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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

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

Strengthening Regulatory Competence through Techno-managerial Knowledge

Integration: Indian Experience, IAEA, Vienna on April 14, 2016

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



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”.



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.

Atomic Energy Regulatory

Board (AERB)

AERB Headquarter,

Mumbai

Southern Regional Regulatory Centre

Kalpakkam

Eastern Regional Regulatory

Centre, Kolkata

Northern Regional Regulatory

Centre, Delhi



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



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



• 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



Radiotherapy

Nuclear Medicine

Diagnostic Radiology

Industrial Applications

Radiation Processing Technology

Emerging Radiation Technologies



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



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.



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



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



• Regulatory inspections in accordance with Safety

Manual on Inspections of Radiation Facilities

(AERB/RF/SM-G-3, 2014)

• Regulatory inspection program for disused sources



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



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



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.



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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