IAEA - Department of Nuclear Safety & Security School on Drafting Regulations Module 1.5 - Key components of regulatory framework IAEA - Department of Nuclear Safety & Security Division of Nuclear Installation Safety | Regulatory Activities Section

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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