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Questions and answers about the Radiation Act reform
The Government submitted a proposal for a new Radiation Act to Parliament on 28 March 2018. Parliament adopted the new Radiation Act and certain other related acts on 29 September 2018. The acts will enter into force on 15 December 2018. We have compiled a list of frequently asked questions and answers about the Radiation Act reform.
The old Radiation Act and the Radiation Decree under it were issued in 1991 and the Decree of the Ministry of Social Affairs and Health on Medical Use of Radiation (423/2000) was issued in 2000. The old Radiation Act and the Radiation Decree had been amended 23 times since they entered into force. The old Radiation Act did not anymore comply with the requirements of the Constitution Act that had entered into force in 2000.
Implementation of the EU's new Basic Safety Standards Directive required many structural and terminological amendments to the Finnish radiation legislation. Therefore, an overall reform of radiation legislation was justified in connection with the implementation of the Directive. In the reform, amendment needs identified by regulatory authorities in their control activities were taken into account.
The Radiation Act and lower-level statutes under it implemented the new Basic Safety Standards Directive of the European Union.
A new topic in the Act is the regulation of other than medical exposure of persons in connection with imaging. The Act revises the training and qualification requirements regarding personnel participating in radiation practices as well as preparedness procedures against radiation safety deviations. In addition, provisions concerning radiation exposure due to natural radiation have been specified.
Provisions on non-ionising radiation were amended at the same time. New provisions on non-ionising radiation enable risk-based control of non-ionising radiation better than before, as required both by today's fast technological product development and the new applications that are taken into use.
The Regulatory Guides on radiation safety (ST Guides) by the Finnish Radiation and Nuclear Safety Authority have been included in acts and decrees, if applicable, or they have become binding regulations of the Radiation and Nuclear Safety Authority.
In addition, the recommendations of the International Atomic Energy Agency (IAEA) that Finland had committed to implement were taken into account, as appropriate, and incorporated into national legislation.
The objective of the reform was to implement the new EU directive on radiation safety. The directive is based on recommendations of the International Commission on Radiological Protection (ICRP) and on newest scientific data. Recommendations of IAEA were also taken into account and the requirements laid down in the recommendations were implemented.
The directive only applies to ionising radiation. Nevertheless, it was necessary to revise the provisions on non-ionising radiation, too, because the technology of devices related to non-ionising radiation is developing very fast and new applications are taken into use. The reform ensures that applications related to non-ionising radiation are safe and it creates a basis for effective risk-based control.
Ionising radiation means radiation that forms ions in the medium. Ionizing radiation includes X-radiation and the alpha, beta and gamma radiation emitted by radioactive substances. Neutrons are released, for example, in spontaneous fissions of uranium nucleus or in reactions that take place in the neutron source. Even cosmic radiation contains lots of neutrons that cause most of the radiation doses to crew and passengers in aircrafts flying high.
Non-ionising radiation means ultraviolet radiation, visible light, infrared radiation, radio-frequency radiation, low-frequency and static electronic and magnetic fields as well as ultrasound.
When preparing the reform, the Government’s objective of deregulation and reducing the administrative burden was taken into account whenever possible. However, it has been necessary to impose certain new obligations on undertakings because radiation causes risks to citizens and the level of radiation protection cannot be lowered. These obligations partly derive from the EU’s Basic Safety Standards Directive.
The preparation process was linked to the schedule for implementing the EU Basic Safety Standards Directive. EU Member States had to implement the Directive by 6 February 2018. Finland was slightly behind this schedule set by the European Commission.
The Government submitted a proposal for a new Radiation Act to Parliament on 28 March 2018. Parliament adopted the new Radiation Act and certain other related acts on 29 September 2018. The acts enter into force on 15 December 2018.
The Ministry of Social Affairs and Health and the Radiation and Nuclear Safety Authority (STUK) drafted the Act as part of their official duties.
A steering group for the overall reform of radiation legislation, appointed by the Ministry of Social Affairs and Health, led the preparing process. In addition to representatives of the Ministry of Social Affairs and Health and STUK, the group included representatives of the Ministry of Economic Affairs and the Employment, the Ministry of the Environment, the Ministry of the Interior, the National Supervisory Authority for Welfare and Health (Valvira), the Association of Finnish Local and Regional Authorities, the Finnish Medical Association (FMA), Aalto University and Pirkanmaa Hospital District.
Eight sub-groups worked under the steering group. The working groups included representatives of key authorities, organisations and undertakings from the relevant sectors. The sub-working groups were:
- Medical uses of radiation
- Non-medical uses targeted at persons
- Exposure to natural radiation (radon, public exposure, building materials)
- Protection of workers and members of the public
- Regulatory control (licensing, registration, qualifications of workers performing radiation work) and administrative enforcement measures
- Radiation protection training (vocational education and training, continuing education, training for radiation safety experts and officers)
- Emergency exposure situations
- Non-ionizing radiation
The government proposal was circulated for comments from key authorities, labour market organisations, education and training organisations, and undertakings in the fields of healthcare and industry. Moreover, the Ministry of Finance was separately asked to comment on the provisions on annual supervision fees and the related annexes that were added to the proposal after it had been circulated for comments. All key labour market organisations and undertakings were given an opportunity to be heard on the matter.
The Ministry of Social Affairs and Health and the Radiation and Nuclear Safety Authority also organised a joint consultation session for stakeholders on 24 March 2017.
The impacts of the reform have been evaluated in a comprehensive assessment carried out as part of official duties. The proposal has impacts on the economy, the activities of authorities, the environment, society, occupational safety and health and children as well as gender impacts.
The Radiation Act emphasises risk-based control and the responsibility of undertakings. The new Act obliges the undertakings to conduct a safety assessment based on the risks involved in their activities. The safety assessment involves assessing radiation exposures in the activities and identifying potential radiation safety incidents. The safety assessment also presents measures to ensure radiation safety, prevent the identified potential radiation safety incidents and prepare for the occurrence of such incidents.
In all activities requiring a safety licence, undertakings have to consult a radiation safety expert when planning, implementing and monitoring safety protection measures concerning workers and members of the public, in accordance with the nature and extent of their activities. Undertakings also have to appoint a radiation safety officer to assist them. The radiation safety officer will monitor in practice that staff at the place of work ensure radiation safety and follow regulations and guidelines.
According to the principle of justification, radiation practices and protection measures are justified if their overall benefits outweigh the detriment they cause (justification principle).
The Act defines more closely the assessment of justification required particularly in connection with new types of practices or such healthcare examinations of asymptomatic persons where ionizing radiation is used. Screenings and similar measures or risk-based examinations of persons showing no symptoms require specific justification. Further provisions on the assessment of justification will be issued by government decree.
Finnish radiation legislation has previously included no provisions on non-medical exposure of individuals. In such cases, the primary purpose of imaging is not to bring a health benefit to the individual being exposed. Until now, legislation has only regulated medico-legal examinations, such as the use of ionizing radiation to determine the age of immigrants.
The provisions of the new Act apply to all examinations carried out using healthcare and other equipment (e.g. X-ray imaging equipment used at airports in some countries). The person exposed to radiation during imaging has to be provided with information on the radiation exposure and potential health detriments. Examinations other than bodily searches performed under the Coercive Measures Act or the Customs Act also require the consent of the individual in question.
According to the proposed Radiation Act, a radiation safety expert has to be consulted when planning, implementing and monitoring the radiation protection of workers and the public. The expert has to be closely involved in demanding practices. It is also possible to use an expert acting as a consultant. A radiation safety officer assists the undertaking and ensures that radiation protection measures are implemented in practical work. Radiation safety officers are replacing the earlier managers who were responsible for radiation safety.
The radiation safety expert and radiation safety officer have to possess the qualifications and radiation protection expertise required by the Radiation Act. Training in radiation protection may be included in a higher education degree or completed as separate continuing education and training. Higher education institutions providing such training can request the Finnish Radiation and Nuclear Safety Authority (STUK) to give an opinion on their radiation protection training. Before, STUK had to approve training programmes for managers responsible for radiation safety. Apart from higher education institutions, other organisers of training for the new radiation safety officers still have to seek STUK’s approval for their training programmes.
Healthcare professionals will continue to be required to have the radiation protection training and work experience needed in their tasks. Regular continuing education and training in radiation protection is still mandatory for all workers participating in the use of radiation. A decree of the Ministry of Social Affairs and Health specifies the provisions on radiation protection training.
Radon is a form of natural radiation. In the Radiation Act, exposure to natural radiation is mainly regulated in the same manner as exposure to radiation from other sources. This enables improved control of radon exposure.
According to the new EU Basic Safety Standards Directive, the reference level for radon concentration is 300 Bq/m3 in dwellings, workplaces and other places with public access. If the radon concentration in the working area cannot be reduced below the reference level despite efforts, the undertaking has to obtain a safety licence for its operations.
The Radiation Act and other statutes issued under it provide more clearly than before, how responsible parties have to notify STUK of practices that may cause exposure to radon. Specific provisions are also issued on the obligation to report and limit radon concentrations.
The Ministry of Social Affairs and Health and STUK will prepare a national action plan to prevent radon-related risks.
The Act lays down the principles and objectives to be followed in preparing for radiation emergencies and protecting the public in the event of an emergency. These principles and objectives guide authorities and undertakings in preparing for emergencies. Personnel working in the event of an emergency exposure situation has to be designated in advance and they have to be provided with appropriate training. The provisions of the Act also take into account that emergency response measures may involve voluntary radiation emergency assistants and employees of private organisations. Moreover, the Act lays down principles determining how these groups may be used in responding to emergencies and how they should be protected.
The Act clarifies the assessment criteria regarding the safety of products exposing the public to non-ionising radiation. This makes it easier to withdraw dangerous products from the market and make the grounds for withdrawal clearer to the undertaking. These products sold to customers include, for example, laser appliances and cosmetic equipment utilising non-ionising radiation, such as skin care, fat removal or hair removal appliances.
The Finnish Radiation and Nuclear Safety Authority (STUK) is the competent market surveillance authority according to the Act on the Market Surveillance of Certain Products (1137/2016). STUK can therefore use the control measures provided by the Market Surveillance Act, in addition to the means of control laid down by the Radiation Act. STUK is thus equipped with a wider range of means to withdraw dangerous products from the market. This means better opportunities to respond to rapid changes in commercial and distribution practices. It also helps ensure that the required measures are commensurate with the risk caused by the dangerous product.