International Standards and Organizations

1. International Standards and Organizations

2. To explain the role of international organizations and to present the main IAEA standard in the field of radiation safety. Objective

3. The International Commission on Radiological Protection (ICRP) and Publication 103. • Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards (GSR Part 3). Contents

4. Relevant International Organizations • The ICRP and the ICRU were established in 1928 by the Second International Congress of Radiology. TheInternational Commission on Radiological Protection (ICRP) • has established fundamental radiation protection principles and recommendations. TheInternational Commission on Radiation Units and Measurement (ICRU)

5. Relevant International Organizations (cont) undertakes regular reviews of the current: • status on the human radiation environment; • knowledge of radiation effects and radiation risks. and is an important information base for: • the recommendations of the ICRP; • programs of the international organizations. United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR) 5

6. The functions of the International Atomic Energy Agency (IAEA) include: Relevant International Organizations (cont) • verifying the peaceful uses of atomic energy; • promoting safety; • enabling the transfer of technology; • establishingstandards of safety and to provide for their application; • facilitatingthe establishment of conventions.

7. Food and Agricultural Organization (FAO) • International Labour Organization (ILO) • World Health Organization (WHO) • Nuclear Energy Agency of the OECD (NEA) • Pan American Health Organization (PAHO) Other Organizations

8. ICRP Background • During the early years of diagnostic radiology, a large number of severe overexposures and radiation accidents occurred. • A growing number of acute radiation exposure incidents led to recommendations on radiation protection in the international literature. • The ICRP was established in 1928 by the Second International Congress of Radiology.

9. generally adopted by regulatory bodies and advisory agencies at national and international levels as the basis for the development of legislation, regulations, codes of practice and guidelines. ICRP Recommendations are: • formulated indifferent areas of radiation protection, are based on current knowledge about the biological effects of ionizing radiation and are revised on regular basis; The ICRP is anon-political organization.Its members are elected on the basis of well-recognized work in radiation protection and related fields.

10. The 2007 Recommendations of the International Commission on Radiological Protection. ICRP Recommendations Annals of the ICRP ICRP Publication 103 Volume 37. No. 2-4 2007.

11. The general purposes of radiation protection are to: • prevent detrimental deterministic effects such as erythema, cataract, etc.; ICRP 103 Recommendations • limit the probability of stochastic effects,such as cancer and hereditary effects, to levels deemed to be acceptable.

12. ICRP 103 Recommendations (cont) Situation-basedapproach applying fundamental principles to all controllable exposure situations: • three exposure situations: • Planned exposure situation • Emergency exposure situation • Existing exposure situation

13. The fundamental principles of radiation protection still are: • justification; ICRP 103 Recommendations (cont) Commission’s extensive review of health effects of ionizing radiation has not indicated that any fundamental changes are needed to the system of radiological protection. • optimizationof protection; • dose limitation.

14. Any decision that alters the radiation exposure situation should do more good than harm • It applies to all 3 exposure situations Note 1: The principles may have different wording but are the same as in IAEA publications Justification 1

15. Optimization • The likelihood of incurring exposure, the number of people exposed, and the magnitude of their individual doses should all be kept AsLowAsReasonably Achievable, taking into account economic and societal factors. • It applies to all 3 exposure situations

16. The process should be constrained by restrictions on: • the doses to individuals (dose constraints), or Optimization (cont) • therisks to individualsin the case of potential exposures (risk constraints), so as to limit the inequity likely to result from the inherent economic / social judgements

17. Dose Limitation The total dose to any individual from regulated sources in planned exposure situations other than medical exposure of patients should not exceed the appropriate limits specified by the Commission. • All the dose limits are the same as in ICRP-60 except the dose limits for lens of eye for workers and apprentices that have been reduced • Dose limitation only applies to planned exposure situations

18. Dose limits: • are aimed at ensuring that no individual is exposed to radiation risks that are judged to be unacceptable; Dose Limitation (cont) • differ dependingon whether the exposure is to workers or to members of the public; • do not apply to medical exposure where the issue is the intended result in terms of diagnosis or treatment.

19. Fundamentals • underlying principles - directed at senior politicians and regulators IAEA Safety Standards Requirements • specify obligations and responsibilities Guides • recommendations in support of the requirements, based on international experience

20. to provide for the application of international standards to facilitate and service international conventions and other undertakings to establish international safety standards IAEA SAFETY FUNCTIONS

21. underlying principles aimed at politicians and regulatory authorities Safety Fundamentals Safety Requirements specify obligations and responsibilities (“shall”) Safety Guides recommendations on meeting requirements (“should”)

22. IAEA Safety Standards are not legally binding - may be adopted at countries’ own discretion however... • IAEA Safety Standards are binding on IAEA for: • its own operations • operations assisted by the IAEA • Member States receiving IAEA assistance must apply IAEA Safety Standards

23. Protection of workers, patients, public, environment

24. Basic Safety Standards The InternationalBasic Safety Standardsfor Protection Against Ionising Radiation and for the Safety of Radiation Sources (BSS) are jointly formulated and sponsored by the: • Food and Agriculture Organization of the United Nations (FAO); • International Atomic Energy Agency (IAEA); • International Labour Organization (ILO); • Nuclear Energy Agency of the OECD(NEA); • Pan American Health Organization (PAHO), and • World Health Organization (WHO).

25. Basic Safety Standards (BSS) – GSR Part 3 - Background First BSS No. 115 1962 Revised 1967 Revised, joint sponsorship with FAO, ILO, OECD / NEA, PAHO, WHO 1982 ICRP Publication 60 1991 SS 115 published 1996 ICRP Publication 103 2007 GSR Part 3 Interim 2011 GSR Part 3 2014

26. The recommendations contained in ICRP Publication 103 have been incorporated into GSR Part 3. Basic Safety Standards (GSR Part 3) • The Standards were established toassist appropriate Regulatory Bodiesto organize and implement an adequate radiation and waste safety infrastructure, together with the necessary regulatory infrastructure. • The Standards were also formulated to providegeneral guidance for organizationsrepresenting employers or workers.

27. The Standards apply to the three exposure situations: • carried out in States that adopt the GSR Part 3; Basic Safety Standards (GSR Part 3) - Scope • undertaken by States with the assistance of FAO, IAEA, ILO, PAHO, WHO; • carried out by IAEA or with materials etc. from IAEA; • where parties to bi / multi-lateral arrangements request the application of the GSR Part 3.

28. The type of regulatory system adopted in a country depends on: Objectives of a Regulatory System • itssize; • thecomplexity and safety implicationsof the regulated practices and sources; • theregulatory traditionsin the country.

29. The general functions of a Regulatory Body include: • assessment of notifications for permission to conduct practices that entail or could entail exposure to radiation; Objectives of a Regulatory System (cont) • authorizationof relevant practices and the sources associated with them, subject to specified conditions; • periodic inspectionfor compliance with conditions; and • enforcement as necessary to ensure compliance with regulations and standards.

30. registration of relevant low risk practices; • licensing of other practices, with Objectives of a Regulatory System (cont) Mechanisms are needed for: • notification of intended radiation uses; provision for theexemption of sources or practices from regulatory requirements under certain conditions.

31. The effectiveness of radiation protection and safety measures for each authorized source should be assessed, as should the total potential health and environmental impact of all authorized sources. Objectives of a Regulatory System (cont) Provision is also needed for: • surveillance, monitoring, review, verification and inspection of sources, and for • ensuring that adequate plans existfor dealing with radiation accidents and emergency situations.

32. each country; • facilities using radiation; • departments within facilities (e.g. universities, hospitals, etc.) System of Radiation Protection Anefficient combinationof: • administration and • organization is needed for achieving the objectives of radiation protection. Anadequate infrastructure for radiation protection is necessaryat all levels within:

33. a safety-based attitude; and • recommendations from international organizations along with the requirements of the national Regulatory Bodies. System of Radiation Protection (cont) Infrastructure for radiation protection should be based on: • asafety culture;

34. Essential National Infrastructure Legislation (Act, Statute, Decree, etc) Regulations A Regulatory Body: • to authorize, review and assess radiation use; • to inspect practices and enforce the legislation; and • with appropriate resources and trained personnel. General provisions /services • education and training of users and Regulatory Body staff • personal dosimetry, calibration, other monitoring, etc

35. 1. INTRODUCTION 2. GENERAL REQUIREMENTS FOR PROTECTION AND SAFETY Application of principles of radiation protection Responsibilities of the government Responsibilities of the regulatory body Responsibilities for protection and safety Management requirements 3. PLANNED EXPOSURE SITUATIONS Scope Generic requirements Occupational exposure Public exposure Medical exposure 4. EMERGENCY EXPOSURE SITUATIONS Scope Generic requirements Public exposure Exposure of emergency workers Transition from an emergency exposure situation to an existing exposure situation 5. EXISTING EXPOSURE SITUATIONS Scope Generic requirements Public exposure Occupational exposure Schedule I EXEMPTION AND CLEARANCE Schedule II CATEGORIZATION FOR SEALED SOURCES USED IN COMMON PRACTICES Schedule III DOSE LIMITS FOR PLANNED EXPOSURE SITUATIONS Schedule IV CRITERIA FOR USE IN EMERGENCY PREPAREDNESS AND RESPONSE 103 The 2007 Recommendations of the International Commission on Radiological Protection

36. I Exemptions and Clearance. . Schedules IICategorizationfor sealed sources used in common practices. IIIDose limits for planned exposure situations. IVCriteria for use in emergency preparedness and response

37. Practice Any human activity that introduces additional sources of exposure or additional exposure pathways, or modifies the network of exposure pathways from existing sources, so as to increase the exposure or the likelihood of exposure of people or the number of people exposed Definitions Licence A legal document issued by the Regulatory Body granting authorization to perform specified activities relating to a facility or activity. Licensee The holder of a current Licence.

38. Definitions (cont) 1 Planned exposure situation A situation of exposure that arises from the planned operation of a source or from a planned activity that results in an exposure from a source. Emergency exposure situation An situation of exposure that arises as a result of an accident, a malicious act, or any other unexpected event, and requires prompt action in order to avoid or reduce adverse consequences. Existing exposure situation A situation of exposure that already exists when a decision on the need for control needs to be taken. Note 1: More definitions available in GSR Part 3 and in IAEA Safety Glossary

39. Responsibilities for implementing requirement assigned to: • Government • Regulatory body or other national authority • Registrant and licensee (main responsibility for application of Standards) • Employers • Radiological medical practitioner • Manufacturers and other suppliers • Providers of consumer products • Emergency response organizations

40. Practices • Production and supply of r/a material & devices that generate radiation; generation of NP and other activities in nuclear fuel cycle; use of radiation or r/a material for industry, medical etc; mining and processing or raw materials Sources with practices • Facilities that contain r/a material / radiation generators e.g. nuclear installation, medical radiation facilities, r/a waste management facility, mineral extraction & mineral processing facilities • Individual sources of radiation Application of the GSR Part 3

41. Occupational, medical and public exposure Natural sources • Material containing natural radionuclides above specified level : • (U/Th decay chains > 1 Bq/g; K-40 > 10 Bq/g) • Radon (Rn-220 and Rn-222) and their progeny • (i) in workplace where radon levels above reference level • (ii) in workplaces where r/nuclides in U/Th chains are above 1 Bq/g Application of the GSR Part 3 (cont)

42. Application of the GSR Part 3 (cont) Planned exposure situations Occupational exposures The GSR Part 3 applies to Emergency exposure situations Public exposures Existing exposure situations Medical exposures

43. 3.7 Notification alone is sufficient provided that the exposures expected to be associated with the practice or action are unlikely to exceed a small fraction, as specified by the regulatory body, of the relevant limits, and that the likelihood and magnitude of potential exposures and any other potential detrimental consequences are negligible. • 3.7 Notification is required for consumer products only with respect to manufacture, assembly, maintenance, import, distribution and, in some cases, disposal. Notification and Authorization (Req. 7) Any person or organization intending to operate a facility or to conduct an activity shall submit to the regulatory body, as appropriate, a notification or an application for authorization.

44. Authorization: registration or licensing (Req. 7) 3.8. Any person or organization intending to carry out any of the actions specified in para. 3.5 (adopt, introduce, conduct, discontinue or cease a practice, or as applicable, mine, extract, process, design, manufacture, construct, assemble, install, acquire, import, export, distribute, loan, hire, receive, site, locate, commission, possess, use, operate, maintain, repair, transfer, decommission, disassemble, transport, store or dispose of a source) shall, unless notification alone is sufficient, apply to the regulatory body for authorization, which shall take the form of either registration or licensing.

45. safety largely ensured by design facilities and equipment; • operating procedures simple to follow; • safety training requirements minimal; • there is history of few problems with safety in operations. Registration (Req. 7) Typical practices amenable to registration: Registration best suited to practices for which operations do not vary significantly

46. A practice or radiation source may be exempted if: • the individual public effective dose is <10 µSv in a year; and 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; • Or regulatory control of the practice or the source would yield no net benefit, in that no reasonable control measures would achieve a worthwhile return in terms of reduction of individual doses or of health risks. Exemption and Clearance (Schedule I) For radioactive substances,either the total activity or the activity concentrationis to be less than the levels specified in Schedule I.

47. Justification of practices (the radiation use has a positive net benefit). Radiation Protection Requirements for Practices Dose limitation(dose limits are applied) for occupational and public exposures. Optimizationof protection and safety (ALARA) by the application of: • doseconstraints; • guidance levelsfor medical exposure.

48. Safety assessment (Req. 13) The Regulatory Body shall establish and enforce requirements for safety assessment, and the person or organization responsible for a facility or activity that gives rise to radiation risks shall conduct an appropriate safety assessment of this facility or activity. Safety assessments must be undertaken to: • identify normal and potential exposure routes; • determine the magnitude and likelihood of exposures (normal operation and potential exposures); • assess protection and safety provisions.

49. Monitor and measure parameters to assess compliance with the requirements for protection and safety: Monitoring for verification of compliance (Req. 14) • using appropriate and calibrated monitoring equipment; • maintaining and testingverification procedures; • recording results; • results of monitoring and verification of compliance are shared with the regulatory body as required.

50. The application of the requirements in planned exposure situations shall be commensurate with the characteristics of the practice or the source within a practice, and with the magnitude and likelihood of the exposures. Graded approach (Req. 6) Management for protection and safety (Req. 5) The principal parties shall ensure that protection and safety is effectively integrated into the overall management system of the organizations for which they are responsible.