ASN Report 2021

within the perimeter undergoing decommissioning must therefore be improved. Lastly, improvements are required in the management of the maximum permissible fire loads in each room of the facility, and in the sealing of certain roofs. During its inspections, ASN will check the conditions for resuming, in the future, the decommissioning work on the TOTEM shielded system, which constitutes the predominant radiological inventory of BNI 49 (contaminated soils excluded). 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. Broadly speaking, ASN f inds that the drive to improve the safety of the facility, already observed in the preceding two years, continued in 2021 despite the disruptions caused by the Covid-19 pandemic. The stability of the organisation and better skills management were factors that favoured this approach. Several projects bringing significant improvements in safety have been completed or should be completed in the short term. Nevertheless, the time frames for carrying out the major actions undertaken by CIS bio international, some of which are difficult to deploy, must be better controlled. The emergency organisation undergoes eff icient preparation exercises. The equipment modification and qualification management processes are found to be appropriate. Control of the work sites involving dosimetric risks and the deployment of the legacy waste removal operations are satisfactory. The organisation for managing transport operations, which are numerous and involve packages with varied contents, is also efficient; quality assurance and document management have been improved. The overall improvement in liquid effluent management following the deviations observed in the last few years is continuing, reflecting an appropriate response which is checked during the ASN inspections. However, management of the periodic inspections of pressure equipment needs to be improved. Although the number of significant events is stable, there are still numerous organisational or human failings. Consequently, compliance with the operational management rules, the operating range, the performance of maintenance and the integration of experience feedback must be further improved. ASN also expects to see improvements in the identif ication of significant events. Improvements are moreover still necessary to meet the licensee’s commitment deadlines. To conclude, ASN observes that CIS bio international is maintaining the recovery drive it initiated in the preceding years. Areas for improvement on which CIS bio international must continue to focus its efforts include the cross-cutting functioning of the organisation, compliance with the facility baseline requirements, schedule control and operations monitoring, while remaining vigilant with regard to operating rigour and improving the safety culture. 70 ASN Report on the state of nuclear safety and radiation protection in France in 2021 REGIONAL OVERVIEWOF NUCLEAR SAFETY AND RADIATION PROTECTION

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