Section 1: General Requirement
1. Radiation protection shall be ensured for any activity and facility authorized by the NRRC.
2. No person shall adopt, introduce, conduct, discontinue or cease a practice, unless the requirements of this regulation, including requirements of notification and authorization, are met.
3. No person shall conduct any activity or practice with radiation source other than in accordance with the requirements of this regulation.
4. The control over any radiation sources within any activity and facility authorized by the NRRC shall be ensured by the authorized person.
5. Any responsible person at facility with existing exposure situations, as specified in Article 287, which are of concern from a radiation protection point of view shall be subject to regulatory control and planned exposure situations requirements.
Section 2: Categorization of Sealed Sources
6. The categorization of sealed sources as specified in Appendix 1 shall be used for the purpose of applying a graded approach for radiation protection prescribed in this regulation.
Section 3: Prohibition of Practices
7. Practices that deem to be not justified, taking into account principles provided in Section 5, shall be prohibited.
Section 4: Requirements for Notification
8. Unless exempt from requirements in accordance with Section 19, any person:
- Who, on the effective date of the publication of this regulation, is responsible for an activity, a facility or a practice involving radiation source, shall immediately submit a notification to the NRRC.
- Who intends to initiate an activity, a facility or a practice shall submit a prior notification to the NRRC of such an intention or to apply for an authorization.
9. Notwithstanding the exemption criteria prescribed in Section 19, in situations where there is concern that a practice involving naturally occurring radioactive material may lead to the presence of such radionuclides in water liable to affect the quality of drinking water supplies or affect any other exposure pathways, so as to be of concern from a radiation protection point of view, the person responsible for such practice shall submit a notification to the NRRC.
10. For those activities where an application for an authorization is submitted, no separate notification shall be required.
11. After submission of notification, any person who is required to apply to the NRRC for an authorization and who submits such an application in accordance with Section 22 is permitted to continue existing activities specified in the notification, in conformance with the applicable requirements of this Regulation, until the NRRC revokes such permission or grants the authorization.
Section 5: Exemption of Practices and Sources
12. The activities involving the following radiation sources are automatically exempted from requirements of this regulation, including the requirements for notification and authorization with prior evaluation:
(a) Radioactive materials in quantities not greater than one tonne for which either the total activity (A) of a given nuclide present on the premises at any one time or its activity (A) concentration does not exceed the levels specified by NRRC.
(b) Radioactive materials in quantities greater than one tonne for which the activity (A) concentration of a given radionuclide of artificial origin used in the practice does not exceed the levels specified by NRRC.
(c) Equipment containing radioactive material exceeding the quantities or concentrations specified in Article 51(a), provided that:
- The equipment containing radioactive material is of a type approved by the NRRC.
- Where the radioactive material is in the form of a sealed source the safety features of the equipment effectively prevent any contact with the radioactive material and prevent its leakage.
- Where the radioactive material is in the form of an unsealed source the total amount of involved activity (A) shall be as small as those used for radioimmunoassay.
- In normal operating conditions the equipment does not cause an ambient dose equivalent rate or a directional dose equivalent rate, as appropriate, exceeding 1 μSv/h at a distance of 0.1 m from any accessible surface of the apparatus.
- Necessary conditions for later management of the equipment have been specified by the NRRC.
(d) Radiation generators of a type approved by the NRRC, or in the form of an electronic tube, provided that:
- They do not in normal operating conditions cause an ambient dose equivalent rate or a directional dose equivalent rate, as appropriate, exceeding 1 μSv/h at a distance of 0.1 m from any accessible surface of the equipment; or
- The maximum energy of the radiation generated is no greater than 5 keV or as specified by the NRRC
13. The practices involving the following radiation sources are exempted from requirements of this Regulation, including the requirements for notification and authorization with prior evaluation:
- A practice in which the radioactive substance derives from discharges of radioactive substances permitted in accordance with Section 102;
- A practice in which the radioactive substance derives from material that has been cleared for reuse, recycling or disposal in accordance with Section 103;
- The use of building materials when the activity (A) concentration of the relevant natural radionuclides is not liable to give doses exceeding the reference level defined by the NRRC.
Section 6: Exemption Under a Decision by the NRRC
14. Exemptions shall not be granted for practices deemed not to be justified as specified in Sections 5.
15. The NRRC may exempt a practice or a source within a practice from the authorization or any other requirement of this regulation provided that the practice is justified and the following general criteria are met:
- Radiation risks arising from the practice or from a source within the practice are sufficiently low as not to warrant regulatory control, with no appreciable likelihood of situations arising that could lead to a failure to meet the general criterion for exemption; or
- Regulatory control of the practice or the source would yield no net benefit, in that no reasonable measures for regulatory control would achieve a worthwhile return in terms of reduction of individual doses or of health risks.
16. The NRRC may exempt a practice or a source within a practice from any requirement of this regulation provided that:
- The effective dose expected to be incurred by any individual is of the order of 10 μSv or less in a year or as specified by NRRC; and
- The effective dose expected to be incurred by any individual for low probability scenarios does not exceed 1 mSv in a year or as specified by the NRRC.
17. The authorized person shall meet the specific conditions defined by the NRRC when approving an exemption.
18. The NRRC has the right to cancel and withdraw the decision if the prerequisites for exemption are not met or if the conditions for exemption have not been complied with and the deficiencies are not remedied within a prescribed period of time despite a request to do so.
Section 7: Requirements for Authorization
19. Except for the conditions as provided in Section 19 of this Regulation, the person or entity responsible for facilities or activities which has plans to implement any practice that results in an exposure due to a source shall file, prior to proceeding with the practice or acquisition of the radioactive source, an application to the NRRC for obtaining an authorization.
20. No practice shall be authorized unless it would be considered justified according to criteria prescribed in Section 5.
21. Any person who has filed an application for an authorization to the NRRC shall proceed with the activity or facility only after securing that the relevant authorization has been issued by the NRRC.
22. The authorized person shall not engage in any activity or facility, nor shall use any radiation source that is different other than that authorized by the NRRC.
23. Any person applying for authorization shall:
- Submit to the NRRC the relevant information necessary to support the application.
- Assess the nature, likelihood and magnitude of the expected exposures due to the source and shall take all necessary measures for protection and safety.
- If considered by the NRRC, have a safety assessment made and submitted to the NRRC as part of the application.
- As required by the NRRC, have an appropriate prospective assessment made for radiological environmental impacts, commensurate with the radiation risks associated with the activity or facility.
24. The application for authorization shall be submitted by the applicant, as per requirements provided in the Regulation on Notification on and Authorization of Facilities and Activities with Radiation Sources (NRRC-R-02). The information shall be commensurate with the nature of the practice and the radiological risks involved.
Section 8: Authorization Process
25. At any situation, all requirement for completing authorization process described in Regulation on Notification on and Authorization of Facilities and Activities with Radiation Sources (NRRC-R-02) shall be complied.
Section 9: Release From Regulatory Control
26. The removal of radioactive materials or radioactive substances within authorized practices from any further regulatory control by the NRRC is subject to authorization requirement.
27. Radioactive materials or objects in solid form can be released from regulatory control provided that they do not exceed the clearance levels given by NRRC.
28. The NRRC may approve the removal of specific materials or objects that are not covered in Article 66, from the system of regulatory control on the basis of an assessment showing that the following clearance criteria are met:
- The effective dose expected to be incurred by any individual is of the order of 10 μSv or less in a year or as specified by NRRC; and
- The effective dose expected to be incurred by any individual for low probability scenarios does not exceed 1 mSv in a year or as specified by the NRRC.
- For radionuclides of natural origin in residues that might be recycled into construction materials, or the disposal of which is liable to cause the contamination of drinking water supplies, the activity concentration in the residues does not exceed specific values derived so as to meet a dose criterion of the order of 1 mSv in a year or as specified by the NRRC.
29. The deliberate dilution of radioactive materials for the purpose of them being released from regulatory control is prohibited.