409 ASN report on the state of nuclear safety and radiation protection in France in 2017 Chapter 14 - Nuclear research and miscellaneous industrial facilities 3. The other nuclear installations 3.1 Industrial ionisation installations Irradiators use irradiation from sealed sources of cobalt-60 to sterilise medical devices, agro-industry products, pharmaceutical raw materials, etc. The irradiation cells are made of reinforced concrete, designed to protect persons and the environment. The sealed sources are either placed in the lowered position, stored in a pool under a height of water which protects the workers in proximity to the pool, or are placed in the raised position to irradiate the items to be sterilised. Personnel exposure to ionising radiation is thus the primary risk in these facilities. The Ionisos Group operates three industrial ionisation facilities located in Dagneux (BNI 68), Pouzauges (BNI 146) and Sablé-sur-Sarthe (BNI 154). ASN considers that the level of safety and radiation protection in these installations is satisfactory. However, the licensee must continue its efforts to detect any deviations. The licensee must also ensure that it complies with the deadlines set for the submission of the files or of requests for additional information. With regard to the Sablé-sur-Sarthe facility (BNI 154), the periodic safety review file is currently being examined by ASN, which will specify the conditions for continued operation in 2018. With regard to the facilities at Pouzauges (BNI 146) and Dagneux (BNI 68), their files were transmitted in 2017. The Synergy Health group operates the Gammaster (BNI 147) irradiator in Marseille and Gammatec (BNI 170) in Marcoule. ASN considers that the level of safety and radiation protection in these installations is satisfactory. ASN does however consider that the results of the radiation protection internal checks should be more clearly formalised. ASN considers that the licensee must continue its efforts to assimilate the regulations, notably for Gammatec and must maintain sufficient human resources for operation of its facilities. The licensee also transmitted its periodic safety review conclusions report for Gammaster (BNI 147) in 2016. This was considered to be acceptable by ASN in 2017. Examination will continue in 2018. In 2017, the licensee was authorised to start-up an irradiation laboratory on the Gammatec site (BNI 170). This laboratory is used by CEA (agreement between the two licensees). 3.2 The radio-pharmaceuticals production facility operated by CIS bio international BNI 29, called the “Artificial Radionuclides Production Unit (UPRA)”, was commissioned in 1964 by CEA on the Saclay site, which in 1990 created the CIS bio international subsidiary, the current licensee. In the early 2000s, 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 thus today forming the Curium group, which owns three production sites (United States, France, 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 the end of 2018, the role of BNI 29 is to recover used sealed sources which were used for radiotherapy and industrial irradiation. Generally speaking, ASN considers that the safety of the facility operated by CIS bio international must progress significantly. ASN does however observe efforts on the part of CIS bio international to make the facility’s safety management more efficient, by reinforcing and modifying its organisation and its operating processes. However, despite a few improvements observed, ASN finds that the results are as yet insufficient. The increase in the number of significant events, the causes of which are almost always organisational and human failures, reflects an unsatisfactory operational safety situation. The recurrence of certain events means that certain lessons have not been learned. ASN also observes that, in the light of the delays that have built up in recent years and despite the efforts made since the end of 2016, the licensee has difficulty in complying with the requirements resulting from the previous periodic safety review, which led it to initiate a formal notice to comply procedure at the beginning of 2018. To conclude, ASN is expecting a lasting turnaround on the part of CIS bio international. Operating rigour, improvements to the safety culture, optimisation of the organisational structure and the workforce, oversight of operations, the transverse nature of the organisation, compliance with the facility’s baseline requirements, with resolutions and with the regulations, must be reinforced. In the light of these findings, ASN is maintaining reinforced surveillance of the licensee. 3.3 Maintenance facilities Two BNIs operated by Areva and EDF (Somanu and BCOT) are devoted to nuclear maintenance activities in France. The facility of the Société de maintenance nucléaire (Somanu) in Maubeuge BNI 143 was authorised in 1985 and specialises in the maintenance and expert assessment of equipment from the primary systems of EDF NPP reactors. The periodic safety review of the facility, submitted by Somanu in 2011, was completed in 2014. Owing to the priority given by ASN to monitoring the post-Fukushima actions on the facilities with the highest safety implications, ASN had temporarily suspended the examination of this review, before resuming it in 2015.