IAEAInternational Atomic Energy Agency

IAEA Safety Publications Related to Regulatory Infrastructure

Safety Fundamentals SF 1Safety Requirements GSR Part 1, GSR Part 3

School of Drafting Regulations, Vienna, November / December 2012

Stephen Evans

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Outline

• Introduction to the IAEA Safety Standards• Safety Fundamentals• GSR Part 1

• Governmental, Legal and Regulatory Framework for Safety

• GSR Part 3• Radiation Protection and Safety of Radiation Sources:

International Basic Safety Standards

• Draft Model Regulations

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IAEA Safety Standards Categories

Safety Guides

Safety Requirements

Safety Fundamentals

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IAEA Safety Standards Categories

Fundamental safety objectives and principles for protecting people and environment

Requirements that must be met to ensure protection of people and the environment – “shall” statements

Recommended ways of meeting the requirements

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IAEA Safety Standards

• In 1958, the IAEA published its first Safety Standard• Safety Series No. 1, Safe Handling of

Radioisotopes

• Over the years, some 200 publications have been issued in the Safety Series

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IAEA Safety Standards

• In 1996 , the Department of Nuclear Safety established:• a new approach to developing Safety Standards

• Harmonized processes involving:• the Commission on Safety Standards (CSS);• the four Safety Standards Committees;• preparation of an overall structure for the Safety

Standards.

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Commissionon Safety Standards

(CSS)

Nuclear Safety StandardsCommittee(NUSSC)

Radiation Safety StandardsCommittee(RASSC)

Waste Safety StandardsCommittee(WASSC)

Transport Safety

StandardsCommittee

(TRANSSC)

Commission & Committees

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The Commission on Safety Standards and the Committees were established with the objective of achieving consensus, quality, coherence and consistency in the development of international standards for safety.

IAEA safety standards are developed in close consultation with Member States and with representatives of relevant international organizations.

Approval by the Board of Governors is required for Safety Fundamentals and Safety Requirements.

The authority to establish Safety Guides has been delegated to the IAEA Director General.

Commission & Committees

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Fundamental Safety Principles

Unified Fundamental Safety Principles

Principle 1: Responsibility for safety“The prime responsibility for safety must rest with the person or organization responsible for facilities and activities that give rise to radiation risks.”

Principle 2: Role of government“An effective legal and governmental framework for safety, including an independent regulatory body, must be established and sustained.”

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Fundamental Safety Principles

Principle 3: Leadership and management for safety

Principle 4: Justification of facilities and activities“Facilities and activities that give rise to radiation risks must yield an overall benefit.”

Principle 5: Optimization of Protection“Protection must be optimized to provide the highest level of safety that can reasonably be achieved.”

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Fundamental Safety Principles

Principle 6: Limits on risks to individuals“Measures for controlling radiation risks must ensure that no individual bears anunacceptable risk of harm.”

Principle 7: Protection of present and future generationsand the environment

Principle 8: Prevention of accidents

Principle 9: Emergency preparedness and response

Principle 10: Protective actions to reduce existing or unregulated radiation risks

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• Published in 2010• Applicable to all States, for all types of facilities and

activities

• Three sets of requirements:• Responsibilities and functions of the Government• The global safety regime• Responsibilities and functions of the regulatory body

Governmental, Legal & Regulatory Framework for

Safety (GSR Part 1)

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1) Responsibilities and functions of the Government

• Safety policy• Safety framework• Establishment of an independent regulatory body• Emergency preparedness and response• Waste management• Existing exposure situations

Governmental, Legal & Regulatory Framework for

Safety (GSR Part 1)

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2) The global safety regime

• International obligations and cooperation• Sharing of operating experience and regulatory

experience

Governmental, Legal & Regulatory Framework for

Safety (GSR Part 1)

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3) Responsibilities and functions of the regulatory body

• Organization• Staffing and Training• Management system• Authorization• Inspection• Enforcement• Regulations and Guides

Governmental, Legal & Regulatory Framework for

Safety (GSR Part 1)

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International Basic Safety Standards

• GSR Part 3• Radiation Protection and Safety of Radiation

Sources: International Basic Safety Standards• Published 2011

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Comprehensive character of the BSS

• Regulatory control of exposure• Occupational and public

exposure from practices• Safety of sources• Safety of radioactive waste• Medical exposure• Existing exposure situations• Emergency preparedness• Rehabilitation• Basis for safe transport

The essential protection and safety requirements of the BSS underpin all circumstances of exposure to radiation

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Structure of the BSS – GSR Part 3

• Three exposure situations:• Planned exposure situations• Emergency exposure situations• Existing exposure situations

• Three categories of exposure• Occupational• Public• Medical

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Responsibilities in the BSS

• Responsibilities for implementing requirements assigned, as appropriate, to:• Government• Regulatory body or other national authority• Registrants and licensees• Employers• Radiological medical practitioners• Manufacturers and other suppliers• Emergency response organizations

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BSS Section 2:General requirements for protection and safety

• Section 2 contains requirements that are applicable to all three exposures situations (planned, emergency, existing)

• It establishes the three radiation protection principles• Justification • Optimization of protection of safety• Dose limitation• Noting that:

• Justification and optimization apply to all three exposure situations; • Dose limitation only applies to planned exposure situations, excluding medical

exposure

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• Responsibilities of government / regulatory body • As in GSR Part 1

• Responsibilities of other parties • Prime responsibility for safety – registrants & licensees• Principal parties:

• Registrants and licensees, and those responsible for notified practices

• Employers – occupational exposure• Radiological medical practitioners - medical exposure• Designated persons or organizations to deal with emergency

exposure situations or existing exposure situations

BSS Section 2:General requirements for protection and safety

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BSS Section 3: Planned Exposure Situations - Scope

• Practices, including:• use of radiation or radioactive material in industry, medicine, etc.;• mining and processing of raw materials that leads to exposure due to

radioactive materials;• generation of nuclear power and other activities in nuclear fuel cycle.

• Sources within practices, including:• facilities that contain radioactive material and radiation generators, e.g.:

• Medical radiation facilities• Irradiation facilities• Radioactive waste management facilities• Mineral extraction & mineral processing facilities• Nuclear installations

• individual sources of radiation• Occupational, medical and public exposure• Some natural sources above specified levels

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BSS Section 3: Planned Exposure Situations - Generic Requirements

• Requirements include:• Graded approach• Notification & Authorization• Exemption & Clearance• Responsibilities of Registrants & Licensees• Justification• Optimization of protection and safety• Dose limits

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BSS Section 3: Planned Exposure Situations - Occupational exposure

• Requirements include:• Responsibilities of regulatory body• Monitoring and recording of exposures• Responsibilities of employers and licensees• Compliance by workers• Arrangements for a Radiation Protection Programme

• Classification of (work) areas• Local rules and personal protective equipment• Monitoring of the workplace

• Assessment of occupational exposure• Information, instruction and training• Conditions of service• Special arrangements – pregnant women, breast-feeding women,

persons under 18 years of age

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BSS Section 3: Planned Exposure Situations - Public exposure

• Requirements include:

• Responsibilities of Government and the Regulatory Body• Establish and enforce requirements that require protection and safety be

optimized and that public exposure is limited

• Responsibilities of relevant parties specific to public exposure

• Radioactive waste and discharges

• Monitoring and reporting

• Consumer products

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BSS Section 3: Planned Exposure Situations - Medical exposure

• Requirements include:• Responsibilities

• Government• Regulatory body• Licensees

• Justification of medical exposures• Optimization of protection and safety• Pregnant women & breast-feeding women• Unintended & accidental medical exposures• Reviews and records

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BSS Section 4: Emergency Exposure Situations

• Requirements include that Government ensures:

• An emergency management system;

• preparedness and response to an emergency;

• arrangements for controlling the exposure of emergency workers;• arrangements for the transition from an emergency exposure

situation to an existing exposure situation

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BSS Section 5: Existing Exposure Situations

• Scope includes:• Exposure due to contamination by residual radioactive material,

arising from:• Past activities that were never regulated• A nuclear or radiation emergency, after such has been declared ended

• Commodities that incorporate radionuclides arising from residual radioactive material

• Food, water, feed, building materials

• Exposure to natural sources, including:• Radon in dwellings and workplaces• Radionuclides of natural origin in commodities• Exposure of aircrew and space crew to cosmic radiation

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BSS Section 5: Existing Exposure Situations

• Requirements include:• Responsibilities of Government

• Ensure that existing exposure situations that have been identified are evaluated from a radiation protection view point

• Specify general principles underlying protection strategies that can be used• Assign responsibilities to establish & implement protection strategies

• Justification for protective actions & optimization of protection and safety

• Responsibilities for remediation of areas with residual radioactive material

• Public exposure due to radon indoors• Exposure due to radionuclides in commodities• Exposure in workplaces

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Summary

• The combination of:

• the Fundamental Safety Principles, SF-1;• Governmental, Legal & Regulatory Framework for

Safety, GSR Part 1; and• Radiation Protection and Safety of Radiation Sources:

International Basic Safety Standards, GSR Part 3

sets the requirements for establishing a national infrastructure for nuclear and radiation safety.

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Application of the Safety Standards

Notable application by MS:

• Formally adopted• Direct use of Safety Standards• Used as reference for review of national

standards and as benchmark for harmonization

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Current Status of the Safety Standards

Since the establishment of the Safety Standards Series:

• Safety Fundamentals issued in 2006• Safety Requirements established from 1996 to 2010• In total 108 Safety Standards published

Updated “Status of Safety Standards” on the web site:

http://www-ns.iaea.org/standards/status.pdf

• Includes hyperlinks to the published Safety Standards in official languages

• Includes general information and link to the IAEA Safety Glossary

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Legal Status of the IAEA Safety Standards

Safety Standards are:• non binding on Member States but may be adopted by them;

• binding for the IAEA’s own activities;• binding on States in relation to operations assisted by the IAEA or

States wishing to enter into project agreements with the IAEA.

• They are also:

• a condition for TC cooperation;• used in the assessment of compliance with Safety Standards for

project approval and source procurement.

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Draft Model Regulations

MODEL REGULATIONS FOR THE USE OF RADIATION SOURCES AND FOR THE MANAGEMENT OF THE ASSOCIATED RADIOACTIVE WASTE:

• Provides States with advice on appropriate regulations covering all aspects of the use of radiation sources and the safe management of the associated radioactive waste.

• Allows States to appraise the adequacy of their existing regulations and regulatory guidance documents.

• Covers the range of circumstances related to most facilities and activities using radiation sources;

• Provides guidance on matters to be addressed in national policy, strategy and regulations.

• Includes examples of texts as reference to assist national authorities, regulatory bodies, technical and legal experts in the development or review of regulations for radiation safety.

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Draft Model Regulations

MODEL REGULATIONS FOR THE USE OF RADIATION SOURCES AND FOR THE MANAGEMENT OF THE ASSOCIATED RADIOACTIVE WASTE:

• Supplements Safety Guide GS-G-1.5 in providing practical advice to States on the development of regulations for the safe use and control of radiation sources in medicine, industry, research, agriculture and education.

• Provides States with model provisions for regulations for the control of radiation sources and safe management of radioactive waste.

• Compatible with, and supplements, the ‘Handbook of Nuclear Law, Implementing Legislation’.

• You are encouraged to use these model regulations extensively during the School.

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…Thank you for your attention