, to July 19, 2021, Holtec made design changes to four multi-purpose canister (MPC) fuel baskets from the standard MPC 68M, 32M, 89, and 37 baskets to the MPC 68M-continuous basket shims (CBS), MPC 32M-CBS, MPC 89-CBS, and MPC 37-CBS basket variants that resulted in a departure from methods of evaluation described in the FSARs (as updated) used in establishing the design bases and failed to submit CoC amendment applications prior to implementing the changes.

SL IV - NOV Holtec As required by 10 CFR 72.48(d)(1), 10 CFR 72.48 Design Changes, tests, and experiments, Changes, Changes Holtec failed to maintain records of Tests, and changes that included written Experiments evaluations that provided an adequate bases for the determination that changing to the MPC CBS basket variants did not require CoC amendments pursuant to 10 CFR 72.48(c)(2).

Holtec failed to maintain records of changes in the spent fuel storage cask design made pursuant to paragraph (c) of 10 CFR 72.48 that included a written evaluation which provided the bases for the determination that the change does not require a CoC amendment pursuant to 10 CFR 72.48(c)(2). Specifically, for the MPC 68M-CBS, MPC 32M-CBS, MPC 89-CBS, and MPC 37-CBS variants, as of February 17, 2021, July 19, 2021, May 13, 2020, and November 6, 2020, Holtecs written evaluations failed to provide an adequate bases for the determination that incorporation of the CBS design fuel basket variants did not require a CoC amendment. Holtec did not clearly and thoroughly discuss the impacts on departures from elements of the MOEs described in the FSARs for the original design (all-welded stainless steel fuel basket) that were affected by the changes to the CBS design fuel basket variants (MPC 68M-CBS, MPC 32M-CBS, MPC 89-CBS, and MPC 37-CBS). The

3 impacted elements included the demonstration of the design criteria of the fuel basket; mathematical model associated with material performance and tip-over analysis; calculational framework on connections between fuel basket and shims; use of revised version of software; new assumptions, etc.

SL IV - NOV Holtec As required by 10 CFR 72.146(c), 10 CFR Design Design control, Holtec failed to 72.146 Changes subject design changes for the MPC Design Control 68M-CBS, MPC 32M-CBS, MPC 89-CBS, and MPC 37-CBS basket variants to design control measures commensurate with those applied to the original design.

Holtec failed to subject design changes, including field changes, to design control measures commensurate with those applied to the original basket design. Specifically, in four examples prior to February 17, 2021, July 19, 2021, May 13, 2020, and November 6, 2020, Holtec failed to subject design changes from the MPC 68M, 32M, 89, and 37 standard basket designs to the MPC 68M-CBS, 32M-CBS, 89-CBS, and 37-CBS basket variants to design control measures commensurate with those applied to the original design, and made changes in the conditions specified in the license that required prior NRC approval. Holtec failed to perform adequate tip-over calculations and to model the basket shim bolts for the four CBS basket variants. In addition, material strength assumptions were different, the deflection design criteria of the fuel baskets were not demonstrated, and thermal expansion interference was not calculated in the CBS baskets.

4 Apparent NAC NAC failed to submit a written report to 10 CFR Reporting Violation International the NRC within 30 days of discovery of 72.242(d)

(NAC) a design or fabrication deficiency, for Recordkeeping any spent fuel storage cask which has and Reports 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 which had been delivered to general licensees (i.e., Palo Verde, McGuire, Catawba, Zion, Kewaunee, and Three Mile Island) when the design deficiency exceed the design limits.

NAC discovered a design deficiency in calculation 71160-2025 on March 29, 2022, that adversely impacted the licensees computation for bending stresses (i.e., negative margins).

Eventually, NAC submitted the required report to the NRC on March 11, 2023, and updated the report on March 28, 2023 (ML23087A062), this was approximately 11 months after NAC identified the issue.

SL IV - NCV Seabrook Improper Removal of Quality Control 10 CFR Procedural Station Hold Points from Dry Cask Storage 72.140 Adherence NextEra Procedures. Quality Energy The inspectors identified a Severity Assurance Seabrook, Level IV non-cited violation of Requirements LLC NextEra's Quality Assurance Manual when the licensee failed to obtain permission from either the Quality Control Level III Inspector or Nuclear Assurance and Assessment Manager prior to removing quality control hold points as specified in the dry cask storage operations procedure.

5 SL IV - NCV Indian Point Failure to Verify HI-LIFT Crane 10 CFR Design DECOM Component Seismic Qualification 72.146 Changes One the NRC identified Severity Level Design Control IV NCV of 10 CFR 72.146 is documented because design control measures did not ensure that appropriate quality standards were specified and included in design documents associated with the HI-LIFT crane structure. Specifically, Holtec Decommissioning International failed to ensure suitability of the crane swing arm hydraulic system counterbalance valves during postulated seismic conditions, which are essential to the function of the HI-LIFT crane and therefore important to safety. Holtec Decommissioning International entered the issue into its CAP as IR-IP3-01202 and completed actions to seismically qualify the valves.

SL IV - NCV Perry Nuclear Zero Profile Transporter 10 CFR 72.48 Design Power Plant The inspectors identified a Severity Changes, Changes FirstEnergy Level IV NCV of 10 CFR 72.48(d)(1), Tests, and Nuclear Changes, Tests, and Experiments, Experiments Operating Co. for the licensees failure to provide a written evaluation describing the basis for determining that the change to the design of the Holtec HI-STORM FW system did not require a license amendment. Specifically, while implementing the HI-STORM FW system, the licensees calculational verification of the Zero Profile Transporter did not adhere to the design requirements resulting in two changes that could result in uncontrolled movements of the HI-STORM FW overpack during transport potentially impacting the shielding function of the overpack.

6 Enforcement Perry Nuclear Tornado Hazards Protection at 10 CFR Tornado Discretion Power Plant Independent Spent Fuel Storage 72.212(b) Hazards Installations (ISFSI) Conditions of Upon issuance of the U.S. NRC CoC Enforcement Guidance Memorandum (EGM) 22-001 (ML22087A496), dated April 15, 2022, the licensee performed an assessment of all outdoor dry cask storage activities that are not explicitly analyzed for tornado hazards in the cask licensing basis. One configuration was identified by the licensee when a loaded Holtec HI-STORM FW storage overpack is brought out of the fuel building without a lid installed. This configuration is not explicitly analyzed in the HI-STORM FW FSAR. The 10 CFR Section72.212 (b)(6), states, in part, that "the general licensee must:...

review the Safety Analysis Report (SAR) referenced in the CoC

[Certificate of Compliance] or amended CoC and the related NRC SAR, prior to use of the general license, to determine whether or not the reactor site parameters, including analyses of earthquake intensity and tornado missiles, are enveloped by the cask design bases considered in these reports. The results of this review must be documented in the evaluation made in paragraph (b)(5) of this section."

Tornado hazards are evaluated in the Holtec HI-STORM FW FSAR section 2.2.3.e, "Environmental Phenomena and Accident Condition Design Criteria," and section 12.2.6.2, "Tornado Analysis." These sections of the FSAR do not include an analysis for tornado hazards with the storage overpack lid removed.

7 Enforcement Waterford Tornado Hazards Protection at ISFSI 10 CFR Tornado Discretion Steam Upon issuance of the U.S. NRC 72.212(b) Hazards Electric Enforcement Guidance Memorandum Conditions of Station (EGM)22-001 (ML22087A496), dated CoC Entergy April 15, 2022, the licensee performed Operations an assessment of all outdoor dry cask Inc. storage activities that were not explicitly analyzed for tornado hazards in the system's FSAR. Two configurations were identified by the licensee where transport activities did not have a related tornado wind and hazard analysis consistent with the cask's design basis requirements.

These situations occurred during outside operations when the HI-STORM FW overpack was on the low-profile transporter and when the Vertical Cask Transporter carried the overpack using the HI-STORM FW lifting brackets.

The Holtec HI-STORM FSAR section 2.2, HI-STORM FW Design Loading, which includes section 2.2 iv. Short Term Operations, "normal operation evolutions necessary to support fuel loading or unloading activities,"

describes the general design criteria for the cask system. This includes all off-normal condition loads, environmental phenomena, and accident conditions. Specifically, FSAR section 2.2.3.e. Environmental Phenomena and Accident Condition Design Criteria - Tornado, describes that the FW system must withstand pressures, wind loads, and missiles generated by a tornado while maintaining kinematic stability and continued integrity of the canister must be demonstrated. Tornado hazards are evaluated in the FSAR section 3.1.2.1.e., Design Criteria and Applicable Loads - Tornado, section 3.4.4.1 Safety Analysis, and section 12.2.6.1, Tornado Analysis. These sections of the FSAR do not include an analysis for tornado hazards when the overpack was on the low-profile transporter and when the Vertical Cask Transporter carried the overpack using the HI-STORM FW lifting brackets.

8 FY 2023 PART 71 INSPECTION VIOLATIONS

Type Licensee/ Description Applicable Category CoC Holder Regulation

SL IV - Best Theratronics Ltd. Failure to perform audits in 10 CFR Audits NCV accordance with QAP 71.137 The certificate holder (Best Audits Theratonics Limited [BTL]) did not carry out a comprehensive system of planned and periodic audits to verify compliance with all aspects of the quality assurance program that determined the effectiveness of the program.

Additionally, BTL did not perform the audits in accordance with written procedures. Specifically, BTL missed performing audits and did not complete audits as scheduled in accordance with written procedures.

SL IV - Industrial Nuclear Co. Failure to promptly correct 10 CFR Procedural NCV (INC) conditions adverse to quality 71.133 Adequacy INC failed to assure that conditions Instructions, adverse to quality were promptly Procedures, corrected. Specifically, INC, failed to and Drawings promptly correct a condition adverse to quality when actions applicable to CAR 21-005 had not been performed to identify or implement corrective actions to bring Quality Procedure (QP) 7.1 into compliance since August 2021.

SL IV - NAC International Failure to notify prior to 10 CFR 71.93 Reporting NOV fabrication Inspections NAC did not notify the NRC, in and Tests accordance with 10 CFR 71.1, 45 days in advance of starting fabrication of the first packaging under a CoC. Specifically, NAC missed opportunities to notify the NRC of fabrication activities prior to completion of the first packaging for use in the United States under the CoC Docket No. 71-9390. This paragraph applies to the OPTIMUS-L transportation packaging because it has a maximum normal operating pressure more than 103kPa. The NAC self-identified the violation and

9 performed a root cause analysis to determine the cause of the violation.

SL IV - NAC International Failure to establish control of 10 CFR M&TE NCV measuring and test equipment 71.125 Control NAC did not establish measures to Control of assure that tools, gauges, Measuring instruments, and other measuring and Test and testing devices used in activities Equipment affecting quality are properly controlled, calibrated, and adjusted at specified times to maintain accuracy within necessary limits.

Specifically, NAC oversight of fabrication activities at Joseph Oat Corporation did not establish measures to assure that the step-wedge film strip used in interpreting film of the CCV shell weld was within the 12-month calibration /

replacement period as required in section 2.3 of SP-1508, revision 3 to maintain accuracy within the necessary limits. At the time when the team discovered this issue, the step-wedge film strip had not been retested and called into question the results of previous tests including radiograph of the CCV shell weld.

10 SL IV - Nordion Failure to submit a change to 10 CFR Quality NCV QAP that reduced commitments 71.106 Assurance Nordion did not submit a description Changes to of proposed changes to its NRC-Quality approved QAP that reduced Assurance commitments in the program Program description as approved by the NRC and implemented those changes before receiving NRC approval.

Specifically, Nordion reduced its commitments for audits, and specific sections that do not reflect the current practice in the quality program description such as inspection, testing, and operating status as approved by the NRC and implemented those changes before receiving prior NRC approval.

SL IV - Source Production & Failure to adequately store 10 CFR Procedural NCV Equipment Co. records per procedure 71.111 Adherence (SPEC) SPEC did not follow the filing and Instructions, storage section of Quality Standard Procedures, Procedure Manual section 17.0 and and Drawings quality records were lost due to Hurricane Ida. Specifically, some quality records were not filed in storage devices/areas free from environmental threats as required.

SL IV - SPEC Failure to properly classify and 10 CFR Design NCV justify sealed source capsule 71.107 Changes quality category Package SPEC failed to establish measures Design to assure that appropriate quality Control standards were specified and included in design documents.

Measures were also not established for the selection and review for suitability of application of materials, parts, equipment, and processes that are essential to the functions of the materials, parts, and components of the packaging that are important-to-safety.

Specifically, SPEC did not perform an engineering evaluation and provide sufficient justification to support the assignment of ITS Category T to the sealed source capsule, which is defined as the

11 primary containment vessel in the SPEC-150 and SPEC-300 SARs.

The sealed source capsule was not properly classified as ITS Category A to ensure all required procurement controls are applied.

SL IV - ROBATEL Failure to evaluate an adverse 10 CFR Corrective NCV TECHNOLOGIES (RT) condition for appropriate 71.133 Action corrective actions Corrective Specifically, RTs QAPD Section 16, Action Corrective Action, requires that conditions adverse to quality (e.g.,

deficiencies, deviations, defective material) be documented in corrective action reports (CARs) to evaluate the cause and actions of significant conditions adverse to quality (SCAQ) to prevent recurrence. Contrary to this, although the weld deficiency was repaired, RT failed to disposition the condition (significant vs adverse) and if required, evaluate the cause and actions to prevent recurrence.

12 SL IV - ROBATEL Failure to comply with 10 CFR Procedural NCV TECHNOLOGIES procurement control procedure 71.111 Adherence The team reviewed RTs PO No. Instructions, 185, dated 05/21/2021, issued to Procedures, NFT-EPD, LLC for performance of and Drawings annual cask maintenance services for RT-100 cask nos. 1, 2, 3, and 4 in accordance with the RT-100 SAR and RT procedures. The team noted, PO No. 185, invoked a restriction that procedures and personnel used on cask maintenance work to be reviewed and approved by RT, prior to the work being performed. Further, RTs procurement control QP (No.

QP-04-01) requires RT supplier documentation approval. Contrary to these requirements, RTs review, and approval of certain cask maintenance EPD examination procedures were not documented.

In addition, documentation of qualification and certification of nondestructive examination Level III personnel performing review and approval of helium leak testing procedure (No.

2013-015-PR-CB-003) utilized during RT-100 casks annual maintenance was not apparent. The team determined that this was a violation of the NRC requirements.

SL IV - Nuclear Fuel Services Failure to have adequate 10 CFR Procedural NCV packaging inspection procedures 71.111 Adequacy Nuclear Fuel Services (NFS) failed Instructions, to prescribe activities affecting Procedures, quality by documented instructions, and Drawings procedures, or drawings of a type appropriate to the circumstances and include appropriate quantitative or qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished. Specifically, NFS failed to include in the LR package loading procedure Standard Operating Procedure 409-SEC 45, revision 18, all the required operational pre-shipment inspections for visible flaws

13 including corrosion, actions in the case of identifying corrosion, and actions for shackle securing or removal as required by the LR package SAR, revision 9, chapter 7.

SL IV - Nuclear Fuel Services Failure to perform independent 10 CFR Audits NCV internal audits 71.137 NFS failed to perform internal audits Audits of all applicable areas with auditors not having direct responsibilities in the areas being audited.

Specifically, NFS failed to perform independent audits of the vendor qualification, receipt inspection, and internal audit areas.

14 FY 2023 PART 71.95 Reports

Docket Package Model No. Description Report Reporting No. Date Requirement

07109291 CoC #9291 Liqui-Rad Westinghouse Electric Company 1/06/2023 71.95(a)(3) -

Transport Package determined that conditions of Conditions of (model LR-230) approval in CoC No. 9291 for the approval in Liqui-Rad Transport Unit Package the Certificate (model LR-230) were not followed of during a shipment on November 9, Compliance 2022. This package is used to were not transport low-enriched uranyl observed in nitrate solutions for repurposing. making a Upon receipt of heeled packages at shipment.

a customer site, the primary lid port 71.95(b) -

plug bolt was determined to have Conditions in not been properly installed prior to the Certificate shipment from Westinghouse. The of bolt was found uninstalled, sitting Compliance inside the boundary of the outer lid were not and outside containment. The followed supplier reported this issue to during a Westinghouse on November 14, shipment.

2022. The error likely occurred as a result of imprecise operation and maintenance requirements that led to a human error of missed installment and verification of the bolt. Procedures were modified to add a verification step to ensure installation and torque tightness of the bolt. No known release of contents occurred.

07109291 CoC #9291 Liqui-Rad The NFS reported that conditions 5/22/2023 71.95(a)(3) -

Transport Package of approval in CoC No. 9291 for the Conditions of (model LR-230) Liqui-Rad Transport Unit Package approval in (model LR-230) were not followed the Certificate during shipments. This package is of used to transport up to 230 gallons Compliance of low-enriched uranyl nitrate were not solution. During an NRC observed in Transportation Quality Assurance making a Inspection on March 28, 2023, shipment.

corrosion was identified on exterior 71.95(b) -

surfaces of a LR-230 container that Conditions in was being prepared for loading. the Certificate Subsequent inspection of a loaded of LR-230 trailer indicated similar Compliance corrosion on multiple containers. were not The corrosion was most significant followed

15 on the carbon steel bracing for the during a packages and on exterior surfaces shipment.

surrounding the equipment data plates. The corrosion along the carbon steel bracing plates could be described as pitting and blistering. The SAR stated that the package should not be used if corrosion is discovered on the exterior surface. The NFS operating procedure did not specifically include corrosion on the preload inspection checklist. As a result, packages were shipped with corrosion present. NFS has shipped LR-230 trailers for many years, with approximately two to three shipments per week to Westinghouse Corporation. NFS immediately stopped shipments of the loaded LR-230 trailers pending resolution with the package owner (Westinghouse Electric Corporation) and Certificate Holder (Orano TN Americas). The NFS evaluated the safety significance of this issue as low. The NFS sought information needed to determine operability for continued use until the packages could be repaired or refurbished. The NFS planned to modify their procedures to capture all applicable inspection criteria, especially corrosion.

16 FY 2023 PART 72.242 Reports

Docket Cask Type Description Report Date Reporting No. Requirement

07201004 NUHOMS 61 BTH In early November, Orano TN 11/30/2022 72.242(d)

Type 2 DSC Americas identified fabrication issues during operation activities.

The 72.242 submitted to the NRC is a proprietary document.

07201015 NAC-UMS and NAC has internally identified a 3/10/2023 72.242(d) 07201031 MAGNASTOR dry licensing basis deficiency for the cask storage NAC-UMS and MAGNASTOR dry systems cask storage systems. Specifically, a parameter used in the computation of bending stress in the finite element model used to structurally evaluate a fuel rod under the non-mechanistic tip-over accident condition was incorrectly specified resulting in the non-conservative calculation of stresses. More specifically, the calculation uses an ANSYS 2-dimensional elastic beam element, BEAM3, to represent a single fuel rod. The BEAM3 element requires the input of various real constants that define physical properties of the element such as cross-sectional area, area moment of inertia, and height. The height real constant is used by ANSYS in the computation of bending stress in the element and is defined in ANSYS documentation to be the total height of the beam (i.e., rod outer diameter in this case). The input code in question incorrectly set the height real constant using a parameter equal to the outer radius of the rod, which is half of the correct value. Use of the correct value effectively doubles the computed bending stress.

NAC has completed an impact to safety evaluation and determined there is no Impact to Safety or concerns relative to the ability of

17 the components to perform their intended safety function based on the error identified. The calculational error is specific to the non-mechanistic tip-over analysis.

Both the MAGNASTOR FSAR and UMS FSAR provide evaluations which determined the loaded systems on the ISFSI pad do not tip-over within licensed conditions.

Additionally, the safety functions of the Vertical Concrete Cask and Transportable Storage Canister e.g., passive heat rejection, environmental protection, TSC confinement, fuel assembly geometry control) are unaffected by the error in fuel rod modeling.

This condition is reportable since the deficiency when corrected results in the non-conservative calculation of fuel rod bending stresses exceeding the licensing basis limits for the NAC-UMS and MAGNASTOR. However, NAC has determined there is no safety consequence. NACs other dry cask storage system, which is the NAC-MPC system, was determined to not have been affected by this issue.

72.75 Reports: None

Part 21 Reports: None

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