1. IAEA - Department of Nuclear Safety & Security
School on Drafting Regulations Module Key components of regulatory framework
IAEA - Department of Nuclear Safety & Security
Division of Nuclear Installation Safety | Regulatory Activities Section

2. Regulatory Body: Responsibilities and Functions Regulatory approach
Content
Regulatory Body: Responsibilities and Functions
Regulatory approach
Regulations and guides
Conclusions
1.5 Regulaory Framework

3. Regulatory Body: Responsibilities and Functions Regulatory approach
Content
Regulatory Body: Responsibilities and Functions
Regulatory approach
Regulations and guides
Conclusions
1.5 Regulaory Framework

4. 1. Regulatory Body: Responsibilities and Functions
16, 18, 19: Organization of the regulatory body [RB]; allocation of resources; Staffing and competence; management system
RB shall, in a graded manner: structure its organisations and manage its resources, and employ a sufficient number of qualified and competent staff
Management system should be used
17: Effective independence, RB shall discharge its responsibilities in such a way as to preserve its effective independence
Separation from promoter bodies which promote or have responsibilities for facilities and activities, Conflict of interest, Recruitment of staff from authorised parties properly consider, Regulation irrespective of the possible costs to the licensees
35: The regulatory body shall make provision for establishing, maintaining and retrieving adequate records relating to safety
Registers of sealed radiation sources, Records of occupational doses, Records relating to the safety of facilities and activities, events, Inventories of radioactive waste and of spent fuel…
Management system should be used established, implemented, assessed and improved (to properly discharge RB’s responsibilities, improve RB’s performance, foster and support safety culture)
1.5 Regulaory Framework

5. 1. Regulatory Body: Responsibilities and Functions
20: RB shall obtain external support as necessary without relieving it of its responsibilities
May decide to formalise the process to get expert opinion and advice
Conflict of interest to be addressed for organisations providing advices or services
Does not relieve the RB of its responsibilities: need to have adequate core competence to make informed decision and means to assess advice
21: Liaison between the regulatory body and authorized parties
Mechanisms to communicate with licensee conducting a professional and constructive liaison
22: Stability and consistency of regulatory control
Regulatory control shall be stable and consistent
1.5 Regulaory Framework

6. 1. Regulatory Body: Responsibilities and Functions
23: Authorization of facilities and activities by the regulatory body
Requirement 24: Demonstration of safety for the authorization of facilities and activities
Authorization to be prerequisite for facilities and activities (if not exempted or approved by notification)
Different steps in the lifetime of facilities and activities
25 and 26: Review and assessment of information relative to safety according to the graded approach
Review and assessment performed according to the stage in the regulatory process
Depth and scope to be commensurate with the risks
Regulatory body
1.5 Regulaory Framework

7. 1. Regulatory Body: Responsibilities and Functions
27, 28 and 29: Inspection of facilities and activities; Types of inspection of facilities and activities; Graded approach to inspections of facilities and activities
Inspection cannot diminish the prime responsibility for safety of the licensee
Free access to any facility or activity at any time
Programme of inspection should be developed and implemented (type of inspection, frequency, covers all areas of RB…
1.5 Regulaory Framework

8. 1. Regulatory Body: Responsibilities and Functions
30: Establishment of enforcement policy for responding to non-compliance by licensee
Commensurate with the significance for safety
Includes: verbal and written notification, new regulatory requirements and conditions, penalties, revocation of authorisation
31: Requiring of corrective action by authorized parties
Licensee is accountable for remedying non-compliances, for investigating thoroughly and for taking all appropriate, including preventive, measures
RB shall establish criteria for corrective actions and oversight the actual implementation of these actions
1.5 Regulaory Framework

9. 1. Regulatory Body: Responsibilities and Functions
36: Communication and consultation with interested parties
RB shall promote the establishment of appropriate means of informing and consulting interested parties
Regulatory judgements and decisions, and the bases for them
Incidents in facilities and activities
Radiation risks
Requirements for protecting people and environment
Consultation of local people in a transparent and open manner
1.5 Regulaory Framework

10. 1. Regulatory Body: Responsibilities and Functions
32, 33 and 34: RB shall establish or adopt, keep update and promote regulations and guides.
Process for establishing or adopting, promoting and amending regulations and guides, including consultation with interested parties
Regulations and guides shall provide the framework of the regulatory requirements and conditions of ‘authorisations’
Consistency and comprehensiveness
To be covered by the management system which should address:
Organisations and resources, including legal support
Identification of the need for regulation and guide (Programme)
Planning and schedule
Source of information (international standards, industry…)
Consultation of interested parties
Etc.
1.5 Regulaory Framework

11. Regulatory Body: Responsibilities and Functions Regulatory approach
Content
Regulatory Body: Responsibilities and Functions
Regulatory approach
Regulations and guides
Conclusions
1.5 Regulaory Framework

12. 2. Regulatory approach REGULATORY APPROACH
Regulations and guides chosen so as to suit:
The legal system of the State
The nature and extent of the facilities and activities to be regulated.
The national regulatory philosophy: balance between flexibility and the need for detailed requirements
The availability of adequate financial and other resources
The availability of the experience and competence
The system of regulations adopted should provide an appropriate balance between regulatory provisions that are:
numerous and detailed enough to achieve and maintain safety, and
flexible enough to permit their application to developing technologies and in new circumstances
REGULATORY APPROACH
National regulatory philosophy: balance between flexibility (easy adaptation of regulation to developing circumstances and technology) and the need for detailed requirements (to facilitate determination of whether the requirements have been met)
1.5 Regulaory Framework

13. Prescriptive versus performance based regulations
2. Regulatory approach
Prescriptive versus performance based regulations
As regulatory approach, a regulatory body may adopt a prescriptive, a performance-based approach, or combination of both
Implications
Number of regulations and guides
Resources
competence
flexibility
Public credibility
expectations
1.5 Regulaory Framework

14. Prescriptive approach
2. Regulatory approach
Prescriptive approach
Advantages
Sets clear expectations and detailed requirements for a particular activity or situation, including means and methods
Applicant knows what will be acceptable for the regulatory body
Reduces time and skills necessary to perform a licensing review or conduct an inspection (and resources?): focus on verification of compliance
Clarifies the relations between the regulatory body and the licensee
Facilitates the interaction between the stakeholders
Drawbacks
Difficulties to establish and maintain the regulations - need expert and detailed knowledge and resources
Need to be regularly reviewed and amended, as necessary, to keep pace with technological changes
May inhibit engineering innovation and good management initiatives which could contribute to a better safety
May tending to relieve the licensee of the prime responsibility for safety
May not help of safety culture promotion
1.5 Regulaory Framework

15. Performance-based regulations
2. Regulatory approach
Performance-based regulations
Advantages
Specify primarily the overall safety objectives
Focus on what is to be achieved in terms of protection and safety
Regulations easier to be developed and maintained
More stable vis-à-vis technology changes and new knowledge
Bring flexibility
Request licensee to discharge effectively its prime responsibility for safety
Promote continual improvements and search for better approaches
Greater involvement in determining how objectives are to be met.
Drawbacks
Need to judge how the operator has interpreted regulations in each specific situation before assessing whether the regulations has been fulfilled
Need expert and detailed knowledge and resources to review, assess and inspect the arrangements of the licensee
Need guides to facilitate a common understanding, acceptable ways of meeting performance based regulations
May need prescriptive requirements if safety objectives are not met
1.5 Regulaory Framework

16. Case-based regulations
2. Regulatory approach
Case-based regulations
Based on licensee safety performances
Overall regulatory requirements applicable to any facility
Regulatory approach may be adapted according to the facility, the licensee or other specific situations
May lead to a perception that regulatory control may be inconsistence (and unfair) between different facilities.
Risk-based regulations
New concept, focus on the most risky facilities and activities
Mostly based on probabilistic safety analysis
May be combined with a performance-based approach and other considerations
Require sound experience and competence to evaluate risks
1.5 Regulaory Framework

17. Level of Prescriptiveness
2. Regulatory approach
Optimum
Optimal area?
Contribution to Safety
Level of Prescriptiveness
1.5 Regulaory Framework

18. 2. Regulatory approach Performance-based Requirements
Accident Management Program shall be established
Only suitable qualified and experienced persons can conduct safety-related activities
A system to transfer heat from SSCs important to safety to an ultimate heat sink under normal operating and accident conditions, shall be provided
In all accident conditions within the design basis, key plant parameters do not exceed the specified design limits so that the prescribed dose limits to the general public are not exceeded
Prescriptive Requirements
The emergency power supply at the NPP shall be capable of supplying the necessary power in anticipated operational occurrences and accident conditions, in the event of the loss of off-site power
The peak pressure in the containment during an accident sequence should not exceed the containment design pressure
The fuel rod cladding temperature should not exceed 1400° degree C under LOCA conditions
The hydrogen concentration in the containment should be kept below 10 vol. % of containment free volume
1.5 Regulaory Framework

19. Regulatory Body: Responsibilities and Functions Regulatory approach
Content
Regulatory Body: Responsibilities and Functions
Regulatory approach
Regulations and guides
Conclusions
1.5 Regulaory Framework

20. 3. Regulations and guides
GS-G1.4 Documentation for Use in Regulating Nuclear Facilities
Regulations and guides should be sufficiently comprehensive and kept up-to-date to ensure that all essential safety requirements are considered in a systematic and orderly manner in the licensing process
The extent and detail of the regulations and guides depend on Regulatory Approach
Legal and regulatory framework for safety
Regulation
CAT 2 - Regulatory requirements related to Licensing Process
Cat 1 - Objectives, Principles & Criteria
Cat 3. Technical and managerial Requirements relating to the stages of the licensing process (E.g., Leadership and management of safety, Siting, Design, Construction, External hazards, Fuel…)
Safety Guides

21. 3. Regulations and guides
GS-G1.4 Documentation for Use in Regulating Nuclear Facilities
Category 1 In initiating a State’s nuclear programme, priority should be given to the establishment of regulations dealing with safety objectives, principles and criteria, in particular those relating to radiation protection, such as dose limits
Category 2 covering applications for authorization and the related documents should be clearly defined from the outset (even if a flexible approach may be considered)
Category 3 Initially may be limited to a single design of facility and may be expressed in a letter to an operator, possibly with reference to international requirements or regulations of other States. As a nuclear programme matures, a more standard and uniform procedure will be beneficial and should be used
1.5 Regulaory Framework

22. 3. Regulations and guides
GS-G1.4 Documentation for Use in Regulating Nuclear Facilities
Technical and managerial requirements (Category 3) should be developed at an early stage according to the planned regulatory approach
Priority to safety considerations relating to site evaluation
Then, general design criteria should be considered (E.g., Defence in depth, Multiple barriers, redundancy and diversity)
Leadership and management of safety, including quality control, process, etc.
Later, in more detailed manner: Design of systems, components and equipment, and their functional and testing requirements…
Operation and decommissioning or closure (affect the design)
Training, competence, emergency preparedness and response…
1.5 Regulaory Framework

23. 3. Regulations and guides
…Source of information: IAEA safety standards
Legislation
Regulation
Safety Guides
+ Detailed
1.5 Regulaory Framework

24. 4. Conclusion
The Government is responsible to establish and maintain an appropriate governmental, legal, and regulatory framework for safety, including an independent RB
GSR part 1 covers the essential aspects for establishing a regulatory framework and for taking actions necessary to ensure the effective regulatory control of facilities and activities
RB is required to establish or adopt, maintain and promote regulations and guides, in compliance with the IAEA Safety standards
1.5 Regulaory Framework

25. 4. Conclusion
Various regulatory approaches exist, the most appropriate approach for the country should be adopted
An optimum should be sought in order to maximise the regulatory requirements' contribution to safety
There is not good or wrong answer: A regulatory system should combine both types of regulations, striking an appropriate balance between performance based and prescriptive regulations to match the anticipated workload and the skills of the regulatory body’s staff
The regulatory body should thoroughly understand and take full ownership of the selected approach in order to ensure an effective regulatory control of safety, including when assessing licence application
A systematic approach should be adopted for establishing regulations and guides based and covered by a well established process
1.5 Regulaory Framework

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