1. REGULATORY REQUIREMENTS FOR HANDLING RADIOISOTOPE Mohd Abd Wahab Yusof (Dr) Malaysian Nuclear Agency

2. RADIOACTIVE MATERIALS APPLICATIONS

3. 3 Radioactive Materials for Non Medical Applications

4. 4 Radioactive Materials in Non Medical Applications

5. Radioactive Materials in Medical Applications

6. ATOMIC ENERGY LICENSING ACT 1984 (ACT 304)

7. Radioactive Substance Act 1968 Atomic Energy Licensing Act 1984 (Act 304) First legislation to control the use of ionizing radiation (medical & non medical) in Malaysia. Director General of Health is the Authority. Repeals the Radioactive Substance Act 1968. Provides powers to control nuclear reactor operation in addition to the power given under Radioactive Substances Act 1968. Introduction

8. Enforced on 1 February 1985 Establishment of the Atomic Energy Licensing Board under Section 3(1), Act 304. There are 5 functions of the Board stated under Section 8 of the Act 304 and one of the functions is: to exercise control and supervision over the production, application and use of atomic energy and matters incidental thereto. Maximum penalty: 10 years imprisonment; or Fine not exceeding RM100,000.00; or both. Atomic Energy Licensing Act 1984 (Act 304) Atomic Energy Licensing Act 1984 (Act 304)

9. Section 12(1), Act 304: …. nobody person shall - (a) site, construct or operate a nuclear installation; (b) deal in, possess or dispose of any radioactive material, nuclear material, prescribed substance or irradiating apparatus, unless he is the holder of a valid licence issued under subsection 16(5) by the appropriate authority for such purpose and as specified in the licence. Appropriate Authority: Medical purposes: Director General of Health Non-medical purposes: Atomic Energy Licensing Board Atomic Energy Licensing Act 1984 (Act 304) Atomic Energy Licensing Act 1984 (Act 304)

10. Subsidiary Regulations under the Act 304 Radiation Protection (Licensing) Regulations 1986 Radiation Protection (Transport) Regulations 1989 Atomic Energy Licensing (Appeal) Regulations 1990 Atomic Energy Licensing (Basic Safety Radiation Protection) Regulations 2010 Atomic Energy Licensing (Radioactive Waste Management) Regulations 2011

11. LICENSING OF ATOMIC ENERGY ACTIVITIES IN MALAYSIA

12. Radiation Protection (Licensing) Regulation 1986 REGULATION 3: CLASSIFICATION OF LICENCE CLASS A ACTIVITY -Manufacture -Trade in -Produce -Process -Purchase -Own -Possess -Transfer -Handle -Sell -Store -Import -Export RADIOACTIVE MATERIAL CLASS B NUCLEAR MATERIAL CLASS C IRRADIATING APPARATUS CLASS D TRANSPORTATION CLASS E IMPORT & EXPORT CLASS F NUCLEAR INSTALLATION CLASS G CLASS H OTHERS DISPOSAL/STORAGE RADIOACTIVE MATERIAL BEFORE DISPOSE ACTIVITY AKTIVITY -Manufacture -Trade in -Produce -Process -Purchase -Own -Possess -Transfer -Handle -Sell -Store -Import -Export -Purchase -Sell -Trade in -Transfer -Import -Export -Possess -Own -Use -Store -Handle -Transport-Import -Export -Site -Construct -Pre-Operate -Operate -to dispose -to store (prior - to their disposal) -to decommission -Maintenance -Leak test -Consultation -Examination Centre -Training Centre -Activity not covered by Class A to G -etc

13.  Licence application shall comply with the requirements of Radiation Protection (Licensing) Regulations 1986.  Applicant shall provide:  Radiation Protection Officer (RPO)  List of radiation workers  Radiation survey meter  Radiation Protection Program  Emergency Plan  List of radioactive materials or irradiation apparatus  Approved registered medical practitioner  Radioactive/irradiation apparatus  Undertaking letter from manufacture or supplier  Other information  Licence will be issued with licence conditions Radiation Protection (Licensing) Regulation 1986

14. SAFETY, HEALTH AND SECURITY

15. System of Radiological Protection  Justification –net benefit  Optimization  Dose Limitation  Dose Constraint Atomic Energy Licensing (Basic Safety Radiation Protection) Regulations 2010 Atomic Energy Licensing (Basic Safety Radiation Protection) Regulations 2010

16. Atomic Energy Licensing (Basic Safety Radiation Protection) Regulations 2010 Atomic Energy Licensing (Basic Safety Radiation Protection) Regulations 2010 Health, Safety and Security  Licensee shall responsible to protect safety and health of the workers and public, and the environment  Shall comply with the requirements of the regulations and directives of Appropriate Authority with regard to:  conditions of exposure  Dose limitation  Occupational exposure  Medical exposure  Exposure of members of the public  Accidental exposure  Emergency exposure and exposure other than any of those specified above  Security of the sources  Records management  Other requirements under the Atomic Energy Licensing (Basic Safety Radiation Protection) Regulations 2010

17. Annual Dose Limit ApplicationOccupationalPublicApprentices and students Effective dose20mSv1mSv6mSv Lens of the eye150mSv15mSv50mSv Skin500mSv50mSv150mSv Hands and feet500mSv-150mSv Atomic Energy Licensing (Basic Safety Radiation Protection) Regulations 2010 Atomic Energy Licensing (Basic Safety Radiation Protection) Regulations 2010

18. TRANSPORT OF RADIOACTIVE MATERIAL

19.  The main objective of the regulations is to protect the public and the environment.  Exemption from the regulations: producing, using or storing of radioactive materials, nuclear materials or prescribed substances within establishments, other than storage in transit; implanting with radioisotopic cardiac pacemakers or other devices to human beings or treating with radiopharmaceuticals; and as an integral part of a conveyance which radioactive materials, nuclear materials or prescribed substances is used. Radiation Protection (Transport) Regulations 1989. Radiation Protection (Transport) Regulations 1989.

20. LAND AIR WATER Radioactive materials, Nuclear materials or Prescribed substances by all modes of transportation  Regulations need to be complied if any person want to transport radioactive materials, nuclear materials or prescribed substances in Malaysia via land, air or water.  The main objective of the regulations to protect public and the environment. Radiation Protection (Transport) Regulations 1989. Radiation Protection (Transport) Regulations 1989.

21. RADIOACTIVE WASTE MANAGEMENT

22. Radioactive Waste Management Radioactive Waste means any waste which consists wholly or partly of- (a) a substance or article which if it were not waste would be radioactive material; or (b) a substance or article which has been contaminated in the course of the production, storage or use of any radioactive material, nuclear material or prescribed substance or by contact with or proximity to any other waste within the meaning of paragraph (a) of this definition (Section 2, Act 304) Objective of Radioactive Waste Management To deal with radioactive waste in a manner that protects health and the environment now and in the future, without imposing undue burdens on the future generations Objective of Radioactive Waste Management To deal with radioactive waste in a manner that protects health and the environment now and in the future, without imposing undue burdens on the future generations

23. All practices that use nuclear and radioactive materials will produce radioactive wastes. The nature of radioactive wastes vary from one radioactive waste to another radioactive waste in terms of volumes, chemical and physical compositions and concentration of radioactivity. The radioactivity contained in the wastes is hazardous to living organisms. The hazardous nature of radioactive wastes to living organisms requires proper radioactive waste management as prescribed by Appropriate Authority. The purpose of proper management of radioactive wastes is to ensure safety and well being of the present and future generations of the general public and the environment. All practices that use nuclear and radioactive materials will produce radioactive wastes. The nature of radioactive wastes vary from one radioactive waste to another radioactive waste in terms of volumes, chemical and physical compositions and concentration of radioactivity. The radioactivity contained in the wastes is hazardous to living organisms. The hazardous nature of radioactive wastes to living organisms requires proper radioactive waste management as prescribed by Appropriate Authority. The purpose of proper management of radioactive wastes is to ensure safety and well being of the present and future generations of the general public and the environment. Radioactive Waste Management

24. Sources of Radioactive Waste Radioactive waste arises from many different activities, for example: Nuclear fuel cycles; Application of radionuclides in industry, medical, and research; Cleanup of contaminated sites; Processing of raw materials containing naturally occurring radionuclides. Nuclear fall-out

25. Atomic Energy Licensing Act 1984 (Act 304) Control & Licensing (Part III) Section 12(1)(b) – no person shall deal in, poses or dispose of any radioactive material or nuclear material or prescribed substances without a valid licence issued by the Appropriate Authority. Disposal of Radioactive Waste (Part VI) Section 26(1) – No person shall dispose of or cause to be disposed any radioactive waste without prior authorization in writing of the appropriate authority. Section 27(1) – No person shall accumulate or cause to be accumulated any radioactive waste on any premises without prior authorization in writing of the appropriate authority.

26. 26 Classification of Radioactive Waste [Atomic Energy Licensing (Radioactive Waste Management) Regulations 2011] Classification of Radioactive Waste [Atomic Energy Licensing (Radioactive Waste Management) Regulations 2011] ClassDecription Cleared waste Materials containing level of radionuclides at activity concentrations less than those specified in the Second Schedule Low Level (Short Lived)/Decay Waste Low level radioactive waste containing short lived radionuclides only (half lives less than 100 days) that will decay to clearance levels within three years after the times of its generation. Low and Intermediate Level Short Lived Waste (LILW-SL) Radioactive waste which will not decay to clearance levels within three years containing beta/gamma emitting radionuclides with half lives less than thirty years or alpha emitting radionuclides with an activity concentrations less than 400Bq/g and a total activity less than 4000Bq in each radioactive waste package. Low and Intermediate Level Long Lived Waste (LILW-LL) Radioactive waste containing radionuclides with activity concentrations more than LILW-SL but which does not generate heat at above 2kW/m 3 High Level Waste (HLW)Radioactive waste containing radionuclides with activity concentrations more than LILW-SL but which generate heat at above 2kW/m 3

27. Management of Radioactive Waste Management  Pre-disposal management radioactive waste covers the whole process of waste handling:  waste collection;  waste segregation and transfer;  waste treatment;  waste conditioning; and  waste storage;  Disposal

28. Geological Disposal

29. Near Surface Disposal Facility

30. Disused Sealed Radioactive Sources (DSRS) are considered as waste:  no longer useful to users;  taken out of service; and  no future use. DSRS with long half-life may be reused or recycled to minimize their quantity or volume. The DSRS shall be returned to their suppliers or manufacturers. The DSRS can be sent to the Radioactive Waste Treatment Facility but shall obtain a written approval first from the Appropriate Authority.The DSRS can be sent to the Radioactive Waste Treatment Facility but shall obtain a written approval first from the Appropriate Authority. The Licensee can keep or store the DSRS at its premises but shall ensure their safety and securityThe Licensee can keep or store the DSRS at its premises but shall ensure their safety and security Management of Disused Sealed Radioactive Sources (DSRS)

31. Summary

32. Terima Kasih wahab@nm.gov.my