EA-97-342 - Mallinckrodt Inc.

December 17, 1997

EA 97-342 & EA 97-355

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

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTIES – $55,000 (NRC Inspection Reports 030-00001/97002(DNMS) and 030-00001/97003(DNMS))

Dear Mr. Sabo:

This refers to the inspections conducted between May 16 and July 14, 1997, at Mallinckrodt Medical, Inc., Maryland Heights, Missouri. The inspections were conducted to review a personnel contamination event and two incidents involving packages containing Mo-99/Tc-99m generators with excessive radiation levels. The NRC inspection reports were sent to you by letters dated July 17 and 25, 1997. On August 7, 1997, a Predecisional Enforcement Conference was conducted with you and members of your staff to discuss the violations, their causes, and your corrective actions. The conference summary report was sent to you by separate correspondence on August 26, 1997.

Based on the information developed during the inspection and the information that you and your staff provided during the conference, the NRC has determined that violations of NRC requirements occurred. These violations are cited in the enclosed Notice of Violation and Proposed Imposition of Civil Penalties (Notice) and the circumstances surrounding them are described in detail in the subject inspection reports. The violations involve: (1) failure to limit the shallow-dose equivalent of an occupational worker to 50 rems in one year (Violation A.1); (2) failure to make or cause to be made surveys that may be necessary to ensure compliance with the requirements in 10 CFR Part 20 (Violation A.2); and (3) delivering to a carrier for transport licensed material in two packages that arrived at their destinations with radiation levels that exceeded 200 millirem per hour on the outer surface of the packages (Violation B).

The violations arose from two separate events. The first event occurred during a rhenium-186 hot cell clean-up operation when the left hand of an occupational worker became contaminated and, as a result, the worker received a radiation dose in excess of 290 rems. The radiation dose was primarily caused by the cross contamination of the worker's hand during removal of radioactive waste and contaminated glassware from a mini-hot cell after processing approximately 40 curies of rhenium-186, and was exacerbated by the failure of the worker to perform an adequate personal survey immediately following the clean-up operation. Although the worker attempted to conduct a personal survey after the clean-up operation, the survey was not completed due to the effect of high background radiation at the frisking station. The worker made no other attempts to conduct a proper survey prior to leaving the building. The second event involved the transport of two packages, each containing 6.4 curie Dry Top Eluting (DTE) generators, between Mallinckrodt Medical, Inc., and Mallinckrodt Nuclear Pharmacies in New Jersey and Pennsylvania. The packages arrived at their destinations with radiation levels that exceeded 200 millirem per hour on the outer surface of the packages. The root cause of this violation was determined to be migration of residual Tc-99m saline solution within the tubing outside of the generator's shielding during pressure or environmental changes in the transportation cycle.

The NRC expects each of its licensees to establish controls and procedures to ensure that personnel radiation exposures are maintained within regulatory limits. The chain of events that allowed the contamination event to occur and then go undetected indicates that the controls and procedures that Mallinckrodt established were insufficient. Although no immediate acute effects from the exposure were observed, Violations A.1 and A.2 are of very significant regulatory concern given the magnitude of the exposure. Had the contamination not been identified when it was, the consequences from the potential prolonged exposure would have been more significant. Therefore, the violations involving radiation exposure in excess of Part 20 limits and performance of an inadequate personal survey are classified in the aggregate in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, as a Severity Level I problem.

Violation B is directly related to a violation, which was the subject of a $13,750 civil penalty issued on May 30, 1997 (EA 97-155), involving a similar incident that occurred in December 1996, when a package containing a 12-curie UltraTechna-Kow Mo-99/Tc-99m generator exhibited surface radiation levels in excess of 200 millirem per hour upon receipt by a nuclear pharmacy. Violation B is of significant regulatory concern because Mallinckrodt staff: (1) had prior knowledge that radiation levels had increased during transportation of some DTE generators (i.e., between the time of initial survey and the survey performed by the end user), but failed to take any actions in response to this information; and (2) failed to perform sufficient and adequate testing to determine whether residual saline remained in the generator column after a test elution prior to commencing routine shipping of the DTE generators. Given the previous problems with high radiation levels on shipping packages and indications that radiation levels on some DTE generators were higher upon receipt than they were at departure, a more rigorous attempt to identify potential shipping problems should have been made. 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 $27,500 is considered for a Severity Level I problem and 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, 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.

Regarding the Severity Level I problem, credit is warranted for identification because Mallinckrodt staff identified that the individual was not properly surveyed and calculated that the individual was overexposed. Credit for corrective action is warranted because you took prompt actions to ensure proper surveys were conducted following the handling of radioactive material and indicated additional actions would be taken after the predecisional enforcement conference to address contamination control problems. These actions included: (1) discussion of the event and its causes with all pertinent personnel; (2) relocation of a hallway personnel monitoring system to improve accessibility for personnel leaving the laboratory; (3) instructions/demonstrations to personnel involved with the laboratory operation on personnel contamination survey techniques and gowning/disrobing of contaminated clothing; and (4) relocation of the cyclotron raw material activity transfer box to reduce background levels near the monitoring station. Two rhenium contamination events occurred subsequent to the overexposure which indicated that your initial corrective actions were somewhat narrowly focused. While your emphasis on proper surveying techniques was effective in promptly identifying the personal contaminations and in preventing significant exposures to the workers, your failure to address contamination control problems with the process allowed the subsequent contaminations to occur. This deficiency was discussed at the predecisional enforcement conference. At the conference you indicated that future rhenium operations would be suspended pending a thorough review of the process. A plan to significantly modify the rhenium cell was then developed such that all handling of contaminated equipment will be done remotely. Based on this plan, your corrective actions now appear to be comprehensive. However, normally Severity Level I problems result in consideration of a civil penalty. Therefore, notwithstanding credit for identification and corrective action, I have decided, after consultation with the Commission, to exercise discretion in accordance with Section VII.A.1.(a) and (b) of the Enforcement Policy by proposing a civil penalty of $27,500 for the Severity Level I problem, because of the excessive dose received by the individual, which was clearly preventable.

Regarding the Severity Level III violation, credit is not warranted for identification because the violation was revealed through an event and because Mallinckrodt staff had prior knowledge of increased radiation levels during transport, but did not investigate the root cause. Credit is warranted for corrective action. The corrective actions included: (1) institution of an additional "dry elution" step to minimize residual activity left in the tubing; (2) addition of a lead shielding cap to cover previously unshielded generator tubing; and (3) establishment of a global task force to evaluate the root cause and to develop a permanent solution to the problem. While the civil penalty process of the Enforcement Policy would normally result in a civil penalty in the base amount of $13,750, discretion is also being exercised in accordance with Section VII.A.1.(d) of the Enforcement Policy to increase the civil penalty by 100 percent to $27,500 to ensure that the civil penalty reflects the repetitive nature of the violation, the significance of the circumstances, and the need for your staff to take actions on information indicating that transportation problems continued to exist.

Therefore, to emphasize the unacceptability of unnecessary exposures to workers and the public, the importance of preventing violations from recurring, the need to properly control radioactive material, and in recognition of your previous escalated enforcement action, I have been authorized, after consultation with the Commission, to issue the enclosed Notice in the total amount of $55,000 for the Severity Level I problem and for the Severity Level III violation. 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.

Sincerely,

Original signed by W. L. Axelson for A. Bill Beach Regional Administrator

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

Enclosure: Notice of Violation and Proposed Imposition of Civil Penalties

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NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTIES

Mallinckrodt Medical, Inc. Maryland Heights, MO

Docket No. 030-00001 License No. 24-04206-01 EA 97-342 &EA 97-355

During NRC inspections conducted between May 16 and July 14, 1997, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the NRC proposes to impose civil penalties 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 violations and associated civil penalties are set forth below:

A. 1. 10 CFR 20.1201(a)(2) requires, with exceptions not applicable here, that the licensee control the occupational dose to the skin and to any extremity of individual adults to an annual dose limit of 50 rems shallow-dose equivalent.

Contrary to the above, the licensee did not limit the annual dose to the extremity of an adult to 50 rems shallow-dose equivalent. Specifically, an adult worker received between 290 rems and 608 rems shallow-dose equivalent to the lateral surface of the left thumb for the period of May 14 and 15, 1997. (01011)

2. 10 CFR 20.1501 requires, in part, that each licensee make or cause to be made, surveys that may be necessary for the licensee to comply with the regulations in Part 20, and that are reasonable under the circumstances to evaluate the potential radiological hazards that could be present.

Pursuant to 10 CFR 20.1003, survey is defined as an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, and presence of radioactive material or other sources of radiation.

Contrary to the above, the licensee did not make surveys to ensure compliance with 10 CFR 20.1201, which limits occupational doses to workers. Specifically, a Mallinckrodt worker did not perform a personal survey upon leaving the production area of Building 600 on May 14, 1997. As a result, contamination went undetected and the individual received a shallow-dose equivalent between 290 rems and 608 rems to the left thumb, a value that is in excess of the Part 20 limits. (01021)

These violations represent a Severity Level I problem (Supplement IV).
Civil Penalty – $27,500

B. 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 of the Department of Transportation (DOT) in 49 CFR Parts 170 through 189 appropriate to the mode of transport.

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 July 8, 1997, the licensee delivered to a carrier for transport, licensed material in two packages that arrived at their destinations, Mallinckrodt Nuclear Pharmacies in Pinebrook, New Jersey, and Folcroft, Pennsylvania, on July 8, 1997, with radiation levels on the outer surface of the packages of 250 millirem per hour and 240 millirem per hour, respectively. (02013)

This is a Severity Level III violation (Supplement V).
Civil Penalty – $27,500

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 Penalties (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 penalties 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 penalties 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 penalties 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 penalties will be issued. Should the Licensee elect to file an answer in accordance with 10 CFR 2.205 protesting the civil penalties, in whole or in part, such answer should be clearly marked as an "Answer to a Notice of Violation" and may: (1) deny the violation(s) 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 penalties should not be imposed. In addition to protesting the civil penalties in whole or in part, such answer may request remission or mitigation of the penalties.

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 civil penalties.

Upon failure to pay any civil penalties 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 penalties, 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, 801 Warrenville Road, Lisle, Illinois 60532-4351.

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 17th day of December 1997