EA-00-060 - Syncor International Corporation
June 28, 2000
Robert Funari, President and CEO
Syncor International Corporation
6464 Canoga Avenue
Woodland Hills, California 91367
|SUBJECT:||NOTICE OF VIOLATION & PROPOSED IMPOSITION OF CIVIL PENALTY - $2,750 [NRC INSPECTION REPORT 030-33224/00-02 AND INVESTIGATION REPORT A4-1999-042]|
Dear Mr. Funari:
This refers to the predecisional enforcement conference conducted in Arlington, Texas on April 18, 2000. The conference was conducted to discuss two apparent violations of NRC requirements related to the transport of radiopharmaceuticals from a Syncor International Corporation pharmacy in Stamford, Connecticut. The apparent violations included an apparent failure to block and brace properly a package of radioactive material that fell from a Syncor vehicle on July 9, 1999, and an apparent failure to assure the door locking mechanisms on a Syncor vehicle were adequate to meet NRC security requirements for radioactive material when the vehicle was left unattended.
During the conference, Syncor officials acknowledged that there had been a failure to block and brace a molybdenum-99/technetium-99m radionuclide generator on July 9, 1999, such that when the rear doors of the Syncor vehicle came open during transport, the generator fell from the vehicle. Syncor officials also acknowledged that there was willfulness associated with this violation, in that the driver of the vehicle had been properly trained in blocking and bracing procedures, yet there was no evidence that any blocking and bracing mechanisms had been used on the date of the incident.
With regard to the security issue, Syncor officials stated that they had checked the rear doors of the Syncor vehicle on more than one occasion and had determined that the doors could be adequately secured. Syncor also asserted that after the doors were opened by an NRC investigator on October 19, 1999, one day after Syncor had last checked and found them adequate, it became necessary to remove the vehicle from service and have the doors repaired. Based on its position that the storage compartment of the vehicle could be adequately secured, Syncor denied that there was a violation of NRC security requirements.
Notwithstanding Syncor's position on the violations, Syncor described a number of corrective actions taken to address these issues following Syncor's corporate office becoming involved in October 1999. These included notifications to all Syncor pharmacies to check the locking hardware on vehicles of the same type, reminders to pharmacies to report all losses of radioactive material, dissemination of guidance on blocking and bracing generators, the installation of safety chains to enhance vehicle security, and ongoing checks by Syncor managers and auditors to assure requirements are being followed.
The NRC has carefully reviewed the information Syncor officials provided at the conference, and has had additional discussions with its investigative staff regarding the condition in which the doors were found in October 1999 when the investigative field work was done. NRC's Office of Investigations (OI) states that the vehicle was first checked on October 16, 1999, and that photographs were taken at that time. OI states that there was a visible gap between the rear doors; that despite being locked, the doors to the storage compartment on the vehicle were easily opened; and that the locking hardware was in such disrepair that it did not appear the doors could be adequately secured, particularly since the top locking rod could not be engaged in its locked position and the bottom locking rod was missing (Syncor acknowledged at the conference that the bottom locking rod had been missing). OI states that the conditions observed and photographed on October 16, 1999, were identical to those observed on October 19, 1999, when OI demonstrated to Syncor personnel the ease with which the doors could be opened.
Based on our review of all of the evidence in this case, including the information Syncor provided at the conference, the NRC has concluded that both violations occurred, and that the violation involving the failure to block and brace the technecium-99m generator was willful. These violations are cited in the enclosed Notice of Violation and Proposed Imposition of Civil Penalty. Both violations contributed to the July 9, 1999 incident, resulting in an 850-millicurie radionuclide generator being out of Syncor's control and accessible to the public for a short period of time. In addition, the security violation posed the potential for unauthorized access to, or theft of, radioactive material from this Syncor vehicle any time it was left unattended during radioactive materials deliveries. Given the relationship between these violations, the NRC is treating them collectively as a Severity Level III problem in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.
In accordance with the Enforcement Policy, a civil penalty with a base value of $2,750 is considered for a Severity Level III problem. Because there was willfulness associated with the blocking and bracing failure, the NRC considered both Identification and Corrective Action in determining whether a civil penalty should be assessed, in accordance with Section VI.B.2 of the Enforcement Policy. With regard to identification, the blocking and bracing failure was revealed by the July 9, 1999 incident, and Syncor failed to identify the security violation (i.e., the inadequate locking hardware) despite clear opportunities to do so in response to complaints from the driver. Thus, the NRC has determined that Syncor is not deserving of identification credit. With regard to corrective action credit, the NRC has determined that Syncor is deserving of credit for the comprehensive actions taken from the time Syncor's corporate office became aware of the incident and the problems with the door locking mechanisms in October 1999. The result of these considerations is the assessment of a civil penalty at the base value.
Therefore, to emphasize the importance of assuring the security of radioactive material in transit, 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 described above and in the Notice. In addition, issuance of this Notice constitutes escalated enforcement action, which 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.
Thomas P. Gwynn Acting for/
Docket No. 030-33224
License No. 04-26507-01MD
Enclosure: Notice of Violation & Proposed Imposition of Civil Penalty
cc w/Enclosure 1
California Radiation Control Program Director
Connecticut Radiation Control Program Director
New York Radiation Control Program Director
New York Dept. of Labor
|Syncor International Corporation
Woodland Hills, California
|Docket No. 030-33224
License No. 04-26507-01MD
During an NRC investigation completed in February 2000, 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 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 set forth below:
10 CFR 71.5(a) requires that a licensee who transports licensed material outside of the site of usage, as specified in the NRC license, or where transport is on public highways, 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 177.842 requires, in part, that packages of radioactive materials be so blocked and braced that they cannot change position during conditions normally incident to transportation.
10 CFR 20.1801 requires, in part, that licensees secure from unauthorized removal or access licensed materials that are stored in unrestricted areas. 10 CFR 20.1802 requires licensees to control and maintain constant surveillance of licensed material that is in an unrestricted area and that is not in storage. As defined in 10 CFR 20.1003, unrestricted area means an area to which access is neither limited nor controlled by the licensee.
- Contrary to the above, on July 9, 1999, the licensee transported a package containing an 850-millicurie molybdenum-99/technetium-99m radionuclide generator on a public highway, and the package was not blocked and braced such that it could not change position during conditions normally incident to transportation. Specifically, while in transport between licensee facilities in Stamford, Connecticut, and Newburgh, New York, the package fell out of a licensee vehicle under conditions normally incident to transportation. Until recovered by the licensee a short time later, the package was in an unrestricted area and was not under the control and constant surveillance of the licensee. (01013)
- Contrary to the above, on multiple occasions between approximately May 1999 and October 1999, the licensee did not secure from unauthorized removal, or limit access to, and did not maintain constant surveillance of, licensed radioactive material that was located in an unrestricted area. Specifically, due to faulty latching and locking hardware on the storage compartment of a licensee vehicle used to transport radiopharmaceuticals, packages containing radioactive material were not adequately secured any time the vehicle was left unattended during deliveries of radioactive materials to customer facilities. (01023)
represent a Severity Level III problem (Supplements V & VI).
Civil Penalty - $2,750
Pursuant to the provisions of 10 CFR 2.201, Syncor International Corporation (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. 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 or the cumulative amount of the civil penalties if more than one civil penalty is proposed, in accordance with NUREG/BR-0254 and by submitting to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555, 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 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 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.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 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: 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 IV, 611 Ryan Plaza Drive, Suite 400, Arlington, Texas 76011. 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 this 28th day of June 2000