A wide range of nuclear and radiation sources and devices are utilised for the benefit of society (such as nuclear energy plant, X-ray machines etc.). The benefits include satisfying energy needs, diagnosis or treatment of diseases etc. However if not strictly regulated, these devices and facilities have huge potential to cause harm to employees and public. The hazard potential in these sources differ widely and so does the pre-requisites for consent. Atomic Energy Regulatory Board (AERB) reviews each facility and participant and grants its approvals accordingly. All organizations and individuals such as end-users, operating facilities, manufacturers and suppliers need AERB licences. While most of the AERB licenses and consents are required by the end-users, such as hospitals, at various stages, Manufacturers/Suppliers also need to obtain design approvals and type approval (prototype approval) of the equipment/device for selling.
All types Nuclear and Radiation facilities need AERB approvals and licensing in India. These may be manufacturing, sales or operating organizations like hospitals.
At different stages, all through the lifecycle of the organization or facility (from inception to de-commissioning/ closure), various approvals, registrations or licenses are required.
AERB Licenses of Radiation Facilities
Following different types of Regulatory Consents are granted based on type of practice/facility:
Manufacturer/ Supplier licensing
While most AERB Licenses/Consents are required by the end-user, design approvals and type approval (prototype approval) of the equipment/device have to be obtained by the Manufacturers and/or Supplier too. The manufacturers of the diagnostic x-ray equipment and Nucleonic gauges have to obtain requisite Licence for setting up the facility. Also the goods Manufacturers/Suppliers have to obtain the requisite Licence for Sale or Supply. This also includes those planning to import equipment or components and assemble and sell the equipment in India. The approvals are required to be obtained before importing even for testing and evaluation. This will be checked at the Customs and goods will not be releases unless proper AERB approvals are in place.
AERB Licenses / Authorization is required for 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
- 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
- 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;
License 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
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.
Licensing of Nuclear Facilities
The various stages at which consents/ licenses are required for Nuclear Facilities are:
- Site selection
- Construction,
- Commissioning,
- Operation and
- De-commissioning.
Various clearances may be required at various sub-stages also.
AERB consents at various stages for Nuclear Facilities
Consent needs to be obtained on the site even before starting any work to check whether the site is suitable for setting-up a nuclear facility from engineering and environmental impact perspectives. Since it is a nuclear facility, it is also checked if it is suitable for emergency actions. In view of the above requirements, a satisfactory review may include several studies like geotechnical, hydrogeological, radioactive impact assessment, baseline natural background, soil studies, mapping of surrounding areas etc.
The consent for construction includes safety review of the design of proposed Nuclear Facility. 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.
Before commissioning the actual performance of the plant and its compliance to approved design needs to be checked. AERB ensures that all safety systems and structures are checked and tested according to approved plans. They also review the commissioning, test reports etc., to satisfy itself about performance of safety systems and structures.
AERB grants licence for operation with stipulated conditions within which the licensee can operate only after satisfactory commissioning and demonstration for safe operation of the nuclear facility, ensuring all systems are in place. During the licensed period also continuous monitoring and review of various aspects are done. The operating license, which is normally issued for a period of 5 years, needs to be renewed by providing necessary details as specified by AERB.
Consenting for Decommissioning
Before decommissioning of a nuclear facility AERB approval needs to be obtained, which is provided after checking if the dismantling plan follows approved strategy This is done to ensure safety of worker, public and environment.
AERB has developed an electronic licensing system for radiation applications called E-LORA for helping users to file applications and associated documents online. Detailed guidelines are also provided.
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