EA-97-155 - Mallinckrodt Medical, Inc.

September 9, 1997

EA 97-155

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

SUBJECT: ORDER IMPOSING CIVIL MONETARY PENALTY – $13,750

Dear Mr. Sabo:

This refers to your letter dated June 30, 1997, in response to the Notice of Violation and Proposed Imposition of Civil Penalty (Notice) sent to you by our letter dated May 30, 1997. Our letter and Notice describe one violation identified during an NRC inspection.

To emphasize the importance of control of licensed materials and comprehensive correction of violations, a civil penalty of $13,750 was proposed.

In your response you admit that the violation occurred and agree that a civil penalty is warranted. However, Mallinckrodt contests the monetary level at which it has been categorized by the NRC. Mallinckrodt does not believe that it operates at the magnitude of risk implied by the examples listed in the "b" category of Table 1A-Base Civil Penalties of the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.

After consideration of your response, we have concluded for the reasons given in the Appendix attached to the enclosed Order Imposing Civil Monetary Penalty that no new information has been received that would change the Mallinckrodt Medical, Inc. categorization. Accordingly, we hereby serve the enclosed Order on Mallinckrodt Medical, Inc. imposing a civil monetary penalty in the amount of $13,750. As provided in Section IV of the enclosed Order, payment should be made within 30 days of the date of this Order, by check, draft, money order, or electronic transfer, payable to the Treasurer of the United States and mailed to James Lieberman, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North, 11555 Rockville Pike, Rockville, MD 20852-2738. We will review the effectiveness of your corrective actions during a subsequent inspection.

In addition to the above, your June 30th letter discusses two items of clarification regarding the fate of the generator returned from the Saginaw pharmacy and the 1995 Wilkes-Barre incident when a package exceeded 200 mR/hr. Regarding the first issue, it was our understanding that before reclamation of the Saginaw generator was to occur, your quality control personnel planned to perform additional testing in an effort to arrive at a root cause for the elevated radiation levels of the package. This was discussed during the enforcement conference held on April 30, 1997. Secondly, we recognize that the circumstances of the Wilkes-Barre incident differed from the incident in question. However, the case was mentioned because it reflects Mallinckrodt's recent enforcement history which was used in accordance with the Enforcement Policy to determine the extent of the current enforcement action.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice", a copy of this letter and the enclosures will be placed in the NRC's Public Document Room.

Sincerely,

Mark A. Satorius, Deputy Director Office of Enforcement

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

Enclosure: As Stated

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UNITED STATES
NUCLEAR REGULATORY COMMISSION

In the Matter of MALLINCKRODT MEDICAL, INC Maryland Heights, Missouri

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

ORDER IMPOSING CIVIL MONETARY PENALTY

I

Mallinckrodt Medical, Inc. (Licensee) is the holder of Materials License No. 24-04206-01 which was first issued by the Nuclear Regulatory Commission (NRC or Commission) on January 6, 1975, and renewed in its entirety on October 12, 1990. The license authorizes the Licensee to prepare and package for distribution Mo-99/Tc-99m generators and other radioactive materials in accordance with the conditions specified therein.

II

An inspection of the Licensee's activities was conducted during January 10-12, 1997, with continuing review through April 8, 1997. The results of this inspection indicated that the Licensee had not conducted its activities in full compliance with NRC requirements. A written Notice of Violation and Proposed Imposition of Civil Penalty (Notice) was served upon the Licensee by letter dated May 30, 1997. The Notice states the nature of the violation, the provision of the NRC's requirements that the Licensee had violated, and the amount of the civil penalty proposed for the violation.

The Licensee responded to the Notice in a letter dated June 30, 1997. In its response, the Licensee admitted that the violation occurred and agreed that a civil penalty is warranted. The Licensee contested the fact that the NRC categorized it as a "b" category, industrial processor, as listed in Table 1A-Base Civil Penalties of NUREG-1600, "General Statement of Policy and Procedures for NRC Enforcement Actions."

III

After consideration of the Licensee's response and the statements of fact, explanation, and argument for mitigation contained therein, the NRC staff has determined, as set forth in the Appendix to this Order, that the violation occurred as stated and that the penalty proposed for the violation designated in the Notice should be imposed.

IV

In view of the foregoing and pursuant to Section 234 of the Atomic Energy Act of 1954, as amended (Act), 42 U.S.C. 2282, and 10 CFR 2.205, IT IS HEREBY ORDERED THAT:

The Licensee pay a civil penalty in the amount of $13,750 within 30 days of the date of this Order, by check, draft, money order, or electronic transfer, payable to the Treasurer of the United States and mailed to James Lieberman, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North, 11555 Rockville Pike, Rockville, MD 20852-2738.

V

The Licensee may request a hearing within 30 days of the date of this Order. Where good cause is shown, consideration will be given to extending the time to request a hearing. A request for extension of time must be made in writing to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, and include a statement of good cause for the extension. A request for a hearing should be clearly marked as a "Request for an Enforcement Hearing" and shall be addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, with a copy to the Commission's Document Control Desk, Washington, D.C. 20555. Copies also shall be sent to the Assistant General Counsel for Hearings and Enforcement at the same address and to the Regional Administrator, NRC Region III, 801 Warrenville Road, Lisle, Illinois 60532-4351.

If a hearing is requested, the Commission will issue an Order designating the time and place of the hearing. If the Licensee fails to request a hearing within 30 days of the date of this Order (or if written approval of an extension of time in which to request a hearing has not been granted), the provisions of this Order shall be effective without further proceedings. If payment has not been made by that time, the matter may be referred to the Attorney General for collection.

In the event the Licensee requests a hearing as provided above, the issue to be considered at such hearing shall be:

Whether on the basis of the violation admitted by the Licensee, this Order should be sustained.

FOR THE NUCLEAR REGULATORY COMMISSION Mark A. Satorius, Deputy Director Office of Enforcement

Dated at Rockville, Maryland
this 9th day of September 1997

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APPENDIX

EVALUATION AND CONCLUSION

On May 30, 1997, a Notice of Violation and Proposed Imposition of Civil Penalty (Notice) was issued for a violation identified during an NRC inspection. Mallinckrodt Medical, Inc. (Licensee) responded to the Notice in a letter dated June 30, 1997. The Licensee admitted the violation but requested mitigation of the proposed civil penalty based on its contention that the civil penalty was assessed at an inappropriate level. The NRC's evaluation and conclusion regarding the licensee's request is as follows:

Restatement of Violation

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 Siginaw, 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

Summary of Licensee's Request for Mitigation

The Licensee agrees in its June 30, 1997 letter that a civil penalty regarding this apparent violation is warranted. However, the Licensee contests the level at which the NRC categorized the civil penalty (i.e.; placement of Mallinckrodt Medical, Inc. into the "b" category (industrial processor) of Table 1A-Base Civil Penalties of Section VI.B.2.d. of the NRC Enforcement Policy, NUREG-1600).

The Licensee does not believe that its operations present the magnitude of risk implied by the examples of types of licensees listed in the "b" category. The Licensee indicates that category "c" or "d" of the referenced table is more appropriate for the nature of its operations.

NRC Evaluation of Licensee's Request for Mitigation

The NRC published a revised "General Statement of Policy and Procedure for Enforcement Actions" (Enforcement Policy) in the Federal Register on June 30, 1995 (60 FR 34381). A significant policy change incorporated into the revised Enforcement Policy was the strategy for assessing civil penalties. According to Table 1A-Base Civil Penalties of the NRC's Enforcement Policy, the current base civil penalty for fuel fabricators, industrial processors, and independent spent fuel and monitored retrievable storage installations is $27,500. The civil penalty for a Severity Level III violation is 50% of the base civil penalty – $13,750. For the purposes of this enforcement action, the staff has determined that the Licensee was properly classified as an industrial processor under category "b" of Table 1A-Base Civil Penalties and that the level of the proposed civil penalty was in accordance with the Enforcement Policy.

Mallinckrodt Medical, Inc. is a large organization that obtains or produces radiopharmaceuticals for worldwide distribution, and the Mallinckrodt Maryland Heights Production Facility is one of the largest manufacturing facilities of diagnostic and therapeutic radiopharmaceuticals in the United States. The Licensee is authorized to possess up to 100 curies of any byproduct material within atomic numbers 1 through 83. In addition, the Licensee may posses up to 10,000 curies of Molybdenum-99, 500 curies of Iodine-131, 200 curies of Selenium-75, 450 curies of Xenon-133, and 200 curies of Rhenium-186. The Licensee employs approximately 280 individuals at its Maryland Heights Production Facility and processes on average 4,000 curies of Molybdenum-99, 70-100 curies of Iodine-131, and 50 curies of Xenon-133 weekly.

Previously, when the Enforcement Policy was published as 10 CFR Part 2, Appendix C, the term "industrial processors" was defined as "Large firms engaged in manufacturing or distribution of byproduct, source or special nuclear material" in a footnote to Table 1A-Base Civil Penalties (e.g.; see footnote 3 to Table 1A-Base Civil Penalties on page 147 of 10 CFR Ch. I (1-1-94 Edition)). On page II.D-39 of the basis document for the revised Enforcement Policy, NUREG-1525, "Assessment of the NRC Enforcement Program," the stated purpose for revising Table 1A-Base Civil Penalties was to simplify it by combining categories of licensees with the same base civil penalty amounts. The proposed Table 1A - Base Civil Penalty Amounts in NUREG-1525 contained a footnote describing industrial processors as "Large firms engaged in manufacturing or distribution of byproduct, source or special nuclear material." Although the footnote that specifically defined the term industrial processors was omitted ¹ when the Enforcement Policy was reprinted as NUREG-1600, there is no indication that the term means anything different now than it has in recent years.

Mallinckrodt Medical, Inc. fits the definition of an industrial processor as previously defined in the Enforcement Policy and is appropriately categorized as an industrial processor for purposes of assessing the civil penalty. On a daily basis, the Licensee manipulates, prepares, and/or distributes to hospitals and radiopharmacies multi-curie quantities of Molybdenum-99, Iodine-131, and other radioactive materials. As a large producer and distributor of radioactive materials, Mallinckrodt's operations involve greater nuclear material inventories and have a greater potential for adverse consequences, if not properly controlled, than many other material licensees (i.e.; those classified as category "c" or "d").

In accordance with the NRC's Enforcement policy, under the revised civil penalty assessment strategy, the base civil penalty for a violation is determined using Table 1A-Base Civil Penalties. Under the revised civil penalty assessment strategy, a violation involving transportation of radioactive materials can be assessed the same base civil penalty as a violation involving plant operations or health physics. This is a significant change from the NRC's prior strategy, which used both the category of the licensee and the type of activity being conducted (e.g.; plant operations, health physics, or transportation) to assess a base civil penalty. Under the prior civil penalty assessment strategy, the base civil penalty for a violation involving transportation of radioactive materials was different than the base civil penalty for a violation involving plant operations or health physics. In accordance with the Enforcement Policy, under the revised civil penalty assessment strategy, the staff does not consider the type of activity (e.g.; the magnitude of risk associated with a particular type of activity such as transportation of radioactive materials versus plant operations) when assessing a civil penalty.

NRC Conclusion

The NRC has concluded that an adequate basis for changing the penalty category was not provided by the Licensee. Consequently, the proposed civil penalty in the amount of $13,750 should be imposed.

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¹ The footnote defining industrial processors as "Large firms engaged in manufacturing or distribution of byproduct. source or special nuclear material" was inadvertently left out of the June 30, 1995, federal Register Notice.