1. BASIC IRRS TRAINING Lecture 15
Reviewing Regulatory Aspects of Emergency Preparedness
and Response

2. Basic IRRS Training - Reviewing Emergency Preparedness and Response
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
Basic IRRS Training - Reviewing Emergency Preparedness and Response

3. Basic IRRS Training - Reviewing Emergency Preparedness and Response
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
Basic IRRS Training - Reviewing Emergency Preparedness and Response

4. Basic IRRS Training - Reviewing Emergency Preparedness and Response
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 )
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 )
GSR Part 1: Governmental, Legal and Regulatory Framework for Safety (2010)
- The Safety Standard includes in total 36 general requirements on safety for the Government and Regulatory Body. Among these, there are three requirements which refers to emergency preparedness and response: R7, R8 and R9. In principle, when evaluating the EPR topic, the following requirements (safety plus EPR) have to be taken into account: R7, R8, R9, R11, R16, R18, R19, R23, R24, R26, R27, R32 – R34, R35, R36.
GSR Part 3: Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards - INTERIM EDITION (2011)
The Safety Standard includes general requirements on emergency preparedness and response:
Requirement 43 (generic requirements),
Requirement 44 (Public exposure) and
Requirement 45 (Emergency workers).
GS-R-2: Preparedness and Response for a Nuclear or Radiological Emergency (2002)
The Safety Standard includes specific (general, functional and infrastructural) requirements on EPR for licensees, local authorities and national organizations (including the Regulatory Body).
Additional support for reviewing - IAEA Safety Guides:
GS-G-2.1: Arrangements for Preparedness for a Nuclear or Radiological Emergency (2007)
GSG-2: Criteria for Use in Preparedness and Response for a Nuclear or Radiological Emergency (2011)
EPR-METHOD 2003: Method for Developing Arrangements for Response to a Nuclear or Radiological Emergency (2003)
Basic IRRS Training - Reviewing Emergency Preparedness and Response

5. 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
Basic IRRS Training - Reviewing Emergency Preparedness and Response

6. Basic IRRS Training - Reviewing Emergency Preparedness and Response
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
Basic IRRS Training - Reviewing Emergency Preparedness and Response

7. 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
GSR Part 1 – Requirement 8, para
GSR Part 1 – Requirement 9, para
Basic IRRS Training - Reviewing Emergency Preparedness and Response

8. Appraisal of EPR regulations and regulatory process
Basic IRRS Training - Reviewing Emergency Preparedness and Response

9. Basic IRRS Training - Reviewing Emergency Preparedness and Response
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
GSR Part 1: Requirement 7, para. 2.18
Basic IRRS Training - Reviewing Emergency Preparedness and Response

10. 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
GSR Part 1: Requirement 7, para. 2.18
GGSR Part 3: Requirements 43, 44
GS-R-2: Basic responsibilities (§3.2, §3.4, § , §3.9, §3.11) and assessment of threats (§3.15)
Regulatory framework and allocation of responsibilities on EPR between the authorities responsible for regulatory control (§3.4)
Existing regulations and guides with requirements on EPR for licensees, upon which regulatory actions are based (§3.9)
Regulatory authorization and inspection system of EPR arrangements for licensees and verification of compliance with regulatory requirements (§3.2, , 3.11)
Role of RB in reviewing the threat assessment of licensees (§3.15)
Basic IRRS Training - Reviewing Emergency Preparedness and Response

11. 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?
Basic IRRS Training - Reviewing Emergency Preparedness and Response

12. Basic IRRS Training - Reviewing Emergency Preparedness and Response
Requirement
Regulatory 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
Basic IRRS Training - Reviewing Emergency Preparedness and Response

13. 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
Basic IRRS Training - Reviewing Emergency Preparedness and Response

14. Basic IRRS Training - Reviewing Emergency Preparedness and Response
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?
The verification of EPR planning and arrangements should be performed for facilities and activities in all threat categories (I to IV), as applicable. Different departments of RB might be involved in this process, therefore a clear mechanism should be defined and procedures should be in place at the level of RB for task allocation and cooperation during the authorization process. The extent of the regulatory evaluation should be commensurate with the radiation risks associated with the facility or activity, following a graded approach.
Basic IRRS Training - Reviewing Emergency Preparedness and Response

15. Basic IRRS Training - Reviewing Emergency Preparedness and Response
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
Basic IRRS Training - Reviewing Emergency Preparedness and Response

16. Basic IRRS Training - Reviewing Emergency Preparedness and Response
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”
Regulatory control on EPR planning and arrangements in place at licensees in threat categories I and/or II (when applicable) should consider the implementation of following functional requirements:
promptly classify an emergency;
protect those on the site and on-site emergency workers;
mitigate the consequences of the emergency;
notify and recommend protective actions for the public to off-site officials;
obtain off-site assistance;
conduct environmental monitoring near the facility;
assist off-site officials in keeping the public informed.
Regulatory control on EPR planning and arrangements in place at licensees in threat category III should focus on how the operator is able to:
classify an emergency;
inform off-site officials;
obtain offsite assistance;
ensure that there are no off-site risks;
Regulatory control on EPR planning and arrangements in place at licensees in threat category IV should focus on how the operator is able to:
recognize an emergency;
take action to protect people nearby;
inform off-site officials of the risks;
and provide technical assistance to off-site officials if needed.
Basic IRRS Training - Reviewing Emergency Preparedness and Response

17. Basic IRRS Training - Reviewing Emergency Preparedness and Response
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?
Basic IRRS Training - Reviewing Emergency Preparedness and Response

18. Recommendation of Experienced Reviewers Give particular attention to:
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
Basic IRRS Training - Reviewing Emergency Preparedness and Response

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

20. 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
GS-R-2: Basic responsibilities (§ , §3.10, §3.12)
Role of RB(s) in preparedness and planning at national level, including the elaboration of regulations and guides on EPR at national level (§3.4, 3.10)
Role of RB(s) in the management of nuclear or radiological emergency (§3.3, 3.12)
GSR Part 1: Requirements 7, 8, 23, 27, 32 – 34
GSR Part 3: Requirements 43, 44
Basic IRRS Training - Reviewing Emergency Preparedness and Response

21. 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
When reviewing compliance of RB as TSO with the functional requirements of GS-R- 2, check mainly for:
- specific roles in preparedness and planning
- specific roles during the response
- cooperation, interfaces and arrangements of RB with the operators and local and national organizations
- harmonization and good coordination of emergency actions of RB and other response organizations
Basic IRRS Training - Reviewing Emergency Preparedness and Response

22. Basic IRRS Training - Reviewing Emergency Preparedness and Response
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
Basic IRRS Training - Reviewing Emergency Preparedness and Response

23. Basic IRRS Training - Reviewing Emergency Preparedness and Response
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
Basic IRRS Training - Reviewing Emergency Preparedness and Response

24. THANK YOU FOR YOUR ATTENTION
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
Photo: V. Friedrich
Basic IRRS Training - Reviewing Emergency Preparedness and Response

25. Basic IRRS Training - Reviewing Emergency Preparedness and Response
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?
Points to discuss include the following:
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?
This vary between countries. At the very least, the RB is responsible for ensuring that the operating organization has adequate EPR arrangements in place to manage the on-site aspects of an emergency and adequately deal with the interface with off-site emergency response authorities. In some cases, this could include, for example, the provision of recommendations for the protection of the public, the conduct of off-site radiation monitoring, warning of the public, the provision of information on the accident assessment. At the very least, it should include notification arrangements and the provision of information on the situation at the plant. Sometimes, the RB’s regulatory authority may be shared with other government organizations. This is often the case, for example, with regards to fire protection, the protection of workers and environmental protection.
Is it the RB’s responsibility to verify that off-site emergency preparedness and response arrangements are adequate?
This is not usually the case, although in some developing countries, the RB can, sometimes, also act as the national authority on EPR. However, the focus of the IRRS should be limited to the regulatory aspects application to operating organizations (licensees). This does include the interface with off-site emergency authorities, and this is a grey area. In many cases, this regulatory responsibility is used to ensure that the local EPR arrangements are adequate. In at least one case, commissioning was delayed due to the lack of appropriate local evacuation arrangements (Shoreham). In some countries, the authority of the RB has been used as a lever for the NPP to better support the development of off-site EPR capabilities. This, however, should not be the focus of the IRRS review.
Basic IRRS Training - Reviewing Emergency Preparedness and Response