overview of regulatory framework - nucleus documents/radiation... · overview of regulatory...

International Atomic Energy Agency

Overview of Regulatory

Framework

Ronald Pacheco Jimenez

UNIT HEAD

Control of Radiation Sources Regulatory Infrastructure and Transport Safety Section

Division of Radiation and Waste Safety

Department of Nuclear Safety and Security

INTERNATIONAL ATOMIC ENERGY AGENCY


Content

• Background

• Gap analysis

• Conclusion


IAEA Statutory Safety functions

IAEA Statutory Functions in Radiation & Waste Safety

(Article III.A.6)

To facilitate and

service international

conventions and

other undertakings

To provide for

the application of

the standards

To establish

standards of

safety


IAEA Statutory Safety functions

IAEA Statutory Functions in Radiation & Waste Safety

(Article III.A.6)

To facilitate and

service international

conventions and

other undertakings

To provide for

the application of

the standards

To establish

standards of

safety

Providing

TECHNICAL

COOPERATION

Rendering

RADIATION

SAFETY

SERVICES

Knowledge

Management &

Networking

Promoting

EDUCATION

& TRAINING

Fostering

INFORMATION

EXCHANGE


IAEA’S RADIATION SAFETY STANDARDS

• IAEA Safety Standards are not legally binding on Member States but may be adopted by them, at their own discretion

• IAEA Safety Standards are binding on IAEA in relation to its

own operations and to operations assisted by the IAEA; and

• Member States receiving IAEA assistance are obliged to

apply IAEA Safety Standards

International Atomic Energy Agency 8

• Board of Governors and GC have specifically requested

that TC projects involving radiation sources should only be

submitted for approval if the country has achieved a certain

minimum level of radiation safety.

• Board of Governors and GC have also requested that no

procurement of sources should be cleared if the country has

not achieved a certain minimum level of radiation safety

accordingly with the IAEA safety standards.

IAEA’S RADIATION SAFETY STANDARDS


What to check Radiation Safety ?

Complying with the (Board resolutions)

Radiation safety for the workers,

Patients and Public .

Regulatory Control in Place.


Nuclear Applications

10

Sources of ionizing radiation are widely used in:

Medicine

Agriculture

Industry

Research and Education

Security checks

Non-Medical Human Imaging

http://www.medical.philips.com/main/products/xray/products/fluoroscopy/index.html

http://de.wikipedia.org/wiki/Bild:PET-MIPS-anim.gif


Regulatory Infrastructure for Radiation Safety

Thematic Safety Area 1 (TSA 1)

Division of Radiation, Transport and Waste Safety


12

TSA 1: Regulatory Infrastructure


To support the regulatory infrastructure for the safety

and control of radiation sources in Member States.

To establish and develop adequate and effective

regulatory mechanisms for the control of radiation

sources in new Member States.

To harmonize and streamline national capabilities for

regulatory control in compliance with the

requirements of the Safety Standards and the

provisions of the Code of Conduct

The main objectives of TSA 1 are:


Legislative framework:

Legislation

Regulations and Guidance,

Regulatory Body Establishment and

independence.

Regulatory Body Staffing and Training.

Regulatory Body Funding.

Coordination and Cooperation and the

National Level.

International Cooperation.

8. Notification and National

Register of Radiation Sources

9. Authorization

10. Safety and Security of R.S

11. Inspection

12. Enforcement

13. Information management

14. Quality Management

Regulatory Infrastructure (TSA 1)

The regulatory control shall be commensurate with the radiation risks

associated with facilities and activities, in accordance with a graded approach.

To cover these topics 14 infrastructure elements constitute TSA 1:

Regulatory Body activities:


Safety Documents related with TSA 1


Safety Guide GS-G-1.5

Principal functions and activities of the Regulatory body

Organization and staffing of the Regulatory Body

Development of Regulations and Guides, Notification and Authorization, Inspection, Enforcement, Dissemination of Information, Quality Management

Additional Guidance in TECDOC 1525 and 1526, DS455

Regulatory Control of Radiation Sources


GSR Part 1 (rev 1)


GSR Part I Rev1 – Objective

• Establish requirements in the respect

of the governmental, legal and

regulatory framework for safety

The framework for safety is to be

established for entire range of facilities

and activities

the safety requirements should account

for circumstances pertaining to the State

and radiation risks


GSR Part I – Scope

• Establishes the essential aspects of the

governmental and legal framework for:

establishing a regulatory body;

taking actions necessary to ensure the

effective regulatory control of all facilities

and activities .


GSR Part I – Scope (cont’d)

• Other responsibilities and functions :

liaison within global safety regime

liaison for providing the necessary services

for the purposes of safety

emergency preparedness and response

nuclear security

system of accounting for and control of

nuclear material


GSR Part I rev.1– Contents

36 requirements are described in four

chapters

Introduction: background, objective, scope,

structure

Responsibilities and functions of the

Government

The global safety regime

Responsibilities and functions of the

Regulatory body


GSR Part 3


Basic Safety Standards GSR Part 3

Three Exposure Situations

• Planned exposure situation

• Existing exposure situation

• Emergency exposure situation

Three Categories of Exposure

• Occupational exposure

• Medical exposure

• Public exposure


Basic Safety Standards GSR Part 3

52 overarching requirements

• SECTION 2. GENERAL REQUIREMENTS FOR PROTECTION AND SAFETY

• SECTION 3. PLANNED EXPOSURE SITUATIONS

GENERIC REQUIREMENTS OCCUPATIONAL EXPOSURE

PUBLIC EXPOSURE

MEDICAL EXPOSURE

• SECTION 4. EMERGENCY EXPOSURE SITUATIONS

• SECTION 5: EXISTING EXPOSURE SITUATIONS

Schedules

• Schedule I:- Exemption and clearance

• Schedule II – Categories for sealed sources

• Schedule III – Dose Limits

• Schedule IV – dose considerations for emergency preparedness


Other International Instruments Code of Conduct on the Safety and Security of Radioactive

Sources

• Published in 2004

• Directed to National Governments and Regulatory Bodies

• Recommendations for the regulatory control of radioactive sources

• Associated Guidance for the import/export of radioactive sources

• National register of sources

• Source categorization

• National strategy for disused sources

• Orphan sources…

• Member States encouraged to formally commit to the Code and its Guidance through a letter to the IAEA DG


Content

• Background

• Gap analysis

• Conclusion


RASIMS

Radiation safety is structured in Thematic Safety Areas (TSA):

• TSA 1: Regulatory Infrastructure for Radiation Safety

• TSA 2: Occupational Radiation Protection

• TSA 3: Medical Exposure Control

• TSA 4: Public & Environmental Exposure Control

• TSA 5: Emergency Preparedness and Response

• TSA 6: Education and Training

• TSA 7: Transport Safety

• Each TSA has a standard set of “essential elements”

used to identify country situation, identify assistance

needs and monitor progress.

• Information is managed in RASIM 27


High progress

Medium progress

Low progress

PI Criteria

3 High Progress

2 Medium Progress

1 Low Progress but actions are under way to make

improvements.

0 Low progress and No action to improve

Generic scheme of Performance Indicators

Quantitative Assessment


TSA1 Regulatory Infrastructure

Level of achievement is allocated a performance indicator between: 0 (no progress) and 3 (good progress)


40 % Low progress 56 % Medium progress 4 % High progress


• To assist Member States to establish or

improve their regulatory framework for

radiation safety:

1. Advisory Missions

2. Training Material for Regulators

3. Self Assessment Tool (SARIS)

4. Integrated Regulatory Review Service (IRRS)

5. Regulatory Authority Information System RAIS


Conclusions

IAEA’s mandate includes assisting Member States

to apply IAEA radiation safety standards, hence

improving the protection of public

Significant improvement have been made to

strengthen radiation safety globally

More efforts are needed to improve the regulatory

infrastructure for the control of radiation sources


Thank You for Your Attention