International Atomic Energy Agency School for Drafting Regulations on Radiation Safety RER/9/096...

International Atomic Energy Agency

School for Drafting Regulations on Radiation Safety RER/9/096

Vienna, 3 May, 2010Adriana Nicic, Regulatory Activities Section, NSNI

Role and Attributes of Good Regulations



• Current and Future Status of Safety Standards

• Governmental, Legal and Regulatory Framework for Safety - GSR, Part 1

• Regulatory Strategies

• Attributes of Good Regulations

• Conclusions

Overview


International Atomic Energy AgencyIAEA Obligation

IAEA Statute (Article III.A.6)

• “To establish or adopt… [in consultation with…] standards of safety for the protection of health and minimization of danger to life and property”

• “…and to provide for the application of these standards”


International Atomic Energy AgencyIAEA Safety Standards

Safety GuidesSafety Guides

Safety RequirementsSafety Requirements

Safety FundamentalsSafety Fundamentals


International Atomic Energy AgencyCurrent Status of Safety Requirements

Legal & G overnm ental In frastructureG S-R-1 (2000) - under revis ion (DS 415)

Em ergency Preparedness & ResponseG S-R-2 (2002)

M anagem ent S ystem sG S-R-3 (2006) - R ecently pub lished

Safe ty A ssessm ent for Facilities adn Activ itiesG SR P art 4Pub. in 2009

S ite Eva luationN S -R -3 (2003) - R ecently published

R adiation S afe tySS 115 (1996) - U nder revis ion (DS 379)

Predisposal M anagem ent of R ad ioactive W asteG SR P art 5 Pub. in 2009

D ecom m ission ingW S -R-5 (2006) - R ecently pub lished

R em edia tion o f C ontam inated A reasW S -R-3 (2003) - R ecently pub lished

T ransport o f R adioactive M ateria lTS-R -1 (2005) - under revis ion (D S 345)Approved by the C S S and the B oG

Them atic A reas

N uclear Pow er P lan ts D esignN S -R -1 (2000) - Revis ion started (D S 414)

N uclear Pow er P lan ts O pera tionN S -R -2 (2000) - Revis ion started (D S 413)

R esearch R eactorsN S -R -4 (2005) - Recently published

Fuel Cyc le Facilities & A ctiv itiesN S -R -5 (2008)- recently published

R adia tion R e lated Facilities & A ctiv itiesP art of S S115 (1996) - U nder revis ion (D S379)

D isposa l FacilitiesW S -R-1 (1999) and W S -R -4 (2006) be ing revised(D S354)

Facilities & A ctivities

Safe ty Fundam entals


International Atomic Energy AgencyGovernmental and Regulatory Framework



“Milestones” document IAEA NG-G-3.1

IAEA SAFETY STANDARDS

GUIDES

REQUIREMENTS

FUNDAMENTALS

IAEA Nuclear Power Support Group’s

BROCHURE

International Nuclear Safety Group’sREPORT-22

Safety Infrastructure Guide DS424

“Establishing a Safety

Infrastructure for a National Nuclear Power Programme”

Safety Guide


International Atomic Energy AgencyStructure of Long Term Set of Safety Requirements

Part 1 Governmental andRegulatory Framework

Part 2 Leadership and Managementfor Safety

Part 4 Safety Assessmentfor Facilities and Activities

Part 5 Predisposal Managementof Radioactive Waste

Part 6 Decommissioning andTermination of Activities

Part 7 Emergency Preparednessand Response

Specific Safety RequirementsGeneral Safety Requirements

Part 3 Radiation Protection and Safety of Radiation Sources

1. Site Evaluation forNuclear Installations

3. Safety of Research Reactors

4. Safety of Nuclear FuelCycle Facilities

5. Safety of Radioactive WasteDisposal Facilities

6. Safe Transport ofRadioactive Material

2. Safety of Nuclear Power Plants

2.1 Design and Construction2.2 Commissioning and Operation


International Atomic Energy AgencyStructure of Reference Set of Safety Guides for Long Term

• Long Term Set of Safety Guides prepared: • General Safety Guides• Facilities and Activities Specific Safety Guides

• Safety Guides GS-G-1.1 to GS- G-1.4 (and additional guidance) will become additional material in the General Safety Guide #2 – “General Regulatory Control of Facilities and Activities”


International Atomic Energy AgencyGovernmental, Legal and Regulatory Framework for Safety – GSR, Part 1

• GSR, Part 1, approved by Board of Governors(March 2010)

• Supersedes GS-R-1, legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety

Draft Safety Requirements: Governmental, Legal and Regulatory Framework for Safety

Revision of Safety Standards Series No. GS-R-1

IAEA SAFETY STANDARDS for protecting people and the environment

Governmental, Legal and Regulatory Framework for Safety Draft Safety Requirements DS415

Revision of Safety Standards Series No. GS-R-1


International Atomic Energy AgencyGovernmental, Legal and Regulatory Framework for Safety

• Establishes international consensus requirements to apply the fundamental safety objectives and principles establishes in SF-1, the IAEA Safety Fundamentals


International Atomic Energy AgencyFundamental Safety Principles

Principle 1: Responsibility for safety

Principle 2: Role of government

Principle 3: Effective Leadership and Management for Safety


International Atomic Energy AgencyGovernmental, Legal and Regulatory Framework for Safety

• Covers all phases of the lifetime of facilities and duration of activities until release from regulatory control

• Does not apply to military or defence related activities unless so decided by the Member State, nor does it apply to nuclear security


International Atomic Energy AgencyGeneral Considerations - Government

State

Government

National Policies for SafetyLaws, Regulations

Functions and Responsibilities of Regulatory Body

Responsibilities and functions of governmental entities for safety and EPR


International Atomic Energy AgencyResponsibilities and Functions of the Government

1. National policy and strategy for safety

2. Establishment of a framework for safety

3. Establishment of a regulatory body

4. Independence of the regulatory body

5. Prime responsibility for safety



6. Compliance with regulations and responsibility for safety

7. Coordination of different authorities with responsibilities for safety within the regulatory framework for safety

8. Emergency preparedness and response9. System for protective actions to reduce existing

or unregulated radiation risks



10.Provision for the decommissioning of facilities and the management of radioactive waste and of spent fuel

11.Competence for safety12.Interfaces of safety with nuclear security and

with the State system of accounting for and control of nuclear material

13.Provision of technical services


International Atomic Energy AgencyThe Global Safety Regime

14.International obligations and arrangements for international cooperation

15.Sharing of operating experience and regulatory experience


International Atomic Energy AgencyGeneral Considerations – Regulatory Body

Regulatory Body

Regulatory Framework/ Documents

Implementation of Safety Policies

and Laws

Regulatory Strategy

Regulatory Programme

System for coordination among governmental

entities – safety and ERP


International Atomic Energy AgencyResponsibilities and functions of regulatory body

• 21 requirements related to responsibilities and functions of regulatory body

• Requirement 16 – 18 relates to organizational structure, independence, staffing, competence, liaison with advisory bodies and other regulators

• Requirement 19 – 22 related to management system and liaison with other interested parties


International Atomic Energy AgencyResponsibilities and functions of regulatory body

• Requirement 23-34 relates to core functions of regulatory body

• Requirement 35 – 36 related to safety records and communication


International Atomic Energy AgencyRequirement 23 - Authorization

• 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 notification process.



05/03/23 23

◄

Demonstration of safety

R241. Authorization of activities2. Diff types, stages and lifetimes3. Commensurate with hazard4. Guidance on format & content5. Submit safety case6. Impose limits, conditions7. Provision for appeal 8. Provision of amendment 9. Formal record of decisions

Requirement 24 –Demonstration of Safety


International Atomic Energy AgencyRequirement 25 – Review and Assessment

• The regulatory body shall review and assess relevant information to determine whether facilities and activities comply with regulatory requirements and the conditions specified in the authorization.

• This review and assessment of information shall be performed prior to authorization and again over the lifetime of the facility or duration of the activity as specified in regulations promulgated by the regulatory body or in the authorization.



25

►

Graded approach

R26

1. Commensurate with hazard2. In accordance with stages3. Purpose to comply requirements• To acquire understanding of design• Accurate, proven• Risk at normal, anticipated, accident• Site conditions• Best practices• Management system• Competence of operators• Arrangement for protection of workers• EPP• Nuclear security• Concept of defense in depth• Operating experience feedback • Info from Inspection• Risk other then radiation

Requirement 26 – Graded Approach


International Atomic Energy AgencyRequirement 27 - Inspection

• The regulatory body shall carry out inspections of facilities and activities to verify that the authorized party is in compliance with the regulatory requirements and with the conditions specified in the authorization



27

Types of Inspection

R281. Prime Responsibility 2. Inspection do not diminish3. Inspection Program4. Results of inspection5. SSC6. MS7. Operational activities8. Records 9. Liaisons with contractors10.Safety culture

Graded approach

R29

Requirement 28, 29 – Graded Approach, Types of Inspection


International Atomic Energy AgencyRequirement 30 - Enforcement

• The regulatory body shall establish and implement an enforcement policy within the legal framework for responding to non-compliance by authorized parties with regulatory requirements or with any conditions specified in the authorization.



05/03/23 29

►

Corrective action

R311. Response to non-compliance2. Verbal notification, written..3. Identify non-compliance4. Remedying non-compliance5. Criteria for corrective action6. On-site inspectors power

Requirement 31 –Corrective Action


International Atomic Energy AgencyRequirement 32 – Regulations and Guides

• The regulatory body shall establish or adopt regulations and guides to specify the principles, requirements and associated criteria for safety upon which its regulatory judgments, decisions and actions are based



05/03/23 31

◄

Review of regulation

R33

Promotion of regulation

R34

Requirement 33 and 34 – Preparation of Regulations

1. Process for regulations2. Consultation3. International standards4. Feedback from experience5. Framework for authorization6. Consistent7. Comprehensive8. Graded approach


International Atomic Energy AgencyRegulatory Strategies

• What is a regulatory strategy?

• An approach to regulation that determines the overarching types of demands that are made on licensees/ applicants

• It is more specific than a regulatory mandate—which is the scope of responsibility given by the government to the regulator, and

• More general than regulatory methods—which are the ways that the regulator determines if operators are fulfilling demands (inspections, document reviews etc.)


International Atomic Energy AgencyImportance of Regulatory Strategies

• Strategies affect the behavior of licensees and therefore have an impact on safety

• Development of regulatory framework is based upon the adopted strategy

• Strategies are a major determinant of how a regulator carries out oversight• e.g. resources used, types of expertise needed


International Atomic Energy AgencyContext Influencing the Regulatory Strategy

• Regulatory mandate

• Nature of the nuclear industry• Culture and history

• of the country, • of the regulatory agency, and • of the facilities and activities being regulated


International Atomic Energy AgencyAlternative Regulatory Strategies

•Prescriptive•Case-based•Outcome-based•Risk-based•Process-based•Licensee self-assessments


International Atomic Energy AgencyAttributes of Good Regulations

• WORKING on it…………..


International Atomic Energy AgencyConclusions



Thank you!

International Atomic Energy Agency School for Drafting Regulations on Radiation Safety RER/9/096...

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