Section 1: Justification
1. Not any practice that alters or could alerts the radiation exposure situation by introducing a new radiation source, by reducing existing exposure or by reducing the risk of potential exposure shall be engaged in unless such practice yields a benefit to all persons exposed to radiation or the community as a whole which justifies the radiation harm that it might cause, taking into account social, economic and other relevant factors.
2. The following practices are deemed to be not justified, unless the applicant demonstrates, by a due process, that concerned practice meet general justification criteria as in Article 9 above:
- The practices whose implementation would result in increasing the volume of the radioactive substance (through addition or activation) in the commodities or products are considered among not justified practices. Such practices shall include the following:
- Fabrication, production, importation or sales of foodstuffs, drinks or other products intended for ingestion, inhalation or penetration of the skin or use by humans in general.
- Utilization of radioactive substances in the products or commodities.
- Human imaging using radiation that is performed as a form of art or for publicity purposes;
- Human imaging using radiation that is performed for occupational, legal or health insurance purposes, and is undertaken without reference to clinical indication;
- Human imaging using radiation for theft detection purposes;
- Human imaging using radiation for the detection of concealed objects for anti-smuggling purposes;
- Human imaging using radiation for the detection of concealed objects that can be used for criminal acts or to pose a national security threat;
- Other activities and practices as determine by the NRRC.
Section 2: Demonstration of the justification of practices
3. Any person intending to conduct a practice shall demonstrate the justification when:
- The practice has not been previously considered as justified.
- The NRRC requests for reviewing the existing type of practice in the light of new information about its efficacy or consequences.
- The concerned practice is one of those mentioned in Section 5, that are deemed to be not justified.
4. The demonstration of justification shall include:
- A description of the type of practice.
- A full characterization of the radiation sources that will be used and the measures that will be taken to ensure safety and to reduce the radiological consequences.
- An appraisal of the benefits and detriments, including radiation detriments. This appraisal should include economic, social, health and safety, waste management, recycling, radiological environmental impact and decommissioning aspects. The assessment of the radiation detriment should cover both the magnitude and the likelihood of expected exposures and an assessment of the potential exposures.
- An indication of the expected extent of use of the type of practice.
5. In the case of practices involving the deliberate exposure of humans for non-medical imaging purposes, when evaluating the justification of the concerned practice, considerations listed in Section 40 shall be taken into account.
6. The demonstration of justification by the applicant, if required, is part of the authorization process referenced in Sections 21 and 22.
Section 3: Optimization of Protection and Safety
7. The authorized person and any other responsible person shall ensure that the system of protection implemented over activities and facilities under its responsibility guarantees the application of:
- Measures for protection that are optimized for the prevailing circumstances, with account taken of the available options for protection and safety as well as the nature, likelihood and magnitude of exposures;
- Measures, on the basis of the results of the optimization, for the restriction of the likelihood and magnitudes of exposures by means of measures for preventing radiation safety deviations and for mitigating the consequences of those that do occur;
- Dose constraints for occupational and public exposure.
8. For occupational exposure and public exposure, the authorized person and any other responsible person shall ensure that the magnitude of individual doses, the likelihood of exposure and the number of individuals exposed are kept as low as reasonably achievable, taking economic and societal factors into account.
9. For the protection of individuals subject to medical exposure, the authorized person and any other responsible person shall ensure that medical exposure is limited to what is necessary to achieve the intended examination or treatment result and performance of the procedure.
10. Measures for the optimization of the protection and safety shall be re-evaluated, by the authorized person on a periodical and timely basis or at any time deem necessary as determine by the NRRC.
Section 4: Dose Constraints
11. The authorized person shall establish dose constraints, as appropriate according to the category of exposure individuals to be approved by the NRRC for the following types of exposure:
- Occupational and public exposures - Where relevant, the doses constraints shall be established in co-operation with the employer of the outside worker.
- Medical exposure - Dose constraints shall apply only with regard to the protection of carers and comforters and volunteers participating in medical or biomedical research.
12. The authorized person shall ensure that the dose constraints are:
- Established in terms of individual effective or equivalent doses over a defined appropriate time period.
- Remained below the generic values defined by the NRRC for similar types of practices.
- Established so that the prospective annual doses to members of the public, including people distant from the source and people of future generations, summed over all exposure pathways, including contributions by other practices and sources, are unlikely to exceed the dose limits for the public or any lower values established by the NRRC for any source that can release radioactive material to the environment.
Section 5: Reference Levels
13. Any person that are involved in any activity concerning emergency or existing exposure situations shall use the relevant References Levels, established by the NRRC, as a boundary condition in identifying the range of options for optimization in implementing protective actions.
Section 6: Dose Limits
14. In planned exposure situations, the authorized person shall ensure that the exposures of individuals due to the activities and practices for which they are authorized are restricted so that the following relevant dose limits:
(a) For occupational exposure of worker over the age of 18 years:
- An effective dose of 20 mSv per year averaged over five consecutive years (100 mSv in 5 years) and of 50 mSv in any single year;
- An equivalent dose to the lens of the eye of 20 mSv per year averaged over five consecutive years (100 mSv in 5 years) and of 50 mSv in any single year;
- An equivalent dose to the extremities (hands and feet) or the skin of 500 mSv in a year.
(b) For occupational exposure of apprentices of 16 to 18 years of age who are being trained for employment involving radiation and for exposure of students of age 16 to 18 who use sources in the course of their studies:
- An effective dose of 6 mSv in a year;
- An equivalent dose to the lens of the eye of 20 mSv in a year;
- An equivalent dose to the extremities (hands and feet) or to the skin of 150 mSv in a year.
15. For a female worker who has notified pregnancy or is breast-feeding, the expected dose for the embryo or fetus or the breastfed infant shall be limited to 1 mSv.
16. For public exposure, the dose limits shall be:
- An effective dose of 1 mSv in a year;
- In special circumstances, a higher value of effective dose in a single year could apply, provided that the average effective dose over five consecutive years does not exceed 1 mSv per year;
- An equivalent dose to the lens of the eye of 15 mSv in a year;
- An equivalent dose to the skin of 50 mSv in a year.
17. The verification of compliance with the dose limit shall consider the criteria, conversion factors and other references values specified by the NRRC which allow to get the best estimation of the quantities used for controlling the dose limits.
18. Whenever the NRRC deems necessary to revise the established dose limits the authorized person shall implement all the necessary corrective actions to ensure compliance with the revised dose adopted limits.