into the radiological status of the soils were conducted over the 2019-2021 period. The licensee submitted a decommissioning decree modification file in December 2021. The justification for the time necessary to complete the decommissioning operations authorised by the Decree of 18 September 2008 shall be reviewed in the ongoing examination of this file. The year 2023 was marked primarily by the investigations and studies allowing the management of unidentified waste discovered in late 2022 in the set of structures constituting the TOTEM shielded process line after resuming the shielded process line decommissioning operations, which had been suspended since late 2018. ASN considers that the level of safety of BNI 49 undergoing decommissioning is on the whole satisfactory. The inspections highlighted the good upkeep of the premises and the CEA’s determination to move forward with finalising the decommissioning of the TOTEM shielded process line despite being behind schedule. Particular vigilance is expected in monitoring the condition of the ventilation ducts, particularly the internal sections which are inaccessible or display defective areas. ASN remains vigilant with regard to the management of the very low level waste zones of BNI 49, particularly on account of the future decommissioning work which will produce additional waste. Consequently, the adequacy of the existing waste storage areas for the future needs is of major importance for the conduct of the decommissioning operations in accordance with the planned schedule. ARTIFICIAL RADIONUCLIDE PRODUCTION PLANT OF CIS BIO INTERNATIONAL The Artificial Radionuclides Production Facility (UPRA) constitutes BNI 29. It was commissioned in 1964 on the Saclay site by the CEA, which in 1990 created the CIS bio international subsidiary, the current licensee. In the early 2000’s, this subsidiary was bought up by several companies specialising in nuclear medicine. In 2017, the parent company of CIS bio international acquired Mallinckrodt Nuclear Medicine LCC, now forming the Curium group, which owns three production sites (in the United States, France, and the Netherlands). The Curium group is an important player on the French and international market for the production and development of radiopharmaceutical products. The products are mainly used for the purposes of medical diagnoses, but also for therapeutic uses. They are manufactured using a cyclotron installed on the site or using radionuclides produced by outside suppliers or other facilities of the Curium group. Until 2019, the role of BNI 29 was also to recover disused sealed sources which were used for radiotherapy and industrial irradiation. Removal of these sources, which have been stored in the facility, is well advanced. The group moreover decided to stop its iodine-131based productions on the Saclay site at the end of 2019, which has significantly reduced the potential consequences of accident situations on the site. After observing improvements in the safety of the facility between 2019 and 2021, the slowing of this trend observed in 2022 got worse in 2023, particularly in view of the notified significant events, be it in the number or the types of events. This observed deterioration in the general level of safety is moreover combined with substantial lateness in sending the replies to ASN follow-up letters or to significant event reports. CIS bio international, which has been capable of mobilising its resources on new projects and large-scale actions associated with its operational services and radiopharmaceutical production, must today focus its efforts on the actions necessary to improve safety in general and the drafting of the justification documents expected by ASN. The company reorganisation initiated in late 2023 should allow the necessary means to be assigned to the departments in charge of these safety-related subjects. The inspections, including one carried out reactively following the notification of a significant event, found margins for improvement in the management of nuclear waste within the facility. Operational management of the facility’s transport operations is efficient, but deviations in the documents are still observed, as they have been over several inspections now. With regard to the overshoots of the annual and monthly gaseous iodine discharge limits at the end of 2022 and beginning of 2023, which gave rise to significant event notifications, one of which was rated level 1, CIS bio international conducted an in-depth deviation analysis and established a detailed action plan which was checked by ASN during an inspection. This action plan was found to be appropriate. As a general rule and in particular further to the inspection conducted on the theme of “meeting commitments”, ASN notes the difficulties CIS bio international has in meeting the deadlines associated with the action plans decided upon further to inspections or significant events. Lastly, the inadequate responses provided after making priority corrective action requests concerning pressure equipment have led ASN to serve CIS bio international with a compliance notice on this subject. The compliance deadline has been set for 2024. The number of significant events again shows a significant increase, with 22 notifications in 2023. As in the preceding year, human or organisational causes are predominant in these events, which concern diverse areas. Compliance with the operational management rules and the operating range, alarm management, maintenance operations and the integration of lessons learned remain the main areas for improvement. Some recurrence of nonconformities is observed in the effectiveness of the facility’s ventilation system filtration levels. Certain events have led to production operations in degraded situations with the application of compensatory measures. The technical causes of these deviations must be determined and they must be prevented from recurring. Lastly, despite the considerably late submission of significant event reports, it is noted that they are always drafted to a high standard and this must be maintained. ABSTRACTS – ASN Report on the state of nuclear safety and radiation protection in France in 2023 67 Regional overview of nuclear safety and radiation protection • ÎLE-DE-FRANCE •
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