AERB Approval

An Overview of the AERB Approval

The essential purpose of the Atomic Energy Regulatory Board, also known as the AERB, is to ensure the utilisation of radiation and nuclear energy for ionising in India is not hampering the health of the citizens or the environment.

The AERB was established during the formation of the Commission of the Tarapur Atomic Power Station, also known as TAPS 1 & 2, in 1969, and the Department of Atomic Energy, also known as DAE, for the setting up of a safety committee with regard to providing advice and granting clearance of the first crucial and subsequent Power Operation of the Station. A separate independent committee was then constituted for monitoring safety measures taken by TAPS 1 & 2, which was named the Design and Operations Review Committee.

Acts and Regulations Enacted for AERB

Specific Acts were necessary to be enacted for concerns with regard to the establishing and utilising any nuclear facilities along with the utilisation of radioactive resources that are conducted anywhere across India that fall under the Atomic Energy Act, 1962. Concerns in relation to securing the environment are governed under the Environmental Protection Act, 1986.

Specific Regulations were necessary to be enacted for concerns with regard to radiation protection that is governed under Radiation Protection Rules, 1962, concerns with regard to mining and milling of authorised substances that are regulated under the Atomic Energy Mines Minerals Prescribed Substance Rules, 1984, disposal of nuclear or radioactive waste securely that is governed under the Atomic Energy Safe Disposal of Radioactive Waste Rules, 1987.

There are various Acts and Regulations enacted in India that govern and grant authorisation for the smooth functioning of AERB. The applicable acts and regulations for AERB are listed as follows –

• Acts –

1. The Atomic Energy Act, 1962
2. The Amendments of Atomic Energy Act, 2015
3. The Environmental Protection Act, 1986
4. The Civil Liability for Nuclear Damage Act, 2010

• Regulations –

1. The Atomic Energy Mines Minerals Prescribed Substance Rules, 1984
2. The Atomic Energy Safe Disposal of Radioactive Waste Rules, 1987
3. The Atomic Energy Factories Rule, 1996
4. The Atomic Energy Radiation Protection Rules, 2004
5. The Civil Liability for Nuclear Damage Rules, 2011

Activities and Facilities Governed by AERB

The essential categories of activities and facilities that are governed by the AERB are provided along with an overview as follows –

• Nuclear Facility –
• Facilities of the AERB are provided for governance over the Nuclear Fuel Cycles and for installations for nuclear energy covering all the activities and the industrial sector in relation to the Nuclear Fuel Cycles, i.e., Water Plants, Beryllium Extraction Plants, Zirconium Plants, etc.
• Radiation Facility –
• Facilities of the AERB are provided for governance over installation or equipment needed or utilisation of Radiation Energy Generating Units or for the usage of Radioisotopes for research purposes, requirements in the industrial sector, medical purposes, and agricultural purposes.
• Activities –
• The activities of the AERB that are provided for the governance over the transportation of all the radioactive substances along with the governance of Radioactive Waste Management across India.

Facilities provided that are under the governance of AERB are mentioned as follows –

• Nuclear Projects
• Nuclear Power Plants
• Operating Nuclear Fuel Cycle Facilities
• Industrial and R & D Facilities
• Radiation Facilities

Activities provided that are under the governance of AERB are mentioned as follows –

• Transportation of Radioactive Substances
• Radioactive Waste Management

Medical Devices That Require AERB Approval

The following is the list of products that produce or utilise radiation that requires AERB Approvals –

• Fixed X-Ray Machineries
• Mobile X-Ray Machineries
• Digital Radiography Machineries, also known as DR
• Portable X-Ray Machineries
• Dental Orthopantogram Machineries, also known as OPG
• Bone Mineral Density Machineries, also known as BMD
• Fluoroscopy X-Ray Machineries
• Computerised Tomography Scan Machineries, also known as CT Scan
• Dental X-Ray Machineries
• C Arm or O Arm
• Cone Beam Computed Tomography Machineries, also known as CBCT
• Mammography Machineries
• Cath Lab Machineries

Any other medical devices that radiate and utilise Radioactive Energy

The Regulatory Procedure of AERB Approval

As mentioned in the name, Atomic Energy Regulatory Board, also known as the AERB, is a regulatory board established for the purpose of governance over Nuclear Facilities, Radiation Facilities and Activities, along with ensuring that the ionising of the Radioactive Nuclear Energy-Based Substances or Radiation of any Radioactive Substances in India is not hampering the health of the citizens or the environment.

AERB is also responsible for regulation over the administration procedure of the industrial safety measures of DAE Units.

The AERB also accepts feedback from both National and International Resources and implements changes if deemed necessary. The Chairman of the AERB has the sole authorisation of enforcing necessary requirements of the new or amended relevant rules and regulations if deemed necessary.

The AERB utilises multiple regulatory procedures for discharging effective responsibilities that ensure the utilisation of the Graded Approach. The essential procedures are stated as follows –

• Developing Safety Measures as required along with regulations for the users and the applicable utilities.
• Regulation of the Licensing Procedure for multiple applicable facilities and activities that are in accordance with the safety requirements.
• The Regulation over Inspections for Compliance Check in accordance with the conditions of the applicable license along with the maintenance of the required safety measures.

Enforcement of Regulations for AERB Approval

For the purpose of administration of the provisions and rules set in accordance with the Atomic Energy Act, 1962, the AERB has complete authorisation for enforcement for needed actions to be taken that ensure the Radiological Safety along with the Industrial Safety.

In accordance with Rule 31 of the Atomic Energy (Radiation Protection) Rules, 2004, it states the provisions for the authorisation for conducting an investigation, for sealing, for seizing of Radiation Installations or of any Radioactive Materials and for providing clear instructions for better and safe management to the employer.  The following is a brief on the provided section –

• Anyone, as per the authorisation provided under Section 17 of the Atomic Energy Act, 1962, has the authorisation for conducting investigations after the conduction of inspections for determination of any contravention of the provided provisions.
• The Investigation can be conducted if any suspicion or complaint has arisen or if any accident or any unusual incident has occurred.
• The Authorised Personnel can investigate in regard to any sealing of any Radiation Installation, any Radioactive Substance, or anything that has been contaminated with Radiating Radioactive Substances.
• The Authorised Personnel can inform the employer in writing in case of any recommendations in relation to ensuring safety measures are maintained, and the licensee has to mandatorily comply accordingly.

In accordance with Rule 35 of the Atomic Energy (Radiation Protection) Rules, 2004, it states the offences and penalties in accordance with the AERB. Anyone who violates any provision of the Atomic Energy (Radiation Protection) Rules, 2004 or the set Terms and Conditions that are mentioned in the issued License or AERB Approval is to be held punishable under the Atomic Energy Act, 1962.

The AERB follows a Graded Approach System for the purpose of enforcement of actions that are to be set on the basis of the severity or the significance of the safety measure. The usual procedure for enforcement actions of the AERB Regulations is mentioned as follows –

• Letter of Enforcement
• Issuance of the Written Directives stating the mandated changes to be implied
• Orders for the Restriction of Activities
• Required Modifications, Suspensions, or Revocations for AERB Approvals, Consents, Authorisations or Licenses
• Initiation with regard to Applicable Penal Actions

Upon consultation with the Chairman of AERB, the lead inspector has the authorisation for the implementation of On Spot Enforcement Actions. If there is any discrepancy of opinion with regard to any decisions issued by the AERB, the Licensee has the right to file an Appeal under the Atomic Energy Commission, also known as AEC.

Documents to be Developed for AERB Approval

Specific Documents are needed to be developed that are of specification for the New Regulatory Safety Documents for each AERB Approval and to be regularly revised in accordance with the technological advances or if any changes in regulation are made internationally, for the purpose of research and development, or any relevant area. 

AERB has a specific Review Procedure, Revision Procedure, and Publication Procedure for the maintenance of the Regulatory Safety Procedure.

The AERB has the authorisation for the development of Documents for the maintenance of the safety measures in accordance with the issuance of Regulatory Safety Documents in specific categories stated as follows –

• Safety Codes and Standards Document –
• The Safety Codes and Standards Document is required to be developed for the establishment of objectives and for setting up of necessities that are in requirement to be fulfilled for providing decent assurance of safety for the public and the environment.
• Safety Guidelines Document –
• The Safety Guidelines Document is needed for providing guidance for all the safety measures needed for specific usage or any applications of nuclear and radiation-based radioactive substances where the Safety Code has not yet been issued.
• Safety Guides Document –
• The Safety Guides Document enlists elaborated specified requirements for the maintenance of Safety Codes and provides guidance for the procedure of implementation.
• Safety Manuals Document –
• The Safety Manuals Document is needed to be developed that enlists details for all required safety measures in relation to specific usage or any applications of nuclear and radiation-based radioactive substances that are needed to be mandatorily followed by the utility.

Safety Review and Assessment for the AERB Approval

The purpose of the Safety Review and Assessment for AERB Approval is to ensure that the provisions and regulations set in regard to the license conditions and requirements are maintained as per the rules and regulations of the AERB are adhered.

The Safety Review and Assessment Procedure are to be conducted by the Staff Members of AERB or a Multi-Level Review if deemed necessary by multiple Safety Committees that can consist of experts in the relevel field, members from DAE, or anyone who is not a part of the AERB.

Upon satisfactory results of the Safety Review and Assessment, the AERB grants the AERB Approval or License for the applicable facility or activity. AERB also has the authorisation for conducting surprise inspections or any focused area inspections, and upon failure of maintenance of any regulation, the granted approval is to be immediately revoked or suspended.

The Safety Review and Assessment can be conducted for any of the following –

• Training Programmes of the Facilities and Activities.
• Qualifications of the staff members and anyone who utilises the Atomic Energy, Nuclear Energy, or Radiating Radioactive Substances.
• Licensing Policies in relation to the projects, plants and facilities.
• Any other department, or organisation, or industry that utilises the Atomic Energy, Nuclear Energy, or Radiating Radioactive Substances.

Regulatory Inspection for AERB Approval

One of the most essential and mandatory core procedures conducted by the AERB for granting any AERB Approval is the Regulatory Inspection, also known as the RI. The Regulatory Inspection is responsible for ensuring the facility of the licensee is complying with all the requirements, both of legal and of the Regulatory, along with the set licensing Terms and Conditions.

The Regulatory Inspections are conducted periodically covering all the actions of activities of the licensee. The inspection that is to be conducted is scheduled prior a year to the date of inspection and the schedule is notified to licensee’s facility prior to the conduction of the inspection. The Regulatory Inspections are authorised for inspections in relation to the technical aspect as well as for inspections in relation to the administration aspect that varies from scrutinisation of Documents, interview of the respective personnel of the facility, observing of tests, required measurements, and field visits.

Aside from routine Regulatory Inspections, AERB additionally leads unique assessments to observe definitive tests or activities at the facilities, and surprise inspections to get firsthand and reliable data on the situation within the facility and its consistency to be safe and secure, fulfilling the requirements of the set rules and regulations. AERB likewise authorises Site Observers at select facilities to monitor the facilities for administrative consistency on an everyday basis.

Approved Inspector of AERB alongside their inspection team is authorised basically for –

• entering the premise at sensible hours, for the purpose of inspection, the facility premises of any Nuclear or Radiation Facility during any phase of the consenting stages for siting, development, authorising, operating, commissioning, and decommissioning
• notice, investigate, examine, measure, duplicate, photo, sketch or test, etc., for any of the installation or equipment, question any faculty, audit and confirm pertinent reports and records etc., for ensuring safety
• review, in accordance with the safety measures, to guarantee that the licensee has Satisfactory and the Radiological Security necessities for completing the practices at the Nuclear or Radiation facilities according to the expectations set down in the Approval.

The findings discovered after the inspection are notified in detail to the Licensee, and the Licensee is approached to present a formal response on the findings to the AERB in a period specified by the AERB upon additional consideration.

Licensing of the AERB Approval

The “Regulatory Consent” is the common term used by the AERB for –

• License
• Authorisation
• Approval
• Registration
• Certification

The procedure for AERB Consent follows in accordance with a Graded Approach in view of concerns that can lead to deadly hazards in association with the Facility or Activity. This Graded Approach System guarantees an adequate degree of audit for various review factors for applicable facilities in accordance with the concerns that can lead to deadly hazards in association with the Facility or Activity.

For the purpose of Administration of provisions that fall under the Factories Act, 1948 and Section 23 of the Atomic Energy Act, 1962 is practised by the AERB via the Department of Atomic Energy Units also known as DAE Units. The grant of AERB Approval for factories of the DAE Units is strictly for the utilisation of Atomic Energy only.

The AERB Approval for Radiation Facilities

The below mentioned are the various types of AERB Approvals that are provided by the Regulatory Board that are granted on the basis of the Type of Practice or Radiation Facilities –

• Consent for the purpose of Licensing of a Radiation Facility
• Licensing for the purpose of Authorising of a Radiation Facility
• Licensing for the purpose of Registering of a Radiation Facility
• Licensing for the purpose of granting Consent for a Radiation Facility
• Licensing for the Applicable Producer or Supplier

The essential factors of the Regulation Procedure for AERB Approval of the Radiation Facilities are mentioned below –

• Conduction of Approval Tests for applicable Radiation Devices and the packages utilised for their transport.
• Issuance of Type Approval Certification for applicable Radiation Devices and the packages utilised for their transport.
• Lay Out Approval of the applicable Radiation Installations in accordance with the safety measures.
• Issuance for the approval of the Radiological Safety Officer also known as the RSO.
• Issuance of License for the Users of the Radiation Resources.
• Issuance of Authorisation for the Users of the Radiation Resources.
• Issuance of Registration for the Users of the Radiation Resources.
• Inspections for applicable Radiation Devices and the packages utilised for their transport.
• Investigation of any occurrence of any unusual activity at the applicable Radiation Facilities.

The Necessity of the Radiation Devices to obtain AERB Approval

The essential responsibility of obtaining an AERB approval for the Radiation Devices is for the protection and ensuring the safety of the patients, the hospital medical staff, and anyone who comes in contact with such devices. Henceforth, it is essential for the owners of such facilities to maintain the safety measures and to ensure that the AERB Registration is approved in accordance with the needed safety measures for AERB Approval as a violation of any measure can be extremely hazardous to humans as well as the environment.

Conditions for Supplier Authorisation of Radiation Devices

The following are the conditioned implied of the Supplier for granting the authorisation of the Radiation Devices –

• The Supplier is to provide shipment of the necessary equipment, which is approved by the AERB.
• For medically used devices such as X-Ray Machineries, the supplier needs to provide servicing of the devices for a lifetime.
• The Report of the Submission of Installation of the device to the applicable authorised body following the specific format as prescribed by the AERB.
• The Supplier needs to ensure that the party purchasing the Radiation Device has all the needed Safety Protection Devices in working condition with no faults or errors, that can be the Protective Apron, the Protective Barrier, etc.
• The Supplier is required to investigate the Purchasing Party’s Site Layout and the maintenance of shielding.
• The Supplier is needed to mandatorily perform the Dismantling and Decommissioning of the Radiation Device, and update the AERB in regard to further actions to be taken by the applicable department.
• The Supplier is required to follow all the Rules and Regulations enacted by the AERB.

Documents Needed for the AERB Approval for Radiation Devices

The below mentioned are the Documents needed mandatorily for licensing an AERB Approval for radiation devices –

• Submission of the Application Form that is correctly filled, stamped and signed by the Authorised Personnel.
• Details of the Residencial Address of the Applicant with mention of the correct Pin Code.
• The details of the Name of the Operator, the Associated Personnel and the Nominated RSO and the entire Staff List.
• Identification proof of the Operator and the Associated Personnel responsible for the utilisation of the radiation devices.
• TLD Badge Numbers assigned to the Radiation Workers and the Provided Staff List that will act as the Employment Proof.
• A Copy of the QA Report of all Radiation Machineries, such as X-Ray Machineries, Mammography Machineries, etc.
• Approval by the RSO that is to be submitted by the Interventional Radiology and Computed Tomology Applicants.
• Th Identification Proof of all the Equipment that radiates Radiation.
• A Copy of the detailed layout of the room where the Radiation Equipment is to be stored, along with the details of the requirements for shielding.
• A Copy of the Valid Type Approval Certification attested with the Copy of the NOC.
• A Copy of the Nominated RSO Proof, providing a detailed copy of their latest Qualification Certifications.
• Survey Reports of the Radiation that can be issued by the supplier of the Radiation Device and the agency that sanctions the Radiation Device.

Registration Procedure of AERB Approval for Radiation Devices

The following is the registration procedure for obtaining an AERB Approval for Radiation Devices –

• An Institute is to be established and registered on e-LORA that falls under the authorisation of the AERB for the purpose of procurement of the AERB License.
• The Applicant is then needed to provide detailed information on the equipment being used for any medical purpose such as X-Ray Machineries, Mammography Machineries, etc., or any other industrial purpose.
• Upon submission of the detailed information along with the needed Documents, the application will be accepted for submission.

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