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Biosafety Assessment

Of Genetically
Modified Crops.

Presented by:-
Charu Sharma (2010)
Richa Gupta (2024)
Divya Tarkar (2068)
What are
BIOHAZARDS?
 A biological hazard or biohazard is an
organism, or substance derived from an
organism, that poses a threat to (primarily)
human health.
 This can include medical waste or samples of a
microorganism, virus or toxin (from a biological
source) that can impact human health. It can
also include substances harmful to animals.
and Potentially
Infectious Materials
 Human, animal and plant pathogens;
 All human blood, blood products, tissues and
certain body fluids;
 Cultured cells (all human or certain animal) and
potentially infectious agents these cells may
contain;
 Allergens;
 Toxins (bacterial, fungal, plant, etc.);
 Certain recombinant products;
 Clinical specimens;
 Infected animals and animal tissues;
 Recombinant DNA (rDNA);
Risk Assessment
 "Risk" implies the probability that harm, injury or
disease will occur.

 In the context of the microbiological and biomedical


laboratories, the assessment of risk focuses primarily
on the prevention of laboratory-associated infections.

 It helps to assign the biosafety levels (facilities,


equipment, and practices) that reduce the worker's
and the environment's risk of exposure to an agent to
an absolute minimum.
Factors of Interest in a
Risk Assessment
1. The pathogenicity of the infectious or suspected
infectious agent, including disease incidence and severity
(i.e., mild morbidity versus high mortality, acute versus
chronic disease). The more severe the potentially
acquired disease, the higher the risk.

2. The route of transmission (e.g., parenteral, airborne,


ingestion) of newly isolated agents may not be
definitively established. Agents that can be transmitted
by the aerosol route have caused most laboratory
infections. I

3. Agent stability is a consideration that involves not only


aerosol infectivity (e.g., from spore-forming bacteria),
but also the agent's ability to survive over time in the
environment.
Factors of Interest in a
Risk Assessment
4. The infectious dose :- It can vary from one to hundreds of
thousands of units.

5. The concentration (number of infectious organisms per unit


volume) :- It will include consideration of the milieu
containing the organism (e.g., solid tissue, viscous blood or
sputum, liquid medium) and the laboratory activity planned
(e.g., agent amplification, sonication, centrifugation).

6. The origin of the potentially infectious material :- "Origin"


may refer to geographic location (e.g., domestic, foreign);
host (e.g., infected or uninfected human, animal); or nature
of source (e.g., potential zoonotic, associated with a disease
outbreak).
Risk Groups
Risk Group 1 Agents that are not associated with disease in
healthy adult humans.

Risk Group 2 Agents that are associated with human disease


which is rarely serious and for which preventive
or therapeutic interventions are often available.

Risk Group 3 Agents that are associated with serious or lethal


human disease for which preventive or
therapeutic interventions may be available (high
individual risk but low community risk).

Risk Group 4 Agents that are likely to cause serious or lethal


human disease for which preventive or
therapeutic interventions are not usually
available (high individual risk but high community
risk).
Biosafety
regulation and
safety
requirements in GM
crops and food
Biosafety regulation and
safety requirements in GM
crops and food
 Crops can be divided broadly into six categories in
accordance with their invasive potential:

 Crops that have no compatible relatives, carry few


weediness traits (less than 40 percent), and do not
persist in natural environments.

 Crops that have no compatible relatives, carry


intermediate numbers of weediness traits, rarely
escape, and do not persist in natural environments.

 Crops that have no compatible wild relatives, carry


many weediness traits, and can escape and persist in
natural environments.
safety requirements in GM
crops and food
 Crops that have compatible relatives, carry few
weediness traits, and can escape but do not persist in
natural environments and dot not spread aggressively.

 Crops that have compatible relatives, carry intermediate


numbers of weediness traits, and can escape but do not
persist in natural environments; their compatible
relatives also carry few weediness traits and do not
spread aggressively.

 Crops that have compatible wild relatives, carry many


weediness traits, and can escape and persist in natural
environments; their compatible relatives also carry many
weediness traits and spread aggressively.
Risk associated with
Genetically Modified
Crops
 Persistence of the transgene or of the
transgene products
 Gene flow
 Resistance/tolerance of target
organisms
Risk associated with
Genetically Modified
Crops
 Loss of biodiversity
 Changes in the soil ecology
 Changes in nutritional level
Containment facility for
GM plant
 Containment is a term used for
physical barriers to restrict the spread
within a structure or enclosed space.
 The basic biosafety requirement in the
development of a GMO is to limit spread
of the GMO and its genetic material.
 A relatively high level of control can be
achieved in the laboratory facilities
including pilot scale fermentation and
small-scale field trials in greenhouses.
(Α) Laboratory
containment
 Physical containment of GMOs is maintained by
good laboratory practices. Care should be
taken that the laboratory facilities are in line
with the risk category of the target organism. It
is necessary to ensure that the organisms
produced under lab conditions are carefully
collected for subsequent use or disposal.
(Β) Greenhouse
containment
 For higher level of containment, facilities have
to meet specifications such as controlled and
filtered airflow, systems to control and disinfect
water leaving the facility, autoclaves for on-site
sterilization of plant material and equipment,
disinfecting the facility after experiments, strict
limits on who is allowed to enter including that
of staff and trainee.
Risk management
strategies
 Confinement- For preventing and minimizing the
unintentional spread of GMO or a genetic material,
measures should be taken to confine them within a
site/zone having designated borders/limits. This can
be used by both physical and biological means.
-Physical
-Biological
 Monitoring
Physical Confinement
 Physical means to confine GMOs particularly in case of
plants and animals consist of geographical or spatial
isolation by the use of structures such as fences,
screens, mesh etc.

 The access to the site should be controlled. In case of


plants, appropriate isolation distance should be worked
out to control the fertilization of sexually compatible
species growing in the vicinity by transgenic pollen.

 It is essential to collect information about the presence


and distribution of cross-fertile wild or weedy relatives
of cultivated species near the proposed site.
Biological
Confinement
 GM plants may be grown in an area where sexually
compatible wild or weedy species are not found.

 All plants of sexually compatible wild or weedy species


found within the known effective pollinating distance of the
GM crop may be removed.

 Flowers may be covered with bags to screen out insect


pollinators or prevent wind pollination.

 Tubers, rhizomes, storage roots, and all tissues capable of


developing into mature plants under natural conditions
may be recovered.
Strategies in
Monitoring
 Accept and involve the public as a legitimate partner and treat
adversaries with respect

 Coordinate, collaborate and provide information through credible


sources

 Be honest, frank and open, don’t keep secrets and acknowledge


mistakes made

 Listen to and acknowledge people’s concerns

 Be proactive and speak clearly with a balanced and realistic


information strategy

 Meet the needs of the media and identify and train communicators
Biosafety
Regulatory bodies
in India for GM
plants
Biosafety rules in India for
GM plants
 Presently, there are three regulatory
authorities to regulate recombinant DNA
related activities including research, product
development and commercialization activity.
These are
(a) Institutional Biosafety Committee (IBSC);
(b) Review Committee on Genetic
Manipulation (RCGM) and
(c) Genetic Engineering Approval Committee
(GEAC).
Institutional Biosafety
Committee (IBSC)
 To note, examine and approve proposals involving
r-DNA work; to ensure adherence of r-DNA Safety
Guidelines- 1990 of Government; inspection of
containment facilities at R&D and production units
and to inform the RCGM about the facilities;

 To recommend for import/ exchange of


GMOs/LMOs/Transgenic seeds, vectors, gene
constructs, plasmids, etc., for research purposes

 To prepare emergency plan according to


guidelines;
Review Committee on
Genetic Manipulation
(RCGM):
 To note and to approve r-DNA work.
 To ensure adherence of r-DNA safety
guidelines of government.
 To prepare emergency plan according to
guidelines.
 To act as nodal point for interaction with
statutory bodies.
 To ensure experimentation at designated
location, taking into account approved
protocols.
Genetic Engineering
Approval Committee
(GEAC):
 To permit the use of GMOs and products thereof for
commercial applications.
 To adopt producers for restriction or prohibition,
production, sale, import & use of GMOs both for
research and applications under EPA.
 To authorize large-scale production and release of
GMOs and products thereof into the environment.
 To authorize agencies or persons to have powers to
take punitive actions under the Environment
Protection Act.