Prospects of GM Crops and Regulatory considerations

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1 Prospects of GM Crops and Regulatory considerations Dr.R.S.Kulkarni Professor of Genetics & Plant Breeding University of Agricultural Sciences GKVK, Bangalore




5 THE GLOBAL VALUE OF THE BIOTECH CROP MARKET In 2005, the global market value of biotech crops, was $5.25 billion representing 15% of the $34.02 billion global crop protection market in 2005 and 18% of the ~$30 billion 2005 global commercial seed market. Biotech crop market comprised of $2.42 billion for biotech soybean (46%), $1.91 billion for biotech maize (36%) $0.72 billion for biotech cotton (14%) $0.21 billion for biotech canola (4%). The accumulated global value for period , is estimated at $29.3 billion. The global value of the biotech crop market is projected at over $5.5 billion for 2006.

6 FRANCE - Bt Maize In 2005, ~ 500 hectares were planted -200 hectares for environmental monitoring, -100 hectares for experimental use, -200 hectares for purely commercial purposes.

7 IRAN - Bt Rice Agricultural Biotechnology Research Institute at Karaj

8 GM crops- Global Scenario (2005) 17 countries currently have commercialized GM crop plantings 85% of GM crops are planted in the US (59%), Argentina (20%) and Canada (6%) Other countries with more significant commercial plantings: Brazil, China, Paraguay, India, South Africa, Australia 6 countries grow 98% of all GM crops

9 GM crops: Crop Status (2005) Of the global acreage of GM crop plantings: Soybean 60% (56% of soybean planted globally is GM) Maize 23 % (14% of maize planted globally is GM) Cotton 11% (28% of cotton planted globally is GM) Canola 6% (19% of canola planted globally is GM)

10 GM crops:global Status 2005 Main traits in global commercial plantings of GM crops: Herbicide tolerance (72%) Insect resistance (19%) Herbicide tolerance & insect resistance (9%)

11 Potential benefits associated with GM-crops increases in crop yields, decreases in the use of pesticides and herbicides, and improvement in nutritional content and storage characteristics. The increases in crop yields are attained indirectly through genetically engineered resistance in plants to certain pests and diseases ( biotic stresses ), and greater tolerance to drought, salinity, frost,etc. ( abiotic stresses ) besides quality enhancement.

12 Potential risks associated with GM-crops Unexpected consequences such as the appearance of allergens, toxins and carcinogens in GM-food and GMlivestock feed. Ecological and environmental risks could arise from cross-pollination between GM-crops and their indigenous wild relatives, potentially leading to loss of biodiversity, Emergence and spread of pests, diseases and weeds that could acquire the same resistances as are engineered into the GM-crops. The socio-economic safety of small farmers may be put at risk by the potentially negative impact on them of the agronomic and trade consequences of GM-crops.

13 Adopting a Transgenic Crop: Production Considerations Technology fee Pest infestation probabilities Yield drag Reduction in pesticide costs

14 Adopting a Transgenic Crop: Environmental Considerations Refuge requirements Impacts on beneficial insects Tillage system adjustments

15 Adopting a Transgenic Crop: Marketing Considerations Potential premiums or discounts Market segregation costs How much premium?


17 Roundup Ready soybeans before spraying with Roundup after spraying with Roundup


19 CROP-WISE CONSUMPTION OF INSECTICIDES IN INDIA Fruits & Vegetables 13% Plantation Crops 8% Others 8% Cotton 54% Rice 17%



22 Bt potatoes Produced by Monsanto express the Cry3A Bt toxin to control Colorado potato beetle marketed as New Leaf potatoes not clear why they were withdrawn

23 APHID TOLERANT MUSTARD Aphid-tolerant Control Aphid-infested Brassica



26 Transgenic papayas are resistant to PRSV

27 Transgenic tomato with resistance to Leaf Curl Virus





32 Different transgenic "events" in Bt corn Bt 11 Cry 1 A(b) Yieldgard Syngenta MON 810 Cry 1 A(b) Yieldgard Monsanto Cry 1F Herculex Mycogen/Dow/Pioneer/DuPont Cry 9C Starlink Aventis - now discontinued Event 176 Cry 1 A(b) Syngenta and Mycogen - now discontinued

33 Refuge strategy

34 Transgenic tomato paste Marketed in the UK by two large supermarket chains lower price and a successful product

35 Important principles behind US regulations First principle - product not process It is the nature of the product that is important, not how it was produced This implies that there is nothing inherently dangerous in the methods of producing transgenic plants transgenic biotechnology is nor more dangerous than conventional breeding

36 Important principles behind US Product not process regulations This does not mean that all products developed via biotechnology are inherently safe It does mean that what has been changed in the plant should be evaluated, not how it was changed

37 Important principles behind US regulations Second principle - substantial equivalence Is the transgenic crop "substantially equivalent" to the conventional crop? i.e. similar in terms of agronomic, biochemical, nutritional parameters If so, little further evaluation is necessary, except for the novel components that have been added

38 The promise and hyperbole of "Golden Rice"

39 Vitamin A and "Golden Rice" Transgenic rice grains have yellow color, thus the term golden rice Accumulation of significant levels of ß-carotene in rice endosperm Being incorporated into established rice varieties

40 Plant Products: Drugs and Industrial Chemicals Laurate Canola Vaccines Trypsin Avidin Beta-glucuronidase

41 PLANTS FOR HUMAN HEALTH Transgenics with increased β carotene & Iron Golden Rice High Carotenoid Canola Edible Vaccines Hepatitis B Surface Antigen: potato Monoclonal antibodies in plants for use in Cancer Therapy Vaccines against Cholera: Banana Vaccines against Diarrhoea

42 What can be patented in biotechnology? Cloned genes Gene promoters Constructed plasmids Recombinant proteins Procedures for gene transfer Devices for gene transfer and all the applications of these items


44 What is the potential impact of transgenic crops on the environment? toxicity to other living organisms persistence or invasiveness genetic impact on other plants influence on pest control effect on wildlife diversity effect on soil and water

45 GMOs and Environmental Impacts 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 Increased efficiency of production / unit fossil fuel energy expended

46 GMOs and Food Safety Genetic engineering creates novel genetic combinations Potential exists for undesirable effects of allergenicity or toxicity All GMOs are tested extensively for food safety prior to sale foods for human consumption and animal feed agricultural products (meat, dairy, fresh produce) To Label or Not to Label? Labels must give accurate information on product composition Identity preservation methods, tolerances, costs

47 GMOs and Global Trade GM Commodity Crops Highlight Differences in Culture and Economic Systems Education level and awareness of agriculture and biotechnology Feelings toward food and agriculture as a way of life Governmental policies on the regulation of GM crops imports, sales Agricultural economies

48 What are the prospects for the future? There are many obstacles to the introduction of new agricultural biotechnology products in the future high R & D costs high costs for regulatory approval intellectual property restrictions low margins on commodity crops small markets with minor crops

49 What are the prospects for the future? However, there are many opportunities as well improved production methods requiring fewer pesticides enhanced output traits new products


51 Global application of GM crops

52 The Global Regulatory Principles for GMOs 1. The principle of risk assessment (SPS, TBT, OECD) 2. The principle of information exchange (CBD, Directive 90/220) 3. The principle of familiarity or substantial equivalence (NRC OECD) 4. The principle of non-discrimination (GATT 1994) 5. The principle of harmonization (TBT, SPM) 6. The principle of private property (TRIPs) 7. The precautionary principle (CBD, SPS) 8. The principle of consent (CBD) 9. The principle of benefit sharing (CBD) 10. The principle of labeling (Directive 90/220, Novel Foods Regulation)

53 What will the consumer say? The tail that wags this dog "The consumer, through the exercise of choice, provides a continuing plebiscite over every feature of the food supply. The consumer may be right or wrong, informed or misguided, flippant or serious. Nonetheless, it is consumer choice that drives the entire food system." Neil Harl, Iowa State University economist

54 I smell a rat Transgenic lettuce expressing a rat gene for a critical step in the pathway to vitamin C in mammals L-gulono-g-lactone oxidase Significantly more (700% higher ) vitamin C in the transgenic lettuce Will consumers accept this? Will it still be considered vegetarian?