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Radiation Decree 20.12.1991/151220.12.1991/1512

With amendments up to and including 93/2009. Unofficial translation by STUK.

The following Decree is issued on the proposal of the Minister of Social Affairs and Health, and pursuant to the Radiation Act (592/1991) enacted on 27 March 1991:

Chapter 1 General provisions

Section 1 Scope of application

This Decree shall apply to the use of ionizing radiation and to other radiation practices causing exposure to ionizing radiation.

This Decree shall also apply to the use of nuclear energy to the extent provided in paragraph 1 of section 3 of the Radiation Act (592/1991).

Section 2 Definitions

Equivalent dose shall denote the product of the mean energy imparted by radiation to tissue or to an organ, per unit mass, and a weighting factor specified for the radiation.

Effective dose shall denote the weighted sum of the equivalent doses of tissues and organs exposed to radiation.

The unit of equivalent dose and effective dose shall be the sievert (Sv).

Monitoring of radiation exposure shall denote measures implemented to monitor and assess the radiation exposure of workers engaged in radiation work by means of individual monitoring and monitoring of working conditions affecting radiation exposure. (23.12.1998/1143).

The Euratom Treaty shall denote the treaty establishing the European Atomic Energy Community. (31.12.1994/1598)

Section 2 a Powers of the Radiation and Nuclear Safety Authority (31.12.1994/1598)

In addition to the provisions of the Radiation Act and other regulations issued pursuant thereto, the Radiation and Nuclear Safety Authority (STUK) shall:

1. serve as the organization responsible for the monitoring referred to in Article 35 of the Euratom Treaty,

2. attend to the official duties, liaison and reporting involved in implementing regulatory control of radiation safety based on the Euratom Treaty.

Chapter 2 (23.12.1998/1143) Maximum values for radiation exposure

Section 3 (23.12.1998/1143) Dose limits in radiation work

The effective dose caused to a worker by radiation work shall not exceed an average of 20 millisieverts (mSv) per year reckoned over a period of five years, nor 50 mSv in any one year.

The annual equivalent dose in the lens of the eye shall not exceed 150 mSv, nor shall the annual equivalent dose at any point on the hands, feet or skin exceed 500 mSv.

Section 4 (23.12.1998/1143) Dose limits in the training of young persons

The effective dose to a young person of no less than 16 but no more than 18 years of age who is involved in the use of radiation sources in the course of vocational training shall not exceed 6 mSv per year. The annual equivalent dose in the lens of the eye shall not exceed 50 mSv, nor shall the annual equivalent dose at any point on the hands, feet or skin exceed 150 mSv.

Section 5 (23.12.1998/1143) Protection during pregnancy and breast-feeding

The foetus shall be protected in the same way as any member of the public. When a woman has announced her pregnancy, her work shall be arranged so that the equivalent dose of the foetus is as low as reasonably achievable, nor shall it exceed 1 mSv for at least the remainder of the pregnancy.

When a woman has announced that she is breastfeeding an infant, she shall not be kept in work involving a risk of significant intake of radioactive substances.

Section 6 (23.12.1998/1143) Dose limits for members of the public

The use of radiation shall be planned and organized so that the annual effective dose of a person not engaged in radiation work does not exceed 1 mSv. The equivalent dose in the lens of the eye shall not exceed 15 mSv per year, nor shall the equivalent dose at any point on the skin exceed 50 mSv per year.

Section 7 (23.12.1998/1143) Application of maximum values and dose constraints

More detailed instructions on the application of maximum values and on the calculation of radiation doses shall be issued by STUK.

STUK shall, as necessary, set limiting values (dose constraints) which are lower than the maximum values prescribed in sections 3–6, when these are warranted in order to implement the principle of optimization prescribed in section 2 of the Radiation Act and in order to allow for exposure resulting from various radiation sources.

Section 7 a (23.12.1998/1143) Medical radiation exposure

When applying the maximum values for radiation exposure, no allowance shall be made for exposure due to the following medical exposures:

1. exposure of a person whose body, or part thereof, is irradiated intentionally in the course of a medical procedure, nor

2. exposure of a person who knowingly and willingly, and otherwise than as part of his/her occupation, assists a person who is irradiated in the course of a medical procedure.

The grounds for limiting radiation exposure in medical examinations and other procedures in which radiation is targeted at a person for a purpose other than the examination or treatment of a disease shall be prescribed in an Order of the Ministry of Social Affairs and Health.

Section 8 (23.12.1998/1143) Immediate measures in accident situations

When applying the maximum values for radiation exposure, no allowance shall be made for exposure arising from immediate measures necessary to limit the radiation hazard resulting from an accident and to bring a radiation source under control. These measures shall be arranged so that the radiation exposure resulting from the situation is limited to the least possible.

If the radiation exposure resulting from measures referred to in paragraph 1 may exceed any of the dose limits prescribed in section 3, then the measures shall be performed on a voluntary basis. The persons performing the measures shall be advised of the hazard pertaining to the said measures. The radiation exposure of persons involved in all immediate measures shall be assessed and their medical surveillance shall be arranged in a manner corresponding to the medical surveillance prescribed for radiation workers in category A.

Except where the matter concerns the saving of human lives, the effective dose of a person involved in the measures referred to in this section shall not exceed 0.5 Sv and the equivalent dose at any point on the skin shall not exceed 5 Sv.

Section 8 a (23.12.1998/1143) Mitigation of the consequences of an accident

When the immediate measures necessary for limiting a radiation hazard and bringing a source of radiation under control have been performed, the dose limits stipulated in section 3 shall apply to protection work and other measures seeking to ameliorate the consequences of the accident. The protection of workers, monitoring of radiation exposure and medical surveillance shall be governed by the provisions prescribed for radiation work.

No duties shall be assigned to a pregnant woman, either during or after an accident situation, which will cause exposure to radiation.

Chapter 3 (23.12.1998/1143) Monitoring of radiation exposure and medical surveillance

Section 9 (23.12.1998/1143) Radiation work

Radiation work shall denote work in which the radiation exposure of the worker can exceed any of the maximum values prescribed in section 6.

Section 10 (23.12.1998/1143) Classification of workers

Workers performing radiation work shall be classified as follows:

1. category A shall include those workers whose effective dose caused by their work exceeds, or may exceed, 6 mSv per year, allowing for the possibility of a work-related incident resulting in abnormal radiation exposure, or an equivalent dose is or may be greater than three tenths of the dose limits stipulated for the lens of the eye, the skin, hands or feet, and

2. category B shall include those workers who are not classified as category A workers.

Section 11 (23.12.1998/1143) Individual monitoring

Individual monitoring shall be arranged for category A workers in order to monitor radiation doses due to their work. The monitoring shall be based on personal dose measurements or on some other appropriate method for determing individual doses.

If so required by the nature of the practice, other methods approved by STUK for determining individual doses shall be used together with, or in lieu of personal dose measurements so that the radiation exposure of every category A worker can be determined.

The responsible party shall ensure that the results of individual monitoring are reported to the worker concerned and to the responsible practitioner.

Section 12 (23.12.1998/1143) Monitoring of working conditions

Monitoring of working conditions affecting the exposure of workers to radiation shall be arranged using methods approved by STUK so as to meet the following requirements:

1. the monitoring shall be adequate to verify that workers have been classified appropriately into categories A and B,

2. the radiation exposure of workers can be determined, and

3. unforeseen abnormalities in factors affecting the radiation exposure of workers can be detected without delay.

Individual monitoring shall be arranged for workers other than category A workers insofar as this is justified in order to meet the requirements of paragraph 1.

Section 13 (23.12.1998/1143) Medical surveillance

The medical practitioner responsible for medical surveillance of category A workers shall be conversant with occupational health care and with the health effects of radiation.

A person performing medical surveillance shall contact STUK as necessary if an observation made during medical surveillance may give cause for investigating whether the worker has been exposed to radiation in an abnormal manner.

More detailed instructions on the implementation of medical surveillance shall be issued by STUK.

Section 13 a (23.12.1998/1143) Observations significant for safety

The responsible party shall report the following observations without delay to the workers concerned, the medical practitioner responsible for their medical surveillance and to STUK:

1. a dose limit has been, or is suspected to have been exceeded,

2. a dose constraint referred to in section 7 has been, or is suspected to have been exceeded, and

3. a result of individual monitoring or an observation made in the course of monitoring working conditions differs from what is typical for the practice or working area in question in a manner significant from the point of view of safety.

The responsible party shall ensure that abnormal radiation exposures and the reasons for them are investigated and reported, and that the necessary remedial measures are implemented.

Chapter 4 Safety licence

Section 14 Application for a safety licence

An application for a safety licence shall include the following details to the extent required by the nature and scope of the use of radiation envisaged:

1. the purpose for which the radiation will be used,

2. the place where the radiation will be used, and the radiation sources to be employed,

3. the protective and safety systems to be used,

4. the arrangements for monitoring radiation exposure,

5. the manner of handling radioactive waste and rendering it harmless,

6. a description of the user's organization, and

7. other significant information required to ensure the safety of the operations.

An official certificate on the applicant or, if the applicant is a private corporation or foundation, an extract from the appropriate register shall be appended to the application.

Section 15 Furnishing security

To ensure that the costs incurred in rendering radioactive waste harmless and in performing any necessary environmental decontamination measures are met, the licensee shall furnish the security referred to in section 19 of the Radiation Act if these costs are estimated to exceed FIM 500,000.

The need to furnish security shall be assessed and the size of the said security shall be determined by STUK when issuing the safety licence. If a security is required, then the licence shall include a condition whereby the operations may not begin until documents verifying the security have been submitted to STUK.

A suretyship given by a bank or a security for credit issued by an insurance company as referred to in section 1 of the Insurance Companies Act (1062/1979) shall constitute an acceptable security.

Section 16 Changes in practice

STUK shall be notified within two weeks of the time when:

1. a radiation appliance is taken into service,

2. a radiation appliance is decommissioned,

3. a radiation safety officer is changed,

4. any essential change occurs in the user´s organization,

5. the use of radiation is discontinued in whole or in part.

If a change planned in the practice is of a character so fundamental that it requires an amendment to the safety licence, then an application to this effect shall be filed in good time before implementing the change.

Section 17 Notifications of abnormal events

STUK shall be notified of the following without delay:

1. any abnormal event pertaining to the use of radiation that is substantially detrimental to safety at the place where the radiation is used or in its environs,

2. any disappearance, theft or other loss of a radiation source such that it ceases to be in the possession of the licensee,

3. any other abnormal observation or information of essential significance for the radiation safety of workers or the environment.

Paragraph 2 was repealed by decree 23.12.1998/1143.

Section 18 (31.12.1994/1598) Shipments of radioactive substances

When transferring between Member States of the European Union radioactive substance which is firmly incorporated in solid material or enclosed in a durable container preventing its dispersion, the holder of the said radioactive substance shall, before effecting the shipment, obtain from the consignee the declaration referred to in Council Regulation (Euratom) No 1493/93 on shipments of radioactive substances between Member States.

In addition to the provisions of paragraph 1, an exporter of radioactive substance shall submit a quarterly report on all such exports to the competent authority in the receiver country, in the manner stipulated in the said Council Regulation.

Shipments of nuclear materials shall be governed by the provisions of the Nuclear Energy Act (990/1987) and other provisions and regulations.

Chapter 5 Licence-free radiation appliances (31.12.1994/1598)

Section 19 (31.12.1994/1598)

Section 19 was repealed by decree 31.12.1994/1598.

Section 20 Registration of a radiation appliance (31.12.1994/1598)

It can be ordered that radiation appliances which have been exempted from a safety licence pursuant to point 3 of paragraph 1 of section 17 of the Radiation Act are to be notified to a register maintained by STUK. Orders on notification to the register shall be included in the decision on exemption. (31.12.1994/1598)

The holder of the radiation appliance shall be responsible for the accuracy of data notified to the register.

Section 21–22 (31.12.1994/1598)

Section 21–22 was repealed by decree 31.12.1994/1598.

Chapter 5 a (29.12.2005/1264) High-activity sealed sources

Section 22 a (29.12.2005/1264) Annual Notification

The holder of a safety licence for the use or custody of high-activity sealed sources referred to in section 31 a of the Radiation Act shall be required at annual intervals to submit to the Radiation and Nuclear Safety Authority – STUK the details specified by the said authority regarding the high-activity sealed sources that are in the possession of the said licensee.

Section 22 b (29.12.2005/1264) Duties on surrendering sources

When surrendering a high-activity sealed source the manufacturer or importer shall ensure that written details of the structure of the source and of any features that affect its safety are supplied with the source.

Before surrendering the source it shall also be ensured that the identifying details of the source and the associated markings, together with the signs warning of the radiation hazard posed by the source are appropriate.

A responsible party surrendering a high-activity sealed source to another party shall supply the information referred to in section 1 together with the source.

Section 22 c (29.12.2005/1264) Export outside European Union

Prior to the approval prescribed in section 31 e of the Radiation Act, the Radiation and Nuclear Safety Authority – STUK shall ensure from the regulatory authority of the destination country that there is no impediment to the transfer of a high-activity sealed source in the said country and that the recipient of the transfer is authorised to receive the source.

Section 22 d (29.12.2005/1264) Determining the size of a security

The standard charge for the security referred to in section 31 f of the Radiation Act shall be EUR 10,000. The surcharge shall be EUR 1,000 per charge unit.

The number of charge units shall be reckoned by dividing a figure describing the activity of the high-activity sealed source in question by a figure of 100 times the activity value specified in Annex 1 of European Union Council Directive no. 2003/122/EURATOM on the control of high-activity sealed radioactive sources and orphan sources.

If the number of charge units exceeds 100, then the Radiation and Nuclear Safety Authority – STUK may estimate and determine the surcharge separately as a smaller charge than the charge reckoned in accordance with paragraph 1.

Chapter 6 Discharges and waste

Section 23 Discharges of radioactive substances

If the nature of the practice requires minor discharges of radioactive substances into the air, sewage system or otherwise into the environment, then special care shall be taken to ensure that the quantities of substances thus discharged remain below the limits imposed by STUK and as low as can reasonably be achieved.

Section 24 Radioactive waste

STUK shall specify the principles and impose the necessary concentration and activity limits for establishing whether waste is to be held to constitute radioactive waste.

Section 24 a (26.2.2009/93)

Section 24 was repealed by decree 26.2.2009/93.

Section 24 b § (29.12.2005/1264) Discharging of the functions of a recognised installation

The Radiation and Nuclear Safety Authority – STUK shall discharge the function of rendering radioactive waste harmless where there is no recognised facility of the kind referred to in paragraph 3 of section 10 of the Radiation Act. The Radiation and Nuclear Safety Authority – STUK may agree with the custodian of the waste that custody of the waste will be permanently assigned to the government in return for a non-recurrent compensation charge.

Responsibility for the waste shall pass to the government when the waste has been surrendered to the Radiation and Nuclear Safety Authority – STUK. The Radiation and Nuclear Safety Authority – STUK shall thereafter attend to the safe long-term storage of the waste.

Section 25 Secondary duty of care

STUK shall ensure performance of the duties of the State prescribed in section 51 of the Radiation Act.

Chapter 7 Natural radiation

Section 26 Reporting data

The results of the investigation referred to in section 45 of the Radiation Act shall be submitted to STUK without delay.

Section 27 (23.12.1998/1143) Limiting exposure to natural radiation

The responsible party shall take all measures which are warranted, having regard to the investigation made and to other circumstances, in order to limit the exposure of workers to natural radiation at work if an investigation indicates that the following are probable:

1. the annual average concentration of radon in the breathing air during working hours at a workplace where work is performed on a permanent basis exceeds 400 becquerels per cubic metre, or

2. the exposure of a worker to natural radiation at work resulting from some other specific source may exceed 1 mSv per year.

STUK shall impose the requirements for limiting the radon concentration of breathing air in working premises in which work is performed only occasionally or for short periods.

Section 28 (23.12.1998/1143) Monitoring of radiation exposure and medical surveillance

If, even after measures have been taken to limit exposure, it is probable that exposure of workers to natural radiation cannot reasonably be reduced below the action levels prescribed in section 27, then the responsible party shall arrange for monitoring of the radiation exposure of the workers and for their medical surveillance in compliance with the applicable provisions of chapter 3.

Section 28 a (23.12.1998/1143) Protection of air crew

If an investigation referred in section 45 of the Radiation Act indicates that the effective dose caused by cosmic radiation to the air crew may exceed 1 mSv per year, then the responsible party shall:

1. maintain records of employee work shifts on flights and, as necessary, plan the shifts so that exposures which considerably exceed the levels typical for aviation work may be prevented,

2. inform the employees of the health hazards of radiation, of the exposure levels typical in aviation work and of the results of exposure assessments,

3. arrange the work of a pregnant worker in accordance with the requirements of section 5

4. arrange the medical surveillance of employees in accordance with the principles stipulated in the Radiation Act.

Section 29 Special duty of notification

Notification of the following operations shall be made to STUK before they commence:

1. Mining operations referred to in the Mining Act (503/1965),

2. Excavation work lasting longer than two months and mainly performed underground or in a confined space, and

3. Extensive utilization of natural resources the uranium or thorium content of which exceeds 0.1 kilogrammes per tonne, with the exception of practices supervised under the Nuclear Energy Act (990/1987).

The notification referred to in paragraph 1 of this section shall provide the following information:

1. The nature of the operations,

2. The volume of materials planned to be handled,

3. Separate schedules for mining and excavation work performed underground or in a confined space,

4. The main types of rock to be excavated, insofar as these are known, and

5. An estimate of the number of workers and hours of work.

The notification referred to in this section shall also be made for work in underground premises in which no air conditioning has been arranged, if the working time of the worker exceeds 100 hours a year. This notification shall include the information referred to at points 1 and 5 of paragraph 2.

Chapter 8 Miscellaneous provisions

Section 30 Advisory Board for Radiation Safety

The Advisory Board for Radiation Safety shall

1. address issues of principle concerning radiation safety,

2. monitor general developments in radiation safety,

3. make proposals and suggestions in matters concerning radiation safety,

4. issue opinions concerning radiation safety, and

5. perform other tasks assigned thereto by the Ministry of Social Affairs and Health.

The Board shall comprise a Chair, a Vice-chair and seven ordinary members. Each member shall have a personal deputy.

The Board can appoint sections and include permanent experts as necessary.

Section 31 (23.12.1998/1143) Duties of customs authorities

The customs authorities shall participate in controlling the import and export of radioactive substances, and in supervising compliance with the prohibition prescribed in paragraph 3 of section 27 of the Radiation Act.

The customs authorities shall ensure that a valid approval document of the kind referred to in section 24 a exists for the import, export or transit of radioactive waste.

STUK shall be authorized to obtain from the custom authorities all information needed to perform its duties with respect to imported and exported radiation equipment and radioactive substances.

The provisions of this section shall not apply to the shipments of radioactive materials referred to in section 18.

Section 31 a (23.12.1998/1143) Customs declaration

When radiation sources are imported to or exported from the Community, the type, quantity and licensing status thereof shall be clearly notified in the customs declaration or in a statement attached thereto. The customs declaration shall also be marked with the number of the licence authorizing the import or export.

Section 32 Entry into force

This Decree shall enter into force on the 1 January 1992.

The measures required to implement this Decree may be taken before its entry into force.

Amendments:

31.12.1994/1598

23.12.1998/1143

29.12.2005/1264

26.2.2009/93