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 will consider the proposal and decide on its entry into force. According to the government proposal, the Radiation Act would enter into force on 1 July 2018.
We have compiled a list of frequently asked questions and answers about the reform of the Radiation Act.
Why will the Radiation Act and the statutes issued under it be reformed?
The current Radiation Act (592/1991) and the Radiation Decree (1512/1991) issued under it were adopted in 1991. The Decree of the Ministry of Social Affairs and Health on the medical use of radiation (423/2000) was adopted in 2000. Since their entry into force, the Radiation Act and Decree have been amended 23 times. The Radiation Act does not meet the requirements of the Constitution of Finland that entered into force in 2000.
In 2013, the European Union (EU) adopted a new Basic Safety Standards Directive concerning radiation safety. Its implementation requires Finland to make many structural and terminological changes to its radiation legislation. Therefore, an overall reform of radiation legislation is justified in connection with the implementation of the Directive. In the reform, amendment needs identified by regulatory authorities during inspection will also be taken into account.
How will the new EU Basic Safety Standards Directive affect Finnish radiation legislation?
The Radiation Act and secondary legislation issued under it would implement the European Union’s new Basic Safety Standards Directive.
As a new feature, the Act would include provisions on . The Act would entail changes to the education and qualification requirements concerning workers participating in radiation practices and to the preparedness for radiation safety incidents. It will also include more specific provisions on exposure to radiation from natural sources.
Provisions on non-ionizing radiation would also be amended. New provisions on non-ionizing radiation would enable improved risk-based control of non-ionizing radiation, which is necessary because of the rapid technical development of products and the introduction of new applications.
The current Regulatory Guides (ST Guides) issued by the Finnish Radiation and Nuclear Safety Authority (STUK) would be included in the Act, decrees or binding STUK Regulations as appropriate.
Moreover, the recommendations of the International Atomic Energy Agency (IAEA), which Finland has committed to implement, would be taken into account and transposed as appropriate.
What is the basis for the reform?
The starting point of the reform is to implement the new EU Basic Safety Standards Directive. It is based on the recommendations of the International Commission on Radiological Protection (ICRP) and the latest scientific knowledge. Moreover, the recommendations of the IAEA will be taken into account and their requirements implemented.
The EU Directive only applies to ionizing radiation. However, there is also a need to reform provisions on non-ionizing radiation because of the rapid technical development and various new applications of equipment using non-ionizing radiation. The reform would ensure the safety of non-ionizing radiation applications and create a framework for efficient risk-based control.
What is ionizing radiation?
Ionizing radiation means radiation that is capable of producing ions in a medium. Ionizing radiation includes X-radiation and the alpha, beta and gamma radiation emitted by radioactive substances. Neutrons are released, for example, as a result of the spontaneous splitting of a uranium nucleus (spontaneous fission) or a reaction in a neutron source. Incoming cosmic radiation also includes numerous neutrons that are the main cause of radiation exposure of aircraft crew and passengers at high altitudes.
What is non-ionizing radiation?
Non-ionizing radiation means ultraviolet radiation, visible light, infrared radiation, radio-frequency radiation, low-frequency and static electric and magnetic fields as well as ultrasound.
How has the Government steered the overall reform of the Radiation Act?
When drafting the proposal, 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 responsible parties 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.
What is the timetable for drafting and adopting the Radiation Act?
The drafting process has been 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 is slightly behind this schedule set by the European Commission.
The government proposal for a new Radiation Act was submitted to Parliament on 28 March 2018. Parliament will consider the proposal and decide on its entry into force. According to the government proposal, the Act would enter into force on 1 July 2018.
How has the reform been prepared?
The Act has been drafted as part of official duties at the Ministry of Social Affairs and Health and the Radiation and Nuclear Safety Authority (STUK).
The process has been led by a steering group for the overall reform of radiation legislation. The steering group was appointed by the Ministry of Social Affairs and Health. In addition to the Ministry and STUK, the group has included representatives of the Ministry of Economic Affairs and 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 the Pirkanmaa Hospital District.
Eight sub-groups were established under the steering group. They include representatives of key authorities, organisations and operators from the relevant sectors. The sub-groups have focused on the following themes:
- 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 has been circulated for comments from key authorities, labour market organisations, education and training organisations as well as responsible parties in the fields of health care 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 responsible parties 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.
How have the impacts of the reform been assessed?
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, gender and children.
What will be the most significant change introduced by the Act at places where radiation is used?
The proposal for the Radiation Act emphasises the responsible parties’ responsibility and risk-based control. The proposed Act will impose on responsible parties a new obligation of conducting a safety assessment based on the risks involved in their activities. The safety assessment would involve assessing radiation exposures in the activities and identifying potential radiation safety incidents. Measures would also be presented 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, responsible parties would 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. Responsible parties would also have to appoint a radiation safety officer to assist them. The officer would monitor in practice that staff at the place of work ensure radiation safety and follow regulations and guidelines.
How will the legislative reform affect the general principles of radiation use, particularly the ‘principle of justification’?
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 proposed Act would define more closely the assessment of justification required particularly in connection with new types of practices or health care examinations of asymptomatic persons using ionizing radiation. Screenings and similar measures or risk-based examinations of persons showing no symptoms would require specific justification. Further provisions on the assessment of justification will be issued by government decree.
How will the Radiation Act affect non-medical imaging exposure of humans?
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 proposal would apply to all examinations carried out using health care and other equipment (e.g. X-ray imaging equipment used at airports in some countries). The person exposed to radiation during imaging would have 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 would also require the consent of the individual in question.
The new Act would require the appointment of a radiation safety expert and a radiation safety officer at the place of use of radiation. What will their tasks include?
According to the proposed Radiation Act, a radiation safety expert would have to be consulted when planning, implementing and monitoring the radiation protection of workers and the public. The expert should be closely involved in demanding practices. It would also be possible to use an expert acting as a consultant. A radiation safety officer would assist the responsible party and ensure that radiation protection measures are implemented in practical work. These persons would replace the radiation safety officers appointed under current legislation.
How will the reform change the education and training requirements of workers at facilities where radiation is used?
The radiation safety expert and radiation safety officer would 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 could request the Finnish Radiation and Nuclear Safety Authority (STUK) to give an opinion on the radiation protection training they offer. Before, STUK had to approve training programmes for the radiation safety officers referred to in current legislation. Apart from higher education institutions, other organisers of training for the new radiation safety officers would still have to seek STUK’s approval for their training programmes.
Health care 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 would still be mandatory for all workers participating in the use of radiation. Further provisions on radiation protection training will be issued by decree of the Ministry of Social Affairs and Health.
What changes will there be to the regulation of radon in indoor air?
Radon is a form of natural radiation. In the proposed Act, exposure to natural radiation would mainly be regulated in the same manner as exposure to radiation from other sources. This would enable 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 decreased below the reference level despite efforts, the responsible party must obtain a safety licence for its operations from the Radiation and Nuclear Safety Authority (STUK).
The Radiation Act and other statutes issued under it would provide more clearly how responsible parties have to notify STUK of practices that may cause exposure to radon. Further provisions would also be issued on the obligations to report and limit radon concentrations.
How will the new Radiation Act improve preparedness for emergency exposure situations?
The Act would lay down the principles and objectives followed in preparing for radiation emergencies and protecting the public in the event of an emergency. This would ensure that these principles and objectives would guide authorities and responsible parties in preparing for emergencies. Personnel working in the event of an emergency exposure situation would be designated in advance. They would also have to be provided with appropriate training. The provisions of the Act would also take into account that emergency response measures may involve voluntary emergency assistants and employees of private organisations. Moreover, the Act would lay down principles determining how these groups may be used in responding to emergencies and how they should be protected.
How will the Act enhance the market surveillance of products emitting non-ionizing radiation?
The Act would clarify the criteria for assessing the safety of products that expose the public to non-ionizing radiation. This would make it easier to withdraw dangerous products from the market and make the grounds for withdrawal clearer to responsible parties. These products include health care equipment or supplies sold to consumers in department stores, such as skin care, fat removal or hair removal appliances, or similar equipment used in consumer services, such as cosmetic treatments.
The Finnish Radiation and Nuclear Safety Authority (STUK) would be added to the market surveillance authorities referred to in the Act on the Market Surveillance of Certain Products (1137/2016). This would enable STUK to use surveillance measures under the Radiation Act as well as the Market Surveillance Act. STUK would be equipped with a wider range of means to withdraw dangerous products from the market. This would mean better opportunities to respond to rapid changes in commercial and distribution practices. It would also help ensure that the required measures are commensurate with the risk caused by the dangerous product.