94-31777. Rosemount Nuclear Instruments, Incorporated; Director's Decision Under 10 CFR 2.206  

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    [FR Doc No: 94-31777]
    
    
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    [Federal Register: December 27, 1994]
    
    
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    NUCLEAR REGULATORY COMMISSION
    [Docket No. 99900271]
    
     
    
    Rosemount Nuclear Instruments, Incorporated; Director's Decision 
    Under 10 CFR 2.206
    
        The Director, Office of Nuclear Reactor Regulation, has taken 
    action with respect to two related Petitions filed by Paul M. Blanch. 
    Notice is hereby given that by letter dated December 31, 1992, Mr. 
    Blanch requested that the Nuclear Regulatory Commission (Commission) 
    impose immediate enforcement action against Rosemount Nuclear 
    Instruments, Incorporated for a knowing and intentional failure to 
    submit, as required by 10 CFR Part 21, a notice to the Commission that 
    ``basic components supplied'' to its customers ``contained defects,'' 
    as defined by 10 CFR Sec. 21.3. In a second letter dated March 28, 
    1994, the Petitioner requested the Commission to inform all users of 
    Rosemount 1150-series pressure transmitters and trip units of 
    ``significant safety problems'' identified in Commission Inspection 
    Report 99900271/93-01, and that the Commission take ``prompt and 
    vigorous'' enforcement action against Rosemount for careless disregard 
    of the reporting requirements of 10 CFR Part 21.
        The Director of the Office of Nuclear Reactor Regulation (NRR) has 
    granted these Petitions in part and denied them in part. The reasons 
    for the Director's actions are set forth in the ``Director's Decision 
    under 10 CFR Sec. 2.206'' (DD-94-12), which is available for public 
    inspection in the Commission's Public Document Room at 2120 L Street, 
    NW. (Lower Level), Washington, DC 20555-0001.
        A copy of the Director's Decision will be filed with the Secretary 
    for the Commission's review in accordance with 10 CFR Sec. 2.206(c) of 
    the Commission's regulations. As provided by that regulation, the 
    Decision will constitute the final action of the Commission 25 days 
    after the date of issuance of the Decision unless the Commission on its 
    own motion institutes a review of the Decision within that time.
    
        Dated at Rockville, Maryland, this 15th day of December, 1994.
    
        For the Nuclear Regulatory Commission.
    William T. Russell,
    Director, Office of Nuclear Reactor Regulation.
    
    Appendix A to This Document--Director's Decision Under 10 CFR 2.206
    
    I. Introduction
    
        On December 31, 1992, Mr. Paul M. Blanch (the Petitioner) filed 
    a Petition with the Executive Director for Operations, pursuant to 
    Section 2.206 of Title 10 of the Code of Federal Regulations (10 CFR 
    2.206), in which he requested that the U.S. Nuclear Regulatory 
    Commission (NRC) impose immediate enforcement action against 
    Rosemount for a knowing and intentional failure to submit, as 
    required by 10 CFR Part 21, a notice to the Commission that ``basic 
    components supplied'' to its customers ``contained defects,'' as 
    defined by 10 CFR 21.3. On March 2, 1993, the Petitioner sent a 
    letter to the NRC in which he stated, in part, that he ``was 
    requesting enforcement action against Rosemount for failing to 
    report defects as required by 10 CFR 21,'' and making ``a simple 
    request that [the NRC] investigate a potential cover-up and a 
    failure to report a defect in accordance with the requirements of 10 
    CFR 21.'' On March 28, 1994, the Petitioner filed a second Petition 
    in which he requested that the NRC inform all users of Rosemount 
    1150-series pressure transmitters and series 510 and 710 DU trip 
    devices of ``significant safety problems'' identified in NRC 
    Inspection Report 99900271/93-01 (which addressed principally the 
    NRC staff inspection of Rosemount's 10 CFR Part 21 and Appendix B to 
    10 CFR Part 50 established programs), and that the NRC take ``prompt 
    and vigorous'' enforcement action against Rosemount for careless 
    disregard of the reporting requirements of 10 CFR Part 21. In a 
    letter dated May 2, 1994, the Petitioner reiterated his request that 
    the NRC take action to inform all users of Rosemount 1150-series 
    pressure transmitters and series 510 and 710 DU trip devices of the 
    ``significant safety problems'' identified in NRC Inspection Report 
    99900271/93-01,
        By letters dated February 2 and April 7, 1993, in response to 
    the Petition of December 31, 1992, and letter of March 2, 1993, the 
    NRC staff stated that the request for immediate action was denied 
    because the actions it had already taken to address the problems 
    with Rosemount transmitters were sufficient to ensure that the 
    problems did not constitute an immediate safety concern for any 
    nuclear power plant. The NRC staff also stated in those letters 
    that, as provided by 10 CFR 2.206, action would be taken on the 
    Petition within reasonable time. By letters dated April 25 and June 
    3, 1994, in response to the Petitioner's letters of March 28 and May 
    2, 1994, the NRC staff stated that the NRC inspection report was 
    included in the April 1994 publication of NUREG-0040,\1\ ``which is 
    sent to all nuclear power plant licensees,''\2\ and that none of the 
    identified issues were considered significant enough to warrant 
    immediate notification of the nuclear industry.
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        \1\NUREG-0040, ``Licensee Contractor and Vendor Inspection 
    Status Report,'' is distributed to NRC licensed facilities, 
    manufacturers, suppliers, architect engineer firms, nuclear steam 
    supply system suppliers and is publicly available at NRC public 
    document rooms, National Technical Information Services (NTIS) and 
    through the Government Printing Office (GPO) sales office.
        \2\Subsequently, NRC staff identified the NUREG-0040 was not 
    distributed to ``all nuclear power plant licensees'' as stated to 
    the Petitioner by letter dated April 25, 1994, because of an NRC 
    staff error that was made concerning the NUREG-0040 distribution 
    process. Therefore, the NRC staff directed in October 1994 that 
    Inspection Report 99900271/93-01 be sent to all power reactor 
    licensees and construction permit holders. NRC staff has verified 
    that the distribution of the inspection reports was completed.
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        In regard to the Petitioner's second request,``to take prompt 
    and vigorous enforcement action against Rosemount for careless 
    disregard of 10 CFR Part 21 requirements,'' the Petitioner was 
    informed in the April 25, 1994, letter, that ``[t]he NRC will make 
    its determination as to enforcement action, [against Rosemount] 
    should such enforcement action be warranted, following the 
    enforcement conference.''
        The Director of the Office of Nuclear Reactor Regulation (NRR) 
    has granted these Petitions in part. Specifically, pursuant to the 
    ``General Statement of Policy and Procedure for NRC Enforcement 
    Actions'' (Enforcement Policy), 10 CFR Part 2, Appendix C, a 
    Severity Level II notice of violation was issued to Rosemount on 
    November 15, 1994. On the basis of the conclusions and findings in 
    NRC Office of Investigations (OI) Investigation Report 4-90-009, 
    dated November 12, 1993, in NRC Inspection Report 99900271/93-01, 
    and NRC staff deliberations on a Rosemount presentation of its 
    relevant information regarding the Rosemount pressure transmitter 
    sensor cell oil-loss problem during the enforcement conference on 
    June 23, 1994, the NRC staff concluded that Rosemount acted in 
    careless disregard of 10 CFR Part 21 requirements and its own 
    procedures by failing to adequately evaluate or to inform its 
    customers of the potential for degraded transmitter operation as a 
    result of the oil-loss problem.
        Additionally, on October 11, 1994, the NRC staff received an 
    unsolicited letter from Rosemount, dated September 28, 1994. In this 
    letter, Rosemount stated that it agreed with the NRC ``views'' 
    expressed at the June 23, 1994, enforcement conference on the 
    importance of 10 CFR Part 21. However, Rosemount stated that it 
    could not concur in the view that Rosemount acted in careless 
    disregard of NRC requirements by failing to adequately identify and 
    report potential defects in its Model 1153 pressure transmitters 
    prior to December 1988. Rosemount attached a 40 page enclosure to 
    its letter that takes exception to a number of statements and 
    conclusions delineated in the NRC inspection report. These 
    exceptions included Rosemount's position that early (1984) 
    transmitter failure mechanisms were never established as resulting 
    from oil loss, and the oil loss problem could have resulted from 
    other factors unrelated to transmitter design. Rosemount 
    additionally disagreed with the position in the inspection report 
    that early non-nuclear grade Model 1151 transmitter failures should 
    have made Rosemount aware of a potentially generic problem affecting 
    its nuclear grade transmitters.\3\ Further, Rosemount disagreed with 
    the portion of the inspection report that identifies the time that 
    Rosemount began to track field returns of failed transmitters.
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        \3\During this particular period of time, the sensor cell for 
    both Model 1151, non-nuclear grade transmitters, and Models 1152 and 
    1153, nuclear grade transmitters, were manufactured in the same 
    production line, utilizing the same manufacturing and production 
    line process controls.
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        The staff reviewed the information in the Rosemount letter and 
    determined that the letter did not provide new information or 
    arguments that would cause any change in the staff's position. The 
    inspection report and the OI investigation identified numerous 
    instances where problems with transmitters implicating the 
    transmitter design, manufacturing or test processes were brought to 
    Rosemount's attention but were not properly addressed by Rosemount 
    for their generic or common-mode failure implications. The staff 
    concluded that Rosemount failed to address these generic or common-
    mode failure implications, initially because it improperly 
    dispositioned the failures as random rather than using available 
    information to identify deviations that clearly, in the staff's 
    view, represented a common mode failure potential. Despite having, 
    as the OI investigation identified multiple examples of transmitter 
    failures and several members of the Rosemount staff convinced that 
    the failures were a result of manufacturing problems common to all 
    the transmitter sensor cells, Rosemount failed to inform NRC 
    licensees of the deviation.\4\ The staff concluded that Rosemount's 
    knowledge of this deviation, coupled with its failure to inform 
    licensees, constituted careless disregard for the requirements of 10 
    CFR Part 21.
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        \4\As defined in 10 CFR 21.3, deviation means a departure from 
    the technical requirements included in a procurement document. The 
    identified oil-loss problem was considered a deviation because 
    sensor cell oil-loss caused Rosemount transmitters to depart from 
    technical performance specifications that were delineated in 
    Rosemount product data sheets.
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    II. Background
    
        Since the mid-1980s, the NRC staff had been aware of several 
    potential problems with Rosemount Models 1152, 1153, and 1154 
    transmitters (1150-series transmitters). In 1987, the NRC conducted 
    an inspection at Rosemount because of a potential generic problem 
    concerning degraded transmitter operation associated with 
    contaminants in sensor cell oil, a condition referred to as ``latch-
    up'' identified in the early 1980s. During the same period that 
    Rosemount was trying to resolve the latch-up problem, another sensor 
    cell related problem was identified that also caused degraded 
    transmitter operation. The second problem involved transmitter 
    sensor cell oil-loss, which was not readily detectable because the 
    sensor cell was sealed inside the transmitter. Rosemount pressure 
    transmitter sensor cell oil-loss problems in nuclear applications 
    occurred in a number of instances and at varying frequencies from 
    1984 on, indicating a potential generic problem with the 
    transmitters. Rosemount nevertheless treated each licensee or 
    Rosemount-identified oil-loss problem as an isolated occurrence, and 
    handled the problems essentially on an individual basis as they 
    arose. Although Rosemount indicated to the NRC staff and licensees 
    that the failures resulting from oil loss appeared to be random and 
    unrelated to any generic problem with Rosemount 1150-series 
    transmitters, the staff nevertheless issued NRC Information Notice 
    89-42, ``Failure of Rosemount Models 1153 and 1154 Transmitters,'' 
    on April 21, 1989, to alert licensees to this potentially generic 
    problem. On May 10, 1989, Rosemount issued the first of four 
    technical bulletins in which it discussed loss of oil in its 
    pressure transmitters. The NRC staff continued to monitor the oil-
    loss problem and discuss the potentially generic problem with 
    Rosemount and the industry.
        The NRC staff remained concerned that the transmitter oil-loss 
    problem did not appear to be isolated, as Rosemount had been 
    informing licensees. Therefore, on March 9, 1990, it issued Bulletin 
    90-01, ``Loss of Fill-Oil in Transmitters Manufactured by 
    Rosemount,'' to ensure that all licensees were adequately informed 
    about the problem and would take appropriate corrective action. 
    After obtaining additional information, the staff issued Supplement 
    1 to Bulletin 90-01 on December 22, 1992.
        In February and March 1993, NRC staff performed an inspection at 
    Rosemount. On March 4, 1994, the staff issued Inspection Report 
    99900271/93-01, in which it identified an apparent violation of 10 
    CFR Part 21 regarding the transmitted oil-loss problem and asked 
    Rosemount to participate in an enforcement conference on the matter. 
    In the report, the staff also identified several other violations of 
    10 CFR Part 21 and several nonconformances regarding Appendix B to 
    10 CFR Part 50. On June 23, 1994, an enforcement conference was held 
    at NRC headquarters in Rockville, Maryland.
    
    III. Discussion
    
        On the basis of the evidence developed during the investigation, 
    OI determined that two allegations were partially substantiated. 
    Regarding the first partially substantiated allegation, OI 
    determined that Rosemount presented incomplete and inaccurate 
    information to the NRC during a public meeting on April 13, 1989. 
    However, the evidence developed during OI's investigation did not 
    substantiate that this presentation of incomplete and inaccurate 
    information was deliberate. Although the NRC staff recognized that 
    the inaccurate and incomplete statements made to the NRC during the 
    public meeting on April 13, 1989, were not deliberate, it had 
    substantial concerns about this matter and emphasized to Rosemount 
    in the letter of November 15, 1994, that the submittal of inaccurate 
    or incomplete information to the NRC is unacceptable and that the 
    NRC expects all licensee and vendor communications to be complete 
    and accurate and to properly reflect situations that could have 
    implications for public health and safety.
        Regarding the second partially substantiated allegation, OI 
    determined that Rosemount acted with careless disregard when, in 
    violation of 10 CFR Part 21, it failed to adequately identify and 
    report a deviation regarding sensor cell oil-loss that was known to 
    Rosemount staff and to inform its customers of the problem.
        This violation was of concern because Rosemount did not fulfill 
    its basic 10 CFR 21.21 responsibility of ``informing the licensee or 
    purchaser of the [transmitter oil-loss] deviation in order that the 
    licensee or purchaser may cause the deviation to be evaluated unless 
    the deviation has been corrected.'' Rosemount was aware that its 
    manufacturing processes and testing were causing and allowing slow 
    leaking sensor cells to be used in nuclear transmitters, but 
    Rosemount did not apprise NRC licensees of those circumstances. 
    Although the different causes of the oil-loss problem were known to 
    the Rosemount staff, that information was not accurately or 
    completely transmitted to individual licensees for their use in 
    performing an evaluation pursuant to Part 21. As a result, the 
    licensee Part 21 evaluations that were performed with the 
    information which was provided to them by Rosemount did not 
    encompass all of the known circumstances surrounding the oil-loss 
    problem. The objective evidence indicated that Rosemount field 
    service staff became concerned after the discovery of several 
    transmitters with degraded operation that exhibited oil-loss at one 
    NRC-licensed facility in 1984. Additional instances of oil-loss in 
    the nuclear transmitters continued to be documented by Rosemount 
    between 1984 and 1988. It appeared to the NRC staff that Rosemount's 
    emphasis was on correcting the manufacturing and testing weaknesses 
    which allowed degraded transmitter operation due to oil-loss without 
    much consideration of candidly informing NRC licensees of the 
    potential for degraded operation of Rosemount transmitters installed 
    in safety-related applications at NRC licensed operating nuclear 
    power plants. Between 1984 and 1988, Rosemount received many of the 
    failed units from its nuclear customers, performed failure analyses, 
    and determined that the degraded operation of these units was caused 
    from sensor cell oil-loss. Despite these numerous indications of 
    potential problems with the Rosemount Models 1152, 1153 and 1154 
    transmitters, Rosemount failed to comply with 10 CFR Part 21 
    requirements and its own internal policy and procedure and inform 
    its customers of the potential problem in a timely fashion. The NRC 
    inspectors concluded, partly on the basis of Rosemount internal 
    memoranda, discussions with past and present Rosemount staff and 
    correspondence between Rosemount and licensees, that weaknesses in 
    Rosemount's 10 CFR Part 50, Appendix B, quality assurance (QA) 
    program and the reluctance of Rosemount managers to be candid in 
    their communications with customers contributed to Rosemount's 
    failure to promptly inform customers of the oil-loss problem. If 
    Rosemount had established effective measures to ensure that 
    conditions adverse to quality, such as failures, malfunctions, 
    deficiencies, deviations and nonconformances, were promptly 
    identified and corrected, Rosemount management could have seen the 
    developing trend of degraded transmitter response caused by 
    inadequate or inconsistent controls over the sensor cell 
    manufacturing process. Rosemount did not begin to inform its nuclear 
    power plant customers, as required by 10 CFR Part 21 and its own 
    procedures, of the deviation regarding the oil-loss problem until 
    December 1988. The NRC staff believes that Rosemount's failure to 
    take action between 1984 and 1988--as a result of its failure to 
    avail itself of the multiple opportunities to recognize the generic 
    implications of sensor cell oil-loss in its 1150-series 
    transmitters, repeated failure to recognize the problems identified 
    by experienced Rosemount personnel, and the reluctance of Rosemount 
    personnel to allow candid communications with customers of the 
    circumstances surrounding the deviations--reflects careless 
    disregard of the requirements of 10 CFR Part 21.
        In summary, the NRC staff concluded that the failure of 
    Rosemount to provide timely and complete notification of NRC 
    licensees in the more than four years that the company was aware, or 
    should have been aware, of the problem indicates a careless 
    disregard of the reporting requirements of 10 CFR Part 21. In 
    accordance with the Enforcement Policy, Supplement VII, Section C.5, 
    the failure either to perform an adequate Part 21 review or to 
    inform Rosemount customers about the problem would be classified as 
    a Severity Level III violation. However, in accordance with Section 
    IV.C of the Enforcement Policy, the severity level was increased to 
    Severity Level II because of the careless disregard of 10 CFR Part 
    21 by the Rosemount nuclear department management between 1984 and 
    1988. No civil penalty was proposed because the staff had not found 
    that the requirements of 10 CFR 21.61 for issuance of a civil 
    penalty--that a director or other responsible officer knowingly and 
    consciously failed to provide the notice required by 10 CFR 21.21--
    have been met in this case.
    
    IV. Conclusions
    
        The Petitioner's requests were granted, in part, and denied, in 
    part, as discussed herein. As provided in 10 CFR 2.206(c), a copy of 
    this Decision will be filed with the Secretary of the Commission for 
    the Commission's review.
    
        Dated at Rockville, Maryland, this 15th day of December, 1994.
    
        For the Nuclear Regulatory Commission.
    William T. Russell,
    Director, Office of Nuclear Reactor Regulation.
    [FR Doc. 94-31777 Filed 12-23-94; 8:45 am]
    BILLING CODE 7590-01-M
    
    
    

Document Information

Published:
12/27/1994
Department:
Nuclear Regulatory Commission
Entry Type:
Uncategorized Document
Document Number:
94-31777
Pages:
0-0 (1 pages)
Docket Numbers:
Federal Register: December 27, 1994, Docket No. 99900271