AERB SAFETY GUIDE NO.

AERB/RF-RS/SG-2

RADIOISOTOPE HANDLING FACILITIES

Atomic Energy Regulatory Board

Mumbai – 400 094
India

August 2015

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 Price:

Orders for this ‘safety guide’ should be addressed to:

The Chief Administrative Officer

Atomic Energy Regulatory Board
Niyamak Bhavan
Anushaktinagar
Mumbai-400 094
India
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 FOREWORD

Activities concerning establishment and utilization of nuclear facilities as well as use of

radioactive sources are to be carried out in India in accordance with the provisions of the
Atomic Energy Act, 1962. In pursuance of the objective of ensuring safety of
occupational workers and members of the public as well as protection of the
environment, the Atomic Energy Regulatory Board (AERB) has been entrusted with the
responsibility of laying down safety standards and enforcing rules and regulations for
such activities. The Board has, therefore, undertaken a program of developing safety
standards, safety codes, and related guides and manuals. While some of these documents
cover aspects such as siting, design, construction, commissioning, operation, quality
assurance, decommissioning of nuclear and radiation facilities, the other documents cover
the regulatory aspects of these facilities.

Safety codes and safety standards are formulated on the basis of nationally and
internationally accepted safety criteria for design, construction and operation of specific
equipment, structures, systems and components of nuclear and radiation facilities. Safety
codes establish the objectives and set requirements that shall be fulfilled to provide
adequate assurance for safety. Safety guides elaborate various requirements and furnish
approaches for their implementation. Safety manuals deal with specific topics and contain
detailed scientific and technical information on the subject. These documents are
prepared by experts in the relevant fields and are extensively reviewed by advisory
committees of AERB before they are published. The documents are revised as and when
necessary in the light of experience and feedback from users as well as new
developments in the field.

Type III radioactive facilities, such as facilities for commercial production of

radioisotopes and radiopharmaceuticals for medical, industrial and research applications,
handle radioisotopes/radioactive substances in all forms and in all stages starting from
receipt of raw materials, production/processing, possession, interim storage, dispatch,
transportation and finally management of the radioactive waste generated. This safety
guide provides regulatory guidance with respect to radiological safety, waste
management and transportation aspects relevant to siting, design, construction, operation
and decommissioning of such facilities. For aspects not covered in this document,
applicable national and international standards, codes and guides acceptable to AERB
should be followed.
Consistent with the accepted practice ‘shall’ and ‘should’ are used in the safety guide to
distinguish between a firm requirement and a desirable option, respectively. Annexures
and bibliography are included to provide further information that might be helpful to the
user. Approaches for implementation, different from those set out in the safety guide may
be acceptable, if they provide comparable assurance against undue risk to the health and
safety of the occupational workers and the general public and protection of the
environment against ionizing radiations.

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4
 DEFINITIONS

ALARA
An acronym for ‘As Low As Reasonably Achievable’. A concept meaning that the design
and use of sources, and the practices associated therewith, should be such as to ensure
that exposures are kept as low as reasonably practicable with economic and social factors
taken into account.

Accident
Any unintended event, including operating errors, equipment failures or other mishaps,
the consequences or potential consequences of which are not negligible from the point of
view of protection or safety.
Annual Limit on Intake (ALI)
The intake, by inhalation, ingestion or through the skin of a given radionuclide in a year
by the ‘Reference Person’ which would result in a committed dose equal to the relevant
dose limit. The ALI is expressed in units of activity.

Applicant
Any person who applies to the competent authority for obtaining consent to undertake
any of the actions for which the consent is required.

Attenuation
The reduction in intensity of radiation passing through matter, due to processes like
absorption and scattering.

Atomic Energy Regulatory Board (AERB)

A national authority designated by the Government of India having the legal authority for
issuing regulatory consent for various activities related to nuclear and radiation and to
perform safety and regulatory functions, including their enforcement for the protection of
site personnel, the public and the environment, against undue radiation hazards.

Authorised Limits
Limits established or accepted by the regulatory body.

Bio-assay
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The determination of the kind, quantity, location, and/or retention of radionuclides in the
body by in-vitro analysis of material excreted or removed from the body.

Competent Authority
Any official or authority appointed, approved or recognised by the Government of India
for the purpose of the Rules promulgated under the Atomic Energy Act, 1962.

Contamination
The presence of radioactive substances in or on a material/the human body or other
places, in excess of quantities, specified by the competent authority.

Containment/Confinement
Barrier, which surrounds the main parts of a nuclear facility, carrying radioactive
materials and designed to prevent or to mitigate uncontrolled release of radioactivity into
the environment during commissioning, operational states, design basis accidents or in
decommissioning phase.

Consent
A written permission issued to the ‘consentee’ by the regulatory body to perform
specified activities related to nuclear and radiation facilities. The types of consents are
'licence', 'authorisation', 'registration' and 'approval', and will apply according to the
category of the facility, the particular activity and radiation source involved.

Controlled Area
A delineated area to which access is controlled and in which specific protection measures
and safety provisions are, or could be, required for
(a) controlling normal exposures or preventing the spread of contamination during
normal working conditions; and
(b) prevention of potential exposures or limiting their extent should they occur.

Cyclotron
A device in which charged particles (other than electrons) travel in a succession of
semicircular orbits of increasing radii, under the influence of a constant magnetic field
and are accelerated by traversing a number of times, in an electric field, produced by a
high frequency generator.
Decommissioning
The process by which a nuclear or radiation facility is finally taken out of operation in a
manner that provides adequate protection to the health and safety of the workers, the
public and the environment.

Decontamination
The removal or reduction of contamination by physical or chemical means.

Defence-in-Depth

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Provision of having multiple levels of protection for ensuring safety of workers, the
public or the environment.

Derived Air Concentration (DAC)

That activity concentration of the radionuclide in air (Bq/m3) which, if breathed by
reference man for a working year of 2000 h, under conditions of light physical activity
(breathing rate of 1.2 m3/h), would result in an inhalation of one ALI. Alternatively, it is
the concentration, which for 2000 h of air immersion, would lead to irradiation of any
organ or tissue to the appropriate annual dose limit.

Design
The process and results of developing the concept, detailed plans, supporting calculations
and specifications for a nuclear or radiation facility.

Discharge (Radioactive)
Planned and controlled release of (gaseous or liquid) radioactive material into the
environment.

Disposal (Radioactive Waste)

The emplacement of waste in a repository without the intention of retrieval or the
approved direct discharge of waste into the environment with subsequent dispersion.

Dose
A measure of the radiation received or absorbed by a target. The quantities termed
absorbed dose, organ dose, equivalent dose, effective dose, committed equivalent dose, or
committed effective dose are used, depending on the context.

Dose Limit
The value of the effective dose or the equivalent dose to individuals from controlled
practices that shall not be exceeded.

Effluent
Any waste discharged into the environment from a facility, either in the form of liquid or
gas.

Emergency
A situation which endangers or is likely to endanger safety of the site personnel, the
nuclear/radiation facility or the public and the environment.

Emergency Plan
A set of procedures to be implemented in the event of an accident.

Exclusion
The deliberate exclusion of a particular category of exposure from the scope of an
instrument of regulatory control.
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Exemption
The deliberate omission of a practice, or specified sources within a practice, from
regulatory control or from some aspects of regulatory control, by the regulatory body on
the grounds that the exposures which the practice or sources cause or have the potential
to cause are sufficiently low so as to be of no regulatory concern.

Existing Exposure Situation

Exposure situations that already exist when a decision on control has to be taken,
typically, such situations as those caused by high natural background radiation.

Exposure
The act or condition of being subjected to radiation. Exposure may be either external
(irradiation by sources outside the body) or internal (irradiation by sources inside the
body). Exposure can be classified as either normal exposure or potential exposure;
occupational, medical or public exposure; and in intervention situations, either
emergency exposure or chronic exposure. The term ‘exposure’ is also used in radiation
dosimetry to express the amount of ions produced in air by ionising radiation.

Half Value Thickness (HVT)

Thickness of the shielding material required to bring down the radiation intensity by half
of the initial value.

Intake
The process of taking radionuclide into the body by inhalation or ingestion, or through
the skin, and the amount of given radionuclide taken in during a given period.

Medical Exposure
Exposure incurred by (i) patients as part of their own medical or dental diagnosis or
treatment; (ii) by persons, other than those occupationally exposed, knowingly while
voluntarily helping in the support and comfort of patients and (iii) by volunteers
participating in a programme of biomedical research involving their exposure.

Member of the Public

Any individual in the population, excepting the one who is subjected to occupational or
medical exposure. For the purpose of verifying compliance with the annual dose limit for
public exposure, the member of the public is the representative individual in the relevant
critical group.

Monitoring
The continuous or periodic measurement of parameters for reasons related to the
determination, assessment in respect of structure, system or component in a facility or
control of radiation.

Occupational Exposure

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All exposures incurred by personnel in the course of their work.

Operation
All activities following and prior to commissioning, performed to achieve, in a safe
manner, the purpose for which a nuclear/radiation facility is constructed, including
maintenance.

Optimisation of Protection
The process of determining the level of protection and safety which makes exposures and
the probability and magnitude of potential exposures, ‘as low as reasonably achievable,
(ALARA)’, economic and social factors being taken into account as required by the ICRP
system of radiological protection.

Packaging
The assembly of components which are necessary to enclose the radioactive contents
completely. It may, in particular, consist of one or more receptacles, absorbent materials,
spacing structures, radiation shielding, service equipment for filling, emptying, venting
and pressure relief devices for cooling, absorbing mechanical shocks, providing handling
and tie-down capability, thermal insulation; and service devices integral to the package.
The packaging may be a box, a drum, or similar receptacle, or a freight container, tank or
an intermediate bulk container.

Personal Protective Equipment (PPE)

Refers to protective gears such as lab-coat, safety shoes, shoe-cover, goggles, respirators,
gloves, helmets, etc. which are used by radiation workers to protect themselves from
hazard or injury.

Planned Exposure Situation

Exposure situations involving planned operations of radiation sources, including
decommissioning, disposal radioactive waste rehabilitation of previously occupied land.

Potential Exposure
Exposure that is not expected to be delivered with certainty but that may result either
from an accident at a source or from an event or sequence of events of a probabilistic
nature, which can arise from equipment failures and operating errors.

Public Exposure
Exposure incurred by members of the public from radiation sources, excluding any
occupational or medical exposure and the normal local natural background radiation, but,
including exposure from authorised sources and practices and from intervention
situations.

Quality Assurance (QA)

Planned and systematic actions necessary to provide the confidence that an item or
service will satisfy given requirements for the quality.

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Radioactive Material
Any substance or material, which spontaneously emits radiation in excess of the levels
prescribed by notification by the Central Government

Radionuclide
An isotope of an element that possesses properties of spontaneous random disintegration
(radioactivity) usually accompanied with emission of radiation.

Radioactive Waste
Any material, whatever its physical form, left over from practices or interventions for
which no further use is foreseen: (a) that contains or is contaminated with radioactive
substances and has an activity or activity concentration higher than the level for clearance
from regulatory requirements, and (b) exposure to which is not excluded from regulatory
control.

Radiopharmaceutical
Radioactive preparations of constant composition and adequate stability employed in
medical diagnosis or therapy, making use of the nuclear decay characteristic of the
constituent radionuclide. The design of these compounds is based solely upon
physiological characteristics and functioning of the target organ. The radiolabeled
preparation has known in vivo distribution pattern and its rate and mode of clearance is
determined by both the biological and effective half-lives of the radionuclide.

Radiotoxicity
A radioactive substance emits radiation and the radiation is harmful to the body. The
extent of the adverse effect viz. the radiotoxicity can be quantified by the magnitude of
the effective dose coefficients.

Radionuclide Generator
A system containing a long lived parent radionuclide in equilibrium with its short-lived
daughter radionuclide; and from which the daughter radionuclide is separated for use,
particularly for medical applications.

Radiological Safety Officer (RSO)

Any person who is so designated by the employer and who, in the opinion of the
Competent Authority, is qualified to discharge the functions outlined in the radiation
protection rules.

Records
Documents which furnish objective evidence of the quality of items and activities
affecting quality. It also includes logging of events and other measurements.

Reference Level

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Action level, intervention level, investigation level or recording level established for any
of the quantities determined in the practice of radiation protection.

Sealed Source
Radioactive source material that is either permanently sealed in a capsule or is closely
bounded and in solid form. The capsule or material of a sealed source shall be strong
enough to maintain leak tightness under conditions of wear and tear while in use for the
intended application as well as under foreseeable mishaps.

Security Survey
A detailed evaluation pertaining to security of facilities involving nuclear material or
radioactive substances, towards prevention, detection and providing response to theft,
sabotage, unauthorised access, illegal transfer or other malicious acts.

Site
The area containing the facility defined by a boundary and under effective control of the
facility management.

Site Evaluation Report (SER)

A document indicating the impact of a nuclear/radiation facility on the environment and
the impact of the environment on the same so as to establish the suitability of the site for
safe operation of the facility.

Siting
The process of selecting a suitable site for a facility including appropriate assessment and
definition of the related design basis.

Shielding
A barrier of appropriate thickness used to reduce radiation levels to specified values.

Source
Anything that causes radiation exposure, either by emitting ionising radiation or by
releasing radioactive substances or materials.

Surveillance
All planned activities, viz. monitoring, verifying, checking including in-service
inspection, functional testing, calibration and performance testing, carried out in order to
ensure compliance with specifications established in a facility.

Transport
International or domestic carriage of radioactive material by any means of transportation;
beginning with the departure from the consignor’s facility and ending with the arrival at
the consignee’s facility.

Tenth Value Thickness (TVT)

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Thickness of the shielding material required to reduce the intensity of radiation to one-
tenth of the initial value.

Radiation Worker
Any person who is occupationally exposed to radiation and who in the opinion of the
regulatory body should be subjected to radiation surveillance.
Zoning
Classification of radioactive areas within a radioactive facility, based on the nature of
operations carried out in the area and the potential for the spread of radioactive
contamination from the area.

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 SPECIAL DEFINITIONS
(Specific for the present ‘Safety Guide’)

Enclosures
Enclosures are containment to prevent the spread of radioactive contamination, protecting
the operators from external radiation exposure and, if required, providing a controlled
atmosphere for processing and/or taking care of the safety aspects.

Fume Hood
Fumehood is a partial enclosure in a radioactive laboratory used when contamination and
external hazards are not significant. An opening of the front panel provides an access for
the handling of the material. Laboratory air is exhausted through the opening to provide
the required number of air changes.

Hot Cell
Hot cell is a shielded and ventilated enclosure which is kept under negative pressure
(inside) and is equipped with remote handling tongs or master-slave manipulators to
handle large amount of radioactive materials, emitting high intensity radiation.

Glove Box
A glove box is a leak-tight total enclosure with a negative pressure inside. The box has
transparent walls/windows and fitted with flexible and good quality gloves for hand-entry
and required handling.

Off-gas (Exhaust) Treatment Systems

Exhaust air from reaction vessels, precipitation tanks, enclosures in radioactive
laboratories, containing radioactive aerosols, volatile chemicals, acid fumes, etc. is
termed as off-gas. This needs to be treated to meet the regulatory requirement for
discharge to the environment. The systems such as air filters, bubblers, condensers,
scrubbers, etc. are used for treating the off-gas and are referred as off-gas treatment
systems.

Radiochemical Purity
The fraction of the total radioactivity in the desired chemical form.

Radionuclide Purity
The fraction of the total radioactivity in the form of the stated radionuclide.

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14
 CONTENTS

FOREWORD 3
DEFINITIONS 5
SPECIAL DEFINITIONS 13

1. INTRODUCTION 17

1.1 General 17
1.2 Objective 17
1.3 Scope

2. CONSENTING REQUIREMENTS FOR RADIOISOTOPE 19

HANDLING FACILITY

2.1 General 19
2.2 Requirements for Siting 19
2.3 Requirements for Design and Construction 20
2.4 Requirements for Operation 24

3. DESIGN AND OPERATIONAL CONSIDERATIONS 25

3.1 General 25
3.2 Type III Laboratories 25
3.3 Zoning of Areas 26
3.4 Enclosures 27
3.5 Shielding 27
3.6 Ventilation 28
3.7 Emergency Power Supply 30
3.8 Automation/Mechanisation 30
3.9 Security of Radiation Sources 30
3.10 Access Control 31
3.11 Manpower Qualifications and Training 31
3.12 Transport of Radioisotopes 31
3.13 Industrial, Fire and Chemical Safety 32

4. RADIOLOGICAL SAFETY CRITERIA 33

4.1 General 33
4.2 Safety Provisions and Practices 33
4.3 Radiation Exposure Control 34
4.4 Radiological Safety Officer (RSO) 34
4.5 Monitoring – Individual and Workplace 34
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 4.6 Health Physics Instruments (Portable and Installed) 36
4.7 Maintenance of Records 36
4.8 Environmental Safety 37

5. EMERGENCY PREPAREDNESS 38

5.1 General 38
5.2 Events 38
5.3 Types of Emergency 38
5.4 Emergency Preparedness Plans 39

6. QUALITY ASSURANCE (QA) 40

6.1 General 40
6.2 QA Programme for the Facility 40
6.3 QA for Radiation Protection Instruments 41
6.4 QA for Packaging/Packages 41
6.5 Radiopharmaceuticals 41

7. DECOMMISSIONING OF FACILITIES 43

7.1 General 43
7.2 Safety Assessment 43
7.3 Decommissioning Operation 43

8. RADIOACTIVE WASTE MANAGEMENT 44

8.1 General 44
8.2 Radioactive Waste Handling Procedures 44
8.3 Regulation for Radioactive Waste 45

ANNEXURE-A: DESIGN FEATURES OF TYPE III RADIOISOTOPE 46

FACILITY
ANNEXURE-B: MAXIMUM INVENTORY OF ACTIVITY AND 47
MODIFYING FACTORS

ANNEXURE-C: DIFFERENT TYPES OF HANDLING 48

FACILITIES – ENCLOSURES

ANNEXURE-D: AERB SAFETY DIRECTIVE 52

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BIBLIOGRAPHY 54

LISTS OF PARTICIPANTS 56

SAFETY COMMITTEE FOR BRIT FACILITIES (SCBF) 56

STANDING COMMITTEE FOR REVIEW AND REVISION 57

OF AERB’S RADIATION SAFETY DOCUMENTS (SCRRRSD)

ADVISORY COMMITTEE ON RADIOLOGICAL SAFETY (ACRS) 58

LIST OF REGULATORY SAFETY DOCUMENTS ON RADIATION 59

SOURCES

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18
 1. INTRODUCTION

1.1 General

Facilities for handling of radioisotopes should be designed and operated with

special care in view of the potential radiation hazards associated with the
operations involving radioactivity. This guide elaborates various requirements
with a view to ensuring the safety of the occupational workers and members of
the public as well as the environment against such hazards, while setting up and
operating such facilities. In India, control on handling radiation and
radioisotopes is exercised as per the provisions of Atomic Energy Act, 1962 and
the Atomic Energy (Radiation Protection) Rules, 2004, made thereunder.
Atomic Energy Regulatory Board (AERB) lays down the safety standards and
formulates appropriate rules and regulations towards ensuring safety associated
with such activities.

1.2 Objective

The objective of this safety guide is to provide guidance for implementing

radiation safety requirements in facilities handling radioisotopes in order to:
(a) ensure that workers and members of the public are not exposed to
radiation, in excess of limits, specified by the competent authority, under
the Atomic Energy (Radiation Protection) Rules, 2004, and safety
directives issued by the competent authority from time to time;
(b) reduce such radiation exposures to levels as low as reasonably achievable
(ALARA);
(c) ensure safe handling, physical security of radioactive materials and
management of radioactive wastes;
(d) provide means for detecting/assessing of hazardous situations and
initiating prompt remedial measures towards mitigating consequences; and
(e) ensure accounting and recording of use of radioactive materials.

1.3 Scope

This document provides the regulatory guidance for a typical Type III
radioactive facility, meant for handling of radioisotopes/radioactive substances
in all forms, in all stages, starting from receipt of raw materials,
production/processing, possession, interim storage, dispatch, transportation and
management of the radioactive waste generated.
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Such facilities are engaged in commercial scale production of radioisotopes and
radiopharmaceuticals used for medical, industrial and research applications.

The safety guide is not applicable to radiation facilities or research facilities

which are handling sealed radioactive sources for medical, industrial and research
applications.

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 2. CONSENTING REQUIREMENTS FOR RADIOISOTOPE HANDLING
FACILITY

2.1 General

Facilities for processing of reactor-irradiated targets and handling of radioisotopes

are specially designed, constructed and operated to meet the objectives of
occupational radiation protection, safety of the members of the public and the
environment. Approval should be sought from the Competent Authority at the
following stages:

(a) Siting
(b) Design and Construction
(c) Commissioning and Operations
(d) Decommissioning

2.2 Requirements for Siting

Any application for obtaining consent for setting up of a radioisotope handling

facility should be submitted to AERB with comprehensive details of the proposed
site. A site evaluation report (SER) should be prepared and submitted along with
the application.

The SER will be reviewed by AERB before according clearance of the site for the
setting up of the proposed facility. The land ownership document and necessary
permissions for industrial use of the site from the local bodies should be submitted
by the applicant alongwith the SER.

Some of the important aspects assessed by AERB with respect to the proposed
site for the radioisotope production/handling facility are:

(a) The location of the project whether it is in an industrial area (and not in a
residential premise, and not in premises shared with a public area)
(b) Existing or proposed industrial and public facilities in the vicinity of the
project and the evaluation of risk-factors from these to the proposed
radioisotope laboratory facility and vice versa
(c) Water table in the area and underground water movement to assess the
potential hazard due to flooding of the facility
(d) Flooding history of the site in last fifty years
(e) Seismic history of the site for in last fifty years
(f) Soil characteristics of the site (applicable only if there is the possibility of
the formation of activation products, e.g. a cyclotron facility)
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2.3 Requirements for Design and Construction

An application for obtaining approval of the design and construction of the

facility should be accompanied by a preliminary safety analysis report (PSAR).
The PSAR should give details of the site, design features of the facility and
describe the operations proposed to be carried out in the new facility. The PSAR
should identify the potential hazards to the proposed facility, describe and analyze
the adequacy of the measures to be taken in order to eliminate, control or mitigate
the identified hazards. The report should analyze and evaluate potential accidental
situations and their associated risks. It should set forth the radiological protection
design aspects of the facility and the envisaged radiation protection programme
for the protection of occupational workers, public and the environment.

PSAR should have typically the following sections:

(a) Summary
(b) Site - description and assessment
(c) Design criteria for the facility
(d) Description of operations
(e) Safety analysis
(f) Quality assurance programme
(g) Health, safety & environment management programme
(h) Waste management programme
(i) Environmental monitoring programme
(j) Radiological emergency preparedness
(k) Security plan for the facility
(l) Decommissioning

Details to be furnished in each of the above sections are as follows:

(a) Summary

This section should contain a brief summary of the objective, operations and
potential benefits of the facility.

(b) Site Description and Assessment

This section should provide information on:

(i) The location of the facility with a sitemap
(ii) Demographical details
(iii) Details about the water sources in the vicinity
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 (iv) Seismicity of the site, if the proposed laboratory is to handle large
quantities of radioactivity
(v) Data on frequency, intensity, and cause for flooding in the past 50 years.
(vi) Site drainage facilities and analyses.

(c) Design Criteria for the Facility

This section should include the following:

(i) Purpose of the facility
(ii) Raw materials and products
(iii) Site plan
(iv) Building plan and structural details
(v) Laboratory layout
(vi) Instrumentation to ensure safety in the related processes
(vii) Description of service and utility systems
(viii) Criteria for the design of the ventilation and off-gas systems
(ix) Radioactive waste handling systems
(x) Other safety related systems viz. industrial, fire and chemical safety.

(d) Description of Operations

This section should focus on potential hazards that could result from
processes/operations such as:
(i) Description of operation of facility and process/operations to be conducted
in the facility
(ii) Typical and maximum quantities and forms of radioactive materials,
utilised, or stored in the facility
(iii) Summary of chemical and mechanical processes and control/support
systems
(iv) Availability of written procedures for the receipt, storage, handling, and
transfer of radioactive materials
(v) Availability of checklist for assessing integrity of the processing
equipment
(vi) Methods for maintaining safe control during normal and abnormal
situations or conditions
(vii) Operational reliability and maintenance
(viii) Provisions to ensure continued safe-operations or safe-shutdown under
accident or abnormal conditions.

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(e) Safety Analysis

This section should contain an analysis of credible accidents of a serious nature

that could result from failure of operational systems and/or from natural
phenomena. Accidents should be assessed for the radiological impact on the
workers, on general public and on environment.

(f) Quality Assurance Programme

This section should include details such as:

(i) Specifications and procurement documents
(ii) Inspection, surveillance, and testing
(iii) Radiometry of hot-cells and other shielded facilities
(iv) Quality assurance (QA) records
(v) QA audits

(g) Health, Safety and Environment Management Programme

This section should include details of:

(i) Health and safety organization
(ii) Radiation protection programme and RSO
(iii) Industrial hygiene and safety
(iv) Fire protection and control
(v) Environmental safety programme

(h) Waste Management Programme

This section should include a description of the waste management program.

(i) Waste management criteria
(ii) Characteristics, concentration and volumes of radioactive wastes
(iii) Radioactive gaseous waste treatment, if any
(iv) Liquid waste management
(v) Solid waste management

(i) Environmental Monitoring Program

This section should describe various components of environmental monitoring

programme to measure radiation / radioactivity levels:
(i) Perimeter monitoring
(ii) Liquid and gaseous effluent monitoring schemes
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 (iii) Environmental soil monitoring
(iv) Environmental water monitoring

(j) Radiological Emergency Preparedness and Response Plan

This section should discuss the provisions made for handling radiological
emergencies. Topics discussed should include:
(i) Potential emergency scenarios
(ii) Emergency-response plans and resources
(iii) Radiation emergency exercise

(k) Security Plan for the facility

This section should have a description of the physical security plans for the
facility. Security of the radiation sources and radioactive materials is to prevent
unauthorised access, damage to, loss of, theft or unauthorised transfer of
radioactive sources. Depending upon the vulnerability of the sources, specific
security plan should be in place implemented. The security plan should include:
(i) Appropriate designing of the facility in order to minimise the feasibility of
malicious actions and to maximise the security considerations
(ii) Prevention of unauthorised access
(iii) Surveillance and alarm system
(iv) Accounting and periodic inventory
(v) Minimisation of consequences of any malevolent use of source
(vi) Reporting to AERB.

(l) Decommissioning

This section should provide the decommissioning plan for the facility under the
circumstances such as the useful life of the facility being over, or the licensee
and the AERB decide to decommission the facility. The plan should ensure that
there are no radiological hazards present in the site after decommissioning.
Some of the requirements are:
(i) Radiological characterisation and activity assessment before
decommissioning
(ii) Availability of technical expertise for decommissioning
(iii) Details with respect to the provision and availability of appropriate
gadgets/equipment
(iv) Resources – technical and financial
(v) Radiological survey

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 (vi) Waste management plan
(vii) Reporting to the regulatory body
(viii) Record keeping

2.4 Requirements for Operation

While seeking license for operation of the facility, the following documents
should be submitted:
(a) Final Safety Analysis Report (FSAR)
The FSAR should reflect the facility as built and include the results obtained
during pre-commissioning tests
(b) Standard operating procedures (SOP)
(c) Technical specifications
(d) Radiation protection manual
(e) Emergency operating procedures (EOP)
(f) Radiation emergency preparedness and response plans
(g) Record of training and qualified/certified manpower
(h) A report on the pre-operational testing and operating startup plans which
should demonstrate that the facility, equipment and processes meet safety
and design intent as described in the PSAR. Test results should be presented
to verify the integrity of the facility, equipment, and process and to
substantiate the safety analysis. Results obtained from carrying out the plans
should be reported as an appendix to the completed application.

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 3. DESIGN AND OPERATIONAL CONSIDERATIONS

3.1 General

The facilities to handle significant quantities of radioisotopes should be designed

so as to ensure that the radioactivity is totally contained and the operations are
conducted safely. The design considerations should ensure radiological safety of
the occupational workers, members of the public and the environment.

3.2 Type III Laboratories

The design safety features of a radioactive facility will depend both on the
inventory and radiotoxicity of the radionuclides handled. Radioisotope facilities
are classified into three categories, Type I, Type II and Type III, depending on
the quantity of different radioisotopes that can be handled in such facilities.
Type III facilities where radioisotopes are handled in commercial scale should
have higher design safety features as compared to other types of facilities.
Annexure-A give the design safety features of a Type III facility.

The radioisotopes are classified into four Groups, 1 to 4, in the order of very
high, high, moderate and low-radiotoxicity hazard, based on the relative
radiotoxicity per unit activity of the radionuclide. The classification is based on
the most restrictive (inhalation/ingestion) ALI (Annual Limit on Intake) values
(ICRP-61, 1991) and specific activity of the radionuclides. Radionuclides which
are highly toxic and with very low ALI-inhalation values are in hazard Group 1,
whereas radionuclides with low toxicity, low specific activity materials such as
natural uranium ore and thorium minerals are placed in Group 4.

Some of the radionuclides of interest are classified as follows:

Very high hazard : 210Pb, 210Po, 226Ra, 90Sr,

(Group 1)

High hazard : 125I, 131I, 99Mo, 32P, 212Pb, 192Ir, 60Co, 89Sr, 90Y
(Group 2)

Moderate hazard :82Br, 14C, 51Cr, 18F, 3H, 24Na, 32S, 153Sm, 99mTc
103
(Group 3) Pd

Low hazard :99Tc, nat U, nat Th

(Group 4)

27
 Typical quantities of radionuclides that should be handled in the Type III
laboratory for various groups of radionuclides are given in Annexure-B.
Depending upon the nature of operations and the associated hazard potential,
modifying factors should be applied to arrive at the maximum amount of activity
that can be handled in the laboratories. These modifying factors are also given in
the Annexure-B. Most of the radionuclides of interest in medical and industrial
applications belong to medium toxicity (Group 2 and Group 3).

3.3 Zoning of Areas

The working areas in a radioisotope facility are segregated, based on the potential
for external exposure and for spread of radioactive contamination. The areas are
classified as "white", "green", "amber" and "red" areas or zones.

TABLE 1: TYPICAL CLASSIFICATION OF LABORATORY AREAS

Zone Access Control Typical Examples and Requirements

White Unrestricted. General Office rooms, where there is no radioactive
background level is prevailing source and no radioactive contamination.
Green Access generally permitted only Health physicists’ room, control room,
to radiation workers. Change of counting room, packing room etc. Being
clothing not necessary. Radiation adjacent to radioactive areas, potential for
level: < 1µSv/h; Airborne radioactive contamination exists. Very low-
activity: <0.1 DAC; and Area active electroplated sources or sealed test
contamination: <0.1 DWL. sources (up to a few MBq) stored in
(Derived working level) appropriately shielded containers, are only
allowed to be handled here.
Amber Controlled areas, Access limited Laboratory areas where radioisotopes are
to radiation workers, entry with handled. Radiation and contamination
proper protective clothing monitoring required. Certain level of surface
through (shoe cover, lab contamination only is allowed. A ventilation
coat/overall, cap if required for system (once-through) having supply and
the process) the barrier. Airborne exhaust through HEPA filters should be in
activity: <1 DAC; Area place. The air activity should be continuously
contamination:< 1 DWL monitored and it should be below derived air
concentration (DAC) levels. TLD dosimeter
should be worn at all times. Other dosimeters
such as pocket dosimeter should be issued for
special operations or jobs involving high
radioactivity.
Red Access to this area is not Areas inside enclosures such as fume hoods,
envisaged during normal glove boxes, shielded boxes and hot cells
operation of the facility. Access where open radioactive sources/materials are

28
 is only through special work handled. External radiation dose levels, air
permit (SWP), with special activity levels and surface contamination levels
protective clothing and can be expected to be high in the red zones.
respiratory protection, as
specified by RSO.

3.3.1 Zoning Requirements

(a) The various zones should be clearly demarcated and identifiable. TLD badges
should be stored and issued in white zone, before the barrier.
(b) A physical barrier and shoe-covers should be provided at the barrier of green
to amber zones. Fresh and used shoe covers should be kept separately.
(c) Additional localized barrier should be erected as and when necessary to
control spread of contamination, particularly during maintenance work.
(d) A change room and decontamination room should be provided at the entry
point to amber zones. Appropriate display boards should be provided to
indicate the requirements for the change of clothing or use of shoe covers.
(e) Hand, foot and clothe monitoring equipment should be made available at exit
point of the facility.
(f) Shower facility as well as decontaminating agents should be provided for
decontamination of the personnel, if necessary.

3.4 Enclosures

Enclosures are the most effective means for restricting spread of radioactivity into
work and general areas. For operations involving open sources / radioactive
materials, suitable enclosures should be provided in the laboratories by way of dry
boxes, fume hoods, glove boxes, shielded boxes or hot cells/mini hot cells
(Annexure-C). These enclosures are physical barriers that together with
ventilation and operating systems prevent leakage/release of radioactive materials
into the workplace and to the environment. The operations in shielded cells and
mini-hot cells/hot cells should be conducted using appropriate remote handling
equipment such as tongs or mini-manipulators / master-slave manipulators or
special gadgets of appropriate size for remote and safe handling of the radioactive
materials.

3.5 Shielding

Radiation sources should be stored, processed and packed in designated areas

with adequate shielding to meet the requirements of the regulatory body. Factors
considered in the design should include the build-up in the shielding material,
29
 allowances for voids and streaming, structural integrity of the shield-wall etc.
Shielding requirements should meet the regulatory limit of < 1 µSv/h in fully
occupied areas.

3.6 Ventilation

Ventilation system should provide a supportive role to the physical containment

systems by ensuring an adequate and directional air supply to maintain the
required air changes in various work areas and air-flow rate across the fume
hood openings.

The design of an appropriate ventilation system requires preliminary safety

analyses, taking into account:
(a) Radiological hazards arising from the radioactive materials and nature of
operations, levels of activity, classification of areas, acceptable levels of
contamination, etc.
(b) Effects on ventilation from possible natural and man-made events
(c) Authorized discharge limits.

The ventilation design should be such that the air concentration in full occupancy
areas should not exceed 1/10thof DAC values.

The ventilation system, normally once-through type, should be so designed as to

direct the air-flow from white zones to green zones, green to amber zone and
finally exhausted out through red zone via a chimney which is taller than
buildings nearby to ensure efficient dispersion of the releases. In white zones, re-
circulatory ventilation system should also be installed.

Sufficient inter-zone pressure differential is maintained to prevent back-flow of

air from higher radioactive zones to lower radioactive zones. The total exhaust is
generally designed to be about 10% higher than the supply air to maintain the
inter-zone pressure differential. Stand-by blower/fan should be provided to
ensure continued safe operations or for safe shut-down during malfunctioning of
the equipment. Table 2 gives the typical pressure gradients maintained across
different zones in a radioisotope laboratory. Table 3 gives the typical number of
air changes maintained in different zones of radioisotope laboratory.

30
 TABLE 2: PRESSURE DIFFERENTIAL IN INTER-ZONE AREAS

Inter-zone Pressure Differential in mm of Water Column (W.C.)

White to Green 2 (19 Pascal)
Green to Amber 5 to 10 (49 to 98 Pascal)
Amber to Red 15 to 45 (147 to 441 Pascal)

TABLE 3: NUMBER OF AIR CHANGES IN DIFFERENT ZONES

Type of Zone Number of Air

Changes/h
White 4
Green 6 to 8
Amber 8 to 15
Red 20 to 25

Separate exhaust ventilation system should be designed for general lab

ventilation and for off-gases from the enclosures (fume hoods, glove box, and
shielded boxes), for filtration of any airborne radioactive particles. The exhaust
system should provide the necessary negative pressure inside enclosures with
respect to operating area. Over-pressurisation of enclosures should be prevented
by providing pressure-relief valves. Exhaust air from glove boxes and shielded
boxes, after filtration through HEPA or charcoal filters (for radioiodine) join the
duct carrying general lab ventilation, and gets filtered again through HEPA
filters before being released to the environment. Releases to the environment
should be within the limits prescribed by the regulatory body.

The design of equipment for air cleaning systems such as absorber columns,
scrubbers, etc. will be different depending upon type, concentration and
chemical nature of airborne radioactive contaminants generated in the
enclosures. Design provisions should be kept to clean-up the exhaust air during
anticipated operational occurrences and also consequent to accidental situations.

The air cleaning equipment may be activated charcoal absorber, water/alkaline

scrubber, condenser, high efficiency particulate air filters, etc. The exhaust air
cleaning system should be designed such to facilitate maintenance and
31
 replacement of components resulting in least exposures to the personnel and also
to control the spread of contamination is possible. Collection of discharge gases
from hot cells into containers and allowing it to decay prior to discharge is
followed in the case of short-lived isotopes produced in cyclotron facilities.

The materials used for construction of the ventilation systems, including air
cleaning systems/filters should be corrosion resistant (for nitric acid, NOx fumes,
etc.) and should adequately be fire resistant, and the system should be able to
confine small fires or explosions. Heat/fire detection devices and alarm systems
should be provided to alert the control room personnel in such situations. The
system should be able to withstand earthquakes or floods of stipulated levels,
specific for the facility/site. Different enclosures for handling radioisotopes,
such as fume hoods, glove boxes and hot cells are given in Annexure-C.

3.7 Emergency Power Supply

The facility should be provided with emergency power supply with diesel
generators of adequate capacity, in order to cater to the power needs of critical
equipment, in case of failure of the mains supply. All the exhaust systems from
radioactive enclosures, safety-related radiation monitoring system and fire
detection system should be provided with emergency power supply.

3.8 Automation/Mechanisation

Design provisions should be available to handle the sources, including chemical

processing of radioactive materials, so as to prevent individual exposures of
workers from exceeding the stipulated limits.

Depending on the type of process/operations, suitably and specially designed

remote handling systems should be fitted into the shielded boxes and hot cells.
Reliable and well-tested equipment should be installed inside the shielded
enclosures such that their maintenance requirements will be low. For critical
equipment, there should be stand-by arrangements for operational convenience
and have minimal intervention of maintenance personnel so as to prevent
radiation exposure. Automation should be resorted to wherever repetitive
operations involving radioactive materials are envisaged.

3.9 Security of Radiation Sources

Radiation sources should be kept secure so as to prevent theft or damage. Loss of

control of radiation sources and malevolent events can lead to potential exposure
32
 situations. The basic principles applicable to the security of radiation sources in
order to prevent theft or damage are given in the Code of Conduct on the Safety
and Security of Radiation Sources (IAEA, 2004) and AERB Safety Guide titled
‘Security of Radioactive Sources in Radiation Facilities’, (AERB/RF-RS/SG-1).

3.10 Access Control

Access to the facilities should be controlled by the appropriate requirements

such as:
(a) Access to only authorised persons to the facility and to the radioactive
areas
(b) Appropriate interlocks for the access
(c) Physical barriers at the entry to the radioactive areas
(d) Proper administrative controls such as mandatory use of biometric
verification, intrusion alarms, permits, etc.

3.11 Manpower Qualification and Training

Handling of radioactivity should be carried out only by adequately qualified and

appropriately trained personnel. The facility should designate one of its staff
members with qualifications as stipulated by AERB as Radiological Safety
Officer (RSO), and the same personnel should be approved as RSO by the
Competent Authority. The radiation workers should be made familiar with the
radiological safety aspects of the facility including the use of personnel
monitoring and protection devices. Periodic refresher courses should be planned
for personnel handling radioactivity. Depending upon the process requirement and
type of the facility, adequate number of trained man power should be available for
the operation of the facility.

3.12 Transport of Radioisotopes

The radioactive material, depending upon the type, radiations emitted and the
quantity, should be appropriately shielded, packed and labeled to meet the
regulatory requirements for storage and transportation, in terms of proper
authorisation, documentation, radiation leakage rates from the package, and
security of the source. The surface of the package should be free of any
radioactive contamination.

The areas used for the preparation of packages, interim storage of the packages
and for dispatch, should be identified accordingly with caution boards. Adequate
33
 shielding should be provided for the storage area. The area should have an area
gamma monitor, should be under regular surveillance by the RSO. In-house
movement of the radioactive sources/samples should be recorded and the source
movement should be always accompanied with the radioactive material transit
tags giving the source details.

Transfer of sources from one authorised user to the other authorised user should
be carried out only after completing all the necessary regulatory requirements,
including the required authorisation to receive the source. The potential recipient
of radioisotope should be made aware of the regulatory requirements and should
be responsible for the safety and accountability of the source.

In cases of transfer of sources to any other agency, the sources should be properly
shielded, packed, monitored and tagged. The source package should be
accompanied with appropriate documentation and necessary clearance from the
regulatory body for transportation. Prior acceptance from the agency which
receives the package should be obtained before the dispatch of the package.

Safety of the package during transport should be ensured as per the transport
regulations. Transport of all radioactive packages should be as per the AERB
Safety Code on ‘Transportation of Radioactive Materials’, AERB/NRF-TS/SC-1
(Rev-1) under preparation.

3.13 Industrial, Fire and Chemical Safety

The design of the radioisotope laboratory should take into account requirements
of industrial safety as per the national standards in order to ensure the health and
welfare of the occupational workers. All chemicals and hazardous materials
should be stored and used as per the standard guidelines. Fire safety should be
ensured in the facility-design in particular with respect to the ventilation system.
The safety aspects considered should include fire prevention, detection and
mitigation systems.

34
 4. RADIOLOGICAL SAFETY CRITERIA

4.1 General

During the handling of radioisotopes in a facility, exposure to radiation can occur

to the occupational workers as well as to the members of the public. An
appropriate radiation protection and safety programme should be established for
control of both occupational exposure as well as public exposure.

4.2 Safety Provisions and Practices

The basic principles of protection and safety to be considered in the design of

radioisotope laboratories are:

(a) All sources of radiation should be contained and shielded.

(b) The radiation level in normal, full-occupancy areas shall not exceed 1µSv/h.
(c) The ventilation design should be such that the air concentration in full occupancy
areas should not exceed 1/10th derived air concentration (DAC) values.
(d) Systems and components should be designed, constructed, operated and
maintained so as to prevent accidents as far as possible.
(e) Provisions should be made for reducing, as far as practicable, the contribution of
human error resulting in accidents and other events that could give rise to
radiation exposures.
(f) Provision for radiation monitoring should be available where conditions for
normal and potential exposure exist.
(g) The layout of the controlled areas should be such that there is a single entry and
exit point at the controlled areas with proper barriers and interlocks.
(h) Operational safety and radiation protection should be ensured by good
engineering and sound management, quality assurance, trained and qualified
personnel and comprehensive safety assessments.

4.3 Radiation Exposure Control

The normal exposures of individuals shall be restricted below the limits

prescribed by AERB (AERB Directive No. 01/2011 provided as Annexure D).
Further, all efforts should be made by the facility to keep the exposures as low as
reasonably achievable (ALARA).

35
4.4 Radiological Safety Officer (RSO)

A person having appropriate training, qualifications and experience as prescribed

by AERB should be designated as RSO by the employer with the written approval
of the Competent Authority. The Responsibilities of the RSO are specified in
Rule 22 of Atomic Energy (Radiation Protection) Rules, 2004.

4.5 Monitoring – Individual and Workplace

Operational radiation protection monitoring practice is an important aspect of

safety and is needed to ensure and demonstrate an appropriate level of protection
to the radiation workers, the members of the public and the environment. The
general objective is the assessment of individual exposures, both internal and
external, and to assess radiological status of the work areas.

4.5.1 Individual Monitoring

The doses due to exposure from external sources should be assessed by systematic
individual monitoring of the workers using TLD. The RSO should ensure that all
radiation workers use the prescribed personal dosimetry device while working in
the radiation area.

In situations where the dose rates vary considerably or during maintenance

operations, an additional electronic direct reading dosimeter (pocket dosimeter)
should be used. In other situations of handling radiation sources where the
radiation levels are expected to be higher, wrist TLD badges should also be used
to evaluate the dose to the extremities. Proper arrangement should be made for
issuing, storing, timely returning of the dosimeters and measurement of the
accrued doses.

Low level contamination monitors using GM counters should be installed at the

zone barriers for monitoring of hand, foot or clothing of the personnel.
Contamination, if detected, should be removed in consultation with the RSO.

Those radiation workers who have potential for internal contamination as assessed
by the RSO should be sent for assessment of internal exposure.

36
4.5.2 Workplace Monitoring

Work place monitoring should be carried out:

(a) Routinely, during normal operations

(b) Whenever, there is a change in the nature and type of operations
(c) Comprehensive monitoring during incidents/accidental situations.

4.5.3 Area Monitoring

Wall mounted area gamma monitors should be installed at carefully chosen

locations of the facility to record the radiation levels in the working areas. In
addition, periodic surveys of the facility with hand held radiation survey meters of
an appropriate type should be carried out by the RSO.

Air Monitoring: The amber areas of the facility should be checked for any
contamination of the working environment by installation of continuous air
monitors. In addition, whenever some special work is carried out or failure of the
ventilation system occurs, spot air samples should be collected and analysed for
checking the air activity levels.

Surface Contamination Monitoring: Presence of surface contamination may cause

intake of the contaminant, either through inhalation or ingestion route. All the
surfaces in the amber area should be routinely monitored by wipe tests to check
the possible presence of loose contamination. The presence and identification of
the radionuclide(s) in the wipe samples can be determined using appropriate
radiation measuring instruments. A direct reading surface contamination monitor
to measure the levels of surface contamination should also be employed. The
contamination levels are then compared with the Derived Working Levels (DWL)
for further action.

4.5.4 Decontamination
The contamination may involve personnel, clothing, equipment or working
surfaces. The radioactive contamination may be fixed, loose or partly fixed. When
the levels of contamination exceed the DWL values stipulated by the AERB,
decontamination should be carried out to in order to bring down the levels to the
acceptable values. The decontamination room should be equipped with all the
decontaminating agents and should have eye wash equipment and a shower
facility.

37
4.6 Health Physics Instruments (Portable and Installed)

The isotope laboratory should be equipped with adequate number of appropriate

health physics instruments, as an essential part of radiation protection programme.
The instruments required for carrying out radiation protection surveys include the
following:

(a) Radiation survey instruments (GM survey-meter)

(b) Pancake-type GM survey meter is recommended for monitoring low
energy radionuclides such as 35S.
(c) Radiation monitoring and alarm systems: area gamma monitors,
continuous air monitors, and neutron monitors (in medical cyclotron
facilities)
(d) Hand, foot and clothing monitor
(e) Health physics counting room instruments such as beta and gamma
activity measurement systems.
(f) Stack monitoring system wherever applicable.

The instruments used for monitoring should be tested periodically using a test
source before taking a measurement. The periodic calibration of radiation
protection instruments should be carried out in an accredited calibration facility as
specified by the regulatory body.

4.7 Maintenance of Records

Every facility should adopt an appropriate procedure for preparation, reporting
and maintenance of the following records:
(a) Radiation monitoring data in the work place
(b) Individual dose records for radiation workers
(c) Record of calibration of radiation protection instruments
(d) Record of the monitoring of liquid, gaseous and solid waste monitoring
(e) Records of transfer of liquid and solid waste and disposal of gaseous waste
(f) Records of significant events
(g) Actions taken in cases of non-compliance with regulations
(h) Carrying out periodic exercises to evaluate emergency preparedness
(i) Training and refresher programmes related to safety.

The suggested retention period for records of work-place monitoring, calibration

of survey-related instrument is five years. The exposure records for each worker
38
 should be preserved during the worker’s life and afterwards, at least, until the
worker attains or would have attained the age of 75 years, and for not less than 30
years after the termination of the work involving occupational exposure.

4.8 Environmental Safety

Routine operations in most facilities generate low level gaseous and liquid
effluents which should be managed safely. Appropriate sampling and monitoring
programme should be established to fulfill the requirements of demonstrating
compliance with the discharge levels authorized by AERB. All environmental
releases from facilities are governed by the limits authorised by AERB as per the
Atomic Energy (Safe Disposal of Radioactive Wastes) Rules, 1987 and/or as
stipulated in approved technical specifications for the facility.

4.8.1 Monitoring of the Environmental Releases

Off-gases, chemicals or some residual radioactivity (e.g. 3H, radioiodine) from
various equipment and the ventilation exhaust from the facility should be routed
after HEPA filtration to a chimney of appropriate height to ensure adequate
dilution and dispersion. The environmental releases should be monitored for the
radioactivity content to ensure that the discharges are within the limits prescribed
by AERB.

39
 5. EMERGENCY PREPAREDNESS

5.1 General
Emergency situations requiring urgent attention may arise during the operation of
a facility. This may be either a consequence of an accident or a result of a
malicious act. In such situations, protective actions are undertaken whenever,
such actions are justified. Optimisation of the actions is required to be done in
order to produce the maximum benefit.
5.2 Events
Event is an occurrence of an unplanned activity or deviation from the normal
activity. It may either be a single or a sequence of occurrences which may lead to
an incident/accident. Such occurrences should be reported to AERB without any
delay.
5.3 Types of Emergency
Emergency situations can arise in a facility due to which the radioactivity in
significant quantities can get released from the containment to working areas and
the adjoining areas. Such situations are termed as Plant Emergency. The activity
is locally contained without any releases outside the plant boundary. Immediate
steps should be taken to bring the situation under control.
Typical examples of minor incidents that can occur in Radioisotope processing
and handling facilities are:
(a) Spillage of radioactive solutions/liquids
(b) Severe Personnel contaminations
(c) Minor injuries while transferring radioactive solutions/liquids
(d) Misplacement or loss of sources.

Any uncontrolled radiological situations in the facility, such as incidents of

serious nature may cause radiation exposures to the plant personnel and the
radioactivity can get released out of the site boundary into the environment which
may result in public exposures.
Some of the more serious radiological emergency situations that can arise in
radiation source/material handling are:
(a) Deliberate dispersion of radioactive materials in public areas with malevolent
intentions
(b) Widespread contamination due to loss of sources
40
 (c) Release of radioactivity due to rupture of exhaust filters
(d) Major spillage of radioactive liquids
(e) Temporary loss of shielding for sources
(f) Rupture of sealed sources
(g) Fire in radioactive areas.

In addition to the above mentioned possible accidental scenarios in facilities

(plant emergencies), accidents may also happen due to many reasons during
transportation of sources, including loss/unauthorised removal of sources due to
terrorism, etc. resulting emergency situations.
5.4 Emergency Preparedness Plans
Every facility should have an emergency plan for responding in case of an
emergency situation and to mitigate the consequences. Essential features of the
plan depend on the radiological evaluation of the facility during normal and
anticipated or foreseeable abnormal situations. A written emergency plan should
be prepared in advance and it should define the role and responsibilities of various
agencies and personnel in the management of the emergency.
The emergency preparedness plans should address inter alia the following:
(a) A quick and reliable monitoring methodology for detection of an emergency
situation
(b) Availability of personnel and material for quick response (emergency
response teams)
(c) A good and reliable communication system
(d) Prompt initiation of the countermeasures.

A list of officers/agencies (fire, security, RSO, etc.) to be contacted during

emergency situations should be prominently displayed in strategic locations in the
facility and also should be circulated among the workers.
The emergency exercises should be conducted at periodic intervals as specified by
the regulatory authority so that all workers and the management are familiar with
the actions to be taken in the event of an emergency. Any deviations observed
during the exercise should be recorded and corrected.

41
 6. QUALITY ASSURANCE

6.1 General
A Quality Assurance (QA) program should be established as part of the radiation
protection program by the licensee/Officer-in-charge of the facility. The program
should be commensurate with the magnitude and the likelihood of potential
exposures from the radioactive sources/materials. Quality control mechanisms
and procedures for reviewing and assessing the overall effectiveness of radiation
protection measures in the facility should be in force.
For the radioisotope handling laboratories, particularly the isotopes used for
medical applications, QA should be part of Total Quality Management (TQM)
Program of the organization, which helps in instilling an attitude for team work
and each individual understands his role and responsibilities in the organisation.
The QA program should cover all safety related structures, systems and
components.
6.2 QA Program for the Facility
A general quality assurance program should be in place in radioisotope
production or dispensing facility, starting with:
(a) The design of the facility and handling equipment (shielding, ventilation,
radiation monitoring etc.)
(b) Wherever applicable, technical specification document should be prepared
and approved by the appropriate authority for compliance during operations of
the facility.
(c) Specifications for raw materials
(d) Specifications for materials of construction
(e) Establishing radiation protection and surveillance programs
(f) Setting standards for commissioning - technical specifications
(g) Checking for shielding adequacy and integrity
(h) Trained and adequate man power
(i) Commissioning to ensure compliance with the design intent
(j) Standard operating procedures (SOP)
(k) Acceptance criteria for products
(l) Documentation at each stage
(m) Incident/event reporting and investigation
42
 (n) Review, approval, issue, distribution and revision as appropriate
(o) Communication/dissemination of information
(p) Maintenance of records to meet regulatory requirements.

6.3 QA for Radiation Protection Instruments

The radiation protection instruments are very important part of the Radiation
Protection Program for any facility. The monitoring and activity measurement
instruments/systems should be procured from qualified vendors to meet the
established criteria and perform as expected to meet the requirements of accuracy
and precision.
Calibration of the instruments should be done at specified time period, against
standard sources of appropriate strength (in terms of energy) of radionuclide. The
calibration facility used should be accredited by the regulatory body.
6.4 QA for Packaging/Packages
QA of various components of packaging should meet the requirement specified
for the given type, physical/chemical form, quantity and mode of transportation of
the radioactive material. Packaging is the assembly of various components
required to enclose and contain the radioactive material contents. These include:
(a) Adequate shielding
(b) Absorbent materials to absorb and contain the radioactive liquid within the
package
(c) Shock absorbing material around the shielded container
(d) Handling provisions, if required.

Packages should meet the labelling requirements as specified for the radioactive
material for safe transportation of different types of radioactive materials.
6.5 Radiopharmaceuticals
Radiopharmaceuticals should be protected from microbiological contamination by
their environment. The quality assurance program should be as per the
requirement of Indian Pharmacopoeia 2014. The facility should meet appropriate
aseptic production conditions such as measuring the number of particles in air,
microbiological contamination, integrity of HEPA filters, determination of fungal
contamination and pyrogenic concentration in the product, etc.
Radionuclide purity and radiochemical concentration should be determined using
well-established quality control techniques using calibrated counting systems and

43
spectrometry systems such as alpha or gamma spectrometry, with the required
accuracy.
Quality assurance of the devices and equipment used in the radioisotope handling
facilities should be well-tested and of standard design and approved quality.

44
 7. DECOMMISSIONING OF FACILITIES

7.1 General
Design of any facility should consider and provide guidelines for the
decommissioning of the facility. Following the completion of useful life of the
facility, there may be requirement for decommissioning. AERB approved plan for
decommissioning should be available at the time of commissioning of the facility.
Plan should address the resources for the decommissioning.
7.2 Safety Assessment
The safety assessment during the decommissioning of radioisotope handling
facility should address the following areas:
(a) Procedures for management hot-spots due to scale formation or deposition
of radioactive materials at some joints/bends/locations due to settling
down/plate-out of activity
(b) Requirement of remote handling mechanisms for heavily contaminated
items
(c) Waste disposal strategies for large quantities of radioactive wastes of
different kind and characteristics, generated during decommissioning
(d) Non-radiological hazards of the decommissioning should also be
identified and action plan should be made available.
7.3 Decommissioning Operation
Decommissioning activities should be controlled through the use of documented
procedures. These procedures should be reviewed and approved by appropriate
agency responsible for ensuring safety. The execution of decommissioning
activities should start only after approval by the Competent Authority.
At the end of the decommissioning activities, the facility or the authorized agency
should demonstrate the stated end-state conditions to the regulatory body, and the
final decommissioning report should be submitted to the regulatory body for
review. The guidance for decommissioning aspects of medical, industrial and
research facilities is provided in the AERB Safety Guide titled ‘Management of
Spent Radioactive Sources and Radioactive Waste arising from the Use of
Radionuclides in Medicine, Industry and Research, including Decommissioning
of Such Facilities’, (AERB/RF/SG/RW-6).

45
 8. RADIOACTIVE WASTE MANAGEMENT

8.1 General
Radioactive waste is generated during the production of radioactive sources and
products and other radiological operations. Such radioactive waste may be in form
of liquid, solid or gas. Appropriate strategy should be in place to manage these
wastes in order to ensure that the radiation exposures to workers and members of
the public are kept within the regulatory limits.
8.2 Radioactive Waste Handling Procedures
Radioactive wastes generated in the facilities during operation and maintenance of
facilities handling radioactive sources/materials, should be managed as per the
requirement of the Atomic Energy (Safe Disposal of Radioactive Wastes) Rules,
1987 and AERB Safety Guide titled ‘Management of Spent Radioactive Sources
and Radioactive Waste arising from the Use of Radionuclides in Medicine,
Industry and Research, including Decommissioning of Such Facilities’,
(AERB/RF/SG/RW-6). This should be ensured by adhering to the stipulated
authorised levels for disposal of the wastes or safe transfer of solid/liquid wastes
to authorised waste management facilities. The radioactive waste generated
should be classified as per the classification basis provided by AERB Safety
Guide titled ‘Classification of Radioactive Wastes’ (AERB/NRF/SG/RW-1).

Solid wastes containing short-lived radioisotopes should be stored for about 10

half-lives and then should be disposed, after monitoring, as institutional waste.

Low-level liquid wastes containing short-lived radionuclides should be stored in

hold-up tanks for sufficient time to allow the radionuclides to decay ensuring that
the radionuclides are in chemical forms which are soluble and dispersible in
water. The waste should be diluted sufficiently to an activity concentration level
which is approved by AERB for disposal in municipal sewer. Organic waste, such
as liquid scintillation cocktail should be disposed as chemical waste after ensuring
the activity concentration is below the limits prescribed by AERB.

The disposal of decayed sources containing GBq/TBq levels of activity needs

special consideration due to the long half-life and high intensity radiations emitted
by the sources. Examples are decayed/disused sources of 60Co, 137Cs and 192Ir.
Such sources should be transferred to the authorised waste management agency
identified by the regulatory body for disposal or sent to the original manufacturer.

46
8.3 Regulation for Radioactive Wastes
The annual limit for disposal of radioactive waste for a given facility is specified
by the AERB in the authorisation issued for disposal of radioactive wastes. The
solid and liquid wastes may be transferred also to authorised waste management
facility after obtaining prior approval from AERB. The facility should maintain
record of the inventory of wastes generated, transferred and disposed. The
radiological protection and surveillance program should include monitoring of the
waste storage and disposal sites.

47
 ANNEXURE-A

DESIGN FEATURES OF TYPE III RADIOISOTOPE FACILITY

A typical Type III facility will have several rooms/laboratories with clear segregation of
areas based on use, scale and type of operation with the radioisotopes. Some of the
features of such a facility are as follows
(a) Polyvinyl floor and epoxy wall surfaces for ease of decontamination
(b) Special table and kitchen cabinets with SS tops
(c) Proper ventilation
(d) Storage safe – concrete/steel/lead
(e) Stainless steel sink (elbow/foot operated tap)
(f) Change room and showers
(g) Fume-hood with absolute filter exhaust
(h) Air and area monitor
(i) Foot, hand and clothing monitor
(j) Decontamination room
(k) Shoe barrier
(l) Shielded enclosures like hot cells, glove boxes, fume hoods, etc.
(m) Master-slave manipulator
(n) Emergency power supply
(o) Planned radioactive waste disposal methods
(p) Foot operated dustbins
(q) Fire safety measures

48
 ANNEXURE-B

MAXIMUM INVENTORY OF ACTIVITY AND MODIFYING FACTORS

INVENTORY OF ACTIVITY

Group of Type III

Radionuclide* Facility

1 >185 MBq

2 > 1.85 GBq

3&4 >18.5 GBq

* Group classification according to radiotoxicity

MODIFYING FACTORS ACCORDING TO TYPE OF OPERATIONS

Procedure / Type of Operation Modifying
Factor
Simple storage x 100
Very simple wet operations such as preparation of x 10
aliquots of stock solutions, dispensing etc.
Normal chemical operations such as analysis, x 1
simple chemical preparations etc.
Complex wet operations with risk of spills x 0.1
Simple dry operations such as manipulation of x 0.1
powders
Dry and dusty operations such as grinding x 0.01

49
 ANNEXURE-C

DIFFERENT TYPES OF HANDLING FACILITIES – ENCLOSURES

C1. Dry Boxes

Dry boxes are simple enclosures to handle low levels of activity. The boxes are
connected to area exhaust system and are partly open from one side. The dry box
isolates the radioactive material from the operator’s environment and an opening
of about 12 inches allows accessibility to the material inside for handling. It is an
all welded construction fabricated out of stainless steel sheets. The linear face
velocity of air across the opening is about 100 - 150 linear feet per minute (30-45
m/min).
The laboratory ventilation air is exhausted through dry boxes and fume hoods.
kBq amounts of beta/gamma activity is handled in dry form and few MBq levels
in solution form in the boxes. Stored amount of activity in dry box should not
exceed 10 times the amount of activity permitted to be handled.
C2. Fume Hood
A fume hood is an enclosed chamber, with a transparent (glass/toughened glass)
vertically rising panel in the front for carrying out of operations. Fume hoods are
located in low level amber areas used for handling low levels of activity. The
actual quantity that can be handled depends on the type of radionuclide, type of
operations (wet/dry), its radiotoxicity and its physical and chemical forms. The
materials for construction of fume hoods can be M.S., S.S., PVC or fiber glass.
Ducts exhausting air from the hoods should be constructed of non-combustible
materials. Occasionally (e.g. during dispensing of high active solutions), lead
shielding may be required in the front of the fume hood to shield the workers from
radiation exposure. The organic solvents used in the chemical operations pose
potential fire hazard. Storage of such solvents should be avoided.
Normally, kBq/MBq amounts of radioactivity are handled in fume hoods. Inside
surface of the fume hood should have smooth finish (epoxy-painted or SS lined)
to provide resistance to corrosion and for ease of decontamination. Services such
as water, gas, vacuum and electricity are provided with the controls located
outside the fume hood.
Containment of material inside the fume hood is achieved by directional air
movement through the front panel opening. The fume hood opening provides
passage for the amber zone ventilation air providing the required number of air

50
 changes in the area. Ventilation of the fume hood is of once-through type. The
minimum face velocity maintained through the front opening (of about 25 cm) of
the fume hood is 0.5 m/s (100 linear feet per min).
The exhaust air from the fume hood is passed through appropriate filters
(example: charcoal filter to retain radioiodine; HEPA filter for particulates), taken
out through the ducting to the general lab ventilation system and released into the
atmosphere through a chimney whose height is about 2 to 5 m above the roof of
the nearest building. The discharge is directed vertically upwards. In situations
where there is a likelihood of radioactivity build-up on the filters, it is advised to
install the filters in a shielded enclosure.
The exhaust fans for the hoods should have a back-up power source, to exhaust
contaminated exhaust air continuously (or until the operations in the hood are
completed) even during power failure situations.
C3. Glove Box
In a glove box, open radioactive sources can be handled in isolation from the
user’s environment. It is a leak-tight total enclosure, with transparent
walls/windows and open ports fitted with flexible good quality gloves (gauntlets)
for hand entry. Portholes and transfer ports with air-locks are provided for
material transfer. Services such as electricity, vacuum, compressed air, effluent
drainage, etc. are provided inside the box.
Operational radiation protection considerations involve periodic monitoring of
integrity of the gloves, healthiness of glove port O-rings, and negative pressure
inside the glove box and dose rates in the vicinity of the gloves box.
Ventilation system for the gloves should be once-through type air supply which is
generally through leakages from the area surrounding the glove box. The normal
leakage rate of a leak-tight glove box is 0.5% of the box volume per hour. The
exhaust from the box is designed so as to provide about 25 mm (water column)
negative pressure inside the glove box using pressure regulating valves.
In an enclosure, at the inside top of the box, absolute filter (HEPA) is provided for
the exhaust air to pass through. Pressure drop across the glove box HEPA filter
should be monitored. Service lines for water, vacuum/compressed air are provided
as per the process requirement. The HEPA filters are replaced when the measured
pressure differential across the filter reaches 100 mm of W.C. or the dose rate on
the filter surface exceeds 2 mSv/h.
Maintenance of adequate negative pressure and periodic checking of the gloves
for pin-hole leaks during operations prevent contaminated air within the box from
leaking into the work environment.
51
C4. Shielded Box
A shielded box (also called shielded tong box) is a shielded air-tight enclosure
fitted with provisions for remote handling, which allows the performance of
operations without subjecting the operators to radiation exposure beyond the
acceptable dose limits. Depending upon the energy of the gamma emissions,
shielded boxes are used to handle beta gamma emitters of MBq levels to TBq
levels. Remote handling tongs are used in these boxes. The walls are constructed
with lead bricks with S.S. lining. Ventilation in shielded boxes is similar to that of
glove boxes. Sufficient numbers of air changes are provided for promoting good
visibility and to dilute sufficiently the airborne activity levels inside the box. The
exhaust from the shielded box passes through double filtration for removal of all
the particulate and gaseous radioactive materials, before it is discharged into the
environment. Sufficient negative pressure is maintained all the time.
Liquid wastes (short-lived, high-level) generated in the operations are stored in
shielded enclosures inside the box, and low level wastes are transferred to delay
tanks.
C5. Hot Cell
Hot cells, in general are used for producing / fabricating sealed radiation sources.
The hot cell is a thick-walled enclosure with remote handling facilities for
handling large quantity (several hundred TBq level) of gamma emitters such 60Co.
Hot cells are usually equipped with master slave manipulators and thick viewing
windows made of high-density lead glass. Almost all physical, chemical and
metallurgical operations can be carried out by remote handling, inside the hot cell.
The design of a hot cell should be carried out after hazard assessment has been
done, taking into account the amount and type of activity to be handled and the
nature of the operation to be carried out in the cell. The concrete shielding should
be adequate to ensure 1 µSv/h dose rate in the working side. Penetrations on the
walls for the service lines and cables and joints/corners should be designed so as
to prevent/minimise the streaming, leakage and scattered radiation contribution to
the dose rate outside the cell. The adequacy of the cell-shielding should be
ensured by radiometry using radiation source of appropriate strength.
Depending upon the nature of operation to be carried out in the cells, ventilation
system is designed to provide sufficient ventilation (20 - 30 air changes per hour).
The exhaust from the cell should be double-filtered using absolute filters (HEPA)
at the exhaust end, and before it is released into the environment. Penetrations of
the service lines on the walls should be designed so as to prevent any streaming or
leakage of radiation to the working areas outside the cell. Negative pressure, of

52
the order of 25–50 mm water column should be maintained in the cell with
respect to the adjoining operating areas.
The internal walls of the cells should be SS-lined or painted for smooth finishing
and easy decontamination. Various services required in hot cells involving the use
of water, steam, chemicals, viewing window and even welding units are provided
inside the hot cells. Adequately shielded doors made of steel/lead should be
provided for access to the cells for decontamination and maintenance.
Adequate lighting, mirrors, periscopes, cameras should be provided inside the cell
in order to ensure effective performance of the work inside the cell.

53
ANNEXURE-D: AERB SAFETY DIRECTIVE 01/2011

54
55
 BIBLIOGRAPHY

1. Atomic Energy Act, 1962.

2. Atomic Energy (Radiation Protection) Rules, 2004.

3. Atomic Energy Regulatory Board, ‘Radiation Protection for Nuclear Facilities’,

AERB Safety Manual No. AERB/NF/SM/O-2 (Rev. 4), Mumbai, India (2005).

4. Atomic Energy Regulatory Board, ‘Consenting Process for Nuclear Fuel Cycle
Facilities and Related Industrial Facilities other than Nuclear Power Plants and
Research Reactors’, AERB Safety Guide No. AERB/NF/SG/G-2, Mumbai, India
(2006).

5. Atomic Energy Regulatory Board, ‘Radioactive Waste Management’, AERB

Safety Code No. AERB/NRF/SC/RW, (2007).

6. Atomic Energy Regulatory Board, ‘Security of Radioactive Material during

Transport’, AERB Safety Guide No. AERB/NRF-TS/SG-10, Mumbai, India
(2008).

7. Atomic Energy Regulatory Board, Transportation of Radioactive Material, AERB

revised Safety Code No. AERB/NFR-TS/SC-1, Mumbai, India (under
preparation).

8. Atomic Energy Regulatory Board, ‘Nuclear Medicine Facilities’, AERB Safety

Code No. AERB/RF-MED/SC -2, Mumbai, India (2011).

9. Atomic Energy Regulatory Board, ‘Classification of Radioactive Wastes’, AERB

Safety Guide No. AERB/SG/RW-1, (2011).

10. Atomic Energy Regulatory Board, ‘Radiation Protection for Nuclear Fuel Cycle
Facilities’, AERB Safety Code, NO. AERB/NF/SC/RP, Mumbai, India (2012).

11. Carter M.W., Burns P and Munslow-Davies L., ‘Development of a Radiotoxicity

Hazard Classification’, Radiation Protection Dosimetry, 46 (1), 37-43 (1993).

12. International Commission on Radiological Protection, ‘Limits for Intake of

Radionuclides by Workers’, ICRP Publication 30, Elsevier (1979, 1980).

13. International Commission on Radiological Protection, ‘1990 Recommendations of

the International Commission on Radiological Protection’, ICRP Publication 60,
Elsevier, (1991).

56
14. International Commission on Radiological Protection, ‘Annual Limits on Intake
of Radionuclides by Workers Based on the 1990 Recommendations’, ICRP
Publication 61, Elsevier, (1991).

15. International Commission on Radiological Protection, ‘The 2007

Recommendations of the International Commission on Radiological Protection’,
ICRP Publication 103, Elsevier, (2007).

16. International Commission on Radiological Protection, ‘Compendium of Dose

Coefficients based on ICRP-60’, ICRP Publication 119, Elsevier, (2012).

17. International Atomic Energy Agency, ‘Occupational Radiation Protection’, Safety

Guide No.RS-G-1.1, IAEA, Vienna, (1999).

18. International Atomic Energy Agency, ‘Decommissioning of Medical, Industrial

and Research Facilities’, Safety Standards Series No.WS-G-2.2, IAEA, Vienna,
(1999).

19. International Atomic Energy Agency, ‘Manual for Reactor Produced

Radioisotopes’, IAEA TECDOC Series No. 1340, IAEA, Vienna, (2003).

20. International Atomic Energy Agency, ‘Cyclotron Produced Radionuclides:

Guidelines for Setting up a Facility’, Technical Reports Series No. 471, IAEA,
Vienna, (2009).

57
 LIST OF PARTICIPANTS

FIRST DRAFT OF THE DOCUMENT PREPARED BY

Dr. Pushparaja : BARC (Former)

SAFETY COMMITTEE FOR BRIT FACILITIES (SCBF)

Date(s) of meeting : October 29, 2012

Chairman and Members of SCBF:

Dr. D.N. Sharma (Chairman) : BARC (Former)

Shri V.V. Pande : AERB

Shri S.S. Sachdev : BRIT

Shri S.S. Sastry : BRIT

Dr. (Smt.) Sharmila Banerjee : BARC

Dr. Pankaj Tandon : AERB

Shri D.K. Sawant : BARC

Smt. Manisha V. Inamdar : AERB

(Member Secretary)

58
 STANDING COMMITTEE FOR REVIEW AND REVISION OF AERB’S
RADIATION SAFETY DOCUMENTS (SCRRRSD)

Date(s) of meeting : July 5, 2013

Chairman and Members of SCRRRSD:

Shri A.R. Sundararajan (Chairman) : AERB (Former)

Dr. D.N. Sharma : BARC (Former)

Dr. B.C. Bhatt : BARC (Former)

Shri P.K. Nema : BARC (Former)

Dr. M.G.R. Rajan : BARC

Dr. A.N. Nandakumar : AERB (Former)

Head, RSD, AERB : AERB

Head, RP&AD, BARC : BARC

Shri V. Mohan : AERB

Dr. (Smt.) Jain Regi George : BRIT

Smt. V. Anuradha : AERB

Shri R.K. Chaturvedi : AERB

(Member Secretary)

59
 ADVISORY COMMITTEE ON RADIOLOGICAL SAFETY (ACRS)

Date(s) of meeting : February 2, 2015

Chairman and Members of ACRS:

Dr. U.C. Mishra (Chairman) : BARC (Former)

Shri A.R. Sundararajan (Vice Chairman) : AERB (Former)

Dr. M.R. Iyer : BARC (Former)

Dr. D.N. Sharma : BARC (Former)

Dr. Sudhir Gupta : MHA

Shri S.P. Agarwal : AERB (Former)

Dr. B.C. Bhatt : BARC (Former)

Dr. S.K. Srivastava : TMH

Dr. A.U. Sonawane : AERB

(Member Secretary)

60
LIST OF REGULATORY SAFETY DOCUMENTS ON RADIATION SOURCES

Safety Series No. Title

AERB/SC/G Regulation of Nuclear and Radiation Facilities

AERB/SS/3 (Rev.1) Testing and Classification of Sealed Radioactive Sources

AERB//RF-RS/SG-1 Security of Radioactive Sources in Radiation Facilities

AERB/RF-RS/SG-2 Radioisotope Handling Facilities

AERB/RF/SG/G-3 Consenting Process for Radiation Facilities

AERB/SG/G-4 Regulatory Inspection and Enforcement in Nuclear and

Radiation Facilities

AERB/RF/SM/G-3 Regulatory Inspection and Enforcement on Radiation

Facilities

61