biosafety assessment of ant organism and vaccines final

8/14/2019 Biosafety Assessment of ant Organism and Vaccines Final

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Biosafety AssessmentBiosafety Assessment

Of GeneticallyOf GeneticallyModified Crops.Modified Crops.

Charu Sharma (2010)Richa Gupta (2024)Divya Tarkar (2068)

Presented by:-


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a area areBIOHAZARDS?BIOHAZARDS?

A biological hazard or biohazard is anorganism, or substance derived from anorganism, that poses a threat to (primarily)human health.This can include medical waste or samples of a

microorganism , virus or toxin (from a biologicalsource) that can impact human health. It can

also include substances harmful to animals.
http://en.wikipedia.org/wiki/Microorganismhttp://en.wikipedia.org/wiki/Virushttp://en.wikipedia.org/wiki/Toxinhttp://en.wikipedia.org/wiki/Toxinhttp://en.wikipedia.org/wiki/Virushttp://en.wikipedia.org/wiki/Microorganism


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and Potentiallyand PotentiallyInfectious MaterialsInfectious Materials

Human, animal and plant pathogens;All human blood, blood products, tissues andcertain body fluids;Cultured cells (all human or certain animal) andpotentially infectious agents these cells maycontain;Allergens;

Toxins (bacterial, fungal, plant, etc.);Certain recombinant products;Clinical specimens;Infected animals and animal tissues;Recombinant DNA (rDNA);


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Risk AssessmentRisk Assessment

"Risk" implies the probability that harm, injury ordisease will occur.

In the context of the microbiological and biomedicallaboratories, the assessment of risk focuses primarilyon the prevention of laboratory-associated infections.

It helps to assign the biosafety levels (facilities,equipment, and practices) that reduce the worker'sand the environment's risk of exposure to an agent toan absolute minimum.


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Factors of Interest in aFactors of Interest in aRisk AssessmentRisk Assessment

1. The pathogenicity of the infectious or suspectedinfectious agent, including disease incidence and severity(i.e., mild morbidity versus high mortality, acute versuschronic disease). The more severe the potentiallyacquired disease, the higher the risk.

2. The route of transmission (e.g., parenteral, airborne,ingestion) of newly isolated agents may not bedefinitively established. Agents that can be transmittedby the aerosol route have caused most laboratoryinfections. I

3. Agent stability is a consideration that involves not onlyaerosol infectivity (e.g., from spore-forming bacteria),but also the agent's ability to survive over time in theenvironment.


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Factors of Interest in aFactors of Interest in aRisk Risk AssessmentAssessment

4. The infectious dose :- It can vary from one to hundreds of thousands of units.

5. The concentration (number of infectious organisms per unitvolume) :- It will include consideration of the milieucontaining the organism (e.g., solid tissue, viscous blood orsputum, 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 natureof source (e.g., potential zoonotic, associated with a diseaseoutbreak).


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Risk GroupsRisk GroupsRisk Group 1 Agents that are not associated with disease in

healthy adult humans.

Risk Group 2 Agents that are associated with human diseasewhich is rarely serious and for which preventiveor therapeutic interventions are often available.

Risk Group 3 Agents that are associated with serious or lethalhuman disease for which preventive ortherapeutic interventions may be available (highindividual risk but low community risk).

Risk Group 4 Agents that are likely to cause serious or lethalhuman disease for which preventive ortherapeutic interventions are not usuallyavailable (high individual risk but high community

risk).


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Biosafetyregulation and

safetyrequirements in GM

crops and food


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safety requirements in GMsafety requirements in GMcrops and foodcrops and food

Crops can be divided broadly into six categories inaccordance with their invasive potential:

Crops that have no compatible relatives, carry few

weediness traits (less than 40 percent), and do notpersist in natural environments.

Crops that have no compatible relatives, carryintermediate numbers of weediness traits, rarelyescape, and do not persist in natural environments.

Crops that have no compatible wild relatives, carrymany weediness traits, and can escape and persist innatural environments.


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safety requirements in GMsafety requirements in GMcrops and foodcrops and food

Crops that have compatible relatives, carry fewweediness traits, and can escape but do not persist innatural environments and dot not spread aggressively.

Crops that have compatible relatives, carry intermediatenumbers of weediness traits, and can escape but do notpersist in natural environments; their compatiblerelatives also carry few weediness traits and do notspread aggressively.

Crops that have compatible wild relatives, carry manyweediness traits, and can escape and persist in naturalenvironments; their compatible relatives also carry manyweediness traits and spread aggressively .


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Genetically ModifiedGenetically ModifiedCropsCrops

Persistence of the transgene or of thetransgene productsGene flowResistance/tolerance of targetorganisms


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Genetically ModifiedGenetically ModifiedCropsCrops

Loss of biodiversityChanges in the soil ecology

Changes in nutritional level


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Containment facility forGM plant

Containment is a term used forphysical barriers to restrict the spreadwithin a structure or enclosed space.

The basic biosafety requirement in thedevelopment of a GMO is to limit spreadof the GMO and its genetic material.A relatively high level of control can beachieved in the laboratory facilitiesincluding pilot scale fermentation andsmall-scale field trials in greenhouses.


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La oratorycontainment

Physical containment of GMOs is maintained bygood laboratory practices. Care should betaken that the laboratory facilities are in line

with the risk category of the target organism. Itis necessary to ensure that the organismsproduced under lab conditions are carefullycollected for subsequent use or disposal.


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reen ousecontainment

For higher level of containment, facilities haveto meet specifications such as controlled andfiltered airflow, systems to control and disinfect

water leaving the facility, autoclaves for on-sitesterilization of plant material and equipment,disinfecting the facility after experiments, strictlimits on who is allowed to enter including thatof staff and trainee.

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Risk managementstrategies

Confinement- For preventing and minimizing theunintentional spread of GMO or a genetic material,measures should be taken to confine them within a

site/zone having designated borders/limits. This canbe used by both physical and biological means.

-Physical-Biological

Monitoring


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Physical ConfinementPhysical means to confine GMOs particularly in case of plants and animals consist of geographical or spatialisolation 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 workedout to control the fertilization of sexually compatiblespecies growing in the vicinity by transgenic pollen.

It is essential to collect information about the presenceand distribution of cross-fertile wild or weedy relativesof cultivated species near the proposed site.

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BiologicalConfinement

GM plants may be grown in an area where sexuallycompatible wild or weedy species are not found.

All plants of sexually compatible wild or weedy speciesfound within the known effective pollinating distance of theGM crop may be removed.

Flowers may be covered with bags to screen out insectpollinators or prevent wind pollination.

Tubers, rhizomes, storage roots, and all tissues capable of developing into mature plants under natural conditionsmay be recovered.


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Strategies in Monitoring

Accept and involve the public as a legitimate partner and treatadversaries with respect

Coordinate, collaborate and provide information through crediblesources

Be honest, frank and open, dont keep secrets and acknowledgemistakes made

Listen to and acknowledge peoples concerns

Be proactive and speak clearly with a balanced and realisticinformation strategy

Meet the needs of the media and identify and train communicators


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Biosafety

Regulatory bodiesin India for GMplants


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Biosafety rules in India forGM plants

Presently, there are three regulatoryauthorities to regulate recombinant DNArelated activities including research, productdevelopment and commercialization activity.

These are(a) Institutional Biosafety Committee (IBSC);(b) Review Committee on GeneticManipulation (RCGM) and

(c) Genetic Engineering Approval Committee(GEAC).


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Institutional BiosafetyCommittee (IBSC)

To note, examine and approve proposals involvingr-DNA work; to ensure adherence of r-DNA SafetyGuidelines- 1990 of Government; inspection of containment facilities at R&D and production unitsand to inform the RCGM about the facilities;

To recommend for import/ exchange of GMOs/LMOs/Transgenic seeds, vectors, geneconstructs, plasmids, etc., for research purposes

To prepare emergency plan according toguidelines;


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Genetic Manipulation(RCGM):

To note and to approve r-DNA work. To ensure adherence of r-DNA safetyguidelines of government.

To prepare emergency plan according toguidelines.

To act as nodal point for interaction withstatutory bodies.

To ensure experimentation at designatedlocation, taking into account approvedprotocols.


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Approval Committee(GEAC):

To permit the use of GMOs and products thereof forcommercial applications.

To adopt producers for restriction or prohibition,production, sale, import & use of GMOs both forresearch 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 EnvironmentProtection Act.


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biosafety assessment of ant organism and vaccines final

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