ML23054A186
| ML23054A186 | |
| Person / Time | |
|---|---|
| Issue date: | 02/23/2023 |
| From: | Andrea Jones NRC/OIP/ECNP |
| To: | Saranteas I Brigham & Women's Hosp |
| Shared Package | |
| ML23054A189 | List: |
| References | |
| EA-23-026 | |
| Download: ML23054A186 (1) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 February 23, 2023 EA-23-026 Irene Saranteas Interim Radiation Safety Officer Brigham and Womens Hospital 75 Francis Street Boston, MA 02115
SUBJECT:
EXPORT OF NUCLEAR MATERIAL UNDER U.S. NUCLEAR REGULATORY COMMISSIONS LICENSING AUTHORITY - NOTICE OF VIOLATION
Dear Ms. Saranteas:
This letter refers to a review of Brigham and Womens, Hospitals (BAWs) export of a Category 1 quantity of cobalt-60 (Co-60) to Best Theratronics, located in Ottawa, Canada. Title 10 of the Code of Federal Regulations (10 CFR) Section 110.50 states(c), in part, a licensee authorized to export or import the radioactive material listed in Appendix P to this part is responsible for notifying U.S. Nuclear Regulatory Commission (NRC) and, in case of exports, the government of the importing country in advance of each shipment. The NRC discussed its findings with BAWs Radiation Safety Officer, Mr. Mark Walsh, in a telephone conversation, on December 9, 2022, with Mr. Stephen Baker, Licensing Officer, Export Controls & Nonproliferation Branch, Office of International Programs, USNRC. During the telephone conversation, you were informed that the NRC determined that one Severity Level IV violation of NRC requirements occurred. This violation was evaluated in accordance with the NRC Enforcement Policy. The current Enforcement Policy is included on the NRCs Web site at http://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html.
According to records provided by Best Theratronics, on November 25, 2022, BAW shipped 128.1 terabecquerels (TBq) of Co-60 from the Brigham and Womens Hospital to Best Theratronics, Ltd. in Ottawa, Canada without first submitting an advanced notification of the shipment to the NRC or to the receiving country as required. Export notifications must be received by the NRC and the importing countrys regulator at least 7 days in advance of each shipment, to the extent practical, but in no case less than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> in advance of each shipment. Specifically, BAW failed to send an export notification to the US NRC and the Canadian Nuclear Safety Commission.
I. Saranteas The violation is cited in the enclosed Notice of Violation (Notice). The violation is being cited in the enclosed Notice because it was identified by the NRC. You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. If you have additional information that you believe the NRC should consider, you may provide it in your response. The NRC will use your response, in part, to determine whether or not further enforcement action is necessary to ensure compliance with regulatory requirements.
In accordance with 10 CFR 2.390 of the NRCs Rules of Practice, a copy of this letter, its enclosures and your response will be made available electronically for public inspection in the Public Document Room or from the NRCs document system Agencywide Documents Access and Management System accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html. To the extent possible, your response should not include any personal privacy or proprietary information so that it can be made available to the public without redaction. If personal privacy or proprietary information is necessary to provide an acceptable response, 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 information, 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 2.390(b) to support a request for withholding confidential commercial or financial information).
Please contact Stephen Baker at (301) 287-9059 if you have any questions regarding this matter.
Sincerely, Signed by Jones, Andrea on 02/23/23 Andrea R. Jones, Acting Branch Chief Export Controls and Nonproliferation Branch Office of International Programs
Enclosure:
Notice of Violation cc: Commonwealth of Massachusetts
ML: 23054A186 (L) ML23054A189 (P)
OFFICE OIP Acting DD: OIP OE BC: OE Acting BC: OIP NAME SBaker PHabighorst DJones JPeralta AJones DATE 02/23/2023 02/23/2023 02/08 /2023 02/23/2023 02/23/2023 NOTICE OF VIOLATION Brigham and Womens Hospital EA-23-026 Boston, MA Based on the U.S. Nuclear Regulatory Commission (NRC) review of shipping records associated with the export of byproduct material on December 12, 2022, a violation of NRC requirements was identified. In accordance with the NRC Enforcement Policy, the violation is listed below:
A. Title 10 of the Code of Federal Regulations (10 CFR) Part 110.50(c)(1), states, in part, a licensee authorized to export or import the radioactive material in listed in Appendix P to this part is responsible for notifying NRC and, in cases of exports, the government of the importing country in advance of each shipment.
10 CFR 110.50(c)(4) states, in part, that export notifications must be received by the NRC at least 7 days in advance of each shipment, to the extent practical, but in no case less than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> in advance of each shipment.
Contrary to the above, BAW, a licensee authorized to export radioactive material listed in Appendix P to this part, failed to notify the NRC and the government of the importing country in advance of its shipment. Specifically, for a November 25, 2022, radiological material shipment (i.e., 128.1 terabecquerels (TBq) of cobalt-60 (Co-60) to Best Theratronics, located in Ottawa, Canada), BAW failed to provide an export notification to the NRC or to the Canadian Nuclear Safety Commission.
This is a Severity Level IV violation (NRC Enforcement Policy, Section 6.15)
Pursuant to the provisions of 10 CFR 2.201, BAW is hereby required to submit a written statement or explanation to the Director, Office of International Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, within 30 days of the date of this Notice of Violation. This reply should be clearly marked as a "Reply to a Notice of Violation (EA-23-016) and should include for each violation: (1) the reason for the violation, or, if contested, the basis for disputing the violation or severity level; (2) the corrective steps that have been taken and the results achieved; (3) any additional corrective steps that will be taken; and (4) the date when full compliance will be or was 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, the NRC may issue an Order or a Demand for Information requiring you to explain why your 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.
If you contest this enforcement action, you should also provide a copy of your response, with the basis for your denial, to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555-0001.
In accordance with 10 CFR 2.390 of the NRCs Rules of Practice, your response will be made available electronically for public inspection in the NRC Public Document Room or from the NRCs document system (ADAMS) accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html. To the extent possible, your response should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the public without redaction.
In accordance with 10 CFR 19.11, you may be required to post this Notice within 2 working days of receipt.
Dated: February 23, 2023 cc:
Jack Priest, Director Department of Public Health Radiation Control Program Bureau of Environmental Health Schrafft Center, Suite 1M2A 529 Main Street Charlestown, MA 02129