EA-01-132 - South Pittsburgh Cancer Center

August 22, 2001

EA-01-132

South Pittsburgh Cancer Center
Attn: Antonio J. Ambrad, M.D.
4941 Clairton Boulevard
Pittsburgh, PA 15236

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY – $8800 (NRC Office of Investigations Report No. 1-2000-038)

Dear Dr. Ambrad:

This refers to the investigation conducted by the NRC Office of Investigations (OI) between October 27, 2000, and May 7, 2001, at the South Pittsburgh Cancer Center (SPCC) in Pittsburgh, Pennsylvania, to review, in part, the circumstances surrounding the possession of NRC regulated material (depleted uranium) without a proper license, as well as the attempted improper disposal of that material. As noted in the factual summary of the OI investigation sent to you on June 12, 2001, the NRC determined that SPCC, without first obtaining authorization via a specific license issued by the NRC, apparently: (1) received title to, owned, received, and possessed depleted uranium (in the form of bricks used for shielding within two linear accelerators) between January 1994 and October 2000; and (2) subsequently transferred the depleted uranium (DU) to unauthorized individuals in April 1998 and October 2000. Your actions constituted violations of NRC requirements. The June 12, 2001 letter stated that the NRC was considering the findings from the OI investigation as two apparent violations of 10 CFR 40.3.

As noted in the factual summary of the OI investigation, the NRC concluded that these apparent violations occurred as a result of your deliberate actions as the owner/Radiation Safety Officer (RSO) of SPCC. As a result, the NRC sent you the June 12, 2001 letter which confirmed the scheduling of a predecisional enforcement conference. The conference was held in the Region I office on July 31, 2001, to discuss the apparent violations, the causes, and your corrective actions.

At the conference, you denied that your actions, as the owner/RSO of the facility, were deliberate. You stated that you did not know until April 1998 that the linear accelerators contained DU for shielding, when you first transferred the material to a handyman. That individual attempted to dispose of the material, but was unable to do so and he returned the material to you after a radiation monitor alarmed at the disposal facility. You also stated that you did not deliberately transfer the material for improper disposal in October 2000. Rather, you contended that you did not remember, in October 2000, that the material was still in the basement area of the facility when you told the scrap hauler to clean up and dispose of scrap metal items in that area. A copy of the enforcement conference summary is attached.

Notwithstanding your contentions at the predecisional enforcement conference, the NRC has determined that two examples of a violation of NRC requirements occurred as a result of your deliberate actions. The violation is described in the enclosed Notice of Violation. With respect to the first example of the violation, you admitted that you took possession of one linear accelerator in January 1994, as well as the other unit in either 1994 or 1995. After you were unsuccessful in your attempt to dispose of the material in April 1998, you clearly knew that the units contained DU. In addition, at that time, you were also told by the RSO from Mercy Hospital that you were required to have a license from the NRC to possess the material. However, you did not take steps to obtain an NRC license for the material, and the material was not properly disposed of until December 2000. This deliberate possession of the DU without an NRC license constitutes a violation of 10 CFR 40.3 for the period from April 1998 until December 2000. The possession of the DU without an NRC license between January 1994 and April 1998 also constitutes a violation of 10 CFR 40.3; however, the NRC has concluded that there is insufficient evidence to conclude that this violation was deliberate.

With respect to the second example of the violation, you admitted that you improperly transferred the DU to an individual not authorized to receive it in April 1998; however, you denied making an improper transfer in October 2000. During your interview with OI, you testified that after the first individual was unsuccessful in disposing of the DU in April 1998, you made inquiries to at least one company regarding the cost for proper disposal of the radioactive material. Nonetheless, you again improperly transferred the DU to a different individual, a scrap hauler, for disposal in October 2000. Although you stated at the conference that you did not know that the DU was in the basement when you asked the scrap hauler to remove the scrap material, the NRC does not find this credible based on a variety of reasons, including your inconsistent explanation at the conference. In addition, the scrap hauler stated to the NRC that you showed him the collimator device which contained DU and specifically gave him permission to take the device. Further, you had a motive to have the DU taken away at no cost to you because the estimates you received for proper disposal were, as you stated, too high. For these reasons, the NRC has determined that the improper transfer of the DU for disposal in October 2000 was a deliberate (willful) violation of 10 CFR 40.3. The improper transfer of the DU in April 1998 also constituted a violation of 10 CFR 40.3; however, the NRC has concluded that there is insufficient evidence to conclude that this violation was deliberate.

During the conference, you and your counsel stated that you believed that you were exempt from NRC requirements for possession of the material under a Commonwealth of Pennsylvania regulation that exempts licensees from regulations pertaining to state-licensed material while in transport. Clearly, the DU contained in the linear accelerators was not in transport. You took possession of one accelerator in January 1994 and the other in either 1994 or 1995 and maintained possession of DU, both as part of the accelerators and removed from the accelerators, until December 2000 when the material was properly disposed. Moreover, the NRC has determined that the Commonwealth of Pennsylvania regulation does not apply to NRC-regulated material (such as the DU shield blocks).

While there were no actual doses to individuals, the significance of the violation for improper disposal would be categorized as a Severity Level III violation since it created a realistic potential for doses to members of the public. In addition, the NRC is particularly concerned that you, as owner/RSO, deliberately violated NRC requirements. It is essential for the NRC to maintain the highest confidence that licensees and their employees will abide by requirements designed to protect the health and safety of the public. Therefore, based on the deliberate nature of the violation, the NRC has increased the severity level and has categorized the violation in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG-1600, May 1, 2000, as a Severity Level II violation.

In accordance with the Enforcement Policy in effect at the time of the violation, a base civil penalty in the amount of $4,400 is considered for a Severity Level II violation. Because the violations was willful, 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 is not warranted for identification because the violations were identified by the NRC. Credit for corrective actions is also not warranted because you knew, at least by April 1998, that an NRC license was required to possess depleted uranium, but you did not appropriately take corrective actions and dispose of the radioactive material until December 2000.

Therefore, to emphasize the significance of deliberate violations, as well as the importance of prompt identification 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 amount of $8,800 (twice the base amount of $4,400) for the Severity Level II 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 and its enclosures, and your response, will be available electronically for public inspection in the NRC Public Document Room or from the Publically Available Records (PARS) component of the NRC's document system (ADAMS). ADAMS is accessible from the NRC Web site (the Public NRC Library).

		Sincerely,
		/RA/ James T. Wiggins Acting For
		Hubert J. Miller Regional Administrator

Docket No. 030-34832
License No. 37-30477-01

Enclosure:  Notice of Violation and Proposed Imposition of Civil Penalty

cc w/encl:
Commonwealth of Pennsylvania

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NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

South Pittsburgh Cancer Center Pittsburgh, Pennsylvania

Docket No. 030-34832 License No. 37-30477-01 EA-01-132

During an NRC investigation conducted by the NRC Office of Investigation between October 27, 2000, and May 7, 2001, one violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, 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 violation and associated civil penalty are set forth below:

10 CFR 40.3 states, in part, that persons may not receive title to, own, receive, possess, transfer or dispose source material unless authorized in a specific or general license issued by the Commission.

Contrary to the above, South Pittsburgh Cancer Center received title to, owned, received, possessed, transferred and disposed of source material without authorization in a specific license issued by the Commission. Specifically;

1. From January 1994 to December 1, 2000, South Pittsburgh Cancer Center received title to, owned, received, and possessed source material without authorization in a specific license issued by the Commission. In particular, South Pittsburgh Cancer Center possessed depleted uranium (in the form of bricks used for shielding in two linear accelerators) but the material was not listed on an NRC license.
   
   
2. In April 1998 and October 2000, South Pittsburgh Cancer Center transferred source material without authorization in a specific license issued by the Commission. In particular, South Pittsburgh Cancer Center transferred depleted uranium (in the form of bricks used for shielding within linear accelerators) in April 1998 and October 2000 to individuals for disposal without authorization via a specific license issued by the Commission.

This is a Severity Level II violation (Supplements VI and VII).
Civil Penalty – $8800

Pursuant to the provisions of 10 CFR 2.201,South Pittsburgh Cancer Center (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. 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 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.

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: F. Congel, 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 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), to the extent possible, it should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the public without redaction. ADAMS is accessible from the NRC Web site (the Public NRC Library). 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).

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

Dated this 22nd day of August 2001