licensing of waste management facilities · management of different types of radioactive waste and...

IAEA International Atomic Energy Agency

name of presenter (e-mail)

training event title

dates

location, host organization, host country

Licensing of waste management facilities

http://www.facebook.com/photo.php?pid=39861&id=1732371649

IAEA

Contents

• Basic Framework

• Roles and Responsibilities

• Licensing Process

• Documentation

• Follow-up Activities

2

IAEA

Scope

• Licensing of waste management facilities,

applicable not only for

larger facilities but also

for smaller (e.g. storage)

facilities

3

IAEA

Relevant IAEA documents

IAEA Safety Standards

Fundamental

Safety Principles

Safety Fundamentals

f or protec ting people and t he env i ronm ent

4

IAEA

Introduction

Licensing:

• Activities/facilities from very low risk to high potential risk

• Extent of control commensurate with potential magnitude and nature of hazard

• Authorization procedures from notification/registration to multistage

licensing

Construction, operation, decommissioning

5

IAEA

Introduction

Authorisation and Licence(s)

• Siting, design, commissioning, operation, maintenance, shutdown and decommissioning

• Different approached in Member States

Safety Documentation and Evolution

• Safety case (SC)

• Safety assessment (SA)

• Other supporting documents

Siting Design Operation Shutdown Decommissioning

6

IAEA

Established regulatory framework a prerequisite:

• Legal framework

• Governmental infrastructure

• Regulatory body (-ies)

Introduction

7

IAEA

• Laws, regulations, guidance, etc.

• Safety requirements and criteria

• Activities and facilities requiring a license (siting, design, construction, operation, closure of a near surface repository)

• Responsible authorities

• Involvement of stakeholders (e.g. public)

• Licensing procedure

• Procedure for refusal and appeal

• Mechanisms for amendment and withdrawal of a license

Framework for Licensing

Ingredients..

8

IAEA 9

Roles and responsibilities

• Identification of the parties involved in waste management activities and their responsibilities;

National Radioactive waste system should include:

Government Regulatory Authority

Generators and operators

IAEA

Parties

• Applicant

• Regulatory body

• Interested parties (e.g. public, politicians)

Responsible Parties

10

IAEA

• Regulatory body or bodies: Clear allocation of authority (eg radiation protection,

environmental protection)

Coordination and consistency in:

• Documentation required

• Review and approval of safety related documentation

Ultimate licence

Control of compliance with licence conditions after

authorization

Governmental Infrastructure

11

IAEA

Responsibilities

Requirement 23: Authorization of

facilities and activities by the

regulatory body

Authorization by the regulatory body,

including specification of the conditions

necessary for safety, shall be a

prerequisite for all those facilities and

activities that are not either explicitly

exempted or approved by means of a

notification process.

12

IAEA

Responsibilities

For a facility, the stages in the lifetime

usually include:

•site evaluation,

•design,

•construction,

•commissioning,

•operation,

•shutdown and

•decommissioning (or closure).

This includes, as appropriate, the

management of radioactive waste and

the management of spent fuel, and the

remediation of contaminated areas. 13

IAEA

Responsibilities

• Any subsequent amendment, renewal, suspension or revocation of the

authorization for a facility or an activity

shall be undertaken in accordance with

a clearly specified and established

procedure.

• The safety assessment may need to be repeated or reaffirmed by the

regulatory body in support of its

decision.

14

IAEA

GSR Part 5. - Requirement 3:

Responsibilities of the regulatory

body: …The regulatory body shall review and assess

the safety case and the environmental impact

assessment for radioactive waste management

facilities and activities, as prepared by the

operator both prior to authorization and

periodically during operation. The regulatory

body shall provide for the issuing, amending,

suspension or revoking of licences, subject to

any necessary conditions. The regulatory body

shall carry out activities to verify that the

operator meets these conditions...

Responsibilities

15

IAEA

Regulatory body:

• Requirements/criteria

• Procedure for review of applications

• Guidance to applicants

• Justify licensing, refusal of granting a license, amendments, withdrawal of a

license

• Provide information to stakeholders

Responsibilities

16

IAEA

Responsibilities

Requirement 24: Demonstration

of safety for the authorization of

facilities and activities

The applicant shall be required to submit

an adequate demonstration of safety in

support of an application for the

authorization of a facility or an activity.

17

IAEA

GSR Part 5. - Requirement 4:

Responsibilities of the operator.

Operators shall be responsible for the safety

of predisposal radioactive waste management

facilities and activities. The operator shall

carry out safety assessment and shall develop

a safety case, and shall ensure that the

necessary activities for siting, design,

construction, commissioning, operation,

shutdown and decommissioning are carried

out in compliance with legal and regulatory

requirements.

Responsibilities

18

IAEA

Applicant:

• Submit complete set of application doc. that

• Demonstrates compliance with safety principles (e.g. optimization, defence in depth, containment and isolation)

• Justifies and demonstrates compliance with safety requirements and criteria (e.g. dose/risk constraints) of the proposed activity/facility (safety assessment and safety case)

• Demonstrates available human and financial resources

• Long-term arrangements (institutional control)

• Consult with the regulatory body

• Consult with other stakeholders (public)

Responsibilities

19

IAEA

Other interested parties • Public

• Part of the licensing process

• Public consultation (e.g. EIA)

• Possible involvement in the review phase

• Parlament/Politicians

• E.g. volunteer of a disposal site

• Some facilities may need parliament endorsement

Responsible Parties

20

IAEA

Licensing Process

Submission

• Documentation according to the legal requirements

• Approval(s) of competent authorities

• Results of consultations (e.g. public)

• Supporting documentation

(e.g. results of peer reviews)

21

IAEA

Supporting documentation

Safety case:

• System description; Safety assessments; Operational limits, controls and conditions; Safety supporting arguments;

Operational Documentation:

• Radioactive waste management program

• Radiation protection program

• Monitoring program

• Management system program

• Record keeping

• Emergency plan

• Physical protection plan

• Training programs

• Outreach programmes;

Justification of resources (human/financial) 22

IAEA

Basis for Evaluation

• Legal and regulatory frameworks

• Governmental infrastructure

• Regulatory body

• Technical and safety requirements and criteria

• Clear allocation of responsibilities

• Authorisation procedure, licence application, review criteria, timeframes and parties involved

23

IAEA

Basis for Authorisation (cont.)

RB Other

Competent

Authorities

Public

Government

International Obligations

International Organisations

Member

States

Licensee RB

Laws and Regulations

24

IAEA


A Legal and Regulatory Frameworks

• Laws, regulations, guidance, etc.

• Safety requirements and criteria

• Activities and facilities requiring a licence (siting, design, construction, operation, shut-down, decommissioning)

• Responsible authorities

• Involvement of stakeholders (e.g. public)

• Authorization procedure

• Procedure for refusal and appeal

• Mechanisms for amendment and withdrawal of a licence

25

IAEA


Government Infrastructure

• To define the national policy for the long term management of different types of radioactive waste and spent fuel

• e.g. existing and planned facilities and activities

• To set clearly defined legal, technical and financial responsibilities for organizations to be involved in waste predisposal management activities

• Waste Management Organisations

• Waste Funds

• Decommissoning Funds

• To define the overall process for development, operation, closure and decommissioning of facilities

• Ensure compliance with international obligations

• Joint Convention, etc.

26

IAEA

Basis for Evaluation (cont.)

Regulatory Body:

• Setting safety requirements and criteria

• Authorisation, inspection, review and enforcement

• Defining licensing application documents

All phases of facility lifetime

• Establishing procedure for review of applications

• Provision of guidance to applicants

27

IAEA

• All steps from an application to a final decision

• Parties involved at each stage (e.g. hearings)

• Timeframes for review and final decision

• Regulatory body/applicant interface

Documentation of the Licensing Procedure

28

IAEA

Licensing Procedure

Parties involved • Operator/licence applicant

• Independent reviewers

• Regulators

• Public/other stakeholders

Review steps • Preliminary review (incl. peer review)

• Presentations of comments, request for additional information

• Consideration of the comments and submission of the required information to the regulatory body for evaluation

• Final review and decision on granting a licence 29

IAEA

Licensing procedure

Regulatory decision making process

How can the regulatory body decide?

To grant or to refuse the licence.

What is the basis of regulatory decision?

Strong justification and clear reasoning

Well documented decision making process

Documentation to be preserved and archived

Dissemination of information to the relevant competent

authorities

30

IAEA


Regulatory Body (cont.): • Justification of licensing, refusal or granting a licence,

amendments or withdrawal of a licence

• Provision of information to stakeholders

• Appealing procedure

• Coordination with other competent authorities Security Non-radiological aspects Emergency planning Environmental monitoring, EIA, etc.

31

IAEA


Technical and safety requirements and criteria

- dose limits

- dose constraints

- discharge limits

- clearance levels

- waste classification

- requirements for processing, storage, transport and disposal of waste, etc.

32

IAEA


Technical and safety requirements and criteria (examples)

a. Criteria for clearance of material

• IAEA Guidance from RS-G-1.7

• Effective dose to individuals not more than about 10 µSv/y

• Collective dose < 1 manSv, or an assessment of optimization of protection shows that clearance is the

optimum option

• Naturally occuring RN – 1 Bq/g and 10 Bq/g (K-40)

• Or set by the national authorities

33

IAEA


b. Waste characterization and classification

In accordance with the requirements established and approved by the regulatory body

GSG-1 Safety Guide (IAEA)

34

IAEA


Technical Requirements for Storage of Radioactive Waste

• Waste characterization

• Waste acceptance criteria

• Description of the facility, components, equipment and systems

• Siting and desing, construction, operation, commissioning, shutdown and decommissioning

• Safety documentation (SC):

SA

Radiation protection programme

Environmental monitoring

Security and physical protection plan

Emergency plan

Management system, etc.

35

IAEA


Parties Involved and their Responsibilities

• Operator/licence applicant (e.g. also TSO)

• Supporting organisations (e.g. (sub)contractors)

• Regulator(s) (e.g. also TSO)

• Independent reviewers (e.g. international - IAEA)

• Public/other stakeholders

36

IAEA


Authorisation Procedure and Review Steps

• Preliminary review (screening) of licence application

• Detailed review (incl. peer review)

• Possible visit to the site/facility

• Presentations of comments, request for additional information, studies or investigations

• Consideration of the comments and submission of the required information to the regulatory body for evaluation

• Final review and decision on granting a licence

37

IAEA


Authorisation Application Review Plan • Regulatory body establishes a plan for review and

evaluation • All steps from an application to a final decision

• Define phases, if necessary • Parties involved at each stage (e.g. hearings)

• Timeframes for review and final decision

• Regulatory body/applicant interface

• Overall responsibility for the review and decision, and

their documentation

38

IAEA

Approach to Evaluation

Scope of Authorisation Application

• Siting, design, operation, modification, shutdown or decommissioning

• Activities/facilities from very low hazards/risk to high potential hazards/risk

• Separate authorization of an activity or a general authorisation for more activities

• Extent of control commensurate with potential magnitude and nature of hazards - graded approach

39

IAEA

Graded Approach

Maintenance waste

candidate for clearance

Spent fuel storage

facility

40

IAEA

Approach to Evaluation (cont.)

Scope of Waste Management Activities

i. Waste processing (pretreatment, treatment and conditioning)

ii. Storage of radioactive materials, previously conditioned in containers that are physical barriers to prevent dispersion of radioactive materials

iii. Removal of control and subsequent authorized release (clearance), in compliance with clearance levels approved by the regulatory body

41

IAEA

Approach to Evaluation (cont.)

Regulated Practice

Regulated transfer

to other facility Regulated disposal

Authorised recycling,

reuse and disposal

Clearance

Authorised release and

discharge

42

IAEA

Licensing procedure

Review of application • Regulatory body programme for review and

assessment

• Review of documentation (SC, supporting arguments)

• Internal (independent assessment)

• External (independent expert(s), international peer review)

• Request for additional information

• Request for additional studies and investigations

• On-site inspections

43

IAEA

Procedure (cont.)

• Parties involved: Applicant / operator ;

Regulator(s);

Independent reviewers;

Public / other stakeholders.

• Timeframes:

• For review (incl. peer review) and within that: Presentations of comments, request for additional

information;

Consideration of comments and submission of

additionally required information;

Final review and decision on granting a license. 44

IAEA

Procedure (cont.)

• Regulatory body/ applicant interface:

• Licensing programme prior to submission: Schedule the main activities;

Agree the scope and content of the main documents;

Methodology for comment and query tracking;

Agree contact persons.

• Effective incorporation of comments & recommendations;

• Detailed face-to-face discussions may help but these should focus on clarification and should

be kept formal.

45

IAEA

Conduct of Evaluation

The Regulatory Body should be sure

that the description of the facility

includes:

Volumes by types of waste

Physical, chemical, radiological and

biological characteristics of waste

Types of containers that are

planned to be used

Principles and methods used

Acceptance criteria for waste which

will be managed in the storage

facility (for a package and for the

facility in total)

Evaluation

Technical

Aspects

Safety

Aspects

Managerial

Aspects

Technical Aspects

46

IAEA

Conduct of Evaluation (cont.)

Description of the facility, components, equipment and systems:

• Main characteristics of the geographical site of the facility, access routes, basic services (electricity, water, etc.) and waste disposal routes

• Layout of the building, construction materials, materials used in finishing and covering of walls and floors etc.

• Storage capacity by package type or forms of waste

• Systems for package handling, transport and lifting

• Radiation protection and environmental monitoring

• Emergency measures

• Ventilation systems

• Technical support for physical security

Technical Aspects

47

IAEA


The regulatory body has to be sure that:

• The actual characteristics of waste accepted meet the characteristics taken into account in the development of the safety case.

• The operator knows the waste acceptance criteria in terms of radiological, mechanical, physical, chemical and biological characteristics

• The operator knows the role of the waste acceptance criteria to ensure the safe handling and storage of waste packages in normal and abnormal conditions

• The operator knows how to identify, assess and deal with waste packages that do not meet specifications

Technical Aspects

48

IAEA


The regulatory body has to implement onsite surveillance, package testing, inspection in order to ensure: • That the waste packages meet the required acceptance

criteria for storage or processing

• Adequacy of the licence application documentation

Technical Aspects

49

IAEA


The regulatory body should be sure that the operator:

• Carries out, reviews and updates safety assessments and develops the necessary supporting safety cases for siting, design, construction, commissioning, operation, shutdown and decommissioning

• Compliance with legal and regulatory requirements

• Takes into account the interdependences among all steps in the predisposal management of radioactive waste, as well as the impact of the anticipated disposal option

Safety Aspects

50

IAEA


Safety Assessment and Safety Case

• Preliminary Safety Assessment Report is submitted together with the construction licence application

• Final Safety Assessment Report is submitted with the operation licence application

• Supporting arguments

• Operational limits and conditions

• SA input to the Safety Case together with, e.g.:

Initial decommissioning plan

Reference background surveys, etc.

Safety Aspects

51

IAEA

Use of safety assessment results

Results of safety assessment will be basis for: • waste acceptance criteria • derivation of procedures or equipment required to

minimize doses

• definition of operational limits, conditions and controls (OLCs) to prevent unacceptable exposures and releases during normal operations and prevent accident conditions or to mitigate accident consequences safe operating envelope

• derivation of operational procedures to ensure that operations remain within the OLCs

Safety Aspects

52

IAEA


Other elements of SC, e.g. emergency planning:

• Planning for emergency response is based on the results of a safety analysis

• Emergency situations

• Response organization for each type of emergency

• Training programme for the responders

• Response arrangements

• Periodic review, update and test

Safety Aspects

53

IAEA



• Demonstrates the commitment of senior management to safety and the establishment and maintenance of a safety culture within the installation

• Demonstrates the implementation of an integrated approach to safety and security in the installation where radioactive waste are stored

Managerial Aspects

54

IAEA



• Applies an effective management system to all elements of radioactive waste storage. Features that are important for the safe operation of the facility or activity should be included on management system and identified in the safety assessment and supporting safety cases.

• Adequate human and financial resources

• Appropriate control (incl. (sub)contractors), etc.

• Safety Manuals, procedures, etc.

Managerial Aspects

55

IAEA


Safety Manual

• Selection of personnel, authorization and training

Qualification needed for important safety positions.

Plans for periodical education and training in

• Administrative regulations such as control of access to controlled zones

• Radiological monitoring of personnel and assessment of individual exposure

Identification of the personnel that need individual radiological surveillance

Description of radiological surveillance services

Assessment methods and measures to be adopted if reference levels are exceeded….

Managerial Aspects

56

IAEA


• Shutdown and Decommissioning

Final disposal arrangements in place

New facility allows for closing of an existing one

• Decommissioning plan

Decontamination and dismantling

Endpoint (unrestricted or restricted use)

Safety assessment for dismantling

Management of waste to be generated in operations

Verification of final conditions of the facilities

• Authorization for release from regulatory control

With or no conditions (WS-G.5.1)

Specific Aspects

57

IAEA

Licensing decisions

Decisions:

• Granting license or refusal of a license

• Strong justification and clear basis

• Well documented

• All documentation maintained and recorded

• Dissemination of information to the relevant competent authorities

58

IAEA

Licence/Authorisation Content

• Basis Licence application (No., date, etc.)

Legal basis (Law, regulations)

Reviewed documents (SARs, limits and conditions, etc.)

On-site visit(s) (protocols, etc.)

• Facility New

Old (with or without a licence) – link to previous licence and conditions

• Authorized entity

59

IAEA

Licence/Authorisation Content

• Authorized activity Siting, design, upgrading, decommissioning, etc.

• Limits, conditions and controls e.g. WAC, periodic reassessment of safety, reporting

• Licence period Put into force, validity

• Registration Number and link to other licenses

60

IAEA

After Granting an Authorisation

• Regulatory control of operation

Inspection

Review and evaluation of safety documents (SA, etc.)

• Periodic safety review (peer reviews)

• Licence modifications (structures, systems and

components, operational limits…)

Established review and approval procedure and

procedure for licence amendment

Dealt with same technical rigor as original licensing

61

IAEA

After Granting an Authorisation (cont.)

• Renewal of licence

Normal licensing procedure, with operational experience and updated documents

• Licence withdrawal

Serious violations of safety requirements, criteria

Serious violation of licence conditions

62

IAEA

Licensing Procedure

Further Regulatory Actions

Are there any regulatory actions after the licence

is granted?

• Inspections • Review and evaluation of safety • Periodic safety review • Modifications (SSC, operational limits..)

Established review and approval procedure or licence amendment

Dealt with same technical rigor as during licensing

• Update / Renewal of licence Normal licensing procedure, with operational

experience and updated documents

63

IAEA

Termination of Authorization

• Termination of a licence Shutdown of facility (e.g. source removal) Completion of decommissioning

• Final decommissioning plan 2 y prior shutdown Strategy, criteria, end state, financial means, etc.

• Final survey report

• Financial means for implementation of controls

• Formal decision of the Regulatory Body Safety Guide WS-G-5.1

64

IAEA

License endorsement

• Responsibility rests with the license holder:

Operator;

Subcontracts another entity.

• Subject of amendment:

Based on results of reassessment;

Change of limits and conditions;

Safety related changes in design.

• Subject of withdrawal:

Violations of safety requirements, criteria;

Unfulfilled license conditions;

Subject of additional conditions, for example:

Periodic report describing accepted / managed waste,

More frequent monitoring of the site.

65

IAEA

Effective licensing • Clear procedure and allocation of responsibilities

• Open dialogue between operators and regulators starting before the formal submission

• Active commitment of both operator and regulator

• Consultation with the public and other stakeholders

• Emphasis: Graded approach

Clear review procedure

Justification and transperancy of decisions

Termination of licence and site relase criteria

Non-radiological aspects and security

Summary

66

IAEA Thank you! 67
http://www.facebook.com/photo.php?pid=39861&id=1732371649

licensing of waste management facilities · management of different types of radioactive waste and...

Documents