ASN Report 2020

Artificial Radionuclide Production Plant of CIS bio international The Artif icial 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. More generally, ASN considers that the facility’s safety improvement initiative, already observed last year, continued in 2020 despite the complications resulting from the health crisis. The measures taken by CIS bio international to ensure the continuity of its activities during the crisis enabled the safety requirements to be met. The stability of the organisation and better skills management were factors that favoured this approach. Several projects bringing signif icant safety improvements are currently coming to a conclusion. Nevertheless, the time f rames for carrying out the major actions undertaken by CIS bio international, some of which are diff icult to deploy, must be better controlled. The inspections found that waste management had improved, in particular with the removal of legacy waste, despite the fact that breaches of the storage rules were again noted. The implementation of a comprehensive plan to improve liquid effluent management, which had been the subject of deviations in recent years, is an appropriate response, and ASN shall check the quality of the results achieved. The organisation for managing transport operations, which are numerous and involve packages with varied contents, is also eff icient, but deficiencies in quality assurance and document management must be remedied. The number of signif icant events is falling signif icantly. Compliance with the operating rules, particularly outside working hours, with the operating range and the integration of experience feedback must be further improved. ASN also expects to see improvements in the identif ication of significant events. Compliance with the deadlines for the site’s commitments must also be further improved. To conclude, ASN expects CIS bio international to keep up the observed performance improvement efforts. Areas for improvement on which CIS bio international must particularly focus its efforts comprise the cross-cutting functioning of the organisation, compliance with the facility baseline requirements and management of schedules, while remaining vigilant with regard to operating rigour and improving the safety culture. As from the beginning of the first lockdown on account of the Covid-19 pandemic, the French Alternative Energies and Atomic Energy Commission (CEA) stopped activities of the Basic Nuclear Installations (BNIs) at the Paris‑Saclay centre. The large majority of the worksites were safely shut down. Only the essential activities, primarily monitoring (including environmental monitoring) and safety oversight, were maintained. However, certain periodic inspections and tests and certain regulatory verifications and maintenance operations were not carried out by the set deadlines. These were operations for which the CEA had analysed the safety impact of not performing them and, where necessary, had defined compensatory measures. At the end of the lockdown period, the activities of the BNIs gradually restarted on the basis of a safety analysis defining the inspections and the steps to take with a view to obtaining an activity resumption authorisation from the Director of the centre. The CEA subsequently adapted its organisational arrangements. Thus, when the second lockdown began in November 2020, the CEA did not shut down its BNIs and it maintained the periodic inspections and tests, the regulatory verifications and the maintenance operations. The overall experience feedback for this period still has to be compiled. Nevertheless, ASN’s inspections have shown that the activity resumption measures were managed satisfactorily and the measures taken by the licensee during the crisis enabled compliance with requirements to be maintained at a good level. THE IMPACT OF COVID-19 ASN Report on the state of nuclear safety and radiation protection in France in 2020 71 REGIONAL OVERVIEWOF NUCLEAR SAFETY AND RADIATION PROTECTION ÎLE-DE-FRANCE