Radiation regulatory bodies

AERB, IAEA, Dose limits

1. RADIATION REGULATORY BODIES PRESENTER : DR SIDDHARTH

2. WHAT IS A REGULATORY BODY? Regulatory body (Regulatory authority,Regulatory agency) is a public authority or government agency responsible for exercising autonomous authority over some area of human activity in a regulatory or supervisory capacity

3. FEATURES OF RADIATION REGULATORY BODIES A regulatory authority be established by the government to regulate the conduct and introduction of any practice involving sources of radiation. Regulatory authority must be independent of registrants,licensees,designers and constructors of radiation sources used in practices.

4. The effective separation of responsibilities between the junctions of regulatory authority and those of any other party is to be made clear so that the regulators retain their independence of judgement and decision as safety authorities. A single regulatory authority is responsible for all aspects of radiation protection and safety in a country. In some countries, regulatory responsibility for different aspects of radiation protection and safety may be divided between different authorities

5. FUNCTIONS OF RADIATION REGULATORY BODIES Assessment of applications for permission to conduct practices pertaining to radiation exposure. Authorisation of practices involving radiation and sources involved. Conduct of periodic inspections Quality assurance Assessing effectiveness of radiation protection and safety measures for each authorized practice.

6. RADIATION REGULATORY BODIES

7. INTERNATIONAL ATOMIC ENERGY AGENCY

8. Autonomous organization Established independent of United Nation through its international treaty on 29 July 1957. Total member countries = 171 ( As of February 2019 ) Director General : Mr.Yukiyo Amano (JAPAN) Headquarters : Vienna,Austria India joined in 1957 as a permanent member of IAEA “ Safe,secure and peaceful uses of nuclear sciences and technology”

9. INTERNATIONAL COMMISSION ON RADIOLOGICAL PROTECTION (ICRP) An independent, international organization that advances for the public benefit the science of radiological protection, in particular by providing recommendations and guidance on all aspects of protection against ionising radiation A charity (not-for-profit organisation ) registered with the Charity Commission of England and Wales A community of more than 250 globally- recognised experts in radiological protection science, policy, and practice from more than 30 countries HEADQUARTERS : Ottawa, Canada.

10. CHAIRPERSON : Dr.Claire Cousins (England) ICRP was established in 1928 at the second International Congress of Radiology to respond to growing concerns about the effects of ionizing radiation being observed in the medical community. At the time it was called the International X-ray and Radium Protection Committee (IXRPC), but was restructured to better take account of uses of radiation outside the medical area and given its present name in 1950.

11. ICRP WORKING Committee 1: RADIATION EFFECTS - Stochastic effects - Deterministic effects Committee 2: DOSES FROM RADIATION EXPOSURE - Dose coefficients - Reference biokinetic and dosimetric models - Reference data for workers &public

12. Committee 3 : PROTECTION IN MEDICINE - Persons,unborn children - Medical diagnosis , therapy or for bio medical research - Medical consequences of accidental exposure Committee 4 : APPLICATION OF COMMISSION’S RECOMMENDATIONS Committee 5 : PROTECTION OF ENVIRONMENT

13. INTERNATIONAL COMMISSION ON RADIATION UNITS AND MEASUREMENT(ICRU) Standardization body setup in 1925 by International Congress of Radiology,originally as X-ray unit committee until 1950. Objective: “Develop concepts,definitions and recommendations for use of quantities and their units for ionisation radiation and its interaction with matter,in particular with respect to biological effects induced by radiation .“

14. ICRU defines units and ICRP recommends, develop and maintain international system of Radiological Protection which uses these units.

15. FOOD AND DRUG ADMINISTRATION (FDA) U.S FDA The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States Federal Executive Departments. Individual states and other federal agencies regulate the use of the x- ray imaging devices through recommendations and requirements for personnel qualifications , quality assurance and quality control programs and facility accreditation.

16. FUNCTIONS OF FDA The FDA conducts an ongoing products radiation control program, regulating the design and manufacture of electronic products, including diagnostic x-ray equipment. Conducts onsite inspections of x-ray equipment, especially mammography units to determine the level of compliance with standards in a given x-ray facility . Compliance with FDA standards ensures protection of occupationally and non-occupationally exposed persons from faulty manufacturing.

17. CDRH The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration (FDA) Responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing performance and safety of these devices. The CDRH also oversees the radiation safety performance of non-medical devices

18. “FDA-Cleared" vs "FDA-Approved" Clearance requests are for medical devices that prove they are " substantially equivalent " to the predicate devices already on the market. Approved requests are for items that are new or substantially different and need to demonstrate " safety and efficacy “.

19. NATIONAL COUNCIL ON RADIATION PROTECTION AND MEASUREMENTS (NRCP) The National Council on Radiation Protection and Measurements (NCRP. is a non government U.S organization The Charter of the Council (Public Law 88-376) states its objectives as follows: “ To: Collect, analyze, develop and disseminate in the public interest information and recommendations about

20. (a) protection against radiation (referred to herein as radiation protection) (b) radiation measurements, quantities and units, particularly those concerned with radiation protection (c) Provide a means by which organizations concerned with the scientific and related aspects of radiation protection and of radiation quantities, units and measurements may cooperate for effective utilization of their combined resources and to stimulate the work of such organizations.

21. (d) Develop basic concepts about radiation quantities, units and measurements, about the application of these concepts, and about radiation protection (e) Cooperate with the international commission on radiological protection, the federal radiation council, the international commission on radiation units and measurements, and other national and international organizations, governmental and private, concerned with radiation quantities, units and measurements and with radiation protection."

22. CE Mark

23. The CE mark , or formerly EC mark, is a mandatory conformity marking for certain products sold within the European Economic Area(EEA) since 1985. CE an abbreviation of Conformité Européenne , meaning " European Conformity“ CE marking indicates the compliance with EU legislation of a product, wherever in the world manufactured, and enables its free movement within the European market.

24. ATOMIC ENERGY REGULATORY BOARD (AERB)

25. The Atomic Energy Regulatory Board (AERB) was constituted on November 15, 1983 by the President of India by exercising the powers conferred by Section 27 of the Atomic Energy Act, 1962 Mission of the Board : To ensure that the use of  ionising radiation and nuclear energy in India does not cause undue risk to health and the environment. Currently, the Board consists of a full-time Chairman, an ex officio Member, three part-time Members and a Secretary. CHAIRMAN : SHRI. G NAGESWARA RAO HEADQUARTERS : ANUSHAKTINAGAR, MUMBAI

26. FUNCTIONS OF AERB Develop safety policies in nuclear, radiation and industrial safety areas for facilities under its purview. Develop Safety Codes, Guides and Standards for siting , design, construction, commissioning, operation and decommissioning of different types of nuclear and radiation facilities. Grant consents for siting , construction, commissioning, operation and decommissioning, after an appropriate safety review and assessment, for establishment of nuclear and radiation facilities.

27. Prescribe the acceptance limits of radiation exposure to occupational workers and members of the public and acceptable limits of environmental releases of radioactive substances. Review the emergency preparedness plans for nuclear and radiation facilities and during transport of large radioactive sources, irradiated fuel and fissile material. Review the training program, qualifications and licensing policies for personnel of nuclear and radiation facilities and prescribe the syllabi for training of personnel in safety aspects at all levels.

28. Take such steps as necessary to keep the public informed on major issues of radiological safety significance. Maintain liaison with statutory bodies in the country as well as abroad regarding safety matters. Promote research and development efforts in the areas of safety. Review the nuclear and industrial safety aspects in nuclear facilities under its purview. Review the safety related nuclear security aspects in nuclear facilities under its purview. Notifying to the public, the 'nuclear incident ', occurring in the nuclear installations in India, as mandated by the Civil Liability for Nuclear Damage Act, 2010.

29. AERB of India recommends and lays down guidelines regarding the Specifications of medical x-ray equipment room layout of x-ray installation work practices in x-ray department protective devices responsibilities of the radiation personnel, employer and radiation safety officer (RSO).

30. REGULATORY CONTROL OF AERB AERB is the regulatory control authority on Approval of new models of x-ray equipment and layout of any new proposed x-ray installation Registration and commissioning of new x-ray equipment Inspection and decommissioning of x-ray installation Certification of a RSO and of service engineers and imposing penalties on any person contravening these rules

31. eLORA (e-Licensing of Radiation Applications) eLORA is a web-based I&CT (Information and Communication Technology) application establishing direct communication channel between AERB and its stakeholders for exchange of information and communication transaction. A state of art e-Governance system, through automation of regulatory processes associated with the use of ionising radiation in India

32. COMPONENTS OF eLORA To achieve business solution with S ecurity P erformance A vailability M anageability and Maintainability S calability

33. ALARA PRINCIPLE ALARA (As Low As Reasonably Achievable) is a safety principle designed to minimize radiation doses and releases of radioactive materials. ALARA is predicated on legal dose limits for regulatory compliance, and is a requirement for all radiation safety programs.

34. To maintain doses As Low As Reasonably Achievable, make sure staff follow these three major safety principles: 1. TIME 2. DISTANCE 3. SHIELDING

35. DOSE LIMITS As per Rule 15 of the Atomic Energy (Radiation Protection) Rules, 2001 General Guidelines The limits on effective dose apply to the sum of effective doses from external as well as internal sources. The limits exclude the exposures due to natural background radiation and medical exposures. Calendar year shall be used for all prescribed dose limits.

36. APPLICATION RADIATION WORKER ( mSv /year) PUBLIC ( mSv /year) EFFECTIVE DOSE (BASED ON STOCHASTIC EFFECTS) 30mSv/year Dose of 20 mSv /yr averaged over five consecutive years (calculated on a sliding scale of five years); 1mSv/year EQUIVALENT DOSE (BASED ON DETERMINISTIC EFFECTS) -LENS -SKIN -HANDS AND FEET 150mSv/year 500mSv/year 500mSv/year 15mSv/year 50mSv/year 50mSv/year PREGNANT WOMEN 2 mSV after declaration of pregnancy upto term N.B : For Trainees,the effective dose in any year shall not exceed 6mSv

37. DOSE LIMITS (ICRP-60,1990) )

38. RADIATION SYMBOL (AERB 2011) RADIOACTIVE SOURCES

39. II. RADIATION GENERATING EQUIPMENTS

40. III. AT ENTRANCE OF X-RAY FACILITY

41. REGULATORY BODIES FOR EQUIPMENT STANDARDS

42. INTERNATIONAL ELECTROTECHNICAL COMMISSION (IEC) World’s leading organization that prepares and publishes International Standards for all electrical, electronic and related technologies Including Medical electrical equipments. 83 members including India Serves world markets and society through its " electro-technology ". Promotes world trade and economic growth and encourages the development of products, systems and services that are safe, efficient and environmentally friendly .

43. BUREAU OF INDIAN STANDARDS(BSI) The Bureau of Indian Standards (BIS) is the national Standards Body of India working under the aegis of Ministry of Consumer Affairs, Food & Public Distribution , Government of India. For formulation of Indian Standards, BIS functions through the Technical Committee structure comprising of Division Councils, Sectional Committees, Subcommittees and Panels. Division Councils are set up by Standards Advisory Committee (SAC) in defined areas of industries and technologies for formulation of standards.

44. The manufacturers of diagnostic x-ray machines in the country are directed that each make/model of X-ray unit manufactured by them shall bear certification mark of the BIS issued by BIS upon demonstration of conformance with IS: 7620 (1&2&3) .

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