1. Topic 2 Safety case development
WG 3
Topic 2
Safety case development

2. How to develop and update a safety case 1/2
Clear context necessary
At which stage do we are? What are the expectations related to this stage?  dealed with in ISAM, PRISM…
Responsibilities of the different actors?
Different peoples involved in the update/development of a safety case  see the PRISM matrix
Globally there seem to be enough guidance on SC development/update.
Idea for future discussions/developments:
Should environmental impact and radiological impact assessments be included into a single safety case? According to IAEA-PRISM and in some countries: yes. In other countries: Not the case (2 different procedures with different RBs)
How to integrate these 2 assessments during the review?

3. How to develop and update a safety case 2/2
Continuous update of the safety case
with a graded approach for the regulatory review ( minor vs important changes). How to put this graded approach into practice?  it seems to be implemented in a similar way in the different countries (but vocabulary may differ).
Periodic Safety Review (PSR) are necessary
Important to continue/follow the R&D at the same time (R&D by operator & regulator/TSO) in order to feed the PSR process (e.g. are the hypotheses of the SA still valid?).

4. Public involvement 1/2
Need of concerted and structured interactions with all the actors 3 Key actors should participate: operator / regulator-TSO / public
Different levels of participation in the decision making process (DMP): Interaction/Discussion/Information
How to put it into practice? E.g.
Public opinion is generally not « homogeneous » … There will always be oponents to the project.  How to deal with the different opinions?
How to give enough expertise to the public to participate in the DMP?
Interaction on what and with which material?
Environmental assessment, safety case, need of an « umbrella » document, executive summary…?
How to present the results? E.g. which indicators? Something else than numbers, such as a discussion on how basic principles are taken into account?

5. Public involvement 2/2
Time spent in interacting with the public is generally important
impact on the resources? It should be started ASAP (this may create a better « atmosphere » for the discussion  more trust!).
Role of the different actors
It should be clear to the public. Explain to the public how the independence between operator/regulator missions is ensured. Necessary to develop trust between the actors.

6. Topic 3 (Licensing process and responsibility for safety)
Challenges
Changing regulations, governments and RB affecting the licensing process.
Sufficient evidence for the RB to make a decision?
How developed must the design be at each stage to obtain permission to move to the next stage?
How to demonstrate that the design has been optimized (for example proper documentation of each decision that has been made at each stage).
Approval of new technology/material is a judgement call by the regulator
Difficulty in keeping the safety case coherent with additional updates brought during the review.

7. Topic 3: Licensing process and responsibility for safety
How to review the safety case?
Availability of skilled worker and securing resources for completing the review, the difficulty for some regulatory body to get and maintain independent and skilled support.
Early interaction between RB and applicant prior to official review to allow for a more efficient licensing process.

8. Topic 3: Licensing process and responsibility for safety
The responsibility of the decision maker changes throughout the life cycle of the facility (government? RB?)
In some countries, the waste producer is responsible for finding a suitable solution for the waste. In other countries, there are specific waste management organization that are independent from the waste producer.