1. IAEA International Atomic Energy Agency Structure of Legal Framework - Legislation Day 8 – Lecture 2

2. IAEA 2 To gain an understanding of the Scope of the radiation safety legal framework. Objective

3. IAEA 3 Structure of the Legal Framework Objectives and Scope of the legislation; Exclusions, Clearances and Exemptions; Regulatory Authority; Prime responsibility for radiation safety and source security; Notification; Authorization; Inspection; Enforcement. Contents

4. IAEA 4 A national legal system should include, as appropriate: statutes or laws; Structure of the Legal Framework decrees; regulations, ordinances; codes of practice; safety guides, standards, etc.

5. IAEA 5 the procedures for issuing regulations; the legislative body  role of the Regulatory Body; new or additional legislation  old legislation; overlap, conflicts or gaps in coverage of radiation protection and safety. Structure of the Legal Framework (cont) the overall legal system; The legal framework will depend on individual national circumstances i.e.:

6. IAEA 6 Structure of the Legal Framework (cont) Principal requirements Detailed requirements Practice specific requirements or guidance Legislation Regulations Codes of practice

7. IAEA 7 establishes fundamental structures and concepts; defines the structure of the legal framework for radiation protection; establishes the infrastructure for regulatory control; sets out the scope of the legislation and the principal protection and safety requirements. Structure of the Legal Framework (cont) The Legislation (e.g. Law, Act, Decree, Statute) is established by the national legislative body;

8. IAEA 8 apply to practices and sources within practices; are developed by the Regulatory Body; are issued by the legislative body, Ministry or Regulatory Body (varies depending on the national legal system). Structure of the Legal Framework (cont) Regulations are more specific in relation to protection and safety requirements;

9. IAEA 9 give practice specific advice on how to achieve protection and safety requirements defined in legislation or regulations; may or may not be legally binding - other procedures might be followed to achieve the same protection and safety goals. Structure of the Legal Framework (cont) Codes of Practice, Guides are usually developed and issued by the Regulatory Body;

10. IAEA 10 Legislation

11. IAEA 11 Legislation - Objectives and Scope The legislation should: set out objectives providing for the beneficial uses of ionizing radiation while protecting individuals, society and the environment from radiation hazards, both for the present and in the future; specify the facilities, activities and materials that are to be included in the scope of the legislation and what is to be excluded from the requirements of any particular part of the legislation.

12. IAEA 12 The Scope of the legislation therefore should encompass: occupational, public and medical exposure; and all sources of ionizing radiation (whether in use or disused). i.e. the legislation should be applicable to both radioactive sources and to machines that generate radiation electrically, e.g. x- ray equipment, particle accelerators. The Scope also should require compliance with the legislation by government ministries, departments and agencies. Legislation - Objectives and Scope

13. IAEA 13 The Scope should include reference to the fundamental radiation protection requirements of: justification of practices; optimization of protection and safety; limitation of doses. Legislation - Objectives and Scope

14. IAEA 14 Exclusions A number of natural radiation sources are not amenable to control. The legislation therefore should specifically exclude: 40 K in the body; cosmic radiation at the earth’s surface; and unmodified concentrations of radionuclides in most raw materials. However, the Regulatory Body also should be given authority to exclude other sources on the grounds that they also may not be amenable to regulatory control by any practicable means.

15. IAEA 15 Exemptions The legislation should give the Regulatory Body authority to exempt certain practices and sources from the application of the regulations when such controls are unnecessary. The general principles for exemption of a practice are: the risks to individuals are sufficiently low as to be of no regulatory concern; the collective radiological impact is sufficiently low as not to warrant regulatory control in the prevailing circumstances; and the practice and sources concerned are inherently safe.

16. IAEA 16 Independence The Regulatory Body should have formal independence from promotional and regulated activities. While not always possible, effective independence is desired. Establishment of a Regulatory Body Funding The Regulatory Body should be funded from the state budget. Funding should not be linked to fees raised (i.e. from authorizations, inspections, etc.)

17. IAEA 17 Powers and responsibilities: to issue regulations and guidance; Establishment of a Regulatory Body (cont) supervisory and enforcement powers; to decide on exemptions; to decide on detailed conditions for authorization; to assist in emergency response.

18. IAEA 18 Relationship to other laws Laws on Nuclear Energy, Safety in Mining, Labour Protection, Environmental Protection, Medical Practices, Transport, etc. Coordination and Cooperation Coordination with other bodies Ministries of Health, Trade and Industry, Environment, Internal Affairs, Customs, etc.

19. IAEA 19 Primary Responsibility for Radiation Safety The legislation should clearly assign the primary responsibility for radiation safety and the security of radiation sources to those authorized by the Regulatory Body to possess, use, manufacture, supply or install radiation sources, etc., i.e. the user has primary responsibility.

20. IAEA 20 Notification One of the most important functions for a Regulatory Body is the establishment and maintenance of a national register (inventory) of all non-exempt radiation sources. The legislation therefore should include a requirement for persons who possess or use radiation sources to provide notification to the Regulatory Body of the sources in their possession, or of their intention to obtain sources.

21. IAEA 21 Notification The legislation should require prompt (and in some cases, possibly prior) notification to be given: by any person who takes possession of a non-exempt radiation source; of the transfer of radiation sources, including sale, leasing, hiring, borrowing, giving, bartering, etc., whether that transfer is from a supplier to a user or from a user to another party; of the planned import or export of radiation sources.

22. IAEA 22 Notification Although notification is primarily for the purposes of ensuring the accuracy of the national register, the legislation should also require prompt notification to be given by authorized persons of: the intended disposal of radiation sources, except for authorized waste disposal methods; plans to modify approved practices or radiation sources where such modifications could have significant implications for protection, safety or source security (and such modifications shall not be carried out unless specifically authorized).

23. IAEA 23 Notification Notification applies to all radiation sources unless an exemption has already been approved. e.g. the Regulatory Body might exempt domestic (radioactive) smoke detectors from all regulatory requirements subject to imports and sales complying with the conditions of the exemption (e.g. design, performance, bulk storage and disposal requirements). New consumer or other products which might meet the Regulatory Body’s exemption criteria initially would be subject to the notification requirements of the legislation.

24. IAEA 24 Authorization Unless a radiation source or practice is exempted, the legislation should make it an offence for a person to possess, use or otherwise deal with a radiation source unless they hold a valid authorization issued by the Regulatory Body. The IAEA BSS recommends that an authorization should be in the form of either a licence or a registration.

25. IAEA 25 Licences and Registrations Registration is a form of authorization for practices of low or moderate risks whereby the person responsible for the practice has prepared and submitted an appropriate safety and source security assessment of the facilities and equipment to the Regulatory Body. The practice or use is authorized with conditions or limitations as appropriate. The requirements for the safety and source security assessment, and the conditions or limitations applied to the practice, are not as stringent as those for licensing.

26. IAEA 26 Authorization A Licence is an authorization granted by the Regulatory Body on the basis of a detailed safety and source security assessment, and accompanied by specific requirements and conditions to be complied with by the licensee. For a proper assessment of safety and source security, the applicant should be required to submit a detailed Radiation Protection Programme including, as appropriate, structural plans and shielding calculations; the radiation sources to be used; names, qualifications and experience of individual users of the sources; waste disposal plans; emergency procedures, etc.

27. IAEA 27 Authorization Authorizations should be issued for a period prescribed by the Regulatory Body (e.g. in the regulations) and related to the category of risk associated with the source or practice. (Note: source categorization is explained in other modules). The authorization should cease to be valid if a renewal application has not been received before the expiry date. Timely renewal notices should be issued by the Regulatory Body.

28. IAEA 28 Authorization – Registration Registration is an option which may be a relatively simple and efficient method of authorization for low risk sources and practices, if certain criteria can be met. It might be applied to: dental x-ray diagnosis; low-activity sealed sources; x-ray fluorescence (analytical) devices; baggage inspection x-ray equipment; and A renewal frequency should be specified in the regulations.

29. IAEA Licensing should be applied to higher risk sources or practices, including: medical applications; industrial radiography; industrial irradiators; high-activity radiation gauges; unsealed sources; manufacture of sources; radionuclide storage, waste and disposal. A renewal frequency should be specified in the regulations. 29 Authorization – Licensing CT Scanner Density Gauge Unsealed source

30. IAEA Provision should be made for: multi-stage licensing. This would be appropriate for practices involving the construction of facilities such as -  commercial product irradiators  teletherapy facilities  waste management and disposal facilities consideration of the financial capability of the applicant to comply with regulations.  e.g. decommissioning and waste management 30 Authorization – Licensing

31. IAEA 31 Practice or source proposed Excluded? Notification alone sufficient? Notification is required Exempted? No Yes Record notification Registration or licence application required No Authorization – Licensing

32. IAEA 32 Notification alone sufficient? Is registration appropriate? Proceed to Authorization No Yes Record notification Licence application required Registration application required Yes Authorization – Licensing

33. IAEA 33 Inspection The Regulatory Body should have the power: to appoint inspectors; to enter, at any reasonable hour for the purpose of inspection, any site or facility subject to an authorization, with or without prior notification to the registrant or licensee; to enter any premises, whether subject to an authorization or not, in situations where the Regulatory Body suspects an offence is being committed, or where it suspects there is a potential radiation hazard or danger to the public. ( A search warrant may be considered).

34. IAEA 34 Inspection The Regulatory Body should be able to authorize inspectors to: undertake any necessary tests or measurements or to confirm calibrations; take away for measurement or assessment such things or samples that are considered relevant to determining compliance with the legislation and regulations; make any necessary enquiry and examine any relevant records for the purpose of determining compliance with the legislation and regulations.

35. IAEA 35 Where registrant or licensee found non compliance with requirements the Regulatory Body shall take enforcement actions Penalties commensurate with seriousness of violation Administrative Penalties: suspension, modification, revocation of authorization Civil (Monetary) Penalties Criminal Penalties Requiring of corrective action by registrant or licensee Enforcement, offences and penalties

36. IAEA 36 Appeals The legislation should establish a procedure for the review of, and appeal against, regulatory decisions with predefined conditions that should be met for an appeal to be considered. The lodging of an appeal should not absolve operators from complying with safety and source security requirements and conditions as specified by the Regulatory Body pending the result of the appeal.

37. IAEA 37 Services and facilities essential for radiation safety, i.e. personal dosimetry; Establishment of services and facilities Such services and facilities might be provided through legislation if they otherwise are not available. training services; environmental monitoring; facilities for waste storage and disposal; radiation measurement and calibration services.

38. IAEA 38 Elements and concepts I. Objectives of the law II. Scope of the law III. Definitions of key terms IV. The regulatory body V. Authorizations (licences, permits, etc.) VI. Inspection VII. Enforcement VIII. Responsibilities of licensees, operators, users IAEA Sample Legislation 1 1 Handbook on Nuclear Law

39. IAEA 39 Governmental, Legal and Regulatory Framework for Safety. General Safety Requirements Part 1 (IAEA Safety Standard Series No. GSR Part 1). Vienna 2010. Handbook on Nuclear Law: Volume 1 & 2 (2010). Model Regulations for the use of radiation sources and for the management of the associated radioactive waste, IAEA- TECDOC-1732 (2013). References