IAEA International Atomic Energy Agency Regulatory Body Day 8 – Lecture 3.

IAEAInternational Atomic Energy Agency

Regulatory Body

Day 8 – Lecture 3

IAEA 2

To understand the essential functions and responsibilities of the Regulatory Body.

Objectives

IAEA 3

• responsibilities;• interaction and cooperation;• independence;• functions;• regulatory Program;• technical services and expert assistance.

Contents

IAEA 4

• the Regulatory Body ’s responsibilities and functions;

• provisions for authority, power, high level of technical competence and human and financial resources.

Regulatory Body

The legislation should specify:

• the establishment and funding of an effectively independent Regulatory Body for the control of radiation safety;

IAEA 5

However, regulatory functions and responsibilities sometimes are divided among several government authorities, e.g:

Division of responsibilities

A single Regulatory Body responsible for all aspects of radiation safety is most desirable.

• Transport;• Environment;• Public health and safety;• Occupational safety.

IAEA 6

• overlapping of authority is minimized;

• conflicting requirements from separate authorities are prevented;

• the users of sources understand which of their activities are subject to various authorities.

Division of responsibilities (cont)

• gaps in protection and safety are prevented;

Where responsibilities are divided, legislation should establish clear lines of authority and responsibility so that:

IAEA 7

Relevant Regulatory Bodies should establish a system of liaison and working procedures to ensure coordination and cooperation including, where appropriate, the development of Memoranda of Understanding (MoU) between government agencies.

Division of responsibilities (cont)

IAEA 8

The Regulatory Body must co-operate with other relevant authorities, advise and provide them with information on safety matters.

Interaction with other national bodies

IAEA 9

Consumer Protection Agency

RegulatoryBody

Defence Forces

Educational Authorities

Emergency Coordination Authority

Environmental Protection Authority

Fire Services

Customs Authority

Food / Agriculture Authority

Health Ministry

Local Government Authorities

Regulatory Body

IAEA 10

Mining / Minerals regulation

RegulatoryBody

Oil / Gas - exploration & regulation

Police Services

Power generation

Professional & Registration Bodies

Sewerage Authority

National Standards Authority

Transport Regulation

Water Supply Authority

Regulatory Body

IAEA 11

Agency / Regulator Suggested Purpose(s)

Consumer Protection

Regulation of radiation in consumer products

Customs Control over the import and export of radiation sources

Defence Forces To ensure compliance with the legislation where this is practicable; visits by foreign nuclear powered vessels

Education Standards and accreditation of training courses for radiation users

Emergency Coordination

Radiation monitoring and advice during radiation emergencies. See also Fire Services

IAEA 12


Environment To align procedures for the disposal of radioactive waste, either by incineration or other dilution and dispersal measures, burial, long term storage; disposal of radioactive consumer products, etc.; clearance of low activity bulk materials (see also Mining)

Fire Services Fires at premises where radiation sources are stored, manufactured or used.

Food / Agriculture Radioactivity in foodstuffs; fertilizer production (radium); food irradiation

Health Public health issues (see also food, water, sewerage, fire); screening programs (mammography, TB, etc)

IAEA 13


Local Government

Alignment of building approvals; standards of facility construction

Mining and minerals

Mining and processing of radioactive minerals; the use of radiation sources on mine sites; the clearance of regulated materials (e.g. the use of tailings); possibly geophysical advice for reactor construction

National Standards

To ensure that national standards dealing with any aspect of ionizing radiation conform to the Regulatory Body’s requirements. e.g. the adoption of standards of the International Electrotechnical Commission, International Standards Organization, traceability of radiation measurements, etc.

IAEA 14


Oil and Gas Production NORM and TENORM regulation; use of radiation sources on oil and gas platforms

Police Dealing with emergencies; assistance with prosecutions

Power Generation Fly ash disposal from coal burning power stations; nuclear power generation

Professional Registration Boards

Qualifications and competence of the professions e.g. medicine, dentistry, etc.

Sewerage Disposal of low level radioactive wastes

Transport Transport of radioactive Sources

Water Supply Drinking water standards (radium, etc)

IAEA 15

The Regulatory Body also should have arrangements on an international level.

Cooperation on international level

• Bilateral agreements

• Multilateral agreements

IAEA 16

• Is established by Government through legislation.

Independence of the Regulatory Body

• Is effectively independent in its decision making

• The Regulatory Body’s shall have sufficient authority, staffing and financial resources.

• There is clear functional separation of the Regulatory Body’s functions from those of other government agencies or other organizations having responsibility for development and promotion of regulated practices.

IAEA 17

• Avoidance of engagement in activities with regulated operators which could endanger the Authority’s independence. For example:

consultant services;

any financial agreements or support.

Independence of the Regulatory Body (cont)

• There needs to be clear separation of the Regulatory Body from practices and others subject to regulation (i.e. from licensees, manufacturers, etc.)

IAEA 18

from those subject to Regulation:

Licensees

RegulatoryBody

Manufacturers

Laboratory services

Training services

Waste facilities

Others

Health services


IAEA 19

If the Regulatory Body has functions such as:

• testing and quality control measurements;

• initiating safety related research and development;

• providing personnel monitoring services,


care must be taken to ensure that all conflicts with the main regulatory functions are avoided and that the prime responsibility of the radiation user for safety is not diminished.

IAEA 20

• establish regulations and issue guidance documents and advice;

• require operators to conduct safety assessments;

• require necessary information from the operator;

• issue, amend, suspend or revoke authorizations;

Empowering the Regulatory Body

• develop safety principles and criteria;

The Regulatory Body shall be empowered to:

IAEA 21

• enter a site or facility at any time to carry out inspections;


Empowering the Regulatory Body (cont)

• inspect relevant facilities and documents;

• enforce the regulatory requirements;

• communicate directly with government authorities;

IAEA 22

• obtain necessary documents from other organizations;


• independently communicate to the public its regulatory requirements, decisions and opinions, and their basis.


IAEA 23

• liase and coordinate with other government or non-government authorities having competence in health and safety, environmental protection, security and transport;

• liase with Regulatory Bodies of other countries and with international organizations to promote cooperation.


• inform other government bodies, national and international organizations, and the public, on incidents, accidents and other safety related abnormal occurrences;


IAEA 24

• implementing procedures for notification, authorization, review and assessment, inspection and enforcement;

• providing for exemptions;

• performing inspections and other compliance monitoring;

• taking enforcement actions in the event of violations of requirements;

• investigating accidents and managing emergencies;

• disseminating information on protection and safety;

• establishing, implementing and assessing and improving a management system.

The Regulatory Program shall include:

• preparing regulations for radiation protection and safety;

IAEA 25

• for creating or modifying conditions of an authorization or of a class of authorizations;

• for providing guidance to the radiation users;

• for review and assess relevant information for safety;

• to ensure that appropriate explanations are provided to applicants for the rejection of authorizations;

Internal Procedures

The Regulatory Body shall establish procedures:

• for receiving and assessing notifications and applications for registration or licence;

IAEA 26

• to ensure that user experience (incidents, accidents, etc.) is appropriately analysed and that any lessons to be learned are disseminated;

• to ensure that records relating to the safety of facilities and radiation practices are retained and retrievable;

Internal Procedures (cont)

The Regulatory Body shall establish procedures:

• to prepare, conduct and follow up inspections;

• to enforce regulatory requirements;

• for communication with, and the provision of, information to other governmental bodies, international organizations and the public;

IAEA 27

• establish, and inform the operator of, any requirements for regular safety reassessments or periodic reviews;

• ensure government is kept informed of important radiation safety issues;

• verify the qualifications, training and experience of personnel responsible for the safe operation of the facility or practice.

Internal Procedures (cont)

The Regulatory Body shall establish procedures to:

• ensure that its regulatory criteria are adequate and valid, and that international standards are taken into account;

IAEA 28

• dosimetry services• laboratory services• calibration services• waste management• medical services• training services• expert assistance

Technical Services

Technical services include:

IAEA 29

Essential technical services (for both radiation users and the Regulatory Body) should be available within the State.

Technical Services (cont)

External technical services may be used but require Regulatory Body approval.

IAEA 30

• The use of consultants shall not relieve the Regulatory Body of any of its responsibilities.

• The Regulatory Body’s responsibility for making decisions and recommendations shall not be delegated.

Expert Assistance

• Consultants should be effectively independent of the operator.

Consultants

IAEA 31

• Advisory bodies are established either on a temporary or permanent basis to give independent expert opinion or advice (e.g. on technical or ethical issues).

• Advice offered shall not relieve the Regulatory Body’s responsibility for making decisions.

• Advisory bodies may be formally appointed by Government or the Regulatory Body.

Expert Assistance (cont)

Advisory Bodies

IAEA 32

• who are appropriately qualified; and

• who have received appropriate training.

Regulatory Body Personnel and Training

In order to properly fulfil its statutory obligations the Regulatory Body requires an appropriate number of personnel:

IAEA 33

• Governmental, Legal and Regulatory Framework for Safety. General Safety Requirements Part 1 (IAEA Safety Standard Series No. GSR Part 1). Vienna 2010.

• Handbook on Nuclear Law: Volume 1 & 2 (2010).

References

IAEA 34

A Regulatory Body is established by legislation to control radiation safety. As there are no such services available in the country, the Regulatory Body is also running a national dosimetry service and a national waste repository.

What administrative and other measures should be considered to ensure the effective independence of regulatory actions (e.g. decisions, inspections, enforcement)?

Exercise

IAEA International Atomic Energy Agency Regulatory Body Day 8 – Lecture 3.

Documents

Transcript of IAEA International Atomic Energy Agency Regulatory Body Day 8 – Lecture 3.