EA-97-155 - Mallinckrodt Medical, Inc.

May 30, 1997

EA 97-155

Les Sabo
Director of Operations
Mallinckrodt Medical, Inc.
2703 Wagner Place
Maryland Heights, MO 63043

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY -$13,750 (NRC Inspection Report No. 030-00001/97001(DNMS))

Dear Mr. Sabo:

This refers to the inspection conducted on January 10-12 1997, with continuing NRC review through April 8, 1997, at the Mallinckrodt Medical, Inc. facility in Maryland Heights, Missouri. During the inspection, an apparent violation of NRC requirements was identified. A copy of the NRC inspection report was sent to you on April 15, 1997. On April 30, 1997, a predecisional enforcement conference was conducted with members of your staff to discuss the apparent violations, their causes, and your corrective actions.

Based on the information developed during the course of the inspection and the information provided by your staff during the conference, the NRC has determined that a violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice) and the circumstances surrounding it is described in detail in the subject inspection report.

The violation pertains to Mallinckrodt's failure to prepare a package containing licensed material transported outside the confines of its 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. Specifically, the radiation level at the surface of a package containing a 12 curie Ultra Techna-Kow Mo-99 generator received by the Saginaw, Michigan radiopharmacy on December 31, 1996, was 210 millirem/hour. Based upon your staff's discussion of the violation at the predecisional enforcement conference, no root cause was determined and the various scenarios explored in an attempt to arrive at a cause were inconclusive. We also learned at the conference that the generator in question was not subjected to further investigation as initially planned because of an apparent misunderstanding between the radiation safety officer and your quality control personnel.

The potential safety significance associated with the licensed material involved and the inability to determine a root cause are of significant concern to the NRC. Incumbent upon each NRC licensee is the responsibility to protect public health and safety by ensuring all requirements of the NRC license are met and any potential violations or situations that could cause violations of NRC requirements are identified and corrected expeditiously. Therefore, this violation has been categorized in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, at Severity Level III.

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 been the subject of escalated enforcement actions within the last 2 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.B.2 of the Enforcement Policy. Credit was warranted for Identification because the problem was self identified and immediate actions were taken to evaluate the generator at the point of receipt. However, credit for Corrective Action was not warranted. The only initial corrective action proposed was to conduct a more extensive radiation survey of each package prior to leaving your facility. While this expanded package survey is a good initiative, it neither addresses the cause of the problem discussed here or actions taken to prevent excessive radiation levels which may arise during transport. Mallinckrodt missed an opportunity to further investigate this event when it lost control of the generator in question. Corrective action for the future includes phasing out the use of most "wet" generators and replacing them with a new Dry Top Eluting generator by the end of 1997. Therefore, to emphasize the importance of control of licensed materials and comprehensive correction of violations, I have been authorized after consultation with the Director, Office of Enforcement, to issue the enclosed Notice of Violation and Proposed Imposition of Civil Penalty in the base amount of $13,750 for the Severity Level III violation. In addition, issuance of this Notice constitutes escalated enforcement action, that may subject you to increased inspection effort.

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosure, and your response will be placed in the NRC Public Document Room (PDR).

Sincerely,

Original Signed by J. Caldwell for A. Bill Beach Regional Administrator

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

Enclosure: Notice of Violation and Proposed Imposition of Civil Penalty

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NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

Mallinckrodt Medical, Inc. Maryland Heights, Missouri

Docket No. 030-00001 License No. 24-04206-01 EA 97-155

During an NRC inspection conducted on January 10-12, 1997, with continuing NRC review through April 8, 1997, a violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the NRC proposes to impose a civil penalty pursuant to Section 234 of the Atomic Energy Act of 1954, as amended (Act), 42 U.S.C. 2282, and 10 CFR 2.205. The particular violation and associated civil penalty are set forth below:

10 CFR 71.5(a) requires that a licensee who transports licensed material outside the confines of its plant or other place of use, 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(a) 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 December 30, 1996, the licensee delivered to a carrier for transport licensed material, a 12 curie Ultra Techna-Kow Mo-99 generator, in a package that arrived at its destination, Mallinckrodt Nuclear Pharmacy in Saginaw, Michigan, with a radiation level of 210 millirem per hour on contact with the outer surface of the package.

This is a Severity Level III violation (Supplement V).
Civil Penalty – $13,750

Pursuant to the provisions of 10 CFR 2.201, Mallinckrodt Medical Inc. (Licensee) is hereby required to submit a written statement or explanation to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, within 30 days of the date of this Notice of Violation and Proposed Imposition of Civil Penalty (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation" and should include for each alleged violation: (1) admission or denial of the alleged violation, (2) the reasons for the violation if admitted, and if denied, the reasons why, (3) the corrective steps that have been taken and the results achieved, (4) the corrective steps that will be taken to avoid further violations, and (5) the date when full compliance will be achieved. If an adequate reply is not received within the time specified in this Notice, an order or a Demand for Information may be issued as why the license should not be modified, suspended, or revoked or why such other action as may be proper should not be taken. Consideration may be given to extending the response time for good cause shown. Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.

Within the same time as provided for the response required above under 10 CFR 2.201, the Licensee may pay the civil penalty by letter addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, with a check, draft, money order, or electronic transfer payable to the Treasurer of the United States in the amount of the civil penalty proposed above, or the cumulative amount of the civil penalties if more than one civil penalty is proposed, or may protest imposition of the civil penalty in whole or in part, by a written answer addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission. Should the Licensee fail to answer within the time specified, an order imposing the civil penalty will be issued. Should the Licensee elect to file an answer in accordance with 10 CFR 2.205 protesting the civil penalty, in whole or in part, such answer should be clearly marked as an "Answer to a Notice of Violation" and may: (1) deny the violations listed in this Notice, in whole or in part, (2) demonstrate extenuating circumstances, (3) show error in this Notice, or (4) show other reasons why the penalty should not be imposed. In addition to protesting the civil penalty in whole or in part, such answer may request remission or mitigation of the penalty.

In requesting mitigation of the proposed penalty, the factors addressed in Section VI.B.2 of the Enforcement Policy should be addressed. Any written answer in accordance with 10 CFR 2.205 should be set forth separately from the statement or explanation in reply pursuant to 10 CFR 2.201, but may incorporate parts of the 10 CFR 2.201 reply by specific reference (e.g., citing page and paragraph numbers) to avoid repetition. The attention of the Licensee is directed to the other provisions of 10 CFR 2.205, regarding the procedure for imposing a civil penalty.

Upon failure to pay any civil penalty due which subsequently has been determined in accordance with the applicable provisions of 10 CFR 2.205, this matter may be referred to the Attorney General, and the penalty, unless compromised, remitted, or mitigated, may be collected by civil action pursuant to Section 234c of the Act, 42 U.S.C. 2282c.

The response noted above (Reply to Notice of Violation, letter with payment of civil penalty, and Answer to a Notice of Violation) should be addressed to: James Lieberman, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North, 11555 Rockville Pike, Rockville, MD 20852-2738, with a copy to the Regional Administrator, U.S. Nuclear Regulatory Commission, Region III.

Because your response will be placed in the NRC Public Document Room (PDR), 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. 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.

Dated at Lisle, Illinois
this 30th day of May 1997

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¹ A Severity Level III violation with no civil penalty was issued on October 6, 1995 (EA 95-179). A package was received at a Wilkes-Barr, PA pharmacy measuring 300 millirem at the external surface. The excessive measurement was caused by the use of the incorrect shielding on the back of the generator.