[Federal Register Volume 60, Number 133 (Wednesday, July 12, 1995)]
[Notices]
[Pages 35966-35968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-17027]



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NUCLEAR REGULATORY COMMISSION
[Docket No. 99900271]


Rosemount Nuclear Instruments, Inc.; Issuance of Director's 
Decision Under 10 CFR 2.206

    Notice is hereby given that the Director, Office of Nuclear Reactor 
Regulation (NRR), has taken action with regard to a Petition for action 
under Part 21 of Title 10 of the Code of Federal Regulations (10 CFR 
Part 21) received from Paul M. Blanch. The Petitioner requested that 
(1) Rosemount Nuclear Instruments, Incorporated (Rosemount) immediately 
inform all users of safety-related transmitters in accordance with the 
requirements of 10 CFR Part 21 of the shelf-life limitations of its 
pressure transmitter sensor cell fill-oil and that its pressure 
transmitter sensor cell fill-oil may crystallize if the transmitters 
are ever exposed to temperatures of less than 70 degrees Fahrenheit, 
and provide all available information to each licensee for evaluation 
as it applies to each licensed facility; (2) the U.S. Nuclear 
Regulatory Commission (NRC) take ``prompt and vigorous'' enforcement 
action against Rosemount for knowingly and consciously failing to 
provide notification as required by 10 CFR Part 21 of the shelf-life 
limitations of the fill-oil and its potential to crystallize, and that 
a ``separate violation must be issued'' for each defect and each day of 
failure to provide the required notice; and (3) the NRC consider 
escalated enforcement action due to the repetitive nature of the 
alleged violations.
    The Director of NRR has denied this Petition. The reasons for the 
Director's actions are set forth in the ``Director's Decision under 10 
CFR 2.206'' (DD-95-13), which is available for public inspection in the 
Commission's Public Document Room, Gelman Building, 2120 L Street, 
N.W., Washington, D.C. 20037. A copy of the Director's Decision will be 
filed with the Secretary of the Commission for the Commission's review 
in accordance with 10 CFR 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.


[[Page 35967]]

    Dated at Rockville, Maryland, this 5th day of July 1995.

    For the Nuclear Regulatory Commission.
William T. Russell,
Director, Office of Nuclear Reactor Regulation.
    In the matter of Rosemount Nuclear Instruments, Incorporated, 
Eden Prairie, Minnesota, Docket No. 99900271 (10 CFR Sec. 2.206), 
July 5, 1995.

I. Introduction

    On November 21, 1994, 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 
Sec. 2.206), in which he requested that (1) Rosemount Nuclear 
Instruments, Incorporated (Rosemount), immediately inform all users of 
safety-related transmitters in accordance with the requirements of 10 
CFR Part 21 of the shelf-life limitations of its pressure transmitter 
sensor cell fill-oil, and that its pressure transmitter sensor cell 
fill-oil may crystallize if the transmitters are ever exposed to 
temperatures of less than 70 degrees Fahrenheit ( deg.F), and provide 
all available information to each licensee for evaluation as it applies 
to each licensed facility; (2) the U.S. Nuclear Regulatory Commission 
(NRC) take ``prompt and vigorous'' enforcement action against Rosemount 
for knowingly and consciously failing to provide notification as 
required by 10 CFR Part 21 of the shelf-life limitations of the fill-
oil and its potential to crystallize, and that a ``separate violation 
must be issued'' for each defect and each day of failure to provide the 
required notice; and (3) the NRC consider escalated enforcement action 
due to the repetitive nature of the alleged violations.
    The Petitioner's letter has been referred to me pursuant to 10 CFR 
Sec. 2.206 of the Commission's regulations. By letter dated December 
22, 1994, I acknowledged receipt of the Petition. As described in that 
letter, the Petitioner's request that Rosemount ``immediately'' inform 
all users of safety-related transmitters of the shelf-life limitations 
of the fill-oil and the potential for crystallization was denied. With 
regard to the Petitioner's request that the NRC take ``prompt and 
vigorous'' enforcement action and consider escalated enforcement action 
against Rosemount for its alleged reporting failures, I informed the 
Petitioner that the staff was evaluating this matter and would take 
appropriate enforcement action after completion of its evaluation, 
should it be warranted.

II. Discussion

    As set forth in 10 CFR Sec. 21.1, the regulations in Part 21 
establish procedures and requirements for implementation of Section 206 
of the Energy Reorganization Act of 1974, which requires notification 
to the Commission of any basic component supplied to a licensed 
facility that has defects which could create a substantial safety 
hazard. Under 10 CFR Sec. 21.21(a), each entity subject to the 
regulations in Part 21 must evaluate ``deviations'' and ``failures to 
comply'' in order to identify a defect or failure to comply that could 
create a substantial safety hazard, were it to remain uncorrected.\1\ 
In accordance with 10 CFR Sec. 21.21(b), if the deviation is discovered 
by the supplier and the supplier determines that it does not have the 
capability to perform the evaluation to determine if a defect exists, 
then the supplier must inform the purchasers or affected licensees 
within five working days so that the purchaser or licensee may evaluate 
the deviation.

    \1\ 10 CFR Sec. 21.3 defines a deviation as a departure from the 
technical requirements included in a procurement document. A defect 
is defined, in part, as a deviation in a basic component delivered 
to a purchaser for use in a facility or an activity subject to the 
regulations in Part 21 if, on the basis of an evaluation, the 
deviation could create a substantial safety hazard; the 
installation, use or operation of a basic component containing a 
defect; or a condition or circumstance involving a basic component 
that could contribute to the exceeding of a safety limit. A failure 
to comply is defined as an activity or basic component that fails to 
comply with the Atomic Energy Act of 1954, as amended, or any 
applicable rule, regulation, order, or license of the Commission 
relating to a substantial safety hazard * * * (See 10 CFR 
Sec. 21.21(a)(3)(i).)
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    The Petitioner asserts that Rosemount became aware of a defect that 
may have created substantial safety hazard and failed to report this 
defect to the affected licensees within five working days for 
evaluation. The Petitioner also asserts that neither the NRC nor 
Rosemount possess the technical areas of expertise to conduct this 
evaluation, and that the ultimate responsiblity for evaluation is with 
the licensees.

A. Shelf-Life Limitations

    The Petitioner's first request was that Rosemount must immediately 
inform all users of its safety-related transmitters of the shelf-life 
limitations of its pressure transmitter sensor cell fill-oil and that 
the pressure transmitter sensor cell fill-oil may crystallize if the 
transmitters are ever exposed to temperatures of less than 70 deg. F. 
The Petitioner further requested that Rosemount must provide all 
available information to each licensee for evaluation as it applies to 
each licensed facility.
    The shelf life issue was first identified and discussed in NRC 
Inspection Report No. 99900271/93-01 which documented the results of an 
inspection conducted on February 1 through 4, and March 8 through 12, 
1993 of the Rosemount Eden Prairie, Minnesota facility. The NRC 
inspection team review of the viscosity test date recorded on a 
container of Dow Corning (DC) 704 silicone oil used for Rosemount 
safety-related transmitter Models 1153 and 1154 sensor cells, located 
in the nuclear production sensor cell oil fill area, indicated that the 
contents were beyond the manufacturer's certified shelf life. The team 
noted that, upon receipt of this material, Rosemount Receipt Inspection 
verified its viscosity value and wrote that value and the date of test 
on the outside of each container. The applicable Dow Corning product 
specification data sheet stated, ``when stored in the original, sealed 
container, at or below 77 degrees F, DC 704 oil has a shelf life of 12 
months from the date of shipment, although no inherent limitations on 
the useful life of this product are known to exist.'' The team 
discussed this issue with Rosemount engineers, who stated that, as a 
result of product liability concerns, Dow Corning, in 1992, changed the 
certified shelf life of the oil listed on their product data sheet from 
``indefinite'' to 12 months. Rosemount, however, still considered the 
shelf life to be indefinite and issued an engineering change notice in 
September 1992 to modify its procurement drawings to reflect this 
position. A letter dated April 14, 1992, from Dow Corning to Rosemount 
stated, in part, that ``Dow Corning certifies that DC 704 will meet the 
sales specification requirements for 12 months from date of shipment 
when properly stored in the original unopened container . . . . Because 
the sensor is completely sealed and free from contaminates and air it 
shouldn't change chemically over a long period of time.'' Another 
letter from Dow Corning to Rosemount, dated August 31, 1992, regarding 
the usable life of DC 704 stated that no inherent limitations on useful 
life of the product are known to exist and that it is the 
responsibility of Rosemount to test and evaluate Dow Corning products 
in their specific applications to determine compatibility. During the 
February and March 1993 inspection, the NRC inspectors observed that 
Rosemount had established a test and evaluation program which 
encompassed its sensor cell application in the safety-related 
transmitters. The inspectors observed that Rosemount has been 
performing functional testing of its transmitters 

[[Page 35968]]
which includes testing at pressure and within the operational limits. 
Based upon the inspectors' observations and their review of Rosemount 
correspondence with Dow Corning, the NRC concludes that the shelf life 
of the oil does not constitute a safety issue.
    The Petitioner filed an earlier Petition on March 28, 1994, 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.'' By letter dated May 2, 1994, the Petitioner repeated 
this request. I responded to this request by letter dated June 3, 1994. 
In my response, I summarized some of the above discussion and stated 
that the staff did not consider the shelf life of the DC 704 fill oil 
to be significant.\2\

    \2\ A Director's Decision responding to the other issues raised 
in the Petitioner's December 31, 1992, and March 28, 1994, Petitions 
(DD-94-12) was issued on December 15, 1994. 40 NRC 370.
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    The Commission's regulations in 10 CFR Part 21 require that 
notification be provided of any basic component supplied to a licensed 
facility that contains defects which could create a substantial safety 
hazard. However, the staff determined that Rosemount was not required 
to notify the NRC nor to inform its customers under the provisions of 
10 CFR Part 21 because a defect or deviation as defined in 10 CFR 
Sec. 21.3 was not identified.

B. Sensor-Cell Fill-Oil Crystallization

    An NRC staff concern regarding potential crystallization of DC 704 
silicone oil that is used in Rosemount Models 1153 and 1154 safety-
related transmitters' sensor-cells was formally transmitted to 
Rosemount by an NRC letter dated June 2, 1994. That letter identified 
the staff's concern regarding an apparent disparity between the fill 
oil manufacturer's precautionary note on temperature limitations and 
the Rosemount product data sheet. The June 2, 1994, letter also noted 
that Rosemount believed it had adequately addressed the concern in 
tests conducted in 1980, but that it was pursuing the matter further 
with the fill oil manufacturer. Rosemount's letter of September 28, 
1994, provided an analysis and response to these concerns. Rosemount's 
analysis concluded that preconditioning of the fill oil during the 
transmitter manufacturing process, coupled with initial and periodic 
testing of the transmitters in service at plants, provide adequate 
assurance that proper transmitter performance is maintained. The 
analysis also noted that Rosemount was aware of the fill oil's 
potential for crystallization and addressed its concerns in a 1980 
report which concluded that crystallization was not a concern as long 
as certain conditions were met. These conditions are assured by 
Rosemount's manufacturing processes and its transmitter's specified 
range of operation. Rosemount informed the staff in a September 1994 
submittal that it found no evidence of fill oil crystallization at 
licensee facilities. In addition, an NRC staff review of industry data 
did not identify any instances of Rosemount Model 1153 or 1154 
transmitter sensor-cell oil crystallization. The NRC staff conducted an 
inspection at the Rosemount facility in January 1995 (Inspection report 
99900271/95-01), specifically to review the crystallization issue. 
Based on the team's review of the Rosemount procedures, manufacturing 
process and personal interviews with the Rosemount manufacturing and 
engineering staff, the NRC staff concluded that Rosemount's actions in 
1980 regarding the DC 704 cautionary note adequately addressed its 10 
CFR Part 21 responsibilities and the validity of its engineering basis 
for its Model 1153 and 1154 low temperature designed application. 
Additionally, the team determined that, although not required by 10 CFR 
Part 21, Rosemount had provided its customers a summary of its 
engineering analysis in a letter of December 1, 1994, and that 
Rosemount had appropriately implemented its applicable manufacturing 
process controls. The team also concluded that Rosemount's conditioning 
of the DC 704 oil before its use should remove any existing seeds which 
could cause crystallization. Based on a review of the information 
provided by Dow Corning, observations of Rosemount testing, and 
industry historical data that indicates no instances of 
crystallization, the staff concludes that the concern regarding 
crystallization of DC 704 oil is adequately addressed by the 
transmitter manufacturing process and performance testing by the 
licensees.
    In summary, the staff found that Rosemount identified, evaluated 
and took appropriate actions regarding the manufacturer's cautionary 
note concerning the transmitter fill-oil temperature limitations in 
1980. Since Rosemount's manufacturing and testing processes are 
sufficient to assure a low probability of crystallization of the fill 
oil, the staff has determined that Dow Corning's cautionary note 
regarding crystallization did not constitute a deviation from the 
Rosemount product data sheet. Therefore, Rosemount was not required to 
inform its customers of the issue under the provisions of 10 CFR Part 
21.
    The aspect of the Petitioner's request regarding shelf life 
limitations and crystallization of the fill oil is denied. The self-
life issue was evaluated by the staff and, as discussed in my December 
22, 1994, letter to the Petitioner, found not to be a significant 
safety issue. As discussed in the NRC's December 9, 1994, letter to 
Rosemount and NRC Inspection Report No. 99900271/95-01, the 
crystallization issue was determined by NRC staff to have been 
adequately addressed by Rosemount in regard to its engineering and 10 
CFR Part 21 responsibilities. Rosemount was not required under Part 21 
to inform affected purchasers of these conditions, therefore, no 
violation of 10 CFR Part 21 was identified. Since the remainder of the 
Petitioner's request relates to enforcement action which is predicated 
on a violation of NRC regulations, the remainder of the Petitioner's 
request is also denied.

III. Conclusion

    As explained above, following its review of the Petitioner's 
request and supporting argument, the NRC staff concludes that Rosemount 
did not violate 10 CFR Part 21 with respect to the issues raised in 
this Petition. Accordingly, the Petition is hereby denied.
    A copy of this Decision will be filed with the Secretary of the 
Commission for the Commission to review as provided in 10 CFR 
Sec. 2.206(c). The Decision will become the final action of the 
Commission 25 days after issuance unless the Commission, on its own 
motion, institutes a review of the Decision in that time.

    Dated at Rockville, Maryland, this 5th day of July 1995.

    For the Nuclear Regulatory Commission.
William T. Russell,
Director, Office of Nuclear Reactor Regulation.
[FR Doc. 95-17027 Filed 7-11-95; 8:45 am]
BILLING CODE 7590-01-M