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3.2 The radio-pharmaceutical
production facility operated by
CIS bio international
CIS bio international is a key player on the French
market for radiopharmaceutical products used for both
diagnosis and therapy. Most of these radionuclides are
produced in BNI 29 (UPRA) at Saclay. This facility also
recovers used sealed sources which had been used for
radiotherapy and for industrial irradiation. By Decree
on 15th December 2008, CIS bio international was
authorised to succeed CEA as operator of BNI 29.
The reorganisation efforts made in 2015 have not yet
given tangible results, in particular for simultaneous
management of large-scale projects, operational rigour,
compliance with deadlines and monitoring operating
compliance with the requirements defined by the licensee
and the regulations. ASN still observes considerable
slippage in the deadlines for transmission of significant
event reports and in the performance of the actions
identified by the inspections. The deviations observed
during inspections and in the causes of events are
indicative of persistent shortcomings in operational
rigour, the intervention process and the assessment of the
importance of the deviations. Equipment maintenance
in particular needs to be improved.
3.3 Maintenance facilities
Two Basic Nuclear Installations, operated by Areva and
EDF, handle nuclear maintenance activities in France.
The facility of the
Société de maintenance nucléaire
(Somanu)
in Maubeuge
Authorised by the Decree of 18thOctober 1985, BNI 143,
a subsidiary of Areva, specialises in the maintenance
and appraisal of equipment coming from the primary
cooling systems of EDF reactors.
ASN considers that even if operation of the facility and the
transparency of exchanges are on the whole satisfactory,
the process to produce safety case studies is a laborious
one. The licensee must therefore reorganise in order to
better address ASN’s requests and the commitments it
has made, more specifically with respect to its periodic
safety review filed at the end of 2011 andmust reinforce
corrective measures concerning compliance with the
provisions of the Order of 7th February 2012.
The consequences of the last periodic safety
review and the stress tests on UPRA (BNI 29)
CIS bio international experienced difficulties with its submission
of the reports that would enable ASN to rule on the continued
operation of the facility or its ability to withstand extreme hazards.
At the request of ASN, it was required to supplement these
periodic safety review and stress tests reports, initially submitted
in 2008 and 2012. These additions were submitted well behind
schedule.
With regard to the periodic safety review, ASN considered that
continued operation was acceptable, provided that significant
improvements were made, more specifically with regard to
control of the fire risk and compliance with the commitments
made by the licensee. With regard to the stress tests and despite
the licensee being unable to identify any cliff-edge effects, ASN
considers that it must be able to manage emergency situations
involving extreme hazards, because the consequences of an
accident would require population protection measures. This is all
the more necessary as the facility is located in Saclay, an area that
has seen extensive urban development.
A number of works, which have been under way for several
years, are thus needed to improve the safety of the facility and
are still not completed. As a rule, the large-scale actions initiated
by CIS bio international are never completed within a reasonable
time-frame.
In 2013, ASN prescribed the main safety improvements
necessary for continued operation of the facility. In 2016, it will
prescribe the deadlines for other safety improvements, for which
CIS bio international has failed to meet its commitments and the
reinforcement of the emergency management measures in the
event of an extreme hazard. It will take appropriate enforcement
and penalty measures should they prove necessary.
Following a failure to comply with the prescriptions issued in
2013 concerning control of the fire risk, ASN applied enforcement
measures and prescribed additional compensatory measures
in 2014 and 2015. In 2015, CIS bio international decided to
contest these measures before the competent jurisdictions.
TO BE NOTED
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CHAPTER 14:
NUCLEAR RESEARCH AND MISCELLANEOUS INDUSTRIAL FACILITIES
ASN report on the state of nuclear safety and radiation protection in France in 2015