ML24177A106
| ML24177A106 | |
| Person / Time | |
|---|---|
| Site: | 99990003 |
| Issue date: | 06/26/2024 |
| From: | Rhex Edwards NRC/RGN-III/DRSS/MIB |
| To: | Tamera Williams Eli Lilly & Co |
| Casto M | |
| References | |
| EA-24-046, EN 57025, NMED 240100 (closed) IR 2024001 | |
| Download: ML24177A106 (4) | |
Text
June 26, 2024 EA-24-046 EN 57025 NMED No. 240100 (closed)
Tracy Williams, Ph.D., DABT VP ATPLV-HSE & Lilly Explored Eli Lilly and Company Lilly Corporate Center Indianapolis, IN 46285
SUBJECT:
NRC SPECIAL INSPECTION REPORT NO. 99990003/2024-001(DRSS) AND NOTICE OF VIOLATION - ELI LILLY AND COMPANY
Dear Dr. Williams:
Between March 12, 2024, and June 12, 2024, inspectors from the U.S. Nuclear Regulatory Commission (NRC) conducted an in-office review of the circumstances surrounding the loss of a generally licensed tritium (H-3) exit sign (Isolite Model SLX-60, Serial Number Z35635) at your facility in Indianapolis, Indiana. The NRC initiated this review after Eli Lilly and Company contacted the NRC Operations Center on March 12, 2024, to report the loss of the H-3 sign and followed that telephone notification with a written report on April 4, 2024. An electronic copy of the written report can be found in the NRCs Agencywide Documents Access and Management System (ADAMS) under Accession Number ML24101A273.
During this in-office review, the NRC staff examined activities conducted under your general license related to public health and safety. Additionally, the staff examined your compliance with the Commissions rules and regulations. The in-office review consisted of interviews with personnel and examination of information provided by you to the NRC.
The NRC inspectors reviewed your written report, dated April 4, 2024, and agreed with your staffs determination that the root cause of the violation was attributed to remodeling contractors who performed sign removal without proper training. The inspectors also agreed with your assessment of the safety significance of the event documented in your staffs written report, given that the material had decayed to 4.4 curies at the time of loss. The NRC has concluded that, given that no additional attempts will be made to recover the missing material, its loss does not present an undue hazard to public health and safety. To prevent a similar violation, remodeling contractors are being retrained, the incident will be reviewed at the next Global Facilities health and safety meeting, and alternatives to improve the current inventory process are being considered. Your corrective actions may be reviewed during a future inspection of licensed activities at your facility.
T. Williams 2
Based on the results of our review and the information your staff provided, the NRC has determined that a Severity Level IV violation of NRC requirements occurred involving the loss of a generally licensed tritium exit sign. The violation was evaluated in accordance with the NRC Enforcement Policy. The current Enforcement Policy is included on the NRCs website at https://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html. The violation involved the failure to properly dispose of or transfer radioactive material from a generally licensed device, contrary to Title 10 of the Code of Federal Regulations (CFR) 31.5(c)(8)(i). The NRC assessed this violation at Severity Level IV (very low safety significance) because the material was contained in a generally licensed device that is not required to be registered under 10 CFR 31.5(c)(13).
The violation is cited in the enclosed Notice of Violation (Notice). The violation is being cited because it was revealed through an event (lost nuclear material Event Notification57025). 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 is already adequately addressed on the docket in this letter. You are not required to respond to this letter unless the description herein does not accurately reflect your corrective actions or your position. In that case, or if you contest this action, you should provide your response, with the basis for your denial, to the Regional Administrator, U.S. Nuclear Regulatory Commission, Region III, 2443 Warrenville Road, Suite 210, Lisle, IL 60532-4352.
In accordance with 10 CFR 2.390 of the NRCs Agency Rules of Practice and Procedure, a copy of this letter will be available electronically for public inspection in the NRCs Public Document Room or from the NRCs Agencywide Documents Access and Management System (ADAMS), accessible from the NRCs website at http://www.nrc.gov/reading-rm/adams.html.
Please feel free to contact Mary Casto of my staff if you have any questions regarding this correspondence. Mary Casto can be reached at 630-829-9837.
Sincerely, Signed by Edwards, Rhex on 06/26/24 Rhex Edwards, Chief Materials Inspection Branch Division of Radiological Safety and Security Docket No. 999-90003 License No. General Licensee
Enclosure:
Notice of Violation cc: State of Indiana
T. Williams 3
Letter to T. Williams, Ph.D., DABT from R. Edwards, dated June 26, 2024.
SUBJECT:
NRC SPECIAL INSPECTION REPORT NO. 99990003/2024-001(DRSS) AND NOTICE OF VIOLATION - ELI LILLY AND COMPANY DISTRIBUTION w/encl:
Jack Giessner Mohammed Shuaibi David Curtis Karla Stoedter Diana Betancourt-Roldan Kenneth Lambert Geoffrey Edwards MIB Inspectors ADAMS Accession Number: ML24177A106 OFFICE RIII-DRSS RIII-DRSS RIII-EICS RIII-DRSS NAME MCasto:brt DPiskura DBetancourt-Roldan REdwards DATE 6/25/24 6/25/24 6/26/24 6/26/24 OFFICIAL RECORD COPY
NOTICE OF VIOLATION Eli Lilly and Company License No. General Licensee Indianapolis, IN Docket No. 99990003 EA-24-046 During an NRC in-office review conducted March 12, 2024, through June 12, 2024, a violation of NRC requirements was identified. In accordance with the NRC Enforcement Policy, the violation is listed below:
Title 10 of the Code of Federal Regulations (CFR) 31.5(c)(8)(i) requires, in part, that any person who acquires, receives, possesses, uses or transfers byproduct material in a device pursuant to a general license shall, except as provided in 10 CFR 31.5(c)(9), transfer or dispose of the device containing byproduct material only by transfer to persons holding a specific license pursuant to 10 CFR Parts 30 and 32 or from an Agreement State to receive the device.
Contrary to the above, between November 9, 2023, and March 12, 2024, the licensee disposed of one exit sign containing 4.4 Ci of hydrogen-3 and this disposal was not made to a person holding a specific license pursuant to 10 CFR Parts 30 and 32 or to an Agreement Sate to receive the device, and the exceptions in 10 CFR 31.5(c)(9) did not apply. Specifically, the device was assumed to have been disposed of in the normal trash and buried in a sanitary landfill which was unlicensed to receive the device.
This is a Severity Level IV violation (NRC Enforcement Policy Section 6.3).
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 this letter. 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, IR 99990003/2024-001(DRSS)" and send it to the U.S. Nuclear Regulatory Commission, ATTN:
Document Control Desk, Washington, DC 20555-0001 with a copy to the Regional Administrator, Region III, within 30 days of the date of the letter transmitting this Notice.
If you choose to respond, your response will be made available electronically for public inspection in the NRC Public Document Room or from the NRC's Agencywide Documents Access and Management System (ADAMS), accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html. Therefore, to the extent possible, the response should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the Public without redaction.
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, DC 20555-0001.
In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days of receipt.
Dated this 26th day of June 2024.
Enclosure