Explanatory Memorandum to COM(2013)715 - Amendment of Directive 2009/71/EURATOM establishing a Community framework for the nuclear safety of nuclear installations

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1. CONTEXT OF THE PROPOSAL

4.

1.1. General context


The accident at the Fukushima Daiichi nuclear power plant (NPP) in 2011 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. The analysis of the Fukushima nuclear accident reveals quite substantial and recurring technical issues as well as persistent institutional failures similar to the ones from the post-accident evaluations of the Three Mile Island and Chernobyl nuclear accidents decades ago. This latest nuclear accident once again undermined public confidence in the safety of nuclear power; and particularly so at a time when the use of nuclear power is being debated as a possible option to meet global energy demands in a sustainable manner.

The Fukushima nuclear accident renewed attention on the paramount importance of ensuring the most robust levels of nuclear safety in the EU and worldwide.

Nuclear energy currently generates close to 30% of all electricity in the EU and about two-thirds of its low-carbon electricity. 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.

Nuclear safety is of the utmost importance to the EU and its people. The effects of nuclear accidents do not stop at national borders and can entail potential harmful consequences for the health of workers and citizens but also wide-ranging economic implications. It is therefore essential for society and the economy to reduce the risk of a nuclear accident in an EU Member State by applying high nuclear safety standards and guaranteeing a high quality of regulatory oversight.

In the aftermath of the Fukushima nuclear accident, the EU response to the events was immediate.

Based upon a mandate from the European Council at its meeting of 24-25 March 2011[1], the European Commission, together with the European Nuclear Safety Regulators Group (ENSREG), launched EU-wide comprehensive risk & safety assessments of nuclear power plants ('Stress Tests'). The Stress Tests were defined as a targeted reassessment of the safety margins of NPPs in the light of the events in Fukushima related to extreme natural events challenging the plants safety functions. All fourteen EU Member States that operate nuclear power plants[2] plus Lithuania[3] participated in these assessments. Switzerland, Ukraine and Croatia participated fully in the EU Stress Tests and the peer review process, while other neighbouring countries (e.g. Turkey, Belarus and Armenia) that agreed to use the same methodology, are working within different timetables. Stress Tests were started in 2011 by self-assessments carried out by nuclear operators and the preparation of national reports by national regulators. Preliminary findings were presented in a Commission Communication on an Interim Stress Tests Report i in November 2011 and an extensive EU-wide peer review process was carried out from January to April 2012. An overview report was produced by the ENSREG Peer Review Board[5] and endorsed by ENSREG. In addition, ENSREG also agreed on an Action Plan[6] to follow up the implementation of the peer review recommendations. In October 2012, the Commission issued a Communication on the Final Stress Tests Report[7]. Currently, in line with the requirements of the ENSREG Action Plan, National Action Plans[8] associated with post-Fukushima lessons learned and Stress Test peer review recommendations have been prepared and were reviewed in terms of contents and status of implementation in the framework of a Workshop in April 2013. The Summary Report of the Workshop is intended to be presented at the 2013 Second ENSREG Conference on Nuclear Safety in Europe[9]. Furthermore in the process of ensuring a proper follow-up of the Stress Tests, the Commission will elaborate, in close cooperation with ENSREG, a consolidated report on the status of the implementation of the Stress Tests recommendations, envisaged to be issued in June 2014 and transmitted to the European Council.

In the legislative domain, the European Commission received a clear mandate from the European Council in March 2011 'to review the existing legal and regulatory framework for the safety of nuclear installations' and propose any improvements that may be necessary.

The European Parliament has also encouraged a legislative review. In the 2011 Resolution on energy infrastructure priorities for 2020 and beyond[10], it stated 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 2011 Resolution on the Commission Work Programme 2012[11], the Parliament called 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'. More recently, in the 2013 Resolution on Stress Tests[12], it called on the revision to be 'ambitious in nature', including major improvements in areas such as "safety procedures and frameworks – in particular through the definition and implementation of binding nuclear safety standards that reflect state-of-the-art practices in the EU in technical, regulatory and operational respects – as well as in the role and resources of the nuclear regulatory authorities and, in particular, should boost the latter's independence, openness and transparency, while also strengthening monitoring and peer review".

The European Economic and Social Committee expressed in the 2012 Opinion on the Commission Communication on a Final Stress Tests Report[13] its support for the "Commission's intention to undertake an ambitious revision of the Nuclear Safety Directive".

In response to the mandate from the European Council and the calls from the other EU institutions and bodies, the Commission engaged in a comprehensive process of analysis and opinion gathering, to identify the appropriate areas and mechanisms for legislative intervention. This process included an open on-line public consultation (December 2011 – February 2012), complemented by an extensive dialogue with the stakeholders.

The 2011 and 2012 Stress Tests Communications contain indications on the potential areas of legislative improvement. In this context, with reference to the existing Council Directive 2009/71/Euratom establishing a Community framework for the nuclear safety of nuclear installations[14] (hereinafter referred to as 'Nuclear Safety Directive'), the latter Communication highlights the areas of safety procedures and frameworks, role and means of nuclear regulatory authorities, openness and transparency, monitoring and verification.

Moreover, the Commission services developed in the course of 2012 an Impact Assessment, based on a wide range of information sources and taking into account the post-Fukushima EU and international developments in the nuclear domain.

On this basis, a proposal for a Directive amending the Nuclear Safety Directive has been developed, benefiting from the input and expertise of the Euratom Treaty Article 31 Group of scientific experts, of the European Economic and Social Committee, as well as an extensive consultation process with the high-level representatives of the national nuclear regulatory authorities reunited in ENSREG.

5.

1.2. Grounds and objectives of the proposal


The current Nuclear Safety Directive has been a key advancement. However, in the spirit of nuclear safety's philosophy of continuous improvement, and thus with the intention to take account inter alia of the lessons learned from the Fukushima nuclear accident and of the outcomes of the subsequent Stress Tests, it was necessary to reconsider the sufficiency of the existing provisions.

The Fukushima nuclear accident has shown that well-known lessons learned from accidents decades ago have not been taken up voluntarily by parts of the industry and not been sufficiently enforced by regulators, even in a nation – Japan – that was assumed to have particularly high standards of industrial and nuclear safety. The technical and organisational issues arising from the analysis of this accident are therefore relevant for wider consideration.

In Europe, the Stress Tests have confirmed that there are continued differences between Member States in ensuring comprehensive and transparent identification and management of key safety issues. Moreover, the Stress Tests clearly showed the benefits of cooperation and coordination mechanisms between all parties having responsibilities for nuclear safety, such as peer reviews.

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.

The Commission considers it therefore appropriate to amend, strengthen and supplement the Nuclear Safety Directive, by combining technical improvements with wider safety issues such as governance, transparency and on-site emergency preparedness and response.

The proposed amendments aim at enhancing the regulatory framework for nuclear safety in the EU, in particular by:

– Strengthening the role and effective independence of the national regulatory authorities;

– Enhancing transparency on nuclear safety matters;

– Strengthening existing principles, and introducing new general nuclear safety objectives and requirements, addressing specific technical issues across the entire lifecycle of nuclear installations, particularly NPPs;

– Reinforcing monitoring and exchange of experiences, by establishing a European system of peer reviews;

– Establishing a mechanism for developing EU-wide harmonised nuclear safety guidelines.

6.

1.3. Existing EU legislation in the nuclear safety area


Following the recognition by the Court of Justice of the EU in the Case 29/99[15] of the intrinsic link between radiation protection and nuclear safety and, thus, of the competence of the Euratom Community to legislate in the area of nuclear safety, the Nuclear Safety Directive is the first EU-wide topical legally binding instrument[16]. The Directive sets up a legally binding framework based upon recognised principles and obligations of the main international instruments available, namely the Convention on Nuclear Safety[17] and the Safety Fundamentals[18] established by the International Atomic Energy Agency (IAEA).

7.

1.4. Consistency with other policy areas


The Euratom nuclear safety legislation, due to the fact that it ultimately aims at ensuring the protection of the workers and the general public against the dangers of ionising radiation, is mainly linked to the Euratom radiation protection corpus of legislation, whose main pillar is the Basic Safety Standards Directive[19]. It is not possible to achieve the protection of workers and the general public from the dangers of ionising radiation without controlling the potentially harmful sources of that radiation.

Nuclear safety is also of paramount importance for the overall prevention, preparedness for and response to disasters in the Member States. The nuclear safety directive is thus closely linked to the Union Civil Protection Mechanism[20] which provides the framework for the EU cooperation in this area, including the response to radiological emergencies inside and outside the Union.

1.

RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND IMPACT ASSESSMENTS



8.

2.1. Consultation of interested parties


In the period following the Fukushima nuclear accident, the Commission has engaged in an extensive and transparent dialogue process with the various stakeholders and the public, which included launching an open consultation via the Internet, in line with the Commission's minimum consultation standards[21].

In response to the on-line public consultation seeking views on areas of reinforcing the existing Euratom nuclear safety legislative framework, contributions were received from nuclear regulatory authorities, other public authorities, companies, non-governmental organisations, as well as individuals. This consultation offers insights into a large range of stakeholder opinions. The broad outcome 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 Commission also 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. In addition, the Commission has organised with ENSREG conferences and public debates involving a wide range of stakeholders, including non-governmental organisations, on the process, the intermediate and final results of the Stress Tests[22].

The European social partners from the Electricity Sectoral Social Dialogue Committee industry have also been consulted. In their response, the social partners underline the role of a Euratom nuclear safety legislative framework in setting up common rules for Member States.

A special role was given to ENSREG, which represents a unique focal point of expertise, as it reunites high-level representatives of the national competent nuclear regulatory authorities from all the EU Member States, nuclear and non-nuclear alike. A detailed contribution of ENSREG was received and taken into account.

As part of the procedure laid out in the Euratom Treaty, the Commission consulted the Article 31 Group of scientific experts. In their opinion, the experts welcomed the Commission proposal for amending the Nuclear Safety Directive and make several suggestions for enhancing the link with radiation protection legislation.

Finally, in its Opinion on the draft proposal issued under Article 31 of the Euratom Treaty[23], the European Economic and Social Committee (EESC) apreciates the prompt action taken by the Commission in bringing forward the proposal for amending the Nuclear Safety Directive. The Committee is pleased that several issues highlighted in its previous opinions on nuclear safety have been adressed in this proposal. In particular, it welcomes the stronger approach to harmonisation amongst Member States, the clarification of regulatory responsibilities, competence and capacity, the enhanced independence of national regulators, and action on on-site emergency preparedness and response. The Committe also commends the strengthened approach to overall transparency. Underlining that new legislative requirements should be necessary, proportionate and serve the purpose of assuring public safety, the Committee welcomes the appropriate balance that has been achieved in that perspective in the amending directive.

The Committee proposed to strenghten the provisions of the draft proposal in some areas and it recommended that Member States are required to ensure that a participative processes for strengthening public involvement in planning, review and decision-making be put in place. In this regard, the Commission believes that the role of the public in the regulatory decision-making is recognised through the requirement of the proposal that it is effectively involved during the licensing process of nuclear installations.

In accordance with the procedure laid down in Article 31 of the Euratom Treaty, the consultation of the European Economic and Social Committee on the draf proposal was a prerequisite for the subsequent adoption of the final proposal by the Commission.

9.

2.2. Impact Assessment


In 2012, an Impact Assessment was developed. The document analyses the challenges of ensuring sufficient levels of nuclear safety in the EU. It defines the general and specific objectives for enhancing the prevention and mitigation of nuclear accidents. A number of policy options are proposed and analysed, ranging from maintaining the current situation to more profound reforms. Each option has been assessed for its estimated safety, economic, environmental and social impacts.

2.

LEGAL ELEMENTS OF THE PROPOSAL



10.

3.1. Legal Basis


Any legislative amendment should build upon and enhance the approach of the current Nuclear Safety Directive. The legal basis remains thus Articles 31 and 32 of the Euratom Treaty.

11.

3.2. Subsidiarity and proportionality


The proposal aims at strengthening even further the role and independence of the competent regulatory authorities, 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. Close cooperation and information-sharing between regulators, taking into account the potential cross-border impacts of a nuclear accident, is encouraged.

Given the wide consequences of a nuclear accident and particularly the public need for information in such a case, 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. The existing provisions of the Directive are amended in this sense.

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 gaps remain. Therefore, the Nuclear Safety Directive is strengthened to include a set of shared objectives aiming at harmonising the EU approach to nuclear safety. Moreover, the experience from the Fukushima nuclear accident and the valuable insights coming from the Stress Tests have clearly shown that exchange of information and peer-reviews are an essential element to ensure the effective and continuous implementation of any safety regime.

In accordance with the proportionality principle, the proposed legislative action does not go beyond what is necessary to achieve the objectives. Furthermore, taking into account the different situations in the Member States, a flexible and proportionate approach as regards the level of applicability is defined. A mechanism of joint development by the Member States of EU-wide technical guidelines is defined with special regard to the principle of proportionality, by using the knowledge and practical experience of the regulatory experts.

The applicability and the extent of the provisions of the proposal vary according to the type of nuclear installation. Therefore, when implementing these provisions, Member States should follow a proportionate approach, taking account of the risks from the specific types of nuclear installations.

12.

3.3. Legal elements of the proposal


The proposal introduces new or strengthens the existing provisions of the Nuclear Safety Directive with the overall aim of continuously improving nuclear safety and its regulation at EU level. Specific information on the main proposed amendments of the Nuclear Safety Directive is presented below.

13.

Objectives


Article 1 is complemented with a new objective aiming at ensuring the avoidance of radioactive releases during all stages of the lifecycle of nuclear installations (siting, design, construction, commissioning, operation, decommissioning).

14.

Definitions


In Article 3, new definitions are introduced corresponding to terms used in the new provisions, such as 'accident', 'abnormal event', 'design basis', 'design basis accident', 'beyond design basis accident', 'periodic safety review'. These definitions are aligned with the international terminology, such as the IAEA Safety Glossary.

15.

Legislative, regulatory and organisational framework


Article 4 is amended in order to further clarify the main elements of the national framework. For instance, it is specified that the national safety requirements mentioned in Article 4(1)(a) should cover all stages of the lifecycle of nuclear installations.

16.

Competent regulatory authority (effective independence, regulatory role)


The Nuclear Safety Directive contains only minimal provisions underlying the independence of the national competent regulatory authority in Article 5(2). These provisions are strengthened in line with latest international guidance[24], by defining strong and effective benchmark criteria and requirements to guarantee the effective independence of regulators. New requirements include ensuring effective independence in decision-making, own appropriate budget allocations and autonomy in implementation, clear requirements for the appointment and dismissal of staff, avoidance and resolution of conflicts of interests, and staffing levels with the necessary qualifications, experience and expertise.

The Nuclear Safety Directive enumerates in a general manner the main competencies of the competent regulatory authority in Article 5(2). Through the amendment, these provisions are further detailed to ensure that regulators possess the appropriate powers to carry out a strong regulatory oversight. For this purpose, the core task of the competent regulatory authority to define national nuclear safety requirements is added to the existing catalogue of regulatory competencies.

17.

Transparency


The existing provisions of Article 8 of the Nuclear Safety Directive are limited to generic requirements on public information. Moreover, this Article does not impose any obligation on the licence holder, who has the prime responsibility for nuclear safety. To fill these gaps, in the proposed amendment, the existing provisions are extended and specified. Thus, both the competent regulatory authority and the licence holder are required to develop a transparency strategy, which covers information provision under normal operating conditions of nuclear installations as well as communication in case of accident or abnormal event conditions. The role of the public is fully acknowledged through the requirement that it effectively participates in the licensing process of nuclear installations. Recently organised exchanges with experts[25] in the field have confirmed that the public has a very important role to play by being involved effectively in the decision-making procedures and that their views should be considered, taking into account the provisions of the Aarhus Convention[26].

18.

Nuclear Safety Objectives


The current Nuclear Safety Directive does not include specific requirements for the different stages of the lifecycle of nuclear installations. Therefore, for example the type of risks related to the issues identified in the analysis of the Fukushima accident and the subsequent Stress Tests are not sufficiently identified and addressed by the provisions of the current Directive, e.g.:

· The need to evaluate the appropriateness of the siting of nuclear installations based on considerations on how to prevent, where possible, and minimise the impact from external hazards;

· The need to continuously re-assess the probability of such hazards and their impacts in the course of periodic safety reviews and perform a corresponding design basis review for each nuclear installation, including for the purpose of possible lifetime extension;

· The need to base risk assessments, including those for external events, on methods reflecting progress in scientific development and thus enable effective continuous improvement of safety.

In line with the principle of continuous improvement of nuclear safety the amendment introduces general safety objectives for nuclear installations (Article 8a) which reflect the progress achieved at the level of WENRA in developing safety objectives for new NPPs.

For achieving these high level safety objectives, more detailed provisions are laid down for different life-cycle phases of nuclear installations (Article 8b).

In addition, in order to support their consistent implementation, methodological requirements concerning the siting, design, construction, commissioning, operation and decommissioning of nuclear installations, are laid out in Article 8c.

This approach provides flexibility to the national frameworks, by assigning high level objectives that have to be fulfilled by national legislation in line with the principle of continuous improvement of nuclear safety. For example, this leaves to Member States the choice of selecting among the available engineering solutions to upgrade their nuclear installations when addressing safety issues based on lessons learned from severe accidents, such as the need to allow safe depressurizing of a reactor containment in case of an accident (e.g. by means of containment filtered venting).

19.

On-site emergency preparedness and response


The amendment includes provisions regarding on-site emergency preparedness and response as the current Directive does not provide for such measures. The new provisions include indications on the planning and organisational measures that should be provided by the licence holder (Article 8d). As an example of new requirements, the amendment prescribes that an on-site emergency response centre is required for a nuclear installation, sufficiently protected against the effects from external events and severe accidents, including radiological ones, and equipped with the necessary material to mitigate the effects of severe accidents.

20.

Peer Reviews


The existing provisions of the Nuclear Safety Directive of Article 9(3) include a requirement for periodic self-assessment of the Member States national framework and competent regulators authorities, combined with the obligation to invite an international peer review on relevant segments. This concept remains unchanged in the proposal, in Article 8e(1).

The amendment introduces new provisions on self-assessments and peer-reviews of nuclear installations based on nuclear safety topics selected by the Member States jointly and in close coordination with the Commission across the entire lifecycle of nuclear installations (example could be the above-mentioned containment depressurisation in case of severe accident in order to avoid hydrogen explosion). Should Member States fail to jointly select at least a topic, the European Commission should select the topics to be subject to the peer reviews. Further, each Member State has to define a methodology for the implementation of the technical recommendations from the peer review process. Should the Commission identify substantial deviations or delays in the implementation of the technical recommendations from the peer review process, the Commission should invite the competent regulatory authorities of Member States not concerned to organise and carry out a verification mission to get a full picture of the situation and inform the Member State concerned about possible measures to remedy any identified shortcomings.

In case of an accident with off-site consequences, a special peer review should be arranged.

This new compulsory and regular mechanism of EU peer reviews (Article 8e(2) to (5)) aims at verifying the level of technical compliance with the safety objectives in each Member State.

These new provisions setting out the peer-review mechanism are without prejudice to the rules governing the infringement procedure in case a Member State fails to fulfil an obligation under the Treaties, as laid out in Articles 258, 259 and 260 of the Treaty on the Functioning of the European Union (TFEU).

21.

Proportionate implementation of the amended Directive


The amendment acknowledges that the applicability and the extent of the provisions of the amended Directive vary according to the type of nuclear installation. Therefore, when implementing these provisions, Member States should follow a proportionate approach, taking account of the risks posed by the specific types of nuclear installations they plan or operate.

22.

Reporting on practical implementation of the amended directive


The provisions of the Nuclear Safety Directive on reporting are not changed by this proposal, leaving the date for the first reporting on 22 July 2014 at which the Member States are expected to submit a report on the implementation of the existing provisions of the Directive. At the time of the second reporting on the implementation however, by 22 July 2017, the Member States should report on the implementation of the Nuclear Safety Directive as amended by this proposal.

3.

BUDGETARY IMPLICATION



The proposal has no budgetary implications for the EU budget.

23.

5. explanatory documents


In accordance with the Joint Political Declaration of Member States and the Commission on explanatory documents of 28 September 2011, Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments.

With regard to this Directive, the Commission considers the transmission of such documents to be justified for the following reasons:

· The complexity of the transposition of the amended Nuclear Safety Directive at national level

The existing provisions of the Nuclear Safety Directive are significantly strengthened by this proposal which also introduces new substantial provisions in several areas. The complexity of transposition of the amended directive is therefore determined by the fact that is covers many different issues, including requirements on national framework for nuclear safety of nuclear installations, role and independence of national regulatory authorities, obligations of the licence holders, skills in nuclear safety, transparency on nuclear safety matters, technical objectives and requirements on nuclear safety of nuclear installations, on-site emergency preparedness and response and provisions on national assessments of nuclear installations and related topical peer-reviews. Moreover, the directive places requirements on different Member States' bodies as well as private actors.

The different obligations inherent to the amended directive are therefore likely to lead to a complex transposition at national level. The existing provisions of the Nuclear Safety Directive have already been transposed in general by several national transposition measures per Member State, the number is however exceeding 15 transposition measures in some cases. The number of notified transposition measures can be legitimately expected to rise with the new provisions brought to the existing directive by this proposal. Furthermore, due to the specificity of nuclear safety, various transposition measures are used and notified to the Commission, ranging from laws, government decrees and ministerial orders to instructions and decisions of national nuclear regulatory authorities.

The need for explanatory documents explaining the relationship between the provisions of the amended Nuclear Safety Directive and the corresponding parts of national transposition measures seems to be obvious under these circumstances.

· Pre-existing national legislation

In some Member States, some legislation is already in place in the area of amendments brought by this proposal. The transposition of the amended Directive is therefore likely to result in a combination of amendments to existing national legislation and adoption of new legislation. In such a situation, the explanatory documents would be necessary to obtain a clear and comprehensive picture of the transposition.

· Framework directive

The proposed amendments do not fundamentally change the framework character of the Nuclear Safety Directive. The amended directive continues to include general principles and requirements.

It is important for the Commission and its monitoring of transposition and implementation to know which national provisions transpose the general principles and requirements that the amended directive lays down. For instance, the proposal introduces general safety objectives and requirements for all types of nuclear installations. Given the very broad scope of these new safety objectives and requirements, it is of utmost importance for the Commission but also the public to be able to ascertain how they are transposed at national level.

24.

PROPORTIONALITY PRINCIPLE


The requirement to provide explanatory documents can create an additional administrative burden on the Member States. This burden is however not disproportionate considering the objectives of the amended Nuclear Safety Directive and the complexity of its subject matter. It is furthermore necessary for the Commission to allow effective verification of correct transposition. There are no less burdensome measures to allow efficient verification, considering the likely complexity of transposition at national level which may result in new or amended legislation. It is also to be mentioned that a relevant number of Member States have already been notifying useful explanatory documents to the Commission on their transposition of the existing Euratom legislation such as the existing Nuclear Safety Directive or other pieces of legislation.