ML14232A816

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Response to NEI Letter Dated July 8, 2014, Reg., Industry Input on the NRC Efforts to Clarify Title 10 of the Code of Federal Regulations, Part 21
ML14232A816
Person / Time
Issue date: 10/28/2014
From: Tracy G
Office of New Reactors
To: Walters D
Nuclear Energy Institute
Heath J. NRO/DCIP, 415-6066
References
Download: ML14232A816 (10)


Text

October 28, 2014 Mr. Douglas Walters Vice President of Regulatory Affairs Nuclear Energy Institute 1201 F Street, NW, Suite 1100 Washington, DC 20004-1218

SUBJECT:

RESPONSE TO NUCLEAR ENERGY INSTITUTE LETTER REGARDING INDUSTRY INPUT ON THE NUCLEAR REGULATORY COMMISSIONS EFFORTS TO CLARIFY TITLE 10 OF THE CODE OF FEDERAL REGULATIONS, PART 21 This letter is in response to the Nuclear Energy Institutes (NEIs) letter submitted to the U.S. Nuclear Regulatory Commission (NRC) regarding industry input on the NRC efforts to clarify Title 10 of the Code of Federal Regulations (10 CFR) Part 21, Reporting of Defects and Noncompliance, dated July 8, 2014 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML14189A169). The NEI letter expressed concerns with the NRCs approach to clarifying 10 CFR Part 21. Specifically, the NEI letter noted that rulemaking is not a practical solution to resolve the regulatory issues associated with Part 21 and that those issues can be completely addressed by issuing guidance. Based on the number of outstanding industry concerns, the NEI letter recommends that the NRC delay the schedule of proposed rulemaking and postpone publication of the revised draft regulatory basis until all the outstanding industry concerns have been resolved.

The NRC appreciates NEIs interest in the staffs effort to clarify 10 CFR Part 21. It is the NRCs policy to develop high quality rules that are consistent with the requirements of all applicable laws and regulations and to conduct rulemakings using a process that is effective, efficient, and open. The staffs regulatory basis development efforts are focused on simplifying and clarifying the rule language in Part 21, providing consolidated regulatory guidance, and enhancing regulatory stability and predictability for the entities to which Part 21 applies.

The staff is aware of the compliance challenges associated with Part 21 implementation.

Because of these challenges, the NRCs stakeholder outreach effort has been extensive. Since August 2011, the NRC has hosted six (6) Category 3 public meetings on the agencys intent to clarify and revise Part 21. The feedback from these interactions received from external stakeholders has generally been positive, particularly from vendors. The staff is considering information from external stakeholders in developing Revision 1 of the draft regulatory basis.

Following the release of Revision 1 of the draft regulatory basis, the NRC will conduct a public meeting to discuss the content and provide an opportunity for additional stakeholder comment.

The NRC is committed to maintaining an effective and efficient regulatory process that is open and transparent. The agency affirms that its efforts are consistent with the Principles of Good Regulation and that the 10 CFR Part 21 rulemaking effort is consistent with the guidelines proposed in SECY-11-0032, Consideration of the Cumulative Effects of Regulation in

the Rulemaking Process, dated March 2, 2011 (ADAMS Accession No. ML110190027). As the Part 21 rulemaking process moves forward, external stakeholders will have the opportunity to formally provide feedback on the CER during the public meeting following the issuance of Revision 1 of the draft regulatory basis, and again during the public comment period following the issuance of the proposed rule.

The NEI letter identified four specific concerns that are awaiting NRC action to enable industry stakeholder involvement. The NRC staffs responses to these concerns are provided in.

If you have any questions regarding this matter, please contact Jermaine Heath at 301-415-6066 or at Jermaine.Heath@nrc.gov.

Sincerely, Glenn M. Tracy, Director /RA/

Office of New Reactors

Enclosures:

1. NRC Response to Four Concerns Identified in NEIs July 8, 2014, Letter (ML14189A169)
2. NRC Staff Evaluation of Licensee Event Reports Sufficiency with Respect to Part 21 Reporting Requirements

ML110190027). As the Part 21 rulemaking process moves forward, external stakeholders will have the opportunity to formally provide feedback on the CER during the public meeting following the issuance of Revision 1 of the draft regulatory basis, and again during the public comment period following the issuance of the proposed rule.

The NEI letter identified four specific concerns that are awaiting NRC action to enable industry stakeholder involvement. The NRC staffs responses to these concerns are provided in.

If you have any questions regarding this matter, please contact Jermaine Heath at 301-415-6066 or at Jermaine.Heath@nrc.gov.

Sincerely, Glenn M. Tracy, Director /RA/

Office of New Reactors

Enclosures:

1. NRC Response to Four Concerns Identified in NEIs July 8, 2014, Letter (ML14189A169)
2. NRC Staff Evaluation of Licensee Event Reports Sufficiency with Respect to Part 21 Reporting Requirements DISTRIBUTION:

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Enclosure NRC RESPONSE TO FOUR CONCERNS IDENTIFIED IN NEIS JULY 8, 2014 LETTER (ML14189A169)

This enclosure sets forth the NRC staffs responses to four concerns set forth in a July 8, 2014, letter from the Nuclear Energy Institute (NEI) (Agencywide Documents Access and Management System (ADAMS) Accession No. ML14189A169).

NEI Concern 1 We have not received NRC feedback on a white paper we submitted in February 2014 (ML14059A217 and ML14059A218) that contains guidance language that clarify issues related to evaluation and reporting, including the unresolved issue of establishing the point of discovery. We value any early NRC feedback, as we plan to incorporate the language from the white paper into industry guidance that we plan to submit for NRC review and endorsement as early as July 2014.

NRC Response 1:

The NRC staff has provided feedback on the NEI white paper. NRC staff attended the NEI meeting on Part 21 guidance held on April 23, 2014. At that meeting, the staff provided feedback on NEIs guidance on evaluating and reporting, including verbal feedback on the NEI white paper. The staff shared early draft language that it intends to include in Revision 1 of the 10 CFR Part 21 draft regulatory basis. The NRC took into consideration pertinent points from the white paper and incorporated them into Revision 1 of the 10 CFR Part 21 draft regulatory basis. By letter dated August 28, 2014, the staff received the NEI guidance document on Part 21 evaluating and reporting, NEI 14-09, Guidelines for Implementation of 10 CFR Part 21 Reporting of Defects and Noncompliance, Revision 0 (ADAMS Accession No. ML14245A416).

The NEI document is currently being reviewed by the NRC staff. If the staff determines that the NEI document is acceptable, the staff will consider approving the NEI document for use via an NRC guidance document such as a regulatory guide.

NEI Concern 2:

We are still awaiting NRC-identified examples that clarify the issue of using evaluations and reports pursuant to 10 CFR Part 50.72 and 50.73 to satisfy the requirements of 10 CFR Part 21. The NRC indicated in a public meeting on May 30, 2013, that they would develop examples to clarify how the NRC believes the rule language is inconsistent with the original intent of the regulation (ML13172A093). Absent such examples, the basis for the NRCs concern about the current rule language is unclear.

NRC Response 2:

See Enclosure 2 for the NRC staffs response.

NEI Concern 3:

We have not received NRC feedback on concerns raised by the fuel cycle facilities as early as May 2013. Specifically, these include but are not limited to: 1) the potential for a lower risk reporting threshold at fuel facilities; 2) the fact that current exemptions are not precedential; 3) the fact that NRC is potentially creating a disincentive for the use of engineered controls (versus administrative controls); and 4) the fact that the safety basis for the proposed changes remains unclear.

NRC Response 3:

The staff has provided feedback on the concerns raised by the fuel cycle industry. This feedback has been provided in the multiple public meetings on the rulemaking effort.

Furthermore, to better understand how fuel cycle licensees interpret and implement 10 CFR Part 21, the staff completed a series of visits to fuel cycle facilities during the summer of 2013.

The staff considered the insights gained from these visits and feedback from industry representatives in the revision to the draft regulatory basis. For example, the revised draft regulatory basis will include the safety basis for the definition of basic component. If industry does not feel that the revised draft regulatory basis addresses the identified concerns, please provide specific comments to the staff.

NEI Concern 4:

We are still waiting for the NRC to issue a white paper detailing insights from their site visits of fuel cycle facilities to inform the NRC proposal to revise the definition of basic component for fuel cycle facilities, which we understood, during NRC meetings held in October 2013 and January 2014, the NRC planned to issue in early 2014. This white paper would provide beneficial insights for industry to understand the basis for NRCs apparent planned revisions to 10 CFR Part 21, particularly a revised definition of basic component.

NRC Response 4:

The staffs revision to the draft regulatory basis would fulfill the purpose of the white paper. The revised draft regulatory basis will include the basis for the definition basic component and the insights gained from the site visits. These insights were discussed with NEI and industry representatives during a March 6, 2014, public meeting (ADAMS Accession No. ML14072A113). The staff recently updated NEI and industry representatives on the project rulemaking schedule during a public meeting on September 22, 2014.

NRC STAFF EVALUATION OF LICENSEE EVENT REPORTS SUFFICIENCY WITH RESPECT TO PART 21 REPORTING REQUIREMENTS INTRODUCTION This enclosure sets forth the NRC staffs response to a concern presented in a July 8, 2014, letter from the Nuclear Energy Institute (NEI) (Agencywide Documents Access and Management System (ADAMS) Accession No. ML14189A169). The NEI concern, as stated in the July 8, 2014, letter is:

We are still awaiting NRC-identified examples that clarify the issue of using evaluations and reports pursuant to 10 CFR Part 50.72 and 50.73 to satisfy the requirements of 10 CFR Part 21. The NRC indicated at a public meeting on May 30, 2013, that they would develop examples to clarify how the NRC believes the rule language is inconsistent with the original intent of the regulation (ML13172A093). Absent such examples, the basis for the NRCs concern about the current rule language is unclear.

DISCUSSION During the May 20, 2013, public meeting the NRC staff led a discussion on the potential problems of using the Licensee Event Reporting process under 10 CFR 50.72 and 10 CFR 50.73 to satisfy Part 21. To address the issue of Part 21 reporting inconsistencies, the staff conducted a review of LERs reported between January 2012 to July 2014 to identify potential Part 21 defects and noncompliances documented in LERs. On the following pages, the staff provides several examples from the LER search illustrating the inconsistency of the reporting process used by licensees. The LERs were organized into two groups: Group 1) Examples of LERs where the licensee denoted the potential 10 CFR Part 21 condition; and Group 2)

Examples of LERs in which the licensee did not denote a potential 10 CFR Part 21 condition, but the staff believes contain Part 21 implications. The staffs evaluation of the Group 2 LERs determined that the issues described were potential Part 21 reportable.

In addition, the staff provided several examples of LERs that were reviewed during audit OIG-11-A-08 and considered to contain potential 10 CFR Part 21 reportable defects that were not indicated as such in the report. The Office of the Inspector General (OIG) sampled the LER database during the performance of audit OIG-11-A-08 in order to identify examples of apparent unreported defective components that could cause a substantial safety hazard but were not reported as Part 21 defective components.

The examples provided illustrate that the reports submitted by licensees pursuant to 10 CFR 50.72 or 50.73 are not used consistently to satisfy the reporting requirements of 10 CFR Part 21.

STAFF REVIEW OF LICENSEE EVENT REPORTS LERs (January 2012 - July 2014)

GROUP 1: EXAMPLES OF LERs THAT DENOTED THE POTENTIAL PART 21 CONDITIONS BY THE LICENSEE For the following list of LERs, the licensee indicated in their submittal that the event was associated with a potential Part 21 condition. In each case, the licensee indicated that the report constituted a Part 21 notification because the failure that initiated the event was attributed to a manufacturing deficiency that could create a substantial hazard.

Browns Ferry, LER 2010-003-03:

Investigation of the valve failure to open determined that the root cause was a manufacturers defect resulting in undersized disc skirt threads at disc connection.

Based on causal analysis information, the stem-to-disc separation occurred sometime before November 2008.

Browns Ferry, LER 2011-002-01:

The root cause of the oil leak was determined to be a less than adequate design of the Unit 1/2 C EDG governor oil piping to compensate for vibration loading.

Waterford, LER 2012-005-02:

The vendor report documents an as-found condition of a missing interior part, the nozzle ball, and states the item will not function without the ball in place. The vendor report does not attribute the deficiency as due to manufacturing.

Nine Mile Point, LER 2012-002-00:

The direct cause of this event was the trip of 2EJS*US1 Normal Supply Breaker due to the trip test switch contacts being made up (latent condition) which completed the circuit to the trip coil when SW1-2CESA20 was actuated. The breaker failure that initiated the event is attributed to an assembly deficiency.

Nine Mile Point, LER 2013-002-00:

The cause of this event was determined to be a turn-to-turn short in the motor winding, attributed to poor manufacturer quality of the original motor.

Comanche Peak, LER 2012-002-00:

Between October 2009 and March 2012, Comanche Peak Nuclear Power Plant Units 1 and 2 experienced three failures of safety related breaker control devices that caused Technical Specification equipment to become inoperableOn June 14, 2012, a failure

analysis concluded that these failures were caused by a material weakness of the control devices' contact carrier frames due to a manufacturing defect. Less than adequate control of the manufacturing process increased the susceptibility to shock loading of the cured phenolic material used to make the contact carrier frames.

GROUP 2: EXAMPLES OF LERs THAT DID NOT DENOTE THE POTENTIAL PART 21 CONDITION, BUT CONTAIN PART 21 IMPLICATIONS The following list of LERs contains information that suggests that the root cause of the event was attributed to a manufacturing material deficiency that could cause a substantial safety hazard, however, in each case the LER did not indicate the Part 21 potential condition, and the issue was not reported as a Part 21.

Palisades, LER 2012-001-00:

The direct cause for the crack indications in the CRDM-24 upper housing assembly was transgranular stress corrosion cracking (TGSCC). TGSCC was the result of stresses applied in the proximity of the inside surface weld onlay caused by manufacturing irregularities and misalignments between CRDM-24 upper housing assembly and supporting components.

Palisades, LER 2014-002-00:

Crack indications in the upper housing assemblies of the CRDMs were caused by transgranular stress corrosion cracking (TGSCC). An accumulation of tensile stress, a susceptible material, and an environment that supports cracking are required for TGSCC to occur. Failure mode analyses are currently in-progress.

It is suspected that manufacturing irregularities in surface onlay weld No.5 produced sufficient tensile stresses within the 316L stainless steel upper housing assemblies to initiate TGSCC.

The upper housing assemblies for 44 of the 45 total CRDM were removed and replaced with upper housing assemblies of modified design. Previously, in August 2012, the upper housing assembly of CRDM-24 was replaced with the same modified design.

Browns Ferry, LER 2009-004-01:

The root cause was a material defect in the diaphragm of 1-PCV-073-0018C, HPCI Turbine Stop Valve Mechanical Trip Hold Valve, [which] allowed the diaphragm to tear under normal system pressure and operating conditions.

Corrective actions to prevent recurrence include the quarantine of spare diaphragms determined to be from same lot as the diaphragm that failed and verifying that diaphragms from the same lot as the failed diaphragm are not currently installed.

Quad Cities, LER 2014-001-00:

An apparent through-wall valve body leak of approximately two drops per minute was discovered on the 2-0305-101-18-27 CRD HCU Scram Insert Isolation Valve. This valve is subjected to full reactor pressure during normal service and during this inspection. This valve is the isolation valve to the reactor vessel CRD drive housing, and since it is the first isolation boundary off of the reactor vessel, it therefore cannot be isolated from the reactor coolant system to allow repairs.

The valve was declared inoperable On April 1, 2014, the 2-0305-101-18-27 valve was removed from the system and shipped for analysis. It was determined that the through wall leak that developed was the direct result of an inherent manufacturing defect that eventually propagated to the valve surface following years of pressure and temperature cycles that the system normally experiences.

Hatch, LER 2012-002-01:

The direct cause for the failure of the breaker to close is attributed to an apparent vendor quality issue associated with the alternate supply breaker for the 1G emergency bus that occurred at the vendor facility during the manufacturing/assembly process. The installation of a screw on an auxiliary switch termination that penetrated the insulation of an adjacent lug created a short circuit condition that could only be manifested during an actual or simulated LOSP condition.

Waterford, LER 2012-002-00:

The diaphragm internal to the valve actuator for EFW-223B had a 1.5 inch tear along the lateral portion of the diaphragm which was the cause of the excessive leakage found during accumulator drop testing. The apparent cause evaluation attributes the cause of the tear as a manufacturing defect of the commercial grade diaphragm.

Susquehanna, LER 2012-008-00:

The direct cause of the event was an open ammeter switch contact causing a phase current imbalance that was detected by the protective relaying and initiated transformer lockout. The root causes of the event included: 1) foreign material from the manufacturing process that prevented the ammeter switch contact from closing and 2) design of the protective relay scheme that included a shared metering function.

Susquehanna, LER 2013-008-00:

The apparent cause of the failure of Reactor Building exhaust fan discharge damper solenoid valve SV17578B was due to in-service degradation of the lubricant used during the valve manufacturing process. The valve manufacturer (ASCO Services) used a silicon-based lubricant which would

migrate to the top of the plunger and become sticky during long periods of being energized. This caused the solenoid plunger to get stuck in the energized position, resulting in the valve porting air.

Byron, LER 2012-001-01:

The insulator failures were caused by service propagation of a large manufacturing material defect. The defect was characterized as poorly vitrified porcelain, which contained a high density of porosity and micro-cracks. All Ohio Brass inverted insulators associated with both Unit's SATs and Main Power transformers have been replaced with insulators from a different manufacturer.

EXAMPLES FROM THE OFFICE OF THE INSPECTOR GENERALS REVIEW OF LERs The Office of the Inspector General (OIG) sampled the LER database to see if there were examples of apparent unreported defective components that could cause a substantial safety hazard but were not reported as Part 21 defective components. This review was conducted as part of the OIG audit, NRCs Implementation of 10 CFR Part 21, Reporting of Defects and Noncompliance, OIG-11-A-08. During the period of June 2009 through June 2010, OIG identified 11 LERs considered to contain potential Part 21 reportable defects that were not indicated as such on the form. The OIG auditors requested the staff to evaluate the results.

The staff concurred that five of the 11 LERs had potential Part 21 reportable defects.

During the evaluation, the staff subsequently noted that some of the LERs evaluated by the OIG had a corresponding Part 21 posted on the Web site. The staff recommended posting three of the 11 LERs on the Operating Experience Part 21 Web site for dissemination by other licensees to evaluate for applicability to their plants.

Robinson, LER 2010-001-01:

Emergency Diesel Generator Inoperable in Excess of Technical Specifications Allowed Completion Time Dresden, LER 2009-007-00:

Reactor Protection System Nonconformance to a Design Standard Three Mile Island, LER 2009-001-01:

Multiple Main Steam Safety Valve Test Failures