Crop BiotechDevelopment & Regulation

Bhagirath Choudhary

TERI09th Feb 2006

• 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

ISAAA’s Global Network of Biotechnology Information Centers

www.isaaa.org/kc

Philippines

Indonesia

Malaysia

Brazil

Argentina

China

India

Egypt

Kenya

South Africa

Thailand

Vietnam

*Costa Rica

*Chile

*Senegal *Ghana

Knowledge and Experience Sharing

Mali

Bangladesh

18 Near-term nodes

Pakistan

*Mexico

*5 Future nodes

Russia

Bulgaria

Italy

Location of the Global Knowledge Center (KC), ISAAA

Sri Lanka

USA

• 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.

BIC Objectives & Activities:

• 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

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

Why Global Status?

Global Status of Biotech/GM Crops

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.

Expansion and Growth

21 countries planted biotech crops in 200514 countries reached “mega-county” status, planting more

than 50,000 hectares.

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

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

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

63 Countries & 57 Fruits, Vegetables, Field crops and other plants-ranging from lab trials to commercial

production

Source: Runge 2004

Sources: ISAAA, IFPRI, Nature, Runge

Sources: ISAAA, IFPRI, Nature, Runge

Sources: ISAAA, IFPRI, Nature, Runge

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)

Impacts of Crop Biotechnology – By Crop Trait

Source: Graham Brookes and Peter Barfoot, 2005 (UK) & NCFAP (US)

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

• 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

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

India-Fastest Growth

State 2004 (ha) 2005 (ha) Rank

2004

Rank 2005

Maharastra 200,000 590,000 1 1

Gujarat 130,000 150,000 2 3

Madhya Pradesh 85,000 145,000 3 4

Andhra Pradesh 80,000 280,000 4 2

Karnataka 18,000 30,000 5 6

Tamilnadu 10,000 25,000 6 7

Northern Zone (Punjab, Hr, Raj)

N/A 60,000 N/A 5

Total 500,000 13,00,000

India-Fastest GrowthState-wise adoption of Bt cotton

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

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.

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

GM Crops in the European Union

Source: GMO Compass

• 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.

GM Crops in the 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

Products “Deregulated” in US

* Not on market

Crops

Biotech Share (%) of US Corn, Soy, & Cotton

1999 2000 2001 2002 2003 2004*

Corn 37 25 26 34 40 46

Soybeans 47 54 68 75 81 86

Cotton 48 61 69 71 73 76

* USDA/NASS 2004 forecast at www.usda.gov/nass

ADOPTION OF GM CROPS IN THE US

US-Regulatory Policy OverviewCoordinated Framework for the regulation of Biotechnology

Agency Jurisdiction Laws

USDA Plant pests, plants, veterinary biology Federal Plant Pest Act (FPPA)

FDA Food, feed, food additives, veterinary drugs, human drugs, medical devices

Federal Food, Drugs & Cosmetic Act (FFDCA)

EPA Microbial and plant pesticides, new uses of existing pesticides, novel microorganisms

Federal Insecticide, Fungicide & Rodenticide Act (FIFRA), Toxic Substance Control Act 9TSCA)

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.

• 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

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.

EC DIRECTIVE90/ 219NOTIFICATION

EC DIRECTIVE90/220APPLICATION

EC REGULATION258/97APPLICATION

HSE DETR FSA

DETR FSA

FACACMSF

COT

ACNFPACRE

COMAACAF ACP

ACGM

EC COMMISSION (DGXI) EC COMMISSION (DGIII)

UK Regulatory Authority and Advisory Committee

DETR - Department of Environment, Transport and RegionsFSA - Food Standards AgencyHSE - Health and Safety Executive ACGM - Advisory Committee of Genetic Modification: Advises on all aspects of human and environmental safety ofcontained use (e.g., laboratory) of GMOs.ACRE - Advisory Committee on Releases to the Environment: Considers the environmental safety of field trials and themarketing of GMOs.ACAF - Advisory Committee on Animal Feeding stuffsACP - Advisory Committee on PesticidesACNFP - Advisory Committee on Novel Foods and Processes: Considers the safety of foods derived from GMOs.ACMSF - Advisory Committee on Microbiological Safety of FoodFAC - Food Advisory CommitteeCOT - Committee on ToxicityCOMA - Committee on Medical Aspects of Food Policy

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.

• Comprehensive and rigorous system for ensuring safety of crop biotech products;

• Process: open, transparent and inclusive

• Information Sharing for public choices and decisions

Adequate Regulation of Crop Biotech Products

• 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

- 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).

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.

Thanks

International Service forthe Acquisition of Agri-biotech Applications (ISAAA)

1st Floor, CG Block, NASC ComplexDPS Marg, Pusa, New Delhi-110012, India

Tel: +91-11-39472302Fax: +91-11-25841294Cell: +91-9891395710

Email: b.choudhary@cgiar.org Visit Us: www.isaaa.org or www.isaaa.org/kc