IAEAInternational Atomic Energy Agency

BASIC IRRS TRAININGLecture 15

Reviewing Regulatory Aspects of Emergency Preparedness

and Response

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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

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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

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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)

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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

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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

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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

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APPRAISAL OF EPR REGULATIONS AND REGULATORY PROCESS

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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

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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

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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?

Recommendation of Experienced Reviewers

Give particular attention to:

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Recommendation of Experienced Reviewers

Give particular attention to:

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

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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

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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?

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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 risksBasic IRRS Training - Reviewing Emergency Preparedness and Response

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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”

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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?

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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

Recommendation of Experienced Reviewers

Give particular attention to:

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APPRAISAL OF RB’s RESPONSE CAPABILITY

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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

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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

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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

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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

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THANK YOU FOR YOUR ATTENTION

Basic IRRS Training - Reviewing Emergency Preparedness and Response

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

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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?

Basic IRRS Training - Reviewing Emergency Preparedness and Response