Submitted by:Chandrakant dubey Jyoti meghani Ankita tanwar

What is a Genetically Modified (GM) Food?

Foods that contain an added gene sequence

Foods that have a deleted gene sequence Products produced by GM organisms Genetic engineering offers a rapid and precise method of altering organisms as compared to traditional methods that are slow and inaccurate.

Possible benefits of GM foods

Food security Reducing strain on nonrenewable sources Development of salt-tolerance crops Reduced use of pesticides and herbicides Frost, flood, drought, disease resistant crops Improved nutritional quality

Possible Risks of GM foods

Insects might develop resistance to pesticide-producing

GM crops Herbicide-tolerant crops may cross-pollinate weeds, resulting in "superweeds" Production of allergens protein unintended harm to wildlife

Bio-safety
OECD defined it as the one which , as far as we know,

and with the exception of some individual, who may be sensitive or allergic, when consumed in moderation over a period of time does not result in identifiable harm to the consumer

The Framework
Core considerations
Gene (s)
Source (s) Molecular characterization Insert/copy no./integrity/ stability

Food/Feed Composition
Key nutrients/anti nutrients Animal performance

Protein
History of safe use & Consumption Function/specificity/ mode of action Levels Toxicology & allergenicity

Environmental

Molecular characterization
Source of gene

Molecular characterization of inserted DNA

Transformation system Genetic stability of introduced trait

The information required

All the genetic elements (promoter, leader, terminator, marker etc) transferred along with

citation Detailed map of plasmid used as a vector indicating location, orientation, size etc of genetic elements
Relevant restriction enzyme sites, location of primers used in PCR, regions used as a probe

Substantial Equivalence
Comparison of existing organism as food sources to modified food Outcomes may be Substantially equivalent to the conventional counterpart Substantially equivalent with some well defined exception Not substantially equivalent

Key parameters for assessment of substantial equivalence

Agronomic traits Key nutrients Toxicants and anti nutrients

Safety assessment for the introduced gene expression product

Define biological function, specificity, and mode of

action of the protein Compare the amino acid sequence to the known sequence in protein databases Digestibility properties Determine the level of protein in the food

Criteria for protein is as-safe-as protein already present in the food

The protein has history of safe consumption Biological function and mode of action of protein

raises no safety concern Amino acid sequence of protein is not similar to known protein allergens, toxins. Protein can be digested

Allergenicity
If gene for protein is derived from a food source with a

history of allergy Amino acid sequence matches with known allergen Detection technique for IgE of sera Radio allergosorbent test(RAST) ELISA Physiochemical properties should be assessed

Toxicity and antnutritional test

Determine no effect level
Exposure assessment Irritation test

Sensitization test

Food nutritional Evaluation

Biosafety and risk assessment procedures for biotech foods (CASE STUDY)
Safety Assessment of the Neomycin Phosphotransferase II (NPTII) Protein:

The data in the review supports the conclusions that NPTII protein used in transgenic plants is not a toxin or allergen;
The NPTII protein caused no deleterious effects when administered by

gavage to a mouse at a cumulative target dosage of up to 5000 mg/kg of body weight. When injected in the plant genome the gene is highly unlikely to move from the plant genome into microorganisms via horizontal gene transfer; that if such transfer were to occur, the impact would be minimal The nptII gene product was similarly determined to be nontoxic for human or animal consumption

This gene and its gene products when expressed in tomato plants,

underwent similar toxicological tests to determine its safety:

Heating steps in commercial processing and cooking methods

denatured and inactivated the gene product; The tomato which had this gene incorporated DNA ingested by humans was degraded in the stomach and small intestine; and in processed tomatoes, the pH is 4.6 or lower, which is far below the pH optimum of NPTII protein (reviewed in Food Additive Petition 1993).
Additionally, human in vivo toxicity studies demonstrated that the

gene and gene product had no adverse effects on human health (Kasid et 3al. 1990; Blaese et al. 1990; UNDP 2001; Gay and Gillespie 2005).

GM Food Debate :
Garry Peterson, Saul Cunningham, Lisa Deutsch, Jon Erickson, Allyson Quinlan, Ernesto RaezLuna, Robert Tinch, Max Troell, &Peter Woodbury,.

Abstract : The benefits and risks of any particular GM crop depend on the interactions of its ecological functions and natural history with the agroecosystem and ecosystems within which it is embedded. These evolutionary and ecological factors must be considered when assessing GM crops

Despite claims of safety and warnings against popular panic, public concern over GM crops has resulted in changes in their marketing, labeling, planting, and trade. These changes have fueled an increasingly heated debate among environmental advocates, critics of industrial agriculture, seed companies, governments, and scientists.

The direct and indirect effects of genetically modified crops interact with the scale at which they are grown to determine the difficulty of predicting, testing, and monitoring their potential impacts.

GM modification

Benefits

Risks

Herbicide resistance in maize, cotton, other crops.

Reduce herbicide use. Increase opportunities for reduced tillage systems.

Reduce in-field biodiversity that may reduce the ecological services provided by agricultural ecosystems.

Maize with Bt toxin.

Reduce pesticide use. Kill fewer non target organisms than other pesticides.

Kill nontarget caterpillars and butterflies, such as monarchs (Pimentel 2000).

Virus resistance in small grains due to coat proteins.

Reduce insecticide use to control insect dispersers of pathogens (Hails 2000).

Facilitate the creation of some new viruses attacts (Hails 2000).

GM modification

Benefits

Risks

Terminator or other Prevent the movement of sterilizing traits in crops and traits to nontarget species. ornamentals. Prevent the movement of introduced species to other ecosystems (Walker and Lonsdale 2000).

Prevent farmers from developing their own seed supplies adapted to local conditions (Conway 2000).

Synthesis of vitamin A or other nutrients.

Improve nutrition of people who depend heavily on rice (Conway 2000).

Disrupt local ecosystems if an ecologically limiting nutrient or protein is produced. Add to excess N leaching from agriculture, degrading human health and reducing biodiversity.

Nitrogen fixation by nonlegumes.

Reduce energy used in fertilizer production and application (Pimentel 2000).

Type of Impact
Agricultural

Benefit-Related Aspects
Are alternatives available that provide greater agronomic, economic, social, and ecological benefits? Does the GM crop prevent some specific harm to humans or ecosystems, e.g., does it reduce pesticide use?

Risk-Related Aspects
Are risks minimized though good design, e.g., is it certain that genes inserted into chloroplast DNA cannot escape through pollen? Has the organism been examined to determine whether genetic modifications do not produce risky changes?

Ecological

Does the GM crop help solve an existing environmental problem, e.g., does it produce sterile feral animals to control pests (Walker and Lonsdale 2000)?

Does the modified trait have the potential to increase the fitness of the organism outside of the managed environment, e.g., does it impart herbivore resistance or increase the reproductive rate? In the locale of release, can the trait spread to other species, i.e., can the species hybridize with other species nearby?

Social

Will the benefits of this GM organism be widely shared?Does the GM crop provide some specific benefit to humans or ecosystems, e.g., does it enhance human nutrition or help restore degraded land?

Is a mechanism in place for surveying for possible negative effects after widespread release has occurred?Who and what are at risk of being negatively affected by this GM crop? Do institutions exist that could mitigate the potential impacts of GM crops?

They concluded that the specific impacts of any particular GM crop depend on the interactions of its ecological function and natural history with the agroecosystem and ecosystems within which it is embedded.

The benefits of some GM crops in some agricultural systems appear to outweigh their relatively low risks, but others are substantially more risky.

While biotechnology could be used to produce large social and ecological benefits, most GM crops developed to date have been designed to benefit agrobusiness while exposing people and ecosystems to substantial risks

GM FOOD IN FUTURE
genetically modified food is seen to help make them taste better and

stay longer
genetically modified food products that contain more essential

nutrients
Genetically modified food can also be developed to help fight disease
GM food with substances that help stimulate the bodys natural

defense mechanisms to better fight diseases.

GM food developed in order to lessen the time for processing them.

FUTURE OF GM FOOD GLOBALLY

The first commercial planting of a genetically engineered (GE) or

genetically modified (GM) crop was in 1995 in North America. Since then, these products of modern agricultural biotechnology have spread throughout the world.
Although, at present, only 20 or so countries commercially grow

generically engineered crops, over 70 have active research programs in agricultural biotechnology
Over 12 million, mostly resource poor, farmers used genetically

engineered seeds last year. This represents an increase of 12 percent over 2009.

 Although herbicide tolerance dominated the first decade of biotech

crops, genetically engineered insect resistance is rapidly gaining ground.

Scientists have developed varieties of corn with built in insect

resistance
several countries have on-going field trials of genetically engineered

fungal resistance in wheat, potatoes, strawberries, bananas, papaya, and rice crops to name but a few.
China alone has carried out over 2000 field trials on different GE crops

and India and Brazil are not far behind.

The demand for biofuels will be met using non-food crops.

FUTURE OF GM FOOD IN INDIA

The ministers favoured immediate setting up of National

Biotechnology Regulatory Authority to tackle GM-related issues.

India is one of the six leading countries that are conducting field trials

of GM crops and foods.

BT brinjal is considered to be in the final stages of approval from the

Genetic Engineering Approval Committee (GEAC), under the environment ministry.

Besides brinjal, there are over two dozen varieties of rice and an equal

number of tomatoes, many types of potato, sugarcane, soy and okra awaiting GEAC approval.

 BUSINESS MODEL OF BT COTTON PRODUCING

FIRM
9 building blocks of business model value proposition:- Bt cotton target customer segments :-farmers communication and distribution channels :- dealers relationships :-customers and dealers core capabilities :- tolerant to herbicides or insect resistant, increase yields configuration of activities:- strategy, processes, units, rules, hierarchies, workflows, and systems. Partners revenue streams cost structure

Business model components

Through established dealers so that word of mouth will be maintained Proper infrastructure is maintained in order to produce bt cotton seeds without any defect

Customer Gestion des Relationship relations-clients Infrastructure Gestion des logistics infrastructures Financial Financial Aspects aspects aspect financiers Through loans from banks and financial institutes

Product Innovation innovation produit Biotech cotton is genetically modified to produce a toxin that kills certain insects or resists certain herbicides, and to increase yields
2001 Pigneur, HEC Lausanne

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