Licensing/Consenting
Regulatory "Consent" is used as a global word that includes "Licence", "Authorisation", "Approval", "Registration" and "Certification".
Licensing of NFs involves stage wise consents throughout the lifetime of NFs, namely, siting, Construction, Commissioning, Operation and De-commissioning. These major stages may be further divided into various sub-stages requiring clearances for each sub-stage.
Consenting for Siting
The consent for Siting involves ensuring of the suitability as well as engineer-ability of the proposed site with respect to proposed NF at that site. It includes review of site and proposed NFs interactions (effect of plant on site and effect of site on plant) as well as suitability for implementation of emergency actions. The satisfactory review requires, as applicable, several studies like geotechnical, hydrogeological, radioactive impact assessment, baseline natural background, soil studies, mapping of surrounding areas etc.
Consenting for Construction/Construction Clearance
The consent for construction includes safety review of the design of proposed NF. This involves design review of various systems, plant layout, structures, their design basis, nuclear systems, electrical systems, instrumentation and control systems, safety systems, common services system and waste disposal systems, radiation protection, radioactive waste management aspects, quality assurance etc.
Licensing/Consenting for Commissioning
The commissioning ensures the necessary check on the performance of the design. It provide vital information as to whether the systems designed, located performs in the manner that they are supposed to. AERB ensures that all safety systems and structures are checked and tested according to approved plans. AERB also reviews the commissioning, test reports to satisfy itself about performance of safety systems and structures.
Licence to Operate
After satisfactory commissioning and demonstration for safe operation of NF, ensuring all systems in place, technical as well as administrative, AERB grants licence for operation with stipulated conditions within only which the licensee can operate. The technical and administrative arrangements result in continuous monitoring of NFs and review of various aspects even within the licensed period as a part of safety review and assessment. Among other things, licence has a validity period (typically 5 years) before expiry of which the licensee needs to renew the licence by providing necessary details as specified by AERB.
Consenting for Decommissioning
Decommissioning refers to end of the operating lifetime of NF to retire it from service with due regard for the health and safety of workers and members of the public and the protection of the environment. It implies that no further use of the facility for its existing purpose. It includes dismantling of NF using an approved strategy (immediate or deferred). AERB grants licence for this stage of NF in order to ensure safety of worker, public and environment.
A wide range of sources and devices are utilised in the society to harness their benefit to mankind. The hazard potential in these sources differ vastly, therefore, pre-requisites for consent also differ widely. Accordingly, the consent is granted in various forms based on hazard associated with the facility/activity. The objectives of consenting is to ensure that only such practices are permitted which are justified in terms of their societal and/or individual benefits, radiation protection is duly optimised in all nuclear/radiation facilities, radiation doses to the personnel in these facilities, and to the members of the public in their vicinity do not exceed the prescribed limits, and potential for accidental exposures from the facilities remains acceptably low. This involves approval of machines/equipment for radiation applications after necessary design safety checks followed by approval of facility using approved machines/equipment after compliance check of the layout and shielding adequacy etc.
Following different types of Regulatory Consents are granted based on type of practice/facility:
Consent in the form of Licence is issued to the following facilities
- land based high intensity gamma irradiators other than gamma irradiation chambers;
- particle accelerators used for research and industrial applications;
- neutron generators;
- facilities engaged in the commercial production of radioactive material or radiation generating equipment;
- Telegamma and accelerators used in radiotherapy;
- computed tomography (CT) unit;
- interventional radiological x-ray unit;
- industrial radiography; and
- such other source or practice as may be notified by the competent authority, from time to time
Licence in the form of Authorisation is issued to the following facilities
- brachytherapy;
- deep x-ray units, superficial and contact therapy x-ray units;
- gamma irradiation chambers;
- nuclear medicine facilities;
- facilities engaged in the commercial production of nucleonic gauges and consumer products containing radioactive material; and
- such other source or practice as may be notified by the competent authority, from time to time;
Licence in the form of Registration is issued to the following facilities
- medical diagnostic x-ray equipment including therapy simulator;
- analytical x-ray equipment used for research;
- nucleonic gauges;
- RIA laboratories;
- radioactive sources in tracer studies;
- biomedical research using radioactive material; and
- such other source or practice as may be notified by the competent authority, from time to time;
Licence in the form of Consent is issued to the following facilities
- approval for siting, design, construction, commissioning and decommissioning of a radiation installation;
- approval for sealed sources, radiation generating equipment and equipment containing radioactive sources, for the purposes of manufacture and supply;
- approval for package design for transport of radioactive material;
- approval for shipment approval for radioactive consignments; and
- Such other source or practice as may be notified by the competent authority, from time to time
Manufacturer/ Supplier licensing
While most Licences/Consents are required by the end-user, design approvals and type approval (prototype approval) of the equipment/device have to be obtained by the Manufacturer/Supplier. The manufacturers of the diagnostic x-ray equipment and Nucleonic gauges have to obtain requisite Licence for setting up the facility. Also the consumer goods Manufacturers/Suppliers have to obtain the requisite Licence for Manufacture/Supply.
The regulatory consenting process for Radiation Facilities involves following activities:
- Conducting type approval tests for radiation devices and packages for transport of radioactive materials so as to ensure compliance with national regulatory requirement.
- Issuance of Type approval Certificate for radiation devices and packages for transport of radioactive material.
- Lay out approval of radiation installations from radiation safety view point.
- Issuance of approval Radiological Safety Officer (RSO).
- Issuance of License / Authorization /Registration to users of radiation sources and radiation generating devices.
- Authorization for decommissioning of radiation facility and transport of spent/disused sources for disposal.
- Inspection of radiation installations, devices and packages containing radioactive material for compliance assurance.
- Investigation of unusual occurrences including excessive exposures.
AERB has developed an electronic licensing system for radiation applications called E-LORA for helping users to file applications and associated documents online. There are guidelines available in this system for all types of facilities and activities involving radiation applications and corresponding requirements. Diagnostic Applications of Radiation (e.g., X-Ray machines, Computed Tomography machine, Cath Lab equipment, C-Arm, Mammography machines, general purpose Industrial radiography machines etc.) and therapeutic applications of radiation such as radiotherapy, nuclear medicine and RIA are covered in this online system. Consenting process is explained in greater detail in e-LORA web portal.