Crop Biotech Development & Regulation Bhagirath Choudhary TERI 09 th Feb 2006

1. Crop BiotechDevelopment & RegulationBhagirath ChoudharyTERI09th Feb 2006

2. ISAAA: International Service for the Acquisition of Agri-biotech Applications (www.isaaa.org) • It is a not-for-profit internaztional organization cosponsored by public and private sector institutions • Objectives: • To facilitates the transfer of crop-biotechnology applications– particularly private sector proprietary technology– from industrial to developing countries for their benefit and, • To share knowledge on crop-biotechnology to various stakeholders in order to equip them with the latest knowledge on crop biotech to make informed decisions

3. Italy Russia China Bulgaria USA Egypt Pakistan Bangladesh *Mexico Mali Vietnam India *Senegal *Ghana Thailand Philippines *Costa Rica Kenya Sri Lanka Malaysia Brazil Indonesia *Chile South Africa Argentina Knowledge and Experience Sharing 18 Near-term nodes *5 Future nodes Location of the Global Knowledge Center (KC), ISAAA ISAAA’s Global Network of Biotechnology Information Centers www.isaaa.org/kc

4. BIC Objectives & Activities: • Serve as global knowledge network on crop biotechnology • Assist national biotech programs in creating an enabling environment for crop biotech • Generate, process, and package knowledge on crop biotech • Facilitate sharing and application of knowledge among various stakeholders and, • Develop and validate appropriate science communication modalities. • ISAAA Annual Review on Global Status of GM Crops • ISAAA Publications kit, CDs. etc • Outreach programs • Media outreach • Study tours for farmers, media, scientists, policy makers, students etc

5. Global Status of Biotech/GM Crops Why Global Status? • Assist developing countries in assessing the potential of biotech crops. The principal aim is to present a set of authenticate, verifiable and referenced data; • to facilitate a knowledge based discussion of the current global trends in biotech crops • to help stakeholders to take informed decision

6. Adoption increases continue after 10 years of commercialization • Global area reached 90 million hectares, up 11 percent in 2005 as compared to 81 million hectares in 2004 • 8.5 million farmers in 21 countries planted biotech crops as compared to 8.25 million farmers in 17 countries in 2004 • Herbicide-tolerant soybeans remained the most widely adopted trait, followed by insect-resistant maize. • More than fifty-fold increase from 1.7 million hectares in six countries in ’96 • In 2005, there were fourteen biotech mega-countries (countries growing 50,000 hectares -125,000 acres - or more, of biotech crops), compared with ten in 2003 - 9 developing countries and 5 industrial countries; they were, in order of hectarage/acreage, USA, Argentina, Canada, Brazil, China, Paraguay, India, South Africa, Uruguay, Australia, Romania, Mexico, Spain and the Philippines.

8. Expansion and Growth 21 countries planted biotech crops in 2005 14 countries reached “mega-county” status, planting more than 50,000 hectares.

10. Global Adoption Rates (%) for Principal Biotech Crops (Million Hectares)

11. 2005: A Year of Milestones • In 2005, farmers planted the 1 billionth cumulative acre, or 400th million hectare, of biotech crops. • The first crop of Bt rice was planted in Iran. • Most important food crop in world • Potential to make substantial contribution to UN Millennium development goal of poverty reduction by 50% by 2015

12. Multiple or “Stacked” Traits • Growing number of varieties with more than one biotech enhancement • “Trait hectares” becoming important growth indicator • 100 million “trait hectares” planted in 2005 • 10 percent more than adopted biotech crop area of 90 million hectares

13. 63 Countries & 57 Fruits, Vegetables, Field crops and other plants-ranging from lab trials to commercial production Source: Runge 2004

15. Sources: ISAAA, IFPRI, Nature, Runge

16. Sources: ISAAA, IFPRI, Nature, Runge

17. Sources: ISAAA, IFPRI, Nature, Runge

18. Global Benefits 1996-2004 • Decrease in pesticide applications: 172,000 metric tons • Greenhouse gas emissions eliminated by reducing tillage: 10 million metric tons • Diesel fuel saved by reduced tillage or plowing: 1.8 billion liters • Increase in net income for farmers: $27billion • China: Cumulatively since 1997 the farm income benefit has been $4.16 billion. In 2004, the net national gain to farm income was $1.1 billion. • India: At the national level, farm income gains amounted to $6.1 million in 2002, $32.4 million in 2003 and $85.7 million in 2004 (cumulative total of $124.2 million). • The planting of biotech crops has reduced the “environmental footprint” of cotton, corn, soy and canola by 14 percent, as calculated using an established environmental index quotient (EIQ) that compares the potential impacts of pesticides used in a conventional field to a field planted with a biotech crop. • Global value of biotech crop market projected at $5.5 billion in 2006, an increase from $5.25 billion in 2005. • No reports of harm to human or animal safety Source: Graham Brookes and Peter Barfoot, 2005 (UK) & NCFAP (US)

19. Impacts of Crop Biotechnology – By Crop Trait Source: Graham Brookes and Peter Barfoot, 2005 (UK) & NCFAP (US)

20. India-Fastest Growth • In 2005, India experienced the highest yearly percentage growth rate increasing its area by 160% to 1.3 million hectare of biotech cotton • Around 10 lakh resource poor farmers elected to plant Bt cotton in Northern, Central and Southern cotton growing zones-three fold increase over 2004 • Grew to seventh largest adopter of biotech crop

21. India-Fastest Growth • 16 new varieties of Bt cotton hybrids belonging to four companies were released in 2005 totaling to 20 Bt cotton hybrids. • More than 25 companies are developing different varieties of biotech cotton hybrids with different genes and with staked genes/multiple traits ie. cry1Ac, cryAb, GFM-cry1Aa, Vip-3a, cry1Ac+cry2Ab • UAS, Dharwad along with CICR Nagpur is developing its own biotech cotton varieties employing Bt gene and is likely to be available to farmers in near term

22. India-Fastest Growth • In 2005, three companies have received permission for large scale field trials of biotech cotton with different genes. • The approval of more no.s of Bt cotton hybrids may further grow in 2006. Future potential for multiple traits in biotech cotton • Biotech eggplant is under near term approval. Total 14 field, vegetable and commercial crops are under advanced stage of development at various institutions in India such as rice, mustard, maize, sorghum, tomato, potato, groundnut, cauliflower, cabbage, chickpea, okra and pigeonpea etc

23. India-Fastest Growth State-wise adoption of Bt cotton

24. Developing Countries Benefit • Resource-poor farmers in developing countries represent 90 percent of biotech growers • Developing nations represent more than one-third of global biotech area. • Growth in developing countries is four times (23 percent) as rapid as industrialized countries (5 percent). • Biotech crops have increased the income of 7.7 million farmers in developing countries, helping alleviate from poverty

25. European Growth • Three more European countries grew biotech crops in 2005, bringing the total number of EU countries to 5 of 25. • The Czech Republic planted Bt maize for the first time. • France and Portugal resumed planting biotech maize after a gap of four and five years. • Germany continued to grow a modest area of Bt maize.

26. GM Crops in the European Union • 2005 GM crop facts: • Spain: about 50,000 hectares (12 percent of the Spanish maize crop) • France: 500 hectares officially, estimated at up to 1000 hectares • Portugal: 780 hectares • Czech Republic: 300 hectares • Germany: 400 hectares Source: GMO Compass

27. GM Crops in the US • Since 1987, over 11,000 field trials authorized at 50,000 sites; over 100 species of plants and microorganisms field-tested • As of December 2005, sixty-six (66) products have completed U.S. regulatory review • “Deregulated” products can be used in food, feed, and in breeding programs in the same way as their conventional counterparts. • Commercialization is determined by market demand.

28. Products “Deregulated” in US • Corn - HT, IR, AP • Soybean - HT, PQ • Cotton - HT, IR • Tomato - PQ • Squash – VR • Papaya – VR • Rapeseed - HT, AP, PQ • Chicorium – AP • Tobacco - PQ • * Potato - IR, VR * Rice - HT * Sugar beet - HT * Flax - HT * Not on market

29. ADOPTION OF GM CROPS IN THE US * USDA/NASS 2004 forecast at www.usda.gov/nass

30. US-Regulatory Policy Overview Coordinated Framework for the regulation of Biotechnology US Regulatory Authorities for Crop Biotech Products • Existing laws were, for the most part, adequate for oversight of biotechnology products • The products, not the process, would be regulated • Genetically engineered organisms are not fundamentally different from non-modified ones and, • Oversight authority should be exercised only where there is evidence that the risk posed by the introduction is unreasonable.

31. USDA-APHIS: Responsible for ensuring that the growth of genetically engineered plants does not harm the agricultural environment (as distinct from the wild environment) EPA: Responsible for assuring the human and environmental safety of pesticidal substances engineered into plants, and FDA: Responsible for assuring that foods derived through genetic engineering are as safe as their traditional counterparts. • Integrated U.S. Government Regulatory Website: • http://usbiotechreg.nbii.gov/ • USDA, FDA and EPA Websites: • www.aphis.usda.gov/brs • www.cfsan.fda.gov/biotechm.html • www.epa.gov/pesticides/biopesticides

32. UK Regulatory Authority and Advisory Committee EC DIRECTIVE 90/ 219 NOTIFICATION EC DIRECTIVE 90/220 APPLICATION EC REGULATION 258/97 APPLICATION HSE FSA DETR ACMSF FAC ACGM ACRE ACNFP ACAF ACP COMA COT FSA DETR EC COMMISSION (DGIII) EC COMMISSION (DGXI) DETR - Department of Environment, Transport and Regions FSA - Food Standards Agency HSE - Health and Safety Executive ACGM - Advisory Committee of Genetic Modification: Advises on all aspects of human and environmental safety of contained use (e.g., laboratory) of GMOs. ACRE - Advisory Committee on Releases to the Environment: Considers the environmental safety of field trials and the marketing of GMOs. ACAF - Advisory Committee on Animal Feeding stuffs ACP - Advisory Committee on Pesticides ACNFP - Advisory Committee on Novel Foods and Processes: Considers the safety of foods derived from GMOs. ACMSF - Advisory Committee on Microbiological Safety of Food FAC - Food Advisory Committee COT - Committee on Toxicity COMA - Committee on Medical Aspects of Food Policy

33. US-EU Crop Biotech Regulations • The US and EU differ in the particulars of how they approach regulation for crop biotech products. • In US and EU, the Current systems are largely designed to address concerns that can be dealt with through science • Bottom Line: Ensuring human and environmental safety • Economic and socio-cultural-ethical factors • One distinct feature is to allow risk assessment - the prediction of likely hazard - to drift into risk management, where economic and socio-cultural-ethical factors may play a role in deciding whether to accept a particular level of risk.

34. Adequate Regulation of Crop Biotech Products • Comprehensive and rigorous system for ensuring safety of crop biotech products; • Process: open, transparent and inclusive • Information Sharing for public choices and decisions

35. Comprehensive and rigorous system for ensuring safety of crop biotech products: Mandatory pre-market examination by the appropriate regulatory authorities and approved for sale only after they are found to meet the standard of presenting a reasonable certainty of no harm. • Regulation (Existing/New) • Biotechnology technique-inherently risky (Process/Product) • Risk Assessment (US & EU) • Substantial Equivalence (genetically engineered organisms are not fundamentally different from non-modified ones) • Assessment of Environmental Impact: likelihood of outcrossing is very low, or because the spread of modified traits will not be favoured by natural selection • Risk-Benefit equations: (US-compared with status quo, EU-other potential alternatives

36. Traceability and Monitoring (US & EU) • Time Limited Licenses (US & EU) • Liability and redress (US & EU) • Co-existence (GM and Non-GM) • Labeling (Voluntary/Compulsory) • Precautionary Principle-substantive uncertainties prevent accurate risk assessment • Process: open, transparent and inclusive • Risk assessment and risk management, should include (e.g., toxicologists, nutritionists, molecular biologists and plant breeders), • A broad range of specialists and stakeholders (e.g., social scientists, ethicists, representatives of civil society).

37. Optimistic Outlook • Future growth expected as second-generation input and output traits are expected in the next decade. • Anticipated adoption of biotech rice in China could significantly impact adoption rates. • The next 10 years may also bring novel crop products for more nutritional food and feed and use as a renewable resource for biofuel production.

38. ThanksInternational Service forthe Acquisition of Agri-biotech Applications (ISAAA)1st Floor, CG Block, NASC ComplexDPS Marg, Pusa, New Delhi-110012, IndiaTel: +91-11-39472302Fax: +91-11-25841294Cell: +91-9891395710Email: b.choudhary@cgiar.orgVisit Us: www.isaaa.org or www.isaaa.org/kc