DOCUMENTATION FOR USE IN REGULATING NUCLEAR FACILITIES

REGULATIONS FOR RW MANAGEMENT Daniela E. Alvarez, Ph.D.ARAB ATOMIC ENERGY AGENCY/ARAB NETWORK OF NUCLEAR REGULATORS (ANNuR)FORUM OF NUCLEAR REGULATORY BODIES IN AFRICA (FNRBA)Regional Workshop on Management and Safe Disposal of Radioactive WasteTunis, 17-21, March 2014

DOCUMENTATION FOR USE IN REGULATINGNUCLEAR FACILITIES The achievement and maintenance of a high level of safety in all stages of nuclear facilities, requires a legal and governmental infrastructure, including a regulatory body with clearly defined responsibilities and functions The process of regulating a nuclear facility entails the preparation of a large amount of documentation, both by the operator of the facility and by the regulatory body Certain formal documents will be required for the regulatory process by the laws and regulations of the State or by the rules of the regulatory body. Other formal documentation will be provided in response to specific requests from the regulatory body or at the initiative of the operator or other parties involved. The regulatory body itself will also produce and disseminate many documents, some of which will form the basis for its decisions. The records of official meetings and hearings could also constitute a means of formally exchanging information

DOCUMENTATION FOR USE IN REGULATINGNUCLEAR FACILITIES • The regulatory body should specify the purposes of the various regulatory documents necessary to perform its functions. The documents may be categorized as comprising: • Legislation (standards); • Regulations, licences and other mandatory documents (requirements); • Guidelines and other advisory documents • The number of documents and their designations will vary substantially among States, depending on the legal system and on regulatory and industrial practices

REVIEW AND ASSESSMENT PROCESS (based on IAEA No. GS-G-1.2 Review and Assessment of Nuclear Facilities by the Regulatory Body) The documentation presented by the operator should be evaluated and approved by the regulatory body THE OBJECTIVES The basic objective of review and assessment is to determine whether the operator’s submissions demonstrate that the facility complies with the safety objectives stipulated or approved by the regulatory body This is applicable for all stages of the facilities: sitting, design, construction, commissioning, operation and decommissioning of nuclear facilities, and the closure of waste disposal facilities The specific objectives of the review and assessment will depend on the stage of the lifetime of the facility

REVIEW AND ASSESSMENT PROCESS THE OBJECTIVES (cont.) • To determine whether an operator has the ability and resources to discharge its obligations associated with any authorization granted for any stage of the lifetime of the facility • To determine whether the site chosen is suitable for the proposed facility (interaction between the site and the facility, anticipated changes to the environment of the site during the proposed period of commissioning and operation) • To determine whether proposals and commitments of the operator in respect of design, operation and decommissioning or postclosuremeet the regulatory body’s requirements

REVIEW AND ASSESSMENT PROCESS THE OBJECTIVES (cont.) • To determine whether the commissioning test programmeis complete and contains a well defined set of operational limits, test acceptance criteria, conditions and procedures • To determine whether the operator uses an appropriate safety management system that meets the regulatory body’s requirements • To determine whether the operator’s personnel meet the regulatory Requirements • To determine whether proposed modifications to the facility, at whichever stage in its lifetime, have been conceived and their implementation planned so that safety isnotcompromised • To evaluate safety reviews performed by the operator

REVIEW AND ASSESSMENT PROCESS THE OBJECTIVES (cont.) • To determine whether the operator’s plans and commitments in respect of decommissioning (and closure and post-closure stages for a disposal facility) meet the requirements of the regulatory body • To determine, if relevant, whether the performance indicators proposed by the operator areappropriated • To determine whether the programme proposed by the operator for confirmation of performance is acceptable • To determine whether any additional requirements (or licence conditions) have been fulfilled by the operator

REVIEW AND ASSESSMENT PROCESS MANAGEMENT OF REVIEW AND ASSESSMENT How to proceed with the review and assessment process? It is important to considerer: • Planning and directing the review and assessment process • Preparing the procedures to be followed in accordance with the overall quality managementprogramme • Co-ordinating all information exchange between the regulatory body and the operator • Keeping a recordfor all documents sent or received • Monitoring the progress of documents submitted by the operator and the progress of the review and assessment process against the tentative programmeagreed by the operator and the regulatory body • Making arrangements for co-ordination between review and assessment activities and inspectionactivities • Facilitating nationally consultation with other regulatory bodies and governmentaldepartments, whereappropriate

REVIEW AND ASSESSMENT PROCESS MANAGEMENT OF REVIEW AND ASSESSMENT (cont.) • Planning for public consultation during the review process, as appropriate • Qualification and training of the personnel engaged in the review and assessmentprocess (IAEA No. GSR Part 1, Governmental, Legal and Regulatory Framework for Safety points) The regulatory body shall acquire an understanding of the design of the facility or equipment, the safety concepts on which the design is based and the operating principles proposed by the operator, to satisfy itselfthat: • The available information demonstrates the safety of the facility • The information contained in the operator’s submissions is accurate and sufficient to enable confirmation of compliance with regulatory requirements • The technical solutions have been proven or qualified by experience or testing, and are capable of achieving the requiredlevel of safety

REVIEW AND ASSESSMENT PROCESS SCHEDULING OF SUBMISSIONS The regulatory body should indicate to the operator the period of time that is considered necessary for the review and assessment process so as to facilitate the process and to minimize delays in the granting of any necessary authorizations It is appropriate to reach an agreement on an indicative schedule. It is possible that several reviews with updated versions of documents are presented, generating a smooth interaction between regulator and operator till get a final version

THE AUTHORIZATION PROCESS (IAEA No. GS-G-1.4 Documentation for Use in Regulating Nuclear Facilities establishes) A fundamental process is the “licensing”. There are many options of "phases of Licensing“, varying between different Member States. Some countries, for example granting a license for the site and others do not. But in all cases the license for design is separated from the one for operation. The same is the case for closure and decommissioning Each of these steps requires a safety assessment that supports the safety case and will be different at each stage of the installation. Similarly, the documentation that must accompany the license application, in addition to the safety case will be different for each phase, since the processes involved are different, the radioactive inventory will be different and so the risks in both normal and accident situations will be different

THE AUTHORIZATION PROCESS Authorization and Licence • Siting, design, commissioning, operation, shutdown and decommissioning • Different approached in Member States Siting Design Operation Shutdown Decommissioning Safety Documentation • Safety case (SC) • Safety assessment (SA) • Other supporting documents

THE AUTHORIZATION PROCESS Authorization is the principal mechanism connecting the legal framework of the regulatory system (the laws and regulations) with the responsibilities of the principal parties that are affected by the regulatory system (the regulatory body and the operator) An authorization is a written permission for an operator to perform a specified activity or a set of activities dealing with the siting, design, construction, commissioning, operation, decommissioning or closure of a facility. It also establishes, directly or by reference, conditions governing the safe performance of these activities (licence, certification or registration) An important task of the regulatory body is the approval or rejection of applications for authorization on the basis of its review and assessment. To obtain an authorization for a facility, the operator submits adequate information to the regulatory body for its review and assessment

REVIEW AND ASSESSMENT PROCESS STAGES OF THE AUTHORIZATION PROCESS The authorization process is a continuing process which may start before the planning and feasibility study for the site and continue through decommissioning or closure of the nuclear facilities until release from regulatory control. As a practical matter, review and assessment of each area may start at an earlier stage and continue into subsequent stages SITE EVALUATION Site evaluation for many facilities is initially determined by processes not greatly influenced by highly prescriptive criteria. However, general requirements concerning remoteness, local population density and transport arrangements will apply. For waste disposal sites, geological and hydrogeological considerations will be major factors in site evaluation

REVIEW AND ASSESSMENT PROCESS DESIGN, CONSTRUCTION AND INSTALLATION Before authorization of construction of the facility, review and assessment will be concentrated on the operator’s approach to safety and safety standards, and how these have been applied in developing the design The regulatory body should review and assess the operator’s arrangements for the control of activities in construction, manufacture and installation. An outline plan for decommissioning, covering issues such as strategies to be used, radiation doses to be expected and amounts of waste to be produced, should be prepared by the operator at the design stage Review and assessment of the design should continue during construction, manufacture and installation as the details become finalized. Changes to the authorized design at this stage should be analyzed by the operator and reported to the regulatory body, which should carry out the necessary review and assessment

REVIEW AND ASSESSMENT PROCESS COMMISSIONING Commissioning, can be considered in two stages: inactive, before fissile and radioactive material is introduced, and active, after fissile and radioactive material has been introduced The inactive stage of commissioning is aimed at ensuring that the facility has been constructed, manufactured and installed correctly and in accordance with the design documentation. If deviations from this documentation have occurred, they should be recorded, and it should be shown that the safety analysis has not been compromised. The results of inactive commissioning should also confirm the operational features of the facility and should lead to the development of detailed instructions for operators

REVIEW AND ASSESSMENT PROCESS COMMISSIONING (cont.) Active commissioning with the introduction of fissile and radioactive material is a major step in the authorization process The review and assessment should take into consideration: the final design of the facility as a whole; the commissioning programme and its progress; the organizational structure; the qualifications of operating personnel; emergency preparedness; the preliminary operational limits and conditions; and the preliminary operating procedures Whenever there are deviations from the design parameters, these should be analyzed by the operator and reported to the regulatory body, which should carry out the necessary review and assessment

REVIEW AND ASSESSMENT PROCESS • OPERATION • Before authorizing routine operation, the regulatory body should review and assess the consistency of the results of commissioning tests • For routine operation, the regulatory body shall require the operator to provide periodically evidence that in routine operation the facility is being operated in accordance with the safety requirements, in particular the operational limits and conditions. This evidence may be provided by means of reporting on operational parameters and occurrences relevant to safety. The regulatory body shall review and assess the reports, and shall perform inspections to ensure that the facility complies with the safety requirements

REVIEW AND ASSESSMENT PROCESS OPERATION (cont.) While the need for reassessment may arise in a number of ways, systematic safety reassessments, periodic safety reviews (PSRs), should be carried out by the operator at intervals to review the cumulative effects of ageing of the facility and of modifications, and the implications of operating experience and technical developments. The nature of this review and the interval between reviews will depend on the nature of the facility and the potential magnitudes of the risks it presents When a review shows that the facility does not meet current regulatory requirements, the significance of the shortcomings should be assessed and possible ways of meeting the requirements should be considered During the operation of the facility, the outline plan for decommissioning should be updated by the operator from time to time and reviewed by the regulatory body in the light of operational experience, new or revised regulatory requirements and technological developments

REVIEW AND ASSESSMENT PROCESS DECOMMISSIONING Decommissioning comprises the preparation and approval of a detailed decommissioning plan; the actual decommissioning activities; and the management of waste arising from these activities. Just before the permanent shutdown of the facility, a detailed plan should be prepared for authorization or approval by the regulatory body. The decommissioning plan should be reviewed and assessed in order to ensure that decommissioning can be accomplished safely with a progressive and systematic reduction in radiological hazards CLOSURE OF A WASTE DISPOSAL FACILITY To closure a disposal facility, ancillary facilities should be decommissioned and the facility should be appropriately sealed. Particular consideration should be given to detailed information, including records of the radionuclide content and physical properties of the waste and its packaging; geological and hydrogeological conditions; performance of the facility’s design (backfill materials, engineered structures and the sealing arrangements); aspects of monitoring and retrievability; and migration of radionuclides

REVIEW AND ASSESSMENT PROCESS RELEASE FROM REGULATORY CONTROL Before an operator can be allowed to relinquish the authorization, it should be ensured that all responsibilities and liabilities that pertain under the authorization have been satisfactorily discharged and that there is no reasonable possibility that any future requirement will be made on the operator. The operator should provide evidence of this and, in particular, should demonstrate that the rehabilitated site will not pose unacceptable radiological risks in comparison with radiological conditions that prevailed before the facility was built The regulatory body should review and assess this evidence and should determine whether it adequately closes the issues

REVIEW AND ASSESSMENT PROCESS • REASSESSMENTS • Throughout the lifetime of a facility, it may be necessary for the operator to make a reassessment of its safety. This reassessment could be at the initiative of the operator or at the request of the regulatory body. The need for reassessment may arise owing to: • Experience relevant to safety that has been gained at the facility, at similar facilities and at other relevant nuclear (and non-nuclear facilities); • Information from relevant tests and from research and development programmes, and new knowledge of technical matters; • Proposed modifications to the facility or to the way in which it is to be managed and operated; and • Changes in the regulatory framework, regulations and guides

REVIEW AND ASSESSMENT PROCESS ORGANIZATION AND TECHNICAL RESOURCES FOR REVIEW AND ASSESSMENT Organization Review and assessment are principal functions of the regulatory body Consultants The regulatory body shall obtain technical or other expert professional advice or services as necessary in support of its regulatory functions, but this shall not relieve the regulatory body of its assigned responsibilities EXTERNAL RELATIONSHIPS Relationshipwiththeoperator The regulatory body and the operator should establish formal relations based on independence and mutual respect. Proper channels of communication between the operator and the regulatory body should be established

REVIEW AND ASSESSMENT PROCESS EXTERNAL RELATIONSHIPS (cont.) Relationship with the operator’s contractors Much of the information to perform the review and assessment may be prepared for the operator by its contractors but these contacts should not diminish the responsibility of the operator for the safety of the facility Relationship with other governmental bodies In addition to the regulatory body, other governmental bodies may participate in the regulatory process in accordance with national legislation, regulations and practices. The regulatory body should establish and maintain liaison throughout the lifetime of the facility with other governmental bodies as appropriate Relationship with regulatory bodies of other States and international bodies “Safety” is of international concern. International conventions relating to various aspects of safety are in force. National authorities, with the assistance of the regulatory body, shall establish arrangements for the exchange of safety related information, bilaterally or regionally, with neighbouring States and other interested States

PERFORMANCE OF THE REVIEWAND ASSESSMENT PROCESS The process of review and assessment consists of examining the operator’s submissions on all aspects relating to the safety of the facility. It should include consideration of both normal operation and failures, and events, including human errors, that have the potential for causing the exposure of workers or the public or radiological hazards to the environment The review and assessment process should include checks on the site and elsewhere to validate the claims made in the submissions. Operators often have external peer reviews conducted at their facilities by national or international organizations. The results of such reviews could provide the regulatory body with additional insights into the activities of the operator

PERFORMANCE OF THE REVIEWAND ASSESSMENT PROCESS How to do that? INTERNAL GUIDANCE The regulatory body should provide internal guidance on the procedures to be followed in the review and assessment process and guidance on the safety objectives to be met REVIEW AND ASSESSMENT PLAN The regulatory body shall prepare its own programme of review and assessment of the facilities and activities under scrutiny. The regulatory body shall follow the development of a facility or activity, as applicable, from initial selection of the site, through design, construction, commissioning and operation, to decommissioning or closure

PERFORMANCE OF THE REVIEWAND ASSESSMENT PROCESS In carrying out a review and assessment of an operator’s submission, the regulatory body should employ a systematic plan to provide assurance that all topics significant to safety will be covered and that operators of similar facilities will be treated equally. This plan should include a series of procedures that the regulatory body will follow for all aspects and topics covered by the submission In practice, the scope and depth of the review and assessment will depend on several factors such as novelty, complexity, previous history, the experience of the operator and the associated risk. The areas on which regulatory review and assessment should be concentrated at different stages can be considered in broad terms. For example, while the site qualification stage is a significant stage for all facilities, it is particularly important for waste disposal facilities

DOCUMENTATION TO BE SUBMITTED BY THE OPERATOR Responsibilities of theoperator The operator should be responsible for submitting documentation in support of its application for authorization. At each stage of the authorization process the operator should be required to demonstrate to the satisfaction of the regulatory body that the facility can be sited, designed, constructed, commissioned, operated, decommissioned or closed without giving rise to undue radiological risks to workers, the public or the environment At all stages the operator should be able to demonstrate that it is in control of the facility and has adequate organization, management, procedures and resources to dischargeitsobligations Any modification to safety related aspects of a facility or activity (or having an indirect but significant influence on safety related aspects) shall be subject to review and assessment, with the potential magnitude and nature of the associated hazard being taken into account

DOCUMENTATION TO BE SUBMITTED BY THE OPERATOR Records of the operator’s submissions The formal exchange of information through agreed channels of communication is a fundamental element of the review and assessment process. Information exchanges that may occur between the regulatory body and other concerned parties (including other governmental bodies, the operator and its contractors, advisory committees, consultants and, as appropriate, members of the public) should be in written form and should be formally recorded upon receipt and stored in a manner that allows easy retrieval Proprietaryinformation and confidentiality Certain information provided by the operator or its contractors should be considered confidential because of its proprietary nature, for security reasons or because of the right of individuals to privacy, in accordance with national law and regulations. Those to whom such information is entrusted should be advised of its confidential nature and should be obliged, consistently with national law and regulations, to protect its confidentiality

BASES FOR DECISIONS • The regulatory review and assessment will lead to a series of regulatory decisions. At a certain stage in the authorization process, the regulatory body shall take formal actions which will result in either: • The granting of an authorization which, if appropriate, imposes conditions or limitations on the operator’s subsequent activities; or • The refusal of such an authorization • The regulatory body shall formally record the basis for these decisions • The purpose of the review and assessment of the documented information submitted by the operator is to enable the regulatory body to make a decision or a series of decisions on the safety of the facility and its associated activities

BASES FOR DECISIONS Decisions relating to safety should be made on the basis of the review and assessment of the operator’s submissions, the studies and evaluations performed independently by the regulatory body itself, and the safety objectives and specific requirements established by the regulatory body. Decisions of the regulatory body should reflect professional judgement by technically competent persons on the basis of regulatory requirements and operational experience throughout the review and assessment process The regulatory body should require that the documentation submitted for review and assessment be prepared subject to a proper and effective quality assurance system and should be appropriately reviewed

BASESFOR REVIEW AND ASSESSMENT • Safety objectives and requirements • Safety objectives and regulatory requirements (used for the regulatory body to evaluate the information presented by the operator) should be communicated to the operator for guidance in preparing its documentation • The regulatory body may develop safety objectives and requirements itself or it may adopt objectives and requirements that have been developed and issued by international organizations or by regulatory bodies in other States, considering: • Nationallaws and regulations; • Advice obtained from consultants, dedicated support organizations, etc; • Standards and guidance used at national and international level; • Requirements and experience in other relevant industries; • Technical results and experience from R&D

BASES FOR REVIEW AND ASSESSMENT Regulations and guides The system of regulations and guides shall be chosen so as to suit the legal system of the State, and the nature of the facilities and activities to be regulated. Where regulations are not issued by the regulatory body, the legislative and governmental mechanisms shall ensure that such regulations are developed and approved in accordance with appropriate time-scales Regulations (mandatory) should be developed on a generic basis or on the basis of facility type and should provide for more detailed requirements to be incorporated into individual authorizations Guides, of a non-mandatory nature, on how to comply with the regulations may also provide information on data and methods to be used in assessing the adequacy of the design and on analyses and documentation to be submitted to the regulatory body by the operator

BASESFOR REVIEW AND ASSESSMENT Auditcalculations The regulatory body may decide to perform a limited number of audit calculations to check that the operator has justified a particular aspect of safety correctly However, it is neither cost effective nor appropriate for the regulatory body to conduct a complete set of calculations for every submission in the licensing process. Performing audit calculations is very resource intensive and, if routinely practiced, could lead to an abrogation of responsibility by the operator

VERIFICATION OF THE SAFETY ANALYSIS General Much effort that the regulatory body will need to expend in the review and assessment process will be concentrated on the performance of a step by step review and assessment procedure to determine whether the applicable safety objectives and requirements for each aspect or topic have been met. This stage of the process consists in examining the submissions from the operator on its managerial arrangements, engineered systems and operational procedures and on the safety analysisforthefacilities

VERIFICATION OF THE SAFETY ANALYSIS Structures, systems and components (SSC) From this analysis, the requirements on the SSCs and operations can be derived and compared with the provisions made by the operator. The review and assessment by the regulatory body should ensure that the operator has used the safety analysis to determine the requirements on the SSCs and that the requirements will be met by the equipment and in operational procedures Organization and management A well engineered facility may not achieve the required level of safety if it is not managed well. Review and assessment by the regulatory body should therefore include consideration of the operator’s organization, management, procedures and safety culture, which affect nuclear, radiation, transport and radioactive waste safety and the operation of the facility. The operator should demonstrate by documentary means that there is an effective safety management system in place which gives nuclear safety the highest priority

RECORDS OF THE REGULATORY BODY’S REVIEW AND ASSESSMENT The review and assessment process will invariably involve the production of reports by various experts in the regulatory body and by any consultants employed. A document control system should be set up for keeping records of the process so as to allow such documents and records to be readily retrieved DOCUMENTATION PRODUCED BY THE REGULATORY BODY Review and assessment should result in a decision on the acceptability of the safety of the facility which may be connected to a stage in the authorization process. The basis for the decision should be recorded and documented in an appropriate form. This documentation should summarize the review and assessment performed and should present a clear conclusion about the safety of the activity authorized

RESEARCH AND DEVELOPMENT INITIATEDBY THE REGULATORY BODY The regulatory body may find that there are aspects of regulated facilities which are insufficiently understood. This may apply to existing or to future facilities. These aspects may involve, among other things, modelling techniques or processes. The regulatory body should encourage the operator (or operators, if similar facilities exist or are planned) to carry out the necessary research and development work to extend understanding of safety related issues The regulatory body may decide to initiate research and development work where it considers that there is a need for additional studies beyond those undertaken bytheoperator

MONITORING OF THE REVIEW AND ASSESSMENT PROCESS The regulatory body should ensure that the findings and decisions of the review and assessment process are subjected to a suitable process of peer review conforming to the national practices of the State and the overall quality assurance system of the regulatory body. The regulatory body should document the findings of its review and assessment and should make them available to the operator and others in accordance withnationalpractice The regulatory body should have a system to audit, review and monitor all aspects of its review and assessment process so as to ensure that it is being carried out in a suitable and efficient manner and that any changes to the process necessitated by advances in knowledge or improvements in methods or for similar reasons are implemented

Thank you

DOCUMENTATION FOR USE IN REGULATING NUCLEAR FACILITIES