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 were stored in the facility, was completed in 2024. 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 potential consequences of accident situations on the site. The manufacture of a new radiopharmaceutical was authorised by ASN in 2024, with a view to obtaining a marketing authorisation. In the light of the inspections and the examination, ASN considers that the deterioration in the overall level of safety of the facility observed in 2023 has not been made up in 2024, despite the licensee’s efforts in mobilising the personnel at various levels of the organisation. Although the number of significant events notified to ASN decreased in 2024, HOFs are still over-represented in the identified causes of the events. A large number of events linked to failure to wear or to activate active dosimeters are still observed. The inspections, one of which focused on HOF aspects, identified that within the facility there is a degree of habituation to deviations, which has led ASN to ask the licensee to conduct an overall analysis of this situation to determine its root causes. With regard to the fire theme, although certain actions identified during the last periodic safety review have been completed, the fire safety system qualification work must still be carried out within time frames appropriate for the risks. Furthermore, the licensee has been unable to transit the required updates of the safety analysis report and the RGEs, in order to demonstrate that the conclusions of the substantial amount of work accomplished in this safety review have been duly taken into account. Moreover, the inspections revealed that several documents relating to emergency situation management are out-ofdate and must therefore be updated. Improvements are expected in the personnel’s emergency situation training, Assessment of the CEA Saclay site ASN considers that the CEA Saclay site BNIs are operated under suitably safe conditions on the whole, and observes that the operations to reduce the radiological inventory stored in the BNIs – which have been in progress for several years now – continued in 2024. The DECPROs and decommissioning work continue for the facilities concerned. Managing work progress and keeping to the associated schedules remain a major challenge for CEA Saclay. This area, which forms the subject of regular ASN inspections and meetings, must still be improved given the drifts in schedule observed over the years. On another note, further to the Fukushima Daiichi NPP accident (Japan), ASN had ordered the creation on the Saclay site of new emergency management facilities capable of withstanding extreme conditions. After discovering reinforcement defects in civil engineering work which led to the suspension of the worksite, CEA failed to meet its commitment to commission the premises before the end of 2021. An inspection conducted in 2022 confirmed that the new premises had not been commissioned, contrary to a requirement of an ASN resolution of 2016. Following the analysis of CEA’s reply to the report established in the presence of both parties, and in view of the reduction in the nuclear risk of the Saclay site further to the shutdown of BNIs 40 and 101, the requirement in question was repealed. A new technical requirement then framed the finalisation of the construction of robust emergency situation management premises, with commissioning planned for 2024. During inspections in 2023 and 2024 ASN observed that work has resumed and was progressing. At the end of 2024 CEA informed ASN of the commissioning of the new premises. An update of the On-site Emergency Plan (PUI) remains necessary to formalise the changes concerning these premises. With regard to the environment, two ASN resolutions dating from 2009 and updated in 2023 regulate all the discharges from the CEA’s BNIs. Following an inspection in 2024 focusing in particular on effluent discharges and groundwater during which samples were taken, ASN observed that the measurements taken by an independent laboratory were consistent with those taken by CEA. The organisation put in place to prevent the risk of frauds was also inspected. Although personnel training sessions have been organised, efforts must nevertheless be made to put in place an overall process for managing the prevention of irregularities and the risk of fraud. Two years after setting up radiation protection skills centres, the subject was inspected by the head offices of CEA, which focused in particular on the skills centres of the CEA Paris-Saclay centre and found the situation to be satisfactory. Lastly, an in-depth inspection involving several inspection teams was carried out in 2024 to examine the monitoring of outside contractors on the CEA Saclay site. ASN considers that outside contractor monitoring is broadly unsatisfactory and insufficient. ASN also underlines the major deficiencies in the application of the regulatory requirements, particularly regarding the identification of protection important components and activities. The first responses on the part of CEA were found to be satisfactory and ASNR will monitor the development of the situation in 2025. ABSTRACTS – ASN Report on the state of nuclear safety and radiation protection in France in 2024 69 Regional overview of nuclear safety and radiation protection ÎLE-DE-FRANCE
RkJQdWJsaXNoZXIy NjQ0NzU=