ML20149H459
| ML20149H459 | |
| Person / Time | |
|---|---|
| Issue date: | 11/15/1994 |
| From: | Miraglia F Office of Nuclear Reactor Regulation |
| To: | Quist S AFFILIATION NOT ASSIGNED |
| Shared Package | |
| ML20149H462 | List: |
| References | |
| REF-QA-99900271 EA-94-049, EA-94-49, NUDOCS 9411220215 | |
| Download: ML20149H459 (5) | |
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NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555 0001 g
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November 15, 1994 l
EA 94-049 Mr. Steve M. Quist, President Rosemount Nuclear Instruments, Incorporated 8200 Market Boulevard Chanhassen, Mianesota 55317
Dear Mr. Quist:
SUBJECT:
NOTICE OF VIOLATION (NRC INSPECTION REPORT 99900271/93-01 & OFFICE OF INVESTIGATIONS CASE No. 4-90-009) t This letter concerns the Rosemount Nuclear Instruments, Incorporated (Rosemount) presentation given to NRC staff at a June 23, 1994, enforcement conference and the NRC staff conclusions based on NRC review of and ,
deliberation on the circumstances in this matter. Our deliberations took into consideration all of the information obtained and developed by NRC staff from 1988 to the present. :
In 1993, NRC staff conducted an inspection to follow up on an NRC concern regarding an oil-loss problem identified in Rosemount Model ll50-series press ure transmitters that could have resulted in undetectable degraded operation of Rosemount nuclear safety-related pressurc transmitters. Based on ,
that inspection and on the findings of a related Office of Investigation (0I) investigation, certain of your activities were found to be in violation of 10 CFR Part 21 (Part 21) requirements, as specified in the enclosed Notice of ,
Violation (Notice). The violation is of concern because Rosemount did not l fulfill its Part 21 responsibilities to its customers between 1984 and 1988, ;
when Rosemount became aware of degraded operation of its ll50-series transmitters in nuclear safety-related applications due to oil-loss problems in the transmitter's sensor cell. Although the initiating events and Rosemount's initial Part 21 violation occurred a considerable time ago, they '
represent a significant weakness in the implementation of Rosemount's 10 CFR Part 21 and 10 CFR Part 50, Appendix B programs. ,
The NRC staff determined that in the mid-1980s, Rosemount provided incomplete [
and inaccurate information to NRC licensed facilities regarding the scope of the Rosemount transmitter oil-loss problem and that some Rosemount staff were not candid about providing comprehensive information regarding the oil-loss matter. Several licensees subsequently used this information, in part, for '
their evaluation of the deviation pursuant to 10 CFR Part 21. The documents and testimony that were reviewed by NRC staff indicated that Rosemount limited !
the oil-loss information it disclosed and the information disclosed was typically site specific. Further, Rosemount did not describe the sensor cell manufacturing and test weaknesses which CoJ1d have allowed transmitters that exhibited slow leaks to be shipped to NRC licensees. These weaknesses in the manufacturing and test processes preceding the late 1980s were potentially i generic, could have caused degraded transmitter operation in any of 9411220215 941115 ('i ii Gj (") o&4 (
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Mr. Steve M. Quist. 2 Rosemount's ll50-series transmitters, and should have been sent to NRC .
licensees for evaluating their specific transmitter safety-related !
applications pursuant to 10 CFR Part 21.
Based on 01's investigation and the NRC staff's inspection, the NRC has 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 sensor cell oil-loss. We have determined that Rosemount's actions in this period between 1984 and 1988 - the multiple opportunities to have i recognized the generic implications of numerous 1150 serics transmitter problems, the repeated failure to recognize these problems by experienced Rosemount personnel, and the reluctance of Rosemount personnel to allow candid !
communications in order to adequately inform customers of the deviations - '
reflect careless disregard for the requirements of 10 CFR Part 21. Therefore,
- n accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), 10 CFR Part 2, Appendix C, the failure to perform an adequate Part 21 review and to inform your customers of the potential for degraded operation of Rosemount's ll50-series transmitters in safety-related applications is being classified as a Severity Level II violation. Your past performance in this matter was unacceptable. A civil .
penalty has not been proposed inasmuch as we were not able to identify any Rosemount Director or Responsible Officer subject to 10 CFR Part 21 who knowingly and consciously failed to provide the notice required by 10 CFR 21.21. In addition, the general standard for imposition of a civil penalty against a licensee under Section 234 of the Atomic Energy Act of 1954, as '
amended, which is less specific and stringent than the " knowingly" and
" consciously" standard for imposition of a civil penalty against a vendor pursuant to 10 CFR Part 21, does not apply in these circumstances.
The failure of the P.osemount staff to candidly inform NRC licensees of the potential oil-loss failure mode in the four years that Rosemount was aware of the problem constitutes a very significant regulatory concern and indicates ,
significant weaknesses in your implementation and complianca with 10 CFR Part 21. The NRC staff does acknowledge that after the Part 21 responsibilities were discussed with Rosemount during the 1993 inspection effort, Rosemount undertook corrective action to preclude recurrence. For example, Rosemount has revised, and provided NRC staff with, its 10 CFR Part 21 procedure DP-N-1626, " Implementation of 10 CFR Part 21 for Deviations i and Failures to Comply in Nuclear Products." The NRC staff also notes that the current Rosemount staff interactions with NRC seem more open and candid l then in the past.
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You are required to respond to this letter and should follow the instructions i specified in the enclosed Notice when preparing your response. In your response, you should document the specific actions taken and any additional actions you plan to take in order to prevent recurrence. After reviewing your response to this Notice, including your proposed corrective actions and the results of future inspections, tha NRC will determine whether further NRC l
Mr. Steve M. Quist 3 enforcement action is necessary to ensure compliance with NRC regulatory requirements. The NRC staff will review the adequacy of Rosemount's corrective actions during a future inspection.
Further, as a result of the inspection and investigation activities conducted by the NRC, the staff concluded that Rosemount provided inaccurate and incomplete information to the NRC during an April 13, 1989, public meeting regarding the failure experience of the Rosemount Model 1152 transmitter.
However, the NRC staff found that Rosemount did not deliberately supply the NRC staff with inaccurate and incomplete information at this meeting. The NRC has not proposed any enforcement action for the inaccurate and incorrect statements made to the NRC and its licensees because the applicable regulation ,
(10 CFR 50.9) applies to applicants and licensees and not an entity like Rosemount under the circumstances of this case. However, the staff has substantial concerns about this matter and the staff must emphasize that Rosemount's actions resulting in the submittal of inaccurate or incomplete information to the NRC and licensees are wholly unacceptable. The NRC expects all licensee and vendor communications to be complete and accurate, and to properly reflect situations that could have implications to public health and safety, especially where an evaluation pursuant to 10 CFR Part 21 is involved. ,
Therefore, in addition to your response to the Notice, you are requested to provide, under oath or affirmation, a written description of those actions that Rosemount has taken or intends to take to ensure that information provided to the NRC or its licensees is complete, candid, and accurate in all material respects. The response to this request should be provided within 30 days of the date of this letter.
Additionally, it is noted that the NRC staff received a Rosemount letter dated September 28, 1994. In this unsolicited letter, Rosemount stated that it .1 agreed with the NRC " views" expressed at the June 23, 1994 enforcement l conference on the importance of 10 CFR Part 21 and was " pleased with the ,
conclusion... that no deliberate violation occurred." Rosemount also stated, l however, that it cannot concur in the view that Rosemount acted in careless !
disregard by failing to adequately identify and report potential defects in i its Model 1153 pressure transmitters prior to December 1988. The NRC staff l noted that Rosemount attached a 40 page enclosure to its letter that takes exception to a number of statements and conclusions delineated in NRC Inspection Report 99900271/93-01.which provided some of the bases for the enforcement action that is set forth in the attached Notice of Violation. The NRC staff has reviewed the information in the Rosemount letter and has ,
determined that the letter does not provide new information or arguments that l would cause any change in the staff's position or enforcement action.
Mr. Steve M. Quist 4 In accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter and its enclosures will be placed in the NRC Public Document Room.
Sincerely, 4
, Gash .
Frank J. iraglia, Deputy Director Office of Nuclear Reactor Regulation Docket No. 99900271
Enclosure:
Notice of Violation cc: See next page i
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l Mr. Steve M. Quist 5 cc: Mr. Kenneth E. Ewald, Business Unit Manager Rosemount Nuclear Instrumenta, Incorporated -i 12001 Technology Drive Eden Prairie, Minnesota 55344 Mr. Paul Blanch 135 Hyde Road West Hartford, Connecticut 06117 i Mr. Ernest Hadley ;
414 Main Street Post Office Box 3121 Wareham, Massachusetts 02571 1
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