List of Contents Section 10, Nuclear Safety and Radiation Protection Legislation Page

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1 List of Contents Section 10, Nuclear Safety and Radiation Protection Legislation Page Overview 1 The Radiation Protection (Medical Exposures) Directive 11 The Public Information (Radiological Emergency) Directive 17 The Directive on Radiation Protection of Outside Workers 22 The Directive on Shipments of Radioactive Waste 27 The Basic Safety Standards Directive 32 The Regulation on Radioactive Contamination of Foodstuffs 44 The Regulation on Imports of Agricultural Products Following the Chernobyl Accident 48 The Regulation on Shipments of Radioactive Waste 50

2 Nuclear Safety and Radiation Protection - Overview 1 Introduction and Overview This Section of the Handbook deals with EC legislation in the Nuclear Safety and Radiation Protection sector. It contains an introductory overview of the sector followed by individual fiches for selected pieces of legislation. 1.1 Overview The Treaty establishing the European Atomic Energy Community (Euratom) is the main legal basis for EU competence in the area of nuclear safety and radiation protection. The Treaty provides for the establishment of uniform basic safety standards to protect the health of workers and the general public against the dangers arising from ionising radiation. The basic standards have now been laid down in the Basic Safety Standards Directive 96/29/Euratom. The Treaty requires each Member State to take appropriate measures, whether by regulation or administrative action, to ensure compliance with the prescribed basic standards, and to take the necessary measures with regard to teaching, education and vocational training. In addition to Council Directive 96/29/Euratom, there are a number of other directives and regulations relating to specific activities within this sector, which deal with the following issues: health and safety at work (Radiation Protection of Outside Workers, Council Directive 90/641/EURATOM); radioactive substances (Shipments of Radioactive Waste, Council Directive 92/3/EURATOM; Shipments of Radioactive Substances, Council Regulation (Euratom) No. 1493/93); radioactive contamination (Radioactive Contamination of Foodstuffs, Council Regulations (Euratom) Nos. 3954/87, 770/90, 944/89, 2219/89; Imports of Agricultural Products, Council Regulation (EEC) No. 737/90); radiation protection from medical exposure (Medical Exposures, Council Directive 97/43/EURATOM); and emergencies (Public Information, Council Directive 89/618/EURATOM; Civil Protection Coordination, Council Decision 2001/792/EC, Euratom see fiche in Section 11 of Handbook) The scope of the above legislation does not include detailed requirements for other areas of activity within the nuclear safety and radiation protection sector. A number of these are covered by other Community provisions or by international conventions. For example, the Regulation on the Shipment of Radioactive Substances (Regulation (Euratom) No 1493/93) requires that the transport operations necessary for the shipment of radioactive substances must comply with Community and national provisions, and with international agreements on the transport of radioactive material. The detailed conditions for transport are laid down in European agreements arising from Council Directive 94/55/EC and Council Directive 96/49/EC on the approximation of the laws of the Member States with regard to the transport of dangerous goods by road and by road/rail respectively. Similarly, in respect of shipments of nuclear materials, such as nuclear fuel, the detailed requirements are set out in relevant international conventions. 1 Overview. Nuclear Safety and Radiation Protection

3 2 Development of a Sectoral Strategy and Implementation Plan The Implementation Management Checklist, presented in Part 1, Section 2 of the Handbook, provides an overall framework for preparing a strategy to implement the legislation contained within this sector. The following text focuses on key issues pertinent to this sector, which are developed in the remainder of this section. Further guidance on implementation is provided in the fiches for individual legal acts. The Basic Safety Standards Directive (96/29/Euratom), would usually be implemented as framework legislation, and be the basis for implementing supplementary directives such as the Radiation Protection (Medical Exposures) Directive. The extent to which the directives and regulations in this sector relating to health and safety at work, medical exposures, public protection, agriculture and environmental protection, etc. would be implemented by the same competent authorities and require the same resources for implementation would depend largely on existing regulatory responsibilities and expertise within government departments. At an early stage in the planning process, it will be necessary for the Candidate Countries to decide whether implementation responsibilities should be given to a single government department or divided among several departments having specific responsibilities. It is likely that responsibilities would be divided between departments having existing responsibilities for the regulation of similar types of hazards, for example safety in the workplace, with the advantage that the arrangements would afford political independence and better integration with the existing responsibilities of those departments. The main disadvantage of this approach is that it could lead to problems of ineffective co-ordination and communication between departments. The key tasks involved in implementing the directives and regulations within the nuclear safety and radiation protection sector are to: establish an institutional structure; set technical standards; introduce a system of authorisation of regulated activities; and introduce a system of monitoring, data collection and reporting. 2 Overview. Nuclear Safety and Radiation Protection

4 3 Institutions and Relevant Parties 3.1 Stakeholders A number of stakeholders have an interest in, or may be affected by, nuclear safety and radiation protection issues. The principal stakeholders, and their roles in the process of developing and implementing a sectoral strategy to achieve compliance with EC legislation on nuclear safety and radiation protection, are identified in Box 1. Box 1 Principal Stakeholders and their roles in the Nuclear Safety and Radiation Protection Sector Stakeholders Central Government (e.g. a Ministry or Department) Agencies working on behalf of central government (e.g. specialists in the nuclear industry or an environmental regulatory agency). Roles Implementation and maintenance of compliance with EC legislation on nuclear safety and radiation protection. Advise government on technical issues. Undertake regulatory activities. Regional and local government Involvement in the planning process for installations handling radioactive material, regulation, and emergency response in the case of accidents. Health services (public and private) Responsible for protecting patients and staff against medical exposure to radiation. Advise on clinical standards. Medical surveillance of workers. Employers Responsible for protecting employees and the public against hazards arising from work activities. Employees Health and safety concerns resulting from working at installations handling radioactive material. General Public Health and safety concerns resulting from working at installations handling radioactive material, and living near such installations, the consequences of accidents, and the consumption of foodstuffs contaminated by radioactivity. Health and safety concerns associated with medical examination and treatment. NGOs Represent the public interest. Lobby government. Research institutions (e.g. Universities) Provide specialist advice and undertake technical research. Private sector Provision of services. 3 Overview. Nuclear Safety and Radiation Protection

5 3.2 Central Government The competent national government department must determine the institutional structure for the key tasks identified to implement EU legislation in this sector, namely: planning; setting technical standards; implementing and enforcing regulatory system; training; and monitoring and data collection. It would be possible for the designated government department itself to undertake all those tasks, but there are a number of advantages in choosing alternative options, such as the appointment of a separate regulatory authority or agency working on behalf of the government department. The advantages of employing a separate agency are likely to include: operational independence; clear accountability; decentralisation and local self-determination; and cost effectiveness. Due to the largely regulatory nature of the obligations arising from the various directives and regulations within this sector, the initiative for implementation of those obligations is likely to be taken, to a large extent, by government - whether regional or central. The regulatory authority (if separate from the competent national government department) however, will need to have an input into the planning process and is normally the logical organisation to be responsible for detailed planning in consultation with the organisations to be regulated. An obligation exists in all the directives in this sector to report to the Commission on transposition of the directive into national legislation and on progress in implementation. Several directives and regulations also require the reporting of non-compliance and the provision of particular items of information, such as shipments of radioactive wastes. It is therefore important for central government to ensure that the necessary mechanisms are in place to monitor compliance with the various requirements of the legislation and also to provide relevant information. Central co-ordination is important also in the case of the Commission Decision 2001/792/EC (see fiche in Section 11 of Handbook) on civil protection assistance. It covers a broad range of emergencies and requires a comprehensive crisis management system, interlinking different authorities from police and fire brigade to various specialised services. The planning and monitoring required naturally calls for a top-down approach, In addition, each national system enters into an international network involving communication with the European Commission as well as with other member states directly. 3.3 Independent Advisory Bodies Due to the specialist nature of radiation hazards it may be desirable to set up an independent body to advise central government on technical standards, collect data and carry out research. It may be necessary to define the responsibilities of that body in separate legislation. Such a body is likely to be made up of staff from existing research laboratories and academic institutions. 4 Overview. Nuclear Safety and Radiation Protection

6 3.4 Regulatory Authority The need for operational independence and clear accountability indicates that the task of regulating activities in this sector should be undertaken by a separate, self-funding executive agency accountable to the appropriate minister. The agency could operate at regional level or be a centralised organisation. The former offers greater local accountability, whilst the latter tends to provide more uniform standards and a better use of skilled human resources. If the responsibility for implementing the obligations of a particular directive is split between two (or more) government departments it may be necessary to have more than one regulatory agency, such as one for aspects of health and safety at work and another for environmental protection issues. The advantage of splitting the regulatory function is that responsibilities under the directive would be better integrated with similar existing responsibilities. The disadvantage is that effective coordination and communication between the separate agencies may be difficult to achieve. Hence, the most satisfactory arrangement in this situation would be to set up a joint regulatory authority or agency reporting to relevant departments. It is important that the regulatory authority should have powers of enforcement and prosecution in the event of non-compliance. These powers should be exercised through the existing legal processes. There should also be a procedure for appeals against decisions and actions of the regulatory authority. 3.5 Private Sector Involvement The relevant government department(s) will be responsible for ensuring the provision of services of an adequate standard to meet the obligations of the various directives and regulations. These include the provision of a radiation dosimetry service, a national dose registry, an instrument calibration service traceable to national standards, analytical laboratories and training facilities. These services could be provided directly by central government or through private sector organisations operating within procedures and standards approved by the regulatory body. From the point of view of costeffectiveness and flexibility, the latter option is likely to be preferable. The Basic Safety Standards Directive (96/29/EURATOM) stipulates that the medical surveillance of certain categories of workers exposed to radiation should be the responsibility of approved medical practitioners or approved occupational health services. Central government will be required to determine the national strategy for the management of radioactive wastes and ensure the provision of adequate waste disposal facilities. The executive arrangements developed in most countries with a nuclear power programme are similar. An organisation is set up under the partnership of industry and government to deal specifically with waste storage and/or disposal. Recognising the long-term nature of the problem, the government invariably retains overall control. Operation of facilities may be contracted to commercial organisations. 3.6 Communication and Consultation Communication between all the institutions involved in the implementation of legislation in this sector is an important task that must be co-ordinated by the responsible government department. During the drafting of new legislation, in particular, it is important that consultation takes place with affected organisations, such as trade unions, industrial associations, professional institutions and organisations representing public opinion. 5 Overview. Nuclear Safety and Radiation Protection

7 4 Technical Issues 4.1 Technical Guidance The principal radiation protection standards, such as maximum permitted levels of exposure to radiation, are clearly set out in the Basic Safety Standards Directive (96/29/EURATOM). However, the interpretation of those basic standards and the setting of secondary standards requires extensive technical expertise. Due to the specialised nature of radiation hazards it may be desirable to set up an independent body to advise central government on technical standards. In the area of medical exposure to radiation, it is important that advice on clinical standards is provided by professional organisations representing the disciplines involved in medical radiological procedures, such as radiologists and radiographers. Those organisations, either jointly or separately, would provide assistance to the government or regulatory authority in preparing guidance on the interpretation and implementation of the relevant legislation. In order to provide an appropriate level of flexibility, a distinction should be made between primary legislation establishing the general regulatory framework and detailed regulations and guidance on technical matters. Legislation may be supplemented by approved codes of practice and other documents providing guidance on legal duties and setting out what is reasonably practical. Guidance may even be given legally binding status. For example, in the event of contravention, the onus could be placed on the alleged non-complying party to demonstrate that the obligations set out in legislation had been complied with otherwise than by observance of the relevant code of practice. Other nonstatutory guidance documents are may be used to provide information of a more general or more technical nature. 4.2 Training Standards In order to implement the obligations of the various directives it is necessary that the following groups of adequately trained and experienced persons should be available: regulatory staff; qualified experts; staff involved in practices covered by the particular directive; and providers of approved services. The objective of a training programme would be to demonstrate competence to act in a particular capacity. The assessment of competence would be based on the relevant level of academic training as well as practical experience. The setting of training standards would be best carried out by a national co-ordinating body, including representatives of the professional institutions, trade unions, industrial associations, as well as the regulatory authority. The assessment body may be a professional institution, employer or other organisation, which needs to satisfy the regulatory authority that they have suitable schemes to assess competence. 6 Overview. Nuclear Safety and Radiation Protection

8 5 Regulation and Enforcement In general, the obligations of the Basic Safety Standards Directive (96/29/EURATOM) are based upon the need for reporting to the regulatory authority and for the prior authorisation of certain defined activities. The latter would be based upon a satisfactory application from an organisation and the issue of a permit or other form of authorisation by the regulatory authority. The regulatory authority will carry out inspection or surveillance of authorised organisations on a regular basis to ensure compliance with the authorisation and relevant legislation. Individual inspectors will have defined rights of entry to the premises, to examine records and to issue prohibition notices or take other action to deal with cases of non-compliance. Approved medical practitioners or occupational health services will be responsible for carrying out medical surveillance of Category A workers, as defined in the Basic Safety Standards Directive. They must be given powers to ask for and obtain any relevant information they require for this purpose. This would include information from operators of regulated organisations on the conditions of their working environment. The form of implementation is likely to differ between the various directives and regulations in this sector. Those regulating contaminated foodstuffs require monitoring by the regulatory authority which has the power to prohibit the marketing of foodstuffs that are not in compliance with legal requirements. Those concerning the shipment of radioactive substances and wastes require notification or prior authorisation of shipments, respectively, to or by the regulatory authority. The Radiation Protection (Medical Exposures) Directive (97/43/EURATOM) requires approval of certain medical procedures by the relevant authority. Monitoring will normally be carried out by the regulatory authority, in order to determine how the obligations of the various directives or regulations have been implemented. Data collection will be undertaken either by the regulatory authority or by the institution set up to advise central government on radiation protection standards and will be based on periodic reports from organisations of issues such as radiation doses, discharges of radioactive waste, and imports/exports of radioactive materials. The regulatory authority will be required to make regular reports to central government. The technical advisory institution, on behalf of central government, will also be required to assess the impact of the various practices on the radiation exposure of the population as a whole. 6 Priorities and Timing In preparing strategies and plans for the implementation of the directive and regulations in this sector, there will be a need to prioritise the various major tasks to be undertaken. Implementation of the Basic Safety Standards Directive (96/29/EURATOM), which lays down the basic standards for the health protection of workers and the general public, must be given the highest priority, as it provides the foundation for most of the other legislation in this sector. Legislation implementing international treaties (for example legislation concerning planning for dealing with radiological emergencies and transboundary shipments of radioactive materials), and those relating to practices thought to pose major potential risks to human health should also be given a high priority where applicable. 7 Overview. Nuclear Safety and Radiation Protection

9 It is not possible to give specific guidance on the time-scale required to implement the obligations of the directives and regulations in this sector. Experience within Member States suggests that the most demanding and time-consuming tasks associated with implementing these directives and regulations are: transposing the requirements of the directives into national legislation; establishing and developing the institutional structure for controlling the particular radiation hazards, including the setting up of co-ordinating bodies, specialist advisory institutions and regulatory agencies; establishing technical standards and drafting codes of practice and other guidance documents; and establishing training standards and providing training facilities. These tasks should therefore be planned to commence during the initial phase of implementation. Depending on the existing institutional structure, the adoption of new legislation may be required before a new structure can be introduced. 7 Economic and Financial Issues The implementation of nuclear safety and radiation protection legislation will entail the following principal areas of cost to the Member State: the establishment of the necessary institutional structure; the provision of facilities of an adequate standard to meet the demands of the legislation; the provision of adequate numbers of trained staff; the cost of regulation and surveillance; and the provision of necessary services, such as radiation dosimetry and waste disposal facilities. The cost of establishing the necessary institutional structure and drafting the relevant legislation is likely to be borne by central government. The provision of adequate facilities, such as laboratories and medical treatment facilities, equipped to a modern standard, is likely to constitute the largest area of expenditure, and this will be borne by the organisations providing these services, as will the costs of providing adequately trained staff. The cost of regulation could be borne either by central government or by the organisations carrying out regulated activities. The latter option is preferable, on the basis that employers are responsible for maintaining the safety of their employees and other persons and, in the case of environmental protection, on the basis of the Polluter Pays Principle. Thus, in the case of radioactive waste disposal, it is desirable that the regulatory body should make a charge for the issue and maintenance of an authorisation for disposal. For the regulation of safety in the workplace it may not be feasible to recover costs directly in the form of a licensing fee, and the costs of inspection will be borne by central government, although the costs attributable to providing relevant services should be recovered where possible. The regulation and monitoring of medical exposures and of the control of foodstuffs is not amenable to a system of charging and it is reasonable that those costs should be borne by central government as part of the provision of public safety measures. 8 Overview. Nuclear Safety and Radiation Protection

10 The cost of necessary services, such as the provision of dosimetry services or radioactive waste disposal facilities, should be borne by the organisations carrying out regulated activities. In the case of waste disposal, it is important that waste producers should pay the full environmental costs of waste management processes. Few studies have been undertaken on the costs of implementing the legislation in the nuclear safety and radiation protection sector. The Danish Environmental Protection Agency 1) estimated that the cost of bringing the upgradeable nuclear power plants up to EC standards in terms of their safety and handling of nuclear waste for the ten Candidate Countries would be about DKK 20 billion (EUR 2.7 billion). 1 The report is entitled The Environmental Challenge of EU Enlargement in Central and Eastern Europe. obtainable on the web at 9 Overview. Nuclear Safety and Radiation Protection

11 8 Summary of Key Issues Achieving and maintaining compliance with EC legislation in the nuclear safety and radiation protection sector needs to be managed in a systematic and cost-effective manner, in order to minimise the associated administrative burden and costs. With this in mind, the governments of Candidate Countries should endeavour to focus their efforts on addressing those issues and requirements that are fundamental to EU approximation in this sector, in particular by ensuring that: the totality of policies, legislation, legal mechanisms and standards adopted at the national level achieve the objectives and results of EC policies and legislation; a single government department is given the overall responsibility for planning and managing the process of achieving compliance with each directive or regulation in this sector; arrangements are put in place for the effective involvement and participation of all other bodies or interest groups which have a significant role or function to perform in nuclear safety and radiation protection; appropriate regulatory agencies or competent authorities are established and their respective functions and powers are clearly defined; sufficient human and technical resources are allocated to allow all key functions and tasks to be performed properly, especially those relating to regulation and enforcement; adequate standards are established for the training of qualified experts and other staff; and the resources and expertise of the private sector are utilised in appropriate ways. A well prepared, integrated strategy provides the means by which these and all other significant issues relating to the nuclear safety and radiation protection sector can be systematically identified and addressed. Box 2 provides a checklist of key questions to be considered in preparing and implementing the sectoral strategy. Box 2 Key Questions to be Considered in Preparing and Implementing Sectoral Strategy Have government departments been given overall responsibility and legislative powers to achieve compliance with each separate Directive and Regulation? Has an assessment been made to identify the activities that involve a risk from radiation? Have the relevant stakeholders been consulted regarding proposed legislation? Has a technical advisory body been appointed to advise on radiation protection standards? Has the regulatory agency been established and its functions defined? Have training and competence standards been defined and training facilities established? Has a system of monitoring, data collection and reporting been established? Have approved services, such as dosimetry services and medical surveillance been provided? Has a system for recognising qualified experts been set up? 10 Overview. Nuclear Safety and Radiation Protection

12 The Radiation Protection (Medical Exposures) Directive Official Title: Council Directive 97/43/EURATOM on health protection of individuals against the dangers of ionising radiation in relation to medical exposure (OJ L 180, ) 1 Summary of Main Aims and Provisions The aim of the Directive, which supplements the Basic Safety Standards Directive, is to lay down principles and rules for the protection of individuals from ionising radiation in relation to medical exposure. The directive applies to the exposure of: patients as part of their own medical diagnosis or treatment; individuals as part of occupational health surveillance, health screening programmes or medicolegal procedures; healthy individuals or patients voluntarily participating in medical research programmes; and individuals who knowingly and willingly help (other than as part of their occupation) to support others undergoing medical exposure. The Directive sets out requirements for training and education of medical staff, and for control over the use of radiological equipment. 2 Principal Obligations of Member States 2.1 Planning Promote the establishment and use of, and the availability of guidance for, diagnostic reference levels (taking into account available European reference levels) (Art. 4). 2.2 Regulation Ensure that medical exposure of patients and other individuals to radiation is justified on the basis that it shows a sufficient net benefit after an assessment of the potential diagnostic and therapeutic benefits and the potential harm. All new types of practices involving medical exposure and all individual medical exposures must be justified in advance. The medical exposure of individuals to radiation where it cannot be justified on this basis must be prohibited. The prescriber and the practitioner should be involved in the justification process. (Arts. 3 and 5). Ensure that medical exposure for biomedical and medical research is examined by an ethics committee; and that special attention is given to the justification of medical exposure where there is no direct health benefit for the person undergoing exposure (Art. 3). Ensure that medical exposure is kept as low as reasonably achievable consistent with the intended purpose of the exposure (Art. 4). Ensure that each biomedical and medical research project in which individuals participate complies with the conditions set out in the Directive (Art. 4). Ensure that dose constraints and appropriate guidance are established for exposure of individuals Handbook for the Implementation of EC Environmental Legislation 97/43/Euratom 11 The Radiation Protection (Medical Exposures) Directive

13 knowingly and willingly helping to support patients undergoing medical treatment; and that written instructions are given to patients or legal guardians on restricting doses to persons in contact with the patient and on the risks of ionising radiation (Art. 4). Ensure that medical exposure is only effected under the clinical responsibility of a practitioner (Art. 5). Establish procedures to be observed in medico-legal examinations (Art. 5). Ensure that procedures for radiological practice are established in accordance with the requirements of the Directive; including written protocols, recommendations on referral criteria, and the involvement of medical physics experts in radiological practices (Art. 6). Ensure that practitioners, recognised specialists, and medical physics experts have adequate training for the purpose of radiological practices, as well as relevant competence in radiation protection, and that continuing education and training is provided (Art. 7 and 9). Take steps to avoid the unnecessary proliferation of radiological equipment; and ensure that radiological equipment is used and maintained in accordance with rules set out in the Directive (Art. 8). Prohibit fluoroscopic examinations without an image intensification or equivalent technique, and limit (to justified circumstances) fluoroscopic examinations without devices to control the dose rate (Art. 8). Ensure that appropriate equipment and techniques are used for the medical exposure of children, as part of health screening programme, or involving high doses to patients (Art. 9). Ensure that specified procedures are followed in the case of women who are, or may be, pregnant and women who are breastfeeding (Art. 10). Ensure that all reasonable steps are taken (taking into account economic and social factors) to reduce the probability and magnitude of accidental or unintended doses of patients from radiological practices (Art. 11) 2.3 Monitoring Estimate the amount of exposure of the population to radiation for medical purposes (Art. 12). Establish and implement a system of inspection to ensure that the requirements of the Directive are complied with (Art. 13). 2.4 Reporting Report to the Commission on: measures taken to comply with the Directive (Art. 14); and transposition, with texts of the main provisions of national law adopted in the field covered by the Directive (Art. 14). Handbook for the Implementation of EC Environmental Legislation 97/43/Euratom 12 The Radiation Protection (Medical Exposures) Directive

14 2.5 Additional Legal Instruments This Directive supplements the Basic Safety Standards Directive (96/29/EURATOM). 3 Implementation 3.1 Key Tasks The key tasks involved in implementing this Directive are summarised in the checklist below. The keys tasks set out in the fiche on the Basic Safety Standards Directive should be taken into account when implementing this Directive. RADIATION PROTECTION (MEDICAL EXPOSURES) DIRECTIVE - KEY IMPLEMENTATION TASKS 1 Planning 1.1 Designate a competent authority (or authorities) for the implementation of this Directive. Responsibilities will include ensuring that: medical exposure to ionising radiation is justified, optimised, and complies with all the requirements of the Directive; protocols for the use of radiological equipment are established; training programmes on radiological practices and radiation protection are set up; and an inspection system is established and implemented. 1.2 Set up an ethics committee to examine medical exposure for biomedical and medical research. 1.3 Provide guidance on justification of exposure where a woman is, or may be, pregnant or is breastfeeding. 2 Regulation and Monitoring 2.1 Set up procedures to ensure that medical exposure to ionising radiation is justified according to the requirements in Art. 3 of the Directive. Procedures should cover: justification of all new types of practices before their adoption; review of existing types of practices when new evidence on their efficacy or consequences is acquired; justification of individual medical exposure in advance, taking into account the specific objectives of the exposure and the characteristics of the individual involved; justification of medical exposures where there is no direct health benefit, especially for exposures on medico-legal grounds; and justification of exposures to individuals knowingly and willingly helping to support others undergoing medical exposures. 2.2 Establish procedures to ensure the optimisation of medical exposure to ionising radiation. Procedures should cover specifications for and/or guidelines on: doses to ensure they are kept as low as reasonably achievable; individual exposure target volumes for radiotherapeutic purposes; quality of radiological equipment; production of adequate diagnostic information or therapeutic outcome; quality assurance; and evaluation of patient doses and relevant activities. 2.3 Put in place measures to: promote the use of diagnostic reference levels for radiodiagnostic examinations; to ensure that biomedical and medical research projects are carried out in compliance with conditions set out in Directive; to ensure dose constraints are established and guidance issued for exposure of individuals who are helping to support those undergoing medical exposure; and to ensure that patients undergoing treatment with radionuclides are provided with written instructions to restrict doses of ionising radiation received by third parties. 2.4 Set up a control system to ensure the safety and safe use of radiological equipment. This would include: measures to avoid unnecessary proliferation of equipment; written protocols for standard radiological practices; surveillance systems for radiological equipment in use; up-to-date inventory of radiological equipment; system to check appropriate quality assurance programmes; system to ensure acceptance testing is carried out before equipment is used for clinical purposes for the first time; system to ensure performance testing is carried our regularly and after major maintenance; criteria for acceptability to indicate when remedial action is required; steps to ensure remedial measures are taken where necessary; and procedure to enforce prohibition or limitations relating to fluoroscopy examinations. Handbook for the Implementation of EC Environmental Legislation 97/43/Euratom 13 The Radiation Protection (Medical Exposures) Directive

15 RADIATION PROTECTION (MEDICAL EXPOSURES) DIRECTIVE - KEY IMPLEMENTATION TASKS 2.5 Put in place a system to ensure that appropriate equipment, practical techniques and ancillary equipment are used in medical exposure: of children; as part of health screening programme; and involving high doses to patients. 2.6 Put in place quality assurance programmes for special practices and systems to ensure that those performing those practices are appropriately trained. 2.7 Establish a system to reduce the probability and magnitude of accidental or unintended exposure to cover: equipment; procedures; and accidents with diagnostic and therapy equipment. The system should incorporate working instructions, written protocols and quality assurance programmes. 2.8 Estimate the distribution of individual dose estimates from medical exposure for the population as a whole and for relevant reference groups. 3 Training 3.1 Put in place measures to ensure that practitioners, medical physics experts and other specialists receive adequate training on radiological practices and radiation protection. These will include: establishing training programmes with appropriate curricula; establishing continuing education and training programmes; organising training on new techniques and relevant radiation protection; and including a course on radiation protection in curricula of medical and dental schools. 4 Reporting 4.1 Report to the Commission on: measures taken to comply with the Directive; and transposition. 4 Implementation Guidance The present status, needs and conditions concerning radiation protection in each Candidate Country will influence implementation of the specific requirements of this Directive. However, drawing upon the experience of selected Member States, a number of general observations and guidelines for implementing this Directive are presented below. Planning and Provision of Infrastructure Central government must set the broad policy for the protection of individuals from radiation. The responsibility for setting policy and meeting the principal obligations of the Directive would usually be taken by the health department or ministry, in consultation with the department responsible for implementing the Basic Safety Standards Directive, which covers other aspects of medical exposure to radiation. The responsible government department will determine the institutional structure for implementing the key tasks, such as planning, regulation and monitoring, and training. It may be possible for the responsible department to undertake all those tasks, but the need for operational independence, clear accountability and decentralisation indicates that the tasks should be undertaken by a separate agency (or agencies) ultimately accountable to the appropriate minister. For historic and practical reasons, it may be appropriate for those responsibilities to be split between the health department, for clinical matters, and the agency responsible for regulating health and safety at work, for all other matters covered by the Directive. The responsible government department and/or competent authorities will be responsible for issuing approved codes of practice and other guidance documents. While determining the institutional structure and establishing national legislation it is important that these should reflect the traditional practices and degree of clinical freedom existing within the medical profession of the Candidate Country. The clinical responsibility for an individual medical Handbook for the Implementation of EC Environmental Legislation 97/43/Euratom 14 The Radiation Protection (Medical Exposures) Directive

16 exposure may be taken by a medical doctor who has received extensive specialist training in radiological procedures or may be taken by a general medical practitioner. The Directive lays down requirements relating to the performance of radiological equipment (Article 8), which may be best dealt with by legislation transposing the Basic Safety Standards Directive. Consultation The independent body set up under the Basic Safety Standards Directive will advise central government on matters of protection from radiation. Advice on clinical matters is likely to be provided by a number of existing professional institutions with expertise and experience in medical radiological procedures, such as radiology and nuclear medicine, rather than by one central organisation set up for that purpose. These institutions will provide guidance, including advice on diagnostic reference levels and dose constraints, as appropriate. The system of regulation for clinical practices will be based upon the requirement to follow written protocols for standard radiological procedures. These protocols will be produced in consultation with the relevant professional organisation. Regulation and Monitoring The regulatory requirements will be implemented and enforced, inter alia, through internal audits of the quality assurance programmes and inspections by the regulatory authorities. An important feature of the monitoring system would be the collection of data to assist in the optimisation of patient s doses and the requirement to estimate population doses arising from medical exposure. Training Training standards for practitioners and others involved in medical radiological practice are likely to be set by the relevant professional organisations, rather than by a separate body set up for the purpose, and the formal qualifications recognised by the regulatory authority. Appropriate curricula may be specified in the national legislation. Handbook for the Implementation of EC Environmental Legislation 97/43/Euratom 15 The Radiation Protection (Medical Exposures) Directive

17 5 Costs The main types of costs associated with the implementation of this Directive are given in the checklist below. The cost of compliance with the Directive is likely to be borne by the medical service, as part of the provision of health care to the public. The principal costs will be the provision of: specialised staff to advise on and audit radiation protection measures; training for medical and other staff involved; and facilities and equipment of an adequate standard to meet the requirements of the Directive. The cost of adequately designed facilities and modern equipment could be considerable. The cost of regulation is unlikely to be amenable to a system of charging for the licensing of individual medical facilities and is therefore likely to be borne by central government. Checklist of the Types of Cost Incurred To Implement the Directive Initial set-up costs: Establishment of competent regulatory authority; Establishment of the specialist institution to provide technical advice; Provision of technical standards and guidance documents; Establishment of training standards and facilities. Capital expenditure: Facilities and equipment of an adequate standard. On-going running costs: Training of medical physics experts and other medical staff; Regulatory costs; Dosimetry services. Handbook for the Implementation of EC Environmental Legislation 97/43/Euratom 16 The Radiation Protection (Medical Exposures) Directive

18 The Public Information (Radiological Emergency) Directive Official Title: Council Directive 89/618/EURATOM on informing the general public about health protection measures to be applied and steps to be taken in the event of a radiological emergency (OJ L 357, ) 1 Summary of Main Aims and Provisions The aim of the Directive is to improve the protection of public health in the event of a radiological emergency (as specified in the Directive), by establishing measures and procedures for providing certain information to the public, both before and during such an emergency. 2 Principal Obligations of Member States 2.1 Planning Designate authorities responsible for taking measures in the event of a radiological emergency (Art. 8). Establish procedures for circulating information to the public on radiological emergencies, both before and during such an emergency (Art. 9). 2.2 Information and Reporting Ensure that the population likely to be affected in the event of a radiological emergency is provided with information on health-protection measures, action to be taken and authorities responsible for implementing measures. The information should be updated and circulated regularly and be permanently available to the public (Arts. 5, 8 and Annex I). Ensure that when a radiological emergency occurs, the population affected is informed of the facts of the emergency, the steps to be taken, the responsible authorities, and the appropriate healthprotection measures applicable to it (Arts. 6, 8 and Annex II). Ensure that those who might be involved in the organisation of emergency assistance in the event of a radiological emergency (but who are not members of staff of the facility, and/or engaged in the activities, concerned) are given adequate and regularly updated information on the health risks involved, the precautionary measures to be taken, and the responsible authorities (Art. 7). Notify the Commission of: information provided, pursuant to Article 5, to the population likely to be affected in the event of a radiological emergency, if this information is requested by the Commission; information circulated, pursuant to Article 6, to the population affected in the event of a radiological emergency; and data relevant to the radiological emergency, in respect of the information provided, pursuant to Article 7, to those who might be involved in the organisation of emergency assistance, if this information is requested by the Commission (Art. 10). 89/618/Euratom 17 The Public Information (Radiological Emergency) Directive

19 Notify Member States affected or likely to be affected by a radiological emergency of the information circulated to the population affected pursuant to Article 6 (Art. 10). Inform the Commission of measures taken to comply with the Directive, and of any amendments to such measures (Art. 12). 2.3 Additional Legal Instruments This directive supplements the requirements of the Basic Safety Standards Directive (96/29/EURATOM). Additionally, Council Decision 87/600/EURATOM on Community arrangements for the early exchange of information in the event of a radiological emergency, ensures that the Commission and Member States are promptly informed in the event of a radiological emergency, and sets out the information which is to be provided. The ECURIE (EC Urgent Radiological Information Exchange) system provides an exchange platform for managing the graded response between Member States. In the area of emergencies, see, too, Council Decision 2001/792/EC on civil protection co-ordination (see Section 11 of Handbook), a measure adopted in the wake of September 11 and establishing the basis for pooling Member States resources for use in emergency situations of all kinds, including radiological and environmental. 3 Implementation 3.1 Key Tasks The key tasks involved in implementing the Basic Safety Standards Directive will be relevant to the implementation of this Directive. Additional key tasks that are specific to the implementation of this Directive are summarised in the checklist below. The key tasks are arranged under sub-headings and organised in chronological order of implementation wherever possible. 3.2 Phasing considerations Experience within Member States suggests that the most challenging and time-consuming tasks associated with implementing this Directive are: Establishing and developing the institutional structure for ensuring the provision of public information in the event of an emergency, including setting up a specialist advisory institution, a regulatory agency, a national co-ordinating body and bilateral arrangements with other Member States. Establishing technical standards, producing codes of practice and other relevant guidance documents, including procedures for informing the public. Drawing up plans to inform the public in the event of a radiological emergency. These tasks should therefore be thoroughly considered and planned before the initial phase of implementation. Depending on the existing institutional structure, the transposition of legislation may be required before a new institutional structure can be introduced. 89/618/Euratom 18 The Public Information (Radiological Emergency) Directive

20 THE PUBLIC INFORMATION (RADIOLOGICAL EMERGENCY) DIRECTIVE - KEY IMPLEMENTATION TASKS 1 Planning 1.1 Designate a competent authority (or authorities) to ensure implementation of the Directive. Responsibilities would include ensuring that: relevant information is supplied to the population likely to be affected in the event of a radiological emergency; relevant information is supplied to the population actually affected by a radiological emergency; and relevant information is supplied to those involved in the organisation of emergency assistance in the event of a radiological emergency. 1.2 Set up a specialist institution to advise on radiation protection standards. 1.3 Set up national and/or local co-ordinating bodies. 1.4 Draft an approved code of practice and other guidance documents. 2 Implementation and monitoring 2.1 Set up systems to provide prior information to the population likely to be affected, about health protection measures and actions to be taken in the event of a radiological emergency. This would involve: identifying the population likely to be affected; and devising a system of communicating, regularly updating and ensuring that information is permanently available. 2.2 Set up procedures to provide information to the population actually affected by a radiological emergency. This would involve: identifying the population actually affected; devising a system of communicating information, and determining the frequency with which the information will be communicated; and determining the advice that will be issued on protection and the frequency with which this information will be reviewed. 2.3 Put in place procedures to provide information to persons involved in the organisation of emergency assistance in the event of a radiological emergency. This would involve: identifying those to whom information must be provided; ensuring that relevant and updated information is provided on health issues and precautionary measures; and making provision for supplementary information following a radiological emergency to take into account specific circumstances. 2.4 Review, practice and improve radiological emergency planning. 2.5 Co-operate with other Member States. 2.6 Put in place procedures for circulating information on risks involved, and measures and actions to be taken in the event of a radiological emergency. 3 Reporting 3.1 Set up systems (including database for information) to enable competent authorities to report to central government where necessary, and to enable central government to notify the Commission and/or other Member States of relevant information as required by the Directive. 4 Implementation Guidance The present status, conditions and requirements regarding radiological emergency planning in each Candidate Country will influence implementation of the specific requirements of this Directive. However, drawing upon the experience of Member States, a number of general observations and guidelines for the implementation of this Directive are given below. Planning and Provision of Infrastructure Central government must set the broad policy on the measures to be taken by the competent authorities and the necessary resources both in personnel and equipment to enable action to be taken to safeguard the general public in the event of a radiological emergency. The government department responsible for emergency planning is likely to be the one responsible for implementing the obligations under the Basic Safety Standards Directive, which contains obligations regarding intervention in cases of radiological emergencies (Title IX). It is therefore appropriate that legislation should be drafted to incorporate the general obligations for emergency preparedness under Title IX, together with those obligations for providing public information under the present Directive. Due to the nature of radiation hazards it may not always be practicable to integrate these requirements with controls over other major industrial accident hazards. 89/618/Euratom 19 The Public Information (Radiological Emergency) Directive

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