ASN Report 2022

Artificial Radionuclide Production Plant of CIS bio international The Artificial Radionuclide Production Plant (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. 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-131-based productions on the Saclay site at the end of 2019, which has significantly reduced the consequences of accident situations on the site. The licensee CIS bio international mobilised its resources in 2022 for its ongoing periodic safety review, as well as carrying out operations that significantly improved safety. Thus, more high-activity disused sealed sources have been removed from the facility where they were stored, further reducing the dispersible inventory. The works conducted to improve liquid effluent management further to the deviations observed over the last few years, continued and underwent checks during ASN inspections. Despite the stability of the internal organisation and better skills management, factors that contributed to the improvement in safety observed in the previous three years, ASN observed in 2022 that CIS bio international was having difficulties in carrying out certain activities within reasonable time frames and under conditions that complied with the safety baseline requirements. This finding applies equally well to ongoing projects, to everyday operation of the facilities, to addressing the responses to inspection follow-up letters and to the in-depth examination of significant events having occurred on the facility. ASN’s inspections in 2022, as in 2021, found that the management of the periodic inspections of Nuclear Pressure Equipment (NPE) must be improved rapidly. This subject has formed the subject of priority corrective action requests from ASN. The tracking of emergency organisation training courses also needs to be improved. ASN has also observed deviations in occupational radiation protection, such as the signalling of the radiological risk and the management of liquid effluents, particularly fire-extinguishing fluids. CIS bio international’s organisation for managing transport movements – which involve large quantities of packages with diverse contents – remains efficient, even if improvements are expected in the associated quality assurance and documentation management. The number of significant events increased in 2022. Even though the events fall under varied themes, there is a predominance of organisational or human deficiencies. Consequently, compliance with the management and operating rules, alarm management, maintenance operations and the integration of lessons learned remain tenuous. Events reports are submitted beyond deadlines in the majority of cases, but the quality of document drafting and of the events analyses must be underlined. In this respect moreover ASN notes an improvement in the detection of significant events. In 2022, ASN thus observed that there is still room for progress in several areas, particularly as concerns meeting the deadlines for the licensee’s commitments. To conclude, ASN observes in 2022 that despite CIS bio international’s efforts, the action to improve the safety of the facility engaged in the preceding years is no longer progressing. This finding does not, at this stage, call into question the continuation of CIS bio international’s activities. However, CIS bio international must focus its efforts in particular on the cross-cutting functioning of the organisation, compliance with the facility’s baseline requirements and keeping to schedules. The shortcomings in operating rigour and safety culture observed in 2022 must be addressed by specific actions, taking particular care to meet the completion deadlines. ABSTRACTS – ASN Report on the state of nuclear safety and radiation protection in France in 2022 69 Regional overview of nuclear safety and radiation protection • ÎLE-DE-FRANCE •