Progress of HERCA Action Plan on the transposition of EU BSS Directive
Following the publication of the new BSS, Council Directive 2013/59/Euratom (1), HERCA established in 2014 a Task Force on the role of HERCA in the transposition of BSS.
HERCA has no statutory role in relation to the transposition of the Euratom BSS. However, it can be a positive force in the transposition process. Uniform transposition or implementation in the Member States is not an objective of HERCA activities: it remains a matter for individual Member States as to the extent to which they avail of HERCA’s work in transposing the BSS into their national regulations.
The transposition of EU BSS Directive has been considered as a cross-cutting issue. In particular, this task force is chaired by T. Ryan (EPA, Ireland) and includes:
- Chairs of the HERCA working groups and task forces for a greater internal coordination,
- An observer from the European Commission for a greater external coordination between HERCA and EC.
In October 2014, the Board of HERCA approved an Action Plan in relation to the transposition and implementation of the new Euratom BSS.
The approved Action Plan covers the following areas:
- Identification of HERCA’s role in the transposition of the new EU BSS to national regulations defined;
- Definition of actions for HERCA in relation to the transposition of the BSS;
- Coordination between HERCA and the EC in relation to BSS transposition activities considered.
First results
The action plan contains 12 actions identified: 2 are completed, 8 are on-going, 2 are in preliminary discussions.
Three workshops were organized in 2015:
- HERCA-WGE Workshop on the implementation of Council Directive13/59/Euratom in the field of Emergency Planning and Response (Berlin, april 2015)
- HERCA Workshop on implementation of RPE & RPO (Paris, July 2015)
- 2nd European Workshop on National Radon Action plan (Geneva, Oct. 2015)
Several WS and multi-stakeholder meetings will be organised in 2016:
- Joint Multi-stakeholders’ meeting on optimization and justification (Vienna, 10 March 2016)
- Workshop on the transposition of the Euratom BSS directive in relation to NORM and TNORM (with focus on building materials) (Norway, Spring 2016)
- Workshop on the implementation of HERCA-WENRA Approach (Slovenia, June 2016)
- Joint Workshop on Reporting and on Generic Justification (Germany, Autumn 2016)
First conclusions
Along the lines of many activities, HERCA is contributing to the transposition of the EU-BSS directive.
The following Issues have been already identified for further exchanges with EC:
- Medical Equipment (HERCA BSS Action #4)
- Radon (HERCA BSS Action #10)
EC remains a major stakeholder for HERCA with EC observers involved in HERCA activities with relation to EU-BSS as observer and EC invited to participate in HERCA WS and multi-Stakeholder meetings
HERCA BSS Actions should be completed by early 2017.
Detailled follow-up of HERCA Action Plan
HERCA BSS Action #1: Elaboration of a Guidance for Bilateral Arrangements
HERCA BSS Action #2: Common understanding of Emergency Workers
HERCA BSS Action #3: Common understanding of the reference level concept concerning EP&R.
HERCA BSS Action #4: Common understanding and sharing of approaches relating to medical equipment.
Emergency preparedness and response
HERCA BSS Action #1
Art. 99: Elaboration of a Guidance for Bilateral Arrangements
Expected outcome: The “HERCA-Approach for a better cross-border coordination of protective actions during the response in the early phase of a nuclear accident; development and practical testing” can be used for Art. 99 transposition. The proposed guidance will assist the implementation of those provisions.
Comments:
- Effective coordination of prot. actions during the nuclear accident early phase
- Collect good practices from existing arrangements
- Develop simple messages
Outcome:
Conclusion:
HERCA BSS Action #1: Completed
HERCA BSS Action #2
Art. 4(31), 17 & 53): Common understanding of Emergency Workers
Expected outcome:
(1) Establish examples of people or functions normally considered as emergency worker;
(2) Defining the need for a common understanding for adequate and regularly updated training;
(3) Defining the need for shared approaches concerning individual protection.
Comments:
- IAEA and EU BSS Definitions: not identical but not contradicting
- Differences between HERCA members not seem to be critical, are limited and do not impact on neighbouring countries.
Outcome
Conclusion
HERCA BSS Action #2: Completed
HERCA BSS Action #3
Art. 4(84), 7: Development of a common understanding of the RL concept concerning EP&R
Expected outcomes:
- Review of the different national interpretations of the concept;
- For planning: Possible approaches concerning the criteria for individual protective actions in relation to a global reference level;
- For the response: Guidance on how to optimise during the response.
Comments:
- RL have a role in both planning and response
- Countermeasures are triggered by predefined criteria,
- Dissens on whether to use one RL for every situation or scenario-specific RL
Conclusions:
- Need for a more pragmatic approach with compatible RL for neighbouring countries and common operational intervention levels.
- New WP on cross-border protective actions.
- HERCA BSS Action #3: on-going
Medical Exposure
HERCA BSS Action #4
Art. 58(b), 60, 78: New detailed provisions relating to medical equipment
Expected outcomes: Common understanding and sharing of approaches to transposition and implementation
Questions:
- Medical Device Directive / Regulation uses the terms “risk assessment” and “clinical evaluation” in a broader sense as the BSS Directive does,
- What are the implications for licensing and authorisation and for justification (both generic and individual)?
- Should it be explicit who should provide the adequate information?
- Should the RP authorities impose an obligation on manufacturers & suppliers?
Comments
- Covers all the bases and HERCA interests relating to equipment & justification (which is referenced separately).
- Article 78 may impact on two work streams.
Action:
- Clarifications to be sought from EC
Conclusion
- HERCA BSS Action #4: on-going
HERCA BSS Action #5
Art. 19, 55.2(a), (c), (f) and (h) + 78.2: Level II Justification: New requirements for consideration of occ. and public exposure when considering justification of medical exposure.
Expected outcome: Common understanding and sharing of approaches to transposition and implementation
Comments:
- Approaches to justification of types/classes of practice varies widely between MS
- Approaches for justification of types of medical exposures need to take into consideration approaches for justification other practices in other sectors within each MS
Actions:
- WP created, action plan defined.
- Multi-stakeholder meeting (Autumn 2016)
- HERCA position paper (early 2017)
Conclusion
HERCA BSS Action #5: on-going
HERCA BSS Action #6
Art. 18: Education & Training on medical radiological practice and RP for staff involved in medical exposures
Expected outcome: Common understanding and sharing of approaches to transposition and implementation
Comments:
- Education and training arrangements for staff involved in medical exposures will be addressed primarily through other processes (legal and administrative) within each MS
Actions:
- Specific session of WG on Medical Applications scheduled in 2016.
- Coordination with the new HERCA WG on Education & Training.
HERCA BSS Action #7
Art. 63 & 96: Notification of significant events: Requirements relating to competent authority of significant events from accidental or unintended medical exposures and associated requirements on the undertaking relating to clinically significant events
Expected outcome: Common understanding of options and difficulties and sharing of approaches to transposition and implementation.
Comments:
- A graded approach is required across all medical exposures, commensurate with risk
- Approaches to significant event reporting need to be understood by healthcare professional bodies
Actions:
- WP on Reporting of Accidental and unintended exposures created, action plan defined.
- Multi-stakeholder meeting (Autumn 2016)
- HERCA position paper (early 2017)
Conclusion
HERCA BSS Action #7: on-going
HERCA BSS Action #8
Art. 63 & 96: Notification of significant event involving underexposures (primarly in RT).
Expected outcome: Common understanding of options and difficulties and sharing of approaches to transposition and implementation.
Comments:
- Subset of the WP on Reporting of Accidental and unintended exposures created, action plan defined.
- HERCA will seek clarification that inclusion of underexposures is appropriate under the legal framework offered by the Directive and originating Euratom Treaty
Actions: See HERCA BSS Action #7
Conclusion
HERCA BSS Action #8: on-going
Non-medical imaging exposure
HERCA BSS Action #9
Art. 22: Non-medical imaging exposure: Imaging of persons for purposes other than diagnosis, treatment or research.
Expected outcome: Common understanding of options and difficulties and sharing of approaches to transposition and implementation, across a range of sectors.
Comments:
- Transposition of requirements for non-medical imaging exposures may vary between MS, reflecting Directive flexibility
- Transposition of non-medical imaging practices involving medical radiological equipment with differ from other non-medical imaging exposures
Actions:
HERCA’s comprehensive approach is under consideration
Conclusions
HERCA BSS Action #9: Preliminary discussions
Radon
HERCA BSS Action #10
How MS transpose the radon requirements of the EU BSS Directive.
Expected outcome: Common understanding of the BSS Requirements and Recommendations.
Comments:
- First WS on Radon national action plans organised in Sept. 2014 (ASN, NRPA), HERCA WS on Radon in workplaces on Oct. 2015,
- Participation of relevant stakeholders in WSs: WHO, IAEA, ILO
- Position papers issued/under preparation.
Actions
- EC to prepare a European Guidance based on good practices and, in relation with ICRP and IAEA, to issue international guidelines to calculate the annual effective dose due to radon exposure in different workplaces.
- HERCA WS on NORM, TNORM (with focus on building materials) (Q3, 2016)
Conclusion
HERCA BSS Action #10: on-going
RPE/RPO
HERCA BSS Action #11
Development of guidance on the implementation of RPE/RPO.
Expected outcome: Common understanding on the implementation of RPE and RPO respecting diversity in the implementation of the BSS.
Comments:
- Workshop organised in July 2015. Interactions with ENETRAP III.
- Participation of RPE/RPO TF Chair in EUTERP Workshop (Sept. 2015)
- Common understanding to be issued.
Conclusion:
HERCA BSS Action #11: on-going
General Exchange of Information
HERCA BSS Action #12
MS are at different stages in their transposition process including the commissioning of specific studies, WS and research in # thematic areas.
Expected outcome: Establish a dedicated page on www.herca.org providing: National Activities; Regional Activities; Research/Survey
Comment:
Page under development.
Conclusions
HERCA BSS Action #12: Preliminary discussions
[1] Published in the Official Journal of the European Union on 17th January 2014. Member States have until the 6th February 2018 to complete the process of transposition into their national regulations.
Information
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