IR 05000220/2015008

Notice of Violation - Severity Level III Problem - NRC IR 05000220/2015008 and 05000410/2015008

ML15100A341
Person / Time
Site:	Nine Mile Point
Issue date:	04/10/2015
From:	Dan Dorman Region 1 Administrator
To:	Orphanos P Exelon Generation Co, Nine Mile Point
Marjorie McLaughlin
References
EA-14-192 IR 2015008
Download: ML15100A341 (9)

Text

UNITED STATES NUCLEAR REGULATORY COMMISSION ril 10, 2015

SUBJECT:

NINE MILE POINT NUCLEAR STATION - NOTICE OF VIOLATION -

SEVERITY LEVEL III PROBLEM - NRC INSPECTION REPORT NO.

05000220/2015008 AND 05000410/2015008

Dear Mr. Orphanos:

This letter provides you the NRC enforcement decision for the apparent violations documented in Inspection Report No. 05000220/2014005 and 05000410/2014005, issued to Exelon Generation Companys (Exelons) Nine Mile Point Nuclear Station (NMP) on February 5, 2015 (ML15037A047)1. The apparent violations, associated with licensed reactor operator medical examinations and related NRC reporting requirements, were discussed with Exelon representatives at an inspection exit meeting on January 8, 2015, and documented in the subject inspection report.

In the letter transmitting the inspection report, we requested that you address the apparent violations identified in the report by either attending a pre-decisional enforcement conference, providing a written response, or requesting Alternative Dispute Resolution, before we made our final enforcement decision. Specifically, we requested additional information from Exelon regarding long-term corrective actions to prevent recurrence of the issue, such as information related to any plans by Exelon to provide continuing training on NRC regulatory requirements and ANSI standards for both site medical staff and licensed operators. In a letter dated March 5, 2015 (ML15091A281), you provided a response to the apparent violations that accepted the violations, described the results of a root cause evaluation of the issue (including the identification of additional violation examples which the NRC determined to be bounded and encompassed by the identified apparent violations), and summarized the corrective actions both taken and planned. In a subsequent telephone conversation on March 11, 2015, Bill Trafton and Terry Syrell of your staff reiterated the contents of the March 5, 2015 letter with Donald Jackson, Chief, NRC Region I Operations Branch, and other members of my staff.

Designation in parentheses refers to an Agency-wide Documents Access and Management System (ADAMS) accession number. Documents referenced in this letter are publicly-available using the accession number in ADAMS. Based on the information developed during the inspection, and that you provided in your March 5, 2015, letter, the NRC has determined that violations of NRC requirements occurred.

These violations are cited in the enclosed Notice of Violation (Notice), and the circumstances surrounding them are described in detail in the subject inspection report and in the NRCs February 5, 2015, letter.

The first violation involved multiple instances between June 2002 and August 2014, in which NMP did not notify the NRC within 30 days of learning of changes in the medical conditions of licensed reactor operators (ROs) and senior reactor operators (SROs) that involved permanent disabilities/ illnesses, as required by Title 10 of the Code of Federal Regulations (CFR) Section 50.74. Specifically, the operators, during biennial medical examinations, informed the NMP medical review officer (MRO) that they had been prescribed medications for such conditions as hypertension, post-traumatic stress disorder, attention deficit disorder, and asthma. However, the MRO did not recognize that these conditions constituted permanent disabilities or illnesses that required NRC notification and, therefore, did not provide the required notification.

Additionally, between June 2002 and September 2014, NMP did not restrict licensed ROs and SROs from performing licensed duties when the individuals had disqualifying medical conditions, in accordance with 10 CFR 55.25. Specifically, the operators performed licensed duties while they had permanent disabilities or illnesses that caused them to not meet the requirements of 10 CFR 55.33(a)(1), since each had medical issues that were defined by ANSI/ANS 3.4-1983 as disqualifying conditions, and the NRC licenses for these operators were not conditioned to accommodate the medical concerns.

The second violation involved the licensee, between September 2002 and February 2012, submitting various licensing applications for the operators referenced above (including applications for RO and SRO initial and/or renewed licenses and RO and SRO license amendments), each of which included NRC Form 396s that certified the medical fitness of these applicants and that did not identify any needed license operator restrictions regarding disqualifying medical conditions or related prescribed medication. However, each of these applicants had medical conditions that did not meet the minimum standards of 10 CFR 55.33(a)(1) and, therefore, required specific license conditions in order to perform licensed activities. Based, in part, on this inaccurate information, the NRC issued operator license documents without proper evaluation of disqualifying medical conditions and application of license operator restrictions.

Each violation was assessed at Severity Level III (SL III), because each was similar to the Enforcement Policy SL III example violation 6.4.c.4 for inaccurate or incomplete information inadvertently provided to the NRC, subsequently contributing to the NRC making an incorrect regulatory decision (such as granting an RO or SRO license, contributing to an individual being permitted to perform the function of an RO or SRO, or contributing to a medically unqualified individual performing the functions of a licensed RO or SRO). However, the NRC has concluded that both violations resulted from the licensees failures to: 1) oversee the licensed operator medical examination process and 2) train the medical staff involved with the process on the requirements of ANSI/ANS-3.4-1983 and 10 CFR Part 55. Accordingly, these violations have been categorized collectively as one Severity Level III (SL III) problem to emphasize the importance of providing suitable training, oversight, and focus on licensed operator medical requirements. In accordance with the NRC Enforcement Policy, a base civil penalty in the amount of $70,000 is considered for a SL III problem involving a power reactor licensee. Because Exelons NMP facility has not been the subject of escalated traditional enforcement action within the last two years or two inspections, the NRC considered only whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section 2.3.4 of the Enforcement Policy. The NRC has concluded that credit is warranted for Exelons corrective actions. Specifically, in addition to requesting that the NRC amend or terminate, as appropriate, each impacted operators license to account for any disqualifying conditions, thereby restoring compliance, Exelon has, in part: (1) conducted a root cause evaluation that included an extent of condition review to determine if other operators had disqualifying medical conditions; (2)

implemented standard Exelon procedures, new to NMP, that resulted in the site instituting a multi-disciplinary oversight committee, that is currently meeting monthly, and that discusses upcoming license submittals, training, and other methods to ensure licensed operators are maintaining their medical qualifications; (3) instituted an independent review of operators medical examinations by Exelon corporate staff; (4) provided read-and-sign training of all licensed operators on the process and requirements for reporting changes in medical conditions, and developed plans to perform more formal training; (5) trained the NMP nurse practitioner on NRC medical restriction requirements and instituted annual training requirements for all site medical personnel; (6) instituted an annual, full audit of all operator medical charts as well as quarterly peer-to-peer audits; and (7) committed to revising its fleet procedure to improve the review and approval process of NRC Form 396s by providing site senior management the opportunity to compare the form to the operators medical file.

Therefore, to encourage prompt and comprehensive correction of violations, and in recognition of the absence of previous escalated traditional enforcement action, I have been authorized, after consultation with the Director, Office of Enforcement, not to propose a civil penalty in this case. However, significant violations in the future could result in a civil penalty.

The NRC has concluded that information regarding: (1) the reasons for the violations; (2) the actions planned or already taken to correct the violations and prevent recurrence; and (3) the date when full compliance was achieved, is already adequately addressed on the docket in Inspection Report No. 05000220/2014005 and 05000410/2014005, in your letter dated March 5, 2015, and in this letter. Therefore, you are not required to respond to this letter unless the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice.

In accordance with 10 CFR 2.390 of the NRC's "Rules of Practice," a copy of this letter and its enclosure will be made available electronically for public inspection in the NRC Public Document Room and in the NRCs Agencywide Documents Access and Management System (ADAMS), accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html. To the extent possible, your response should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the Public without redaction. If personal privacy or proprietary information is necessary to provide an acceptable response, please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such information, you must specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.390(b) to support a request for withholding confidential commercial or financial information).

The NRC also includes significant enforcement actions on its Web site at (http://www.nrc.gov/reading-rm/doc-collections/enforcement/actions/).

Sincerely,

/RA/

Daniel H. Dorman Regional Administrator Docket Nos. 50-220; 50-410 License Nos. DPR-63; NPF-69 Enclosure: Notice of Violation cc w/enclosure: Distribution via ListServ