Genetically Modified (GM) crops are they safe to grow? Are

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1 Genetically Modified (GM) crops are they safe to grow? Are they safe to eat? Eija Pehu ARD

2 Biotechnology - Definition Biotechnology implies the use of microbial, animal or plant cells, or parts thereof to synthesize, breakdown or transform biological materials to produce useful products and services.

3 Conventional breeding a numbers game: crossing, evaluation, selection, backcrossing Variety development for Potato can take 30 years

4 Gene technology enables precision breeding ; - Can transfer only the gene of interest - DNA slicing enzymes, plant transformation technology, first report gene can be from any organism - essential to combine molecular biologists and breeders: smart-breeding

5 Examples of Present and Future Ag-biotech Innovations

6 Insect Resistant Cotton Cotton with Bollgard II Cotton without Bollgard II

7 Ingo Potrykus Genetic engineering: contributions to food security. The golden colour is indicative of provitamin A

8 Rice with enhanced photosynthesis (M. Ku)

9 Engineering for drought and salinity tolerance in crops GMO (left) and conventional variety (right) grown in highly saline conditions

10 Better feed utilization - Less environmental problems Phosphorus in manure can be reduced by inserting an enzyme gene from a microbe to feedcrops used for pigs and poultry.

11 Crops can be engineered to break their lignin and cellulose to make biofuel production more efficient and cheaper.

12 How much is produced today?

13

14 Is it safe to grow? Is it safe to eat?

15 International Governance Cartagena Protocol on Biosafety - protocol in the CBD convention - trade of Living Modified Organisms (seeds, tubers, etc.) and their introduction to a new environment - Advance Informed Agreement (AIA) provided by exporters and approved by importers - science driven risk assessment - can include socio-economic concerns Codex Alimentarius - principles for the Risk Analysis of Foods Derived from Modern Biotechnology in framework for food safety risk analysis

16 What are the key concerns about agricultural biotechnology? Food safety Nutritive value Allergens Toxins Safety assessment regulations/reliability Environmental safety Non-target effects Outcrossing Modifying biodiversity Regulation of technology Social & economic issues IP protection; Gene patents Equity; cost of technology Access; control of technology Cultural issues Trade and competitiveness Religious/ Choice issues Vegetarianism Halal or Kosher Sources of meat Church leaders?

17 Food safety assessment Substantial equivalence principal Nutritional content: Bioavailability of lipids, carbohydrates, vitamins, minerals Allergenicity: physical and sequence properties of the protein, animal tests Toxicity Strict testing before release Food safety approvals can be accepted internationally No adverse incidences reported Biotechnology can also reduce food allergens and toxins (e.g. peanut, rye-grass)

18 Environmental Risk Assessment Risk assessment location specific Risks related to pollination biology, presence of close species and the trait transferred assessed (desk reviews, laboratory, green house and field tests) Impact on non-target organisms, fitness advantage by the new trait. Risk management

19 The PROCESS : Insect-Protected Corn - From Idea to Reality, 14 Years of Research and Development First transgenic plant First Bt corn plants 6/90 Seed companies cross into elite germplasm 11/93 First field tests 6/92 Safety First US sales studies Insect-protected completed 4/97 5/95 EU approval 8/ Lead lines selected EPA approval 12/96 FDA Consultation completed 9/96 USDA deregulation of Insect-protected 3/96 Commercialization decision 10/95 SEED COMPANY BREEDING AND BULKUP REGULATORY GLOBAL EXPANSION

20 Time taken for Bt cotton approval in India, 6 years Bio Safety RCGM Received Import permit GH Trial Limited field trial 1 location Limited field trial 4 locs Allergenicity, Toxicity & Other studies Final Safety package Submitted to RCGM Research Field Trials RCGM Multi centric Trials at locations Multi centric trials at 11 locations RCGM Recommends To GEAC GEAC, Studies &Large scale Trials Large scale Trials 85 Ha Production 150 Ha. Large scale Trials 100 Ha Production 300 Ha Various studies Report Submitted Containing Reports on all Studies stipulated In 2001 ICAR trials First year Trials planted Late Trials conducted Under the AICCIP 2 nd Year trials

21 Scientific Concensus on Risks Emerging The potential occurrence of unintended effects is not unique to the application of recombinant DNA techniques but is also a general phenomenon in conventional breeding. FAO/WHO Expert Consultation, No strict distinction exists between the health and environmental risks posed by plants genetically engineered through modern molecular techniques and those modified by conventional breeding practices. U.S.National Research Council. Risks associated with biotechnology-derived foods are not inherently different from the risks associated with conventional ones. OECD.

22 Support to Agricultural Biotechnology by the World Bank Investments in biotechnology so far about 50 million USD through agricultural R&D support Since 2003: WB implementing agency for GEF funded biosafety projects in Colombia and India Regional projects in biosafety being prepared for LAC and West- Africa

23 India Biosafety Capacity Building Project Started 2003; implemented by CBD focal point in MOEF, capacity to comply to Cartagena Protocol, 1 million USD for 3 years Components: I Improving institutional capacity in line ministries, related agencies and state governments II Enhanced technical capacity in risk assessment and management III Establish Biosafety Clearinghouse Mechanism IV Support centers of excellence for GMO detection and research networking

24 Lessons learnt On-going debate on the roles of different ministries in regulation and approvals (MOEF, MOA, MOST), made inter-ministerial coordination difficult Technical advances in BCH, GMO detection and crops databases achieved Importance of biotechnology communication Focus on core curriculum development and sharing with other providers for most impact Emerging issues: Food safety capacity building? Approvals of public sector events? For more information visit:

25 Information and support: Saski Thematic group: joint seminar series with ENV-GEF unit on biotech/biosafety FAO Biosafety/biotech: Agbios Ltd. Cornell school education program: http: //

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