1. Establishing the Infrastructure for Radiation Safety Preparatory Actions and Initial Regulatory Activities

2. The Government is responsible for developing the national regulatory infrastructure for radiation safety
The Government should:
Design an integrated roadmap that fits the national circumstances to develop national regulatory infrastructure in line with IAEA safety standards

3. Considerations by the Government in developing notational regulatory infrastructure for radiation safety
national circumstances,
legal system in the State,
governmental structure,
availability of human, technical and financial resources

4. Areas for National Regulatory Infrastructure for the Control of Radiation Sources
Legal framework for safety
laws or acts for radiation safety
To provide for the legal frame to regulate the use of radiation sources in the country
Regulatory framework for safety
regulatory body and regulatory system
Established by the Law to ensure the implementation of the provisions of the Law

5. Legal and Regulatory Infrastructure
Radiation Safety Law
to provide for the legal frame to regulate the use of radiation sources in the country
Establishing
Provided with
Resources,
Funds, Staff
Independent Regulatory Body
established by the Law to ensure the implementation of the provisions of the Law
Empowered
Licensing
Inspection
Enforcement
Regulations

6. Steps for enacting the Radiation Safety Law:
Designate a body to draft the law
Committee encompassing legal, political and technical experts in radiation safety
Draft the law
IAEA standards, international obligations, inputs from interested parties
Review of the draft by IAEA to ensure its compliance with IAEA safety standards
Finalise the draft law
Approval of the law

7. Radiation Safety Law cont.
The legislative framework for safety should cover, inter alia, the following:
The safety principles for protecting people, society and the environment from radiation risks, both at present and in the future;
Provisions for assigning the prime responsibility for safety to the persons or organizations responsible for the facilities and activities,
The types of facilities and activities in its scope
The establishment of an independent regulatory body;
Provisions for the authorization of facilities and activities;

8. Radiation Safety Law cont.
Provisions for the inspection of facilities and activities;
Provisions for enforcement and for the specifications of offences and the corresponding penalties;
The authority and responsibility of the regulatory body for promulgating (or preparing for the enactment of) regulations and preparing guidance for their implementation;
Provision for appeals against decisions of the regulatory body;
Provisions for communication and consultation of the regulatory body with interested parties and the public

9. Radiation Safety Law cont.
The designated body for drafting the Law should ensure that: The draft legislation provides for functional separation of the regulatory body from governmental departments or agencies and other organizations that are charged with the promotion of radiation applications or are responsible for facilities or activities

10. How long it will take for the Country to approve the Law and establish the regulatory body?
Establishment of the legislative framework and regulatory framework for safety will take time depending on the country system in drafting, reviewing and approving and implementing Laws.
Meanwhile :
Government should, as far as practicable,
Take actions to protect public, workers, patients and the environment from harmful effects of ionizing radiation using the existing legislative and governmental framework
INITIAL REGULATORY ACTIVITIES WITHIN THE EXISTING LEGISLATIVE FRAMEWORK

11. Initial Regulatory Activities within the existing legal framework
The Government: explore and implement possible activities for controlling radiation sources within the existing legal framework
Some of the actions relating to establishing the national radiation safety infrastructure could be taken by the government within the existing legislative and governmental framework
Several governmental agencies as defined in their existing legislative framework are authorised to perform some initial regulatory activities for example :
Customs authorities may have responsibility for controlling the import and export of radiation sources
Ministry of Health may have responsibility for performing some initial regulatory activities relating to the use of ionizing radiation in the medical field

12. Initial Regulatory Activities within the existing legal framework Cont.
should be conducted in parallel with the process of establishing the legislative framework for safety
should not lead to:
Unnecessary delays in developing the legislative framework or
Fragmentation of regulatory control among different bodies

13. Who will implement these actions? Government should appoint:
Initial Regulatory Activities within the existing legal framework Cont.
Who will implement these actions?
Government should appoint:
Steering Group (SG)
existing organization or
newly established organization or
Committee from representatives of the main interested parties in the State
SG should:
Collate information on the relevant national legal and administrative instruments

14. Actions to be taken within the existing legal framework
Collection of the necessary information on the radiation sources and their users in the State
Actions to be taken within the existing legal framework
To register import and export of radiation sources and make this information available to other relevant authorities
Establish requirements for radiation safety within the existing legal framework
Maintain cooperative relationships with the users of ionizing radiation and should promote awareness of measures to enhance safety

15. steering group should:
Action 1
Collection of the necessary information on the radiation sources and their users in the State
steering group should:
Conduct survey of radiation sources and facilities in the country
identify possible means for obtaining relevant information about the inventory of radiation sources within the area of competence of each relevant authority
An important mean is to make arrangements with other authorities and organizations for regular provision of such information. Example: customs authorities to provide information on the import and export of radiation sources regularly

16. Other sources of information could be
Action 1 Cont.
Collection of the necessary information on the radiation sources and their users in the State
Other sources of information could be
Distribution of questionnaires
media announcements
To perform site visits to facilities where radiation sources are likely to be used in:
medical facilities,
industrial complexes, construction sites,
oil industry facilities, research centres and
universities.
Notifications by the suppliers and users of radiation sources:
on a voluntary basis,
when requested or
in response to instructions by the government within the existing legislative framework.
Facilitated by
IMPORTANT
The collected information on radiation sources and their users should be properly managed, kept up-to-date and ultimately transferred to the regulatory body, once it has been established by Law

17. Action 2
To register import and export of radiation sources and make this information available to other relevant authorities
Examples: Customs, Port Authorities,….
usually have records of the import and export of all goods including records on the import and export of radiation sources
Import and export data should be made available to the relevant authorities (For Action 1 )
Formal arrangements should be in place to facilitate such exchange of information such as:
official correspondence or
memorandum of understanding

18. Examples of possible mandates
Action 3
Establish requirements for radiation safety within the existing legal framework
Certain authorities may have a mandate within the existing legislative framework to establish and enforce requirements relating to radiation safety in their areas of competence
Examples of possible mandates
Health Authorities
in establishing radiation safety requirements in the medical field and to inspect medical facilities
Labour Authorities
in establishing radiation safety requirements relating to occupational exposure
Environment Authorities
in establishing requirements relating to discharges and other areas of environmental protection
Transport Authorities
in establishing requirements for the safe transport of radioactive material
Agencies that have the power to inspect facilities and activities
for reasons other than radiation safety may be able to include radiation safety within the scope of their inspection

19. Action 3 Cont.
Establish requirements for radiation safety within the existing legal framework
The relevant authorities should:
develop the necessary competence for the establishment and enforcement of radiation safety requirements
ensure that the requirements are in compliance with the IAEA safety standards and international arrangements or regulations as applicable
Important
Consideration should be given to ensuring the smooth transfer of responsibility for enforcing such safety requirements to the regulatory body when it is established and integrated into the radiation safety regulations that will be established

20. The relevant authorities should
Action 4
Maintain cooperative relationships with the users of ionizing radiation and should promote awareness of measures to enhance safety
Promote awareness of safety within the existing legislative framework Through:
seminars
conferences
training courses
media
Internet
The relevant authorities should
promoting the exchange of information and experience
providing advice
promoting safety culture
encouraging the implementation of safety measures
strengthening staff training and qualifications
Establish with the users (or potential users) of ionizing radiation and other interested parties formal or informal arrangement for:

21. REGULATORY FRAMEWORK FOR SAFETY
The establishment of legislative framework for safety marks a significant milestone on the roadmap to the national radiation safety infrastructure.
Once the legislative framework for safety is in place, regulatory responsibilities shall be clearly assigned to the newly established regulatory body.

22. Cease those initial regulatory activities
REGULATORY FRAMEWORK FOR SAFETY Cont.
Once the legislative framework for safety is in place and the regulatory body has been established, the government should:
Cease those initial regulatory activities
Ensure that the associated responsibilities are transferred to the regulatory body.
Ensure that all relevant information and records relating to the initial regulatory activities are made available to the regulatory body.

23. Regulatory Framework for Safety(Cont.)
set out requirements for the regulation of facilities and activities
set out development of the other areas of the national radiation safety infrastructure
The newly established regulatory body should
apply a graded approach to gradually building the regulatory system
prioritize its activities needed

24. Regulatory Framework for Safety (Cont.)
Issues to be considered by newly established regulatory body:
Implementation of Core Regulatory Functions
Notification
Authorization
Inspection
Enforcement
Development of regulations and guides
Its Organizational Structure and Competence
Establishment of Safety Related Records
Means of Communication and Consultation

25. IAEA Assistance Sensitisation events Advise the national authorities
Review the draft law
Train the Steering Group members
Provide some equipment
Send experts
Assist to participate in regional events for experience exchange