1. IAEA International Atomic Energy Agency

2. IAEA Outline Learning objectives Introduction Functions of Regulatory Body (RB) on EPR Appraisal guidance: Part 1: Appraisal of RB’s EPR regulations and regulatory processes Part 2: Appraisal of RB’s response capabilities 2Basic IRRS Training - Reviewing Emergency Preparedness and Response

3. IAEA Learning objectives After finishing this lecture the trainee will: Understand IRRS Module 10 (EPR) Know what is included in the review of the regulatory aspects of Emergency Preparedness and Response (EPR) Be familiar with the questions and issues to be considered for interviews and discussions with the RB representatives 3Basic IRRS Training - Reviewing Emergency Preparedness and Response

4. IAEA Introduction Basis for review - IAEA Safety Standards: GSR Part 1 (Requirement 8) Governmental, Legal and Regulatory Framework for Safety (2010) (referenced 7 times during missions in the period 2006- 2011) GSR Part 3 Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards - INTERIM EDITION (2011) GS-R-2 Preparedness and Response for a Nuclear or Radiological Emergency (2002) (referenced 63 times during missions in the period 2006-2011) 4Basic IRRS Training - Reviewing Emergency Preparedness and Response

5. IAEA Introduction (cont’d) Regulatory bodies have a dual role REGULATOR To regulate, authorize and control facilities and activities in the nuclear field RESPONSE ORGANIZATION To provide advice and expert services on EPR at national level To coordinate with the National EPR system 5Basic IRRS Training - Reviewing Emergency Preparedness and Response

6. IAEA As an EPR regulator: Establish regulations EPR requirements for the licensees The RB does not usually have jurisdiction on non- licensees But “The RB shall ensure that [..] emergency arrangements are integrated with those of other response organizations [and..] that the co-ordinated arrangements are implemented adequately by the operators [..]” (GS-R-2) Authorize Establish an authorization system Provide reasonable assurance that adequate EPR arrangements are in place for all licensees Verify Establish an inspection system Check the compliance of EPR arrangements with legal requirements for all licensees Including the systematic evaluation of some exercises 6Basic IRRS Training - Reviewing Emergency Preparedness and Response

7. IAEA As a response organization: Preparedness Provide support to and coordinate with other competent authorities in the preparedness and planning phase Response Advise the government and competent authorities Provide expert services As stipulated in the national emergency response framework This role may vary from MS to MS 7Basic IRRS Training - Reviewing Emergency Preparedness and Response

8. IAEA APPRAISAL OF EPR REGULATIONS AND REGULATORY PROCESS 8Basic IRRS Training - Reviewing Emergency Preparedness and Response

9. IAEA Regulatory framework The RB Develops regulations Authorizes licensee’s EPR arrangements Verifies The RB’s mandate is usually limited to licensees Other authorities usually set and maintain requirements for the national emergency response framework The RB is not usually the national co-ordinating authority for EPR Therefore, co-ordination with those other authorities on EPR regulatory or legislative matters is required Regulatory responsibilities of the RB on EPR matters must be clear Coordination mechanisms and processes to ensure comprehensive coverage of all EPR requirements and consistent approaches in areas of overlapping jurisdiction For example on the protection of emergency workers 9Basic IRRS Training - Reviewing Emergency Preparedness and Response

10. IAEA The RB develops EPR regulations The EPR regulations issued by the RB should be complete and consistent with GS-R-2 Within the scope of the RB’s jurisdiction Unless otherwise stated in the legal framework, this normally covers the responsibility of the operator for on-site and off-site areas under its direct control and the interface with other competent authorities The regulatory body should coordinate with other competent authorities in regulatory areas not under its direct jurisdiction 10Basic IRRS Training - Reviewing Emergency Preparedness and Response

11. IAEA Recommendation of Experienced Reviewers Give particular attention to: GS-R-2: General requirements For each GS-R-2 general, functional and infrastructure requirement:  Does the RB have regulatory responsibility for that requirement?  If yes, is there a regulatory requirement or guide on this, and is it consistent with GS-R-2 and associated guidance?  If no, who is responsible for that requirement and how does the RB coordinate with them?  If overlapping jurisdiction for that requirement, how is coordination effected and final regulatory decisions made? 11 Recommendation of Experienced Reviewers Give particular attention to: Basic IRRS Training - Reviewing Emergency Preparedness and Response

12. IAEA Recommendation of Experienced Reviewers Give particular attention to: 12Basic IRRS Training - Reviewing Emergency Preparedness and Response RequirementRegulatory jurisdiction of the RB National Reference Consistent with int’l requirements? Remarks Basic responsibilities Note that not all these areas apply to operating organizations to the same extent. For example, the RB is not usually responsible for establishing the responsibilities of other governments organizations involved in EPR; the RB is also often not the organization responsible for establishing requirements for informing the public. Assessment of threat Emergency management and operations Identifying, notifying and activating Urgent protective actions Information and instructions Protecting emergency workers Assessing initial phase Medical response Agricultural and longer term countermeasures Non-radiological impacts Recovery Authority Organization Coordination Plans and procedures Logistics Training, drills and exercises QA

13. IAEA The RB authorizes EPR arrangements The applicant normally submits its Emergency Preparedness and Response Plan As part of the application for the authorization Documents should cover preparedness processes (sustainability) and response arrangements (actions) “Preparedness” and “Response” are not always in the same document The RB evaluation should be systematic, complete and consistent This suggests the need for an evaluation methodology and standard Graded approach The extent and depth of the regulatory evaluation should be commensurate with the radiation risks 13Basic IRRS Training - Reviewing Emergency Preparedness and Response

14. IAEA Recommendation of Experienced Reviewers Give particular attention to:  How are EPR arrangements evaluated? Those documented in the licensee’s EPR plan Those documented in the other plans? Note that the RB does not necessarily have jurisdiction over those Against what regulatory guide or standard? Is there a systematic methodology? How is the interface between the licensee and other authorities for EPR evaluated?  How does the RB coordinate with other competent authorities for the evaluation of common areas? For example, readiness of emergency services that may support the operator during an emergency? 14Basic IRRS Training - Reviewing Emergency Preparedness and Response

15. IAEA The RB verifies Verification is normally through: Inspections (plans, equipment, systems, facilities) Audits (of the EPR preparedness process, training programme and records, etc.) Exercises There should be a process in place Procedures and standards Regulatory guides Etc. Graded approach The extent of the regulatory control should be commensurate with the radiation risks 15Basic IRRS Training - Reviewing Emergency Preparedness and Response

16. IAEA Recommendation of Experienced Reviewers Give particular attention to:  What is the verification process? Look for: EPR inspection and audit schedule, methodology, procedures and records Past inspection and audit reports Periodic review of the hazard assessment  Check if the inspections and audits cover all relevant regulatory areas Refer to the section/Table on regulations Note that the verification method might vary between EPR requirements For example, equipment “inspection” vs training programme “audit” 16Basic IRRS Training - Reviewing Emergency Preparedness and Response

17. IAEA Recommendation of Experienced Reviewers Give particular attention to:  How are exercises evaluated? Is there a standard methodology? Is it consistent with EPR Exercises 2005? Check exercise reports, corrective actions and trends If an operator has an exercise, evaluate how the RB evaluates it How often are exercise evaluated by the regulator?  How does the RB ensure the continued harmonization of licensee EPR arrangements with those of local response organizations?  How does the RB monitor continuous improvement in EPR? 17Basic IRRS Training - Reviewing Emergency Preparedness and Response

18. IAEA  Note: big difference between Hazard Categories (I to III), and IV I to III have a “site operator” and off-site authorities IV do not Response by local emergency services may NOT be within the RB’s jurisdiction But emergency plans by source owners are 18Basic IRRS Training - Reviewing Emergency Preparedness and Response Recommendation of Experienced Reviewers Give particular attention to:

19. IAEA APPRAISAL OF RB’s RESPONSE CAPABILITY 19Basic IRRS Training - Reviewing Emergency Preparedness and Response

20. IAEA Legislative framework Legislative framework defines the role of the RB Roles and responsibilities of the RB in preparedness and response should be clearly defined As a minimum, the RB provides advice and expert services Additional roles possible depending on Member State The RB must have the capabilities and meet the infrastructure requirements that apply to these roles The RB coordinates Coordination focused on preparedness and response of the national system Within the “limited” jurisdiction of the RB 20Basic IRRS Training - Reviewing Emergency Preparedness and Response

21. IAEA Examples of possible response roles Notification point Consequence assessment Advice on: Facility status, evolution and prognosis Protective actions for workers and public Public information Radiation monitoring On-scene response (hazard category IV) In many MS, the RB does not actively respond at the scene In some, they do Again, the response role varies between various MS The IRRS review of the response capabilities of the RB must reflect the MS-specific roles 21Basic IRRS Training - Reviewing Emergency Preparedness and Response

22. IAEA Recommendation of Experienced Reviewers Give particular attention to:  What is the extent of the RB role during response?  Does the RB have the tools, systems, capabilities and training to fulfill this role?  Does the RB exercise this role on a regular basis?  Do exercises cover all interfaces, with other response and operating organizations?  Check training and exercise records Check records and reports Look for corrective action plans and continuous improvement If they have an exercise, review the way they evaluate themselves 22Basic IRRS Training - Reviewing Emergency Preparedness and Response

23. IAEA Summary (Module 10 EPR) Module 10 is based on GSR Part 1, GSR Part 3 and GS-R-2 The RB is both a regulator and a response organization Module 10 (EPR) focuses on: Completeness of the EPR regulations Effectiveness of the regulatory approval process for EPR Effectiveness of the regulatory verification process for EPR Coordination with other authorities in setting EPR requirements Ability of RP to perform its assigned response functions Graded approach: regulatory control in EPR commensurate with radiation risk IRRS module 10 (EPR) must recognize the limits of the RB’s jurisdiction in EPR 23Basic IRRS Training - Reviewing Emergency Preparedness and Response

24. IAEA THANK YOU FOR YOUR ATTENTION Basic IRRS Training - Reviewing Emergency Preparedness and Response24 Photo: V. Friedrich This activity is conducted by the IAEA, with funding by the European Union. The views expressed in this presentation do not necessarily reflect the views of the European Commission

25. IAEA Discussion Since the RB does not have jurisdiction over all EPR aspects, how do we establish which EPR requirements from GS-R-2 apply, and to what extent? Is it the RB’s responsibility to verify that off-site emergency preparedness and response arrangements are adequate? 25Basic IRRS Training - Reviewing Emergency Preparedness and Response