[Federal Register Volume 59, Number 247 (Tuesday, December 27, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-31777]
[[Page Unknown]]
[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