2017 School on Drafting Regulations.Radiation Safety StreamIAEA Regional Workshop

Vienna, Austria16 – 27 January 2017

Module 1.4Key Components of the Regulatory

Framework

Simone Kodlulovich Renha

Radiation Application in day life

Medicine

~3.6 billons DR in the world/year –UNSCEAR 2012

WHO 2015: annual new cancers~15 millions, 2/3 in developing countries

NM: 32,700,000 procedures/ annually in the world

Food Irradiation

Environmental Protection

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 RisksOccupational exposure: uranium miners and radium ingestion (dial painters)

115 patients overexposed

Abandoned Sources: Another problem, another risk!

Radiation Applications: Shall beControlled and Regulated

Radiation Applications: Increasing in all countries

Requires: establishment of

Regulatory framework

to protect workers, patients, public and environment from harmful effects of ionizing

radiation

Radiation Applications

must be subject to

standards of safety.

But...what is regulatoryframework (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 Circumstanceseconomic-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 Structuregovernment plan, strategies/ priorities, educational politics, nuclear program, plans for expansion of radiation applications.

AvailabilityHuman, technical and financial resources, viability of accreditation courses for : MP, RPO, Physicians..

National Safety Infrastructure

1. National policy and strategy for safety2. 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 anddescommissioning

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 standardsInternational 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

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 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

Set responsibilities

Fundamental Safety Principles

Responsibility for Safety

Role of Government

Leadership and management for

safety

Justification of Facilities and

activities

Optimization of protection

Limitation of risks to

individuals

Protective actions to reduce existing

or unregulated radiation risks

Emergency preparedness and

Response

Prevention of accidents

Protection of Present and future

generations

Establishment of a legal and RF (GSR Part 1): Provision for:

interested parties: involvement and input to

decision making

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;

appeals against decisions of the RB

Who is responsible for the establishment of a RF?

GovernmentSHALL Promulgate laws

and statuteseffective legal and RF

governmental for safety Define responsibilities

Established and maintained

independent RB

Provides the statutory basis for requirements for protection and safety for all exposure situations

Essential elements of a RF:

RB: Role/ responsibilities/ functions. Organization and competent staff

Hierarchy: governments-RB/organizations/ persons

in activities involving radiation exposure

Government Responsibilities

RB Authority/ responsibility :

promulgate regulations guidance

- implementation

Authorization and LicensingFramework: encompass

assignment and discharge of governmental responsibilities; regulatory control of facilities/ activities that give rise to radiation risks

The rationale for the authorization of new

facilities and activities, as well as the applicable decision making process

Management system

$$ support

Establishment of a legal and RF

Facilities/activities: Included in RF scopeSafety principles: people/

environment - radiation risks. Present/future

Shall establish/define

Grade approach:to gradually building the

regulatory system

Prioritize: activities needed

Types of authorization (graded approach)

Legislative and governmental responsibilities

Regulatory infrastructure: Legal and technical requirements

Assign responsibilities for the establishment and implementationof protection strategies to the RB and to other authorities and, as appropriate, to registrants, licensees and other parties involved

Regulatory Framework: RB

RB

Set out/implementation

regulation requirements/guides

enforcement

Licensing and

Inspections

notification

nuclear or radiological emergency response

Authorization(graded approach)

export and import

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 : self-assessments 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 (TranSAS);

Thank you!simone@cnen.gov.br