ML22188A106

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Enclosure 1 - Apparent Violations Being Considered for Escalated Enforcement
ML22188A106
Person / Time
Issue date: 01/26/2023
From:
Division of Fuel Management
To:
Thermo Fisher Scientific
M.SHOEMAKER NMSS/DFM/MCAB 3014157363
Shared Package
ML22188A104 List:
References
EA-22-031
Download: ML22188A106 (1)


Text

APPARENT VIOLATIONS BEING CONSIDERED FOR ESCALATED ENFORCEMENT APPARENT VIOLATION 1:

Title 10 of Code of Federal Regulations (CFR) 110.5 states, in part, that no person may export any nuclear equipment or material listed in 10 CFR 110.9, unless authorized by a general or specific license issued under 10 CFR Part 110. The list in 10 CFR 110.9 includes special nuclear material.

10 CFR 110.9, states, in part, special nuclear material is under NRCs export licensing authority.

10 CFR 110.20(a) states, in part, that if an export or import is not covered by the NRC general licenses in §§ 110.21 through 110.27, a person must file an application with the Commission for a specific license in accordance with §§ 110.31 through 110.32.

10 CFR 110.23(a) states, in part, that a general license is issued to any person to export special nuclear material, other than plutonium-236 and plutonium-238, in sensing components in instruments, if no more than 3 grams of enriched uranium are contained in each sensing component.

Contrary to the above, Thermo Fisher Scientific exported special nuclear material without a general or specific license. Specifically, on December 28, 2018, Thermo Fisher Scientific exported special nuclear material in sensing components containing more than 3 grams of enriched uranium to the Republic of Korea, without obtaining a specific license authorizing its export as required by 10 CFR 110.5. The export contained two fission chambers each containing 11 grams of U-235 isotope weight, for a total of 22 grams U-235.

APPARENT VIOLATION 2:

Title 10 CFR 150.16(a)(1) requires reporting a transfer of 1 gram or more of special nuclear material within one day to the Nuclear Materials Management and Safeguards System (NMMSS). These reporting requirements extend to Agreement State Licensees and are reflective of reporting requirements for all possessors of special nuclear material as described in Part 74; furthermore, Part 74.15(a) prescribes the submission of an electronic nuclear material transaction report (NRC/DOE Form 741) to NMMSS no later than the close of business the next working day.

Contrary to the above, Thermo Fisher Scientific failed to report the transfer of 1 gram or more of special nuclear material no later than close of business the next working day. Specifically, on December 28, 2018, Thermo Fisher Scientific transferred a total of 22 g of special nuclear material and failed to report no later than close of business on December 29, 2018.

APPARENT VIOLATION 3:

Title 10 CFR 150.17(a), in part, requires a licensee that has possessed in the previous reporting period, at any one time and location, under an Agreement State license, special nuclear material in a quantity totaling one gram or more of contained uranium-235, uranium-233, or plutonium, to complete and submit, in computer-readable format Material Balance Reports concerning special nuclear material that the licensee has received, produced, possessed, Enclosure 1

transferred, consumed, disposed of, or lost. The annual reports for the previous annual reporting period (typically calendar year (CY)) must be filed by March 31 of each year.

Contrary to the above, Thermo Fisher Scientific failed to submit annual reports for the previous annual reporting period by March 31. Specifically, Thermo Fisher Scientific failed to submit the annual reports for the annual reporting periods covering CY2018 and CY2019 by March 31 of the following year.

APPARENT VIOLATION 4:

Title 10 CFR 110.5 states, in part, that no person may export any nuclear equipment or material listed in 10 CFR 110.9, unless authorized by a general or specific license issued under 10 CFR Part 110. The list in 10 CFR 110.9 includes special nuclear material.

10 CFR 110.9, states, in part, special nuclear material is under NRCs export licensing authority.

10 CFR 110.20(a) states, in part, that if an export or import is not covered by the NRC general licenses in §§ 110.21 through 110.27, a person must file an application with the Commission for a specific license in accordance with §§ 110.31 through 110.32.

10 CFR 110.23(a) states, in part, that a general license is issued to any person to export special nuclear material, other than plutonium-236 and plutonium-238, in sensing components in instruments, if no more than 3 grams of enriched uranium are contained in each sensing component.

Contrary to the above, Thermo Fisher Scientific exported special nuclear material without a general or specific license. Specifically, on July 1, 2022, Thermo Fisher Scientific exported special nuclear material in sensing components containing more than 3 grams of enriched uranium to Spain, without obtaining a specific license authorizing its export as required by 10 CFR 110.5. The export contained two fission chambers each containing about 4 grams of U-235 isotope weight, for a total of 8 grams U-235.

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