Iaea-Ns-Irrs-2011/05

IAEA-NS-IRRS-20xx ORIGINAL: English Template Version No. 5

INTEGRATED REGULATORY

REVIEW SERVICE (IRRS) MISSION

DEPARTMENT OF NUCLEAR SAFETY AND SECURITY

i INTEGRATED REGULATORY REVIEW SERVICE (IRRS) REPORT TO

ii INTEGRATED REGULATORY REVIEW SERVICE (IRRS) REPORT TO Mission date: Regulatory body: Location: Regulated facilities and activities: Organized by:

IRRS REVIEW TEAM

IAEA-2011

iii The number of recommendations, suggestions and good practices is in no way a measure of the status of the regulatory body. Comparisons of such numbers between IRRS reports from different countries should not be attempted.

iv CONTENTS EXECUTIVE SUMMARY...... 8 I. INTRODUCTION...... 9 II. OBJECTIVE AND SCOPE...... 10 III. BASIS FOR THE REVIEW...... 11 1. RESPONSIBILITIES AND FUNCTIONS OF THE GOVERNMENT...... 15 1.1. NATIONAL POLICY AND STRATEGY FOR SAFETY...... 15 1.2. ESTABLISHMENT OF A FRAMEWORK FOR SAFETY...... 16 1.3. ESTABLISHMENT OF A REGULATORY BODY AND ITS INDEPENDENCE. .16 1.4. COMPLIANCE WITH REGULATIONS AND RESPONSIBILITY FOR SAFETY ...... 17 1.5. COORDINATION OF AUTHORITIES WITH RESPONSIBILITIES FOR SAFETY WITHIN THE REGULATORY FRAMEWORK...... 17 1.6 SYSTEM FOR PROTECTIVE ACTIONS TO REDUCE UNREGULATED RADIATION RISKS...... 17 1.7. PROVISIONS FOR DECOMMISSIONING AND MANAGEMENT OF RADIOACTIVE WASTE AND SPENT FUEL...... 18 1.8. COMPETENCE FOR SAFETY...... 18 1.9. PROVISION OF TECHNICAL SERVICES...... 19 1.10. SUMMARY...... 19 2. GLOBAL NUCLEAR SAFETY REGIME...... 20 2.1. INTERNATIONAL OBLIGATIONS AND ARRANGEMENTS FOR INTERNATIONAL COOPERATION...... 20 2.2. SHARING OF OPERATING EXPERIENCE AND REGULATORY EXPERIENCE...... 20 2.3. SUMMARY...... 21 3. RESPONSIBILITIES AND FUNCTIONS OF THE REGULATORY BODY...... 22 3.1. ORGANIZATIONAL STRUCTURE OF THE REGULATORY BODY AND ALLOCATION OF RESOURCES...... 22 3.2. EFFECTIVE INDEPENDENCE IN THE PERFORMANCE OF REGULATORY ACTIVITIES...... 23 3.3. STAFFING AND COMPETENCE OF THE REGULATORY BODY...... 23 3.4. LIAISON WITH ADVISORY BODIES AND SUPPORT ORGANIZATIONS...... 23 3.5. LIAISON BETWEEN THE REGULATORY BODY AND AUTHORIZED PARTIES...... 24 3.6. STABILITY AND CONSISTENCY OF REGULATORY CONTROL...... 24 3.7. SAFETY RELATED RECORDS...... 25 3.8. COMMUNICATION AND CONSULTATION WITH INTERESTED PARTIES. .25 3.9. SUMMARY...... 25 4. MANAGEMENT SYSTEM OF THE REGULATORY BODY...... 27

v 4.1. IMPLEMENTATION AND DOCUMENTATION OF THE MANAGEMENT SYSTEM...... 27 4.2. MANAGEMENT RESPONSIBILITY...... 28 4.3. RESOURCE MANAGEMENT...... 28 4.4. PROCESS IMPLEMENTATION...... 29 4.5. MEASUREMENT, ASSESSMENT AND IMPROVEMENT...... 29 4.6. SUMMARY...... 30 5. AUTHORIZATION...... 31 5.1. GENERIC ISSUES...... 31 5.2. AUTHORIZATION OF NUCLEAR POWER PLANTS...... 32 5.3. AUTHORIZATION OF RESEARCH REACTORS...... 33 5.4. AUTHORIZATION OF FUEL CYCLE FACILITIES...... 33 5.5. AUTHORIZATION OF RADIOACTIVE WASTE MANAGEMENT FACILITIES ...... 34 5.6. AUTHORIZATION OF RADIATION SOURCES FACILITIES...... 34 5.7. AUTHORIZATION OF DECOMMISSIONING ACTIVITIES...... 35 5.8. AUTHORIZATION OF TRANSPORT ACTIVITIES...... 35 5.9. SUMMARY...... 36 6. REVIEW AND ASSESSMENT...... 37 6.1. GENERIC ISSUES...... 37 6.2. REVIEW AND ASSESSMENT FOR NUCLEAR POWER PLANTS...... 38 6.2.1. MANAGEMENT OF REVIEW AND ASSESSMENT...... 38 6.2.2. ORGANIZATION AND TECHNICAL RESOURCES FOR REVIEW AND ASSESSMENT...... 39 6.2.3. BASES FOR REVIEW AND ASSESSMENT...... 39 6.2.4. PERFORMANCE OF THE REVIEW AND ASSESSMENT...... 40 6.3. REVIEW AND ASSESSMENT FOR RESEARCH REACTORS...... 41 6.4. REVIEW AND ASSESSMENT FOR FUEL CYCLE FACILITIES...... 41 6.5. REVIEW AND ASSESSMENT FOR WASTE MANAGEMENT FACILITIES...... 41 6.6. REVIEW AND ASSESSMENT FOR RADIATION SOURCES FACILITIES...... 42 6.7. REVIEW AND ASSESSMENT FOR DECOMMISSIONING ACTIVITIES...... 42 6.8. REVIEW AND ASSESSMENT FOR TRANSPORT ACTIVITIES...... 43 6.9. SUMMARY...... 43 7. INSPECTION...... 44 7.1. GENERIC ISSUES...... 45 7.1.1. INSPECTION APPROACHES, METHODS AND PLANS...... 45 7.1.2. INSPECTION PROCESSES AND PRACTICES...... 45 7.1.3. INSPECTORS...... 46 7.2. INSPECTION OF NUCLEAR POWER PLANTS...... 46 7.3. INSPECTION OF RESEARCH REACTORS...... 46 7.4. INSPECTION OF FUEL CYCLE FACILITIES...... 47 7.5. INSPECTION OF WASTE MANEGEMENT FACILITIES...... 47 7.6. INSPECTION OF RADIATION SOURCES FACILITIES...... 48 7.7. INSPECTION OF DECOMMISSIONING ACTIVITIES...... 48 7.8. INSPECTION OF TRANSPORT ACTIVITIES...... 48 vi 7.9. SUMMARY...... 49 8. ENFORCEMENT...... 50 8.1. ENFORCEMENT POLICY AND PROCESSES...... 50 8.2. ENFORCEMENT IMPLEMENTATIONS...... 51 8.3. SUMMARY...... 51 9. REGULATIONS AND GUIDES...... 52 9.1. GENERIC ISSUES...... 52 9.2. REGULATIONS AND GUIDES FOR NUCLEAR POWER PLANTS...... 53 9.3. REGULATIONS AND GUIDES FOR RESEARCH REACTORS...... 53 9.4. REGULATIONS AND GUIDES FOR FUEL CYCLE FACILITIES...... 54 9.5. REGULATIONS AND GUIDES FOR WASTE MANAGEMENT FACILITIES....54 9.6. REGULATIONS AND GUIDES FOR RADIATION SOURCES FACILITES...... 55 9.7. REGULATIONS AND GUIDES FOR DECOMMISSIONING ACTIVITIES...... 55 9.8. REGULATIONS AND GUIDES FOR TRANSPORT ACTIVITIES...... 56 9.9. SUMMARY...... 57 10. EMERGENCY PREPAREDNESS AND RESPONSE...... 58 10.1. GENERAL REQUIREMENTS...... 58 10.2. FUNCTIONAL REQUIREMENTS...... 59 10.3. REQUIREMENTS FOR INFRASTRUCTURE...... 60 10.4. SUMMARY...... 61 11. ADDITIONAL AREAS...... 62 11.1. CONTROL OF MEDICAL EXPOSURES...... 62 11.2. OCCUPATIONAL RADIATION PROTECTION...... 62 11.3. CONTROL OF DISCHARGES, MATERIALS FOR CLEARANCE, AND CHRONIC EXPOSURES; ENVIRONMENTAL MONITORING FOR PUBLIC RADIATION PROTECTION...... 63 11.4. SUMMARY...... 64 12. INTERFACE WITH NUCLEAR SECURITY...... 65 12.1. LEGAL BASIS...... 65 12.2. REGULATORY OVERSIGHT ACTIVITY...... 65 12.3. INTERFACE WITH OTHER AUTHORITIES...... 66 12.4. SUMMARY...... 66 13. REGULATORY IMPLICATIONS OF THE TEPCO FUKUSHIMA DAI-ICHI ACCIDENT...... 67 13.1. IMMEDIATE ACTIONS TAKEN BY THE REGULATORY BODY...... 67 13.2 TECHNICAL AND OTHER ISSUES CONSIDERED IN THE LIGHT OF THE ACCIDENT...... 67 13.3 PLANS FOR UPCOMING ACTIONS TO FURTHER ADDRESS THE REGULATORY IMPLICATIONS OF THE ACCIDENT...... 67 13.4 CONCLUSIONS BY REVIEWED AREAS...... 68

vii EXECUTIVE SUMMARY

Instructions for writing this part: Summarize the main messages of the report with particular emphasize to the subjects below:  Who requested, when and where the mission took place.  What was the purpose of the mission?  Comparison of the regulatory framework to the IAEA safety standards.  Composition of the IRRS Review Team.  Reviewed areas and facilities in the country.  What was not reviewed?  Method of work (advance reference material, interviews, observations, emergency exercises, visits to facilities, institutions, governmental bodies, etc.).  Advance reference material, prepared by the host, and self-assessment.  Appreciation of the host cooperation.  Main observations: o Very short description about the situation in the country o Generally about compliance with IAEA Safety Standards o Summary of good practices o Summary list of areas for improvement, i.e. recommendations and suggestions

8 I. INTRODUCTION

At the request of the Government of Hostcountry, an international team of senior safety experts met representatives of the regulatory body of the host country (XXX) from day to day Month 201n to conduct an Integrated Regulatory Review Service (IRRS) mission. The purpose of the peer review was to review the Hostcountry regulatory framework for nuclear and radiation safety. The review mission was formally requested by the Government of Hostcountry in month 201n. A preparatory mission was conducted day- day Month 201n at XXX Headquarters in location to discuss the purpose, objectives, scope and detailed preparations of the review in connection with the facilities regulated by XXX and selected safety aspects. The IRRS review team consisted of nn senior regulatory experts from mm IAEA Member States, k IAEA staff members and 1 IAEA administrative assistant (+observer). The IRRS review team carried out the review in the following areas: responsibilities and functions of the government; the global nuclear safety regime; responsibilities and functions of the regulatory body; the management system of the regulatory body; the activities of the regulatory body including the authorization, review and assessment, inspection and enforcement processes; development and content of regulations and guides; emergency preparedness and response; occupational radiation protection, patient protection, public and environmental exposure control, transport, waste management and decommissioning. As recommended by the IAEA Nuclear Safety Action Plan, special attention was given to regulatory implications in the Finnish framework for safety of the TEPCO-Fukushima Dai-ichi accident. In addition, policy issues were discussed, including: xxxx XXX conducted a self-assessment in preparation for the mission and prepared a preliminary action plan. The results of XXX self-assessment and supporting documentation were provided to the team as advance reference material for the mission. During the mission the IRRS review team performed a systematic review of all topics by reviewing the advance reference material, conducting interviews with management and staff from XXX and performed direct observation of XXX working practices during inspections. Meetings with the Ministry xxxx, the Ministry yyyy, …. were also organized. All through the mission the IRRS team received excellent support and cooperation from XXX.

9 II. OBJECTIVE AND SCOPE

The purpose of this IRRS mission was to conduct a review of the Hostcountry radiation and nuclear safety regulatory framework and activities to review its effectiveness and to exchange information and experience in the areas covered by the IRRS. The IRRS review scope included all facilities regulated by XXX with the exception of the xxxx. The review was carried out by comparison of existing arrangements against the IAEA safety standards. It is expected that the IRRS mission will facilitate regulatory improvements in Hostcountry and other Member States from the knowledge gained and experiences shared XXX and IRRS reviewers and through the evaluation of the effectiveness of the Hostcountry regulatory framework for nuclear safety and its good practices. The key objectives of this mission were to enhance nuclear and radiation safety, emergency preparedness and response:  Providing Hostcountry and XXX, through completion of the IRRS questionnaire, with an opportunity for self-assessment of its activities against IAEA safety standards;  Providing Hostcountry and XXX with a review of its regulatory programme and policy issues relating to nuclear and radiation safety, and emergency preparedness;  Providing Hostcountry and XXX with an objective evaluation of its nuclear safety, and emergency preparedness and response regulatory activities with respect to IAEA safety standards;  Contributing to the harmonization of regulatory approaches among IAEA Member States;  Promoting the sharing of experience and exchange of lessons learned;  Providing reviewers from IAEA Member States and the IAEA staff with opportunities to broaden their experience and knowledge of their own fields;  Providing key XXX staff with an opportunity to discuss their practices with reviewers who have experience with different practices in the same field;  Providing Hostcountry and XXX with recommendations and suggestions for improvement; and  Providing other States with information regarding good practices identified in the course of the review.

10 III. BASIS FOR THE REVIEW

A) PREPARATORY WORK AND IAEA REVIEW TEAM At the request of the Government of Hostcountry, a preparatory meeting for the Integrated Regulatory Review Service (IRRS) was conducted from day to day Month 201n. The preparatory meeting was carried out by the appointed Team Leader Ms/Mr Team Leader, Deputy Team Leader Ms/Mr Deputy Teamleader and the IRRS IAEA Team representatives, Ms/Mr Team Coordinator, Ms/Mr Deputy Teamcoordinator and Ms/Mr IEC Repr. The IRRS mission preparatory team had discussions regarding regulatory programmes and policy issues with the senior management of XXX represented by Ms/Mr Represen Tative , XXX Title, other senior management and staff. The discussions resulted in agreement that the regulatory functions covering the following facilities and activities were to be reviewed by the IRRS mission:  Nuclear power plants;  Fuel cycle facilities;  Waste facilities;  Radiation sources facilities;  Decommissioning;  Transport;  Patient protection;  Occupational radiation protection;  Public and Environmental exposure control;  Waste management (policy and strategy, predisposal and disposal);  Regulatory implications of the TEPCO Fukushima Dai-ichi accident; and  Selected policy issues. Ms/Mr Represen Tative made presentations on the national context, the current status of XXX and the self-assessment results to date. IAEA staff presented the IRRS principles, process and methodology. This was followed by a discussion on the tentative work plan for the implementation of the IRRS in Hostcountry in Month 201n. The proposed IRRS Review team composition (senior regulators from Member States to be involved in the review) was discussed and the size of the IRRS Review team was tentatively confirmed. Logistics including meeting and work space, counterparts and Liaison Officer identification, proposed site visits, lodging and transportation arrangements were also addressed. The XXX Liaison Officer for the preparatory meeting and the IRRS mission was Ms/Mr Liaison Officer. XXX provided IAEA (and the review team) with the advance reference material for the review at the end of August 2012, including the self-assessment results. In preparation for the mission, the IAEA review team members conducted a review of the advance reference material and provided their initial review comments to the IAEA Team Coordinator prior to the commencement of the IRRS mission. B) REFERENCE FOR THE REVIEW 11 The most relevant IAEA safety standards and the Code of Conduct on the Safety and Security of Radioactive Sources were used as review criteria. A more complete list of IAEA publications used as the reference for this mission is given in Appendix VIII.

C) CONDUCT OF THE REVIEW An opening IRRS Review team meeting was conducted on Weekday, day Month, 201n in Location by the IRRS Team Leader and the IRRS IAEA Team Coordinator to discuss the general overview, the focus areas and specific issues of the mission, to clarify the basis for the review and the background, context and objectives of the IRRS and to agree on the methodology for the review and the evaluation among all reviewers. They also presented the agenda for the mission. In addition, the IAEA Team Coordinator and Review Area Facilitator presented the expectations regarding the module on the “Regulatory implications from TEPCO-Fukushima Dai-ichi Accident” to be applied. The Liaison Officer was present at the opening IRRS Review team meeting, in accordance with the IRRS guidelines, and presented logistical arrangements planned for the mission. The reviewers also reported their first impressions of the advance reference material. The IRRS entrance meeting was held on Weekday, day Month, 201n, with the participation of XXX senior management and staff. Opening remarks were made by Ms/Mr Represen Tative, XXX Title, Ms/Mr Represen Tative, Title from the Ministry of Employment and Economy…, … Ms/Mr Team Leader, IRRS Team Leader and Ms/Mr Team Coordinator, IRRS Team Coordinator. Ms/Mr Represen Tative gave an overview of the Hostcountry context, XXX activities and the action plan prepared as a result of the self-assessment. During the mission, a review was conducted for all the review areas with the objective of providing Hostcountry and XXX with recommendations and suggestions for improvement as well as identifying good practices. The review was conducted through meetings, interviews and discussions, visits to facilities and direct observations regarding the national practices and activities. The IRRS Review team performed its activities based on the mission programme given in Appendix II. The IRRS exit meeting was held on Weekday, day Month, 201n. The opening remarks at the exit meeting were presented by Ms/Mr Represen Tative and were followed by the presentation of the results of the mission by the IRRS Team Leader Ms/Mr Team Leader. Closing remarks were made by Ms/Mr Di Rector, IAEA, Director, Division of Nuclear Installation Safety. A joint IAEA and XXX press conference took place at the end of the mission during which an IAEA press release was issued.

12 STANDARD IRRS CROSS-CONTRIBUTION TABLE

The Standard Cross Contribution Table below shows the way how the various Groups of an IRRS team are supposed to cooperate in writing and compilation of the mission report.

 The first column of the table refers to the team group (A through H) according to the notations used in the Standard IRRS Team Assignments.  In the second column those topics are listed which are to be reviewed written and inserted into the mission report by the given group. The topics that are to be provided by the given group to other groups are in red colour.  The groups that expect the contribution from this group in the topics in red are listed in the third column of the table.  The fourth column lists those topics (in blue) that are to be provided by other groups to the given group in order to be included into the report.  In the fifth column the groups that have to provide the topics in the previous column are listed.

The groups that receive contribution from other groups are expected to insert the contributions into the report chapters they are responsible for in a logical, structured and coherent manner.

13 Table 1: Standard IRRS Cross-Contribution Table Gr. Topics to review, write and provide to Gr. Topics to obtain from Gr.  Governmental responsibilities and -  Module-wise legal C,D,E,F functions (mod 1) background  Global Nuclear Safety Regime (mod 2) - A  Interface with security (mod 12) -  Implication of the Fukushima accident on H modules 1, 2 and 12  Responsibilities of the RB (mod 3) -  Management system (mod 4) -  Development of regulations and guides – -  Contents of regulations and C,D,E,F B in general (mod 9) guides  Implication of the Fukushima accident on H modules 3, 4 and 9  Authorization – in general and for NPPs -  Authorization of facilities and E (mod 5) activities other than NPP  Review & assessment (R&A) – in general -  R&A of facilities and activities E and for NPPs (mod 6) other than NPP  Legal background of authorization and A C R&A  Contents of regulations and guides B related to authorization and R&A  Implication of the Fukushima accident on H modules 5 and 6  Inspection – in general and for NPPs -  Inspection of facilities and E (mod 7) activities other than NPP  Enforcement – in general and for NPPs -  Enforcement of facilities and E (mod 8) activities other than NPP  Legal background of inspection and A D enforcement  Contents of regulations and guides B related to inspection & enforcement  Implication of the Fukushima accident on H modules 7 and 8 For facilities and activities (other than NPP)  Legal background A E  Authorization and review & assessment C  Inspection and enforcement D  Contents of regulations and guides B  Emergency preparedness and response - (EPR) (mod 10)  Legal background of EPR A F  Contents of regulations and guides B related to EPR  Implication of the Fukushima accident on H modules 1, 2 and 12 G  Other optional thematic area - H  Implication of the Fukushima accident -  Module-wise implications A,B,C,D,F 14 1. RESPONSIBILITIES AND FUNCTIONS OF THE GOVERNMENT

General instructions for writing the chapter: The structure of each subchapter should be as follows: Description of the situation in the country with regard to the subject of the given subchapter and based on the Advance Reference Material, interviews and other inputs: 1. General description should be kept to minimum. Organizational and legal details should be avoided. 2. Those issues, which are in line with the IAEA safety standards, should only be described briefly 3. Solutions, that may be considered to be a good practice, should be explained in some details. 4. Issues not adequately compatible with the applicable IAEA safety standards should be addressed in detail. This description must be sufficient for understanding the reasons for the Recommendations or Suggestions that follow. In every subchapter there are additional instructions or reminders on how to write it.

Depending on the scope of the mission there may be separate subchapters dedicated to NPPs, RRs, FCFs or other facilities or activities.

Based on experiences of previous missions the suggested length of the chapter is 9 pages. The actual length may depend on the scope of the mission and on the specificities of the host country but in any case it should not exceed 13 pages.

Interrelation with other modules Review in this module may have relationship with several other modules, so that there is a potential for overlapping among the modules. In this chapter only the legal basis is described. Implementation of the legal basis belongs to the modules mentioned below. Reviewers of the overlapping modules should coordinate when writing the report. The relevant modules are:  Module 3 (regulatory body related issues),  Module 4 (management system of the regulatory body)  Module 6 (coordination among different authorities in general versus specific involvement of authorities in review and assessment),  Module 9 (legal framework and regulations and guides).

Further questions related to this module in connection with the regulatory implications of the Fukushima accident are listed in subchapter 13.4. Please answer also those!

1.1. NATIONAL POLICY AND STRATEGY FOR SAFETY Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how:  GSR Part 1, Requirement 1, paragraphs 2.3 and 2.4

Particular attention should be given to:  Long term commitment to safety  Promulgated as a statement (document)  Basis for graded approach

Include the following table only if there is R, S or GP:

15 RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: Government should …

1.2. ESTABLISHMENT OF A FRAMEWORK FOR SAFETY Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how:  GSR Part 1, Requirement 2, paragraph(s) 2.5 and 2.6

Particular attention should be given to:  Legally binding framework for safety  Covering all types of activities and facilities  Clearly allocated responsibilities  Legal and financial provisions for management of radioactive waste and spent fuel

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: Government should …

1.3. ESTABLISHMENT OF A REGULATORY BODY AND ITS INDEPENDENCE Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how:  GSR Part 1, Requirement 3 and 4, paragraphs 2.7 to 2.13

Particular attention should be given to:  Legal authority  Necessary resources  Decision making process (for details on authorization see Chapter 5)  Effective independence as provided by the legal basis  Free from conflicting responsibilities

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: Government should …

16 1.4. COMPLIANCE WITH REGULATIONS AND RESPONSIBILITY FOR SAFETY Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how:  GSR Part 1, Requirement 5 and 6, paragraphs 2.14 to 2.17

Particular attention should be given to:  Prime legal responsibility for safety to the person/organization responsible for a facility/activity  Authorized party always responsible  Responsibility for safety covers all stages in the lifetime of the facility/activity  Transfer of responsibility for safety only after approval by the regulatory body  Regulatory body requirements may not relieve licenses from their prime responsibility for safety  Authority of regulatory body to require demonstration of compliance with safety requirements

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: Government should …

1.5. COORDINATION OF AUTHORITIES WITH RESPONSIBILITIES FOR SAFETY WITHIN THE REGULATORY FRAMEWORK Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how:  GSR Part 1, Requirement 7, paragraphs 2.18 and 2.19

Particular attention should be given to:  Responsibilities and functions of each authority are legally specified  Appropriate and documented coordination and liaison among the authorities

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: Government should …

1.6 SYSTEM FOR PROTECTIVE ACTIONS TO REDUCE UNREGULATED RADIATION RISKS Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how:  GSR Part 1, Requirement 9, paragraphs 2.25 - 2.27

Particular attention should be given to:  Protections against radiation risks not being under regulatory control 17  Unacceptable risk as a consequence of an accident, discontinued practice, inadequate control related to radiation sources  Role of regulatory body in such cases

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: Government should …

1.7. PROVISIONS FOR DECOMMISSIONING AND MANAGEMENT OF RADIOACTIVE WASTE AND SPENT FUEL Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how:  GSR Part 1, Requirement 10, paragraphs 2.28 to 2.33

Particular attention should be given to:  The governmental policy and strategy on waste and spent fuel management and decommissioning including final disposal  Existence of the respective legal requirements  Interim targets and end states  Governmental provisions for appropriate financial resources, fund  Governmental provisions for appropriate research and development programmes  Interdependences in the management of radioactive waste

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: Government should …

1.8. COMPETENCE FOR SAFETY Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how:  GSR Part 1, Requirement 11, paragraphs 2.34 to 2.38

Particular attention should be given to:  Required for all parties with safety responsibilities o Licensees o Regulatory body o Research and development centres  Definition of necessary competence levels 18  Arrangements for professional training programmes  Requirements for provision of sufficient number of suitably qualified and experienced staff  Provisions for appropriate research and development programmes

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: Government should …

1.9. PROVISION OF TECHNICAL SERVICES Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how:  GSR Part 1, Requirement 13, paragraph 2.41

Particular attention should be given to:  Provisions for/availability of technical services where necessary

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: Government should …

1.10. SUMMARY Instructions for writing this subchapter: Summarize in a brief, condensed manner the main messages of the above subchapters by  reiterating the issues that led to the recommendations or suggestions;  referring to the good practices noted;  concluding on the general status of the subject (if appropriate)

The subchapter should be kept as short as possible (and certainly should be less than a half page), preferably formulating the above main messages in bulleted lists of the issues or statements in the shortest possible summarized forms

19 2. GLOBAL NUCLEAR SAFETY REGIME

General instructions for writing the chapter: The structure of each subchapter should be as follows: Description of the situation in the Country with regard to the subject of the given subchapter and based on the Advance Reference Material, interviews and other inputs: 1. General description should be kept to minimum. Organizational and legal details should be avoided. 2. Those issues, which are in line with the IAEA safety standards, should only be described briefly 3. Solutions, that may be considered to be a good practice, should be explained in some details. 4. Issues not adequately compatible with the applicable IAEA safety standards should be addressed in detail. This description must be sufficient for understanding the reasons for the Recommendations or Suggestions that follow. In every subchapter there are additional instructions or reminders on how to write it. Depending on the scope of the mission there may be separate subchapters dedicated to NPPs, RRs, FCFs or other facilities or activities.

Based on experiences of previous missions the suggested length of the chapter is 3 pages. The actual length may depend on the scope of the mission and on the specificities of the host country but in any case it should not exceed 5 pages.

Further questions related to this module in connection with the regulatory implications of the Fukushima accident are listed in subchapter 13.4. Please answer also those!

2.1. INTERNATIONAL OBLIGATIONS AND ARRANGEMENTS FOR INTERNATIONAL COOPERATION Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how:  GSR Part 1, Requirement 14, paragraph 3.2

Particular attention should be given to:  International conventions  Codes of conduct  Use of and participation in development of IAEA Safety Standards  International peer reviews  Multilateral and bilateral cooperation programmes

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: Government should …

2.2. SHARING OF OPERATING EXPERIENCE AND REGULATORY EXPERIENCE Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how:  GSR Part 1, Requirement 15, paragraphs 3.3-3.5 20 Particular attention should be given to:  Reporting of operating and regulatory experience  Receiving of information from other states and authorized parties  Dissemination of lessons learned and their use  Feedback on measures taken in response to information received

Include the following table only if there is R, S or GP: RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: Government should …

2.3. SUMMARY Instructions for writing this subchapter: Summarize in a brief, condensed manner the main messages of the above subchapters by  reiterating the issues that led to the recommendations or suggestions;  referring to the good practices noted;  concluding on the general status of the subject (if appropriate)

21 3. RESPONSIBILITIES AND FUNCTIONS OF THE REGULATORY BODY

Interrelation with other modules Review in this module may have relationship with several other modules, so that there is a potential for overlapping among the modules. Reviewers of the overlapping modules should coordinate when writing the report. The relevant modules are:  Module 1 (coordination among different authorities),  Module 4 (management system)  Module 5 (authorizations)  Module 6 (organizational structure, independence, staffing, liaison with technical support organization, liaison with authorized parties, safety related records – all these components in general versus specific for review and assessment),  Module 9 (development and review of regulations and guides),

Further questions related to this module in connection with the regulatory implications of the Fukushima accident are listed in subchapter 13.4. Please answer also those!

3.1. ORGANIZATIONAL STRUCTURE OF THE REGULATORY BODY AND ALLOCATION OF RESOURCES Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how:  GSR Part 1, Requirement 16, paragraphs 4.4 and 4.5

Particular attention should be given to:  Sufficiency of human and financial resources  Organizational structure  Decision making process, distribution of responsibilities

Include the following table only if there is R, S or GP:

22 RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

3.2. EFFECTIVE INDEPENDENCE IN THE PERFORMANCE OF REGULATORY ACTIVITIES Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how:  GSR Part 1, Requirement 17, paragraphs 4.6-4.10

Particular attention should be given to:  Independent decision making  Functional separation from undue influence and from promotion or application of nuclear technologies  Prevention or resolution of conflicts of interest  Integrity of staff

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

3.3. STAFFING AND COMPETENCE OF THE REGULATORY BODY Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how:  GSR Part 1, Requirement 18, paragraphs 4.11-4.13

Particular attention should be given to:  Sufficiency and competence of staff  Long term human resource and succession planning and recruitment process  Training programmes and knowledge management (coordinate with subchapter 4.3)

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

3.4. LIAISON WITH ADVISORY BODIES AND SUPPORT ORGANIZATIONS Instructions for writing this subchapter: 23 Describe whether the following requirements are met, and if so, how:  GSR Part 1, Requirement 20, paragraphs 4.18-4.22

Particular attention should be given to:  Advisory bodies  Dedicated Technical Support Organizations  Avoiding/handling of conflicts of interest related to technical support  The regulatory body as an intelligent customer

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

3.5. LIAISON BETWEEN THE REGULATORY BODY AND AUTHORIZED PARTIES Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how:  GSR Part 1, Requirement 21, paragraphs 4.23-4.25

Particular attention should be given to:  Meeting types and schedules  Nature of relationship  Justification and explanation of regulatory decisions  Role, activity, empowerment, length of stay of resident inspectors (if any)

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

3.6. STABILITY AND CONSISTENCY OF REGULATORY CONTROL Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how:  GSR Part 1, Requirement 22, paragraphs 4.26-4.28

Particular attention should be given to:  Predictability of the regulatory body (in the sense of the consistency of its decision making based on regulations, principles, policies)  Avoiding subjectivity in decision making  Process and transparency of change in regulatory requirements (coordinate with Module 9)

24 Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

3.7. SAFETY RELATED RECORDS Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how:  GSR Part 1, Requirement 35, paragraphs 4.63-4.65

Particular attention should be given to:  Scope of records to be kept  Management of records  Use of the records

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

3.8. COMMUNICATION AND CONSULTATION WITH INTERESTED PARTIES Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how:  GSR Part 1, Requirement 36, paragraphs 4.66-4.69

Particular attention should be given to:  Information policy, including interfaces with the media  Types of meetings with interested parties and the public  Use of the regulator’s website  Issue of regulatory reports  Liaison with interested parties within the vicinity of authorized facilities

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

25 3.9. SUMMARY Instructions for writing this subchapter: Summarize in a brief, condensed manner the main messages of the above subchapters by  reiterating the issues that led to the recommendations or suggestions;  referring to the good practices noted;  concluding on the general status of the subject (if appropriate)

26 4. MANAGEMENT SYSTEM OF THE REGULATORY BODY

Based on experiences of previous missions the suggested length of the chapter is 5 pages. The actual length may depend on the scope of the mission and on the specificities of the host country but in any case it should not exceed 8 pages.

Interrelation with other modules Review in this module is closely related to Modules 1 and 3, so that there is a potential for overlapping among them. Reviewers of the overlapping modules should coordinate when writing the report.

Further questions related to this module in connection with the regulatory implications of the Fukushima accident are listed in subchapter 13.4. Please answer also those!

4.1. IMPLEMENTATION AND DOCUMENTATION OF THE MANAGEMENT SYSTEM Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how:  GSR Part 1, Requirement 19, paragraphs 4.14-4.17,  GS-R-3, paragraphs 2.1-2.10

Particular attention should be given to:  Documentation of the Management System, existence of manual (electronic or paper based), overall process map  All regulatory activities and support activities being defined by documented processes  Integration of all requirements on the organization  Priority to safety  Promotion of continuous improvement  Promotion of safety culture  Application of the graded approach

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GS-R-3 para. 2.2 states that “The… 27 RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES R Recommendation: The regulatory body should …

4.2. MANAGEMENT RESPONSIBILITY Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how:  GS-R-3, Paragraph 3.1-3.11

Particular attention should be given to:  Demonstration of management commitment at all levels to the establishment, implementation, assessment and continual improvement of the Management System  Means to collect and address expectations of interested parties and to communicate with stakeholders (coordinate with subchapter 3.8)  Development, documentation and evaluation of organizational policies  Establishment of measurable goals, strategies, plans and objectives  Follow up of strategic and annual planning

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GS-R-3 para. 2.2 states that “The… R Recommendation: The regulatory body should …

4.3. RESOURCE MANAGEMENT This subchapter should be coordinated with Module 3, subchapter 3.3! Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how:  GS-R-3, Paragraphs 4.1-4.5

Particular attention should be given to:  Determination of resources necessary to carry out the activities of the organization  Determination of competence requirements  Development of staffing plan  Implementation and follow up of staff training  Resources for the development and improvement of the Management System  Handling of working environment issues

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GS-R-3 para. 2.2 states that “The…

28 RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES R Recommendation: The regulatory body should …

4.4. PROCESS IMPLEMENTATION This subchapter should be coordinated with Module 3, subchapter 3.7! Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how:  GS-R-3, Paragraphs 5.1-5.12, 5.21-5.22, 5.26-5.29

Particular attention should be given to:  Methods for identification and development of processes  Documentation of processes, process maps  Scope of process owner responsibility  Control of working documents  Control of records  Internal and external communication  Management of organizational change

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GS-R-3 para. 2.2 states that “The… R Recommendation: The regulatory body should …

4.5. MEASUREMENT, ASSESSMENT AND IMPROVEMENT Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how:  GS-R-3, Paragraphs 6.1-6.18

Particular attention should be given to:  Management self-assessment  Independent audits  Management System review, a systematic approach should be demonstrated with a defined methodology  Management of non-conformances  Management of potential non-conformances  Opportunities for improvements of the Management System

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below 29 RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES (1) BASIS: GS-R-3 para. 2.2 states that “The… R Recommendation: The regulatory body should …

4.6. SUMMARY Instructions for writing this subchapter: Summarize in a brief, condensed manner the main messages of the above subchapters by  reiterating the issues that led to the recommendations or suggestions;  referring to the good practices noted;  concluding on the general status of the subject (if appropriate)

30 5. AUTHORIZATION

Based on experiences of previous missions the suggested length of the chapter is 8 pages. The actual length may depend on the scope of the mission and on the specificities of the host country but in any case it should not exceed 14 pages.

Depending on the scope of the mission there may be separate subchapters made for 1. Nuclear power plants 2. Research Reactors 3. Fuel Cycle Facilities 4. Radioactive Waste Management Facilities 5. Radiation Sources 6. Decommissioning 7. Transport

Further questions related to this module in connection with the regulatory implications of the Fukushima accident are listed in subchapter 13.4. Please answer also those!

5.1. GENERIC ISSUES Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how:  GSR Part 1, Requirements 23 and 24, paragraphs 4.29 - 4.39  GSR Part 4, Requirement 21, paragraphs 4.66 - 4.71

Particular attention should be given to: 31  Roles and responsibilities for authorization o Roles and responsibilities of stakeholders in the authorization defined (government, regulatory body, other regulators) o Competence available to the regulatory body for authorisation (coordinate with Modules 3 and 4) o Interfaces between the regulatory body and others involved in licensing (The license applicant, advisory boards, Technical Support Organisations (rules applied to avoid conflict of interest), public, etc.)  Types of authorizations o Site license, construction license, operating license, decommissioning license, closure license for disposal facilities o Authorization for plan modifications o Certification of personnel (tracking of records of personnel certification, training of operating personnel reflecting plant modifications, training of trainers)  Process of Authorization o Licensing steps and decisions (siting, design and construction, commissioning, operation, decommissioning, closure of disposal facilities) including corresponding inspections o License amendment, renewal, revocation o Decision making process of the Regulator o Independent verification of the safety assessment included in the application o Independent assessment performed by the regulatory body o Traceability o Application of graded approach in the authorization o Right of appeal (licensee or public) o Requirements for submittals (content, level of detail, quality) reflecting graded approach (criteria) o Safety demonstration required from the license applicant (fulfilment of criteria, requirements, safety objectives, independent assessment)

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

5.2. AUTHORIZATION OF NUCLEAR POWER PLANTS Instructions for writing this subchapter: Describe the situation in the country with respect to the compatibility with:  SSR-2/1 Safety of Nuclear Power Plants: Design Specific Safety Requirements,  SSR-2/2 Safety of Nuclear Power Plants: Commissioning and Operation Specific Safety Requirements  NS-R-3 Site Evaluation for Nuclear Installations  SSG-12 Licensing Process for Nuclear Installations

Any notable issues from subchapter 5.1 relevant to nuclear power plants should be elaborated. Particular attention should be given to:  Application for authorization  Documentation of the licensing basis (modifications to licensing documentation e.g. PSAR, FSAR)  Ageing management

32  Severe accident management  Licensing of plant personnel

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

5.3. AUTHORIZATION OF RESEARCH REACTORS Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how:  NS-R-4, paragraphs 3.4 to 3.10  Code of Conduct on the Safety of Research Reactors.  NS-R-3 Site Evaluation for Nuclear Installations  SSG-12 Licensing Process for Nuclear Installations

Any notable issues from subchapter 5.1 relevant to research reactors should be elaborated. Particular attention should be given to:  Ageing management  Licensing of personnel  Existence of safety committees that are independent of the reactor manager  Experimental devices  Lines of authority and communications between the reactor manager, the safety committee(s), the radiation protection group, maintenance groups, the quality assurance personnel and the experimenters  Influence on DBA by experiments and experimental devices, e.g. flooding or voiding, temperature effects, insertion of fissile material or removal of absorber material.

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

5.4. AUTHORIZATION OF FUEL CYCLE FACILITIES Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how:  NS-R-5 Safety of Nuclear Fuel Cycle Facilities, paragraphs 3.6 - 3.10.  NS-R-3 Site Evaluation for Nuclear Installations  SSG-12 Licensing Process for Nuclear Installations

33 The scope of fuel cycle facilities could be very broad and different from each other. Describe specific authorization requirements for facilities (such as processing, refining, conversion, enrichment, fabrication of UOX and MOX fuel, SF storage, SF reprocessing, fuel cycle research and development installations) available in the host country.

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

5.5. AUTHORIZATION OF RADIOACTIVE WASTE MANAGEMENT FACILITIES Instructions for writing this subchapter: Describe the situation in the country with respect to the compatibility with:  GSR Part 5 Predisposal Management of Radioactive Waste, Requirement 3 and 4  SSR-5 Disposal of Radioactive Waste, Requirement 2, 3 and 19,  NS-R-3 Site Evaluation for Nuclear Installations  SSG-12 Licensing Process for Nuclear Installations  WS-G-2.5 Predisposal Management of Low and Intermediate Level Radioactive Waste,  WS-G-2.6 Predisposal Management of High Level Radioactive Waste,  WS-G-2.7 Management of Waste from the Use of Radioactive Material in Medicine, Industry, Agriculture, Research and Education,  WS-G-6.1 Storage of Radioactive Waste,  SSG-1 Borehole Disposal Facilities for Radioactive Waste,  SSG-14 Geological Disposal Facilities for Radioactive Waste,  SSG-15 Storage of Spent Nuclear Fuel,  GS-G-3.4 The Management System for the Disposal of Radioactive Waste.

Particular attention should be given to the need for authorization of closure of a disposal facility. Any notable issues from subchapter 5.1 relevant to the authorization of waste management facilities (such as waste treatment, waste conditioning and storage, predisposal and disposal) should be elaborated here.

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

5.6. AUTHORIZATION OF RADIATION SOURCES FACILITIES Instructions for writing this subchapter: Describe the situation in the country with respect to the compatibility with:  GSR Part 3 Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards  Code of Conduct on the Safety and Security of Radioactive Sources and its associated Guidance on the Import and Export of Radioactive Sources.

34  GS-G-1.5 Regulatory Control of Radiation Sources

Any notable issues from subchapter 5.1 relevant to the authorization of radiation sources should be elaborated. Particular attention should be given to:  Safety (and security) hazards associated with sources delivered to the industry and health facilities.  Reuse or recycling of radioactive material;  The authorization of the import or export of sealed radioactive sources in a manner consistent with the guidance of the Code of Conduct on the Safety and Security of Radioactive Sources and its associated Guidance on the Import and Export of Radioactive Sources

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

5.7. AUTHORIZATION OF DECOMMISSIONING ACTIVITIES Instructions for writing this subchapter: Describe the situation in the country related to  WS-R-5 Decommissioning of Facilities Using Radioactive Material Safety  SSG-12 Licensing Process for Nuclear Installations

Any notable issues from subchapter 5.1 relevant to authorization of decommissioning should be elaborated. Particular attention should be given to:  Provision to ensure that key staff are retained and that institutional knowledge about the facility is maintained and is accessible  Responsibilities with respect to financial provisions for decommissioning  Demonstration of the compliance of the decommissioned facility with the end state criteria as defined in the decommissioning plan  Controls approved by the regulatory body if a facility cannot be released for unrestricted use.

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

5.8. AUTHORIZATION OF TRANSPORT ACTIVITIES Instructions for writing this subchapter: Describe whether all requirements of  TS-R-1 Regulations for the Safe Transport of Radioactive Material are addressed in the authorization process (e.g. shipment, special arrangement, package design, radioactive material in special form). 35 Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

5.9. SUMMARY Instructions for writing this subchapter: Summarize in a brief, condensed manner the main messages of the above subchapters by  reiterating the issues that led to the recommendations or suggestions;  referring to the good practices noted;  concluding on the general status of the subject (if appropriate)

36 6. REVIEW AND ASSESSMENT

Depending on the scope of the mission there could be separate subchapters made for 1. Nuclear power plants 2. Research Reactors 3. Fuel Cycle Facilities 4. Radioactive Waste Management Facilities 5. Radiation Sources 6. Decommissioning 7. Transport

Interrelation with other modules Review in this module may have relationship with several other modules, so that there is a potential for overlapping among the modules. Reviewers of the overlapping modules should coordinate when writing the report. The relevant modules are:  Module 1 (coordination among different authorities in general versus specific involvement of authorities in review and assessment),  Module 3 (organizational structure, independence, staffing, liaison with technical support organization, liaison with authorized parties, safety related records – all these components in general versus specific for review and assessment),  Module 5 (authorizations versus review and assessment associated with authorizations),  Module 7 (Inspections in general versus review and assessment specific),  Module 9 (regulations and guides in general versus specific for review and assessment).

To minimize repetition and overlapping review in this module should be strongly focused on specific provisions relevant to review and assessment only, with reference made to more general modules as appropriate.

Further questions related to this module in connection with the regulatory implications of the Fukushima accident are listed in subchapter 13.4. Please answer also those!

6.1. GENERIC ISSUES Instructions for writing this subchapter: 37 Describe whether the following requirements are met, and if so, how:  GSR Part 1, Requirements 25and 26, paragraphs 4.40 - 4.48  GSR Part 4, Requirements 1 - 4

Particular attention should be given to:  Graded approach related to the various facilities and activities  Responsibility for the review and assessment  Safety assessment has to address all radiation risks

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

6.2. REVIEW AND ASSESSMENT FOR NUCLEAR POWER PLANTS Describe the regulatory oversight in the country making due reference – besides the requirements listed in the subchapters that follow – to the nuclear Safety Guides listed below. It is not necessary to address the full content of these Guides. Rather, they provide guidance for the reviewer and a reference point wherever issues are found  GS-G-1.2 Safety Assessment and Verification for Nuclear Power Plants,  SSG-2 Deterministic Safety Analysis for Nuclear Power Plants,  SSG-3 Development and Application of Level 1 Probabilistic Safety Assessment for Nuclear Power Plants,  SSG-4 Development and Application of Level 2 Probabilistic Safety Assessment for Nuclear Power Plants,  NS-G-2.10 Periodic Safety Review of Nuclear Power Plants,  NS-G-2.11 A System for the Feedback of Experience from Events in Nuclear Installations,  NS-G-2.15 Severe Accident Management for Nuclear Power Plants,  NS-G-2.12 Ageing Management for Nuclear Power Plants,  NS-G-2.3 Modifications to Nuclear Power Plants,  NS-G-2.8 Recruitment, qualification and training of personnel for NPPs

6.2.1. MANAGEMENT OF REVIEW AND ASSESSMENT Instructions for writing this subchapter: Describe whether the following requirements of GSR Part 1 are met, and if so, how:  Requirement 2, paragraph 2.5 (8),  Requirement 4, paragraph 2. 12,  Requirement 7, paragraph 2. 18 and 2.19,  Requirement 19, paragraphs 4.14-4.17,  Requirement 24, paragraph 4.39,  Requirements 25 and 26, paragraph 4.48

Particular attention should be given to:  Overview of types and number of documents subject to review and assessment  Availability of internal guidance for review and assessment

38  Availability of the regulatory body’s review and assessment plan including prioritization of various submissions  Interface between various regulatory bodies involved in review and assessment (if relevant)  Monitoring (tracking) of the review and assessment process and document control system  Documentation of review process and bases (justification) for regulatory decisions, including use of feedback from previous review and assessment  Quality control of review and assessment processes and documents  Use of graded approach in review and assessment

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

6.2.2. ORGANIZATION AND TECHNICAL RESOURCES FOR REVIEW AND ASSESSMENT Instructions for writing this subchapter: Describe whether the following requirements of GSR Part 1 are met, and if so, how:  Requirement 4, paragraphs 2.8 and 12,  Requirement 11, paragraphs 2.34 – 2.38,  Requirement 14, paragraph 3.2,  Requirement 15, paragraphs 3.3 – 3.5,  Requirement 16, paragraphs 4.4 and 4.5,  Requirement 17, paragraphs 4.6 and 4.8,  Requirement 18, paragraphs 4.11 – 4.13,  Requirement 20, paragraphs 4.18 – 4.22

Particular attention should be given to:  Internal manpower and organizational arrangements of the review and assessment  Staff specific competence and training in the area of review and assessment  Availability of external independent resources for review and assessment, including TSO, including cooperation at the international level  Use of advisory bodies/committees in the area of review and assessment  Specific regulatory tools for review and assessment (computer codes, experimental facilities) and internal capability for use of the tools

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

6.2.3. BASES FOR REVIEW AND ASSESSMENT Instructions for writing this subchapter: 39 Describe whether the following requirements are met, and if so, how:  GSR Part 1 o Requirement 22, paragraphs 4.26, 4.27, 4.28, o Requirements 23 and 24, paragraphs 4.33-4.34, o Requirements 25 and 26, paragraphs 4.40- 4.41,  GSR Part 4, Requirements 2-21

Particular attention should be given to:  Availability of relevant regulation/guidance for safety assessment by the licensees  Availability of specific regulations/guidance on scope and quality of deterministic/probabilistic safety analysis  Alignment of the regulatory requirements on safety assessment with the IAEA Safety Standards and with international good practices  Regulatory access to additional information not directly included in the submission  Consistency in regulatory requirements on safety assessment in various licensing documents

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

6.2.4. PERFORMANCE OF THE REVIEW AND ASSESSMENT Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how:  GSR Part 1 o paragraphs 4.2 and 4.3, o Requirement 21, paragraphs 4.23, 4.24, o Requirements 23 and 24, paragraphs 4.29, 4.30, 4.38, o Requirements 25 and 26, paragraphs 4.43- 4.48,  GSR Part 4, Requirements 2-21

Particular attention should be given to:  Methods for verification of comprehensiveness and quality of safety assessment submitted by the licensees (including independent verification by the licensee)  Verification of the scope and quality of safety analysis, including independent regulatory audits  Scope of regulatory review and assessment associated with various kinds of authorizations o various types and stages of an authorization, in particular those including Safety Analysis Report o periodic safety reviews o operational experience feedback o lifetime extension o modifications of facilities, including power uprating o competences of operating personnel  Communication with the licensees in connection with review and assessment  Arrangements for interface between review and assessment and inspections  Regulatory support to development of relevant tools and methods

40 Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

Any issues from subchapter 6.1 relevant to nuclear power plants should be elaborated.

6.3. REVIEW AND ASSESSMENT FOR RESEARCH REACTORS Describe whether the following requirements are met, and if so, how:  NS-R-4, paragraphs 3.11 to 3.13

Any issues from subchapters 6.2.1 through 6.2.4 relevant to review and assessment of research reactors should be elaborated. In particular, Periodic Safety Review is to be discussed.

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

6.4. REVIEW AND ASSESSMENT FOR FUEL CYCLE FACILITIES Describe the situation in the country related to:  NS-R-5 Safety of Nuclear Fuel Cycle Facilities, paragraph 3.9  SSG-5 Safety of Conversion Facilities and Uranium Enrichment Facilities  SSG-6 Safety of Uranium Fuel Fabrication Facilities,  SSG-7 Safety of Uranium and Plutonium Mixed Oxide Fuel Fabrication Facilities,  SSG-15 Storage of Spent Nuclear Fuel,

Any issues from subchapters 6.2.1 through 6.2.4 relevant to review and assessment of fuel cycle facilities should be elaborated. In particular, Periodic Safety Review is to be discussed.

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

41 6.5. REVIEW AND ASSESSMENT FOR WASTE MANAGEMENT FACILITIES Instructions for writing this subchapter: Describe the situation in the country related to  GSR part 5, Predisposal Management of Radioactive Waste  SSR-5 Disposal of Radioactive Waste Specific Safety Requirements, Requirements No. 12 and 13, in particular describe the review and assessment process that extends beyond the operational phase of the disposal facility, to the post-closure period evaluating the long term performance of the disposal system.  WS-G-2.5 Predisposal Management of Low and Intermediate Level Radioactive Waste,  WS-G-2.6 Predisposal Management of High Level Radioactive Waste,  WS-G-6.1 Storage of Radioactive Waste,  SSG-1 Borehole Disposal Facilities for Radioactive Waste,  SSG-15 Storage of Spent Nuclear Fuel,

Any issues from subchapters 6.2.1 through 6.2.4 relevant to review and assessment of waste management facilities should be elaborated.

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

6.6. REVIEW AND ASSESSMENT FOR RADIATION SOURCES FACILITIES Describe whether the following requirements of GSR Part 1 are met, and if so, how:  Requirement 2 paragraph 2.5 (8),  Requirements 23 paragraph 4.35, and  Requirements 25 and 26.

Any issues from subchapters 6.2.1 through 6.2.4 relevant to review and assessment of radiation sources should be elaborated.

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

6.7. REVIEW AND ASSESSMENT FOR DECOMMISSIONING ACTIVITIES Describe the situation in the country with respect to compatibility with:  WS-R-5 Decommissioning of Facilities Using Radioactive Material, paras 3.4, 3.6, 4.5, 5.7, 5.13, 6.3, 7.5, 8.6, 8.9, 9.3,  WS-G-2.1 Decommissioning of Nuclear Power Plants and Research Reactors, paras 2.11, 5.9  WS-G-2.2 Decommissioning of Medical, Industrial and Research Facilities, paras 5.6, 7.6 42  WS-G-2.4 Decommissioning of Nuclear Fuel Cycle Facilities, paras 2.12, 5.2, 5.3, 5.9, 5.10,  WS-G-5.2 Safety Assessment for the Decommissioning of Facilities Using Radioactive Material, paras 3.32, 3.33, 5.1-5.12

Any issues from subchapters 6.2.1 through 6.2.4 relevant to review and assessment of decommissioning should be elaborated.

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

6.8. REVIEW AND ASSESSMENT FOR TRANSPORT ACTIVITIES Describe whether all requirements of  TS-R-1 Regulations for the Safe Transport of Radioactive Material are addressed in the review and assessment process (e.g. shipment, special arrangement, package design, radioactive material in special form). Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

6.9. SUMMARY Instructions for writing this subchapter: Summarize in a brief, condensed manner the main messages of the above subchapters by  reiterating the issues that led to the recommendations or suggestions;  referring to the good practices noted;  concluding on the general status of the subject (if appropriate)

43 7. INSPECTION

Based on experiences of previous missions the suggested length of the chapter is 6 pages. The actual length may depend on the scope of the mission and on the specificities of the host country but in any case it should not exceed 9 pages.

Interrelation with other modules Attention should be paid to the fact that the review in this module is closely related to several other modules, so that there is a potential for overlapping among the modules. Reviewers of the overlapping modules should coordinate when writing the report. The most relevant modules are  Module 3 (organizational structure, independence, staffing),  Module 5 (authorizations versus inspections as associated with authorizations),  Module 6 (interrelation between review and assessment and inspections)  Module 8 (enforcement actions often resulting from inspections).

In order to minimize repetition and overlapping of work done by experts responsible for different modules, review in this module should be strongly focused on specific provisions relevant for inspections only, with reference made to more general modules as appropriate.

Further questions related to this module in connection with the regulatory implications of the Fukushima accident are listed in subchapter 13.4. Please answer also those!

44 7.1. GENERIC ISSUES

7.1.1. INSPECTION APPROACHES, METHODS AND PLANS Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how:  GSR Part 1, Requirements 27, 28, 29, paragraphs 4.50 and 4.53,

Particular attention should be given to:  Inspection areas and aspects related to facilities and activities  Use of graded approach for inspections  Types of inspections (announced, unannounced, proactive, reactive)  Inspection methods (document reviews, interviews, walk downs, observation of activities)  Annual inspection plans  Use of third party for the inspection (TSO, inspection organisations, consultants)  Joint inspections with other regulators, sharing of inspection results with other regulators  Interfaces with authorization, review and assessment and enforcement

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

7.1.2. INSPECTION PROCESSES AND PRACTICES Instructions for writing this subchapter: Describe whether the following requirement is met, and if so, how  GSR Part 1, Requirement 29, paragraph 4.51,

Particular attention should be given to:  Inspection procedure(s)/guidance, check list(s) used  Inspection techniques used  Reporting the results of an inspection  Follow up and closure of corrective actions (and the interface with enforcement)  Inspection report  Use of the inspection results (development of the inspection process and programme, information to the public) and other inputs for the development of the process  Reactive inspections (verify the adequacy through the reports)  Effectiveness of the inspection process and programme  Observation of an inspection (site visit)

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below 45 RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

7.1.3. INSPECTORS Instructions for writing this subchapter: Describe whether the following requirement is met, and if so, how  GSR Part 1, Requirement 29, paragraph 4.52

Particular attention should be given to:  Manpower available, qualification and training of inspectors (training records)  Resident/site inspectors (management methods to prevent capture)  Presence of inspectors on site (especially in case where there are no resident inspectors)  Authority of inspectors (unlimited access to authorized facilities and activities, authority to enforce)

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

7.2. INSPECTION OF NUCLEAR POWER PLANTS Describe the situation in the country related to  GS-G-1.3 on regulatory inspections.

This guide does not distinguish between different nuclear installations, although it is clear that in accordance with the graded approach the inspection of nuclear power plants should be the most comprehensive. Any issues from subchapter 7.1 relevant to inspection of nuclear power plants should be elaborated.

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

7.3. INSPECTION OF RESEARCH REACTORS Describe whether the following requirements are met, and if so, how  NS-R-4 (Safety of Research Reactors), paragraphs 3.14 – 3.16

Any issues from subchapter 7.1 relevant to inspection of research reactors should be elaborated.

46 Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

7.4. INSPECTION OF FUEL CYCLE FACILITIES Describe the situation in the country with respect to compatibility with:  NS-R-5 Safety of Nuclear Fuel Cycle Facilities, 3.11 – 12,  SSG-5 Safety of Conversion Facilities and Uranium Enrichment Facilities  SSG-6 Safety of Uranium Fuel Fabrication Facilities,  SSG-7 Safety of Uranium and Plutonium Mixed Oxide Fuel Fabrication Facilities,  SSG-15 Storage of Spent Nuclear Fuel,

Any notable issues from subchapter 7.1 relevant to inspection of fuel cycle facilities should be elaborated.

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

7.5. INSPECTION OF WASTE MANAGEMENT FACILITIES Describe the situation in the country with respect to compatibility with:  GSR Part 5 Predisposal Management of Radioactive Waste, paras 4.22, 5.14, 5.15, 5.20,  SSR-5 Disposal of Radioactive Waste, paras 3.15, 3.48, 5.19,  WS-G-2.5 Predisposal Management of Low and Intermediate Level Radioactive Waste,  WS-G-2.6 Predisposal Management of High Level Radioactive Waste,  WS-G-2.7 Management of Waste from the Use of Radioactive Material in Medicine, Industry, Agriculture, Research and Education,  WS-G-6.1 Storage of Radioactive Waste,  SSG-1 Borehole Disposal Facilities for Radioactive Waste,  SSG-14 Geological Disposal Facilities for Radioactive Waste,  SSG-15 Storage of Spent Nuclear Fuel,  GS-G-3.4 The Management System for the Disposal of Radioactive Waste.

Any notable issues from subchapter 7.1 relevant to inspection of waste management facilities should be elaborated.

Include the following table only if there is R, S or GP:

47 RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

7.6. INSPECTION OF RADIATION SOURCES FACILITIES Describe the situation in the country with respect to compatibility with:  GS-G-1.5 Regulatory Control of Radiation Sources  RS-G-1.10 Safety of Radiation Generators and Sealed Radioactive Sources

Any notable issues from subchapter 7.1 relevant to inspection of radiation sources should be elaborated.

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

7.7. INSPECTION OF DECOMMISSIONING ACTIVITIES Describe the situation in the country with respect to compatibility with:  WS-R-5 Decommissioning of Facilities Using Radioactive Material, paras 3.6, 8.9, 9.2,  WS-G-2.1 Decommissioning of Nuclear Power Plants and Research Reactors,  WS-G-2.4 Decommissioning of Nuclear Fuel Cycle Facilities,  WS-G-5.2 Safety Assessment for the Decommissioning of Facilities Using Radioactive Material,

Any notable issues from subchapter 7.1 relevant to inspection of decommissioning should be elaborated.

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

7.8. INSPECTION OF TRANSPORT ACTIVITIES Describe the situation in the country with respect to compatibility with:  TS-R-1 Regulations for the Safe Transport of Radioactive Material  TS-G-1.1 Advisory Material for the IAEA Regulations for the Safe Transport of Radioactive Material  TS-G-1.2 Planning and Preparing for Emergency Response to Transport Accidents Involving Radioactive Material  TS-G-1.3 Radiation Protection Programmes for the Transport of Radioactive Material 48  TS-G-1.4 The Management System for the Safe Transport of Radioactive Material  TS-G-1.5 Compliance Assurance for the Safe Transport of Radioactive Material

Any issues from subchapter 7.1 relevant to inspection of transport should be elaborated.

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

7.9. SUMMARY Instructions for writing this subchapter: Summarize in a brief, condensed manner the main messages of the above subchapters by  reiterating the issues that led to the recommendations or suggestions;  referring to the good practices noted;  concluding on the general status of the subject (if appropriate)

49 8. ENFORCEMENT

Based on experiences of previous missions the suggested length of the chapter is 2 pages. The actual length may depend on the scope of the mission and on the specificities of the host country but in any case it should not exceed 4 pages.

Interrelation with other modules Review in this module is closely related to Module 7 (Inspections). To minimize repetition and overlapping review in this module should be strongly focused on specific provisions relevant for review and assessment only, with reference made to more general modules as appropriate.

Further questions related to this module in connection with the regulatory implications of the Fukushima accident are listed in subchapter 13.4. Please answer also those!

8.1. ENFORCEMENT POLICY AND PROCESSES Instructions for writing this subchapter: Describe whether the following requirements of GSR Part 1 are met, and if so, how:  Requirement 30,  Requirement 31, paragraphs 4.54, 4.57-4.60,

Particular attention should be given to:  Graded approach applied in the enforcement (actions are commensurate with safety significance)  Enforcement processes (from oral to written warnings and penalties, ultimately withdrawal of an authorization)  Different enforcement tools and powers of the regulatory body clearly defined in the legislation o Possibility to amend or revoke a license o Possibility to shut down a facility o Possibility to stop activities o Possibility to require additional safety analysis o Possibility to require modifications of a facility  Decision making process to prosecute (inspection vs. investigation) and the interface between regulatory body and the prosecutor  Consideration of safety culture aspects and licensee’s responsibility for safety in the enforcement (Focus of enforcement on individuals vs. organizations, credit on licensee’s performance in detecting a non- compliance, willingness to self-report, capacity to analyse root cause and correct the issue)  Possibility for the licensee to appeal  Interface of enforcement actions with authorizations, review and assessment and inspections

50 Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

8.2. ENFORCEMENT IMPLEMENTATIONS Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how:  GSR Part 1, Requirement 31, paragraphs 4.55 and 4.56,

Particular attention should be given to:  Enforcement possible by the inspectors (on spot enforcement in case of an acute health and safety issue) vs. enforcement possible by the regulatory body  Consideration to flexibility or/and managerial discretion to enforcement vs. prosecution  Transparency and openness related to the enforcement process and decision making  Guidance, criteria and examples for different enforcement tools used by inspectors and the regulatory body  Overview and experience with using various types of enforcement actions  Training of inspectors on the enforcement  Demonstration of the effectiveness of the enforcement process

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

8.3. SUMMARY Instructions for writing this subchapter: Instructions for writing this subchapter: Summarize in a brief, condensed manner the main messages of the above subchapters by  reiterating the issues that led to the recommendations or suggestions;  referring to the good practices noted;  concluding on the general status of the subject (if appropriate)

51 9. REGULATIONS AND GUIDES

Based on experiences of previous missions the suggested length of the chapter is 7 pages. The actual length may depend on the scope of the mission and on the specificities of the host country but in any case it should not exceed 13 pages.

Interrelation with other modules Review in this module is closely related with several other modules, so that there is a potential for overlapping among the modules. Reviewers of the overlapping modules should coordinate when writing the report. The relevant modules are:  Module 1 (legal framework),  Module 3 (regulatory body organisation and processes).

Further questions related to this module in connection with the regulatory implications of the Fukushima accident are listed in subchapter 13.4. Please answer also those!

9.1. GENERIC ISSUES Instructions for writing this subchapter: Describe how national regulations and guides are in line with the requirements of:  GSR Part 1, Requirement 32, 33 and 34, paragraphs 4.61 to 4.62  NS-R-3 - Site Evaluation For Nuclear Installations

Particular attention should be given to:  Process for development of regulations and guides including consultations with stakeholders and the public  Use of the graded approach  Review and updating of the regulations and guides  Regulations and guides reflect IAEA safety requirements and best practices

52  Specific review and assessment topics (Probabilistic Safety Analysis, Periodic Safety Review, Operating Experience Feedback, Severe Accident Management, ...)  Regulations and guides address specific authorization topics  Promotion of regulations

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

9.2. REGULATIONS AND GUIDES FOR NUCLEAR POWER PLANTS Instructions for writing this subchapter: Describe how national regulations and guides are in line with the requirements of:  SSR-2/1 – Safety of Nuclear Power Plants: Design,  SSR-2/2 – Safety of Nuclear Power Plants: Commissioning and Operation

Particular attention should be given to:  Regulatory requirements and guidance on design, in specific o Fundamental safety functions o Application of defence in depth o Plant states o Design basis, design extension, design limits, postulated initiating events, o Reliability an failure tolerance requirements  Regulatory requirements and guidance on operation, in specific o Operational Limits and Conditions o Personnel qualification and training o Monitoring of safety performance o Accident management o Operating procedures o Maintenance, testing, surveillance, inspection

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

9.3. REGULATIONS AND GUIDES FOR RESEARCH REACTORS Instructions for writing this subchapter: Describe how national regulations and guides are in line with the requirements of:  NS-R-4 - Safety of Research Reactors  Code of Conduct on Safety of Research Reactors 53 Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

9.4. REGULATIONS AND GUIDES FOR FUEL CYCLE FACILITIES Instructions for writing this subchapter: Describe how national regulations and guides are in line with the requirements of:  NS-R-5 - Safety of Nuclear Fuel Cycle Facilities Safety Requirements

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

9.5. REGULATIONS AND GUIDES FOR WASTE MANAGEMENT FACILITIES Instructions for writing this subchapter: Describe the situation in the country related to selected requirements of:  GSR Part 5 Predisposal Management of Radioactive Waste,  SSR-5 Disposal of Radioactive Waste,  WS-G-2.5 Predisposal Management of Low and Intermediate Level Radioactive Waste,  WS-G-2.6 Predisposal Management of High Level Radioactive Waste,  WS-G-2.7 Management of Waste from the Use of Radioactive Material in Medicine, Industry, Agriculture, Research and Education,  WS-G-6.1 Storage of Radioactive Waste,  SSG-1 Borehole Disposal Facilities for Radioactive Waste,  SSG-14 Geological Disposal Facilities for Radioactive Waste,  SSG-15 Storage of Spent Nuclear Fuel,  GS-G-3.4 The Management System for the Disposal of Radioactive Waste, paras

Particular attention should be given to the following:  Defining requirements on national policy and strategy for radioactive waste and spent fuel management (Requirement No. 2 of GSR Part 5);  Identifying the interdependences among all steps in the predisposal management of RAW, as well as the impact of the anticipated disposal option (Requirement No. 6 of GSR Part 5);  Providing requirements on the identification, control and minimisation of RAW (Requirement No. 8 of GSR Part 5);  Characterizing and classifying the RAW (Requirement No. 9 of GSR Part 5);  Providing the requirements on derivation, structure and use of waste acceptance criteria (Requirement No. 12 of GSR Part 5, Requirement No. 20 of SSR-5); 54  Developing regulations for dealing with legacy waste, abandoned radioactive material, sources, RAW management sites or facilities (Requirement No. 22 of GSR Part 5, Requirement No. 26 of SSR-5). For RAW predisposal management facilities, which are considered for practices for which the requirements for planned exposure situations apply (see GSR Part 3), pay special attention to:  RAW packages design, manufacturing and safety case (Requirement No. 10 of GSR Part 5), incl. dual purpose storage and transport cask (if used or planned to be used in the host country);  Retrievability of RAW, passive safety features and expected period of storage in RAW storage facilities (Requirement No. 11 of GSR Part 5); The RAW disposal facilities are also considered for practices for which the requirements for planned exposure situations apply (see GSR Part 3). However their safety must be assured not only during the operational period but also over post closure period, which reaches unprecedented timescales. SSR-5 defines following, disposal facility specific requirements, which need to be reflected in national regulations and guides:  Passive means to ensure the safety and their surveillance and control (Requirement No. 5, 10);  Defence in depth (Requirement No. 7);  Conditions for siting (Requirement No. 15);  Closure of a disposal facility (Requirement No. 19);  Institutional control arrangements (Requirement No. 22).

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

9.6. REGULATIONS AND GUIDES FOR RADIATION SOURCES FACILITES Instructions for writing this subchapter: Describe how national regulations and guides are in line with the requirements of:  GSR Part 3 - Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards  Code of Conduct on the Safety and Security of Radioactive Sources.

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

9.7. REGULATIONS AND GUIDES FOR DECOMMISSIONING ACTIVITIES Instructions for writing this subchapter: Describe the situation in the country related to selected requirements of:  WS-R-5 Decommissioning of Facilities Using Radioactive Material, paragraphs 3.5, 8.8, 55  WS-G-2.1 Decommissioning of Nuclear Power Plants and Research Reactors,  WS-G-2.2 Decommissioning of Medical, Industrial and Research Facilities,  WS-G-2.4 Decommissioning of Nuclear Fuel Cycle Facilities,  WS-G-5.2 Safety Assessment for the Decommissioning of Facilities Using Radioactive Material.

In particular describe if in the country the safety regulations and guides for all phases of decommissioning from initial planning to termination of the practice or final release of the facility from regulatory control have been established. Particular attention has to be paid to:  provisions to develop decommissioning strategy (chapter 4 of WS-R-5, paragraphs 4.1);  responsibilities with respect to financial provisions for decommissioning (chapter 6 of WS-R-5, paragraphs 6.1);  provisions to ensure that key staff are retained and that institutional knowledge about the facility is maintained and is accessible (paragraphs 5.9, 7.3 of WS-R-5);  demonstration of the compliance of decommissioned facility with the end state criteria as defined in the decommissioning plan (paragraphs 9.1, 9.2 of WS-R-5);  controls approved by the regulatory body if a facility cannot be released for unrestricted use (paragraphs 9.6 of WS-R-5)

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

9.8. REGULATIONS AND GUIDES FOR TRANSPORT ACTIVITIES Instructions for writing this subchapter: Describe the situation in the country related to the transport requirements of  TS-R-1 Regulations for the Safe Transport of Radioactive Material. Particular attention should be given to:  Covering of all modes of transport in regulations;  Ratification of international conventions and agreements dealing with the transport of dangerous goods;  Requirements for reporting criteria for incidents/accidents occurring during the transport (paragraph 309 (a), (b) (iv) and (c));  Availability of guides for users and applicants to meet the requirements as described in TS-R-1 and advised in o TS-G-1.1 (Advisory Material for the IAEA Regulations for the Safe Transport of Radioactive Material) o TS-G-1.2 (Planning and Preparing for Emergency Response to Transport Accidents Involving Radioactive Material), o TS-G-1.3 (Radiation Protection Programmes for the Transport of Radioactive Material), and o TS-G-1.4 (The Management System for the Safe Transport of Radioactive Material)

Include the following table only if there is R, S or GP:

56 RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

9.9. SUMMARY Instructions for writing this subchapter: Summarize in a brief, condensed manner the main messages of the above subchapters by  reiterating the issues that led to the recommendations or suggestions;  referring to the good practices noted;  concluding on the general status of the subject (if appropriate)

57 10. EMERGENCY PREPAREDNESS AND RESPONSE – REGULATORY ASPECTS

General instructions for writing the chapter: The structure of each subchapter should be as follows: Description of the situation in the country with regard to the subject of the given subchapter and based on the Advance Reference Material, interviews and other inputs: 1. General description should be kept to minimum. Organizational and legal details should be avoided. 2. Those issues, which are in line with the IAEA safety standards, should be described only briefly 3. Solutions, that may be considered to be good practice, should be explained in sufficient detail. 4. Issues not adequately compatible with the applicable IAEA safety standards should be addressed in detail. Description must be sufficient for understanding the reasons for the Recommendations or Suggestions that follow. In every subchapter there are additional instructions or reminders on writing it effectively.

Based on experiences of previous missions the suggested length of the chapter is 7 pages. The actual length may depend on the scope of the mission and on the specifics of the host country but the team should endeavour to keep it to a maximum 10 pages.

Further questions related to this module in connection with the regulatory implications of the Fukushima accident are listed in subchapter 13.4.

10.1. GENERAL EPR REGULATORY REQUIREMENTS Instructions for writing this subchapter: The requirements for an adequate level of preparedness and response for a nuclear or radiological emergency in any Member State are provided in  GS-R-2 Preparedness and Response for a Nuclear or Radiological Emergency,  GS-G-2.1 Arrangements for Preparedness for a Nuclear or Radiological Emergency.  GSG-2 Criteria for Use in Preparedness and Response for a Nuclear or Radiological Emergency These requirements apply to all those practices and sources that have the potential for causing radiation exposure or environmental radioactive contamination warranting an emergency intervention. The following points and key elements of GS-R-2 should be checked by the review of consecutive subchapters:

Basic responsibilities  Scope of the regulatory mandate of the RB over emergency preparedness and response for licensees involved in nuclear, radiological and transport activities;  Role of the licensees in EPR as stated by regulations, including its consistency with the division of roles and responsibilities in the national EPR framework;  Coordinating and advisory role of the RB with respect to other organizations involved; Assessment of threats  Regulatory requirements and guidance for the licensees on developing hazard assessment as the basis for its EPR plans (with emphasis on coverage of all postulated events)  Emergency planning and hazard categorization for licensed facilities and activities, consistent with Table 1 of GS-R-2

Include the following table only if there is R, S or GP:

58 RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GS-R-2 para. 3.5 states that “The… R Recommendation: The regulatory body should …

10.2. FUNCTIONAL REGULATORY REQUIREMENTS Instructions for writing this subchapter: The requirements for an adequate level of preparedness and response for a nuclear or radiological emergency in any Member State are provided in  GS-R-2 Preparedness and Response for a Nuclear or Radiological Emergency,  GS-G-2.1 Arrangements for Preparedness for a Nuclear or Radiological Emergency.  GSG-2 Criteria for Use in Preparedness and Response for a Nuclear or Radiological Emergency The requirements apply to all those facilities and activities as well as sources with the potential for causing radiation exposure, environmental contamination or public concern warranting protective actions and other response actions in a nuclear or radiological emergency. The following points and key elements of GS-R-2 should be checked by the review of consecutive subchapters:

Establishing emergency management and operations  Regulatory requirements on the licensee’s emergency management structure, specifically addressing the need for the prompt transition from normal operation to emergency operation command and control  Regulatory approach for verification of licensee’s emergency management effectiveness Identifying, notifying and activating  Requirements for licensee to classify emergencies consistent with GS-R-2, paragraph 4.19  Regulatory requirements for notification of an emergency by licensees consistent with GS-R-2, paragraph 4.12 (including timing requirements)  Regulatory approach for verification of the ability of the licensee to meet the requirements  Scrap metal issues: countries where it is within the scope of the mission, they should be covered. The respective arrangements are aimed at the discovery/detection of potential “orphan” sources Taking mitigatory actions  Regulations regarding provision of emergency services at the licensed facilities  Regulations regarding the use of external emergency services as part of the licensee’s plan to take mitigatory actions  Regulatory verification approach that these arrangements are in place.

Taking urgent protective action  Role or cooperation of the RB in establishing regulations or levels for the protection of public in an emergency and consistency of the respective regulatory requirements (if exist) with IAEA standards  Role or cooperation of the RB in the definition of emergency planning zones and consistency of the zones with IAEA guidance Providing information and issuing instructions

59  Role, responsibility and cooperation of the RB in regulating the licensee’s activity in instructing public and keeping the public informed, and consistency of the regulations (if by the RB) with IAEA standards (note that this area covers two functional areas in GS-R-2: 4.53 to 4.55 and 4.82 to 4.84) Protecting emergency workers  Role, responsibility and cooperation of the RB in regulation for the protection of on-site emergency workers and consistency of the regulations (if by the RB) with GS-R-2 Annex 1 and other IAEA guidance  Role, responsibility and cooperation of the RB in regulation for the protection of off-site emergency workers (for those involved as well as those not involved in on-site support to the licensee) and, if there is such a role of the RB, consistency of the regulations with GS-R-2 Annex 1 and other IAEA guidance Assessing the initial phase  RB regulations on assessment of the initial phase, with particular emphasis on whether the regulatory requirements include the need to take into account both radiation levels and plant/site conditions in the assessment of the initial phase?  Approach for verification of the ability of the licensee to assess the initial phase Managing the medical response  Role, responsibility and cooperation of the RB in regulation for medical response management by the licensees and consistency of the regulations (if by the RB) with GS-R-2 paragraphs 4.78 and 4.79 and other IAEA guidance Other activities in emergency preparedness  Role, responsibility and cooperation of the RB in defining criteria for agricultural countermeasures and countermeasures against ingestion and longer-term protective actions, and, if there is such a role, consistency with GS-R-2, paragraphs 4.88  Role, responsibility and cooperation of the RB in regulations on the need for mitigating the non- radiological consequences of the emergency and response, and, if there is such a role, consistency with GS- R-2, paragraphs 4.95  Role, responsibility and cooperation of the RB in regulations of the conduct of recovery operations, and, if there is such a role, consistency with GS-R-2, paragraphs 4.98

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GS-R-2 para. 3.5 states that “The… R Recommendation: The regulatory body should …

10.3. REGULATORY REQUIREMENTS FOR INFRASTRUCTURE Instructions for writing this subchapter: The requirements for an adequate level of preparedness and response for a nuclear or radiological emergency in any Member State are provided in  GS-R-2 Preparedness and Response for a Nuclear or Radiological Emergency,  GS-G-2.1 Arrangements for Preparedness for a Nuclear or Radiological Emergency.  GSG-2 Criteria for Use in Preparedness and Response for a Nuclear or Radiological Emergency These requirements apply to all those practices and sources that have the potential for causing radiation exposure or environmental radioactive contamination warranting an emergency intervention. 60 The following points and key elements of GS-R-2 should be addressed: Authority

 Authority of the RB in the regulation of the licensees’ EPR  Coordination mechanism between all organizations in accordance with GS-R-2, paragraphs 3.8 and 3.9 Organization  Regulatory requirements on staffing of licensee EPR organization in line with GS-R-r paragraph 5.9  Verification of meeting the requirements Coordination of emergency response  Regulatory requirements addressing coordination of licensee’s and off-site emergency services, their consistency with other national requirements and with GS-R-2 paragraph 5.10  Verification of the effectiveness of coordination Plans and procedures  Regulatory requirements on plans and procedures for licensees and coverage of GS-R-2 requirements by them  Regulatory approval of emergency plans  Regulatory control of adequate implementation of emergency plans, in accordance with GS-R-2, paragraph 5.23 Logistical support and facilities  Regulatory requirements on EPR logistics and facilities for the licensees and coverage of and consistence with the infrastructure elements in GS-R-2  Verification of effectiveness and adequacy of logistical support and facilities Training, drills and exercises  Regulatory requirements for EPR training, drills and exercises by the licensee and their consistency with GS-R-2 paragraphs 5.31 through 5.36  Evaluation of licensee’s training programme, training and exercises in accordance with GS-R-2 paragraph 5.36 Quality assurance programme  Regulatory requirements on quality assurance and continuous improvement in EPR in general and on the periodic revision of the plans and procedures in specific  Verification the effectiveness of the licensee’s quality assurance programme

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GS-R-2 para. 3.5 states that “The… R Recommendation: The regulatory body should …

10.4. ROLE OF REGULATORY BODY DURING RESPONSE Instructions for writing this subchapter:

61 The requirements for an adequate level of preparedness and response for a nuclear or radiological emergency in any Member State are provided in  GS-R-2 Preparedness and Response for a Nuclear or Radiological Emergency,  GS-G-2.1 Arrangements for Preparedness for a Nuclear or Radiological Emergency.  GSG-2 Criteria for Use in Preparedness and Response for a Nuclear or Radiological Emergency These requirements apply to all those practices and sources that have the potential for causing radiation exposure or environmental radioactive contamination warranting an emergency intervention. The following points and key elements of GS-R-2 should be addressed:  Role of the RB in an emergency  Plans and procedures of the RB related to its role in EPR  Coordination with other organizations having role in the EPR  EPR in the management system of the RB  EPR training drill and exercise programme of the RB  Facilities, support and logistics for the EPR programme  Verification of the effectiveness of the RB arrangements, programme for continuous improvement

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GS-R-2 para. 3.5 states that “The… R Recommendation: The regulatory body should …

10.5. SUMMARY Instructions for writing this subchapter: Summarize in a brief, condensed manner the main messages of the above subchapters by  reiterating the issues that led to the recommendations or suggestions;  referring to the good practices noted;  concluding on the general status of the subject (if appropriate)

62 11. ADDITIONAL AREAS

Based on experiences of previous missions the suggested length of the report is 5 pages. The actual length may depend on the scope of the mission and on the specificities of the host country but in any case it should not exceed 7 pages.

11.1. CONTROL OF MEDICAL EXPOSURES Instructions for writing this subchapter: Describe how the regulatory control of medical exposures is in line with the requirements of the following:  GSR Part 3 - Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards  RS-G-1.5 Radiological Protection for Medical Exposure to Ionizing Radiation  Section to be structured along the following topics:  Responsibilities of registrants and licensees  Responsibilities of the government  Responsibilities of the regulatory body  Justification of medical exposure  Optimization of medical exposure  Pregnant and breast feeding women  Release of patients  Unintended medical exposures  Review and records

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

11.2. OCCUPATIONAL RADIATION PROTECTION Instructions for writing this subchapter:

63 Describe the regulatory oversight of occupational radiation protection in the country reflecting all relevant requirements published in GSR Part 3, i.e. general requirements for protection and safety, planned, emergency and existing exposure situations.

Section to be structured along the following topics:  Legal and regulatory framework  General responsibilities of registrants, licensees and employers  General Responsibilites of workers  Requirements for radiation protection programmes  Monitoring programmes and technical services

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

11.3. CONTROL OF DISCHARGES, MATERIALS FOR CLEARANCE, AND CHRONIC EXPOSURES; ENVIRONMENTAL MONITORING FOR PUBLIC RADIATION PROTECTION Instructions for writing this subchapter: Describe the regulatory oversight of  Control of radioactive discharges and materials for clearance in the country reflecting all requirements published in GSR Part 3and the relevant requirements in GSR Part 5 and WS-G-2.3  Environmental monitoring associated with authorized practices for public radiation protection purposes reflecting the relevant requirements published in GSR Part 3 and RS-G-1.8  Control of chronic exposures (Radon, NORM and past practices) and remediation reflecting the relevant requirements published in GSR Part 3 and WS-G-3.1

In particular pay attention to following issues which have to be implemented in the national legal system:  requirements on exemption and clearance to be in line with Requirement 8 of the GSR Part 3, taking into account RS-G-1.7 (guidance on the application of the concepts of exclusion, exemption and clearance);  consideration of the dose constraint principle in the regulations and guides (Requirement 11, para 3.22);  establishment of regulatory limits for the discharges of radioactive substances from each nuclear or radiation facility and activity (Requirement 29, para 3.123);

Section to be structured along the following topics:  Control or radioactive discharges and materials for clearance  Environmental monitoring  Control of public exposure  Remediation safety requirements

Include the following table only if there is R, S or GP:

64 RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.5 (9) states that “The… R Recommendation: The regulatory body should …

11.4. SUMMARY Instructions for writing this subchapter: Summarize in a brief, condensed manner the main messages of the above subchapters by  reiterating the issues that led to the recommendations or suggestions;  referring to the good practices noted;  concluding on the general status of the subject (if appropriate)

65 12. INTERFACE WITH NUCLEAR SECURITY

The structure of each subchapter should be as follows: Description of the situation in the country with regard to the subject of the given subchapter and based on the Advance Reference Material, interviews and other inputs: 1. General description should be kept to minimum. Organizational and legal details should be avoided. 2. Those issues, which are in line with the IAEA safety standards, should only be described briefly 3. Solutions, that may be considered to be a good practice, should be explained in some details. 4. Issues not adequately compatible with the applicable IAEA safety standards should be addressed in detail. This description must be sufficient for understanding the reasons for the Recommendations or Suggestions that follow. In every subchapter there are additional instructions or reminders on how to write it.

12.1. LEGAL BASIS Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how  GSR Part 1, Requirement 12, paragraph 2.39 and  INSAG 24

Particular attention should be given to:  Existence of legal framework for oversight and enforcement security arrangements needed for maintaining nuclear safety

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.39 states that “The… R Recommendation: The regulatory body should …

12.2. REGULATORY OVERSIGHT ACTIVITY Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how  GSR Part 1, Requirement 12, paragraphs 2.39 and 2.40

Particular attention should be given to:  Regulatory program and organization related to the interface  Authorization, inspection and enforcement activity  Operational experience feedback

Include the following table only if there is R, S or GP:

66 RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.39 states that “The… R Recommendation: The regulatory body should …

12.3. INTERFACE WITH OTHER AUTHORITIES Instructions for writing this subchapter: Describe whether the following requirements are met, and if so, how  GSR Part 1, Requirement 12, paragraphs 2.39 and 2.40

Particular attention should be given to:  Cooperation with other agencies responsible for security  Distribution of responsibilities and activities

Include the following table only if there is R, S or GP:

RECOMMENDATIONS, SUGGESTIONS AND GOOD PRACTICES

Observation: Summarize the facts and observations that have led to the R, S, or GP below (1) BASIS: GSR Part 1 para. 2.39 states that “The… R Recommendation: The regulatory body should …

12.4. SUMMARY Instructions for writing this subchapter: Summarize in a brief, condensed manner the main messages of the above subchapters by  clearly indicating areas that are in line with the IAEA Safety Standards;  reiterating the issues that led to the recommendations or suggestions;  referring to the good practices noted.

67 13. REGULATORY IMPLICATIONS OF THE TEPCO FUKUSHIMA DAI-ICHI ACCIDENT

13.1. IMMEDIATE ACTIONS TAKEN BY THE REGULATORY BODY Instructions for writing this subchapter: Particular attention should be given to:  Emergency response by the regulatory body (activation, response actions, evaluations, international information exchange and cooperation, information of governmental organizations, …)  Safety evaluations promptly required from the licensees  Public communication  Lessons learned from the immediate actions (development of emergency response organization and activity, cooperation with other organizations and the media, public communication)

13.2 TECHNICAL AND OTHER ISSUES CONSIDERED IN THE LIGHT OF THE ACCIDENT Instructions for writing this subchapter: Particular attention should be given to:  Results of in-depth analysis by the licensees (e.g. stress test) on the issues raised by the accident (extreme external events, LOOP, LOUHS, severe accident management, multiple unit failures, etc.)  Corresponding actions by the regulatory body  Activities related to the IAEA Nuclear Safety Action Plan  Longer term impact of the accident and the subsequent activities on the public (public poll results, results of regulatory hearings and of other means of communication with the public)

Summarize the observations above in a short conclusion regarding the appropriateness and effectiveness of the actions taken by the regulatory body as a consequence of the accident.

CONCLUSION [1]

The IRRS Team considers that

13.3 PLANS FOR UPCOMING ACTIONS TO FURTHER ADDRESS THE REGULATORY IMPLICATIONS OF THE ACCIDENT Instructions for writing this subchapter: Particular attention should be given to:  Action Plans of the licensees and the regulatory body to address long term implications  Planned changes in the legal background and regulations  Planned changes in the organization and working method of the regulatory body  Planned activities related to the IAEA Nuclear Action Plan

Summarize the observations above in a short conclusion regarding the appropriateness of the actions planned by the regulatory body as a consequence of the accident.

CONCLUSION [2]

The IRRS Team concludes that

68 13.4 CONCLUSIONS BY REVIEWED AREAS

Note: The significance of Fukushima implications was considered as part of the review of each IRRS module. The review conclusions below and the plans presented by the host country to further address TEPCO Fukushima Dai-ichi issues in the coming years should be included in the scope of the follow- up IRRS mission to be invited by the host country. Instructions for writing this subchapter: For each module a short summary of the actions taken and issues considered as a consequence of the regulatory implications of the accidents shall be given with particular attention to the issues listed for the individual modules below. Each module shall be concluded by stating no more than three of the unified conclusions below to represent the status of the module with respect to the implications of the accident: 1. No concern raised 2. The existing status is appropriate 3. The necessary actions have been recognised 4. The regulatory body is committed to act as necessary 5. The necessary further actions have been planned 6. The necessary further actions have been initiated 7. Appropriate actions have been taken/completed 8. The actions taken by the regulatory body were exemplary 9. The regulatory body participated in a “stress test”-type exercise 10. Further actions are needed and are suggested 11. Other (please describe it in concrete) Module 1: Responsibilities and Functions of the Government Particular attention should be given to the following questions:  Are responsibilities clearly allocated in the governmental legal and regulatory framework for safety also in emergency/accident situations?  If several authorities are involved, are the responsibilities and functions of each authority clearly specified within the governmental, legal and regulatory framework for safety, also for emergency/accident situations?  Is the role of the authorized party clearly specified in the framework for safety in the case of emergency/accident situations?  Are provisions made in the framework for safety to ensure that the regulatory body is effectively independent also in emergency/accident situations?  Are governmental provisions made to ensure the availability of personal dosimetry service in emergency/accident circumstances

CONCLUSION [3]

The IRRS Team considers - to state no more than three out of the eleven unified conclusions above

Module 2: Global Nuclear Safety Regime Particular attention should be given to the following questions:  Are provisions in place to implement the Convention on Early Notification of a Nuclear Accident and the Convention on Assistance in Case of a Nuclear Accident? Are other mechanisms in place to effectively communicate at the international level in case of crisis situations?

69  Is the Government fulfilling its obligations towards the Convention on Nuclear Safety, including a continued participation in the activities and mechanisms of the Convention?  Is the Government demonstrating sufficient openness for, and involvement in international peer review missions?

CONCLUSION [4]

The IRRS Team considers - to state no more than three out of the eleven unified conclusions above

Module 3: Responsibilites and Functions of the Regulatory Body Particular attention should be given to the following questions:  Is the regulatory able to exercise its authority to intervene in any facility or activity that present significant radiation risks, irrespective of the possible costs to the authorized party?  Is the regulatory body empowered to take timely decisions in case of an emergency/accident?  Are adequate communication tools and procedures established between the regulatory body and the authorized parties in case of an emergency/accident situation?  What provisions are taken to ensure that means of communications to reach the local population remain operable in accident circumstances coupled with a natural disaster?  What provisions are taken to ensure that appropriate information reflecting the regulatory activity can be provided in a timely manner on radiation risks and protection measures, associated with forecasts whenever possible?  What procedures and arrangements ensure adequate coordination for public information between all relevant organizations in emergency/accident situation?

CONCLUSION [5]

The IRRS Team considers - to state no more than three out of the eleven unified conclusions above

Module 4: Management System of the Regulatory Body Particular attention should be given to the following questions:  Is the management system of the regulatory body continuously assessed and improved so that implications of the Fukushima accident are appropriately addressed as lessons are learned? In particular, are self- assessments and independent assessments regularly conducted?  Does the management system of the regulatory body ensure that the following items are appropriately taken into account:  long-term and balanced management commitment to provide sufficient resources and competence;  promotion of safety culture, especially a questioning attitude;  promotion of transparency and openness; and  development and maintenance of open and constructive relations with regulators of neighboring countries.

CONCLUSION [6]

The IRRS Team considers - to state no more than three out of the eleven unified conclusions above

70 Module 5: Authorization Particular attention should be given to the following questions:  Are the methods applied to characterize external hazards during siting (in particular for earth-quakes and tsunamis), and the related regulation, judged sufficiently robust in the light of the Fukushima accident?  Is a review planned or have been conducted to reassess the design provisions:  to ensure removal of heat from the reactor and from the fuel store in accident states?  to ensure the confinement of radioactive material in accident states and the limitation of accidental radioactive releases?  Was a set of design extension conditions reviewed during the authorization process for Nuclear Power Plants, and if not, is there a planned process to introduce such design extension conditions for regulatory reassessment?  Are potential harmful interactions of systems important to safety properly evaluated?  Are procedures available to prevent any effect of harmful interactions?  What are the expectations for the authorization process of the following components and are they considered sufficient in light of the Fukushima accident?  means of cooling the reactor core  systems aimed at transferring the residual heat from items important to safety to the ultimate heat sink  emergency power supply  fuel handling and storage  Is the requirement for a supplementary control room part of the authorization process?

CONCLUSION [7]

The IRRS Team considers - to state no more than three out of the eleven unified conclusions above

Module 6: Review and Assessment Particular attention should be given to the following questions:  Are systematic approaches and guidance defined to identifying a comprehensive set of postulated initiating events with the potential for serious consequences?  Is a review of such approaches and guidance planned or has it been performed in the light of the Fukushima accident, with appropriate revisions if necessary? Careful consideration should be given to:  the respective use of deterministic and probabilistic safety analysis;  the identification of internal and external hazards;  the possible combination of initiating events.  Is a review/revision of the requirements of the review and assessment process regarding design provisions planned or has it been performed:  to ensure removal of heat from the reactor and from the fuel store in accident states;  to ensure the confinement of radioactive material in accident states and the limitation of accidental radioactive releases;  for assessment of the occurrence and possible consequences of external hazards and other siting issues;  on organizational and communication preparedness for response in accident conditions?  Was a set of design extension conditions reviewed during the review and assessment process for Nuclear Power Plants, and if not, is there a planned process to introduce such design extension conditions for regulatory reassessment? 71 CONCLUSION [8]

The IRRS Team considers - to state no more than three out of the eleven unified conclusions above

Module 7: Inspection Particular attention should be given to the following questions:  Is the inspection programme able to detect precursor events on a continuing, exhaustive and systematic basis?  Are targeted inspections to review Fukushima implications integrated in the inspection programme?  Has an inspection programme been performed or planned to reassess the status of all NPPs regarding design provisions:  to ensure removal of heat from the reactor and from the fuel store in accident states?  to ensure the confinement of radioactive material in accident states and the limitation of accidental radioactive releases?  Do inspections  review alternative on site or off site means for ensuring these safety functions available in case of an emergency?  confirm robustness of the emergency power supply system?  confirm robustness of the fuel handling and storage system?  investigate the actual arrangements between the operator’s headquarters and the plant management in case of an emergency? Are adequate procedures available to respond to such situations?

CONCLUSION [9]

The IRRS Team considers - to state no more than three out of the eleven unified conclusions above

Module 8: Enforcement Particular attention should be given to the following questions:  Is the regulatory body in the position to exercise a graded enforcement policy whenever necessary and in particular in a situation similar to the Fukushima accident?  What is the process which will be implemented by the regulatory body if Fukushima implications would lead to identify unforeseen radiation risks?  What process will be used by the regulatory body to ensure that the corresponding corrective actions are implemented by the authorized parties?

CONCLUSION [10]

The IRRS Team considers - to state no more than three out of the eleven unified conclusions above

Module 9: Regulations and Guides Particular attention should be given to the following questions:  Does the current content of guides reflect the best available knowledge including the implications of the Fukushima accident?

72  Does the current regulatory framework effectively address through regulations and guides all technical points listed below requiring particular attention in light of the Fukushima accident?  Are reviews and, as necessary, revisions, of regulations and guides on nuclear power plants scheduled or have been performed to address the implications of the Fukushima accident as lessons are learned?  In particular, are there plans to review the available guidance or to issue new guidance or have they been issued in the light of the Fukushima accident on the following areas:  Siting, design and licensing process;  External hazards, including seismic and tsunami risks assessment;  Possible combination of initiating events  Emergency preparedness and response;  Use of deterministic and probabilistic safety analysis  Is a set of design extension conditions specified in the regulations and guides applicable to Nuclear Power Plants, and if not, is there a planned process to introduce such design extension conditions for regulatory reassessment?

CONCLUSION [11]

The IRRS Team considers - to state no more than three out of the eleven unified conclusions above

Module 10: Emergency Preparedness and Response Particular attention should be given to the following questions:  Are beyond design basis accidents adequately addressed in the emergency preparedness and response programme of the operating organization, as reviewed by the regulatory body?  Are accidents affecting more than one unit/facility (if applicable) considered in the emergency preparedness and response plans?  What provisions are taken to ensure that means of communications to reach the local population can operate in accident circumstances coupled with a natural disaster, and that appropriate information can be provided in a timely manner?  What procedures and arrangements ensure the best coordination for public information among all relevant organizations in crisis situation?

CONCLUSION [12]

The IRRS Team considers - to state no more than three out of the eleven unified conclusions above