EA-01-108 - Mallinckrodt, Inc.

July 3, 2001

EA-01-108

Joel Timberlake
Vice President
Imaging Operations
Mallinckrodt, Inc.
675 McDonnell Boulevard
P.O. Box 5840
St. Louis, MO 63134

SUBJECT:

NOTICE OF VIOLATION (NRC INSPECTION REPORT 03000001/2001-002(DNMS))

Dear Mr. Timberlake:

This refers to the special inspection conducted on April 3 - 6, 2001, at the Mallinckrodt, Inc., Maryland Heights, Missouri, facility. During the inspection, an apparent violation of NRC requirements was identified and was described in the inspection report transmitted with our May 9, 2001 letter. In that letter, we provided you the opportunity to address the apparent violation identified in the report by either attending a predecisional enforcement conference or by providing a written response before we made our final enforcement decision. In a letter dated June 8, 2001, you provided a response to the apparent violation.

Based on the information developed during the inspection and the information that you provided in your response to the inspection report, 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 it are described in detail in the subject inspection report. The violation pertains to your staff's failure to prepare a package containing licensed material that was transported outside the confines of your plant, so that under conditions normally incident to transport, the radiation levels do not exceed 200 millirem per hour at any point on the external surface of the package. On April 2, 2001, your staff shipped a package from the Maryland Heights facility containing a nominal 19 curie molybdenum/technetium generator that arrived at its destination with external surface radiation levels of 210 millirem per hour. Your staff determined that the cause of the elevated radiation level was excess fluid in the lines of the generator's hood, combined with movement of the needle caps, allowing the fluid to move during transport. In addition, your staff determined that the shielding inside the package was not sufficient to maintain radiation levels within acceptable limits in these circumstances.

The health and safety consequences were minimal in this case, since the package was in transit for less than 24 hours and the radiation level was only slightly above the regulatory limit for surface radiation levels. However, incumbent upon each licensee is the responsibility to protect the public health and safety by ensuring that all NRC requirements are met. The NRC expects each of its licensees to establish controls and procedures to ensure that surface radiation levels for packages remain within NRC requirements during transportation. The lack of adequate procedures for evacuating reworked generators and the movement of the needle caps resulted in the elevated radiation levels on the package surface. Therefore, this violation has been categorized in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, February 16, 2001, at Severity Level III.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $15,000 is considered for a Severity Level III violation. Because your facility has been the subject of escalated enforcement actions within the last two years⁽¹⁾, the NRC considered whether credit was warranted for Identification and Corrective Action in accordance with the civil penalty assessment process in Section VI.C.2 of the Enforcement Policy. Credit for identification is warranted because of your staff's noteworthy effort in identifying the root cause of the violation. Although the violation was revealed through an event, after your staff was informed by the receiving pharmacy of the elevated exposure rates on the package surface, two health physicists were dispatched to investigate the incident. The health physicists identified excess liquid in the lines, the loose tip caps and the internal package damage. This information allowed your staff to identify the likely causes of the increased radiation levels on the package surface. Credit for corrective actions is warranted because your staff's actions were both prompt and comprehensive. These actions included: (1) revising procedures for reworked generators to include a minimum time requirement for elution; (2) adding three new visual checks to the standard elution process to verify that the correct amount of saline solution was removed from the generator; and (3) implementing changes to the generator hood design to improve flow.

Therefore, to encourage identification, and prompt and comprehensive correction of violations, 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.

The NRC has concluded that information regarding the reason for the violation, the corrective actions taken and planned to correct the violation and prevent recurrence, and the date when full compliance will be achieved, is already adequately addressed on the docket in a letter from Mr. James Schuh, dated June 8, 2001. 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 provide one, will be made available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of NRC's document system (ADAMS). ADAMS is accessible from the NRC Web site at the Public NRC Library.

 

		Sincerely,
		/RA/
		J. E. Dyer Regional Administrator

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

Enclosure: Notice of Violation

cc  State of Missouri

 

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NOTICE OF VIOLATION
Mallinckrodt, Inc. St. Louis, Missouri		Docket No. 030-00001 License No. 24-04206-01 EA-01-108

During an NRC inspection conducted on April 3 - 6, 2001, a violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, February 16, 2001, the violation is listed below:

10 CFR 71.5(a) requires that a licensee who transports licensed material outside of the site of usage, as specified in the NRC license, or who delivers licensed material to a carrier for transport, comply with the applicable requirements of the regulations appropriate to the mode of transport of the Department of Transportation (DOT) in 49 CFR Parts 170 through 189.

49 CFR 173.441 requires, in part, with exceptions not applicable here, that each package of radioactive materials offered for transportation be designed and prepared for shipment so that under conditions normally incident to transportation the radiation level does not exceed 200 millirem per hour at any point on the external surface of the package.

Contrary to the above, on April 2, 2001, the licensee delivered to a carrier for transport, licensed materials and did not prepare the package so that under conditions normally incident to transportation, the radiation level would not exceed 200 millirem per hour at any point on the external surface of the package. Specifically, the licensee offered for shipment a package containing 19 curies of molybdenum-99 such that it arrived at its destination on April 3, 2001, with a radiation level of 210 millirem per hour on the external surface of the package.

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

The NRC has concluded that information regarding the reason for the violation, the corrective actions taken and planned to correct the violation and prevent recurrence, and the date when full compliance will be achieved, is already adequately addressed on the docket in a letter from the licensee, dated June 8, 2001. However, you are required to submit a written statement or explanation pursuant to 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, DC 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 (Notice).

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

If you choose to respond, your response will be made available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of NRC's document system (ADAMS). ADAMS is accessible from the NRC Web site at the Public NRC Library. Therefore, to the extent possible, the response should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the Public without redaction. If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, you must specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information). If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.

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

Dated this 3^rd day of July 2001.

 

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1. On December 21, 2000, a Severity Level I violation with civil penalty was issued for the failure to maintain extremity exposures below the annual limit (EA-00-178).

On January 11, 2000, a Severity Level III violation, with no civil penalty was issued for the failure to notify the NRC within one hour after declaring an alert (EA-99-322).