IR 05000282/2009012

IR 05000282-09-012(DRS); 05000306-09-012(DRS); 05/1/2009 - 08/10/2009 (in-office Review); Prairie Island Nuclear Generating Plant, Units 1 and 2; Licensed Operator Requalification

ML092460343
Person / Time
Site:	Prairie Island
Issue date:	09/03/2009
From:	Boland A Division of Reactor Safety III
To:	Schimmel M Northern States Power Co
References
EA-09-193 IR-09-012
Download: ML092460343 (15)

Text

ber 3, 2009

SUBJECT:

PRAIRIE ISLAND NUCLEAR GENERATING PLANT UNITS 1 AND 2 NRC INSPECTION REPORT 050000282/2009012(DRS);

05000306/2009012(DRS)

Dear Mr. Schimmel:

On August 10, 2009, the U. S. Nuclear Regulatory Commission (NRC) completed a review of a request to medically condition a Prairie Island Nuclear Generating Plant operators senior reactor operator (SRO) license. The enclosed report documents our findings which were discussed with you and other members of your staff on August 10, 2009. On August 14, 2009, a subsequent discussion was conducted with J. Anderson and other members of your staff concerning cross-cutting issues associated with our findings and determined that this apparent violation does not have a cross-cutting aspect.

The review examined activities conducted under your license as they relate to safety and compliance with the Commission=s rules and regulations and with the conditions of your license.

One operators medical docket was reviewed and compared with 10 CFR Part 50 and 10 CFR Part 55 requirements.

Based on the results of this review, one apparent violation involving 10 CFR 50.9, Completeness and Accuracy of Information, was identified. The violation is being considered for escalated enforcement action in accordance with the NRCs Enforcement Policy. The current Enforcement Policy is included on the NRC=s Web site at http://www.nrc.gov/about-nrc/regulatory/enforcement/enforc-pol.pdf.

On May 11, 2007, the facility licensee requested the NRC to condition the SROs license with a Corrective Lenses Must Be Worn When Performing Licensed Duties restriction. On May 22, 2007, the NRC amended the SROs license to include the corrective lenses restriction.

On May 1, 2009, the facility licensee requested the NRC amend the SROs license to include a Must Take Medication as Prescribed to Maintain Medical Qualifications restriction. While reviewing the medical information supporting the requested license restriction, the inspector identified that the SRO had been taking medication for a potentially disqualifying medical condition since July 1998. The May 2007 license change request did not include a request by the facility licensee to have the SROs license amended to include a Must Take Medication as Prescribed to Maintain Medical Qualifications restriction. Title 10 CFR 50.9 requires, in part, that information provided to the Commission by an applicant for a license or by a licensee or information required by statute or by the Commissions regulations, Orders, or license conditions to be maintained by the applicant or the licensee shall be complete and accurate in all material respects.

The facility licensees failure to provide complete and accurate information regarding the medical condition of the SRO and to request that a medical restriction to be included in the SROs license change request in the NRC Form 396 provided to the NRC on May 11, 2007, is an apparent violation of 10 CFR 50.9. As a result of inaccurate information in the renewal request, the NRC renewed the SROs license without a restriction for the medical condition.

The incomplete and incorrect information in the renewal application was material to the NRC because it had the ability to, and did, incorrectly influence an NRC licensing action.

The circumstances surrounding the apparent violation, the significance of the issues, and the need for lasting and effective corrective actions were discussed with members of your staff during an exit meeting on August 10, 2009. As a result, it may not be necessary to conduct a Pre-decisional Enforcement Conference (PEC) in order to enable the NRC to make an enforcement decision. In addition, since your facility has not been the subject of escalated enforcement actions within the last two years, and based on our understanding of your corrective actions, a civil penalty may not be warranted in accordance with Section VI.C.2 of the Enforcement Policy. The final decision will be based on your confirming on the license docket that the corrective actions previously described to the staff have been or are being taken.

Before the NRC makes its enforcement decision, we are providing you an opportunity to either:

(1) respond to the apparent violation addressed in this inspection report within 30 days of the date of this letter; or (2) request a PEC. If a PEC is held, it will be open for public observation.

The NRC will also issue a press release to announce the conference. Please contact Mr.

Hironori Peterson at (630) 829-9707 within seven days of the receipt of this letter to notify the NRC of your intended response.

If you choose to provide a written response, it should be clearly marked as a "Response to an Apparent Violation in Inspection Report No 050000282/2009012(DRS);

05000306/2009012 (DRS); EA-09-193" and should include for the apparent violation:

(1) the reason for the apparent violation, or if contested, the basis for disputing the apparent violation; (2) the corrective steps that have been taken and the results achieved; (3) the corrective steps that will be taken to avoid further violations; and (4) the date when full compliance will be achieved. Your response may reference or include previous docketed correspondence, if the correspondence adequately addressed the required response. If an adequate response is not received within the time specified or an extension of time has not been granted by the NRC, the NRC will proceed with its enforcement decision or schedule a pre-decisional enforcement conference.

In addition, please be advised that the number and characterization of the apparent violation described in the enclosed inspection report may change as a result of further NRC review. You will be advised by separate correspondence of the results of our deliberations on this matter. In accordance with 10 CFR 2.390 of the NRC's "Rules of Practice," a copy of this letter, its enclosure, and your response, if you choose to provide one, will be available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records System (PARS) component of NRC's Agencywide Documents Access and Management System (ADAMS), accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html (the Public Electronic Reading Room). To the extent possible, your response should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the Public without redaction.

Sincerely,

/RA by Kenneth G. OBrien Acting for/

Anne T. Boland, Director Division of Reactor Safety Docket Nos. 50-282; 50-306 License Nos. DPR-42; DPR-60 Enclosure: Inspection Report 050000282/2009012(DRS);

05000306/2009012(DRS)

w/attachment: Supplemental Information cc w/encl: D. Koehl, Chief Nuclear Officer G. Salamon, Regulatory Affairs Manager P. Glass, Assistant General Counsel Nuclear Asset Manager J. Stine, State Liaison Officer, Minnesota Department of Health Tribal Council, Prairie Island Indian Community Administrator, Goodhue County Courthouse Commissioner, Minnesota Department of Commerce Manager, Environmental Protection Division Office of the Attorney General of Minnesota Emergency Preparedness Coordinator, Dakota County Law Enforcement Center

SUMMARY OF FINDINGS

IR 05000282/2009012(DRS); 05000306/2009012(DRS); 05/1/2009 - 08/10/2009 (in-office review); Prairie Island Nuclear Generating Plant, Units 1 and 2; Licensed Operator Requalification.

This report covers an approximate three-month period of in-office review of documents used for individual operator license renewal in the area of licensed operator requalification. The review was conducted by one regional specialist inspector. One apparent violation was identified during the review. The significance of most findings is indicated by their color (Green, White,

Yellow, Red) using Inspection Manual Chapter (IMC) 0609, ASignificance Determination Process.@ Findings for which the Significance Determination Process does not apply may be AGreen@ or be assigned a severity level after NRC management review. The NRC=s program for overseeing the safe operation of commercial nuclear power reactors is described in NUREG-1649, AReactor Oversight Process,@ Revision 3, dated July 2000.

A. Inspector-Identified and Self-Revealed Findings

Cornerstone: Mitigating Systems

Apparent Violation. On May 11, 2009, while reviewing an application to incorporate a medical restriction into an SROs operating license, an NRC inspector identified that Prairie Island Nuclear Generating Plant (PINGP) had provided incomplete and inaccurate information to the NRC when a license renewal was requested for the SRO in May 2007. The issue was considered to be of very low safety significance, but was considered to have important regulatory significance because the information was provided to the NRC under a signed statement and resulted in a licensing action that would not have been taken had complete and accurate information been provided to the NRC. This was an apparent violation of 10 CFR 50.9, Completeness and Accuracy of Information.

Because the issue affected the NRC=s ability to perform its regulatory function, it was evaluated using the traditional enforcement process. The finding was determined to be of low safety significance because the licensed operator had taken medications as prescribed and had not made errors during any emergency condition prior to the license being amended.

However, the regulatory significance was important because the incomplete and inaccurate information was provided under a signed statement to the NRC and impacted a licensing decision for the licensed operator. This was preliminarily determined to be an apparent violation of 10 CFR 50.9, Completeness and Accuracy of Information. No cross-cutting element for this finding was assigned. This appears to be a misunderstanding of NRC reporting requirements since they changed in January 2006 and is not reflective of current plant standards or processes in this area.

Licensee-Identified Violations

No violations of significance were identified.

REPORT DETAILS

1R11 Licensed Operator Requalification Program

.1 Conformance with Operator License Conditions

a. Inspection Scope

The inspector reviewed one senior reactor operators (SROs) license change request submitted in May 2009, which included an NRC Form 396, ACertification of Medical Examination by Facility Licensee to add a license restriction for the SRO to take prescribed medication. The inspector reviewed a request submitted in May 2007 from the licensee to amend the SROs operating license to require the operator to use corrective lenses. The amendment request in May 2007, included a new NRC Form 396 and a letter from the facilitys Medical Review Officer (MRO) submitted to the NRC in support of the request to restrict the SROs operating license. The original records are maintained by the facility licensee and document compliance with the medical standards delineated in ANSI/ANS 3.4-1983, AAmerican National Standard Medical Certification and Monitoring of Personnel Requiring Operator Licenses for Nuclear Power Plants,@

and with 10 CFR 55.21, 10 CFR 55.25, and 10 CFR 55.53(j).

b. Findings

Introduction:

On May 11, 2009, while reviewing an application to incorporate a medical restriction into an SROs operating license, an NRC inspector identified that Prairie Island Nuclear Generating Plant (PINGP) had provided incomplete and inaccurate information to the NRC when a license renewal was requested for the SRO in May 2007.

The issue was considered to be of very low safety significance, but was considered to have important regulatory significance because the information was provided to the NRC under a signed statement and resulted in a licensing action that would not have been taken had complete and accurate information been provided to the NRC. This was an apparent violation of 10 CFR 50.9, Completeness and Accuracy of Information.

Description:

Operator licenses expire every six years and must be renewed to allow the operator to continue to perform license duties. When a license renewal occurs, the licensee must submit an NRC Form 398, Personal Qualification Statement - Licensee, and an NRC Form 396, ACertification of Medical Examination by Facility Licensee,@

(required by 10 CFR 55.21) to the NRC. The NRC Form 396 certifies, when signed by a senior facility licensee official, that the individual licensee has been examined by a doctor and meets the medical standards in ANS/ANSI-3.4-1983. In February 2006, the NRC Region III Operations Branch issued a letter to all Region III nuclear stations explaining that a new NRC Form 396 had been issued with new reporting requirements for license restrictions. On May 11, 2007, the licensee requested a conditioned license for an SRO requiring corrective lenses. On May 22, 2007, the SROs operating license was renewed with only the corrective lenses restriction. The license renewed in May 2007 occurred after the new NRC Form 396 reporting requirements were instituted in January 2006.

On July 6, 1998, the SRO, who was a licensed Reactor Operator (RO) at the time, reported to PINGP medical personnel that he had started taking prescribed medication for a potentially disqualifying medical condition. [Note: The information concerning the individuals specific medical condition is considered medical privacy information under 10 CFR 2.390(2)(6) and is not specifically discussed here.] Because the medication the SRO reported he was taking involved a potentially disqualifying medical condition, PINGP management was required to notify the NRC of the operators condition to allow the NRC an opportunity to review the medication type, dosage and frequency to determine if a license restriction should be applied to the operators license. The facility licensee notified the NRC of the condition and the NRC conditioned the operators license, requiring him to submit additional medical data in October 1998, for continued monitoring of his condition. The SRO submitted the required data in October 1998, whereupon his license was again conditioned to re-submit the required data in April 1999, for continued monitoring. The SRO submitted the required data in April 1999, and provided a letter from the stations MRO that stated, Based on review of this medical information, it appears to me that Mr. (operator) is qualified to function under his NRC licensure according to ANSI Standard 3.34 1983 10 CFR Part 55 without restrictions or need for accommodation. The NRC did not re-condition the SROs license at that time, with the understanding that the SRO was no longer required to take any medication nor had a need for accommodation for a potentially disqualifying medical condition.

In a letter dated April 25, 2003, PINGP management applied to Region III to renew the SROs operating license. The application included an NRC Form 398 and an NRC Form 396. The NRC Form 396 certified that no restrictions were needed for the operators license. The SROs license was renewed without restrictions in May 2003.

In a letter dated July 21, 2005, the PINGP management requested the SRO be administered an Upgrade SRO license examination. The NRC Form 396 that accompanied the upgrade examination request stated the license should have no restrictions. The SRO received his SRO license in September 2005. In a letter dated May 11, 2007, the facility requested we condition the SROs license with a Corrective Lenses Must Be Worn When Performing Licensed Duties, restriction. The amended license was sent to the operator on May 22, 2007.

In May 2007, the NRC Region III renewed the SRO=s license based on the NRC Form 396 from the facility licensee that requested only a corrective lenses license restriction. Therefore, the information provided to the NRC in the May 2007 license renewal application was material to the NRC licensing action. Because the license application, and specifically the NRC Form 396, did not inform the NRC of the medication being taken by the SRO for the potentially disqualifying condition, nor request a Must Take Medication as Prescribed to Maintain Medical Qualifications restriction, a licensing action was taken by the NRC Region III that was incorrect in that the renewed license did not include a Must Take Medication as Prescribed to Maintain Medical Qualification license restriction. Because the licensee failed to provide complete and accurate information to the NRC in the license renewal application and on the NRC Form 396 concerning the SROs health, this was an apparent violation of 10 CFR 50.9.

In a letter dated May 1, 2009, (L-PI-09-062) following a review of medical records by the facilitys MRO, PINGP management determined a medical restriction was necessary and requested an amendment to the SROs license to add the AMust Take Medication as Prescribed to Maintain Medical Qualifications license restriction. The NRC=s MRO reviewed the medical information submitted by the licensee, which now included a list of medications prescribed and the diagnosis of the potentially disqualifying medical condition and determined the restriction was required. The SRO=s license was conditioned accordingly and an amended license was issued to the SRO on May 20, 2009.

This apparent violation does not have a cross-cutting aspect. The licensee inadvertently missed the need for the medical condition on the operators license. Additionally, this error does not reflect current performance in this area. The licensee has developed a medical review standard that should eliminate this category of licensing error.

Analysis:

Because a violation of 10 CFR 50.9 is considered to be a violation that potentially impedes or impacts the regulatory process, it is dispositioned using the NRC Enforcement Policy instead of the Significance Determination Process. Using Inspection Manual Chapter (IMC) 0612, Appendix B, AIssue Dispositioning Screening,@ the findings were determined to be more than minor because the information associated with the SROs license renewal was provided to the NRC under a signed statement by the Site Vice President and impacted an NRC licensing decision. An SRO that required a AMust Take Medication as Prescribed to Maintain Medical Qualifications@ restriction on his license was issued a license without such a restriction. An operator that cannot perform licensed duties due to a medical condition that might be exacerbated by the stress resulting from a reactor accident scenario could be a significant distraction to the rest of the crew. Therefore, the safety significance of this issue was determined to be more than minor. The regulatory significance was high because the information was material to an NRC licensing decision and an NRC operating license was issued without all of the proper medical restrictions because incomplete and inaccurate information was provided to the NRC in the application in May 2007.

Enforcement:

Title 10 CFR 50.9 requires, in part, that information provided to the Commission by an applicant for a license, or by a licensee, or information required by statute, or by the Commissions regulations, orders, or license conditions to be maintained by the applicant, or the licensee shall be complete and accurate, in all material respects.

Title 10 CFR 55.23 requires that to certify the medical fitness of the applicant, an authorized representative of the facility licensee shall complete and sign NRC Form 396, "Certification of Medical Examination by Facility Licensee."

The NRC Form 396, when signed by an authorized representative of the facility licensee, certifies that a physician conducted a medical examination of the applicant, and that the guidance contained in American National Standards Institute/American Nuclear Society (ANSI/ANS)-3.4-1983, AMedical Certification and Monitoring of Personnel Requiring Operator Licenses for Nuclear Power Plants,@ was followed in conducting the examination and making the determination of medical qualification. In particular, it identifies required medical condition restrictions to maintain medical qualifications.

American National Standards Institute/American Nuclear Society-3.4-1983, Section 5.3, provides, in part, that the presence of certain medical conditions, unless adequately compensated by the methods specified in subsections 5.3 1 through 5.3.9, shall disqualify the individual.

On May 11, 2007, the licensee submitted an application to condition an SROs operating license with a Corrective Lenses Must Be Worn When Performing Licensed Duties license restriction. An NRC Form 396 associated with the renewal certified the medical condition of the SRO. That NRC Form 396 was not complete and accurate in all material respects. Specifically, the NRC Form 396 certified that the applicant met the medical requirements of ANSI/ANS-3.4-1983, with only a corrective lenses license restriction when, in fact, the operator was relying on prescription medication to maintain medical qualifications. This information was material to the NRC because the NRC relied on the NRC Form 396 to determine whether the applicant met the requirements of 10 CFR Part 55 to operate the controls of a nuclear power plant. This was an apparent violation of 10 CFR 50.9. (AV 05000282/2009012-01; 05000306/2009012-01)

Although the licensee eventually identified the need for the required restriction on the SROs operating license, the licensee provided incomplete and inaccurate information material to the NRC that resulted in an incorrect licensing action and failed to identify there was a violation of NRC requirements. Because NRC intervention was required to identify that a violation of NRC requirements had occurred, this apparent violation was considered NRC identified. This issue was entered in the licensees corrective action program as CAP 1184252. The licensee took or planned to take the following corrective actions.

The licensee will review the root cause evaluation performed at Monticello Nuclear Generating Plant in response to a similar violation, to:

(1) determine if the corrective actions put in place will prevent similar violations from occurring which would indicate this is a legacy issue, and

(2) to determine if any new corrective actions are required.

The licensee will conduct an extent of condition to identify upcoming Form 396 submittals that fall in this category that need to be flagged in records to ensure proper updates are not missed. The site nurse will evaluate this condition to identify and implement any additional corrective actions.

4OA6 Management Meetings

.1 Exit Meeting Summary

On August 10, 2009, the inspector presented the inspection results to M. Wadley and other members of the PINGP staff. Mr. Wadley and the staff acknowledged the issue presented. The inspector confirmed that none of the potential report input discussed was considered proprietary.

On August 14, 2009, the inspector discussed cross-cutting aspects associated with this apparent violation with Mr. J. Anderson and others of your staff and determined that the issue does not have a cross-cutting aspect. Mr. Anderson acknowledged the issues presented. The inspectors confirmed that none of the potential report input discussed was considered proprietary.

ATTACHMENT:

SUPPLEMENTAL INFORMATION

KEY POINTS OF CONTACT

Licensee

M. Wadley, Site Vice President

B. Swatzke, Director, Site Operations

J. Sternisha, Plant Training Manager

J. Anderson, Manager, Regulatory Affairs

M. Davis, Analyst, Regulatory Compliance

J. Sorensen, General Manager, Nuclear Training - Xcel Corporate

T. Ouret, Licensed Operator Training

J. Peterson, Site Medical Services

J. Lash, Manager, Operations

Nuclear Regulatory Commission

H. Peterson, Chief, Operations Branch, Region III

D. McNeil, Senior Operations Engineer, Region III

LIST OF ITEMS

Opened

05000282/2009012-01 AV Failure to Provide Complete Information to the NRC which

05000306/2009012-01 Impacted a Licensing Decision. (Section 1R11)

Closed

None

Discussed

None Attachment