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DEPT. OF AGRI. BIOTECHNOLOGY
In general, “BIOSAFETY” refers to the efforts
that ensure safety in using, transporting,
transferring, handling, releasing and disposing
of biological organism including genetically
modified organism which are capable of
harming human, animals, plants or
BIOLOGICAL RISK ASSESSMENT-
Genetically Modified Organism : It is operationally defined as an
organism whose hereditary traits have been modified by human
intervention using any method that results in the introduction,
rearrangement or removal of genetic material from the genome of
Risk Assessment :It refers to assessment of the risks of introducing
GMO into the environment, to human and natural or managed
Biosafety : It refers to the polices and procedures adapted to
ensure the environmentally safe application of biological agents.
DEFINITION OF HAZARDS- A hazard is the presence
of an inherent characteristic that threatens human
health. This characteristic may be attributed to an
object (machine),chemical agent, biological agent ,to a
process (movement, transport, chemical process,
biotechnological processes) or to a situation (climate,
storage). A hazard may have adverse effects on the
product (quality), on the environment and on the
health of workers (safety-health).
DEFINITION OF BIOHAZARD – is a hazard that
originates from living organisms. These may be
animals, microorganisms, materials that originate from
animals (including humans) or plants.
Biological Agents and Hazard Groups: Biological
agents are classified under four hazard groups
according to the severity of the harmful effects they
may have on workers’ health. Consideration is given to:
the ability of the biological agents to cause disease in
“healthy” people; the mean severity of the disease; the
likelihood of the biological agents causing epidemics,
and the existence of effective treatments and suitable
HAZARDS GROUPS ARE DEFINED IN THE FOLLOWING MANNER:
Hazard group 1—Biological agent unlikely to cause disease in humans.
Hazard group 2—Biological agent that can cause a disease in human
and could be a hazard to directly exposed workers. It is unlikely to
spread to the community. Effective prophylaxis and treatment are usually
Hazard group 3—Biological agent that can cause severe human
diseases and is a serious hazard to directly exposed workers. It may
present a risk of spreading to the community. Effective prophylaxis and
treatment are usually available.
Hazard group 4—Biological agent that can cause severe human
diseases is a serious hazard to directly exposed workers. May present a
risk of spreading to the community. Effective prophylaxis or treatment
are usually not available.
CRITERIA IN BIOLOGICAL RISK ASSESSMENT:
Characterizing the biological agent and classifying it in one of the four
Identifying the potential immediate and delayed harmful effects for
humans and the environment;
Defining the work situation and looking for procedures that favor the
Evaluating the probability of the occurrence of immediate harm in view
of the work situation;
Evaluation of the potential consequences of each adverse effect if it
Evaluation of the likelihood of the occurrence of each identified
potential adverse effect;
Estimation of risk posed by each identified characteristic of the GMO;
Application of management strategies for risks from the deliberate
release or marketing of the GMO;
Determination of the overall risk of the GMO
GUIDELINES FOR CATEGORIZATION OF GENETICALLY MODIFIED
PLANTS FOR FIELD TEST-
For experimental plants, considered to have a history of safe use in field
work as follows;
• A. Modified plants that result from conventional breeding practices (e.g.
selective breeding, mutagenesis, protoplast fusion or embryo rescue)
• B. Genetically modified plants, having inherent characteristics typical of
modified plants from conventional breeding practices.
• C. Plants, with genetic inserts that are known to be harmless and
inoffensive to the environment.
Let work proceed in accord with the basic standards appropriate to the
For field testing of experimental plants with a history of
prior field work, a project notification or proposal form
has to be submitted to the Institutional Biosafety
The IBC shall evaluate the proposed ambient working
conditions through the accredited containment
resources, in determining the sufficiency of biosafety
provisions. Measures for the control and containment of
field work should observe relevant past regulations and
address the particular plant(s) under study.
Only after receiving IBC endorsement, work may begin.
The IBC must forward all proposals and the committees,
assessments thereof, to the National Biosafety
Committee (NBC) for records and information.
For experimental plants that do not have history of safe
use, the work should proceed under the appropriate
containment level if any of the following conditions is met.
• A. There is no cross-hybridization.
• B. There are arrangements to contain the dispersal of
plants and plant materials.
• C. Introduced gene expression is stable, and does not
fluctuate with changing environmental conditions.
Field testing experimental plants with no history
of prior field work should proceed under the
advice, counsel, and direction of the IBC and NBC.
In both cases, committee recommendations and
the command of work, shall be grounded on the
biosafety concerns that may be gathered from
the written proposals submitted.
The project supervisor is prohibited from
initiating work before consent is granted directly
by the NBC.
REGULATORY FRAMEWORK FOR GMOS IN
Ministry of Environment & Forests, Government of
India notified the rules and procedures for the
manufacture, import, use, research and release of
GMOs as well as products made by the use of such
organisms on December 5, 1989 under the
Environment (Protection) Act, 1986 (EPA). These
rules and regulations, commonly referred as Rules
1989 cover areas of research as well as large scale
applications of GMOs and its products. These Rules
are implemented by the Ministry of Environment &
Forests and the Department of Biotechnology,
Government of India.
Six Competent Authorities and their composition
have been notified under this Rules which are as
i. Recombinant DNA Advisory Committee (RDAC)
ii. Institutional Biosafety Committees (IBSC)
iii. Review Committee on Genetic Manipulation
iv. Genetic Engineering Appraisal Committee (GEAC)
v. State Biosafety Coordination Committees (SBCC)
vi. District Level Committees (DLC).
While the RDAC is of advisory in function, the IBSC,
RCGM, and GEAC are of regulatory function, SBCC
and DLC are for monitoring purposes.
The approvals and prohibitions under Rules
1989 are summarized below-
No person shall import, export, transport, manufacture, process,
use or sell any GMOs, substances or cells except with the approval
of the GEAC.
Use of pathogenic organisms or GMOs or cells for research purpose
shall be allowed under the Notification, 1989 of the EPA, 1986.
Any person operating or using GMOs for scale up or pilot
operations shall have to obtain permission from GEAC.
For purpose of education, experiments on GMOs IBSC can look
after, as per the guidelines of the Government of India.
Deliberate or unintentional release of GMOs not allowed.
Production in which GMOs are generated or used shall not be
commenced except with the approval of GEAC
GEAC supervises the implementation of rules and guidelines.
GEAC carries out supervision through SBCC, DLC or any
If orders are not complied, SBCC/DLC may take suitable
measures at the expenses of the person who is
In case of immediate interventions to prevent any
damage, SBCC and DLC can take suitable measures and
the expenses incurred will be recovered from the
All approvals shall be for a period of 4 years at first
instance renewable for 2 years at a time.
GEAC shall have powers to revoke approvals in case of:
i. Any new information on harmful effects of GMOs.
ii. GMOs cause such damage to the environment as could
not be envisaged when approval was given.
iii. Non-compliance of any conditions stipulated by GEAC.
THE PROCEDURES INVOLVED IN THE
APPROVAL OF GMOS IN INDIA ARE
• The following are some brief descriptions of Laboratory
BIOSAFETY LEVEL 1 (BS-1)-
Biosafety Level 1 is suitable for work involving well-
characterized agents not known to consistently cause
disease in healthy adult humans, and of minimal potential
hazard to laboratory personnel and the environment.
The laboratory is not necessarily separated from the
general traffic patterns in the building. Work is generally
conducted on open bench tops using standard
microbiological practices. Special containment equipment
or facility design is neither required nor generally used.
Laboratory personnel have specific training in the
procedures conducted in the laboratory and are
supervised by a scientist with general training in
microbiology or a related science.
BIOSAFETY LEVEL 2 (BS-2)-Biosafety Level 2 is similar to
Biosafety Level 1 and is suitable for work involving agents of
moderate potential hazard to personnel and the
environment. It differs from BSL-1 in that
Laboratory personnel have specific training in handling
pathogenic agents and are directed by competent
Access to the laboratory is limited when work is being
Extreme precautions are taken with contaminated sharp
Certain procedures in which infectious aerosols or
splashes may be created are conducted in biological
safety cabinets or other physical containment equipment.
• BIOSAFETY LEVEL 3 (BS-3)-
Biosafety Level 3 is applicable to clinical, diagnostic,
teaching, research, or production facilities in which work
is done with indigenous or exotic agents which may
cause serious or potentially lethal disease as a result of
exposure by the inhalation route.
Laboratory personnel have specific training in handling
pathogenic and potentially lethal agents, and are
supervised by competent scientists who are experienced
in working with these agents.
All procedures involving the manipulation of infectious
materials are conducted within biological safety cabinets
or other physical containment devices, or by personnel
wearing appropriate personal protective clothing and
The laboratory has special engineering and design
• BIOSAFETY LEVEL 4 (BS-4)-
Biosafety Level 4 is required for work with dangerous and
exotic agents that pose a high individual risk of aerosol-
transmitted laboratory infections and life-threatening
Agents with a close or identical antigenic relationship to
Biosafety Level 4 agents are handled at this level until
sufficient data are obtained either to confirm continued
work at this level, or to work with them at a lower level.
Members of the laboratory staff have specific and
thorough training in handling extremely hazardous
infectious agents and they understand the primary and
secondary containment functions of the standard and
special practices, the containment equipment, and the
laboratory design characteristics.
They are supervised by competent scientists who are
trained and experienced in working with these agents.
Access to the laboratory is strictly controlled by the
The facility is either in a separate building or in a
controlled area within a building, which is completely
isolated from all other areas of the building. A specific
facility operations manual is prepared or adopted.
Within work areas of the facility, all activities are
confined to Class III biological safety cabinets, or Class II
biological safety cabinets used with one-piece positive
pressure personnel suits ventilated by a life support
system. The Biosafety Level 4 laboratory has special
engineering and design features to prevent
microorganisms from being disseminated into the
SAFETY EQUIPMENT (PRIMARY
BIOLOGICAL SAFETY CABINETS (BSCS)
Biological safety cabinets (BSCs) are designed to
protect the operator, the laboratory environment
and work materials from exposure to infectious
aerosols and splashes that may be generated
when manipulating materials containing
infectious agents, such as primary cultures, stocks
and diagnostic specimens. Aerosol particles are
created by any activity that imparts energy into a
liquid or semiliquid material, such as shaking,
pouring, stirring or dropping liquid onto a surface
or into another liquid.
Aerosol particles of less than 5 µm in diameter
and small droplets of 5–100 µm in diameter are
not visible to the naked eye.
The laboratory worker is generally not aware that
such particles are being generated and may be
inhaled or may cross contaminate work surface
BSCs, when properly used, have been shown to
be highly effective in reducing laboratory-
acquired infections and cross-contaminations of
cultures due to aerosol exposures. BSCs also
protect the environment
CLASS I BIOLOGICAL SAFETY CABINET
Room air is drawn in through the front opening at a minimum velocity of 0.38 m/s, it
passes over the work surface and is discharged from the cabinet through the exhaust
duct. The directional flow of air whisks aerosol particles that may be generated on the
work surface away from the laboratory worker and into the exhaust duct.
CLASS II BIOLOGICAL SAFETY
The Class II BSC was designed not only to provide personnel
protection but also to protect work surface materials from
contaminated room air. Class II BSCs, of which there are four
types (A1, A2, B1 and B2), differ from Class I BSCs by allowing
only air from a HEPA-filtered (sterile) supply to flow over the
work surface. The Class II BSC can be used for working with
infectious agents in Risk Groups 2 and 3.
Owing to the relative size of these filters, about 70% of the air
recirculates through the supply HEPA filter back into the work
zone; the remaining 30% passes through the exhaust filter
into the room or to the outside.
CLASS III BIOLOGICAL SAFETY
This type provides the highest level of personnel
protection and is used for Risk Group 4 agents. All
penetrations are sealed “gas tight”. Supply air is
HEPA-filtered and exhaust air passes through two
The Class III cabinet may be connected to a
double-door autoclave used to decontaminate all
materials entering or exiting the cabinet. Several
glove boxes can be joined together to extend the
work surface. Class III BSCs are suitable for work
in Biosafety Level 3 and 4 laboratories.