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Module 1.4 Key Components of the Regulatory Framework Simone Kodlulovich Renha

2017 School on Drafting Regulations. Radiation Safety Stream IAEA Regional Workshop Vienna , Austria 16 – 27 January 2017. Module 1.4 Key Components of the Regulatory Framework Simone Kodlulovich Renha. Radiation Application in day life. Medicine. NM: 32,700,000 procedures/ annually

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Module 1.4 Key Components of the Regulatory Framework Simone Kodlulovich Renha

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  1. 2017 School on Drafting Regulations.Radiation Safety StreamIAEA Regional Workshop Vienna, Austria 16 – 27 January 2017 Module 1.4 Key Components of the Regulatory Framework Simone KodlulovichRenha

  2. Radiation Application in day life

  3. Medicine NM: 32,700,000 procedures/ annually in the world WHO 2015: annual new cancers ~15 millions, 2/3 in developing countries ~3.6 billons DR in the world/year – UNSCEAR 2012

  4. Environmental Protection Food Irradiation Techniques: isotopes minimize land degradation and water pollution, and improve soil fertility Insert Pest Control By SIT

  5. Non-destructive:Industrial Radiography

  6. Sterilization Security Screening Energy Generation

  7. Radiation Risks Occupational exposure: uranium miners and radium ingestion (dial painters) 115 patients overexposed

  8. Abandoned Sources: Another problem, another risk!

  9. Radiation Applications: Shall beControlled and Regulated Radiation Applicationsmust be subject to standards of safety. RadiationRisks

  10. But...what is regulatory framework (RF) ???? • Set of rules of behavior aiming on ensuring and protection of common goal - safety objective • Institutions designated and responsible for reaching the common goal: to protect people and the environment from harmful effects of ionizing radiation • Set of regulations, laws and policies that govern work health and safety plus all the activities that support compliance with those laws applying legal instruments such as legislation (work health and safety or occupational health and safety acts), regulations and codes of practice • Or just…set of regulations, rules, laws, guidance, policies and regulatory bodies

  11. What should be consider? National Circumstances economic-social-political factors, acceptance, awareness, agreement,... State Legal system Civil, common and statutory laws. Legal system: specific for each country: process to promulgate legal documents. Country law-making. State Structure government plan, strategies/ priorities, educational politics, nuclear program, plans for expansion of radiation applications. Availability Human, technical and financial resources, viability of accreditation courses for : MP, RPO, Physicians..

  12. National Safety Infrastructure • National policy and strategy for safety • Legal framework for safety (laws, acts) • Regulatory framework for safety (RB and System) • Coordination of different authorities with responsibilities for safety RB, health authorities, customs, police • Emergency preparedness and response

  13. National Safety Infrastructure System for protective actions to reduce existing or unregulated radiation risks Management of radioactive waste anddescommissioning Transport of radioactive material Competencefor safety (education and training) Provision of technical services (personal and environmental monitoring, calibration, etc) Participation in the global safety regime

  14. Effective Support: IAEA safety standards OBS: Member States receiving IAEA assistance are obliged to apply IAEA Safety Standards International consensus: high level of safety. Requirements and guidance: effective/ efficient radiation safety infrastructure

  15. GSR Part 1: Safety Requirements for establishing a national infrastructure for Radiation Safety Government: responsibilities/functions for safety. Requirements: governmental, legal and regulatory framework for safety. Applies to all exposure situations and in all facilities/activities No More!

  16. GSR Part 3: Safety Requirements for establishing a national infrastructure for Radiation Safety • Regulatory control of exposure • Safety of sources • Safety of radioactivewaste • Occupationaland publicexposure • frompractices • Medical exposure • Existingexposuresituations • Emergencypreparedness • Rehabilitation • Basisforsafetransport Set responsibilities The essential protection and safety requirements of the underpin all circumstances of exposure to radiation

  17. Fundamental Safety Principles Responsibility for Safety Protective actions to reduce existing or unregulated radiation risks Role of Government Emergency preparedness and Response Prevention of accidents Leadership and management for safety Protection of Present and future generations Optimization of protection Justification of Facilities and activities Limitation of risks to individuals

  18. Establishment of a legal and RF (GSR Part 1): Provision for: Legal responsibility for safety: persons /organizations responsible for the facilities/activities; Ensuring: responsibility where activities are carried out by several persons/organizations successively Review/assessment: facilities/activities (graded approach) Inspections and enforcement (graded approach) Emergency: preparedness/response Interface: system of accounting/ control of nuclear material; interested parties: involvement and input to decision making appealsagainst decisions of the RB

  19. Who is responsible for the establishment of a RF? Government SHALL Promulgate laws and statutes effective legal and RF governmental for safety Define responsibilities Provides the statutory basis for requirements for protection and safety for all exposure situations Established and maintained independent RB

  20. Essential elements of a RF: Hierarchy: governments-RB/organizations/ persons in activities involving radiation exposure RB: Role/ responsibilities/ functions. Organization and competent staff Authorization and Licensing Government Responsibilities Framework: encompass assignment and discharge of governmental responsibilities; regulatory control of facilities/ activities that give rise to radiation risks Management system RB Authority/ responsibility : promulgate regulations guidance - implementation $$ support The rationale for the authorization of new facilities and activities, as well as the applicable decision making process

  21. Establishment of a legal and RF Facilities/activities: Included in RF scope • Safety principles: people/ environment - radiation risks. Present/future Types of authorization (graded approach) Shall establish/ define Legislative and governmental responsibilities Prioritize: activities needed Assign responsibilities for the establishment and implementation of protection strategies to the RB and to other authorities and, as appropriate, to registrants, licensees and other parties involved Regulatory infrastructure: Legal and technical requirements Grade approach: to gradually building the regulatory system

  22. Regulatory Framework: RB Authorization (graded approach) notification Set out/implementation regulation requirements/guides RB Licensing and Inspections nuclear or radiological emergency response enforcement export and import

  23. Regulatory Framework: RB Use of external technical support and consultancy Relations with the applicant/licensee The RB established should: International cooperation Communication with the public

  24. Attributes of a Mature RB Independence Transparency + communication Able to make decisions Regulatory ownership Access to information and expertise Meet international obligations Regulatory Research

  25. Summary: Key elements of the regulatory Framework • Government Commitment • Effective and independent RB • Implemented regulations, guides and rules updated in accordance with international recommendations and national requirements • Participation and involvement of interested parties on protection and safety • Society Awareness • Compliance with national formal legislation and with international requirements and good practices • Communication with the public • International Agreements

  26. Conclusions Government: responsible to establish and maintain an appropriate governmental, legal, and regulatory framework for safety, including an independent RB RB: establish and promote regulations and guides, in compliance with the IAEA Safety standards Regulatory framework for safety: marks a significant milestone on the roadmap to the national radiation safety infrastructure that meets international safety standards; Dynamic process: requires periodic review based on the new technologies and new international recommendations to be consistently updated.

  27. Conclusions Properly regulatory framework: provides for the regulation of facilities and activities that give rise to radiation risks. Government collaboration: participation in relevant international events, including peer reviews; Continuous improvement : self-assessments to evaluate the Regulatory Infrastructure for Safety and improvements *IAEA SARIS is a useful tool

  28. Recomendations Participation in Independent assessment : Integrated Regulatory Review Services (IRRS); Advisory Missions: relating to the national regulatory infrastructure; Occupational Radiation Protection Appraisal Service (ORPAS); Emergency Preparedness Review (EPREV); International Physical Protection Advisory Service (IPPAS); Transport Safety Appraisal Service (TranSAS);

  29. Thank you!simone@cnen.gov.br

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