35 AERB Annual Report - 2018 2.1 APPLICATIONS OF RADIATION SOURCES IN MEDICAL, INDUSTRY AND RESEARCH Radiation sources such as radioisotopes ( 192 Ir, 60 Co, 137 Cs, 170 Tm, 75 Se, 241 Am, 99m Tc etc.) and radiation generating equipment (X-ray machines, accelerators etc.) are being used in multifarious and ingenious ways to achieve overall societal health and prosperity. The radiation sources have a wide range of applications in the industry, medicine, agriculture and research institutions and AERB regulates these facilities/institutions. These sources have the radiation hazard potential ranging from very low to high. Proper design, handling and disposal methodologies are required for ensuring safe and intended use of radiation sources. Regulation of these sources is in accordance with the radiation hazard potential involved and the extent of use in the public domain. A glimpse on the various applications of these sources and their licensing status is as given below. Description No. of Facilities/ Equipment Licenced as on December 31, 2018 MEDICAL APPLICATIONS OF RADIATION SOURCES Teletherapy In teletherapy (branch of radiotherapy), tumour is treated using ionising radiation keeping radiation source(s) at certain distance. The radioisotope like 60 Co and radiation generators such as Linear Accelerators are used. They have high radiation hazard potential. 468 facilities with 687 teletherapy units Brachytherapy In brachytherapy (branch of radiotherapy in which the source is kept very near to the lesion) the isotopes used are 192 Ir, 137 Cs, 90 Sr, 106 Ru, 125 I and 60 Co with activity range from few MBq to GBq. They are of moderate radiation hazard potential as compared to teletherapy. 305 Remote After Loading and 49 Manual After Loading equipment Chapter 2 SAFETY SURVEILLANCE OF RADIATION FACILITIES
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35AERB Annual Report - 2018
2.1 APPLICATIONS OF RADIATION SOURCES IN MEDICAL, INDUSTRY AND RESEARCH
Radiation sources such as radioisotopes (192Ir, 60Co, 137Cs, 170Tm, 75Se, 241Am, 99mTc etc.) and radiation generating equipment (X-ray machines, accelerators etc.) are being used in multifarious and ingenious ways to achieve overall societal health and prosperity. The radiation sources have a wide range of applications in the industry, medicine, agriculture and research institutions and AERB
regulates these facilities/institutions. These sources have the radiation hazard potential ranging from very low to high. Proper design, handling and disposal methodologies are required for ensuring safe and intended use of radiation sources. Regulation of these sources is in accordance with the radiation hazard potential involved and the extent of use in the public domain.
A glimpse on the various applications of these sources and their licensing status is as given below.
Description No. of Facilities/Equipment Licenced as on December 31, 2018
MEDICAL APPLICATIONS OF RADIATION SOURCES
Teletherapy In teletherapy (branch of radiotherapy), tumour is treated using ionising radiation keeping radiation source(s) at certain distance. The radioisotope like 60Co and radiation generators such as Linear Accelerators are used. They have high radiation hazard potential.
468 facilities with687 teletherapy units
Brachytherapy In brachytherapy (branch of radiotherapy in which the source is kept very near to the lesion) the isotopes used are 192Ir, 137Cs, 90Sr, 106Ru, 125I and 60Co with activity range from few MBq to GBq. They are of moderate radiation hazard potential as compared to teletherapy.
305 Remote After Loading and 49 Manual After Loading equipment
Chapter 2SAFETY SURVEILLANCE OF
RADIATION FACILITIES
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Description No. of Facilities/Equipment Licenced as on December 31, 2018
Cath Lab X-rays are used in medicine as an important diagnostic tool. Diagnostic Radiology using X-rays are:• Interventional Radiology equipment
(Cath-Lab ): These equipment are used in operation
theatres for various interventional procedures and pose moderate radiation hazard to patients and medical professionals involved in operation of the equipment.
• Computed Tomography (CT): These equipment are of moderate
radiation hazard potential to both worker and patient.
• General purpose radiography and fluoroscopy equipment and dental equipment:
These constitute around 70-80% of all X-ray equipment that are used, and are of low to very low radiation hazard potential, to both worker and patients.
• Mammography, Bone Mineral Densitometer:
These equipment are of very low radiation hazard potential.
• 1,684 Cath Lab. equipment
• 4,071 CT equipment
• 55,733 other medical X-ray equipment
Computed Tomography
Radiography and Fluroscopy
Nuclear Medicine Facilities
In Nuclear Medicine, radio-pharmaceuticals, such as 99mTc, 131I, 201Tl and 18F are used for diagnosis and treatment. 18F Radiopharmaceuticals are routinely used in PET-CT facilities, while 131I is used for diagnosis and treatment of thyroid cancers. The facilities using pharmaceuticals are of moderate-low radiation hazard.
310 facilities (PET-CT, SPECT, Gamma Camera and Radionuclide Therapy)
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Description No. of Facilities/Equipment Licenced as on December 31, 2018
Medical Cyclotron Radio-isotopes that are used in Nuclear Medicine are generally produced in Medical Cyclotron facilities. Cyclotrons are utilised for the production of 18F labelled radio-pharmaceuticals. The medical cyclotron facilities are of high to moderate radiation hazard potential.
18 facilities
INDUSTRIAL APPLICATIONS OF RADIATION SOURCES
RPF Radiation Processing Facilities (RPF) including Gamma Irradiators and Electron Beam Accelerators are used mainly for radiation processing of food, sterilisation of healthcare products and crosslinking of polymers in cable industries. Radiation processing of food items includes inhibiting sprouting, delay in ripening, microbial decontamination, insect disinfestation, shelf-life extension etc. The activity range is about few PBq (1015). They are of high radiation hazard potential.
21 Gamma Irradiators
11 Accelerator Facilities
IRED Industrial Radiography using Industrial Radiography Exposure Device (IRED), is one of the important non-destructive (NDT) methods used for study / evaluation of weld joints, castings etc. Radioisotopes like 192Ir, 60Co, 170Tm, 75Se and different energies of X-rays are used in the field of industrial radiography. The activity range is from few TBq to few tens of TBq. The X-ray energy range is from few hundreds of keV to few MeV. They are of high to moderate radiation hazard potential.
563 facilities with 2,772 equipment
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Description No. of Facilities/Equipment Licenced as on December 31, 2018
GIC Gamma Irradiation Chamber (GIC) is basically used for research and development and also in blood banks for irradiation of blood and its components. Usually 60Co and 137Cs radioisotope are used in this application. The activity ranges from few tens of TBq to few hundreds of TBq. They are of high to moderate radiation hazard potential.
Irradiator based on X-ray generator are also used in blood banks.
114 facilities with 120 devices
Nucleonic Gauges Nucleonic Gauges also known as Ionising Radiation Gauging Devices (IRGD) are used for online monitoring of quality control parameters such as thickness, level, density, coating thickness, elemental analysis etc. Sources used for nucleonic gauges consist of gamma sources such as 60Co, 137Cs, 241Am etc., beta sources such as 85Kr, 90Sr, 147Pm, 204Tl and neutron sources such as 241Am-Be and 252Cf. The activity range is from MBq to GBq. They are of low radiation hazard potential.
1,920 facilities*
Well Logging Radioactive sources are used in well logging application for exploration of oil, coal, geophysical logging etc. The sources used are mainly 137Cs, 241Am-Be, some calibration sources such as 60Co, 226Ra, 232Th etc. and neutron generators e.g. Deuterium-Tritium (DT) generators. The activity range is from kBq to GBq. They are of moderate to low radiation hazard potential.
51 facilities
* Data migration of IRGDs and institute registration of NG facilities were in progress in e- LORA.
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Description No. of Facilities/Equipment Licenced as on December 31, 2018
RADIATION SOURCES IN RESEARCH APPLICATIONS AND CONSUMER PRODUCTS
Consumer Goods Manufacturing Facilities
Consumer products such as smoke detectors, thorium gas mantles and starters, gaseous tritium luminescence devices use exempt quantity of radioactive sources. They are of very low hazard potential. However, regulatory control exists on the manufacturing facilities of these devices.
16 facilities
Container Scanner Facility Container scanners are used at various land/sea ports for inspection of material inside cargo/container without opening them. These scanners are either accelerators or 60Co based. They are high to moderate radiation hazard potential.
15 Scanners/ equipment
Facilities using Sealed Sources
Though sealed radioactive sources are used in various industrial and medical applications, but here sealed source means those used in education, research and calibration purposes. The activity range is from kBq to GBq. They are of low to moderate radiation hazard potential.
166 facilities
Facilities using Unsealed Sources
Unsealed sources are used in various research and academic institutions such as agriculture, veterinary science, tracer studies etc. They are of low radiation hazard potential.
177 facilities
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2.2 SAFETY REVIEW MECHANISM OF RADIATION FACILITIES
2.2.1 Issuance of Consents
Consenting process involves the issuance of Licence, Authorisation, Registration or Consent (in the order of decreasing hazard potential), to operate the equipment/ facility. Type Approvals are issued to manufacturer/ supplier for equipment conforming to the regulatory standards. Approvals are also issued as an interim consent towards the respective Licences. No Objection Certificates (NOC) are issued to the stakeholders to import either equipment or radioactive source, after which the stakeholders need to obtain either a Type Approval or the respective consent for use.
AERB has a system of multi-tier review process for various consents depending on the hazard potential involved. The process of issuance of various consents is as per AERB Safety Guide on ‘Consenting Process for Radiation Facilities’ (AERB/RF/SG/G-3).
The transportation of radioactive material (including that of nuclear material from nuclear facilities) is governed by regulations specified by AERB in Safety Code on ‘Safe Transport of Radioactive Materials’ and is in line with the international requirements specified by IAEA.
The number of licences for various radiation facilities issued during the year are as follows:
Practice Number of Licence Issued
Radiotherapy 130
Nuclear Medicine 210
Diagnostic X-ray 16,861
Manufacturing of X-ray equipment 02
Industrial Radiography 150
Radiation Processing and Accelerators 15
Gamma/X-ray Irradiation Chambers 23
Medical Cyclotron Facilities 04
Nucleonic Gauges (NG) Facilities 92
Well Logging (WL) Facilities 13
Manufacturer of Consumer Products & Scanning Facilities 53
Container Scanner 04
Total 17,557
* Licence includes Licence, Authorisation, Registration for various radiation facilities
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The other approvals issued during the year are as follows:
Service Agency Diagnostic X-ray 82Supplier Authorisation Diagnostic X-ray 23
Transport of Radioactive Material
Registration of Type A Package 09Approval of Type B Package 01Approval of design for special form radioactive material
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2.2.2 Safety Committees for Radiation Facilities
The safety committees review the radiation safety aspects of medical, industrial and research institutions which use radioactive sources/ radiation generating equipment.
The committees also recommend issuance of licence for operation or issuance of Type Approval, based on their review. The committees consist of experts in the field from the industry, medicine and academic institutions apart from the experts from Bhabha Atomic Research Centre (BARC), Board of Radiation & Isotope Technology (BRIT) and AERB.
2.2.3ApprovalofRadiologicalSafetyOfficers
While the built-in safety of the equipment and institution’s operational preparedness towards safety are ensured by adhering to requirements specified by AERB, the implementation of radiation safety is carried out by AERB approved Radiological Safety Officers (RSO). The RSOs are thus not only acting as extended arms of the regulatory body at every radiation facility, but are also the pivotal interface between the radiation facility and the regulatory body.
The number of RSOs’ approvals/renewals issued for different practices during the year are as follows:
Name of Committee Abbreviations Number of Meetings
Safety Review Committee for Applications of Radiation SARCAR 4
Accelerator and Laser Safety Committee ALSC 4
Safety Review Committee for Radiation Processing Plants SRC-RPP 4
Committee on Safe Transport of Radioactive Material COSTRAM 8
Safety Committee for Hadron Therapy Facilities SCHTF 2
Committee for Investigation and Review of Exposure in Nuclear Fuel Cycle and Radiation Facilities
Diagnostic X-ray facilities 1,953 Nucleonic Gauges & Well Logging 445
Research Centres 44 Consumer Product Manufacturer & Scanner Facilities
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2.3 UNUSUAL OCCURRENCES AND ENFORCEMENT ACTIONS
(i) Abnormal Radiation levels on the Radiography Device and Accessories
Abnormal radiation levels were observed, on an Industrial Gamma Radiation Exposure Device (IGRED) and its accessories viz. driving unit and guide tube belonging to a Chennai based radiography
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agency. The incident was reported to AERB on January 26, 2018, immediately after observation by the institution. As per the information received, radiation levels were also observed on two other sets of driving units and guide tubes which were used with above mentioned device. The radiation level on the IGRED and its accessories was about 500 mR/h and 600 mR/h respectively. AERB advised the institution to keep the radiography device and its accessories in a safe and secure condition. Subsequently, physical verification of source capsule was carried out by source supplier i.e. BRIT in the hot cell in presence of AERB representative and no damage to the source could be detected during verification.
(ii) Suspension of Operation of Gamma Radiation Processing Facility (GRAPF)
A GRAPF facility was inspected by AERB owing to pending non-compliances and non-renewal of Licence under the AE (RP) Rules, 2004 on January 31, 2018. During the inspection serious violations of safety requirements such as operation of the facility by non-qualified persons, non-availability of area monitors, facility not taking corrective action on AERB recommendations based on earlier inspection findings, were observed. Based on the current inspection findings, AERB issued a show-cause notice to the facility on February 22, 2018 which was responded by the facility on March 26, 2018. The response was reviewed in division and was found unsatisfactory and the matter was put to Safety Committee. Representative from the facility was invited to defend their position but refrained from doing so.
On recommendation from Safety Committee, owing to lack of attitude towards safety, the operation of the GRAPF was suspended for a period of 6 months. The RSO approval was also withdrawn for a period of one year and decided to consider his nomination after re-assessment of his competence. Till date, after expiry of the
suspension period, the facility has not applied for renewal of Licence and was not in operation as per the physical check performed by AERB.
(iii) Incident of Detachment of Source Capsule of IGRED
On December 16, 2017, there was an incident of detachment of source capsule, containing, 192Ir source of 47.77 Ci (1.76 TBq) from the source assembly of an Industrial Gamma Radiography Exposure Device (IGRED). The decoupling of the source capsule was noticed through an alarm of area monitor installed near the security cabin in BRIT, Vashi premises, while a car containing above IGRED was about to leave the BRIT premises. The main reasons behind the incident were (i) Modification of the source holder by the Indian supplier in order to make compatible with the source capsule supplied by BRIT, (ii) Shipping plug of the device was not available, (iii) No quality check of source holder prior to fixing the source capsule. After this incident modification of the source holder was stopped by the Indian Supplier and BRIT revised their checklist for receipt/delivery of radiography devices. Due to this incident, three persons (two from BRIT and one car driver of the institution) received radiation dose more than 100 mSv.
2.4 AERB INITIATIVES TOWARDS MAXIMUM GOVERNANCE, MINIMUM GOVERNMENT
(i) Discontinuation of Separate Siting Consent for Radiation Facilities
As per the current practice, siting consent is required for radiation facilities viz. Gamma Radiation Processing Facilities (GRAPF), Industrial Accelerator Radiation Processing Facilities (IARPF), Particle Accelerator Research Facilities (PARF), Medical Cyclotron Facilities (MCF), Hadron Therapy Facility and Integrated Facilities for Radiation Technology (IFRT). Since the facilities requiring siting consent, do not cause
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significant impact on the site due to the size, type and/or inherent design features, such type of facilities may not require a separate siting consent.
A Task Group was constituted for detailed analysis and recommendation w.r.t. requirement for a separate siting consent for all radiation facilities (except facilities like RAPPCOF and PARF> 10MeV energy used for advanced nuclear applications, which are DAE installations). The Task Group recommended that no separate siting consent is required. However the site specific requirements (as applicable) are to be submitted by the facility along with the submission of PSAR. Based on review, AERB revised the regulatory requirements and discontinued the practice of separate siting consents for all radiation facilities except RAPPCOF and PARF> 10MeV.
(ii) SimplificationofRegulatoryRequirementsof Dental Radiology Practice
Dental radiography is very useful and necessary in the diagnosis and treatment of oral diseases. In dentistry, intra-oral dental equipment is used more frequently as compared to extra-oral dental equipment viz. dental orthopan tomography (OPG) and dental cone beam computed tomography (CBCT) on a routine basis for diagnosis of oral diseases. Dental (intra-oral) equipment is technically simpler for operation as compared to other diagnostic X-ray equipment. Dental (OPG)/Dental (CBCT) equipment are operated behind a lead protective barrier. A study conducted by AERB on all types of dental x-ray equipment showed that these equipment posed very low radiation hazard to the operators.
In order to follow graded approach in regulation of diagnostic radiology practice, AERB simplified the licensing requirements without compromising on the radiological safety. The simplified measures are as follows (i) Mandatory requirement of personnel monitoring for operators of dental X-ray equipment was
made recommendatory, i.e. Personnel monitoring (TLD badges) may be provided to the operators of dental X-ray equipment in institutions (such as academic institutions) having high workload, (ii) Periodicity of quality assurance (QA) of dental (OPG)/dental (CBCT) equipment was changed from ‘once in two years’ to ‘once in five years’. (iii) e-LORA module was modified to facilitate the end users. It is expected that implementation of simplified approach in regulation would facilitate most of dental X-ray institutions to comply with the licensing requirements.
(iii) Safety Review of Proton Therapy Facility
AERB Safety Code on ‘Radiation Therapy Sources, Equipment and Installations’, [AERB/RF-SC/MED-1 (Rev.1) 2011] does not include the regulatory requirements for installation and operational safety aspects of Proton Therapy facility. It was challenging for AERB to carry out safety review of Proton Therapy facility in view of non-availability of regulatory requirements for such facility. AERB received an application from M/s Ion Beam Applications (IBA) Particle Therapy India Pvt. Ltd., Chennai seeking no objection certificate (NOC) for supply of 230 MeV Proton Therapy facility, which was first-of-a-kind manufactured by M/s IBA, Belgium to one of the hospital in Chennai.
AERB constituted the ‘Safety Committee for Hadron Therapy Facilities (SCHTF)’ with members from BARC, IGCAR, TMH & AERB to evolve the regulatory requirements. The committee reviewed the application along with technical details of the Proteus 235 Proton Therapy Accelerator and recommended for issuance of NOC. AERB further approved layout plan and formulated acceptance criteria for performance evaluation. Based on review of these criteria, AERB issued licence for operation to the Proton Therapy Facility on December 29, 2018, which is first such facility in the country.
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(vi) Establishment of Help Desk for Radiation Facilities
Regulatory consenting processes for all stakeholders of radiation facility are executed through e-Licensing of Radiation Applications (eLORA) which is a web based system implemented by AERB. Over a period of time, significant growth of the application submissions in eLORA has been recorded. In order to facilitate the user institutions for easy application submission process, guiding them towards better clarity in regulatory
consenting process and to have centralised data of issues/queries raised by end users, a “Help Desk” facility has been established at AERB which is in operation since September 2018. This facility not only provides support to end users but also draws various inputs for improving the regulatory system implemented in eLORA. On an average 70 calls were being received daily on helpdesk. The contact number of Help Desk is 022-2599 0675, it is functional on all working days from 10:00 to 17:00 hrs.
