1. Meet your Regulator Workshop with FANR licensees (medical) October 2011 Dr. John Loy Director, Radiation Safety Federal Authority for Nuclear Regulation

2. PROGRESS WITH LICENSING As at end September 2011, FANR had received 543 applications for licences to conduct Regulated Activity using Regulated Material from government and private entities. To date: 381 Licences have been issued 19 Applications found not to require a licence 37 Applications amalgamated into other licences 106 Applications remaining under assessment TO BE COMPLETED BY END 2011 2

3. LICENCES ISSUED BY FANR TILL SEP 2011 3

4. 4 Different Purpose of the LicencesNumber of practice Diagnostic Radiology: medical91 Diagnostic Radiology: Medical & Dental87 Diagnostic Radiology: dental66 Radiotherapy3 Nuclear Medicine9 Blood Irradiator3 Radiopharmaceutical Production2 Mobile Gauges14 Fixed Gauges24 Element analysis15 Industrial Radiography50 Well logging13 Security Screening20 Research and Education1 Others18 It would seem likely that there remain a significant number of dental practices still to apply to be licensed.

5. 5 PERMITS: Under the standard licence conditions the licensee must obtain a permit from FANR prior each import/ export of Regulated Materials authorized by their licence.

6. 6 INSPECTION: As at end September 2011, FANR had carried out 188 inspection visits:

7. FANR INSPECTIONS:  Generally notified in advance  reserve the right to undertake unannounced inspections  Entrance meeting to describe scope  Inspection carried out  Exit meeting  Provides notice of findings, which licensee should understand  Final report provided to licensee for action, if necessary 7

8. Some Needs for Improved Compliance  Providing updated inventory and dose records to FANR  Ensuring that where personal dosimetry for workers is required it is effectively managed  Procedures for investigation of overexposures, accidents and incidents  Leakage of radiation from x-ray suites into public areas; interlocks for CT scanners  Training and training records need improvement  Inventory records need to be kept up to date and FANR advised. 8

9. THE SAFETY MESSAGES OF THIS WORKSHOP: 1.The Licensee is primarily responsible for protection and safety –Not FANR; –Not the RPO; –Not the workers. 2.Protection and safety is about optimisation – keeping exposures ALARA 3.Know your licence conditions; know regulation: FANR-REG-24; to be supported by regulatory guide RG 007 9

10. Regulatory Guide 007 – Radiation Safety  Contains 33 Topics of guidance concerning the application of FANR-REG-24  Now Under External Review  Draft Copies Available Today  Public comments will be sought shortly  Watch the FANR website

11. RG 007 – Specific Topics  Justification of medical exposures  Need for individual patient justification  Dose Constraints – guide to acceptable values  Tools for optimisation; not legal limits  Occupational; public; medical  Investigation Levels – when should you look at your protection arrangements  Raising a flag that your arrangements may not be effective  Protection and Safety Programme – your local rules  It is a licence condition that you follow your programme  Radiation Protection Officers – responsibilities, qualifications and training 11

12. Dosimetry  Where personal dosimetry is required it is very important workers use dosimetry properly  Workers must wear their dosimeters at all times when they are on the job.  They should never work without them and they must never leave their dosimeters in areas where they might be exposed to radiation.  Licensees must establish local rules for using dosimeters and ensure that workers follow them.  If a worker uses a dosimeter improperly, FANR will hold the licensee accountable 12

13. RG 007 – Dosimetry  When and how to wear dosimeters  How often dosimeters should be read  How dosimeters should be identified  Approved dosimetry services  Procedure for estimating doses when dosimeters are lost or damaged

14. Overexposures (exceeding dose limits)  Licensees are ultimately responsible for overexposures.  Overexposures arise from failed equipment, procedures, training, supervision, all of which are the responsibility of the licensee.  A licensee’s reaction to an overexposure should recognize these responsibilities and emphasize health, safety and fairness.  Take particular care not to damage safety culture by implying a blame culture 14

15. RG 007 – Evaluation of Overexposures (Dose Limit Exceeded)  Have a written procedure  Report to FANR within 24 hours  Investigate as soon as possible  Follow guidance in Article 21 of RG 007  Produce a written report

16. Investigations  Licensees must conduct formal investigations and produce written report when when investigation levels are exceeded  Not because there are likely to be health effects, but there may be a lack of control and optimisation  RG-007 provides guidance for these investigations. 16

17. Unintended or Accidental Medical Exposures  FANR-REG-24 requires reporting to FANR and Ministry of Health of unintended or accidental medical exposures  Wrong individual or wrong tissue of patient; wrong radiopharmaceutical; dose substantially different from that prescribed;  Inadvertent exposure of foetus  Equipment, software, system failure, accident or error with potential for patient exposure substantially different from that intended.  RG 007 suggest ‘substantially’ as 20% for diagnostic and 10% for therapy. 17

18. TRAINING  In RG 007, the Authority discusses the requirements for:  Training  Periodic re-training  Emergency response training  It endorses : IAEA Safety Report Series No. 20: Training in Radiation Protection and the Safe use of Radiation Sources  Also see new ICRP 113: Education and Training in Radiological Protection for Diagnostic and Interventional Procedures Available at: http://www-pub.iaea.org/books/IAEABooks/6147/Training- in-Radiation-Protection-and-the-Safe-Use-of-Radiation- Sources

19. TRAINING IAEA Safety Report discusses training in radiation protection for Persons such as:  Radiation Protection Officers  Qualified Operators  Exposed Workers Practices such as  Industrial Radiography (Annexes)  Gauges  Diagnostic Radiology

20. RADIOACTIVE WASTE  FANR has regulation for clearance of decayed waste; discharge authorisation; and radioactive waste management in preparation  RG 007 describes process for clearance or exemption to allow radioactive waste to be released to the sewers  Current FANR survey/inspection of nuclear medicine practices to review arrangements for disposal of decayed wastes.

21. Pregnant and Breast-feeding Female Patients  RG007 adopts IAEA guidance that a pregnant woman should not be subject to therapeutic applications of radioisotopes unless the application is life-saving  Breast-feeding is contraindicated after therapeutic administration of radionuclides  May be stopped for 12 hours to 3 weeks after diagnostic procedure, depending on the radionuclide  IAEA Safety Report series 40: Applying Radiation Safety Standards in Nuclear Medicine

22. Medical Quality Assurance  Requirements in Article (38) of FANR-REG-24  Active participation of medical Physicists; Radiological medical Practitioners; Medical Radiation technologists; radio pharmacists (where necessary)  Extensive guidance in RG 007:  Content of QA programme  QA programme for radiation sources  QA of instrumentation for calibration and clinical dosimetry

23. Radiation Protection Committee  Required by Article 67 of the Nuclear Law  Established by the Board of Management of FANR  First meeting 6 October 2011  Memberships includes health, environment, emergency response agencies  Terms of reference include advising on radiation protection issues in emergency response; radiation protection training; and infrastructure  May also consider medical constraints and reference levels, including national DRLs. 23

24. Development of Enforcement Program  So far, when FANR inspections have identified safety issues, we have provided licensees with recommendations and asked that they respond to these recommendations.  Beginning around January 2012, if licensees’ activities do not comply with their licence conditions and our regulations, we will issue notices of violation.  Licensees will then be required to take whatever action is necessary to come into compliance.  Regulation on administrative fines and penalties in preparation 24

25. Questions ? Thank You