Euradwaste '08 - EU Bookshop - Europa

and for independently investigating the possible impact of alternative PA parameter values and assumptions.
The Finnish regulator plans to use a simple code to verify what the developer has modelled.
The UK environmental regulators rely on consultants to develop and run codes only as necessary.
The question was discussed of how distant or close the regulator should be to the developer during
the development of the safety case to avoid compromising its review process during a licence application
stage. Although the onus for developing the safety assessment, safety case and licence application
rests with the developer, it is the regulator that grants the licence or authorisation, and it is
the regulator, not the developer, which has to defend and justify to the public and other stakeholders
the decision to dispose of waste. Stakeholders must recognise that although a regulator must not be
compromised in any way and should have freedom to make decisions once a licence application is
submitted, it nevertheless needs detailed knowledge of the safety assessment and safety case in order
to review the application and defend its decision to grant or recommend a licence or authorisation.
Ideally, regulatory decisions should not be bound by any commitments made to the developer
prior to receipt of the application. Basic scientific knowledge can be jointly gained and commonly
understood, but it is used differently by the developer and regulator.
A pre-application review procedure means, by necessity, that a regulator will advise or require a
developer at various intervals to do specific pieces of research or investigation, and this appearance
of working together needs to be explained to stakeholders in order to avoid misunderstanding during
the licensing process. A regulator might pose questions to, and place requirements on, the developer
via regulatory review, but the regulator should not provide the answers.
A formal process of staged authorisation has been outlined in the UK in new regulatory guidance on
requirements for authorisation for geological disposal facilities, with a series of formal hold-points
to be decided by the regulator [6]. If adopted, this regulatory process will formalise the need for
dialogue between the regulator and the developer.
4.3 Main Messages
Some key messages arising from the workshop were:
Although international harmonisation of dose and risk constraints would be ideal for communication
with the public, the practicalities of national contexts mitigate against this being achieved.
There is now less emphasis than before being placed in the safety case on the traditional comparison
between safety assessment calculation results and dose/risk criteria set by the regulator.
Optimisation and safety functions are increasingly being used as alternative safety indicators or
additional arguments in a safety case in support of compliance with the regulatory dose/risk criteria
and to build confidence in long-term safety. These changes in the emphasis of safety cases
may require additional regulatory research and capabilities.
Most regulators want to match the level of scientific understanding and knowledge of the developer/implementer
in order to be capable of performing meaningful reviews of RD&D programmes,
safety cases and licence applications.
Many regulators have taken steps to have modelling capabilities independent of the developers’
capabilities in order to be able to verify the results of the developers’ assessment calculations
and to investigate alternative conceptual or models.
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