IAEA International Atomic Energy Agency Presenter Name School of Drafting Regulations for Borehole Disposal of DSRS 2016 Vienna, Austria Overview and use.

IAEA International Atomic Energy Agency Presenter Name School of Drafting Regulations for Borehole Disposal of DSRS 2016 Vienna, Austria Overview and use of model regulations for the predisposal management of radioactive waste TECDOC 1732

IAEA Structure of regulations: administrative requirements, performance regulations, prescriptive regulations / guidance. Performance versus prescriptive regulations: advantages and disadvantages. Scope of regulations. Application of the concepts of exclusion, exemption and clearance. How are presented the requirements for the safe management of radioactive waste in the model regulation. Contents 2 Overview and use of model regulations for the predisposal management of radioactive waste

IAEA Legislation - Hierarchy Guidance documents (Guidance, Code of Practices, etc) Subordinate Legislation (Regulations) Primary Legislation (Law, Decree etc) 4 Overview and use of model regulations for the predisposal management of radioactive waste

IAEA Legislation normally comprises of primary legislation and sub-ordinate legislation, the provisions both of which are legally binding Primary and sub-ordinate legislation is usually supplemented by Guidance Documents (e.g. ‘Codes of Practice’). Such guidance documents give practical advice or recommendations on ways by which the legal requirements of the primary and sub-ordinate legislation can be met. 5 Overview and use of model regulations for the predisposal management of radioactive waste

IAEA Primary Legislation / The Law The legal basis for regulating Safety is provided by primary legislation generally referred to as the ‘Law’ and issued by the supreme law-making organ of the government (i.e. the national legislature or parliament). Examples: Law on Radiation Protection, Human Health and Environmental Protection; Law on the Use of Atomic Energy. 6 Overview and use of model regulations for the predisposal management of radioactive waste

IAEA Sub-ordinate Legislation / The Regulations Sub-ordinate or Secondary legislation, often known as Regulations or Decrees according to the country’s legal system, are issued by a Government Minister or other ‘Competent Authority’ (often the regulatory body) as specified under the Law. In this case they establish the general principles (if not already established under the Law) and specify particular requirements necessary to achieve compliance with the provisions of the Law. Regulations are normally of general application but may authorize the imposition of site-specific conditions and requirements or in some cases be site specific. They are subject to change more frequently than the primary law. 7 Overview and use of model regulations for the predisposal management of radioactive waste

IAEA There may be one or more regulations for implementation of the Law. Preparation of the regulations may require extensive co- operation and consultations with other national organizations. This can be facilitated if there is an advisory body. However it may be difficult to set up such an advisory body in some countries. In such cases the organization preparing the regulations must find some other means to ensure that the regulations cover all necessary aspects, do not conflict with other regulations under other laws and do not place unnecessary restrictions on operators. Sub-ordinate Legislation / The Regulations 8 Overview and use of model regulations for the predisposal management of radioactive waste

IAEA Regulations should be written in straightforward language so that users and others can clearly understand them. Users should know what they have to do to comply and be able to demonstrate they do. Lack of clarity or ambiguity in regulations can lead to failure by the regulators to enforce them when poor practices are observed. Sub-ordinate Legislation / The Regulations 9 Overview and use of model regulations for the predisposal management of radioactive waste

IAEA GSR Part 1 Requirement 32 – Regulations and Guides The regulatory body shall establish or adopt regulations and guides to specify the principles, requirements and associated criteria for safety upon which its regulatory judgments, decisions and actions are based 10

IAEA 2/5/2016 11 ◄ Review of regulation R33 Promotion of regulation R34 GSR Part 1 Requirement 33 and 34 – Preparation of Regulations GSR Part 1 Requirement 33 and 34 – Preparation of Regulations 1.Process for regulations 2.Consultation 3.International standards 4.Feedback from experience 5.Framework for authorization 6.Consistent 7.Comprehensive 8.Graded approach 11

IAEA Sub-ordinate Legislation / The Regulations Overview and use of model regulations for the predisposal management of radioactive waste 12

IAEA Regulatory Strategies What is a regulatory strategy? An approach to regulation that determines the overarching types of demands that are made on licensees/ applicants It is more specific than a regulatory mandate—which is the scope of responsibility given by the government to the regulator, and More general than regulatory methods—which are the ways that the regulator determines if operators are fulfilling demands (inspections, document reviews etc.) Overview and use of model regulations for the predisposal management of radioactive waste 13

IAEA Importance of Regulatory Strategies Strategies affect the behavior of licensees and therefore have an impact on safety Development of regulatory framework is based upon the adopted strategy Strategies are a major determinant of how a regulator carries out oversight e.g. resources used, types of expertise needed Overview and use of model regulations for the predisposal management of radioactive waste 14

IAEA Context Influencing the Regulatory Strategy Regulatory mandate Nature of the nuclear industry Culture and history of the country, of the regulatory agency, and of the facilities and activities being regulated Overview and use of model regulations for the predisposal management of radioactive waste 15

IAEA Alternative Regulatory Strategies Prescriptive Case-based Outcome-based Risk-based Process-based Licensee self-assessments Overview and use of model regulations for the predisposal management of radioactive waste 16

IAEA Strategies for Establishing Practice-Specific Regulations and Guides The RB has several options : Adopt international safety standards Develop its own national practice-specific regulations, codes and guides Using standards from the industry or independent organizations The option chosen should be decided on a risk informed basis Overview and use of model regulations for the predisposal management of radioactive waste 17

IAEA Adopt International Safety Standards into National Regulations and Guides Depending upon the RB’s enabling legislation, the RB may be able to reference or quote in regulations and license conditions IAEA practice-specific safety standards, thereby making these into legal requirements. The disadvantage of doing so is that when the IAEA changes a safety standards, this will call for the RB to make corresponding changes to its regulations and guides. Overview and use of model regulations for the predisposal management of radioactive waste 18

IAEA Develop National Practice-specific Regulations, Codes and Guides National regulations, codes and guides are usually desirable because they refer to specific national circumstances. It is also advantageous to prepare regulations, codes and guides in local languages and include photographs and illustrations that are more relevant than those that are prepared outside the State. Overview and use of model regulations for the predisposal management of radioactive waste 19

IAEA Develop or adopt industry standards The RB may also take the approach of developing or adopting industry standards produced by medical, academic, or professional standards associations such as those developed and prepared by the ISO, IEC, etc. The development of consensus industry standards is a process usually managed by a standards agency. The process should include participation by RB experts at drafting meetings and the RB should have input into the final version. Overview and use of model regulations for the predisposal management of radioactive waste 20

IAEA Consultation about Regulations and Guides Having taken the decision to develop or revise regulations, the RB shall take into account consistency with international standards, obligations imposed by conventions, relevant industrial standards, advances in technology and possible discrepancies with regulations and guides from other states. Overview and use of model regulations for the predisposal management of radioactive waste 21

IAEA Consultation about Regulations and Guides New regulatory requirements should be published in draft form for a suitable period of review and comment by licensees and other stakeholders. Consultation meetings should be held and documented (who attended, when, where, what was discussed and the outcomes of the discussions) Reports of consultation meetings may be made available to the interested parties, e.g. by posting them on the RB website. Overview and use of model regulations for the predisposal management of radioactive waste 22

IAEA Guidance Documents Guidance documents give practical advice or recommendations on ways by which the legal requirements of the primary and sub- ordinate legislation can be met. In some Member States they might be not legally binding. They are normally issued by the regulatory body to give recommended, generally applicable, detailed operational and technical standards or criteria to ensure that the objectives of the Law and Regulations are achieved. The Guidance documents are expected to be subject to revision and amendment with changes in the national practice, technical developments, and in the evolution over time of international and national radiation protection standards, goals and policies. 23 Overview and use of model regulations for the predisposal management of radioactive waste

IAEA Performance regulations: give general requirements; specify overall radiation safety requirements and basic operational parameters; and key objectives to be achieved. Role and Structure of Regulations Prescriptive Regulations: give detailed requirements; state how to achieve radiation safety. Most regulations contain both types: i.e. some are more performance oriented, other descriptive oriented 25 Overview and use of model regulations for the predisposal management of radioactive waste

IAEA 1.Dose constrains (a)Dose constraints or reference levels will be used when the exposure situation, but not necessarily the exposure itself, usually benefits individuals. Performance Regulations - Example (b)Records shall be maintained to demonstrate compliance with this regulation. 26 Overview and use of model regulations for the predisposal management of radioactive waste

IAEA Advantages easy to develop; Performance Regulations (cont) are focused on objectives: i.e. what should be achieved in terms of protection and safety; applicable to a range of practices; easily adapted to evolving circumstances and technology (i.e. do not need to be changed frequently). 27 Overview and use of model regulations for the predisposal management of radioactive waste

IAEA Disadvantages need to be interpreted in relation to each practice; time and skill is needed from both regulatory staff and the users. Performance Regulations (cont) 28 Overview and use of model regulations for the predisposal management of radioactive waste

IAEA 2.Dose constraints Prescriptive Regulations - Examples (1)Dose constraints or reference levels of 1–20 mSv would be used when the exposure situation, but not necessarily the exposure itself, usually benefits individuals. This would be the case, for instance, when establishing dose constraints for occupational exposure in planned exposure situations or reference levels for exposure of a member of the public in existing exposure situations. (2)The records prescribed by the Regulatory Body on dose received by the workers and on the results of monitoring the working place shall be maintained to demonstrate compliance with this regulation. 29 Overview and use of model regulations for the predisposal management of radioactive waste

IAEA Prescriptive Regulations: define exactly how to achieve adequate dose restrictions; Prescriptive Regulations may define where to conduct workplace monitoring; may define what type of instruments shall be used; may define how and what type of records should be maintained; may be specific to certain types of practices. 30 Overview and use of model regulations for the predisposal management of radioactive waste

IAEA Advantages easy to determine when requirements are met; Prescriptive Regulations (cont) reduce time and skills necessary to conduct a licensing review or an inspection; enable authorization and inspection process to focus on simple verification of compliance. 31 Overview and use of model regulations for the predisposal management of radioactive waste

IAEA Disadvantages can drive a “compliance culture” instead of a “safety culture”; Prescriptive Regulations (cont) can be difficult to prepare; require considerable practice specific knowledge and experience; may be narrowly applicable to a specific practice; need to be regularly amended to keep pace with changes in technology. 32 Overview and use of model regulations for the predisposal management of radioactive waste

IAEA Codes of Practice: are usually developed and issued by the Regulatory Body; Practice Specific Guides give practice specific advice on how to achieve protection and safety requirements defined in legislation or regulations; are not necessarily legally binding (also other procedures might be followed to achieve the same protection and safety goals). 33 Overview and use of model regulations for the predisposal management of radioactive waste

IAEA Codes of Practice may be developed for: radiation therapy; Practice Specific Guides (cont) diagnostic radiology; use of radiation in Industry; research, education and commerce; specific radioactive waste management activity e.g. compaction; other practices. 34 Overview and use of model regulations for the predisposal management of radioactive waste

IAEA IAEA Safety Guide RS-G-1.7, Application of the concepts of exclusion, exemption and clearance (2004) IAEA Safety Report 44, Derivation of activity concentration values for exclusion, exemption and clearance (2005) IAEA Safety Requirement Series GSR part 3. Radiation Protection and Safety of Radiation Sources. 36 Overview and use of model regulations for the predisposal management of radioactive waste

IAEA Application of the GSR Part 3 The GSR Part 3 applies to Occupational exposures Medical exposures Existing exposure situations Planned exposure situations Emergency exposure situations Public exposures 37 Overview and use of model regulations for the predisposal management of radioactive waste

IAEA Some practices and radiation sources may be exempted: from regulatory control requirements including those of notification and authorization; Exemption from procedural requirements of regulations to accommodate a specific situation, providing that the same level of protection and safety can be achieved by alternative methods. 38 Overview and use of model regulations for the predisposal management of radioactive waste

IAEA Exemption of practices and sources defined by: exemption levels (e.g. GSR Part 3 Schedule I); any exemption level defined by the Regulatory Body on the basis of the criteria for exemption (GSR Part 3, Schedule I). Exemption (cont) Exemptions shall not be granted to practices deemed not to be justified. 39 Overview and use of model regulations for the predisposal management of radioactive waste

IAEA Workshop on Revision of the BSS Rio De Janeiro, April 2010 40 Schedule I EXEMPTION AND CLEARANCE TABLE I-1: LEVELS FOR EXEMPTION OF MODERATE AMOUNTS OF MATERIAL WITHOUT FURTHER CONSIDERATION: EXEMPT ACTIVITY CONCENTRATIONS AND EXEMPT ACTIVITIES OF RADIONUCLIDES Radio nuclide Activity concentration (Bq/g) Activity (Bq) Co-601 × 10 1 1 × 10 5 Tc-99m1 × 10 2 1 × 10 7 I-1311 × 10 2 1 × 10 6 Cs-137a1 × 10 1 1 × 10 4 Sm-1531 × 10 2 1 × 10 6 Tl-2011 × 10 2 1 × 10 6 For radioactive substances, either the total activity or the activity concentration is to be less than the levels specified in GSR Part 3 Schedule I table I-1 40 Overview and use of model regulations for the predisposal management of radioactive waste

IAEA Exemption criteria (GSR Part 3, Schedule I) Where the expected effective dose incurred to a member of the public due to the practice or source is in the order of 10 microsievert per year. Exemption (cont) Where the effective dose expected to be incurred by any member of the public for such low probability scenarios does not exceed 1 mSv in a year. 41 Overview and use of model regulations for the predisposal management of radioactive waste

IAEA Type approved sealed radioactive sources ≤ 1  Sv h -1 at 0.1 m from any accessible surface of the device; the dose to members of the public ≤ 10  Sv a -1 Exempted Sources Type approved electrical apparatus ≤ 1  Sv h -1 at 0.1 m from any accessible surface of the apparatus; or the maximum radiation energy is 5 keV. 42 Overview and use of model regulations for the predisposal management of radioactive waste

IAEA i.e. radioactive sources, material and objects, which were the subject of an authorization, may be released from regulatory control subject to compliance with clearance levels approved by the Regulatory Body. Clearance Definition (BSS) The removal of regulatory control by the regulatory body from radioactive material or radioactive objects within notified or authorized practices. 43 Overview and use of model regulations for the predisposal management of radioactive waste

IAEA Clearance criteria and levels Clearance levels shall be approved by the Regulatory Body. Clearance levels  exemption levels. For bulk amounts of materials, clearance levels << exemption levels. Clearance (cont) 44 Overview and use of model regulations for the predisposal management of radioactive waste

IAEA Workshop on Revision of the BSS Rio De Janeiro, April 2010 45 Schedule I EXEMPTION AND CLEARANCE TABLE I-2: LEVELS FOR CLEARANCE AND FOR EXEMPTION OF BULK AMOUNTS OF MATERIAL WITHOUT FURTHER CONSIDERATION: ACTIVITY CONCENTRATIONS OF RADIONUCLIDES OF ARTIFICIAL ORIGIN Radio nuclide Activity concentration (Bq/g) Moderate amount Co-601 × 10 -1 1 × 10 1 Tc-99m11 × 10 2 I-131101 × 10 2 Cs-1371 × 10 -1 1 × 10 1 Sm-1531 × 10 2 Tl-2011 × 10 2 45 Overview and use of model regulations for the predisposal management of radioactive waste

IAEA Unconditional clearance No further control. Conditional clearance First destination of the material is known (e.g. used for road construction) and after that no further control. Clearance (cont) 46 Overview and use of model regulations for the predisposal management of radioactive waste

IAEA 47 Source Exclusion Regulatory domain of planned exposure situations Exemption Application for authorization Clearance Regulatory control AuthorisedDischarges AuthorisedDisposal Regulatory framework 47 Overview and use of model regulations for the predisposal management of radioactive waste

IAEA Overview and use of model regulations for the predisposal management of radioactive waste The need to revise regulations and guides is driven by scientific and technological advances (e.g. new ICRP recommendations) changes in international safety standards (e.g. new IAEA BSS) changes in national circumstances (e.g. new policy or strategy on rad waste management) Maintaining regulations and guides is often an ongoing the process that can benefit from a risk-informed approach. 48

IAEA The need for any revision of the regulations and guides should be carefully evaluated and implemented on a graded basis. The need to revise regulations and guides may be obvious, but it may not be immediate. Can the amended regulations wait? Would a regulatory guide be a suitable interim measure? Overview and use of model regulations for the predisposal management of radioactive waste 49

IAEA 51 Overview and use of model regulations for the predisposal management of radioactive waste These Model Regulations illustrate a way to incorporate the IAEA’s requirements and guidance regarding: radiation protection and safety of radiation sources found in GSR Part 1, GSR Part 3, as well as waste safety GSR Part 5. into the national regulatory infrastructure.

IAEA 52 Overview and use of model regulations for the predisposal management of radioactive waste The Model Regulations are designed to focus on the following objectives: 1.To establish and maintain regulatory control of radiation sources throughout their entire lifecycle; 2.To keep doses from normal operations as low as reasonably achievable and within prescribed limits; 3.To avoid accidents or incidents; 4.To achieve and maintain a high level of radiation safety for each radioactive source that is commensurate with the potential hazard posed by the radioactive source, while recognizing the need to ensure appropriate use of the radioactive source for beneficial purposes; 5.To prevent unauthorized access or damage to, and loss, theft or unauthorized transfer of, radioactive sources; 6.To mitigate or minimize the radiological consequences of any accidents or malicious act involving a radioactive source.

IAEA 53 Overview and use of model regulations for the predisposal management of radioactive waste These Model Regulations are not the only way to adopt the IAEA’s requirements and guidance in national regulations. The Model Regulations were chosen to be as clear and as simple as possible in view of the particular needs of the countries that might like to adopt this model. The types of practices generally used within most of countries are the most common uses of radiation sources. Most of these uses involve equipment and procedures for which there is a well-established operational experience, with the exclusion of complex nuclear facilities.

IAEA 54 Overview and use of model regulations for the predisposal management of radioactive waste The notes in italics under the relevant section or article in the Model Regulations are explanatory and not necessarily part of the national regulations.

IAEA 55 Overview and use of model regulations for the predisposal management of radioactive waste The Model regulation in the part on waste safety follow the structure of the IAEA Safety Requirements GSR Part 5 on Predisposal Management of Radioactive Waste. Part 11: Responsibilities Associated with the Predisposal Management of Radioactive Waste Article 72: General Licensee Responsibilities Article 73: Licence Applications Article 74: Management system for management of radioactive waste Article 75: Appointment of Radioactive Waste Management Officer Article 76: Radioactive Waste Records and Reports Article 77: Interdependencies in the predisposal management of radioactive waste Article 78: Emergency Preparedness Article 79: Physical Protection and Security Article 80: Nuclear safeguards

IAEA 56 Overview and use of model regulations for the predisposal management of radioactive waste The Model regulation in the part on waste safety follow the structure of the IAEA Safety Requirements GSR Part 5 on Predisposal Management of Radioactive Waste. Part 12: Steps in the Predisposal Management of Radioactive Waste Article 81: Control of Radioactive Waste Generation Article 82: Radioactive Waste Characterization and Classification Article 83: Acceptance Criteria for Radioactive Waste Article 84: Processing of radioactive waste from collection up to treatment Article 85: Conditioning Article 86: Storage of Radioactive Waste Article 87: Management of Disused Radioactive Sources Article 88: Recycle and Reuse Article 89: Discharge of Radioactive Materials to the Environment Article 90: Clearance and its Control

IAEA 57 Overview and use of model regulations for the predisposal management of radioactive waste The Model regulation in the part on waste safety follow the structure of the IAEA Safety Requirements GSR Part 5 on Predisposal Management of Radioactive Waste. PART 13: Development and operation of radioactive waste management facilities Article 91: Location and Design of Radioactive Waste Management Facilities Article 92: Construction and Commissioning of Radioactive Waste Management Facilities Article 93: Operation of Radioactive Waste Management Facilities Article 94: Existing facilities Article 95: Disposal of Radioactive Waste Article 96: Disposal of Radioactive Waste from Mining and Mineral Processing

IAEA 58 Overview and use of model regulations for the predisposal management of radioactive waste In summary, the establishment of an appropriate legal framework and regulatory infrastructure should proceed in steps. These steps will include: governmental commitment to radiation and waste safety; this is a pre-requisite to reach the desired objective; national inventory of radiation sources, radioactive waste and waste streams present or anticipated in the country, so as to establish the prioritization of operational activities; definition of a national policy on radiation safety and radioactive waste management at the government level; selection of appropriate strategies for the safe management of radioactive sources (including strategies to gain or regain control over orphan and vulnerable radioactive sources) and of radioactive waste;

IAEA 59 Overview and use of model regulations for the predisposal management of radioactive waste In summary, the establishment of an appropriate legal framework and regulatory infrastructure should proceed in steps. These steps will include: involvement of agencies and technical experts with major interest in radiation safety and waste management (‘stakeholders’) to make an assessment of the required legislation and to establish or guide the drafting of the law; establishment of a regulatory body through the promulgation of a national law; development of regulations and supplementary guidance; development of import/export controls (at least for Category 1 and 2 radioactive sources); availability or development of supporting technical services to assure an efficient radiation safety and waste management; implementation of a regulatory system including requirements for notification; issuing of authorizations, conduct of inspections and enforcement of legislation.

IAEA 60 Thank you!

IAEA International Atomic Energy Agency Presenter Name School of Drafting Regulations for Borehole Disposal of DSRS 2016 Vienna, Austria Overview and use.

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IAEA International Atomic Energy Agency Presenter Name School of Drafting Regulations for Borehole Disposal of DSRS 2016 Vienna, Austria Overview and use.

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