EA-00-180 - Mallinckrodt, Inc.

October 4, 2000

EA 00-180

Stephen J. Garner
Director, Radiopharmaceutical Operations
Mallinckrodt, Inc.
Nuclear Medicine Division
2703 Wagner Place
Maryland Heights, MO 63043

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY -$2,750 (NRC Inspection Report No. 03032995/2000001)

Dear Mr. Garner:

This refers to the NRC inspection conducted at the Mallinckrodt facility in Harrisburg, Pennsylvania on July 5, 2000. The inspection was performed to review the circumstances associated with a radiation exposure in excess of the regulatory limits to the hand of a worker at the facility. You reported the exposure to the NRC on June 30, 2000. You provided additional information to the NRC in a written report dated July 31, 2000, which was received and examined by the NRC Region I staff on August 1, 2000. We sent you the inspection report on August 15, 2000. During the inspection, two apparent violations of NRC regulations were identified. We held a predecisional enforcement conference with you and others from Mallinckrodt, Inc. on August 30, 2000, to discuss the violations, their causes, and your corrective actions. A copy of the meeting summary is enclosed. Subsequent to the meeting, you submitted supplemental information in letters dated September 12 and 13, 2000, regarding this exposure and we have received and reviewed this information.

Based on the information developed during the inspection, and the information that you provided during the conference and in your September 12 and 13, 2000, letters, the NRC has determined that two violations of NRC requirements occurred. The violations are cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding them are described in detail in the subject inspection report. The first violation involved the failure to maintain radiation exposure to one of the workers below the regulatory limits. Specifically, the worker (a radiopharmacist preparing radiopharmaceuticals) received a cumulative radiation dose of approximately 62 rem shallow-dose equivalent to his right hand (extremity) for the period from January 2000 through June 2000, an amount in excess of the annual limit of of 50 rem shallow-dose equivalent for any extremity.

The second violation involved the failure to perform adequate radiation surveys to preclude such an exposure. Specifically, the worker was not monitored (or surveyed) for radiation exposure in a timely manner to prevent his cumulative radiation exposure from exceeding the annual limit, and the worker's handling techniques were not adequately reviewed to identify that appropriate safety equipment was not being used consistently by the worker. Although the worker who received the over-exposure was being monitored on a monthly basis from January 2000 to June 2000, you did not identify the higher than normal extremity dose until May 2000, at which time the annual limit had already been exceeded. The NRC is concerned that TLD badge readings for March and April 2000 indicated that the individual had a cumulative extremity exposure of approximately 40 rem shallow-dose equivalent; however, you did not restrict the individual from all work with radiopharmaceuticals at that time. Rather, the worker continued to perform restricted work assignments with radiopharmaceuticals, notwithstanding the verbal notification from the dosimetry processor in late May regarding the March results. The restricted work assignments with radiopharmaceuticals continued until you reviewed the final written exposure reports for the March exposure on June 8, 2000. You also accepted delays from your dosimetry processor that prevented you from evaluating the actual exposure to the individual's hand in a timely manner.

During the conference and in your September 12, 2000 letter, you contended that an actual overexposure did not occur. You indicated that after further review, using the H150 beam code (as described in ANSI N43.11-1993, "Personnel Dosimetry Performance - Criteria for Testing"), you concluded that the actual exposure was 49.74 rem, which is slightly below the 50 rem limit. In support of this contention, you indicated that the H150 beam code was the most appropriate calibration factor for determining the extremity dose for the individual. The NRC does not accept your contention that the overexposure did not occur because we found that your calculations do not consider (1) the percentage of technetium-99m activity handled when compared to the total activity handled; and (2) the molybdenum-99 contribution to the individual's dose. Based on data provided by you in your September 13, 2000 letter, the NRC concludes that the percentage of technetium-99m activity handled when compared to the total activity handled is closer to 80 percent and therefore, we do not agree that the H150 beam code is the appropriate code to use. Therefore, since the violations involved an overexposure, the violations are classified as a Severity Level III problem in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Action" (Enforcement Policy), NUREG 1600, dated May 1, 2000. Even if an overexposure had not occurred, the survey violation itself would be classified at Severity Level III, consistent with the Enforcement Policy, on the basis that it had created a substantial potential for an overexposure.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level III problem. Because your facility has not been the subject of escalated enforcement actions within the last two inspections, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section VI.C.2 of the Enforcement Policy. The NRC recognizes that a number of corrective actions were taken to correct the violations and preclude recurrence. Those actions, which were described at the conference, as well as in your written event report dated July 31, 2000, included; (1) implementing a system for tracking personnel radiation monitoring devices (dosimeters), (2) placing all new pharmacy employees on a weekly dosimeter exchange (versus monthly) for the first six months of employment, (3) requiring radiation monitoring of both hands for all new dispensing personnel, (4) reviewing dosimetry results from the processing vendor by Radiation Safety Officer (RSO) within 24 hours of receipt of weekly results to assure early detection of cumulative radiation exposures approaching limits, (5) trending of weekly dosimetry results by the RSO to identify abnormally high cumulative doses, (6) implementing a requirement for an ALARA investigation if the ALARA action levels are exceeded, and (7) requiring training for managers and RSOs regarding the new requirements. However, credit is not warranted for those corrective actions since they were not considered sufficiently comprehensive. In particular, your corrective actions did not appear to address all the root causes identified by your staff. For example, your review indicates that the use of improper techniques for handling radioactive material was a root cause of the exposure. In response, your corrective actions included formalizing the "on-the-job" training program, as well as direct oversight by your corporate staff during periodic audits conducted twice per year at the various facilities. However, those actions did not address the need for improvement in oversight (by management at the Harrisburg facility) of the employee's handling of material to ensure that appropriate techniques are used in the future. Therefore, the corrective actions did not fully address the root cause identified as the use of improper techniques by workers for handling radioactive materials (i.e., inconsistent use of flange shields and handling of syringes).

Therefore, to emphasize the importance of adequate surveys and oversight of activities at your facility to ensure that workers' radiation exposures are maintained within regulatory limits, 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 (Notice) in the amount of $2,750, for the Severity Level III problem set forth in the Notice. 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 and its enclosure will be 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/ James T. Wiggins acting for
		Hubert J. Miller Regional Administrator

Docket No. 030-32995
License No. 24-04206-01

Enclosure: Notice of Violation and Proposed Imposition of Civil Penalty

cc w/encls:
Commonwealth of Pennsylvania

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NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

Mallinckrodt, Inc. Harrisburg, PA

Docket No. 030-32995 License No. 24-04206-01MD EA 00-180

During an NRC inspection conducted at the licensee's facility on July 5, 2000, and continued in the Region I office on August 1, 2000, two violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG-1600, dated May 1, 2000, 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 violations and associated civil penalty are listed below:

A.	10 CFR 20.1201(a)(2)(ii) requires, with exceptions not applicable here, that the licensee control the occupational dose to the skin or to any extremity of individual adults to an annual dose limit of 50 rem shallow-dose equivalent. Contrary to the above, the licensee did not limit the annual dose to the right hand (extremity) of an adult radiopharmacist to 50 rem shallow-dose equivalent. Specifically, the individual received an exposure (based on the written report to the NRC) of approximately 62 rem shallow-dose equivalent to the right hand for the period from January 2000 through June 2000. This amount was determined based on the following exposure results obtained from the licensee's dosimetry processing vendor during this period: January - 0.6 rem; February - 8.3 rem; March - 26.6 rem; April - 13.1 rem; May - 12.1 rem; and June - 1.3 rem.
B.	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 extent of radiation levels, concentrations or quantities of radioactive materials, and the potential radiological hazards that could be present. Pursuant to 10 CFR 20.1003, survey means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of radioactive material or other sources of radiation. Contrary to the above, as of July 5, 2000, the licensee did not make adequate surveys to assure compliance with 10 CFR 20.1201, which limits radiation exposure to the extremities. Specifically, a radiopharmacist was not monitored (or surveyed) for radiation exposure in a timely manner to prevent the cumulative exposure to the individual's hand from exceeding the annual limit. For example:
	1.	the licensee did not adequately evaluate the dosimetry results for this individual, in that the licensee did not adequately review the exposed individual's work habits upon notification, in April and May 2000, of higher than normal monthly dosimeter results (8.3 rem for February 2000 and 26.6 rem for March 2000);
	2.	despite the indications of abnormally high dosimeter results from the February and March 2000 monitoring periods, the licensee accepted delays from its dosimetry processor in the processing of dosimeters, which contributed to the lack of recognition that the individual's exposure was near the regulatory limit of 50 rem; and
	3.	after receipt of the dosimetry results, the licensee did not immediately monitor the individual on a more frequent basis (via weekly dosimeter badges) so as to control exposures and assure that regulatory limits were not exceeded, and did not adequately assess the individual's technique for handling licensed material to determine how the technique contributed to the excessive radiation exposure.

This is a Severity Level III problem (Supplement IV).
Civil Penalty – $2,750

Pursuant to the provisions of 10 CFR 2.201, Mallinckrodt, Inc. is hereby required to submit a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555, with a copy to the Regional Administrator, Region I, within 30 days of the date of the letter transmitting 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 violation: (1) admission or denial of the alleged violation, (2) the reasons for the violation if admitted, or, if denied, the basis for disputing the violation or severity level, (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. Your response may reference or include previous docketed correspondence, if the correspondence adequately addresses the required response. 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 to why the license should not be modified, suspended, or revoked, or why such other action as may be proper should not be taken. Where good cause is shown, consideration will be given to extending the response time.

Within the same time as provided for the response required above under 10 CFR 2.201, the Licensee may pay the civil penalty proposed above, in accordance with NUREG/BR-0254 and by submitting to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, a statement indicating when and by what method payment was made, 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.C.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, statement as to payment of civil penalty, and Answer to a Notice of Violation) should be addressed to: R. W. Borchardt , 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 I.

Because your response will be placed in the NRC Public Document Room (PDR) and on the NRC Web site 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. However, if you find it necessary to include such information, you should clearly indicate the specific information that you desire not to be placed in the PDR, and provide the legal basis to support your request for withholding the information from the public.

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

Dated this 4th day of October 2000