Regulatory Challenges While Harnessing Societal Benefits of Radiation Sources in India

Transcription

1 Regulatory Challenges While Harnessing Societal Benefits of Radiation Sources in India Avinash U. Sonawane, Ph.D Radiological Safety Division ATOMIC ENERGY REGULATORY BOARD Mumbai, India

2 Content National regulatory framework Electronic governance of radiation facilities Regulation of emerging radiation technologies Management of disused sources Regulating transboundry movement of radioactive sources Regulatory control over medical X-ray equipment Inspections of radiation facilities Security of radioactive sources Conclusion

3 National Regulatory Framework System of Regulatory Control Issued by Central Government Act [Atomic Energy Act, 1962] Rules [Atomic Energy (Radiation Protection) Rules, 2004] Notifications Published by national Regulatory Authority Safety Codes Safety Standards Safety Guides Safety Manuals

4 Atomic Energy Act, 1962 Atomic Energy (Radiation Protection) Rules (AERPR), 2004 Atomic Energy (Safe Disposal of Radioactive Wastes) Rules, 1987 The Radiation Surveillance Procedures for Medical Applications of Radiation, G.S.R 388 (1989) Industrial Radiography (Radiation Surveillance) Procedures; GSR 735, 1980 Safety Codes and Standards published by the Regulatory Authority Safety Guides and Manuals published by the Regulatory Authority Licence in accordance with Atomic Energy (Radiation Protection) Rules, 2004 is the mandatory requirement for the handling of radiation sources in India.

5 Atomic Energy Regulatory Board (AERB) The National Regulatory Authority AERB constituted in 1983 The mission of the Board is to ensure that the use of ionizing radiation and nuclear energy in India does not cause undue risk to health and the environment. Chairman, AERB is the Competent Authority for radiation protection in India.

6 Northern Regional Regulatory Centre, Delhi AERB Headquarter, Mumbai Eastern Regional Regulatory Centre, Kolkata Southern Regional Regulatory Centre Kalpakkam

7 Electronic Governance of Radiation Facilities Web-based system called e-licensing of Applications of Radiation (elora) has been developed and implemented. Objectives of e-lora Online registration of radiation facilities / institutions and radiation professionals Electronic submission of applications for regulatory clearances Online review and e-approvals Radioactive source and equipments accounting Tracking of radioactive materials from cradle to grave Auto-verification of regulatory status of radiation facilities e-lora has been launched since August 2013

8 1. One time registration of radiation facility / institution 2. Declaration of information on required manpower 3. Providing details of radiation professionals, radiation surveillance requirements / radiation measuring & monitoring tools and other details 4. Apply for regulatory clearances though elora

9 Three tier architecture protects already encrypted data from direct access Role based access control to users and only through Secured Socket Layer (SSL) connection System hosted on sets of high availability clusters of servers Redundancy of critical components and physically separate Disaster Recovery Center are implemented Day to day monitoring for ensuring availability and performance of System

10 Emerging Radiation Technologies Radiotherapy Nuclear Medicine Diagnostic Radiology Industrial Applications Radiation Processing Technology

11 Dealing with Emerging Radiation Technologies Development of regulatory requirements in addition to existing Codal requirements Demonstration and studies of advance QA protocols Human resource development by, -- prescribing syllabi and qualifications -- organising more training courses -- recognition of more institutions for conducting courses To make available adequate number of calibration facilities for all types of dosimeters and radiation survey instruments

12 In accordance with Atomic Energy (Safe Disposal of Radioactive Wastes) Rules, 1987 Requirement of returning imported sources to original supplier for disposal. Disposal of indigenously made sources by the local manufacturer. Difficulties experienced in exporting disused sources which were imported in the past. Reuse/Recycling of disused sources by indigenous manufacturer of source. Prior approval of AERB is the regulatory requirement for disposal.

13 Accreditation of Pre-Shipment Inspection Agencies (PSIA) of other countries by Central Ministry of Commerce under Export-Import policy PSIAs issue certificates and are authorised to inspect containers of metal scrap to be imported Pre-shipment inspection certificate (PSIC) is mandatory requirement for import of metal products Installation of portal monitors at sea ports/air cargo areas/major metal recycling industries & foundries Training and awareness among stakeholders

14 Large number of medical X-ray facilities are operational. Efforts initiated for ensuring effective regulatory control over such wide spread facilities Formation of Directorates of Radiation Safety in various States Main hindrances: Harmonization in qualifications of X-ray technologist Accreditation of adequate number of QA agencies for periodic quality assurance. Issues on large number of Import of pre-owned X-ray equipment

15 Regulatory inspections in accordance with Safety Manual on Inspections of Radiation Facilities (AERB/RF/SM-G-3, 2014) Regulatory inspection program for disused sources

16 AERB Safety Guides Security of Radioactive Sources in Radiation Facilities (AERB/RF-RS/SG-1) Security of Radioactive Material During Transport (AERB/NRF-TS/SG-10) Security plan approval is a mandatory pre-licensing requirement for ensuring security during complete life cycle of sources

17 Establishment of Regional Regulatory Centers at Kalpakkam (SRRC), Kolkata (ERRC) and recently at Delhi (NRRC) Maintenance and update of inventory of sources through web-based licensing system, i.e. e-lora (electronic licensing of application of radiation sources) Special inspection programme for institutions possessing disused radiation sources Strengthening routine inspections of RFs for identifying disused sources and to ensure their security and safe disposal Awareness programs on safety, security and disposal aspects of disused sources Inter-ministerial co-ordinations and liaison with other academic / research institutions in the country Advertisements, publication of articles

18 The regulatory requirements for control over radiation sources throughout their life-cycle has evolved over the years from experience gained. The national regulatory body ensures safety and security of radiation sources by enforcing provisions in the national law and other relevant rules issued thereunder. The enforcement of detailed requirements contained in practice specific Safety Codes and Standard and issuance of Safety Directives by the Competent Authority brings effectiveness in ensuring safe handling and secure management of radiation sources.

19 Applications of ionising radiation in the country are increasing for societal benefits in multifarious field. The regulatory activities which require special attention have been identified such as - the development of regulation to deal with advance emerging radiation technology in applications of radiation in medicine and industry; sustaining continuity in ensuring human resource development programme; inspections of disused sources & ensuring their safe disposal; measures for controlling transboundary movement of radiation sources. The complete involvement of the management of radiation facilities, radiation workers and their commitment in establishing and maintaining safety and security culture is essential to handle the radiation sources safely and manage securely at all times.

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