1. Regulatory Body
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Day 8 – Lecture 3

2. Objectives
To understand the essential functions and responsibilities of the Regulatory Body.
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3. Contents responsibilities; interaction and cooperation; independence;
functions;
regulatory Program;
technical services and expert assistance.
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4. Regulatory Body The legislation should specify:
the establishment and funding of an effectively independent Regulatory Body for the control of radiation safety;
the Regulatory Body ’s responsibilities and functions;
provisions for authority, power, high level of technical competence and human and financial resources.
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5. Division of responsibilities
A single Regulatory Body responsible for all aspects of radiation safety is most desirable.
However, regulatory functions and responsibilities sometimes are divided among several government authorities, e.g:
Transport;
Environment;
Public health and safety;
Occupational safety.
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6. Division of responsibilities (cont)
Where responsibilities are divided, legislation should establish clear lines of authority and responsibility so that:
gaps in protection and safety are prevented;
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.

7. Division of responsibilities (cont)
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.
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8. Interaction with other national bodies
The Regulatory Body must co-operate with other relevant authorities, advise and provide them with information on safety matters.
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9. Regulatory Body Regulatory Body Consumer Protection Agency
Customs Authority
Defence Forces
Regulatory
Body
Educational Authorities
Emergency Coordination Authority
Environmental Protection Authority
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Fire Services
Food / Agriculture Authority
Health Ministry
Local Government Authorities

10. Regulatory Body Regulatory Body Mining / Minerals regulation
National Standards Authority
Oil / Gas - exploration & regulation
Regulatory
Body
Police Services
Power generation
Professional & Registration Bodies
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Sewerage Authority
Transport Regulation
Water Supply Authority

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15. Cooperation on international level
The Regulatory Body also should have arrangements on an international level.
Bilateral agreements
Multilateral agreements
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16. Independence of the Regulatory Body
Is established by Government through legislation.
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.
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17. 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.)
Avoidance of engagement in activities with regulated operators which could endanger the Authority’s independence. For example:
consultant services;
any financial agreements or support.
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18. from those subject to Regulation:
Independence of the Regulatory Body (cont)
from those subject to Regulation:
Licensees
Health services
Regulatory
Body
Manufacturers
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Laboratory services
Training services
Waste facilities
Others

19. Independence of the Regulatory Body (cont)
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.
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20. Empowering the Regulatory Body
The Regulatory Body shall be empowered to:
develop safety principles and criteria;
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;
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21. Empowering the Regulatory Body (cont)
The Regulatory Body shall be empowered to:
enter a site or facility at any time to carry out inspections;
inspect relevant facilities and documents;
enforce the regulatory requirements;
communicate directly with government authorities;
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22. Empowering the Regulatory Body (cont)
The Regulatory Body shall be empowered to:
obtain necessary documents from other organizations;
independently communicate to the public its regulatory requirements, decisions and opinions, and their basis.
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23. Empowering the Regulatory Body (cont)
The Regulatory Body shall be empowered to:
inform other government bodies, national and international organizations, and the public, on incidents, accidents and other safety related abnormal occurrences;
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.
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24. The Regulatory Program shall include:
preparing regulations for radiation protection and safety;
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.
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25. Internal Procedures The Regulatory Body shall establish procedures:
for receiving and assessing notifications and applications for registration or licence;
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;
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26. 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;
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;
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27. 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;
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.
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28. Technical Services Technical services include: dosimetry services
laboratory services
calibration services
waste management
medical services
training services
expert assistance

29. Technical Services (cont)
Essential technical services (for both radiation users and the Regulatory Body) should be available within the State.
External technical services may be used but require Regulatory Body approval.
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30. Expert Assistance Consultants
Consultants should be effectively independent of the operator.
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.
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31. Expert Assistance (cont)
Advisory Bodies
Advisory bodies may be formally appointed by Government or the Regulatory Body.
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.
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Advisory bodies to the Regulatory Body should have an adequate number of member so that a range of views can be presented. Nominations for membership should be called from relevant professional bodies.

32. Regulatory Body Personnel and Training
In order to properly fulfil its statutory obligations the Regulatory Body requires an appropriate number of personnel:
who are appropriately qualified; and
who have received appropriate training.
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33. References
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).
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34. Exercise
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)?
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Example of measures to ensure independence:
Responsibilities and functions of separate departments/sections within the Regulatory Body are clearly defined in legislation and/or in internal guidance.
Funding for regulatory operations is provided through the State budget, and it is not depending on fees for technical services.
Same persons are not involved both in regulatory activities and in service functions.
Advice of independent consultants is used.
Independence of regulatory processes is periodically reviewed by assessors from other organizations and by internal audits.