1. RER/9/111: Establishing a Sustainable National Regulatory Infrastructure for Nuclear and Radiation Safety TCEU School of Drafting Regulations 03-14 November 2014 Presentation 1.9: Planned Exposure Situations – Generic safety requirements Cait Maloney

2. Content of the Presentation Contents: Concept of planned exposure situation Generic requirements/responsibilities of Government/Regulatory body Applicant Licensee/registrant Manufacturer/supplier 2

3. Definition A planned exposure situation is a situation of exposure that arises from the planned operation of a source or from a planned activity that results in an exposure from a source. (GSR-3 definition) Planning means controls can be put in place before exposures occur – with objective of reducing potential and magnitude of exposures. 3

4. Application of concept (1) Practices, and sources within practices, such as : Production, supply and transport of radioactive material and devices containing radioactive material Production and supply of devices that generate radiation Generation of nuclear power Use of radioactive material or radiation for medical, industrial, agricultural, training, research etc purposes Mining and processes of raw materials that involve exposure to radioactive material Any other practice specified by the regulatory body 4

5. Application of concept (2) Planned exposure situations include all types of exposure: occupational medical public 5

6. Application of concept (3) Exceptions: Exposures due to natural sources are viewed as “existing exposure situations”, not planned exposure situations, except for specific scenarios involving: higher activity concentrations of radionuclides in U/Th chain or Potassium 40 Radons – when exposures to other radionuclides are controlled (i.e. mining) Ra-222 levels in workplaces exceed reference level established by regulatory body 6

7. Generic restriction No person or organization shall adopt, introduce, conduct, discontinue or cease a practice, or shall, as applicable, mine, extract, process, design, manufacture, construct, assemble, install, acquire, import, export, distribute, loan, hire, receive, site, locate, commission, possess, use, operate, maintain, repair, transfer, decommission, disassemble, transport, store or dispose of a source within a practice other than in accordance with the requirements of these Standards” » Para 3.5 GSR Part 3 7

8. Generic Requirements: government/regulatory body Government/regulator shall ensure that: only justified practices are authorized protection and safety are optimized regulatory requirements, including safety assessments, are graded (commensurate with risk) the regulatory regime makes provision for exemption and clearance of sources dose limits for occupational and public exposures are established human imaging for non-medical purposes (e.g. detection of contraband) is included in the protection and safety system 8

9. Generic Requirements: applicants Anyone intending to do something that requires regulatory action must seek authorisation from regulatory body (before starting) (paraphrase of requirement 7, GSR Part 3) 9

10. Generic requirements: Registrants/Licensees (1) Registrants/licensees shall: be responsible for protection and safety – and compliance with regulatory requirements ensure protection and safety are optimized apply dose limits that are established by regulatory body conduct appropriate safety assessments monitor to verify compliance 10

11. Generic requirements: Registrants/Licensees (2) Registrants/licensees shall: take reasonable steps to prevent accidents and mitigate consequences of accidents (good engineering practices, emergency preparedness) provide regulator with information on operating experience (routine and abnormal) relevant to protection and safety. 11

12. Generic requirements: manufacturers and suppliers Manufacturers and suppliers of radiation generators or sources shall: supply well-designed, well-manufactured and well- constructed generators/sources demonstrate generators/sources meet specifications provide instructions on installation, operating and maintenance ensure protective devices (e.g. shielding) are optimized mark any radioactive source or device containing a radioactive source with the ISO radiation warning symbol 12

13. Summary Concept of planned exposure situation Generic requirements/responsibilities of various groups More specific detail on planned occupational, medical and public exposure situations to come… 13

14. References / Further Reading GSR Part 3 paragraphs 3.1 – 3.67 14