The safety licence system, inspections at the place of use of radiation and the necessary orders, prohibitions and enforcement measures form a system for regulating the safety of the use of radiation which is based on the Radiation Act. The enforcement measures are the strongest method the authority can use to correct discovered deviations.
The implementation procedures and enforcement measures are based on the authorisations granted to the regulatory authority in the legislation. Chapter 14 of the Radiation Act (592/1991) governs the powers of Radiation and Nuclear Safety Authority and the inspectors in its service. Chapter 15 of the Radiation Act includes provisions regarding enforcement measures.
The procedures can be used if a deviation is discovered in the use of radiation. Deviation refers to a safety deficiency, discrepancy or negligence that requires intervention by means of a regulatory measure that obliges the responsible party. A deficiency or negligence can be related to the deteriorated safety of operations, i.e. to the required level of safety not being met in some parts. On the other hand, the deviation may be administrative by nature – for example, the application for a licence, the preparation of a statutory notification or the provision of a clarification requested by an authority has been neglected.
Issuing orders to correct deviations is part of normal regulatory control. For example, orders are common in inspection protocols. In contrast, the interruption of operations or the imposition of a conditional fine constitute strong measures which are rarely necessary.
Orders and prohibitions
Orders in inspections
Orders to correct deviations observed in inspections are provided in writing in the inspection protocol, which is sent to the responsible party. A deadline is set for carrying out corrective measures. The inspection protocol also includes stipulations regarding necessary notifications to the Radiation and Nuclear Safety Authority on the correction of the deviations. Furthermore, the inspection protocol is supplemented with a mention of a possible re-inspection if one is necessary with regard to the safety significance of the deviation.
Interruptions or limitations of operations
If an activity causes an obvious detriment to health or the danger thereof, then the Radiation and Nuclear Safety Authority may order that it be interrupted or restricted pursuant to Section 55 of the Radiation Act. If the matter cannot be delayed, the inspector may, during an inspection, give an immediate order to interrupt or limit the operations. The reason may be X-ray equipment that lacks the appropriate safety licence, for example. In such cases, the inspector may order the operations for this appliance to be interrupted.
Issuing a prohibition of sale and transfer
Radiation appliances, radioactive substances or materials containing radioactive substances, or equipment or other products pertaining to safety of radiation practices must meet the applicable safety requirements (Radiation Act, Section 21). If a product fails to meet the safety requirements pertaining thereto, then the Radiation and Nuclear Safety Authority is authorised to prohibit the sale or other transfer thereof (Radiation Act, Section 56).
In case of radiation appliances in health care, the sales prohibition is implemented in co-operation with the National Supervisory Authority for Welfare and Health (Valvira). Valvira regulates the entry of health care equipment and supplies on the market based on the Medical Devices Act (629/2010).
Enforcement measures defined in Section 59 of the Radiation Act include
- imposing a conditional fine,
- threatening that the neglected measure be performed at the defaulter's expense,
- threatening that the operations will be interrupted, and
- threatening that the use of the radiation source be prohibited.
The use of enforcement measures will be considered if the responsible party has not executed the orders issued by the deadline or is otherwise neglecting the fulfilment of a specific obligation imposed upon it. The responsible party is heard before using threats pursuant to Section 59.