ANALYSIS OF IRRS MISSIONS,

Transcription

1 ANALYSIS OF IRRS MISSIONS,

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3 Executive summary This report provides an analysis of the Integrated Regulatory Review Service (IRRS) missions conducted from 2006 to During this period, the Agency conducted 69 initial missions and 26 follow-up missions. This is the first report to analyze all of the IRRS missions conducted to date. IRRS missions vary substantially in their scope, based both on the nuclear and radiological activities taking place in the Member State and the decision by the Member State on what activities to include in the scope of the mission. Nevertheless, the 95 IRRS missions include sufficient information to draw meaningful conclusions on general characteristics and trends. The observations arising from an IRRS mission are categorized as: Recommendations: which reflect non-compliance with a requirement from the IAEA Safety Standards; Suggestions: which identify opportunities for improvement: and, Good Practices: which identify regulatory practices superior to those observed elsewhere. Almost half of the references for Recommendations and Suggestions are to GSR Part 1 (Rev. 1): Governmental, Legal and Regulatory Infrastructure for Safety. GSR Part 3: Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards accounts for 15% of the references with GSR Part 2: Leadership and Management for Safety, GSR Part 7: Preparedness and Response for a Nuclear or Radiological Emergency each accounting for about 10% of the references. The most frequently referenced GSR Part 1 (Rev. 1) requirements for Recommendations and Suggestions were: Requirement 2: Establishment of a framework for safety; Requirement 24: Demonstration of safety for the authorization of facilities and activities; Requirement 32: Regulations and guides; Requirement 18: Staffing and competence of the regulatory body; Requirement 4: Independence of the regulatory body; Requirement 29: Graded approach to inspections of facilities and activities. The most frequently referenced GSR Part 2 requirements for Recommendations and Suggestions were: Requirement 10: Management of processes and activities; Requirement 8: Documentation of the management system; Requirement 13: Measurement, assessment and improvement of the management system; Requirement 6: Integration of the management system; Requirement 4: Goals, strategies, plans and objectives. The most frequently referenced GSR Part 3 requirements for Recommendations and Suggestions were: Requirement 2: Establishment of a legal and regulatory framework; Requirement 34: Responsibilities of the government specific to medical exposure; Requirement 38: Optimization of protection and safety (for medical exposure); Requirement 32: Monitoring and reporting (public exposure); Requirement 47: Responsibilities of the government specific to existing exposure situations; Requirement 3: Responsibilities of the regulatory body. i

4 The most frequently referenced GSR Part 7 requirements for Recommendations and Suggestions were: Requirement 2: Roles and responsibilities in emergency preparedness and response; Requirement 7: Identifying and notifying a nuclear or radiological emergency and activating an emergency response; Requirement 25: Training, drills and exercises for emergency preparedness and response; Requirement 4: Hazard assessment; Requirement 23: Plans and procedures for emergency response. For Good Practices, GSR Part 1 accounted for the most references. However, many IRRS missions identified at least one Good Practice related to GSR Part 2, GSR Part 3 and GSR Part 7 requirements. The most frequently referenced requirements all come from GSR Part 1, namely: Requirement 18: Staffing and competence of the regulatory body; Requirement 36: Communication and consultation with interested parties; Requirement 27: Inspection of facilities and activities; Requirement 14: International obligations and arrangements for international cooperation and assistance; Requirement 24: Demonstration of safety for the authorization of facilities and activities. Another way of categorizing IRRS observations is according to subject. In the analysis, each observation was placed into one of 73 subject groups. The highest number of observations for Recommendations and Suggestions were in the following subject groups: Basic safety requirements; Specific topics for regulations and guides; National policies and strategies for safety; Authorization procedures and guides; Providing / using the legal framework. Regarding the topic of processes, procedures and guidance, these observations were broken out in the various modules for management system, authorization, review and assessment, inspection, enforcement and emergency preparedness and response. Taken together, however, they account for 289 Recommendations and 230 Suggestions, making the topic of procedures and guidance the most frequent observation. Not all Member States have requested a follow-up mission, where peer reviewers determine if Recommendations and Suggestions can be closed or remain open. For those Member States that have hosted a follow-up mission, the closure rate for Recommendations and Suggestions directed to Member State governments is 73%, while the closure rate for Recommendations and Suggestions directed to the regulatory body is 84%. New observations are also normally included in follow-up missions, with more than 40% of these new observations referencing a requirement in GSR Part 1. GSR Part 7, GSR Part 3 and Other Requirements documents each account for around 14% of the references, while various Safety Guides are referenced in about 10% of the observations. GSR Part 2 is referenced in about 5% of the observations. The requirements most frequently referenced in new Recommendations or Suggestions in follow-up missions are all from GSR Part 1: Requirement 18: Staffing and competence of the regulatory body; Requirement 7: Coordination with different authorities; Requirement 33: Review of regulations and guides. ii

5 Requirement 16: Organizational structure of the regulatory body and allocation of resources; Requirement 20: Liaison with advisory bodies and support organizations. The report also noted in the outlook section that in some Member States some regulatory issues require actions that are still work underway. The level of completion of actions associated with these issues varies among different countries. For illustration, some highlights are presented here: The effective separation between the functions of the regulatory body and those of any other body or organization concerned with the promotion or utilization of nuclear energy is essential to ensure that the regulatory body is free from any undue pressure from interested parties; The development of the regulatory body integrated management system is a key issue for regulatory effectiveness; International cooperation for information exchange among regulatory bodies is essential for enhancing nuclear and radiation safety worldwide; Processes, procedures and guidance are required for the regulatory body to conduct its functions in a consistent manner; Sharing of IRRS recommendations, suggestions and good practices is of utmost importance; Transparency and openness in the regulatory process is significantly improving as part of new communication practices and consultations with the public and other interested parties; There is an increasing harmonization between national safety standards and the IAEA Safety Standards. Finally, there is general consensus about the benefits of self-assessment and peer review processes and the knowledge and experience exchange associated with the IRRS. iii

6 Contents Executive summary... i 1 Introduction The Integrated Regulatory Review Service Objective and scope Structure of the report Background Structure of the IRRS Relationship between IRRS and the IAEA Safety Standards GSR Part 1 (Rev. 1) versus GS-R GSR Part 2 versus GS-R GSR Part 7 versus GS-R Missions analyzed Limitations and assumptions of the analysis Basis for the analysis of findings to the IAEA Safety Standards Analysis of Recommendation and Suggestion references to the IAEA Safety Standards General references to IAEA Safety Standards References to GSR Part 1: Governmental, Legal and Regulatory Infrastructure for Safety References to GSR Part 3: Protection and Safety of Radiation Sources: International Basic Safety Standards References to GSR Part 2: Leadership and Management for Safety References to GSR Part 7: Preparedness and Response for a Nuclear or Radiological Emergency Analysis of Good Practice references to the IAEA Safety Standards Overall references to Good Practices Good Practice references to GSR Part Good Practice references to GSR Part Good Practice references to GSR Part Good practice references to GSR Part Analysis of observations by subject groups iv

7 5.1 Introduction Module 1: Responsibilities and functions of the government Highlights of observations Module 2: Global Nuclear Safety Regime Highlights of observations Module 3: Responsibilities and functions of the regulatory body Highlights of observations Module 4: Management system of the regulatory body Highlights of observations Module 5: Authorization Highlights of observations Module 6: Review and assessment Highlights of observations Module 7: Inspection Highlights of observations Module 8: Enforcement Highlights of observations Module 9: Regulations and guides Highlights of observations Module 10: Emergency preparedness and response (regulatory aspects) Highlights of observations v

8 5.12 Overall analysis of subject groups Follow-up missions Closure rates for Recommendations and Suggestions New observations resulting in Recommendations and Suggestions in follow-up missions Analysis of IRRS missions related to the regulation of operating nuclear power plants (NPPs) Introduction Reference to IAEA Safety Standards Reference by subject group Analysis of IRRS missions related to the regulation of radioactive sources Introduction Reference to IAEA Safety Standards Reference by subject group Outlook Appendix 1: Mapping of GS-R-1 to GSR Part vi

9 1 Introduction 1.1 The Integrated Regulatory Review Service In 2006, the Agency introduced the Integrated Regulatory Review Service (IRRS), which replaced its IRRT, RaSSIA and TranSAS services, as well as the regulatory aspects of its EPREV service. To the end of 2017, the Agency had conducted 95 IRRS missions (including both initial and follow-up missions) to 65 Member States. 1.2 Objective and scope This report summarizes the analysis of the IRRS missions conducted from 2006 to Although all IRRS review missions cover key aspects of the regulatory programme in a Member State, the modular nature of the IRRS service allows Member States to specify the scope of the review. In many cases, the Member State requests a review of the entire regulatory programme, while in some cases, the Member State requested that the IRRS review focus on a limited number of facilities and activities. The result is that the scope of the various missions varies considerably in terms of size and complexity. 1.3 Structure of the report Chapter 2 provides the background to the IRRS and the nature of the analysis. Chapter 3 is the analysis of the Recommendations and Suggestions references to the IAEA Safety Standards. Chapter 4 is the analysis of the Good Practices references to the IAEA Safety Standards. Chapter 5 is the analysis of the observations by subject group and Chapter 6 is the analysis of information from followup missions. Chapter 7 provides some details on IRRS observations regarding the regulation of operating nuclear power plants. Chapter 8 provides some details on IRRS observations regarding the regulation of radioactive sources. Chapter 9 provides an outlook for future work needed by Member State governments and regulatory bodies to further enhance regulatory effectiveness. 2 Background 2.1 Structure of the IRRS The Agency established the IRRS to strengthen and enhance the effectiveness of national regulatory infrastructures for nuclear, radiation, radioactive waste and transport safety and the security of radioactive sources while recognizing the ultimate responsibility of each Member State to ensure safety. Using the IAEA Safety Standards, the IRRS considers both regulatory technical and regulatory policy issues. As Figure 1 shows, the IRRS has a modular structure designed to be tailored to both generic and Member State specific needs and to facilitate the review of circumstances where the scope of regulatory responsibility may be changing. 1

10 Figure 1 Modular structure of the IRRS The observations arising from an IRRS mission are categorized as: Recommendations: which reflect non-compliance with a requirement from the IAEA Safety Standards; Suggestions: which identify opportunities for improvement; Good Practices: which identify regulatory practices superior to those observed elsewhere. To review the progress in the implementation of the Recommendations and Suggestions from the IRRS mission, the Agency recommends that a follow-up mission takes place two to four years after the initial mission. The follow-up mission will rate each Recommendation and Suggestion as either closed or open. The follow-up mission will typically also identify further observations, resulting in new Recommendations, Suggestions or Good Practices. 2.2 Relationship between IRRS and the IAEA Safety Standards The IAEA Safety Standards provide the basis for all of the Agency s safety related services, including the IRRS. For the IRRS, the main safety standards used for the 2006 to 2017 missions are: GSR Part 1 (Rev. 1): Governmental, Legal and Regulatory Framework for Safety; GSR Part 2: Leadership and Management for Safety; GSR Part 3: Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards; GSR Part 7: Preparedness and Response for a Nuclear or Radiological Emergency. In addition to these four main IAEA Safety Standards, IRRS missions frequently reference other IAEA Safety Standards. 2

11 GSR Part 1 (Rev. 1) comprises 36 overarching requirements on the governmental, legal and regulatory framework for safety. The 36 requirements form the basis for the IRRS as shown in Table 1. Table 1 Modules and the associated safety requirements of the IRRS Module No GSR Part 1 (Rev. 1) Overarching Requirement R1: National policy and strategy R2: Establishment of a framework for safety R3: Establishment of a regulatory body R4: Independence of the regulatory body R5: Prime responsibility for safety 1 R6: Compliance with regulations and responsibility for safety R7: Coordination of different authorities with responsibilities for safety within the regulatory framework for safety R9: System for protective actions to reduce existing or unregulated radiation risks R10: Provision for the decommissioning of facilities and the management of radioactive waste and of spent fuel R11: Competence for safety R13: Provision of technical services R14: International obligations and arrangements for international cooperation 2 R15: Sharing of operating experience and regulatory experience R16: Organizational structure of the regulatory body and allocation of resources R17: Effective independence in the performance of regulatory functions R18: Staffing and competence of the regulatory body R20: Liaison with advisory bodies and support organizations 3 R21: Liaison between the regulatory body and authorized parties R22: Stability and consistency of regulatory control R35: Safety related records R36: Communication and consultation with interested parties 4 R19: The management system of the regulatory body R23: Authorization of facilities and activities by the regulatory body 5 R24: Demonstration of safety for the authorization of facilities and activities R25: Review and assessment of information relevant to safety 6 R26: Graded approach to review and assessment of a facility or an activity R27: Inspection of facilities and activities 7 R28: Types of inspection of facilities and activities R29: Graded approach to inspections of facilities and activities R30: Establishment of an enforcement policy 8 R31: Requiring of corrective action by authorized parties R32: Regulations and guides 9 R33: Review of regulations and guides R34: Promotion of regulations and guides to interested parties 10 R8: Emergency preparedness and response 11 Observations from Module 11 are reallocated to Modules 1-10 as appropriate 12 R12: Interfaces of safety with nuclear security and with the State system of accounting for, and control of, nuclear material 2.3 GSR Part 1 (Rev. 1) versus GS-R-1 The IRRS missions between 2006 and early 2010 were based on IAEA Safety Standard GS-R-1: Legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety, published in This was superseded in 2010 by GSR Part 1, which was updated to GSR Part 1 (Rev.1) in GSR Part 1 (Rev.1) did not introduce any new requirements. Although the main principles and requirements of GS-R-1 and GSR Part 1 (Rev. 1) are the same, they differ both in structure and format. To be able to make valid statements on the references and observations of all missions, references from GS-R-1 were converted to their equivalent in GSR Part 1 (Rev. 1) 1. 1 For the remainder of this document, (Rev. 1) is to be implied when references are made to GSR Part 1 3

12 2.4 GSR Part 2 versus GS-R-3 The IRRS missions before 2016 were based on IAEA Safety Standard GS-R-3: The Management System for Facilities and Activities, published in This was superseded in 2016 by GSR Part 2: Leadership and Management for Safety. To be able to make valid statements on the references and observations of all missions, references to GS-R-3 were converted to their equivalent in GSR Part GSR Part 7 versus GS-R-2 The IRRS missions before 2016 were based on IAEA Safety Standard GS-R-2: Preparedness and Response for a Nuclear or Radiological Emergency, published in This was superseded in 2015 by GSR Part 7: Preparedness and Response for a Nuclear or Radiological Emergency. Although the main principles and requirements of the two documents are the same, they differ both in structure and format. To be able to make valid statements on the references and observations of all missions, references to GS-R-2 were converted to their equivalent in GSR Part 7. Moreover the content of the module 10 was revised in 2017 to ensure more adequate focus on the regulatory aspects of emergency preparedness and response. This revision has been reflected in the report template used from the second half of Therefore direct comparison might not be easily to conduct. This has been taken into account in producing this report. 2.6 Missions analyzed This analysis covers 69 initial and 26 follow-up IRRS missions to 65 Member States. Figure 2 shows the year and location of the IRRS missions conducted. Follow-up missions are denoted by (f), the UK part 2 mission was a mixture of follow-up and initial mission, all other missions were initial missions. Belgium (f) Tanzania Botswana Ireland Cyprus Republic of Korea (f) Indonesia South Africa Czech Rep (f) Niger UAE France Finland (f) Italy Ethiopia Mexico Germany Canada (f) Zimbabwe Croatia Belarus France (f) Mauritius Ukraine Russia Switzerland Netherlands Hungary Estonia Greece (f) Cameroon Sierra Leone UK (part 2) Kenya Namibia Vietnam Slovenia Uganda Madagascar Lebanon Ukraine (f) France Gabon Botswana Canada USA Australia (f) Belgium Cameroon Armenia Kenya Guatemala Germany (f) Republic of Korea Finland Czech Rep Russia (f) Vietnam (f) Slovenia (f) Switzerland (f) Malta China (f) Sweden (f) Jordan (f) FYR of Macedonia Greece UK (f) Jordan India Lithuania Nigeria UK Australia Spain Peru China Spain (f) Slovakia Bulgaria Pakistan Slovakia (f) Romania Japan Cote d Ivoire France (f) Bulgaria (f) Iran Romania Sweden Poland USA (f) UAE (f) Japan Figure 2 IRRS Missions from 2006 to Limitations and assumptions of the analysis Poland (f) Romania (f) IRRS missions vary substantially in their scope, based both on the nuclear and radiological facilities and activities in the Member State and the decision by the Member State on what facilities and activities to include in the scope. This analysis includes data from 95 IRRS missions, which is sufficient to draw meaningful conclusions on general characteristics and trends. However, individual mission data vary substantially, due to: 4

13 Scope and size of the mission; Composition, expertise and size of the team; Working methods of the team leader and members; Nuclear and radiological activities in the Member State; Evolution of the IRRS process over time. 2.8 Basis for the analysis of findings to the IAEA Safety Standards The purpose of the IRRS is to assess the host Member State national regulatory infrastructure against the relevant IAEA Safety Standards through a peer review. Thus, the Recommendations, Suggestions and Good Practices identified during a mission are based on IAEA Safety Standards that are clearly documented in the mission report. Any requirement in any IAEA Safety Standard may form the basis for a Recommendation, Suggestion or Good Practice. Figure 3 shows how the IRRS mission report identifies the basis for Recommendations, Suggestions and Good Practices. Figure 3 Examples of IAEA Safety Standard requirements as bases for observations 5

14 Number of references Each time a particular requirement from an IAEA Safety Standard was used as a basis for a Recommendation or Suggestion was counted as a reference to that requirement. If two separate requirements from the same IAEA Safety Standard were cited as the basis for a particular Recommendation or Suggestion, then that would count as two references to that IAEA Safety Standard. However, if a requirement was cited more than once for the same Recommendation or Suggestion, then that would count as a single reference. 3 Analysis of Recommendation and Suggestion references to the IAEA Safety Standards 3.1 General references to IAEA Safety Standards As Figure 4 shows, almost half of the references are to GSR Part 1. GSR Part 3 accounts for 15% of the references, with GSR Part 2, GSR Part 7 and various IAEA Safety Guides accounting for around 10% each Recommendations Suggestions Figure 4 References to IAEA Safety Standards Referring again to Figure 4, for the requirements documents (GSR Part 1, GSR Part 2, GSR Part 3 and GSR Part 7), the references are predominantly related to Recommendations, while for the Safety Guides, the references are predominantly related to Suggestions. This is as expected, since Recommendations are only issued where there is non-compliance with a safety requirement. Guidance documents identify approaches for achieving the safety requirements but do not introduce new safety requirements. In every case where an IAEA Safety Guide is used as a basis for a Recommendation, there is also an IAEA Safety Requirements document as a basis. 6

15 Number of references Number of references 3.2 References to GSR Part 1: Governmental, Legal and Regulatory Infrastructure for Safety Recommendations Suggestions Requirement number Figure 5 References to GSR Part 1 (sorted by Requirement number) As Figure 5 shows, every requirement in GSR Part 1 was referenced by at least one Recommendation and one Suggestion during the reporting period, with the references for Recommendations usually outnumbering the references for Suggestions for a given requirement. Figure 6 presents the same data sorted from most frequent to least Recommendations Suggestions Requirement number Figure 6 References to GSR Part 1 (sorted by frequency) Figure 6 shows that the following requirements are referenced most frequently: Requirement 2: Establishment of a framework for safety; Requirement 24: Demonstration of safety for the authorization of facilities and activities; Requirement 32: Regulations and guides; 7

16 Number of references Requirement 18: Staffing and competence of the regulatory body; Requirement 4: Independence of the regulatory body; Requirement 29: Graded approach to inspections of facilities and activities. The least frequently referenced requirements are: Requirement 12: Interfaces of safety with nuclear security and with the State system of accounting for, and control of, nuclear material; Requirement 21: Liaison between the regulatory body and authorized parties; Requirement 6: Compliance with regulations and responsibility for safety; Requirement 8: Emergency preparedness and response; Requirement 13: Provision of technical services. 3.3 References to GSR Part 3: Protection and Safety of Radiation Sources: International Basic Safety Standards The second most frequently referenced requirements document was GSR Part 3. As Figure 7 shows, almost three quarters of the references to GSR Part 3 were for Recommendations Recommendations Suggestions Requirement number Figure 7 References to GSR Part 3 (sorted by frequency) Figure 7 shows that the following GSR Part 3 requirements are referenced most frequently: Requirement 2: Establishment of a legal and regulatory framework; Requirement 34: Responsibilities of the government specific to medical exposure; Requirement 38: Optimization of protection and safety (for medical exposure); Requirement 32: Monitoring and reporting (public exposure); Requirement 47: Responsibilities of the government specific to existing exposure situations; Requirement 3: Responsibilities of the regulatory body. The following GSR Part 3 requirements are not referenced in any IRRS mission: Requirement 5: Management for protection and safety; 8

17 Number of references Requirement 15: Prevention and mitigation of accidents; Requirement 16: Investigations and feedback of information on operating experience. Of the GSR Part 3 requirements that are referenced in an IRRS mission, the least frequently referenced requirements are: Requirement 18: Human imaging using radiation for purposes other than medical diagnosis, medical treatment or biomedical research; Requirement 46: Arrangements for the transition from an emergency exposure situation to an existing exposure situation; Requirement17: Radiation generators and radioactive sources; Requirement 4: Responsibilities for protection and safety; Requirement 43: Emergency management system; Requirement 9: Responsibilities of registrants and licensees in planned exposure situations; Requirement 44: Preparedness and response for an emergency; Requirement 1: Application of the principles of radiation protection. 3.4 References to GSR Part 2: Leadership and Management for Safety Recommendations Suggestions Figure 8 References to GSR Part 2 As shown in Figure 8, the five most common GSR Part 2 requirements referenced are: Management of processes and activities (Requirement 10); Documentation of the management system (Requirement 8); Measurement, assessment and improvement of the management system (Requirement 13); Integration of the management system (Requirement 6); Goals, strategies, plans and objectives (Requirement 4). Figure 8 also shows that three GSR Part 2 requirements received fewer than 10 references: 9

18 10 Management of the supply chain (Requirement 11); Achieving the fundamental safety objective (Requirement 1); Interaction with interested parties (Requirement 5).

19 Number of references 3.5 References to GSR Part 7: Preparedness and Response for a Nuclear or Radiological Emergency Another frequently referenced standard in IRRS mission Recommendations and Suggestions was GSR Part Recommendations Suggestions Figure 9 References to GSR Part 7 As shown in Figure 9, the top five requirements referenced are: Roles and responsibilities in emergency preparedness and response (Requirement 2); Identifying and notifying a nuclear or radiological emergency and activating an emergency response (Requirement 7); Training, drills and exercises for emergency preparedness and response (Requirement 25); Hazard assessment (Requirement 4); Plans and procedures for emergency response (Requirement 23). Figure 9 also shows that the following requirements were not referenced in any IRRS mission: Mitigating non-radiological consequences of a nuclear or radiological emergency and of an emergency response (Requirement 16); Requesting, providing and receiving international assistance for emergency preparedness and response (Requirement 17). 11

20 Number of references 4 Analysis of Good Practice references to the IAEA Safety Standards 4.1 Overall references to Good Practices Another objective of the IRRS is to share Good Practices among regulatory bodies. Many IRRS initial missions identified at least one Good Practice. Figure 10 shows the references related to Good Practices GSR Part 1 Safety Guides GSR Part 7 GSR Part 2 GSR Part 3 Other Requirements documents Figure 10 Overall references to Good Practices GSR Part 1 accounted for 65% of the references. However, IRRS missions identified Good Practices related to GSR Part 2, GSR Part 3 and GSR Part 7 requirements. For GSR Part 1, the ratio of Good Practices to Recommendations and Suggestions was 1:7, while for GSR Part 2 and GSR Part 7, the ratio was around 1:10, and for GSR Part 3, the ratio was around 1:30. 12

21 Number of references 4.2 Good Practice references to GSR Part Requirement number Figure 11 Good Practice references to GSR Part 1 (sorted by frequency) Figure 11 shows that every GSR Part 1 requirement except Requirements 6 and 13 were referenced in at least one IRRS mission. The top five requirements referenced with respect to a Good Practice are: Requirement 18: Staffing and competence of the regulatory body; Requirement 36: Communication and consultation with interested parties; Requirement 27: Inspection of facilities and activities; Requirement 14: International obligations and arrangements for international cooperation and assistance; Requirement 24: Demonstration of safety for the authorization of facilities and activities. The least referenced requirements with respect to a Good Practice are: Requirement 13: Provision of technical services; Requirement 6: Compliance with regulations and responsibility for safety; Requirement 30: Establishment of a compliance policy; Requirement 12: Interfaces of safety with nuclear security and with the State system of accounting for and control of nuclear material; Requirement 5: Prime responsibility for safety. 13

22 Number of references Number of references Recommendations & Suggestions Good Practices Requirement number Figure 12 Recommendation & Suggestion vs Good Practice references to GSR Part 1 Figure 12 shows that, with three exceptions, the number of references to a requirement for Good Practices is a small fraction of those references for Recommendations and Suggestions combined. The three exceptions are for: Requirement 14: International obligations and arrangements for international cooperation; Requirement 21: Liaison between the regulatory body and authorized parties; Requirement 36: Communication and consultation with interested parties. In these cases, the number of references to Good Practices is more than 40% of the number of Recommendations and Suggestions combined. 4.3 Good Practice references to GSR Part Figure 13 Good practices references to GSR Part 2 14

23 Number of references Figure 13 shows that the GSR Part 2 requirements receiving the highest number of references for Good Practices are: Provision of resources (Requirement 9); Management of processes and activities (Requirement 10); Foster a culture for safety (Requirement 12); Measurement, assessment and improvement of the management system. Four requirements did not receive a reference for a Good Practice: Management of the supply chain (Requirement 11); Application of the graded approach (Requirement 7); Interaction with interested parties (Requirement 5); Achieving the fundamental safety objective (Requirement 1) Recommendations & Suggestions Good Practices Figure 14 Recommendation & Suggestion vs Good Practice references to GSR Part 2 Referring to Figure 14, it is seen that for the number of references to a Good Practice is a fraction of the number of references to a Recommendation or Suggestion. Note that Requirement 11: Management of the supply chain, was never referenced in an IRRS mission. 15

24 Number of references Number of references 4.4 Good Practice references to GSR Part Requirement number Figure 15 Good Practice references to GSR Part 3 Figure 15 shows that only 18 GSR Part 3 requirements were referenced for a Good Practice. The GSR Part 3 requirements receiving more than one reference for a Good Practice are: Requirement 2: Establishment of a legal and regulatory framework; Requirement 30: Responsibilities of relevant parties specific to public exposure; Requirement 31: Radioactive waste and discharges; Requirement 32: Monitoring and reporting (public exposure); Requirement 37: Justification of medical exposures; Requirement 41: Unintended and accidental medical exposures; Requirement 49: Responsibilities for remediation of areas with residual radioactive material Recommendations & Suggestions Good Practices Requirement number Figure 16 Recommendation & Suggestion vs Good Practice references to GSR Part 3 16

25 Number of references Referring to Figure 16, it is seen that the number of references to a Good Practice is a small fraction of the number of references to a Recommendation or Suggestion. Three GSR Part 3 requirements, namely: Requirement 5: Management and protection for safety; Requirement 15: Prevention and mitigation of accidents; Requirement 16: Investigations and feedback of information on operating experience, have never been referenced in an IRRS mission. The essential elements of these three requirements are covered by requirements in other IAEA Safety Standards. 4.5 Good practice references to GSR Part Figure 17 Good Practice references to GSR Part 7 As Figure 17 shows, 17 GSR Part 7 requirements were referenced for a Good Practice. The GSR Part 7 requirements receiving more than two references are: Roles and responsibilities in emergency preparedness and response (Requirement 2); Logistical support and facilities for emergency response (Requirement 24); Managing operations in an emergency response (Requirement 6); Training, drills and exercises for emergency preparedness and response (Requirement 25); Identifying and notifying a nuclear or radiological emergency and activating an emergency response (Requirement 7); Communicating with the public throughout a nuclear or radiological emergency (Requirement 13); Plans and procedures for emergency response (Requirement 23). 17

26 Number of references Recommendations & Suggestions Good Practices Figure 18 Recommendation & Suggestion vs Good Practice references to GSR Part 7 Referring to Figure 18, it is seen that, with three exceptions, the number of references to a Good Practice is typically a small fraction of the number of references to a Recommendation or Suggestion. For two of the exceptions, namely: Logistical support and facilities (Requirement 24); Emergency management system (Requirement 1), the number of Good Practice references is around half of the Recommendation and Good Practice references. One requirement Requirement 16: Mitigating the non-radiological consequences of a nuclear or radiological emergency is only referenced for a Good Practice. Finally, one requirement Requirement 17: Requesting, providing and receiving international assistance for emergency preparedness and response was not referenced in any IRRS mission. 5 Analysis of observations by subject groups Another way of categorizing the observations from IRRS missions is to sort them according to the subject. The subjects that more frequently result in Recommendations and Suggestions should receive further consideration, as this indicates that a number of Member States may face the similar challenges. 5.1 Introduction The subject groups do not have exact definitions; rather they comprise sufficient numbers of observations sharing the same or similar characteristics. Consequently, although a mission report may 18

27 place a Recommendation in a particular module, for the purpose of this analysis, observations may be allocated to another, more appropriate subject group in another module. In the following sections, the number of observations (Recommendations, Suggestions and Good Practices) for each module are tabulated, with those subject groups with the most observations highlighted. Observations from Module 11 2 of IRRS missions have been reallocated to Modules 1 to 10 as appropriate. Every observation from the IRRS missions is included in the analysis by subject groups. In the following sections, the number of observations (Recommendations, Suggestions and Good Practices) for each module is tabulated, with those subject groups with the most observations highlighted. 5.2 Module 1: Responsibilities and functions of the government There are eight subject groups associated with the responsibilities and functions of the government: a) Cooperation/interaction among organizations, bodies: Role of the regulatory body in various fields and cooperation amongst the respective authorities; coordination with other governmental organizations; common use of databases; memoranda of understanding. b) National policies and strategies for safety: National safety policy and strategy; training policy and strategy; competence/human resources building strategy. c) Providing resources to the regulatory body: Provision of financial and human resources by the government; resources for international cooperation; adjusting funding to workload. d) Providing/using legal framework for regulatory activities: Revision of regulations to provide authority; reflecting independence of the regulatory body; issuance of decrees and orders; relieving time constraints on decision making. e) Transparency, public involvement: Determining the role of the public in the regulatory process; stakeholder engagement; establishing communication strategy; informing the public; meeting with residents; public consultations; impact of transparency on safety. f) Prime responsibility for safety: Clarifying the responsibilities of the regulatory body; declaration by law; declaration by the regulatory body. g) Building competence in safety: Recommending training for other organizations; qualification and registration of experts; establishment of international school; capacity building programme for students. x) Other: Any other government responsibilities and functions subject not included above. As Table 2 shows, a total of 825 observations were related to the responsibilities and functions of the government, the largest number of any module. Four subject groups accounted for most of these observations, namely: Cooperation / interaction among organizations, bodies; National policies and strategies for safety; Providing / using the legal framework for regulatory activities; Independence of the regulatory body. Table 1 Number of observations by subject group for government responsibilities and functions Subject group R S GP 2 Such as: transport; control of medical exposures, occupational radiation protection; control of radioactive discharges and materials for clearance; environmental monitoring associated with authorized practices for public radiation protection purposes; control of chronic exposures and remediation 19

28 a Cooperation/interaction among organizations, bodies b National policies and strategies for safety c Providing resources to the regulatory body d Providing/using legal framework for regulatory activities e Transparency, public involvement f Prime responsibility for safety g Building competence in safety h Independence of the regulatory body x Other Σ Sum of observations Highlights of observations Cooperation / interaction among organizations, bodies Arrangements should be made for the effective coordination of the authorities having regulatory responsibilities for nuclear and radiation safety, as well as those responsible for the regulation of the transport of radioactive material. Consideration should be given to assigning one organization the responsibility for coordinating the nuclear and radiological safety infrastructure. Formal agreements and memoranda of understanding should be used to clarify the relationships between organizations. Consideration should be given to conducting joint activities, such as review and assessment and inspections National policies and strategies for safety A national policy and strategy for safety should be established. The policy and strategy should include all nuclear and radiological facilities and activities in the Member State, including decommissioning, waste management and the transport of radioactive material. The national strategy should include mechanisms for the funding of the decommissioning of nuclear and radiological facilities. Time limits prescribed for the completion of a safety review prior to the granting of an authorization for a facility or activity should be flexible enough to ensure safety is not compromised. Organizations taking actions to recover and manage orphan sources should have access to adequate funding and resources. Action should be taken to bring all unlicensed nuclear and radiological facilities under regulatory control. An action plan for controlling public exposure due to radon should be established and implemented Providing resources to the regulatory body The regulatory body should have sufficient human and financial resources to completely fulfil its statutory regulatory obligations. 20

29 Providing / using the legal framework for regulatory activities The legal framework should extend to include all nuclear and radiological facilities and activities in the Member State, including the regulation of patient protection, transport of radioactive material, waste management and disposal of radioactive material. The legal framework should clearly delineate the roles, responsibilities and authorities of the various entities in the Member States and should include a requirement that a positive decision from the regulatory body is a prerequisite to issuing an authorization. The legal framework should empower the regulatory body to establish requirements for authorization. The legal framework should include provisions for an applicant or authorized party to appeal a decision of the regulatory body. The legal framework should explicitly address the interface between safety and security, including oversight and enforcement Transparency, public involvement Interested parties including the public should be informed and consulted regarding possible radiation risks associated with facilities and activities, and about the processes and decisions of the regulatory body. Specific provisions should be in place to foster consultation of interested parties in regulatory body processes Prime responsibility for safety Legislation should explicitly assign primary responsibility for safety to the persons or organizations responsible for facilities and activities Building competence in safety Provisions should be in place to ensure the competence of all parties having responsibilities for the safety of facilities and activities. Appropriate qualification requirements should be established and training arrangements should be made to ensure a reliable supply of competent radiation specialists (i.e., Radiation Protection Officers, medical radiation technologists, radiopharmacists and radiochemists). A process for the formal recognition of medical physicists and qualified experts for radiation protection should be established. Provisions should be in place for research and development programmes to support nuclear and radiological safety Independence of the regulatory body Provisions should be in place to ensure that the regulatory body is effectively separate from entities having responsibilities or interests that could unduly influence its decision-making. The regulatory body should have the authority to assign its resources and reorganize or restructure to enable it to discharge its assigned responsibilities. 21

30 With regard to the national policy and strategy, the regulatory body should limit its advice to nuclear and radiological safety issues. In addition, the regulatory body should avoid assuming responsibilities that conflict with its statutory regulatory responsibilities Good Practices A statutory requirement to comply with IAEA Safety Standards. Cooperation between the regulatory body and police and customs services supports an integrated approach to safety and security of radiation sources. The national radon control strategy uses a top down approach driven by Government, ensuring all stakeholders work together. The Member State system of radiation protection education and training is exemplary. The promotion of public education on national television and the engagement of the regulatory body to provide technical expertise. Routine workshops and training for news media to inform them of the safety of facilities and activities, and about the processes and decisions of the regulatory body. 5.3 Module 2: Global Nuclear Safety Regime There are three subject groups associated with the Global Nuclear Safety Regime: a) Operating and regulatory experience exchange with international community: Operating and regulatory experience feedback in line with the international recommendations; exchange with the international community; publication of research results and experience; action plan based on review missions; use of IAEA Safety Standards. b) Relationship with international organizations: Resources for international cooperation; role of national coordinator; inviting IRRS missions; participation in international conventions. c) Relationship with other countries regulatory bodies: Establishing liaison and cooperation with neighbouring countries, countries with similar technology and countries supplying technology or equipment. x) Other: Any other Global Nuclear Safety Regime subject not included above. Table 3 shows that 103 observations were related to the Global Nuclear Safety Regime, the fewest number of any module. This module was unique in that the number of Good Practices was almost the same as the number of Recommendations. Table 2 Number of observations by subject group for Global Nuclear Safety Regime Subject group R S GP a Operating and regulatory experience exchange with international community b Relationship with international organizations c Relationships with other countries regulatory bodies x Other Σ Sum of observations Highlights of observations Operating and regulatory experience exchange with international community Arrangements for operating and regulatory experience feedback should include radiation safety and radiation protection. The operating and regulatory experience feedback should be disseminated to authorized parties, the regulatory body and other relevant authorities. 22

31 Relationship with international organizations Resources should be provided to enable active participation in international cooperation activities for safety, such as sharing of regulatory experience and participation in IAEA safety review missions Relationships with other countries regulatory bodies Neighbouring countries should be included in the public consultation process for nuclear facilities that could affect those countries. Countries should liaise with, and establish arrangements with, regulatory bodies of other countries using similar technology Good Practices Active engagement in international cooperation including international arrangements, peer reviews and international support programmes. Use of state-of-the-art safety standards from foreign regulatory bodies to cover gaps in the national framework. 5.4 Module 3: Responsibilities and functions of the regulatory body There are nine subject groups associated with the responsibilities and functions of the regulatory body: a) Staffing of the regulatory body: Staffing needs; recruitment programme; rotation of positions; exchange of staff with technical support organizations; retention, hiring, motivation of staff; filling vacancies; recruitment of successors. b) Competence of the regulatory body: Necessary/adequate qualifications and expertise; competence requirements; continuity of actions and consistency of priorities following staff changes; capability of performing tasks; procedure and control of staff qualification needs. c) Resources of the regulatory body: Determining/planning/reviewing resource needs for given tasks; managing available resources; financing external support; salaries; charging fees for regulatory activities; resources for research activities. d) Organization of the regulatory body: Evaluating task assessments; integration of inspector tasks; reviewing the organization to increase effectiveness; internal cooperation. e) Developing documents for regulatory activities and cooperation: Research and development programme; cooperation documents; document management. f) External involvement in the regulatory process: Advisory committees; involvement of other organizations in nuclear safety matters; technical support organizations; policy for seeking external expert advice; relationship with licensees. g) Training of regulatory body personnel: Establishment of a systematic training programme; specific contents of training; training requirements of staff; mentoring programme. h) Decision-making process, content of decisions: Developing/reviewing the decision-making process; communicating the bases of decisions; diverse decision formats. x) Other: Any other regulatory body responsibilities and functions subject not included above. As seen in Table 4, there were 292 observations related to the responsibilities and functions of the regulatory body, the third highest number of observations for a module. The subject groups most frequently identified were: Staffing of the regulatory body; Competence of the regulatory body; Training of the regulatory body. 23