COMMISSION STAFF WORKING DOCUMENT

IMPACT ASSESSMENT

Accompanying the document

Proposal for a Council Directive amending Directive 2009/71/EURATOM establishing a Community framework for the nuclear safety of nuclear installations

LIST OF ABBREVIATIONS

AC Alternating current

AHGNS Ad-hoc Group on Nuclear Security

BWR Boiling Water Reactor

CNS Convention on Nuclear Safety

DC Direct current

ENSREG European Nuclear Safety Regulators' Group

IAEA International Atomic Energy Agency

NPP Nuclear Power Plant

SAM Severe Accident Management

SAMG Severe Accident Management Guidelines

SBO Station Black-Out

OSART Operational Safety Review Team

PSA Probabilistic Safety Assessment

PSR Periodic Safety Reviews

TMI Three Mile Island

WANO World Association of Nuclear Operators

WENRA Western European Nuclear Regulators' Association

TABLE OF CONTENTS

INTRODUCTION

Section 1: Procedural issues and consultation of interested parties.............................................. …8

Section 2: Problem definition....................................................................................................... 13

Section 3: Objectives.................................................................................................................. 29

Section 4: Overview of the policy options.................................................................................... 31

Section 5: Analysis of impacts of the policy options...................................................................... 33

Section 6: Comparing the policy options...................................................................................... 43

Section 7: Monitoring and evaluation........................................................................................... 46

ANNEX I.................................................................................................................................. 48

Comprehensive risk and safety assessments ('Stress Tests') of nuclear power plants in the European Union 48

ANNEX II................................................................................................................................. 53

1.1........ Overview of the results of the on-line public consultation on Areas of reinforcing the existing Euratom nuclear safety legislative framework.................................................................................................... 53

1.2........ Overview of the contributions received from various stakeholders in addition to the on-line public consultation 68

ANNEX III................................................................................................................................ 72

Socio-Economic role of Nuclear Energy to Growth and Jobs in the EU for time horizon 2020-2050 72

ANNEX IV................................................................................................................................ 83

Examples of measures responding to the specific objectives......................................................... 83

ANNEX V................................................................................................................................. 89

Detailed description of the Policy Options analysed in the IA........................................................ 89

ANNEX VI – Competitiveness Proofing Study ............................................... (Separate document)

Introduction

On 11 March 2011, a magnitude 9.0 earthquake struck some 80 km off Japan's Tohoku coast. The ensuing tsunami set off by the earthquake devastated communities along the Japanese coast, killing some 16000 people[1]. The natural disaster also triggered the shutdown and subsequent meltdown of three reactors at the Fukushima Daiichi Nuclear Power Plant (NPP). Some 100000 people had to be evacuated because of radioactive contamination[2], and the total costs of the accident have been estimated as high as $250 billion[3].

While Fukushima is not the world's worst nuclear accident[4], history has shown that each major nuclear accident (Three Mile Island (TMI) (USA, 1979), Chernobyl (Soviet Union, 1986)) has caused a re-examination of the risks of nuclear power leading to more stringent safety requirements. In Fukushima's aftermath came a vigorous reassessment of the safe use of nuclear energy in Europe and worldwide, firstly because it is a severe accident, and secondly because it occurred in a nation that was assumed to have a high standard of safety and technical expertise.

Although the technical challenges are different with each accident, the analysis of the Fukushima nuclear accident reveals quite substantial, well-known and recurring technical issues[5]: faulty design, insufficient backup systems, human error, inadequate contingency plans, and poor communications.

Even more striking are the persistent institutional failures revealed by a comparison between the post-accident evaluations of 1979's TMI and 2011's Fukushima, including failure of voluntary self-regulation, denial of the reality of risk, lack of safety culture, lack of a comprehensive and consistent regulatory framework, failure to resolve outstanding safety issues, failure to add safety measures to existing reactors because of cost, and complexity and confusion in the response to a severe accident.

Fukushima has shown that well-known lessons learned from accidents decades ago have not been taken up voluntarily by parts of the industry and not sufficiently been enforced by regulators, even in a nation that was previously assumed to have a high standard of safety.

Nuclear energy currently generates close to 30% of all electricity in the EU and about two-thirds of its low-carbon electricity. Nuclear safety is of the utmost importance to the EU and its people. The costs of a nuclear accident could be so large, that they are potentially ruinous to national economies. It is therefore essential for society and the economy to avoid the occurrence of any nuclear accident in a Member State of the European Union (hereinafter referred to as 'Member State'), by ensuring the highest possible quality of regulatory oversight and standards of nuclear safety. The Fukushima nuclear accident has renewed political attention on the measures needed to minimise risk and guarantee the most robust levels of nuclear safety.

Based upon a clear mandate from the European Council at its meeting of 24-25 March 2011[6], the European Commission, together with the European Nuclear Safety Regulators Group (ENSREG), launched an EU-wide comprehensive risk & safety assessments of NPPs (hereinafter referred to as 'Stress Tests'). These tests identified a large number of shortcomings in nuclear safety approaches and industry practices in the participating countries[7].

In addition to the Stress Tests process, the mandate from the European Council included the request to the Commission to "review the existing legal and regulatory framework for the safety of nuclear installations" and to "propose by the end of 2011 any improvements that may be necessary". Initial views on potential areas of legislative improvements have already been included in the Commission Communication on the interim report on the comprehensive risk and safety assessments ('stress tests') of nuclear power plants in the European Union[8] (hereinafter referred to as 'Commission interim stress tests report'). Any legislative proposals that could be put forward should take into account various sources, inter alia the conclusions of the Stress Tests, any lessons learned from the Fukushima nuclear accident, initiatives from various expert groups and international developments, as well as the results of the open public consultation and the stakeholders' input. The areas identified for revising the current Nuclear Safety Directive are described in more detail in the Communication from the Commission to the Council and the European Parliament on the comprehensive risk and safety assessments ("stress-tests") of nuclear power plants in the EU and related activities[9] of 4 October 2012 (hereinafter referred to as 'Commission final stress tests report').

This Impact Assessment takes into account the above-mentioned factors. It defines in Section 2 the problems in ensuring sufficient levels of nuclear safety in the EU and the need for EU action to meet the challenges. It articulates in Section 3 the general and specific objectives for the enhanced prevention and mitigation of nuclear accidents. In Section 4 a number of policy options progressing steadily from the current starting point to more profound reforms are set out and analysed. Each option is assessed in Section 5 for its estimated safety, economic, environmental and social impacts. This sets the scene in Sections 6 and 7 for the selection of a preferred option to go forward.

The selected option amends the existing Council Directive 2009/71/Euratom establishing a Community framework for the nuclear safety of nuclear installations[10] (hereinafter referred to as 'Nuclear Safety Directive'), by strengthening existing / introducing new general nuclear safety principles and requirements, complemented by harmonised Euratom nuclear safety criteria and procedures to verify their implementation at national level. It also provides for greater independence of the regulators and increased public transparency about the performance of the industry and the regulators. Based upon the principle of risk-informed decision making support, it avoids wholly new or unfamiliar approaches, and thereby avoids the risk of destabilising the currently best performing national nuclear safety regimes. While some of the underlying measures of the preferred option can be implemented without delay, others require technical development work with input from Member States to enable or complete their implementation.

Section 1: Procedural issues and consultation of interested parties

1.1. Timing and organisation

Timing

In the aftermath of the nuclear accident that occurred at the Fukushima NPP in Japan, the EU launched an immediate response. In addition to performing the extensive Stress Tests (presented in Annex I of the IA), the European Council also mandated the European Commission, in the Conclusions of the meeting of 24-25 March 2011, to "review the existing legal and regulatory framework for the safety of nuclear installations" and "propose by the end of 2011 any improvements that may be necessary". In a first response to this mandate, the Commission included initial views on potential areas of legislative improvement in the November 2011 Commission interim stress tests report. Next, the European Council called in the Conclusions of the meeting of 9 December 2011[11] that "continued priority to be given to the extensive review of nuclear safety, taking account of the Commission communication of 23 November". The areas which have been identified for revising the current Nuclear Safety Directive are described in the aforementioned Commission final stress tests report.

The European Parliament has also called for a review. In the Resolution of 5 July 2011 on energy infrastructure priorities for 2020 and beyond[12], it "considers that future legislative initiatives to set up a common framework for nuclear safety are essential in order to continuously improve safety standards in Europe". Furthermore, in the Resolution of 6 July 2011 on the Commission Work Programme 2012[13], it "calls for an urgent revision of the Nuclear Safety Directive with a view to its strengthening, namely by taking into account the results of the Stress Tests implemented in the aftermath of the Fukushima accident".

Organisation

For the purpose of developing the current Impact Assessment (IA), a European Commission inter-service Impact Assessment Steering Group (IASG) was established, led by DG ENER, and comprising representatives of other services i.e. SG, SJ, DG CLIMA, DG DEVCO, DG ECHO, DG ECFIN[14], DG EMPL, DG ENTR, DG ENV, DG HOME, DG JRC, DG RTD, DG SANCO. The IASG met four times, on 9 February 2012, 11 May 2012, 13 July 2012 and 6 September 2012.

The Impact Assessment Board (IAB) assessed the draft IA submitted for its attention on 19 September 2012, had its meeting on 17 October 2012 and issued an opinion on 19 October 2012.

In line with the opinion delivered, this impact assessment has been revised, in order to:

· Strengthen the problem definition, and in particular explain the current architecture for the regulatory framework governing nuclear safety in the EU, clarify the current roles and competences of the various players at national and international level and more clearly describe the various existing legal requirements at national, EU and international (see sections 2.1. and 2.2.);

· Add information on the views of various stakeholders (see sections 1.2.1.–1.2.3., 2.2.2.-2.2.5. and section 1.2. of Annex II);

· Add information on the specific weaknesses identified in the different Member States in the Stress tests (see mainly section 2.2.); it is better explained how these weaknesses are related to the deficiencies in the EU regulatory framework (see section 2.2.);

· Further justify why action is necessary at this stage (see mainly sections 2.2., 2.2.3. and 2.2.4.);

· Further develop the baseline scenario in order to demonstrate what would happen in the event of no EU action (see mainly section 2.5.);

· Better explain the content of the options (see sections 4., 5. and 5.4. as well as Annexes IV and V);

· Better assess and compare impacts (see section 6.).

· Moreover, Section 7 of the IA on monitoring and evaluation has been further developed.

1.2. Consultation and expertise

The input presented in Sections 1.2.1 – 1.2.3 below has been taken into account for the purposes of this IA.

1.2.1. On-line open public consultation

In line with its general principles of consultation and dialogue[15], the Commission launched an on-line public consultation (published on the Europa website[16]), seeking views on Areas of reinforcing the existing Euratom nuclear safety legislative framework. The consultation was open during the period 21 December 2011 – 29 February 2012.

In response, the Commission received 134 contributions from nuclear regulatory authorities, other public authorities, companies, non-governmental organisations, as well as individuals. This public consultation offers therefore insights into a large range of stakeholder opinions.

In addition to gauging opinions in the frame of the review of the legal and regulatory framework for the safety of nuclear installations, the consultation also covered a number of other topics related to the use of nuclear power, i.e. enhancing emergency preparedness and response, nuclear liability, improving the global legal framework, and enhancing scientific and technological competence.

In relation to the areas of reinforcement of the existing Euratom nuclear safety legislative framework, opinions were sought on: the importance of setting up common rules for all Member States; the need to reinforce the existing legislation at Euratom level, given the trans-frontier aspects of radiological accidents; the preferred means for achieving this and the level of prescription needed (e.g. defining Euratom-wide basic principles only or complementing these with associated technical criteria); the need to bolster provisions for independence and transparency; the opportunity of strengthening the competencies of national regulators in the shaping and implementation of Euratom nuclear safety legislation.

The broad outcome of this on-line public consultation shows that more than 90% of respondents agree on the importance of a Euratom nuclear safety framework, setting up common rules for EU Member States, whilst 76% agree with the need to reinforce the existing safety legislative framework. The nuclear industry (operators, suppliers, associations) views as important the role of the Euratom nuclear safety legislative framework, but has a more divided view on the need for reinforcing the existing rules. Those favouring enhancement of the current rules prefer a combined approach of binding and non-binding Euratom legislation, principally in the areas of strengthening the role, competencies and independence of national regulatory authorities, and increasing transparency. Some also support the defining of EU-wide basic principles and requirements (with associated technical criteria) on the siting, design, construction and operation of NPPs. Many NGOs and interested citizens also consider the role of the Euratom legislative framework as important and agree with the need to reinforce the existing framework, mainly through strengthening and harmonizing national approaches. The outcomes of this on-line public consultation are summarised in Annex II (Section 1.1) of the IA.

1.2.2. Contributions from stakeholders

In addition to the on-line public consultation, the Commission has received both written and meeting-based contributions from various stakeholders, e.g. nuclear regulatory authorities, other public authorities, individual companies, industry associations and non-governmental organisations.

The European social partners from the Electricity Sectoral Social Dialogue Committee have also been consulted, and expressed the view that the nuclear industry needs to meet the highest levels of safety possible and consider that a European approach in this area is needed[17]. The social partners will be further involved, through the consultation of the European Economic and Social Committee, in the process of the preparation of any legislative proposal based on Articles 31 and 32 Euratom Treaty.

A summary and analysis of the inputs received from these stakeholders is included in Annex II (Section 1.2) of the IA.

In addition, the Commission has organised with ENSREG several Conferences and public debates in Brussels together with a wide range of stakeholders, including NGOs, on the process, the intermediate and final results of as well as the conclusions from the Stress Tests: the 1st European Nuclear Safety Conference on 28-29 June 2011, a Stakeholders Conference on Peer Reviews on 17 January 2012, and a Public Debate on Stress Tests and Peer Review Results on 8 May 2012. This will be followed up by the 2nd European Nuclear Safety Conference, scheduled for June 2013 in Brussels.

1.2.3. Main information sources

· Information from the Member States based on the Article 33 Euratom Treaty submissions

According to Article 33 Euratom Treaty, Member States are bound to communicate to the Commission their draft legislation in order to ensure its conformity with basic standards. The Commission may make recommendations within a three-month period from the communication of these drafts.

The aim of the notification procedure laid down in Article 33 of the Euratom Treaty is to ensure harmonisation of the applicable provisions in the Member States. Thus, the submission of draft texts under Article 33 Euratom Treaty allows the Commission to make appropriate recommendations or remarks before the finalisation of the national procedure for the adoption of transposition measures, so that possible instances of non-compliance can be identified even before the texts are adopted.

In the framework of the Nuclear Safety Directive, 21 Member States (AT, BE, CY, CZ, EE, FI, DE, EL, EE, IT, LV, LT, LU, MT, NL, PT, PL, RO, SL, SK and SV) communicated draft transposing measures during the transposition period. Although most of them aimed to transpose individual Directive provisions and not the Directive as a whole, a large number of Member States argued that they already had legislation in force that would transpose important parts of the Directive.

Based on the Commission's preliminary assessment of the notified draft measures, it is concluded that, although they don’t contain elements deviating from the main requirements set by the Directive, the wide range of legal solutions, in particular to ensure the effective independence of the national regulatory body and the adequacy of its legal powers and its human and financial resources to the mission attributed by the national legal framework and the Directive provisions, could prevent the realisation of the Directive objectives in a harmonised way within the Community.

· Preliminary assessment of the Member States' transposition measures of the Nuclear Safety Directive

The preliminary assessment of the Member States' transposition measures of the Nuclear Safety Directive, although indicating that these largely meet the main requirements set by the Directive, has identified a number of areas where improvement would be needed (effective independence of the national regulatory authority and transparency).

· Results of the Stress Tests

An important input was the findings of the Stress Tests, which involved a range of stakeholders across the 15 Member States with NPPs in operation or being decommissioned (plus 2 neighbouring countries). In particular, the process involved the Commission and ENSREG, who, with the expertise of the Western Nuclear Regulators' Association (WENRA), developed the scope and modalities of the tests; the plant operators who carried out the assessments; the national regulators in the 15 countries who reviewed the reports; a team of 80 regulatory experts from 24 European countries who carried out the peer review of the national reports. The results and conclusions of the Stress Tests process therefore provide valuable input to the present consideration of areas of improvement to the legislative and regulatory framework.

· International dimension

In June 2011 a Ministerial Conference on Nuclear Safety was convened under the auspices of the International Atomic Energy Agency (IAEA), for the process of learning and acting upon lessons following the Fukushima accident in order to strengthen nuclear safety, emergency preparedness and radiation protection of people and the environment worldwide. The Ministerial Conference adopted a Ministerial Declaration[18] that, inter alia, requested the IAEA Director General to develop a draft Action Plan on Nuclear Safety. Developed in intensive consultation with IAEA Member States, the Action Plan on Nuclear Safety was adopted by the IAEA's Board of Governors and subsequently unanimously endorsed by the IAEA General Conference in September 2011[19]. The Ministerial Declaration and the subsequent Action Plan provide the international dimension to the sources of information considered in this IA.

In addition, during the 5th Review Meeting of the Convention on Nuclear Safety, the Contracting Parties in attendance agreed to hold an Extraordinary Meeting (EM) of the CNS, which was held in Vienna from 27-31 August 2012. The meeting aimed to enhance safety through reviewing and sharing lessons learned and actions taken by Contracting Parties in response to events at Fukushima and to reviewing the effectiveness and, if necessary, the continued suitability of the provisions of the Convention on Nuclear Safety.

The six topical discussions at the EM (External Events, Design Issues, Severe Accident Management and Recovery (on-site), National Organizations, Emergency Preparedness & Response and Post-accident Management (off-site), and International Cooperation) were used to identify the key actions taken, the challenges faced and the initial lessons learned by many Contracting Parties from the Fukushima Daiichi accident which were summarised in its Final Summary Report[20] where the suggested steps to strengthen the effectiveness of the Convention were also included.

The other important sources of information mentioned in this IA are the official investigation reports into the Fukushima accident issued by the Japanese authorities. The reports of the Japanese Government to the IAEA (June[21] and September 2011[22]) contain a detailed description of the events in the accident sequence, accident response and initial lessons learnt. Separately, investigations were launched by the Governmental Cabinet Office ("Investigation Committee on the Accident at Fukushima Nuclear Power Stations of Tokyo Electric Power Company", final report July 2012[23]) and another by the National Diet of Japan ("The Fukushima Nuclear Accident Independent Investigation Commission", final report July 2012[24]). The latter two investigation reports contain testimonies of a larger group of affected persons and also contain a wider analysis of the accident causes and subsequent response.

· Results of Eurobarometer surveys

The Eurobarometer surveys are major policy instrument that enable citizens’ views to be taken into account in the framing of EU policies and initiatives. The Commission has taken into account the results of the latest Special Eurobarometer survey "Europeans and Nuclear Safety"[25]. The survey was conducted in the 27 Member States between September and October 2009 and the report was published in March 2010. Almost 26500 European citizens were interviewed face-to-face. The survey covers both the wider theme of nuclear issues in general and the topic of nuclear safety in particular.

Throughout the report, the results have clearly shown that nuclear safety aspects are of crucial importance against a background where the potential danger posed by nuclear power appears to be one of the major drivers of reluctance regarding nuclear energy. In this regard, one of the conclusions of the survey is that "European citizens are extremely conscious of the importance of safety and protection, as far as nuclear energy is concerned but most feel ill-informed about nuclear safety issues related to nuclear power plants". Furthermore, the survey seems to reveal that European citizens trust the European legislation and recognize the usefulness of a European framework.

Section 2: Problem definition

2.1. The problem that requires action

The accident at the Fukushima Daiichi NPP has resulted in significant environmental, economic and social damage, and raised concerns about possible health effects in the affected population in Japan. Although triggered by an earthquake and tsunami of an immense magnitude, investigations of the causes of the accident reveal a range of foreseeable factors which combined to produce a catastrophic outcome. In other words, although the tsunami was not an unforeseeable event (and thus clearly within the realm of risk-informed, probabilistic assessment), strong deficiencies of the plant’s design basis caused the accident. As the analysis of the Fukushima accident reveals quite substantial, well-known and recurring technical issues as well as persistent institutional failures that emerged to a large degree already from the post-accident evaluations of 1979's TMI and 1986's Chernobyl nuclear accidents, the attention of the public and policy makers focused on the safety and security risks associated with the NPPs in their own region. As with the TMI accident in 1979 and the Chernobyl accident in 1986, this latest nuclear accident once again undermined public confidence in the safety of nuclear power; and particularly so at a time when the increased use of nuclear power is being debated as possible option to meet global energy demands whilst addressing greenhouse gas emissions in a sustainable manner.

The EU has 132 operating reactors, representing about one-third of the 437 operating nuclear power reactors in the world. Many of the EU NPPs were constructed already three to four decades ago, and are based on designs and safety provisions that were continuously updated since then. In May 2011, the Commission together with ENSREG launched a comprehensive review of the NPPs in the EU and some neighbouring countries to assess if current safety margins are sufficient to cover various unexpected events. The results of these tests show various strengths and weaknesses, including the clear need to implement for a number of plants measures to increase the robustness against external hazards. The tests also showed significant differences in national approaches to beyond-design basis assessments that make an adequate assessment of current safety levels difficult or impossible. For example, in some cases earthquake risk was not considered in the original design basis but only introduced at a later stage or clearly underestimated. New methodologies in seismic hazard and risk assessment have since been developed, but not all operators have reassessed site hazards and seismic risks with recent methodologies.

These tests were organised taking due account of the distribution of current responsibilities among the various stakeholders in the area of nuclear safety. According to article 6 of the Nuclear Safety Directive, the prime responsibility for nuclear safety lies with the "licence holder" (i.e. the plant operator) under the supervision of the national competent regulatory authority. Member States are responsible for establishing and maintaining a national legislative, regulatory and organisational framework for nuclear safety. Under the Euratom Treaty, the Commission can make legislative proposals to create an EU legislative framework for nuclear safety,

Severe accidents leading to radioactive releases may result in the need for countermeasures such as sheltering or evacuation of the affected population. Estimates show that the number of people living close to NPPs in the EU vary significantly. However, as many as 1.74 million people live, for example, within 30km of one of the larger NPPs[26]. Thus the practicalities of such large scale countermeasures point to the key importance of accident preventative measures.

The lessons from the Fukushima disaster and the outcome of the Stress Tests have provided a strong impetus for examining the factors shaping the technical safety and the safety governance of nuclear power in the EU. It is opportune to ask whether existing measures are sufficient; to what extent strengthened or additional requirements could prevent a similar disaster occurring in the EU; and what type of technical and organisational measures would be most effective.

2.2. Specific problems to be addressed

Based on various sources of expertise, such as corresponding initiatives by the IAEA and WENRA as well as lessons learned from the EU Stress Tests and Fukushima accident investigations, as well as from the prima facie assessment of the Member States' transposition measures of the Nuclear Safety Directive, key areas for improvement of nuclear safety have been identified. These problem areas are presented below under Sections 2.2.1 to 2.2.5 and concern technical issues (in particular plant siting and design), the regulatory oversight, aspects related to nuclear safety governance (regulatory independence and transparency) as well as the issue of emergency preparedness and response.

• Technical issues • Regulatory oversight issues • Regulatory independence issues • Transparency issues • Emergency preparedness and response issues

It is also explained below what are the main shortcomings identified in Member States, such as gaps in ensuring comprehensive and transparent identification and management of key safety issues, failure to implement important safety measures and last but not least the continued significant differences between Member States resulting in the absence of a consistent approach to regulation of nuclear safety despite its global nature.

Under each identified problem area presented below, the weaknesses of the current Euratom nuclear safety legislation, in particular of the Nuclear Safety Directive, to address them, are highlighted. This Directive sets up a legally binding Euratom framework based upon internationally recognised principles and obligations, underlying a nuclear safety legislative, administrative and organisational system[27].

Firstly, taking into account that the scope of this Directive is limited to overall principles, it can by no means address the technical issues identified as key risk contributors in the Fukushima nuclear accident and the Stress Tests, nor take account of initiatives from various expert groups and international developments in this area, as those matters are simply not covered by the scope of the current Directive. Examples are the methods and criteria used to assess the adequacy of existing safety margins of plant-specific safety functions against the various possible impacts from both internal and external hazards, the minimum provisions that need to be incorporated in the design of NPPs in order to achieve sufficient levels of safety, the minimum severe accident management provisions to be in place, etc. A detailed summary of the safety issues and good practices specific to each Member State and each NPP are described in the Staff Working Document[28] accompanying the Commission Communication on the Stress Tests[29].

In the following text, it is explained that notwithstanding the role of the Stress Tests in enhancing the safety of EU NPPs, the weakness of this exercise is related to its non-binding nature. Indeed, the Stress Tests are only a voluntary exercise which does not guarantee that the recommended improvements will be (fully) implemented. Another weakness of the Stress Tests is that they are only a one-time, ad-hoc exercise. It does not guarantee that the identified measures will be regularly updated and implemented also in the future, where appropriate. Further, as the EU Stress Tests were developed in the light of the events which occurred at the Fukushima NPP in March 2011, they represent targeted reassessments of the safety margins of NPPs against impacts from a limited range of extreme external initiating events. Therefore, various important aspects of nuclear safety have not explicitly been treated, such as ageing of structures and components, human and organisational factors or independence of the regulator vis-à-vis the licensee.

Secondly, as explained below, the current provisions of the Directive concerning regulatory independence do not appear to be sufficient anymore in the light of the Fukushima nuclear accident, which showed the paramount importance of the independence of national regulatory authorities and the consequences of the lack of such independence. The preliminary assessment of the transposing measures in Member States has also identified the regulatory independence as an area where improvement would clearly be needed.

Moreover, the Stress Tests show that cooperation and coordination mechanisms between all parties having responsibilities for nuclear safety, such as peer reviews, should be strengthened beyond the current requirements of the Directive.

Thirdly, the lessons learned from the Fukushima nuclear accident, as well as the outcome of a prima facie check of the transposition measures of the existing requirements at Member State level suggest that the current provisions of the Directive concerning transparency should be further enhanced.

In addition, in the course of the public meetings held in the framework of the Stress Tests, demands have emerged to extend the assessment to emergency preparedness and response arrangements. In this context, the area of on-site emergency preparedness and response should be considered.

Following the events at Fukushima, IAEA Member States generally acknowledge the need to enhance the effectiveness, governance and enforceability of the international legal framework for nuclear safety. At international level, safety principles and standards governing nuclear safety have been developed and agreed. Through the IAEA, the main instruments governing nuclear safety are recommended IAEA safety "standards"[30] and international Conventions[31]. However, these safety "standards" are legally non-binding, while the international Conventions are legally binding but not enforceable. Thus, for example, the CNS does not provide sanctions, penalties or other types of coercive implementation mechanisms in case the Contracting Parties do not comply with its requirements. The CNS provides for a dispute-settlement mechanism which relies solely on consultations between Contracting Parties in case of a disagreement on the interpretation or application of the Convention. On the other hand, the Euratom legislation benefits from clear and strong mechanisms for sanction for its proper transposition and implementation,

Any revision of the international Conventions can be expected to take considerably longer than the possible Euratom legislative amendment process, due to the complex procedures in place, requiring consensus or the condition of attaining a certain quorum of the Contracting Parties' votes.

Moreover, the rules agreed at international level have a more general character, as they need to be applied worldwide, while Euratom legislation would be tailored to the specific needs and situations existing in the Member States.

2.2.1. Technical issues

Ø Observations from the Fukushima nuclear accident

· Plant Siting and Design: One lesson learned from Fukushima seems to be that the tsunami hazard was underestimated and thus not adequately reflected in the plant design, mostly due to systemic and organisational factors. A single external event (the tsunami) disabled all but one emergency diesel generators at the plant simultaneously, shutting down all safety systems of Units 1-4. Due to the multi-unit site layout, problems at one Unit created negative safety-related situations at adjacent Units. For example, the hydrogen explosion at Unit 3 disabled some fire pumps used for seawater injection at Unit 2. Units 5-6, which are far from Units 1-4, were unaffected by the hydrogen explosions at Units 1 and 3. Thus, Fukushima showed both the need for continuously updating a site's hazard profile with follow-ups, e.g. in the periodic safety reviews (PSR) (rather than in a one-shot exercise at the initial licensing stage), as well as for implementing – and for verifying implementation – of adequate risk reduction measures. This applies to possible impacts from seismic hazards, flooding and other external natural hazards, such as severe weather conditions or man-made external hazards[32], including combined hazards and multi-unit events and collocated nuclear and industrial facilities. Corresponding design-basis protection should be re-evaluated.

· Emergency Power following Beyond-Design-Basis Events: The loss of offsite power due to the earthquake and onsite AC power due to the tsunami, combined with rapid discharge of DC batteries led to a complete Station Blackout (SBO), which in turn led to fuel overheating and damage with consequent radiological implications.

· Reactor Containment and Hydrogen Management: SBO resulted in complete loss of the heat removal function. Deficient fuel cooling resulted in overheating of the fuel, enabling rapid oxidation of fuel cladding thus generating large amounts of hydrogen. The operators had to vent the containment manually to prevent containment over-pressurisation. Some vented gases leaked into the reactor building, which had no ventilation (again due to SBO), resulting in hydrogen accumulation and ultimately explosion of or damage within the reactor buildings at Units 1-4.

· Spent Fuel Pools: Design and location of the spent fuel pools in the upper part of the reactor buildings exposed them to damage from hydrogen explosions in reactor buildings at Units 1, 3 and possibly 4. The loss of spent fuel pool cooling due to SBO, and the large amount of debris accumulated in the spent fuel pools as a result of structural damage of the upper part of the reactor building affected the heat removal process. This concern led to one-week-long unconventional cooling efforts (e.g. helicopters, water cannons).

Ø Lessons learned from the Stress Tests

· The type of accident that occurred at Fukushima is well known in nuclear safety as the SBO scenario. Since decades, SBO has been one of the great concerns and been subject to detailed analysis and development of improvement measures[33]. As dramatically proven in Fukushima and as confirmed also by the Stress Tests[34], SBO is the limiting case for many NPP Units, leading to fast reactor core heat-up if no counter-measures are implemented[35]. However, despite being known since decades as limiting case, there is still need, also in a number of European NPPs, to implement effective preventive or mitigative measures[36].

· Fukushima highlighted once again the key importance of the containment function, which is critical as the last barrier to protect people and environment against radioactive releases resulting from an accident. Following the accidents at TMI and Chernobyl, urgent implementation of recognized measures to protect containment integrity was already considered crucial. The Stress Tests proved that even today, decades after TMI and Chernobyl, their implementation is still pending in some Member States.

· The Stress Tests identified a significant lack of consistency with respect to assessing and managing external hazards to plant safety. Already the national Stress Tests and their topical peer review (see Annex I) showed that there is no consistency in the handling of important safety margins against internal and external hazards across NPPs in Europe. This was then confirmed in the course of the country-specific peer reviews. Significant differences exist in national approaches and strong difficulties were encountered with corresponding beyond design basis margins and cliff-edge effects assessments, leaving the interpretation that what is considered a sufficient margin of safety is often left to expert judgment only. As an example, IAEA guidance suggests that minimum 0.1g horizontal peak ground acceleration should be adopted for seismic loading, where a national approach to seismic hazard assessment may indicate a lower level for design or reassessment. As shown in the Stress Tests, this minimum level has not yet been fully adopted in a number of Member States.

· As it is essential to ensure that severe accidents, should they occur, can be managed and mitigated properly, international standards require since some time Severe Accident Management Guidelines (SAMGs) to be available in all NPPs. Despite forming the organisational basis to successfully mitigate accidents once steps to prevent fuel damage have failed, the Stress Tests have shown that SAMGs are still lacking implementation, full scope application or even basic development in a large number of Member States.

Ø Provisions in the current Nuclear Safety Directive

At Euratom level, the current Nuclear Safety Directive defines the term "licence" as "any legal document granted under the jurisdiction of a Member State to confer responsibility for the siting, design, construction, commissioning and operation or decommissioning of a nuclear installation" [Article 3(4)]. It includes a general requirement that license holders, under the supervision of the regulatory authority, should regularly assess and verify, and continuously improve, as far as reasonably achievable, the nuclear safety of their nuclear installations in a systematic and verifiable manner [Article 6(2)]. This assessment must include verification that measures are in place for prevention of accidents and mitigation of consequences of accidents, including verification of the physical barriers and licence holder's administrative procedures of protection that would have to fail before workers and the general public would be significantly affected by ionising radiations [Article 6(3)].

However, the Directive does not include specific Euratom nuclear safety requirements or technical criteria on the siting, design & construction and operation of nuclear installations. Therefore, the risks from none of the above-described issues are managed by the provisions of the current Directive at the level of detail considered necessary.

2.2.2. Regulatory oversight issues

Ø Observations from the Fukushima nuclear accident

· The initial lessons from the Fukushima accident clearly indicated a serious failure in implementing requirements and recommended actions for protecting the plant against external hazards.

· One of the key findings of the 26 December 2011 Interim Report of the Investigation Committee on the Accident at Fukushima Nuclear Power Stations of Tokyo Electric Power Company (ICANPS)[37] was that operators and the authorities had become complacent about nuclear safety standards in Japan, and a radical review is required. The official report of the Japanese parliament, National Diet of Japan, Fukushima Nuclear Accident Independent Investigation Commission[38] (July 2012) referring to regulatory inadequacies notes that "The regulators did not monitor or supervise nuclear safety. The lack of expertise resulted in “regulatory capture,” and the postponement of the implementation of relevant regulations." It adds "Autonomy and transparency must be built into the new regulatory organizations to be created. They must have significant powers of oversight in order to properly monitor the operators of nuclear power plants."

Ø International developments

· The importance of "further strengthening the authority, competence and resources of national regulatory authorities" has been highlighted in the Declaration by the IAEA Ministerial Conference on Nuclear Safety[39] and reiterated in the subsequent Action Plan on Nuclear Safety[40].

· In the Final Summary Report of the 2nd Extraordinary Meeting of the Contracting Parties to the CNS (Annex containing action-oriented objectives for strengthening nuclear safety), one of the items included therein is to "Ensure the effectiveness of its regulatory body by providing for adequate legal authority, sufficient human and financial resources, staff competence, access to necessary external expertise for its decision-making based on adequate scientific and technical knowledge, access to international cooperation, and other matters needed for fulfilling its responsibilities for the safety of nuclear installations."

Ø Lessons learned from the Stress Tests

· In the course of the Stress Tests, tangible safety improvements have been identified in all the participating countries, based on the lessons learned from Fukushima. The expenses for implementing these upgrading measures on a plant-specific basis are likely to be significant. However, the main weakness of the Stress Tests is the difficulty of giving a relative priority in terms of risk reduction to the hundreds of improvement measures identified. To be able to judge the importance of the different proposed measures, to prioritize between them and to allocate funding to those areas which would bring the greatest safety benefits, sufficiently consistent and comprehensive risk-informed methods and related criteria would need to be implemented in a consistent manner across the entire nuclear sector, in response to the urgent need to efficiently reinforce nuclear installation safety based on risk assessment conclusions. The Stress Tests have shown that operators and regulators in many Member States make already some use of risk-informed methods[41] to help support regulatory oversight and decision-making when identifying weaknesses and prioritizing safety improvements. Probabilistic Safety Assessment (PSA) forms an essential part of these decision-making processes[42]. However, as also shown by the Stress Tests, the scope and depth of these analyses significantly differ and in some Member States there is an urgent need to bring them up to accepted international standards. Fukushima reiterated the importance of harmonization of PSA and the urgent need to efficiently reinforce nuclear installation safety based on risk-informed conclusions[43].

· Individual Member States may implement all or some of the measures that were identified in the course of the Stress Tests, intensify regulation and oversight, but – considering the sobering experience from the aftermath of the accidents in TMI and Chernobyl decades ago (see above) – it is probable that this will concern particularly only those countries where the level of safety is already above average. Follow-up visits to the Stress Tests to verify plant-specific implementation of proposed improvement measures will not be sufficient as such an "ad-hoc approach" neither improves the underlying safety requirements and criteria used as a basis for regulatory decision-making in a sustainable manner nor does it strengthen the independent role of the regulator to control risks. What is currently missing is a coordinated European approach for cooperation between various competent regulatory authorities and international peer reviews.

· As a basis for efficient safety improvements, the Stress Tests confirmed the need for adequate staff training, including for extreme situations, as well as adequate human resources and expertise. Such requirements concerning training and expertise should apply to direct employees of the licence holder as well as to subcontractors working on the NPP sites.

· The using of subcontractors must not impair the organisational capacity of the licence holder who should preserve his full control and responsibility over the safety of the nuclear installation. Moreover, the licence holder must maintain his own internal competence in particular as regards the full control of the planning and quality of interventions.

Ø Provisions in the current Nuclear Safety Directive

At Euratom level, the current Nuclear Safety Directive obliges Member States to establish a competent regulatory, which is equipped with the required legal power, human and financial resources. It also enumerates in a general manner the main competencies of the national regulatory authorities [Article 5(3)].

However, the existing catalogue of regulatory competencies is not complete and could be strengthened. This reinforces the fundamental principle that only strong regulatory oversight can guarantee the safe operation of nuclear installations in the EU.

2.2.3. Regulatory independence issues

Ø Observations from the Fukushima nuclear accident

· One of the key lessons learned from the Fukushima accident is that the effective independence of the national regulatory authorities must be ensured. A culture where ties between the regulator and operator are too close, may lead to situations where recommended or even required actions are not properly implemented in the absence of control mechanisms and sanctions. There should be provisions de facto and de jure which allow an independent regulatory judgement and an effective enforcement.

· In the Additional Report of Japanese Government to IAEA - Accident at TEPCO's Fukushima Nuclear Power Stations[44](September 2011), it is mentioned that "Due to the unification of administrative organizations over the utilization and regulation of nuclear power and the non-centralized administrative organizations for ensuring nuclear safety, it was unclear until recently which organization has primary responsibility for disaster prevention and the protection of public safety. Reviews of such bodies and the enhancement of nuclear regulatory bodies need to be done promptly". The above-mentioned Fukushima Nuclear Accident Independent Investigation Commission (July 2012) report notes the lack of independence of the regulators in the Nuclear and Industrial Safety Agency (NISA), noting "…the problem was the fact that NISA was created as part of the Ministry of Economy, Trade & Industry (METI), an organization that has been actively promoting nuclear power."

· The IAEA Mission Report of the IAEA fact-finding expert mission of the Fukushima Dai-ichi NPP accident following the great East Japan earthquake and tsunami (24 May – 2 June 2011)[45], mentions among the lessons learned that "Nuclear regulatory systems should ensure that regulatory independence and clarity of roles are preserved in all circumstances in line with IAEA safety standards".

Ø International developments

· The commitment of continuously ensuring the effective independence of the national regulatory authorities has been also affirmed in the Declaration by the IAEA Ministerial Conference on Nuclear Safety and reiterated in the subsequent Action Plan on Nuclear Safety.

· Also, in the Final Summary Report of the 2nd Extraordinary Meeting of the Contracting Parties to the CNS (Annex containing action-oriented objectives for strengthening nuclear safety), one of the items included therein is to "Ensure that its regulatory body is effectively independent in making regulatory judgments based on scientific and technological grounds and taking enforcement actions and that it has functional separation from entities having responsibilities or interests, such as the promotion or utilisation of nuclear energy (including electricity production), that could conflict with safety or other important regulatory objectives or otherwise unduly influence the decision making of the regulatory body."

Ø Provisions in the current Nuclear Safety Directive and preliminary assessment of transposition measures

· The effective independence of the national regulatory authority is one of the issues arising from a prima facie check of the transposition measures of the existing requirements at Member State level. This preliminary assessment shows that although the Nuclear Safety Directive contains minimal provisions underlying the independence of the national regulatory authorities (Article 5(2)), the existing requirements do not define benchmark criteria for ensuring their effective independence, thus not allowing for a consistent interpretation of the concept of "effective independence" throughout the Community. For instance, based on information available to the Commission from various sources, the current provisions of the Directive are not sufficient for avoiding or improving existing situations where, in some Member States, the regulatory responsibility is still split between several entities or is included directly in Ministries (Economy, Environment, etc.).

· Finally, it should be acknowledged that, since the adoption of the current Directive, the provisions therein on regulatory independence fall short of international requirements (e.g. Governmental, Legal and Regulatory Framework for Safety GSR part1, IAEA, 2010).

2.2.4. Transparency issues

Ø Observations from the Fukushima nuclear accident

· Another key lesson learned from Fukushima is the importance of enhancing transparency on nuclear safety matters.

· In the Additional Report of Japanese Government to IAEA it is mentioned that "In the initial stages of the accident, communication and cooperation between the central and local governments as well as between various relevant organizations were not achieved to a sufficient degree, due to the difficulty in securing means of communication and also due to the fact that the roles and responsibilities of each side were not always clearly defined." Furthermore, it is mentioned that "Especially immediately after this accident, actions were not sufficiently taken to provide local residents with information or easily-understood explanations about radiation, radioactive materials, or information on future outlooks on risk factors". The Fukushima Nuclear Accident Independent Investigation Commission report, commenting on the lack of openness of the operator even after the accident says that it: "… continued to avoid transparency in disclosing information. It limited disclosure to confirmed facts, and failed to disclose information that it felt was uncertain or inconvenient."

Ø International developments

· The Declaration by the IAEA Ministerial Conference on Nuclear Safety emphasised "the responsibility of the nuclear industry and operators in the implementation of nuclear safety measures and call upon them and their associations to fully support and actively contribute to international efforts to enhance nuclear safety by, inter alia, furthering transparency and prioritizing safety considerations". A number of measures aiming at enhancing transparency are included in the subsequent Action Plan on Nuclear Safety.

· In the Final Summary Report of the 2nd Extraordinary Meeting of the Contracting Parties to the CNS (Annex containing action-oriented objectives for strengthening nuclear safety), one of the items included therein is to "Ensure that its regulatory body operates in a transparent and open manner, taking into account legitimate concerns over security and other sensitive interests that might be adversely affected by the public disclosure of particular information."

Ø Lessons learned from the Stress Tests

· The transparent process of the Stress Tests, the public availability of documents, the involvement of safety authorities not operating nuclear installations have allowed interested parties to observe the progress of the work. For example, licensee reports, national reports and peer-review reports of the Member States have been made available on the ENSREG website. This openness has greatly added value to the exercise.

Ø Provisions in the current Nuclear Safety Directive and preliminary assessment of transposition measures

· Transparency is one of the issues arising from a prima facie check of the transposition measures of the existing requirements at Member State level. The existing provisions of the Nuclear Safety Directive contain indeed only generic requirements on public information (Article 8), without offering concrete guidance on implementation. For instance, the current Directive does not impose transparency obligations on the licence holders (who have the prime responsibility for nuclear safety). Moreover, it does not offer more specific indications on the types of information that should be provided, as a minimum, to the public by the competent regulatory authority.

Ø Expert groups' guidance

· Finally, it should be noted that ENSREG has already developed useful guidance on transparency matters (e.g. Guidance for National Regulatory Organisations, Principles for Openness and Transparency, HLG_p(2011-14)_57).

2.2.5. Emergency preparedness and response issues

Ø Observations from the Fukushima nuclear accident

· In the light of the Fukushima accident, the importance of improving emergency preparedness and response arrangements is clearly acknowledged. Apart from lack of sufficient severe accident prevention and mitigation measures, a major shortcoming of the safety of both the Fukushima plant and the surrounding communities was that the accident had not been assumed to occur as a complex disaster.

· In the Additional Report of Japanese Government to IAEA, it is mentioned that "Shortly after the accident, under the damage conditions caused by the earthquake and tsunamis, the securing of emergency response equipment and the mobilization of rescue teams to support accident control activities were not performed sufficiently". The Fukushima Nuclear Accident Independent Investigation Commission report mentions the problematic coordination of the emergency response, saying that "The Commission concludes that the situation continued to deteriorate because the crisis management system … did not function correctly. The boundaries defining the roles and responsibilities of the parties involved were problematic, due to their ambiguity."

Ø International developments

· In the Declaration by the IAEA Ministerial Conference on Nuclear Safety, the ministers emphasised "the need to improve national, regional and international emergency preparedness and response to nuclear accidents, including through the possible creation of rapid reaction capacity and the development of training in the field of crisis management at the regional and international levels, as well as to strengthen cooperation among national authorities, technical safety organizations, operators and among relevant intergovernmental and non-governmental organizations". A number of measures aiming at strengthening emergency preparedness and response are included in the subsequent Action Plan on Nuclear Safety.

Ø Lessons learned from the Stress Tests

· In the EU, specific actions and decisions in the area of preparedness and response in case of a nuclear emergency are taken mainly at national level. Following Fukushima, some Member States and neighbouring countries have now started to evaluate their emergency management provisions also under "beyond design-basis" accident conditions (i.e. accidents which are possible, but were not fully considered in the design because they were judged to be too unlikely) and identified possible improvements, as shown by the Stress Tests. However, the final report of ENSREG on the peer reviews of the EU Stress Tests summarises that[46]: "One of the important results of the public interaction is a strong demand for a European initiative on off-site emergency preparedness".

Ø Provisions and mechanisms at EU and Euratom level

In the EU, specific actions and decisions in the area of emergency preparedness and response in case of nuclear and radiological emergences are taken mainly at national level. A range of relevant EU and Euratom legislative instruments are also in place[47], as well as several mechanisms[48] which could be activated in case of a nuclear or radiological emergency.

The Community Mechanism for Civil Protection[49] facilitates co-operation between the Member States in civil protection assistance interventions in the event of major emergencies taking place both inside and outside the Union for any type of disasters, including radiological and nuclear accidents (e.g. assistance through the Mechanism has been provided to Japan following the Fukushima accident). In addition, a number of activities are undertaken at EU level to promote prevention/risk management and enhance the level of preparedness through risk assessments, establishment of modules (including CBRN), training and exercises for large-scale disasters, scenario development and contingency planning.

Off-site emergency preparedness and response

For the purpose of this IA, a distinction is made between the off-site emergency preparedness and response on the one hand and the on-site emergency preparedness and response on the other.

Given the wide range of the off-site emergency preparedness and response responsibilities, this area is outside the scope of the current IA and will be treated in a separate process[50]. The rest of this document only considers the on-site aspects.

On-site emergency preparedness and response

Further improvements in preparing and responding to a serious nuclear or radiological emergency could be made more effective, by strengthening on-site emergency preparedness and response arrangements.

The regulatory body and licence holder should have appropriate arrangements in place for emergency preparedness and response. The current Nuclear Safety Directive does not include provisions regarding on-site emergency preparedness and response, nor does it offer more specific indications on the types of measures and equipment that should be kept, as a minimum, by the licence holder.

2.3. Underlying drivers of the problem

2.4. Who is affected, in what ways, and to what extent?

Nuclear safety regulation affects:

· Workers who are exposed to ionising radiation;

· EU citizens, who, according to the conclusions of the latest 2010 Eurobarometer Europeans and Nuclear Safety, are extremely conscious of the importance of safety and protection, as far as nuclear energy is concerned;

· Industrial and private consumers, who pay the price of electricity;

· National regulatory authorities who have the responsibility for ensuring a high level of nuclear safety compliance;

· Operators and licence holders, who have the prime responsibility for the nuclear safety of nuclear installations;

· Research and technical support organisations, expert groups who provide the needed scientific and technical support, such as developing harmonised nuclear safety criteria.

· Member States, who are responsible for formulating national policies for nuclear safety.

2.5. Evolution of the problem all things being equal

Nuclear energy currently generates ~30% of the electricity consumed in the EU via operation of NPPs in 14 different Member States[51], 9 of which depend on more than 30% of their electricity generation on nuclear[52]. This electricity is mainly stable and reliable base load, secure from a supply perspective, CO2 free, and competitive/affordable. As a result, nuclear energy is a significant positive contributor to the EU economy, growth and jobs. The nuclear sector employs today ~500000 persons in the EU, directly and indirectly. One might also count additional "induced" jobs – which then leads to a grand total of around 900000 persons employed. The corresponding total "valued added" for the European economy can be estimated to ~70 Billion Euros per year. Despite the key contribution of nuclear energy to the competitiveness of the EU economy, the Commission remains committed to ensuring that the continued commercial use of nuclear power must not be undertaken in the form of a low-cost approach to nuclear safety. Currently, without uniform EU-wide standards, there remains a risk that operators could build NPPs in Member States with lower nuclear safety requirements. This is also important for fair competition in a liberalised electricity market.

Throughout the world, the accident at the Fukushima NPP has re-launched the public debate on the use of nuclear energy. Both in Europe and worldwide, countries re-examined their plans to introduce nuclear programmes, to construct new NPPs and to extend the operating life of existing plants. Some European countries, such as Germany, Belgium and Switzerland opted in the immediate wake of Fukushima for an early phase-out of their NPPs, while Italy voted in a public referendum against a return to generating nuclear electricity domestically.

It is obvious that a sudden phase-out of this technology due to another severe accident, particularly one in Europe, would result in severe difficulties to ensure the EU's continued energy security, affordability and achievement of its ambitious climate protection goals[53].

Therefore, strengthening the EU nuclear sector's capability to ensure that a severe accident will never occur at one of its NPPs is of vital interest for the European society as a whole[54].

Despite having set in 2009 the first steps towards a common Euratom nuclear safety legal framework via the Nuclear Safety Directive, based upon overall principles to which all national approaches have to commit, the Stress Tests have confirmed that there are not only continued significant differences between Member States, but that also significant gaps remain in ensuring comprehensive and transparent identification and management of key safety issues. Measures of crucial importance that have been identified decades ago as urgent for implementation still remain unaddressed in some Member States. Therefore, it can be assumed that baseline evolution will not lead to major reduction of the risks of NPPs in Europe.

As explained in Section 2.2., the scope of the Nuclear Safety Directive is limited to some important overall safety principles, without however addressing technical aspects. Therefore, this Directive does not respond to the needs stemming from the lessons learned from the Fukushima nuclear accident and the Stress Tests, nor take account of initiatives from various expert groups and international developments in the nuclear safety area.

As regards the Stress Tests exercise, due to the fact that it was a one-off, voluntary exercise, there is no obligation to be continued on a regular basis also in the future. As the Stress Tests were developed in the wake of the Fukushima nuclear accident, their scope is essentially limited to assessing the adequacy of existing safety margins against impacts from extreme external initiating events. Being an exceptional exercise, the Stress Tests do not deal with the appropriateness of the existing periodic safety assessments and inspection activities.

As regards coordinated Member States approaches, such as the WENRA Reference Levels[55], it should be noted that they might have an impact in the sense of guiding the regulatory national approaches. However, even if the WENRA Reference Levels have been established since 2006, they were not effectively transposed in the Member States' national regulatory frameworks EU-wide.

The nuclear safety international regime has an incentive, non-enforceable character, and does not assure the implementation of the relevant safety requirements set up therein.

In addition, as explained earlier in the document, the preliminary assessment of the Member States' transposition measures of the Nuclear Safety Directive has identified areas of improvement in terms of effective independence of the national regulatory authority and transparency.

Without new or revised Euratom legislation, the problem areas described in Section 2.2 will continue to exist and will show little prospect of improvement. This can particularly be expected in the case of countries where the level of safety is currently below average. Some improvements may occur in the area of international standards and Conventions but this is likely to be slow and less effective than common Euratom rules at sufficiently detailed levels.

2.6. Euratom competence, principles of subsidiarity and proportionality

The competence of Euratom to regulate in the field of the health protection against ionising radiation is explicitly recognised by the Euratom Treaty. In the Treaty's Preamble, the Member States declare themselves "anxious to create conditions of safety necessary to eliminate hazards to the life and health of the public". Pursuant to Article 2(b) of the Treaty, the Community is mandated to "establish uniform safety standards to protect the health of workers and of the general public and ensure that they are applied." Title II, Chapter 3 "Health and Safety", sets up a number of detailed provisions intended to establish, give effect and apply the basic safety standards mentioned in Article 2(b) of the Euratom Treaty. Article 30(1) of the Euratom Treaty establishes that "basic standards shall be laid down within the Community for the protection of the health of workers and the general public against the dangers arising from ionizing radiations."

Article 31 sets out the procedure for establishing the basic standards, while Article 32 provides that the basic standards may be revised or supplemented. The ruling of the Court of Justice of the EU in the Case C29/99[56] acknowledged that "it is not appropriate, in order to define the Community's competences, to draw an artificial distinction between the protection of the health of the general public and the safety of sources of ionising radiation". The basic safety standards aiming mainly at the protection of the health of the workers and the general public against the dangers arising from ionising radiation can be thus "supplemented", in the sense of the Euratom Treaty, with safety requirements. Consequently, the legal basis for regulating nuclear safety on Community level is defined by Articles 31 and 32 Euratom Treaty. Therefore the Nuclear Safety Directive is legally based on Articles 31 and 32 Euratom Treaty. For this reason, any legislative amendment of the Safety Directive in the scope of the "basic standards" as defined in Article 30 Euratom Treaty has to be based on the same Treaty provisions.

The legislative revision should build upon and enhance the approach of the current Nuclear Safety Directive.

As regards the competent regulatory authorities, any revision proposal should enhance the existing provisions, but aim at strengthening even further the role and independence of the regulators, as it is clear that only strong regulators endowed with all the necessary powers and independence guarantees can oversee and ensure the safe operation of nuclear installations in the EU. For this purpose, benchmark criteria could be defined for allowing for a consistent interpretation of the concept of "effective independence" throughout the Community. Close cooperation and information-sharing between regulators, taking into account the potential cross-border impacts of a nuclear accident, should be encouraged.

Given the cross-border consequences of a nuclear incident and particularly the public need for information, an EU wide approach on transparency issues is essential. This can ensure that, irrespective of state borders, the public is properly informed on all relevant nuclear safety matters to ensure uniform level of transparency and information throughout the EU.

It is evident that the effects of nuclear accidents do not stop at state borders and can entail potential harmful consequences for the health of workers and citizens but also wide-ranging economic implications. In Europe, the Stress Tests have confirmed that there are not only continued differences between the EU Member States in ensuring comprehensive and transparent identification and management of key safety issues, but that also significant gaps remain. Therefore, a strengthened Euratom legislation could include a set of technical provisions at an appropriate level of detail for a framework legal instrument. These provisions should ensure a common EU approach to nuclear safety, taking into account the progress towards harmonisation reflecting the consensus reached by the Member States in fora such as the IAEA or WENRA.

The experience from the Fukushima accident and the valuable insights coming from the Stress Tests have clearly shown that a strong and transparent monitoring system (including peer-reviews) is an essential element to ensure the effective and continuous implementation of any safety regime. Lessons learned from past major accidents have not been taken up voluntarily by parts of the industry and have not sufficiently been applied by regulators. Consequently, the envisaged revision of the Euratom nuclear safety legislation should ensure the effective implementation of the required nuclear safety measures throughout the EU.

At the international level, through the International Atomic Energy Agency (IAEA) the main instruments governing nuclear safety are the recommended safety "standards" and international Conventions. However, these safety "standards" are legally non-binding, while the international Conventions are legally binding but not enforceable. On the other hand, the Euratom legislation benefits from clear and strong mechanisms for sanction for its proper transposition and implementation.

In accordance with the proportionality principle, the envisaged revision should not go beyond what is necessary to achieve the objectives as defined under Section 3. Furthermore, taking into account the different situations in the Member States, a flexible and proportional approach as regards the level of applicability of the provisions of the Nuclear Safety Directive was already acknowledged in recital (10) of the current Directive's Preamble, which provides that national circumstances will be taken into account when developing the appropriate national framework. A possible revision of the Directive should reflect this requirement. For this purpose, a proportionate approach would have to be applied for those Member States without any nuclear installations or with minor ones falling under the scope of the Nuclear Safety Directive. For instance, the duties of the regulatory authority should reflect the scale and nature of their nuclear industry. However, clear regulatory responsibilities for aspects such as emergency preparedness and response, regular training programmes, availability of public information should be foreseen. When proposing new requirements, no unnecessary administrative burdens should be imposed on the Member States.

A flexible mechanism of developing EU-wide technical criteria with special regard to the principle of proportionality should be envisaged in which the knowledge and practical experience of the experts from the Member States is fully used.

Section 3: Objectives

3.1. General objectives

· To protect workers and the general public from dangers arising from ionising radiations from nuclear installations, by achieving proper operating conditions, preventing accidents and mitigating accident consequences;

· To maintain and promote the continuous improvement of nuclear safety and its regulation at Euratom level;

· To ensure that Member States provide for appropriate national arrangements to meet these objectives.

3.2. Specific objectives

In order to meet the general objectives, a number of specific objectives are identified below:

A) Continuously improving the overall nuclear safety architecture (e.g. by strengthening existing / introducing new general nuclear safety Principles and Requirements).

B) Continuously improving the specific nuclear safety architecture (e.g. by complementing the above-mentioned safety principles and requirements by Euratom Nuclear Safety Criteria).

C) Continuously improving the nuclear safety assessment methodologies (e.g. by encouraging the consistent and comprehensive use of risk-informed methods for decision-making support);

D) Ensuring cooperation and coordination between all parties having responsibilities for nuclear safety on technical matters, including peer-reviews;

E) Strengthening the role of the national regulatory authorities;

F) Strengthening the effective independence of the national regulatory authorities;

G) Enhancing nuclear safety transparency;

H) Reinforcing on-site emergency preparedness and response arrangements.

Examples of measures which could potentially respond to the specific objectives are presented in Annex IV to the IA.

3.3. The consistency of these objectives with other EU policies

Nuclear safety is a key area, supporting one of the main priorities of the current 2010-2014 Commission, i.e. building a Union of sustainable growth and solidarity. The Commission Communication of the Commission Work Programme 2012 – Delivering European renewal[57] mentions under this heading that "a proposal to enhance the framework for nuclear safety will integrate lessons from the stress tests of EU nuclear power plants, technical progress and international regulatory developments".

The specified objectives, due to the fact that they ultimately aim at ensuring the protection of the workers and the general public against the dangers of ionising radiation (Article 31 Euratom Treaty), are in line with those of the Euratom radiation protection acquis, whose main pillar is the Basic Safety Standards Directive[58]. It is not possible to achieve the protection of workers[59] and the general public from the dangers of ionising radiation without controlling the potentially harmful sources of that radiation.

In addition, the objectives do not cover aspects falling under the general EU acquis in the field of health and safety of workers at work. The 'Framework' Directive 89/391/EEC of 12 June 1989 saw the introduction of measures to encourage improvements in the safety and health of workers[60] at work[61]. It establishes general principles for the prevention of occupational risks, requiring the employer to evaluate all risks relating to the health and safety of workers, to put in place preventative measures and to provide appropriate protection. In addition a number of individual Directives[62] related to different aspects of workers health and safety have also been issued. These Directives establish minimum requirements for safety and health which shall be transposed by Member States into their national law. Member States are allowed to maintain or introduce more stringent protective measures compatible with the Treaties. Increasing the level of on-site nuclear safety would also contribute to a higher protection of the population and the environment by preventing and managing the risks of nuclear accidents. Thus, the objectives of the revision are consistent and complementary to the EU civil protection policy[63] which sets the framework at EU level for the prevention, preparedness, response and recovery form all types of natural and man-made disasters, including nuclear accidents.

The objectives would also have potential beneficial impact on fundamental rights, as enshrined in the Charter of Fundamental Rights of the European Union, in particular those related to fair and just working conditions, health care and environmental protection.

Section 4: Overview of the policy options

A number of Policy Options is analysed under this IA, as summarised below. The detailed description of the Policy Options is presented in Annex V of the IA. Concrete examples of possible measures is provided in Annex IV of the IA

POLICY OPTION 0

Description: Consists in leaving the current situation unchanged (Business as usual).

· No new legislative action at Euratom level.

· Not amending the current Euratom framework Directive (Nuclear Safety Directive).

· At the same time, use the existing mechanism of cooperation between the European Commission and the Member States on the implementation of the measures arising from the Stress Tests process through ENSREG.

POLICY OPTION 1

Description: Proposing new Euratom legislation by strengthening existing / adding new general nuclear safety Principles and Requirements.

· Legislative action (legally binding act) at Euratom level.

· Amending the Nuclear Safety Directive by strengthening existing general Principles and Requirements (e.g. role & independence of the national regulatory authorities; transparency) and adding new general Principles and Requirements [e.g. on-site emergency preparedness and response; siting, design & construction, and operation (e.g. periodic safety assessments) of nuclear installations].

· At the same time, use the existing mechanism of cooperation between the European Commission and the Member States on the implementation of the measures arising from the Stress Tests process through ENSREG.

POLICY OPTION 2

Description: Proposing new Euratom legislation by strengthening existing / adding new general nuclear safety Principles and Requirements complemented by Euratom Nuclear Safety Criteria[64].

SUB-OPTION 2.1

· Legislative action (combination of legally binding & specifying legally non-binding acts) at Euratom level.

· Amending the Nuclear Safety Directive by strengthening existing / introducing new general Principles and Requirements (Policy Option 1) + Introducing in the Directive the mandate for the European Commission to to support a consistent implementation of the general Principles and Requirements, by developing legally non-binding Euratom Nuclear Safety Criteria (Commission Recommendations).

· These Euratom Nuclear Safety Criteria would be developed in close cooperation with experts from the Member States. One option might be that the existing mechanism of cooperation between the European Commission and the Member States through ENSREG and WENRA, could be used and further enhanced for this purpose.

SUB-OPTION 2.2

· Legislative action (combination of a legally binding act & specifying legally binding acts) at Euratom level

· Amending the Nuclear Safety Directive by strengthening existing / introducing new general Principles and Requirements (Policy Option 1) + Introducing in the Directive the mandate for the European Commission to to support a consistent and verifiable implementation of the general Principles and Requirements, by developing legally binding Euratom Nuclear Safety Criteria (Commission Regulations).

· In the first step, the nuclear safety criteria would be developed in close cooperation between expert working groups such as ENSREG and WENRA, and Commission experts. Subsequently, the nuclear safety criteria would be adopted as the Commission's "implementing acts" according to Article 291 TFEU and using the relevant "comitology" procedure laid down in Regulation 182/2011. For this purpose, a "comitology" committee, composed of representatives of all Member States, would be created by the legislative proposal to assist the Commission.

POLICY OPTION 3

Description: Proposing new Euratom legislation including the setting up of a Euratom nuclear safety regulatory Agency.

· Legislative action (legally binding act) at Euratom level

· Establishing a Euratom Nuclear Safety Regulatory Agency[65] to administrate and further develop the Euratom nuclear safety acquis, as developed under Policy Option 2, under the supervision of the European Commission.

· With the mission to promote the highest common standards for safe generation of nuclear power in the EU.

· With the tasks:

· To assist the European Commission to develop harmonised technical nuclear safety requirements / standards / criteria, which would be incorporated in proposals for new Euratom nuclear safety legislation;

· To conduct inspections in order to monitor the correct implementation by national regulators and licence holders of this legislation and report back to the Commission;

· To develop an Euratom certification system of standard designs of nuclear facilities;

· To elaborate a uniform license content (including a minimum set of requirements for the applicants) & licensing procedure, as well as detailed guidance for its application;

· To intervene in case of nuclear accidents or incidents (e.g. sending its experts on site);

· To formulate opinions and recommendations to the Commission on nuclear safety matters;

· To collect and analyse data to further improve nuclear safety.

Table 1 – Policy Options according to type of Commission legislative action

|| TYPE OF COMMISSION LEGISLATIVE ACTION

Not proposing new Euratom legislation || Proposing new Euratom legislative action

Legally binding act || Legally non-binding act

Policy Option 0 || ü || ||

Policy Option 1 || || ü ||

Policy Option 2 (Sub-option 2.1.) || || ü || ü

Policy Option 2 (Sub-option 2.2.) || || ü ||

Policy Option 3 || || ü ||

Table 2 – Policy Options according to level of detail of the Commission legislative action

|| LEVEL OF DETAIL OF THE COMMISSION LEGISLATIVE ACTION

General Principles and Requirements || Basic Principles and Requirements complemented by Euratom minimum nuclear safety criteria || Euratom Regulatory Nuclear Safety Agency

Policy Option 0 || (current ones only) || ||

Policy Option 1 || ü || ||

Policy Option 2 (Sub-option 2.1.) || ü || ü ||

Policy Option 2 (Sub-option 2.2.) || ü || ü ||

Policy Option 3 || ü || ü || ü

Section 5: Analysis of impacts of the policy options

In this section, each of the policy options outlined in Section 4 is assessed on the basis of its most important and relevant likely impacts with regard to the effectiveness of the individual measures foreseen within the context of these options, i.e. with regard to:

· The extent to which they mitigate the risk of nuclear accidents (safety impact),

· Regulatory and compliance costs on Member States, industry and the Commission (economic impact),

· Environmental and social impacts.

The effectiveness of the proposed policy options in delivering the objectives set out in Section 3 and thus in reducing the probability and the consequences of accidents in nuclear installations is expressed largely qualitatively in terms of the extent to which the aim of the measure is likely to be attained. Estimating this effectiveness is a difficult task and can only be made by qualitative judgment based on the currently best available information.

· First, in line with the basic principle to give due priority to nuclear safety[66], the main objective of any policy action in the field of nuclear safety is to reduce the risk of accidents (i.e. in terms of both probability of occurrence and extent of consequences) and thereby to avoid human, environmental and economic losses. Therefore, the first criterion to be evaluated is the proposed policy's impact on mitigating the risk of nuclear accidents.

· Secondly, the additional financial and administrative costs of implementing the proposed policies to Member States, to NPP operators and to the Commission will be highlighted and to the possible extent quantified:

· These economic costs can be roughly divided into regulatory costs (the costs incurred by public authorities in providing the oversight necessary to effectively implement the policies, i.e. labor costs and other expenses (missions, studies, etc.) for developing new regulations, labor costs and other expenses (missions, studies, etc.) for performing plant-specific inspections and evaluating the results, financing of topical studies, general administrative costs) and compliance costs (the costs incurred by industry, i.e. labor costs and equipment costs (purchase, installation, testing, operation, maintenance) for implementing new regulations, financing of topical studies, general administrative costs).

· Regarding regulatory costs, the cost to the regulator of enforcing regulations is primarily the cost of the time taken to enforce and provide support to the operators as required.

· Finally, a section for each option summarizes other relevant environmental and social impacts associated with the policy option.

In the following Sections 5.1 - 5.4, safety benefits, costs, environmental and social impacts are presented for each individual policy option. As the policy options constitute a phased approach not only with regard to increasing scope and level of detail in the Commission's legislative action to deal with safety in a consistent and comprehensive EU-wide manner but also with regard to the time until the option could actually be implemented on national level, the benefits and costs will accrue with the execution of each policy option.

Section 6 then shows the incremental (aggregated) benefits and costs for all the policy options.

5.1. Policy Option 0

Policy Option 0 is the baseline option which leaves the status quo evolve. We describe this situation in more detail in Section 2 and in particular in Section 2.5. concerning "Evolution of the problem all things being equal".

· Safety Impact

Despite having achieved in 2009 to set-up for the first time the basics of a common Euratom nuclear safety legal framework by means of the current Nuclear Safety Directive, making the EU the first major regional nuclear actor to provide legally binding and enforceable rules to the main international nuclear safety standards[67], the scope of the existing Directive is limited to these overall principles. Though mandatory, their practical interpretation and transformation into more detailed safety requirements and criteria as well as their concrete implementation at national levels is difficult to monitor on the basis of the current Directive. To compensate for the absence of any European standards, the existing IAEA standards and recommendations, as well as WENRA reference levels or even requirements from the reactor vendor's country are currently used by Member States as guidance when establishing national requirements and criteria for nuclear safety.

The March 2011 nuclear accident at the Fukushima NPP and the consequential Stress Tests of nuclear installations in 15 Member States and 2 neighboring countries have shown that this current approach is no longer sufficient:

· As recognized by all European regulators at the end of the Stress Tests[68], the depth and detail of safety requirements as well as the way how regulations are implemented differ significantly between the countries. Whereas some countries are very specific in their requirements, others only define general safety goals.

· The Stress Tests have confirmed that there are not only continued significant differences between Member States, but that also significant gaps remain in ensuring comprehensive and transparent identification and management of key safety issues. Measures of crucial importance that have been identified decades ago as urgent for implementation remain still unaddressed in some Member States.

Moreover, we explain in more detail in Section 2 above that the current Stress Tests exercise, due in particular to its voluntary and ad-hoc nature, does not guarantee that the identified measures to improve safety of EU NPPs will be (fully) implemented and, where appropriate, also regularly updated in the future. We also recall above that the instruments existing at international level, i.e. the IAEA safety standards and Conventions cannot provide a solution to the identified problem areas mainly because they are not binding and/or enforceable. It also results from the detailed analysis conducted under Section 2 that the current Euratom nuclear safety provisions are no longer sufficient and that without new or revised Euratom legislation, the problem areas described in Section 2.2 will continue to exist and will show little prospects of improvement.

In view of the above, the baseline evolution with regard to safety could be summarized thus: substantial and transparent improvements to the overall level of risk and risk control in the EU as a whole by operators and regulatory authorities are not considered likely without an EU policy stimulus which goes substantially beyond the scope of the current Directive. Therefore, Policy Option 0 is very unlikely to reduce the current risks related to NPPs in Europe.

· Economic impact:

Compliance costs for operators:

Costs for NPP operators related to this policy option consist of their ongoing costs of implementing the provisions of their national safety requirements and criteria based upon the general principles included in the current Directive and their costs of implementing the national Stress Tests results.

Regarding the costs of implementing the current Directive, it has to be kept in mind that the current Directive was adopted only in 2009 and gave the Member States time until 22 July 2011 to comply with it. In some cases, this process is not yet finalized even in 2012. For these reasons, there is a lack of data currently available on the costs of implementing the current Directive for both operators and Member States.

Regarding costs for implementing the results of the Stress Tests, according to first estimates by the French regulator ASN (01/2012)[69], the additional expenses for the French fleet for implementing the Stress Tests related upgrades are likely to cost "several billion Euros". This order of magnitude estimate was confirmed in the course of the peer reviews of the Stress Tests where the costs of additional safety improvement measures were estimated in the range from €30 million per reactor unit (e.g. Switzerland) to €200 million (e.g. Slovenia)[70]. Assuming a similar range of costs for most NPPs in Europe, an average of €100 million per reactor unit could be realistic, totaling ~€10 billion for all NPP units in the EU[71] over the coming, say 5-10, years[72].

The distribution of this cost range across the different NPPs in the different Member States can only be assessed on the basis of the National Action Plans, which will describe the implementation of the recommendations from the stress tests peer review process at national level and which are expected to be submitted to the Commission by the end of 2012 (to be peer reviewed in early 2013). However, considering that the stress test peer reviews showed that (1) improvement measures are required at all NPP sites, (2) for many reactor units only relatively minor improvement measures need to be implemented, and (3) for only a few reactor units ones more effort might be necessary not only for implementation of available solutions but also for their development, the resulting cost distribution for all NPPs could have quite a positive skew with a weighted average of around ~€100 million per reactor unit (over 5-10 years).

This estimate of ~€10 million per reactor unit per year due to improvement measures originating from the Stress Tests is also confirmed by an on-going OECD-NEA study on the economics of long-term operation of NPPs[73] which collected specific investment figures for post-Fukushima costs of compliance with national safety requirements in different OECD member countries. The resulting range for European countries is ~€400 - €800 per kWe nuclear generation capacity, i.e. up to ~€100 million per reactor unit, i.e. ~€10 million per reactor unit per year over the next ~5-10 years, ~10% of which is due to post Stress Tests improvements.

Regulatory costs and administrative burden for Member States:

Costs for Member States related to this policy option consist of their ongoing costs of enforcing their national regulations (based upon the general principles included in the current Directive and including Stress Tests follow-up).

This is assessed by using current figures of the costs of regulating the French nuclear fleet, taken from the 2012 Cour des comptes report on the past and current costs of the French nuclear program[74]. As the French report is the only one currently available from Member States on the total costs of their national nuclear programs, and considering the large experience of the French regulator, this information is used to estimate a (conservative) EU average figure for the regulatory costs and administrative burden of Member States in the order of ~€3 million per reactor unit per year. The range of this figure across Europe could be from €1 million (UK (conservative estimate)) to €4 million (Switzerland) per reactor unit per year[75].

Regarding costs for carrying out the Stress Tests, in terms of man hours, reference to an overall estimate of ''roughly 500 man-years devoted to completing the stress tests and peer reviews'', covering the effort of both operators and regulators, was made at the second public meeting on the Post-Fukushima stress tests peer reviews, which took place in Brussels, on 8 May 2012[76].

Costs for Commission:

Costs for Commission related to this policy option correspond to the effort currently spent (=e0).

Costs for Electricity Consumers:

Costs for electricity consumers related to this policy option correspond to the current costs for nuclear generated electricity (=f0).

Table 3 – Summary of the Economic impact of Policy Option 0

Policy Option || Costs for Operators (per reactor unit) || Costs for Member States (per reactor unit per year) || Costs for Commission || Costs for Electricity Consumers

0 || Range: ~€30-200 million || ~€3 million Range: ~€1-4 million || e0 || f0

· Environmental impact:

During normal operation, there is no difference in the environmental impact between the different policy options presented in this document. Only during accident conditions, the different policy options chosen are likely to result in different environmental impacts. As an increase in plant safety is, however, always correlated to corresponding decreases in (potentially harmful) environmental impacts, the environmental impact category is thus considered to be covered by the safety impact category.

· Social impact:

Europe's nuclear sector currently employs ~500000 people[77], including those in the associated supply chain[78]. In France ~100000 people are employed in the nuclear sector. In the UK the figure is ~85000 of which 45000 work at the power plants and 40000 in the supply chain. In Finland, ~6000 people work at the 5 nuclear reactors. The jobs are well-paid and attract qualified people with a broad range of skills such as engineers, physicists, chemists, IT specialists, administrative and security staff. Because the average operati