Transgenics, Environmental Concerns & Biosafety Issues Related To BT Gene

The presentation gives insight idea about transgenics and biosafety issue in brief.

1. By : Major Advisor Mr.Vikas Verma Dr . Anita Babbar Department of Plant Breeding and Genetics Jawaharlal Nehru Krishi Vishwa Vidhyalaya , (JNKVV) Jabalpur, (M.P.) Credit Seminar on Transgenics, Environmental Concerns & Biosafety Issues Related To BT Gene

2. What is a transgenic? Exotic gene added to a species through recombinant DNA technology - Transgene The organism that develop after successful transformation - transgenic BT COTTON GOLDEN RICE FLAVR SAVR TOMATO Introduction

3. Shigetane Ishiwatari (1901), first isolated Bacillus thuringiensis . Bt is commonly abbreviated as Bacillus thuringiensis,is a gram-positive, facultative aerobic, rod-like, motile and sporulating bacterium. Bt is a naturally-occurring soil borne bacterium that is found worldwide Ubiquitous in nature. Produces crystals of endotoxin (Cry protien or delta toxin) - toxic to insect mainly in their larval stage, thus they act as insecticides. Bacillus thuringiensis

4. These crystal proteins (Cry proteins) are insect stomach poisons. Insects stop feeding within two hours of a first bite and, if enough toxin is eaten, die within two or three days Important biological insect control agent. Bt crystals, sometimes referred as insecticidal crystal proteins (ICP), are protein crystals formed during sporulation in some Bt strains coded by cry genes. C onti .....

5. 1. Ingestion 2. Solublization & proteolytic activation 3. Binding to target site 4. Formation of toxic lesions HOW Bt WORKS ?

6. Mode of Action of Bt Toxin in Insect Gut

7. Development of GM Crop/ Transgenics Identify gene(s) giving a desired trait Make copies of the gene Transfer to plant tissue Regenerate plants Lab analysis and safety testing Development of a variety Field tests Approval by Government agencies Commercialization Monitoring of efficacy and safety

8. Schematic Diagram of Bt Crop Improvement

9. Delivering the Gene to the Plant Transformation cassettes are developed in the lab They are then introduced into a plant Two major delivery methods Agrobacterium Gene Gun Tissue culture required to generate transgenic plants

10. The Lab Steps

11. Transgenic Crops: Development Objectives First-generation GM crops Herbicide resistance:- Corn,Soybean,rice,and Sugar beet Insect Pest resistance:- Corn, rice tomato and potato Viral resistance:- Papaya, Squash and potato Slow ripening and softening- Tomato and melon Improved oil quality -Canola and soybean Male sterility - Canola and corn

12. Second generation of GM crops Increased levels of protein Modified and healthier fats Modified carbohydrates Improved flavor characteristics Increased levels of micronutrients Third generation of GM crops Resistance to abiotic stress “ Pharmaplants ” Conti..

13. Insect resistant cotton – Bt toxin kills the cotton boll worm transgene = Bt protein Insect resistant corn – Bt toxin kills the European corn borer transgene = Bt protein Agriculture Transgenics On the Market

14. Herbicide resistant crops Now: soybean, corn, canola transgene = modified EPSP synthase or phosphinothricin -N- acetyltransferase Virus resistant papaya transgene = virus coat protein

15. Next Generation of Ag Biotech Products Golden Rice – increased Vitamin A content transgene = three pathway enzymes Sunflower – white mold resistance transgene = oxalate oxidase from wheat

16. Only one crop approved i.e. Bt cotton Three hybrids containing Cry1Ac gene approved in 2002 New events approved i.e. cry1Ac gene (event 1) by M/s J.K. Agri Seeds Ltd. In 2006 Fused genes cry 1Ab+cry 1A c ( event GFM )by M/s Nath Seeds in 2006 S tacked genes cry1Ac and cry1Ab by M/s MAHYCO Synthetic cry1C (event MLS-9124) by Metahelix Life Sciences in 2009. STATUS OF GM CROPS IN INDIA: Crops approved for commercial use

17. Traits Crops Insect resistance Blackgram , brinjal , cabbage, cauliflower, chickpea, cotton, maize, pigeon pea, potato, rice, tobacco, tomato, wheat Disease resistance Blackgram , brinjal , chickpea, coffee, rice, tomato Herbicide tolerance Blackgram , cotton, mustard, rice   Stress tolerance Mustard, rice   Edible vaccines Muskmelon, tomato   Fruit ripening Banana, potato, tomato   Nutrition enhancement Mustard, potato Transgenic research on other crops in India

18. Global Status of Commercialized Biotech/GM Crops In 2017, the accumulated biotech crop area (planted since 1996) surged to a record 2.3 billion hectares or 5.8 billion acres .Of the total number of 24 countries planting biotech crops in 2017, 19 were developing countries and 5 industrialized countries . To put the 2017 global area of biotech crops into context, 189.8 million hectares of biotech crops is equivalent to almost 20% of the total land area of China (956 million hectares) or the USA (937 million hectares) and more than 7 times the land area of the United Kingdom (24.4 million hectares). The 3% increase between 2016 and 2017 is equivalent to 4.7 million hectares or 11.6 million acres.( Source: ISAAA, 2017).

19. Global Adoption of Biotech Soybean, Maize, Cotton, and Canola The most planted biotech crops in 2017 were soybean, maize, cotton, and canola. Although there was only 3% increase in the planting of biotech soybean, it maintained its high adoption rate of 50% of the global biotech crops or 94.1 million hectares. This area is 80% of the total soybean production worldwide . Biotech maize occupied 59.7 million hectares globally, which was 32% of the global maize production in 2017. A slight decline (1%) in the biotech maize area from 2016 is due to the unfavorable weather conditions in Latin America, low market price, lesser pest incidence, high year-end stocks .

20. Biotech cotton was planted to 24.1 million hectares in 2017, which indicates a decrease by 8% from 2016. The 8% increase in total biotech cotton area globally was due mainly to the improved global market value and the high adoption rate of insect resistant/herbicide tolerant cotton in 2017. Biotech canola increased by 19% from 8.6 million hectares in 2016 to 10.2 million hectares in 2016. This raise is attributed to the two-digit increases in biotech canola plantings in the USA, Canada, and Australia, addressing the demand for edible oil.

21. Discussion Questions 1. What are regulations supposed to achieve? 2. With GM crops spreading so quickly , how are we assured of their health and environmental safety? 3. How is genetic engineering (biotechnology) regulated? 4. How do the risks posed by products of biotechnology compare to those posed by conventional technologies? 5. How does biotechnology threaten biosafety ? 6. How do different countries regulate products of biotechnology?

22. Environmental concern And Bio- safety Issues Related to BT gene

23. Bio-safety of human and animal health Labeling GM and non-GM food Antibiotic resistance genes in GM food Environmental concerns Gene transfer Effects on bio-diversity Public awareness Socio-economic issues Major concerns related to Bt gene / transgenic crops :

24. 1.Safety of source organism and genes a. safety of inserted DNA b. safety of DNA c. safety of antibiotic resistance marker 2.Safety issue of newly developed product a. potential for toxicity (protein product) b. potential of allergencity (protein product) c. safety of any unintended effects 3.Equivalence of composition 4.Retention of nutritional value 5.The human dietary exposure Food safety issues

25. With the kind of concerns witnessed among the public, keeping GM and non GM products separately with appropriate labelling , perhaps also through colour codes for illiterate people, may be absolutely necessary. The related issue is the need for a certification agency specializing in certifying the GM nature of a product. However, labeling may create confusion among consumers and add to the cost of GM products. Labeling GM and non GM Food

26. Another concern is the transfer of antibiotic resistance from the GM food consumed by people into the bacteria inhabiting the human gut, which might result in a disease causing bacterial population to become resistant to antibiotics. The transgenic developers should continue to remove more rapidly all such markers from GM plants and utilize alternative markers for the selection of new varieties. Resistance to Antibiotics

27. Effect of transgenic plants on population dynamics of target and non target pests Secondary pest problems Insect sensitivity Evolution of new insect biotypes Environmental influence on gene expression Development of resistance in insect population Development of resistance to herbicide Environmental Concerns

28. Direct effects on non-target organisms In May 1999, it was reported that pollen from Bacillus thuringiensis (Bt) insect resistant corn had a negative impact on Monarch butterfly larvae. This report raised concerns and questions about potential risks to Monarchs and perhaps other non-target organisms.

29. Development of insect resistance The use of Bt crops is that it will lead to the development of insect resistance to Bt • Insect resistance management plans have been developed by government, industry, and scientists to address this issue – These plans include a requirement that every field of insect-resistant crops must have an associated refuge of non-GM crops in order for the insects to develop without selection to the insect resistant varieties.

30. Gene flow • Accidental cross breeding between GMO plants and traditional Varieties through pollen transfer can contaminate the traditional local varieties with GMO genes resulting in the loss of traditional varieties of the farmers.

31. Increased weediness • Weediness means the tendency of the plant to spread beyond the field where it was first planted. • There are apprehensions about GM crops becoming weeds. • For example, a salt tolerant GM crop if escapes into marine areas could become a potent weed . • There is also fear about the development of superweeds i.e. a weed that has acquired the herbicide tolerant gene due to genetic Contamination. • With a herbicide tolerance GMO through in field cross breeding to related species or through horizontal gene transfer.

32. GM crops could lead to erosion of biodiversity and 'pollute' gene pools of endangered plant species. The large acreage of elite varieties have pushed and will continue to push the landraces out of cultivation The potential transfer of a transgene to local flora to and its any possible subsequent impact on specific plant species is thus an issue that needs to be kept in view before commercial release of specific transgenes . Effect on Biodiversity

33. Consumer response depends on perceptions about risks and benefits of genetically modified foods. In order to maximize the trust, it is essential that relevant and reliable information about the genetically modified food is communicated to the consumers and stake holders. The media, individuals, scientists and administrators, politicians and NGO have the responsibility to educate the people about the benefits of GM foods. Public Attitude

34. Potential benefits to the consumers and farmers. Due to increasing seed market, the developing countries may get dependent on few suppliers. Countries with effective and efficient technology will obtain and sustain advantage of international market. Reservation of E.U. for acceptance of GM crops. Socio economic issues

35. Genetic engineering creates novel genetic combinations All GMOs are tested for potential environmental impacts prior to sale •influence on soil and water composition •insect resistance management •gene/trait transfer to weedy relatives •interactions with agricultural environment GMO Crops Have Many Significant Environmental Benefits •Reduced chemical pesticide and herbicide use •More sustainable pest management •Better erosion control through no-till practices GMOs-Impacts Analysis and Benefits

36. Registration of transgenic agricultural organisms

37. The Genetically Modified Organisms (GMOs) and products thereof are regulated articles in India in view of potential risks to human health and environment by indiscriminate use under “Rules for Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically engineered organisms or cells, 1989 under the EPA (1986)”. • India has ratified the Biosafety Protocol in January 2003 Biosafety Framework Government Commitment

38. The Cartagena Protocol on Biosafety to the Convention on Biological Diversity has been ratified and signed by 171 parties ( Fabruary 2018). According to the Cartagena Protocol, field trials and all other activities involving genetically modified organisms must be regulated and approved by national governments. Regulatory and Approval system for release of GM plant

39. The European Community (EC) Organization for Economic Cooperation and Development (OECD) WHO/FAO Working Group on Biosafety United Nations Conference on the Environment and Development (UNCED) Codex Alimentarius Commission Biosafety Regulating Agencies of the World

40. Government of India Department of Biotechnology Ministry of Environment ,forest & Climate Change RDAC RCGM GEAC Institutional Biosafety Committee State Biotechnology Coordination Committee District Level Committee Indian biosafety regulatory framework

41. Procedure for GEAC approval for field trials and environmental release of transgenic crops. Institutional Biosafety Committee (IBSC) (Forwarding applications for approval of RCGM) Review Committee on Genetic Manipulation (RCGM) (green house experiments, contained field trails i.e .in –house trial / intial hybrid trial, generation of data on gene stability and expression , biosafety data) RCGM ( approval for conduct of multi-location field trials on selected varieties )/hybrid)and biosafety data) Evaluation of field trails by Monitoring –Cum-Evaluation Committee (MEC) Through SAUs

42. Genetic Engineering Approval Committee(GEAC) Large Scale Trials Seed production 10 ha ICAR trials 1 St year (LST) Large Scale Trials (LST) Seed production 100 ha ICAR trials 2 St year MEC GEAC ( Enviornmental clearance of the event/gene in a given backgrounnd ) Material cleared from Enviornmental sensitivity by MoEF/ or otherwise C onti .....

43. Future Prospects Future envisaged applications of GMOs are diverse and include drugs in food, bananas that produce human vaccines against infectious diseases such as Hepatitis B, metabolically engineered fish that mature more quickly, fruit and nut trees that yield years earlier, and plants that produce new plastics with unique properties. While their practicality or efficacy in commercial production has yet to be fully tested, the next decade may see exponential increases in GM product development as researchers gain increasing access to genomic resources that are applicable to organisms beyond the scope of individual projects. Safety testing of these products will also at the same time be necessary to ensure that the perceived benefits will indeed outweigh the perceived and hidden costs of development .

44. Biotech crops is not a panacea; but they have the potential to make a substantial contribution in cutting poverty by half, by optimizing crop productivity, which can be achieved by public-private sector partnerships.

45. Conclusion The development of Transgenic plants is the result of integrated application of rDNA technology,Gene transfer methods and Tissue culture techniques. T ransgenic plants are designed to acquire useful quality attributes such as insect resistance, herbicide tolerance, abiotic stress tolerance, disease resistance, high nutritional quality, high yield potential , delayed ripening, enhanced ornamental value, male sterility, and production of edible vaccines. Biosafety regulations required to assess the safety of transgenic crops before its release in to environment . “ The controversy about the health safety of Transgenic foods is complex and good science and its communication are required in order to find solutions”

46. Case studies : 1. Socio-Economic Impact of Bt Cotton — A Case Study of Karnataka V.R. Kiresur and Manjunath Ichangi University of Agricultural Sciences, Dharwad-580 005, Karnataka The performance Bt technology and its impact on farming community have been assessed in northern Karnataka based mainly on primary data processed using production functions, decomposition analysis and logit model. On an average, per farm area under Bt cotton was 2.21 ha, accounting for 66 per cent of the total landholding. With a yield of 24 q/ha, Bt cotton has registered 31 per cent higher yield and 151 per cent higher net return over non-Bt, the net additional benefit being ` 18429/ha. The non-Bt cotton farmers use chemical fertilizers, organic manures and bullock labour excessively which result in a lower net returns. Technology has been found the major contributor to the total productivity difference between Bt and nonBt cottons. Seed cost, yield of Bt cotton and cost of plant protection have been found to greatly influence the probability of adoption of Bt cotton.

47. Non-availability of quality seeds and in required quantity have been identified as the most important factors constraining Bt technology adoption. The impact of Bt cotton, as perceived by the farmers, has been in terms of enhanced yield; reduced pest and disease incidence; increased income, employment, education and standard of living; and reduced health risk. To foster adoption, availability of quality and quantity of Bt cotton seed to farmers needs greater attention of development agencies, while researchers’ attention is called for incorporating resistance/ tolerance to Spodoptera and pink bollworms. 2.Genetically Modified Crops in India: The Bt Brinjal Controversy The Genetic Engineering Approval Committee (GEAC)5 announced approval for large scale field trials for Bt brinjal6 in September 2007, and probably its commercialization by early 2009. It also cleared proposals for biosafety studies for other food crops such as okra (lady's finger), rice, and tomatoes. In February 2008, the apex legislative body in India, the Supreme Court, revoked the ban it had earlier placed on the approval of large scale field trials of transgenic crops. Following this announcement, Bt brinjal became a hotly debated topic among activists, scientists, farmers and Multi National Companies (MNCs).

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