Need for a Regulatory Program

1. Need for a Regulatory Program

2. Objective • To understand the role of regulatory program in providing adequate safety in the use of radiation sources in various practices (e.g. medical, industrial, agriculture, research etc).

3. Contents • Beneficial uses of ionizing radiation. • Harmful effects due to the lack of and / or effectiveness of an adequate and appropriate radiation safety Program. • Consequences of radiological accidents and lessons learned.

4. science; Uses of Radiation Radiation sources have been used to benefit society in: • research; • industry; • medicine; • environmental protection; and • a number of academic and commercial fields.

5. Regardless of the beneficial uses, many people are afraid of radiation and the potentially harmful effects. • The public is concerned about accidents that could affect their health and everyday lives. Uses of Radiation (cont)

6. “Governments, regulatory bodies and operators everywhere must ensure that nuclear material and radiation sources are used beneficially, safely and ethically” Basic Safety Standards (GSR Part 3) Risk control

7. The Main Uses of Radiation Sources

8. The primary purpose of a regulatory program is to provide an appropriate standard of protection and safety for humans without unduly limiting the benefits of the practice giving rise to the exposure. Purpose of a Regulatory System

9. prevent the occurrence of deterministic effects in individuals by ensuring doses are kept below the relevant threshold; Purpose of a Regulatory System (cont) Effective defences against radiological hazards from sources should be established and maintained to: • ensure that all reasonable steps are taken to minimize the occurrence ofstochastic effectsin the population.

10. Deterministic effects • There is a threshold dose below which no short term effect is observed. • Above this threshold the severity of the effect increases with dose e.g. burns, nausea. Deterministic and Stochastic Effects • Stochastic effects • There isno established threshold dose. • Theprobability of a long term effect increases with dosee.g. the induction of cancer.

11. Early Observed Effects of Ionizing Radiation

12. Balance benefits / costs and detriments through: • justification; Basic Principles • optimization; • limitation. Implement the regulatory requirements through: • prevention; • mitigation. Proper organization and management

13. The justification of a practice implies doing more good than harm. Basic Principles (cont) • Theoptimizationof protection implies maximizing the margin of good over harm (ALARA). • The use of recognizeddose limitsimplies an adequate standard of protection even for the most highly exposed individuals.

14. The Standards are intended: • to place requirements on personsor organizations authorized to conduct practices causing radiation exposure, and • to provide for intervention in order to reduce existing exposures. Restriction of Risks The risks associated with radiationexposure must be minimizedandworkers and the public protectedby applying basic radiation safety standards.

15. The implementation of the Standards requires that a Regulatory Body be established by the Government to regulate the introduction and conduct of any practice involving sources of radiation. Implementation of the Standards • TheRegulatory Body should implementa national regulatory program for the control of radiation sources.

16. in industrial irradiators; Lessons to be Learned Accidents resulting infatalities and injurieshave been reported: • industrial radiography; • radiotherapy; and • as the result of lost or abandoned sources, etc.

17. Reports on Lessons from Major Accidents

18. Individual Accident Reports

19. An inadequate regulatory framework in respect of: • authorizations; • inspections; • enforcement. Causes of Accidents • Poor user safety culturein areas such as: • management; • quality control; • training and qualifications of personnel.

20. Accidents with Irradiators

21. Accidents with Irradiators (accelerators)

22. Accidents with Irradiators (gamma)

23. Accidents with Radiotherapy Patients

24. Number of Patients involved in Radiotherapy Accidents

25. Accidents due to loss of control of sources • Generallyinvolve the public;and • workerswho are not involvedwith the normal use of the sources.

26. Deaths due to loss of control of sources

27. Deterministic Effects in Diagnostic Radiology Skin damage 18-21 months after this 40 year old patient underwent2 coronary angiograms and a coronary angioplasty in the one day. Estimated skin dose > 20 Gy. Source: Radiation Induced Skin Injuries from Fluoroscopy Thomas B Shope 1995 USFDA Center for Devices and Radiological Health

28. Deterministic skin injuries reported to USFDA 1992-94

29. There was an excessive and / or inappropriate use of the high dose rate mode. • The filtration of the x-ray beam was inadequate. • A fixed beam geometry was used (radiation entering through the same skin surface all the time). • There was an undetected malfunction of the automatic exposure control system. Diagnostic Radiology Incidents - Summary of Lessons • The x-ray tube wastoo close to the patient.

30. Severe deterministic effects e.g. death, loss of limbs, erythema, acute radiation syndrome. General Consequences of Accidents • Contamination of the environment. • Social impact. • Economic impact.

31. } SAFETY CULTURE • maintenance; • control. Safe use of Radiation Sources • Radiation Sources: • are widely used; • provide substantial benefits; but • can cause harmful effects (injury or death). • Safe operation requires: • training;

32. Safe use of Radiation Sources the RISKS BENEFITS should outweigh

33. References • Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards. Generic Safety Requirements. GSR Part 3 (Interim) Vienna (2011). • Handbook on Nuclear Law: Volume 1 & 2 (2010). • Model Regulations for the use of radiation sources and for the management of the associated radioactive waste. Draft:2012-04-04. • Regulatory Control of Radioactive Sources, Safety Standards Series No. GS-G-1.5, IAEA, Vienna (2004). • Notification and Authorization for the Use of Radiation Sources(Supplement to IAEA Safety Standards Series No. GS-G-1.5) IAEA TECDOC 1525, Vienna (2007). • Inspection of Radiation Sources and Regulatory Enforcement (Supplement to IAEA Safety Standards Series No. GS-G-1.5) IAEA TECDOC 1526. • Lessons Learned from Accidents in Radiotherapy, Industrial Irradiation Facilities and Industrial Radiography, (reports in) IAEA Safety Reports Series. • Safety of Radiation Generators and Sealed Radioactive Sources, Safety Standard Series No. RS-G-1.10, IAEA, Vienna (2006). IAEA, Accident reports (various).