During the two-week IRRS mission, the IAEA experts will investigate how ENSI performs its supervisory duties. To ensure that this scrutiny of ENSI is conducted in an orderly and systematic manner, the IAEA has developed a list containing about 2000 questions. The mission’s objective is to investigate the extent to which ENSI applies the safety requirements developed by the IAEA. For this reason, the questions focus on these safety requirements.
The list of questions is divided into twelve subject-related segments known as modules. In turn, each module is divided into various topic areas. In this way, the IAEA ensures that appropriate questions are available regarding all aspects of the supervisory activities.
Module 1: Responsibilities and Functions of the Government
It is the state’s duty to create a framework of conditions for the safe operation of nuclear plants. The government and Parliament define the statutory boundary conditions for the operation of nuclear plants. In Switzerland, the people are also involved because laws are subject to optional referendums. The IAEA experts examine which responsibilities the state takes on for the construction, operation and dismantling of nuclear plants and for the management of radioactive waste, and whether it has appointed competent and independent regulatory authorities for the purpose of monitoring nuclear plants.
This module covers the following key subject areas:
1. Government strategy for the safety of nuclear plants 2. Regulatory framework in the nuclear sector 3. Responsibilities in the nuclear sector 4. Remit and independence of the regulatory bodies 5. Operator’s prime responsibility for the safety of nuclear plants 6. Coordination of regulatory authorities in the nuclear sector 7. Competence in the area of safety for nuclear plants 8. Federal technical facilities in the area of nuclear technology and radiation protection
Module 2: Global Nuclear Safety Regime
The operation of nuclear plants must comply with international standards. An active interchange of ideas and information with other countries and international organisations in the nuclear energy sector are indispensable conditions so that nuclear plants can make comparisons with the international status of safety technology, and are able to adapt and continue to develop at all times. Furthermore, it is crucial for international experience of the operation of nuclear plants to be taken into account so that it can be used to improve the country’s own plants.
This module covers two key issues:
1. International agreements and cooperation 2. Exchange of operating experience with nuclear plants and supervisory practice
Module 3: Responsibilities and Functions of the Regulatory Body
The IAEA carries out a detailed examination of ENSI’s responsibilities and tasks, and determines the extent to which it is able to carry out its tasks independently of external influences. This central module investigates ENSI’s independence and its communication with the public. Especially in recent months, severe criticism was levelled at ENSI’s independence and its dealings with the public. As well as clarifying other aspects, the investigation by the experts will show whether or not this criticism was justified.
This module is divided into eight subject areas:
1. Organisational structure of the regulatory body and allocation of resources 2. Effective independence during conduct of regulatory activities 3. Staffing and competence of the regulatory body 4. Liaison with advisory bodies and support organisations 5. Liaison between the regulatory body and authorised parties 6. Stability and consistency of regulatory control 7. Safety related records 8. Communication and consultation with interested parties
Module 4: Management System of the Regulatory Body
The key question in module 4 is whether the regulatory body has a management system that is actually put into practice on a daily basis. A management system of this sort is also essential at authority level nowadays in order to ensure that employees work according to the same specified requirements and that transparency of the authority’s activities is guaranteed. Moreover, the management system is an important instrument for constant analysis and improvement of the authority’s working methods.
Key subject areas in this module are as follows:
1. Development and implementation of the management system
- Mapping of ENSI’s goals and strategy
- Does the management system cover all the authority’s activities?
- Are all statutory remits enshrined in the management system?
- Do the central supervision processes ensure that safety has absolute priority?
- Is the management system actively supported by the Executive Board, and does it set an example in this regard?
- Is the management system understood and implemented by the employees?
- Is the documentation for the management system universally accessible?
2. Monitoring and continuous improvement of the management system
- Is the management system subjected to periodic reviews?
- Are performance parameters defined?
- Have auditors been appointed?
3. Control of documentation 4. Training concept and advanced training 5. Occupational safety 6. Environmental management
Module 5: Authorisation
Construction, operation, dismantling, management of radioactive waste, transport of nuclear goods and major changes to nuclear plants all require licences or approvals. The licensing procedure varies from one country to another. In Switzerland, licences are issued by the Federal Council, a government department, a Federal authority or a body designated by the Federal government. In the nuclear sector, most rulings, permits and licences are issued by ENSI. The IAEA will examine whether the licensing procedure in Switzerland meets the IAEA’s requirements.
Key topics in this area are:
1. Statutory basis for licences 2. Changes to issued licences 3. Licences
- General licence
- Construction licence
- Operating licence
- Additional licences
4. Rulings 5. Permits 6. Licensing
Module 6: Review and Assessment
Comprehensive review of submitted applications for the construction and operation of structures, systems and components that are relevant to safety (and especially for changes to them), and of organisational changes and adaptations to important plant documentation, is a central duty of the regulatory authority. Reviews of this sort provide the basis for decisions as to whether the applications can be granted, whether additions or improvements are still necessary, or whether the application cannot be approved. The results of a review are documented in detail; for licensing procedures this takes the form of an assessment, whereas a stand-alone report is drawn up for change applications of a technical or organisational nature. For relatively straightforward applications – e.g. for the replacement of a component – the documentation may also be included in the relevant permit letter.
The IAEA experts verify whether ENSI implements the IAEA’s requirements for reviewing applications, how it examines the quality of the submitted documents, which analytical test methods are used by ENSI, and how the entire examination process is documented.
Key issues in this module are:
1. Statutory basis 2. Safety analyses to be submitted
- For new plants
- During operation, e.g. periodic safety analyses
- For changes
- In case of events
3. Safety review by ENSI
Module 7: Inspection
Inspections are an important supervisory instrument for the purpose of ensuring that the operator of a nuclear plant conforms to the requirements stipulated in the regulatory framework, and that it takes all precautions to guarantee safe operation of the plant. ENSI conducts about 400 inspections each year in the Swiss nuclear plants. These inspections cover not only technical equipment but also the behaviour of the operating team, e.g. during tours of inspection of the plant, system and component tests, basic and advanced training, emergency exercises, etc. These inspection activities give ENSI a good overview of the technical and organisational aspects of safety at a nuclear plant. The IAEA experts will verify the extent to which ENSI has implemented the IAEA requirements regarding the inspection system, and will also take part in an inspection so that they can observe the work of the ENSI inspectors.
Key issues in this area are:
1. Statutory basis 2. Inspection programme 3. Training of inspectors 4. Aspects inspected 5. Planning, performance and evaluation of inspections
Module 8: Enforcement
This module discusses the statutory enforcement measures that are available to the regulatory authorities if operators do not comply with statutory requirements. ENSI can order all measures required for compliance with nuclear safety, protection and security. In case of punishable offences, ENSI reports violations to the Office of the Attorney General of Switzerland, which then decides on further procedure. The IAEA requires that in case of breaches of regulatory requirements, each country must be able to have recourse to appropriate sanctions and, during the IRRS, it will examine how far the enforcement measures available in Switzerland conform to the IAEA requirements.
1. Statutory basis 2. ENSI’s enforcement practice 3. Influence of sanctions on a plant’s safety culture
Module 9: Regulations and Guides
The regulatory framework comprises laws, ordinances and guidelines as well as designated bases. This provides the framework for nuclear activities which must be implemented by operators. The regulatory framework is constantly undergoing development. This is essential for it to take account of the state of the art in safety engineering. Laws and ordinances are enacted by the Federal government, and ENSI issues guidelines which add detail to the laws and ordinances. The IAEA will examine whether the Swiss regulatory framework meets international requirements, and whether the technical and organisational requirements and recommendations stipulated in numerous IAEA documents are taken into account.
Key issues are:
1. Laws and ordinances
- Procedure for the drafting of laws and ordinances
- Procedure for drafting guidelines
Module 10: Emergency Preparedness and Response
The ability to bring a potential emergency in a nuclear plant under control is an important prerequisite for the issuance of an operating licence. Prepared technical and organisational measures must be in place for all conceivable accidents (including those which are extremely unlikely) in order to bring the accident under control and/or to mitigate its effects. Emergency preparedness is not only a matter of concern for the plant operators and ENSI, but also to official organisations and institutions at commune, cantonal and Federal level. This makes it necessary to carry out emergency exercises with all parties who could be potentially affected.
The IAEA will verify whether emergency preparedness and the emergency response organisation in Switzerland meet the international requirements, and in particular will also examine the interfaces between the individual emergency response organisations, as well as looking closely at communication within the emergency response organisations and with the outside world. The IAEA experts will inspect an emergency exercise.
Key issues in this module are:
1. Statutory basis 2. ENSI’s emergency response organisation 3. National emergency response organisation 4. Emergency protection zones in the areas surrounding nuclear plants 5. Emergency preparedness 6. Warning system
Module 11: Thematic Areas
The thematic areas are specifically tailored to the authority under review. This is necessary because the responsibilities and competences of nuclear regulatory authorities differ from country to country. In Switzerland, ENSI is responsible for nuclear and radiological inspections in nuclear plants and also for the transport of radioactive substances from and to nuclear plants, as well as for preparatory activities in connection with the management of radioactive waste. However, these arrangements may differ in other countries. Some countries have dedicated regulatory authorities for radiation protection or waste management.
In the thematic area, ENSI has included those supervisory activities for which it is responsible and which are not already covered by the preceding modules. These are:
- Radiation protection in nuclear plants
- Waste management of radioactive substances
- Transport of radioactive substances from and to nuclear plants
Sub-module: radiation protection
The main aim of radiation protection in a nuclear plant is to minimise exposure to radiation for the operational staff. A series of technical measures is required for this purpose. However, importance also attaches to organisational measures and training, as well as clear rules of conduct in the radiation field. Technical measurement equipment ensures that the operating staff are always informed about the current radiation exposure at every location in a nuclear plant.
Radiation protection also includes protecting the environment against radioactive radiation. Monitoring of the discharge of radioactive substances into the environment and the measurement of radiation exposure in the area surrounding a nuclear plant are important tasks in order to ensure compliance with the exposure levels permitted by law. The IAEA experts will verify whether ENSI implements the international requirements regarding radiation protection in nuclear plants, and will also gather information on cooperation with other bodies in the area of radiation protection.
Key issues in this sub-module are:
1. Statutory basis 2. Cooperation among regulatory bodies in the area of radiation protection 3. Radiation protection zones 4. Dose limits 5. Dosimetry 6. Monitoring of surrounding areas 7. Clearance measurement of contaminated materials and areas 8. Responsibility of the operator in the area of radiation protection
Sub-module: waste management
The management of radioactive waste is a key duty of every operator of a nuclear plant. Waste management comprises the collection and conditioning of the waste in the plant, as well as the safekeeping and interim storage of radwaste in a secure area. Highly active waste originates mainly from the reactor core of a nuclear power plant, and must first be cooled for some time in a spent fuel pool in the plant before it is either reprocessed or placed into interim storage in special containers in the form of entire fuel assemblies. Deep geological repositories are used for the final disposal of the waste in Switzerland. In other countries, some low-activity waste is also kept in storage facilities close to the surface.
The IAEA will examine the structure of the waste management programme in Switzerland, which tasks ENSI has in connection with waste management, and how cooperation with other Federal agencies is handled. Questions regarding the involvement of the affected population will be a key aspect. The IAEA will, of course, verify whether the international requirements are implemented.
Key issues in this area are:
1. Statutory basis 2. Waste management strategy and programme 3. Classification of radioactive waste 4. Central interim radwaste storage 5. Nuclear plants in process of dismantling 6. Sectoral planning procedure for deep geological repositories
Various authorities are responsible for the transport of radioactive substances in Switzerland. ENSI is the responsible regulatory authority for the transport of radioactive substances from and to nuclear plants. Monitoring includes the transport of smaller containers with radioactive substances, e.g. radioactive sources, as well as the transport of heavier containers with highly active vitrified (glassy) waste from reprocessed fuel. All transport operations require a permit from the responsible authority. For this purpose, ENSI supplies the technical assessment of the transport container and the goods to be transported, i.e. of correct packaging. The IAEA will examine how the very detailed international regulations concerning the transport of radioactive substances are implemented in Switzerland, and how the various authorities collaborate in the area of transport.
Key issues in this sub-module are:
1. Statutory basis 1. For rail transport 2. For waterborne transport 3. For road transport 4. For air transport 5. Practical implementation of the statutory requirements in Switzerland 6. Inspection of transport operations by ENSI
Module 12: Interfaces with Nuclear Security
Security comprises the technical and organisational measures implemented to protect against effects and impacts caused by third parties. As these are confidential (for understandable reasons), only the interface between safety and security will be reviewed by the IAEA experts during the IRRS mission. This interface is important because the requirements for security can in some cases conflict with those for safety. The key issue in this module will be the approach taken to problems such as these, and how decisions on them are ultimately reached.
Questions related to Fukushima
The IAEA recently drew up a special questionnaire in the aftermath of the accident at the Fukushima Dai-ichi plant in Japan. The questions aim to ascertain how individual countries have dealt with the knowledge gained from the accident, and which measures they have ordered or will order. ENSI received this questionnaire shortly before the mission, but has nevertheless attempted to answer it as fully as possible.
“Consequences of the Accident at Fukushima” will be a subject of special discussion during the IRRS mission, and the measures implemented and envisaged by ENSI will be assessed by the IAEA experts.