ML19266A572
| ML19266A572 | |
| Person / Time | |
|---|---|
| Site: | 99990003 |
| Issue date: | 09/20/2019 |
| From: | Aaron Mccraw NRC/RGN-III |
| To: | Mays T Eli Lilly & Co |
| Null K | |
| References | |
| EA-19-102, EN53914, NMED 190121 IR 2019004 | |
| Download: ML19266A572 (3) | |
Text
September 20, 2019 EA-19-102 EN53914 NMED 190121 (Closed)
Mr. Trenton Mays, RSO Eli Lilly and Company Lilly Corporate Center Indianapolis, IN 46285
SUBJECT:
NRC SPECIAL INSPECTION REPORT NO. 99990003/2019004(DNMS) AND NONCITED VIOLATION - ELI LILLY AND COMPANY
Dear Mr. Mays:
Between March 7, 2019, and August 23, 2019, an inspector 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 2040, Serial No. A11223) at your facility in Indianapolis, Indiana. The NRC initiated this review after Eli Lilly and Company contacted the NRC Operations Center on March 7, 2019, to report the loss of the H-3 sign and followed that telephone notification with a written report on April 4, 2019. An electronic copy of the written report can be found in the NRCs Agencywide Documents Access and Management System (ADAMS) under Accession Number ML19095B771.
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.
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. The violation was evaluated 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 violation concerned 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 NRC inspector reviewed your staffs written report, dated April 4, 2019, and agreed with your staffs determination that the root cause of the violation was failure to identify the exit sign during a pre-planning checklist. The inspector 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 2.52 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, Lilly facilities
T. Mays 2 management met with the contract company to reiterate Eli Lillys process for maintaining the scope of work, including retraining in specific documents regarding removal of tritium exit signs. The inspector determined that your corrective actions appear adequate to prevent recurrence. Your corrective actions may be reviewed during a future inspection of licensed activities at your facility.
Because you identified the violation and took timely and effective corrective actions and because the violation was neither willful on the part of a licensee employee nor repetitive, this violation is being treated as a Noncited Violation (NCV), consistent with Section 2.3.2.b.
of the Enforcement Policy. 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 Rules of Practice, 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 Mr. Kevin Null of my staff if you have any questions regarding this correspondence. Mr. Null can be reached at 630-829-9854.
Sincerely,
/RA/
Aaron T. McCraw, Chief Materials Inspection Branch Division of Nuclear Materials Safety Docket No. 999-90003 License No. General License cc: State of Indiana
T. Mays 3 Letter to Trent Mays from Aaron McCraw dated September 20, 2019.
SUBJECT:
NRC SPECIAL INSPECTION REPORT NO. 99990003/2019004(DNMS) AND NON-CITED VIOLATION - ELI LILLY AND COMPANY DISTRIBUTION w/encl:
Darrell Roberts Jack Giessner David Pelton Christine Lipa Jamnes Cameron Kenneth Lambert Paul Pelke MIB Inspectors ADAMS Accession Number: ML19266A572 OFFICE RIII-DNMS C RIII-EICS C RIII-DNMS C NAME KNull:ps JCameron AMcCraw DATE 09/13/19 09/19/19 09/20/19 OFFICIAL RECORD COPY