The GM-FOOD debate and Bio-safety Assessment procedure for Biotech food

Submitted by:-Chandrakant dubey

Jyoti meghaniAnkita tanwar

introduction

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 sourcesDevelopment of salt-tolerance cropsReduced use of pesticides and herbicidesFrost, flood, drought, disease resistant cropsImproved 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 proteinunintended harm to wildlife

Bio-safetyOECD 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

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

Food/Feed Composition

•Key nutrients/anti nutrients•Animal performance

Environmental

Molecular characterization

Source of geneMolecular characterization of inserted DNATransformation 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 foodOutcomes may be -Substantially equivalent to the conventional

counterpartSubstantially equivalent with some well

defined exceptionNot 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 propertiesDetermine 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 consumptionBiological function and mode of action of

protein raises no safety concernAmino 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 allergyAmino acid sequence matches with known

allergenDetection technique for IgE of sera Radio allergosorbent test(RAST)ELISAPhysiochemical properties should be assessed

Toxicity and antnutritional testDetermine “no effect level”Exposure assessmentIrritation testSensitization 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 Raez-Luna, 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 sterilizing traits in crops and ornamentals.

Prevent the movement of traits to nontarget species. 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.

Nitrogen fixation by nonlegumes.

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

Add to excess N leaching from agriculture, degrading human health and reducing biodiversity.

Type of Impact

Benefit-Related Aspects

Risk-Related Aspects

Agricultural 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?

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?

CONCLUSION

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 FUTUREgenetically 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 body’s natural defense mechanisms to better fight diseases.

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

FUTURE OF GM FOOD GLOBALLYThe 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 INDIAThe 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 modelvalue proposition:- Bt cottontarget customer segments :-farmerscommunication and distribution channels :- dealers relationships :-customers and dealerscore capabilities :- tolerant to herbicides or insect resistant, increase

yieldsconfiguration of activities:- strategy, processes, units, rules,

hierarchies, workflows, and systems. Partnersrevenue streamscost structure

© 2001 Pigneur, HEC Lausanne e-business 30

Innovationproduit

Gestion desrelations-clients

Gestion desinfrastructures

Aspectsfinanciers

Business model components

Financialaspects

Financialaspects

Through established dealers so that word of mouth will be maintained Customer

Relationship Customer

Relationship

Biotech cotton is genetically modified to produce a toxin that kills certain insects or resists certain herbicides, and to increase yields

ProductinnovationProduct

innovation

Proper infrastructure is maintained in order to produce bt cotton seeds without any defect

Infrastructurelogistics

Infrastructurelogistics

Financial aspect

Through loans from banks and financial institutes