ML25092A065
| ML25092A065 | |
| Person / Time | |
|---|---|
| Issue date: | 04/16/2025 |
| From: | David Skeen NRC/OIP |
| To: | Tan F Eckert & Ziegler Isotope Products |
| References | |
| EAF-OIP-2025-0064 | |
| Download: ML25092A065 (1) | |
Text
EAF-OIP-2025-0064 Frida Tan Director of Quality Operations Eckert & Ziegler Isotope Products 24937 Avenue Tibbitts Valencia, CA 91355
SUBJECT:
ECKERT & ZIEGLER ISOTOPES PRODUCTS - U.S. NUCLEAR REGULATORY COMMISSION REVIEW RELATED TO EXPORT OF SOURCE MATERIAL AND APPARENT VIOLATION
Dear Ms. Tan:
This letter refers to the U.S. Nuclear Regulatory Commission (NRC) review of Eckert & Ziegler Isotope Products (Eckert & Ziegler) export records conducted from October 2, 2024, through December 6, 2024. The review examined Eckert & Zieglers export of radioactive material to the Peoples Republic of China (PRC) without an export license and whether you were in compliance with applicable requirements for exporting radioactive material. On February 27, 2025, Ms. Andrea Jones of the NRC discussed the preliminary results of our review with you as documented in the enclosure.
Based on the results of this review, an apparent violation was identified and is being considered for escalated enforcement action in accordance with the NRC Enforcement Policy. The current Enforcement Policy is included on the NRCs website at http://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html. The apparent violation involves the export of a calibration source containing 1.14 E-9 kilograms of thorium-230 (Th-230) to the PRC without filing an application for a specific export license as required by NRC Order, Order Suspending General License Authority to Export Special Nuclear Material, Source Material, and Deuterium for Nuclear End Use to the People's Republic of China, dated August 8, 2023 (88 FR 55081). This Order suspended NRC general license authority to export special nuclear material, source material, and deuterium for nuclear end use to the People's Republic of China under Sections 54, 64, and 109b of the Atomic Energy Act and Title 10 of the Code of Federal Regulations (10 CFR) 110.21, 110.22, and 110.24 requirements. Accordingly, any person wishing to export special nuclear material, source material, and deuterium for nuclear end use to the People's Republic of China must apply for a specific license in accordance with 10 CFR 110.31 requirements. The apparent failure to conduct activities in accordance with the Order is significant because it impacts the NRCs ability to conduct regulatory oversight to ensure the safe and appropriate use of radioactive material. Since the NRC has not made a final determination in this matter, a notice of violation is not being issued at this time. In addition, be advised that the characterization of the apparent violation may change as a result of further NRC review.
April 16, 2025
F. Tam Before the NRC makes its enforcement decision, we are providing you an opportunity to (1) respond in writing to the apparent violation addressed in this letter within 30 days of the date of this letter, or (2) request a Pre-decisional Enforcement Conference (PEC). If a PEC is held, it will be open for public observation and the NRC will issue a press release to announce the time and date of the conference. If you decide to participate in a PEC, please contact Ms. Andrea Jones at 404-997-4443 or via email at Andrea.Jones@nrc.gov within 10 days of the date of this letter. A PEC should be held within 30 days of the date of this letter.
If you choose to provide a written response, it should be clearly marked as a Response to An Apparent Violation - EAF-OIP-2025-0064 and should include: (1) the reason for the apparent violation or, if contested, the basis for disputing the apparent violation; (2) the corrective steps that have been taken and the results achieved; (3) the corrective steps that will be taken; and (4) the date when full compliance will be achieved. Your response may reference or include previously docketed correspondence if the correspondence adequately addresses the required response. Additionally, your response should be sent to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555- 0001; with a copy mailed to David L. Skeen, Director, Office of International Programs, 11555 Rockville, MD 20852, or via E-mail to David.Skeen@nrc.gov, within 30 days of the date of this letter. If an adequate response is not received within the time specified or an extension of time has not been granted by the NRC, the NRC will proceed with its enforcement decision or schedule a PEC.
If you choose to request a PEC, the conference will afford you the opportunity to provide your perspective on these matters and any other information that you believe the NRC should take into consideration before making an enforcement decision. The decision to hold a PEC does not mean that the NRC has determined that a violation has occurred or that enforcement action will be taken. This conference would be conducted to obtain information to assist the NRC in making an enforcement decision. The topics discussed during the conference may include information to determine whether a violation occurred, information to determine the significance of a violation, information related to the identification of a violation, and information related to any corrective actions taken or planned.
In accordance with 10 CFR 2.390 of the NRC's "Rules of Practice," a copy of this letter, its enclosure(s), and your response, if you choose to provide one, will be made available electronically for public inspection in the NRC Public Document Room or from the NRCs Agencywide Documents Access and Management 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. Any information forwarded to the NRC on this matter should be clearly labeled on the first page with the case reference number:
EAF-OIP-2025-0064.
Should you have any questions, please contact Ms. Andrea Jones at 404-997-4443 or via email at Andrea.Jones@nrc.gov Sincerely, David L. Skeen, Director Office of International Programs
Enclosure:
As stated Signed by Skeen, David on 04/16/25
ML25092A065 OFFICE OIP/ECNP OE BC:ECNP/OIP Acting NAME AJones DFurst AJones DATE 04/02/2025 04/07/2025 04/03/2025 OFFICE OE OD: OIP NAME JPeralta DSkeen DATE 04/16/2025 04/16/2025
Enclosure BASIS FOR APPARENT VIOLATION BEING CONSIDERED FOR ESCALATED ENFORCEMENT From October 2, 2024, through December 6, 2024, the NRC conducted a review of Eckert &
Zieglers export records. The review examined the export of source material to the Peoples Republic of China (PRC). Based on its review, the NRC identified that Eckert & Ziegler Isotope Products exported a calibration source containing 1.14 E-9 kilograms of thorium-230 without an NRC specific license that resulted in an apparent violation, which is being considered for escalated enforcement.
Apparent Violation:
NRC Order, Order Suspending General License Authority To Export Special Nuclear Material, Source Material, and Deuterium for Nuclear End Use to the People's Republic of China, dated August 8, 2023, states, in part, exporters are no longer authorized to use the NRC general license to export special nuclear material, source material, or deuterium for nuclear end use to the PRC and must apply for a specific license in accordance with Title 10 of the Code of Federal Regulations 110.31.
Contrary to the above, on July 12, 2024, the licensee exported source material to the PRC, without filing an application for a specific export license, as required by the NRC August 8, 2023, Order. Specifically, the licensee shipped 1.4e-9 kilograms of thorioum-230 source material to the PRC that was not authorized for export under a general license and without Executive Branch review.