EA-99-322 - Mallinckrodt, Inc.

January 11, 2000

EA 99-322

Les Sabo, Director
U.S. Nuclear Medicine Operations
Mallinckrodt, Inc.
2703 Wagner Place
Maryland Heights, MO 63043

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report 030-00001/99004(DNMS))

Dear Mr. Sabo:

This refers to the inspection conducted November 22 through 24, 1999, at Mallinckrodt, Inc. in Maryland Heights, Missouri. During the inspection, an apparent violation of NRC requirements was identified and documented in the NRC inspection report sent to you by our letter dated December 29, 1999. In that letter we indicated that NRC had sufficient information to proceed with the enforcement action, however, you were given an opportunity to discuss the apparent violation at a predecisional enforcement conference or address the apparent violation in writing. During a telephone conversation between Mr. J. Schuh of your staff and Mr. G. Wright of my staff on January 5, 2000, Mallinckrodt, Inc. declined a conference and declined to provide additional written correspondence.

Based on the information developed during the inspection, the NRC has determined that a violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation (Notice), and the circumstances surrounding the violation are described in detail in the subject inspection report. The violation involves a failure to notify the NRC and the state agency after declaring an Alert.

On November 17, 1999, during a routine operation involving the processing of 155 curies of xenon-133, 137 curies were inadvertently released into the process room and the environment. Your staff correctly implemented Mallinckrodt's NRC-approved contingency plan and declared an Alert. However, contrary to the requirements of the contingency plan, your staff did not notify the NRC, or state authorities within one hour of the declaration. The event was subsequently discussed with Region III personnel on November 19, 1999. Following that conversation your staff made the appropriate notification some 50 hours after the Alert had been declared. The NRC expects its licensees to maintain awareness of all notification and reporting requirements that are applicable to them. This is especially important for licensees who are required to have emergency plans, in accordance with 10 CFR 30.32(i). When radiological conditions arising from licensed operations warrant implementation of an emergency plan, it is imperative that licensee's notify the NRC so we can meet our regulatory responsibilities to the public. Mallinckrodt's failure to provide the timely, required notification to the NRC interfered with our exercise of that responsibility. That failure denied us the opportunity to fully evaluate the root and contributing causes of the release and your proposed corrective actions prior to the resumption of xenon-133 processing. It is fortunate that Mallinckrodt staff aggressively investigated the event, correctly identified the root and contributing causes, and instituted corrective actions that appear effective at preventing similar events prior to resuming operations. The NRC has considered all of the information surrounding this violation and concluded that while the actual safety consequences to the workers and the public were minimal, the violation is of significant concern in that it denied the NRC and others from fulfilling our responsibilities. Therefore, the violation has been categorized in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions (Enforcement Policy)," NUREG-1600, as a Severity Level III violation.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $13,750 is considered for a Severity Level III violation. Because your facility has not been the subject of escalated enforcement actions within the last two years, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Corrective Action credit is warranted because your corrective actions were both prompt and comprehensive. These actions included but were not limited to: (1) the emergency procedure for regulatory notifications has been revised; (2) instruction has been provided to all personnel who would be involved in providing senior management guidance regarding notification requirements; and (3) all emergency plan implementing procedures are being evaluated to ensure that all commitments in the plan are adequately and accurately addressed.

Therefore, to encourage prompt and comprehensive correction of violations and in recognition of the absence of recent escalated enforcement action, I have been authorized not to propose a civil penalty in this case. However, significant violations in the future could result in a civil penalty. In addition, issuance of this Severity Level III violation constitutes escalated enforcement action, that may subject you to increased inspection effort.

The NRC has concluded that information regarding the reasons for the violation, and the corrective actions taken and planned to correct the violation and prevent recurrence are already adequately addressed in our inspection report. 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 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosure, and your response, if you choose to respond, will be placed in the NRC Public Document Room.

		Sincerely,
		/s/ James L. Caldwell (for)
		J. E. Dyer Regional Administrator

Docket No. 030-00001
License No. 24-04206-01

Enclosure: Notice of Violation

 

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NOTICE OF VIOLATION
Mallinckrodt, Inc. Maryland Heights, Missouri		Docket No. 030-00001 License No. 24-04206-01 EA 99-322

During an NRC inspection conducted November 22 through 24, 1999, a violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the violation is listed below:

Condition 18 of License No. 24-04206-01 requires that the licensee maintain and execute the response measures of its Emergency Plan dated November 25, 1991, and as revised by letters dated March 30, 1993 and March 27, 1998, with attachments, and the application dated June 29, 1995, with attachments.

Section 3.2.1 of the licensee's Emergency Plan, Rev. 1, dated February 1, 1998, and attached to the referenced March 27, 1998, letter, requires that the licensee notify the U.S. NRC Operations Center and the State of Missouri Bureau of Environmental Epidemiology within one hour of declaring an Alert.

Contrary to the above, on November 17, 1999, at 8:30 a.m. (C.S.T.) an Alert was declared at Mallinckrodt, Inc. in accordance with the provisions of an approved Emergency Plan. However, the licensee did not notify the U.S. NRC Operations Center or the State of Missouri Bureau of Environmental Epidemiology of the declaration until November 19, 1999, a period in excess of one hour. (01013)

This is a Severity Level III violation (Supplement VIII).

The NRC has concluded that information regarding the reasons for the violation, and the corrective actions taken and planned to correct the violation and prevent recurrence is already adequately addressed in our inspection report. However, you are required to respond to the provisions of 10 CFR 2.201 if the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to respond, clearly mark your response as a "Reply to a Notice of Violation," and send it to the U. S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, D.C. 20555, with a copy to the Regional Administrator, Region III, 801 Warrenville Road, Lisle, Illinois 60532-4351, within 30 days of the date of the letter transmitting this Notice of Violation.

If you contest this enforcement action, you should also provide a copy of your response to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, D.C. 20555-0001.

If you choose to respond your response will be placed in the NRC Public Document Room (PDR). Therefore, to the extent possible, it should not include any personal, privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction. Under the authority of Section 182 of Act 42 U.S.C. 2232, any response shall be submitted under oath or affirmation.

In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.

Dated this 11^th day of January 2000.