2017 School on Drafting Regulations Radiation Safety Stream

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 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

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

Non-destructive: Industrial Radiography

Sterilization Security Screening Energy Generation

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

Abandoned Sources: Another problem, another risk!

Radiation Applications: Shall be Controlled and Regulated Radiation Applications: Increasing in all countries n o i t ia d a R sks Ri Requires: establishment of Regulatory framework Radiation Applications must be subject to standards of safety. to protect workers, patients, public and environment from harmful effects of ionizing radiation

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

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 lawmaking. 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. .

National Safety Infrastructure 1. National policy and strategy for safety 2. Legal framework for safety (laws, acts) 3. Regulatory framework for safety (RB and System) 4. Coordination of different authorities with responsibilities for safety RB, health authorities, customs, police 5. Emergency preparedness and response

National Safety Infrastructure 6. System for protective actions to reduce existing or unregulated radiation risks 7. Management of radioactive waste and descommissioning 8. Transport of radioactive material 9. Competence for safety (education and training) 10. Provision of technical services (personal and environmental monitoring, calibration, etc) 11. Participation in the global safety regime

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

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

GSR Part 3: Safety Requirements for establishing a national infrastructure for Radiation Safety § § § § § Regulatory control of exposure Safety of sources Safety of radioactive waste Occupational and public exposure from practices Set responsibilities Medical exposure Existing exposure situations Emergency preparedness Rehabilitation Basis for safe transport The essential protection and safety requirements of the underpin all circumstances of exposure to radiation

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 Justification of Facilities and activities Optimization of protection Limitation of risks to individuals Protection of Present and future generations

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) Emergency: preparedness/response interested parties: involvement and input to decision making Inspections and enforcement (graded approach) Interface: system of accounting/ control of nuclear material; appeals against decisions of the RB

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

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

Establishment of a legal and RF Facilities/activities: Included in RF scope Safety principles: people/ environment - radiation risks. Present/future Legislative and governmental responsibilities Types of authorization (graded approach) Shall establish/ define 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 Prioritize: activities needed Regulatory infrastructure: Legal and technical requirements Grade approach: to gradually building the regulatory system

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

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

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

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

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.

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 : selfassessments to evaluate the Regulatory Infrastructure for Safety and improvements *IAEA SARIS is a useful tool

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 (Tran. SAS);

Thank you! simone@cnen. gov. br