1. IAEA Safety Publications Related to Regulatory Infrastructure Safety Fundamentals SF 1 Safety Requirements GSR Part 1, GSR Part 3 School of Drafting Regulations, Vienna, November / December Stephen Evans

2. 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

3. IAEA Safety Standards Categories
Safety Fundamentals
Safety Requirements
Safety Guides

4. 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

5. 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

6. 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.

7. Commission & Committees
on Safety Standards
(CSS)
Nuclear Safety Standards
Committee
(NUSSC)
Radiation Safety Standards
(RASSC)
Waste Safety Standards
(WASSC)
Transport Safety Standards
(TRANSSC)

8. Commission & Committees
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.
Consensus at the highest level
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. The Commission has a special overview role in the preparation and review of the IAEA safety standards.
Consensus on what constitutes a high level of safety is reached at the highest level: IAEA safety standards are developed in close consultation with Member States (through their representatives in the Commission and Committees and the 120 day comment period) and with representatives of relevant international organizations.
Approval by the Board of Governors is required for Safety Fundamentals and Safety Requirements. The authority to issue Safety Guides has been delegated to the IAEA Director General.

9. 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.”

10. 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.”

11. Fundamental Safety Principles
Principle 6: Limits on risks to individuals
“Measures for controlling radiation risks must ensure that no individual bears an
unacceptable risk of harm.”
Principle 7: Protection of present and future generations
and the environment
Principle 8: Prevention of accidents
Principle 9: Emergency preparedness and response
Principle 10: Protective actions to reduce existing or unregulated radiation risks

12. Governmental, Legal & Regulatory Framework for Safety (GSR Part 1)
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

13. Governmental, Legal & Regulatory Framework for
Safety (GSR Part 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

14. Governmental, Legal & Regulatory Framework for
Safety (GSR Part 1)
The global safety regime
International obligations and cooperation
Sharing of operating experience and regulatory experience

15. Governmental, Legal & Regulatory Framework for
Safety (GSR Part 1)
Responsibilities and functions of the regulatory body
Organization
Staffing and Training
Management system
Authorization
Inspection
Enforcement
Regulations and Guides

16. International Basic Safety Standards
GSR Part 3
Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards
Published 2011

17. 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
Many countries have stressed the need to retain the comprehensive character of the BSS. The essential protection and safety requirements, including requirements for regulatory control of sources, justification, optimization, responsibilities of the various parties, numerical values of dose limits, exemption levels, etc, underpin all circumstances of exposure to radiation.
This does not mean that a revised BSS will absorb other existing Safety Requirements, such as GS-R-1 and GS-R-2, but that appropriate essential requirements will be included in the revised BSS for completeness, with cross-linkages to the detailed requirements in other documents.

18. 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

19. 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

20. 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

21. BSS Section 2: General requirements for protection and safety
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

22. 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

23. 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

24. 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

25. 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

26. 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

27. 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

28. 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

29. 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

30. 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.

31. 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

32. 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:
Includes hyperlinks to the published Safety Standards in official languages
Includes general information and link to the IAEA Safety Glossary

33. 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.

34. 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.

35. 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.

36. …Thank you for your attention
IAEA Headquarters in Vienna, Austria.
The IAEA was established in 1957.