EA-02-097 - Eastern Isotopes, Inc.

July 30, 2002

EA-02-097

Eastern Isotopes, Inc.
ATTN: C. Joseph Harless, CNMT, BSHP
Vice President, General Operations
1226 Leolillie Lane
Charlotte, NC 28216

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY – $4,800 (NRC INSPECTION REPORT NO. 45-25221-01MD/01-01)

Dear Mr. Harless:

This refers to the inspection conducted on October 24, 2001, to review the circumstances surrounding an apparent overexposure to a pharmacist. Subsequent discussions regarding this event were held with you and members of your staff from December 2001 through February 2002, and the subject inspection report was forwarded to you by letter dated February 21, 2002. At the NRC's request, an open predecisional enforcement conference was conducted with you and members of your staff on July 2, 2002, in the Region II office. The enclosures to this letter include the list of conference attendees, and copies of the material presented by Eastern Isotopes, Inc. (EII) and the NRC at the conference.

Based on the information developed during the inspection and investigation, and the information you provided during the conference, the NRC has determined that a violation of regulatory requirements occurred. The violation is cited in the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice), and the circumstances surrounding it are described in detail in the subject inspection report. The violation involved an extremity exposure to an EII pharmacist of approximately 127 rem and 86 rem to the right and left index fingers, respectively, which exceeded the NRC's regulatory dose limit of 50 rem as specified by 10 CFR 20.1201(a)(2)(ii). The pharmacist was conducting activities using both NRC- and State-licensed material, and received a majority of the annual dose in the months of September and October 2001 from the improper handling of Fluorine-18 (F-18) labeled radiopharmaceuticals (a State-licensed isotope). Since 10 CFR 20.1003 defines occupational dose as the dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to radiation from licensed and unlicensed sources of radiation, NRC regulations require that the total dose not exceed the limits specified in 10 CFR Part 20. As you stated at the conference, the cause of the overexposure involved the failure of an employee to follow industry accepted practices for the safe handling of F-18. Once you identified the overexposure, you immediately removed the pharmacist from handling activities for the remainder of 2001.

As stated in our letter of February 21, 2002, the NRC retained the services of a medical consultant to review the circumstances surrounding the event. Based on this review, the NRC concluded that it is highly unlikely that the dose received by the pharmacist resulted in any significant health effects. However, the actual consequence of the violation was an exposure to an employee which was greater than two times the regulatory limit and the potential existed for much greater radiation exposure, which under different circumstances may have presented a significant hazard to the pharmacist or other EII staff. Therefore, the violation has been categorized in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions", NUREG-1600, at Severity Level II.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $4,800 is considered for a Severity Level II violation. The NRC considered whether credit was warranted for the factors of Identification and Corrective Action in accordance with the civil penalty assessment process described in Section VI.C.2 of the Enforcement Policy. Regarding the factor of identification, the NRC concluded that the EII staff identified this issue based on a review of monthly reports of extremity dosimetry. As such, credit was warranted for the factor of Identification. In addition to the immediate removal of the pharmacist from handling activities for the remainder of 2001, your immediate and long-term corrective actions included, in part, thorough investigation and evaluation of the cause of the incident including prompt estimates of the overexposure, review of exposure records to other personnel to confirm that the incident was not a result of a system breakdown, a review of the existing barriers in place to preclude such incidents (such as available robotics, syringe shield, tongs), the issuance of updated directives for F-18 handling, and a review of basic radiation safety practices with EII staff. Additional corrective actions taken by EII were discussed at the conference and are included in Enclosure 3. Based on the above, the NRC concluded that credit was warranted for the factor of Corrective Action.

Notwithstanding credit for Identificationand Corrective Action, civil penalties are normally assessed for Severity Level II violations. In addition, the NRC considers the exercise of discretion in accordance with Section VII.A.1 of the Enforcement Policy to propose a civil penalty for violations resulting in overexposures. In this case, the Severity Level II violation involved an overexposure to the pharmacist in excess of NRC requirements. Therefore, after consultation with the Director, Office of Enforcement, and the Deputy Executive Director for Materials, Research, and State Programs, I have been authorized to exercise discretion to propose a base civil penalty of $4,800 in this case. In addition, issuance of this Notice constitutes escalated enforcement action that may subject you to increased inspection effort.

The NRC has concluded that information regarding the reason for the violation, the corrective actions taken and planned to correct the violation and prevent recurrence, and the date when full compliance was achieved is adequately addressed on the docket in this letter and the information you presented at the conference (Enclosure 3). Therefore, you are not required to respond to this violation unless the description herein does not accurately reflect your corrective actions or your position. In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosures, and your response (should you choose to provide one) 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). ADAMS is accessible from the NRC Web site at the Public NRC Library.

If you have any questions regarding this matter, please contact Douglas M. Collins, Director, Division of Nuclear Materials Safety, at 404-562-4700.

		Sincerely,
		/RA/
		Luis A. Reyes Regional Administrator

Docket No. 030-32974
License No. 45-25221-01MD

Enclosures:
1. Notice of Violation and Proposed Imposition Of Civil PenaltyList of Attendees
2. Information presented by EII
3. Information presented by NRC
4. NUREG/BR-0254 Payment Methods (Licensee only)

cc w/ encl:

Commonwealth of Virginia
Barry A. Siegel, M.D.
Mallinckrodt Institute of Radiology
510 Sough Kingshighway Blvd.
St. Louis, MO 63110

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NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

Eastern Isotopes, Inc. Charlotte, NC

Docket No. 030-32974 License No. 45-25221-01MD EA-02-097

During an NRC inspection conducted on October 24, 2001, 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 is set forth below:

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

10 CFR 20.1003 defines occupational dose, in part, as the dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to radiation or to radioactive material from licensed and unlicensed sources of radiation.

10 CFR 20.1003 defines shallow-dose equivalent, in part, as the dose equivalent at a tissue depth of 0.007 centimeter (7 mg/cm²) averaged over an area of 1 square centimeter.

Contrary to the above, the licensee failed to control the annual occupational dose to the extremity of an adult to 50 rems shallow-dose equivalent. Specifically, for the period of January 1, 2001 through December 31, 2001, the licensee allowed an authorized nuclear pharmacist to receive a shallow-dose equivalent to the right hand of approximately 127.38 rems and a shallow-dose equivalent to the left hand of approximately 86.31 rems.

This is a Severity Level II violation (Supplement IV).
Civil Penalty – $4,800

The NRC has concluded that information regarding the reason for the violation, the corrective actions taken and planned to correct the violation and prevent recurrence, and the date when full compliance was achieved is already adequately addressed on the docket in the letter transmitting this Notice of Violation (Notice), and the information presented by Eastern Isotopes, Inc., at the conference (Enclosure 3). However, you are required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to respond, clearly mark your response as a "Reply to a Notice of Violation," and send it to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555 with a copy to the Regional Administrator, Region II within 30 days of the date of the letter transmitting this Notice.

Within 30 days of the date of this Notice, 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 30 days of the date of this Notice of Violation and Proposed Imposition of Civil Penalty, 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 violation 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 (statement as to payment of civil penalty) should be addressed to Frank 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 II, 61 Forsyth Street, SW, Atlanta, GA 30303.

Should you choose to respond to the violation, 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 at 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). If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.

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

Dated this 30^th day of July 2002