Representing the Plant Science Industry Field Trials of Experimental, Field Trials of Experimental, Genetically Engineered Plants Genetically Engineered Plants CropLife CropLife International Compliance International Compliance Management Programme Management Programme for Confined for Confined Field Trials Field Trials
Issues that we are NOT dealing with during Issues that we are NOT dealing with during this workshop this workshop Benefits Openness and Public Trust Transparency Risk Communication Grower Satisfaction Globalization Segregation Identity Preservation Risks Social Acceptability Regulatory Oversight Commodity Markets Confined Trials Testing and Labelling Traceability
Continued growth in GM crop area Continued growth in GM crop area · For 2004, it is estima For 2004, it is estimated that ted that Global Area of Transgenic Crops total acreage 200 million – total acreage 200 million – a (Source: Clive James, 2004) 20% increase over 2003 20% increase over 2003 160 · More than 8.25 millio More than 8.25 million n farmers are growing farmers are growing 140 transgenic crops, 90% of transgenic crops, 90% of 120 Acres (million) these are resource-poor these are resource-poor 100 farmers in developing farmers in developing countries untries 80 60 · The percentage growth in The percentage growth in area between 2003 and area between 2003 and 40 2004 in developing 2004 in developing 20 countries (35%) was almost countries (35%) was almost 3X greater than for 3X grea ter than for 0 industrialized countries industrialized countries 1996 1997 1998 1999 2000 2001 2002 2003 2004 (13%) (13%) Year Industrial Developing
Distribution of GM crops by country Distribution of GM crops by country · In 2004, six countries In 2004, six countries Acreage of Transgenic Crops by grew 98% of the global grew 98% of the global Country (Source: Clive James, 2004) GM crop area GM crop area – USA – USA – 59% 59% 120 – Argentina – Argentina – 20% 20% 100 Acres (millions) – Canada – Canada – 6% 80 60 – Brazil – Brazil – 6% 40 – China – China – 5% 20 – Paraguay – Paraguay – 2% 0 1996 1998 2000 2002 2004 Year USA Argentina Canada China
Distribution of GM crops by crop Distribution of GM crops by crop · Nearly all of the area Nearly all of the area Global Acreage by Crop plant planted to transgenic d to transgenic ( Source: Clive James, 2004) crops is accounted for crops is accounted for 140 by four crops, which in by four crops, which in 120 2004 were represented 2004 were represented Acres (millions) 100 by: by: 80 60 – Soybean – Soybean – 60% 60% 40 – Maize – Maize – 23% 3% 20 – Cotton – Cotton – 11% 1% 0 1996 1997 1998 1999 2000 2001 2002 2003 2004 Year – Canola – Canola – 6% Soybean Maize Cotton Canola
Global adoption of GM soy, cotton, canola & Global adoption of GM soy, cotton, canola & maize maize · Of the global aggregate Of the global aggregate area of these 4 crops area of these 4 crops Global Area Adoption Rates by (710 M acres) in 2004, (710 M acres) in 2004, Crop (Source: Clive James, 2004) 29% was planted to 29% was planted to biotech varieties. biotech varieties. 400 350 Acres (millions) 300 · In 2004, the global In 2004, the global 250 market value of biotech market value of biotech 200 crops was e crops was estim timated at d at 150 $4.7 billion, re $4.7 billion, representing presenting 100 16% of the $30 16% of the $30 billion billion 50 global global commercial seed commercial seed 0 Soybean Cotton Canola Maize market market Crop Transgenic Total
· Broader applicati Broader application of n of plant biotechnol plant biotechnology ogy produ products ne ts needs a syste eds a system in place to permit the safe in place to permit the safe conduct of confined field conduct of confined field trials rials. · Capabilit Capability to safely y to safely pe perfo rform confined t m confined trials is rials is equally impo equally important in both rtant in both industrialized and industrialized and developing countries. developing countries. · A system must exist A system must exist whereby locally developed whereby locally developed and fo and foreign applications reign applications can be assessed and can be assessed and evaluated for potenti evaluated for potential al biosafety impacts. biosafety impacts.
Global snapshot: Africa Global snapshot: Africa soya sugar cane
Global snapshot: Asia Global snapshot: Asia
Global snapshot: Central & Eastern Europe Global snapshot: Central & Eastern Europe I think we should change this to Europe including the new accession states
Global snapshot: Central & South America Global snapshot: Central & South America
Regulatory framework for confined field trials Regulatory framework for confined field trials in the Philippines in the Philippines Roles CBI Timeframes
Terminology Terminology · Contained use (laboratory, Contained use (laboratory, greenhouse, screenhouse) greenhouse, screenhouse) Risk Mitigation Experimental · Confined environmental Confined environmental release (field test) release (field test) Risk Assess. · Unconfined environmental Unconfined environmental release (commercialization) release (commercialization)
What is a confined field trial? What is a confined field trial? · A confined field trial is a A confined field trial is a small-scale experimental field trial of a genetically field trial of a genetically engineered plant species carried out engineered plant species carried out to to collect the data necessary for a necessary for a complete environmental risk complete environmental risk assessment that is performed under assessment that is performed under terms and conditions that terms and conditions that mitigate impacts on the surrounding on the surrounding environment environment
Trials we are all familiar with Trials we are all familiar with · Breeders’ trials (experimental) Breeders’ trials (experimental) – Agronomic evaluation of new crosses Agronomic evaluation of new crosses – Evaluation of new germplasm, perhaps Evaluation of new germplasm, perhaps imported from elsewhere imported from elsewhere · Variety registration trials Variety registration trials – Performance trials, demonstration of merit Performance trials, demonstration of merit (value) (value) · Plant breeders’ rights trials Plant breeders’ rights trials – DUS – DUS – demonstration of distinctness, emonstration of distinctness, uniformity, and stability uniformity, and stability
Purpose of confined field trials Purpose of confined field trials · For the breeder – For the breeder – to collect agronomic performance o collect agronomic performance data (efficacy of the modification, yield, etc), same data (efficacy of the modification, yield, etc), same as for a conventional trial as for a conventional trial · To collect data to complete the environmental risk To collect data to complete the environmental risk assessment assessment – Secondary effects on non-target organisms Secondary effects on non-target organisms – Morphological characterization – Morphological characterization – seed dissemination, eed dissemination, do dormancy of seed, ge rmancy of seed, germination rate rmination rate, time , time to maturit to maturity, y, disease and pest resistance disease and pest resistance · To generate data for variety registration To generate data for variety registration
Purpose of confined field trials (cont’d) Purpose of confined field trials (cont’d) · To produce material for livestock feed performance To produce material for livestock feed performance trials trials · To produce material for food safety evaluations (raw To produce material for food safety evaluations (raw seed/grain and derived fractions) seed/grain and derived fractions) – Nut Nutritional compositional an ritional compositional analysis (proximates, amino alysis (proximates, amino acids, fatty acids, minerals, vitamins, etc) acids, fatty acids, minerals, vitamins, etc) – Levels of endogenous anti Levels of endogenous antinutrients, toxicants, and nutrients, toxicants, and allergens allergens · Data are usually collected from trials in multiple Data are usually collected from trials in multiple locations, representing a range of growing locations, representing a range of growing conditions, and over multiple years conditions, and over multiple years
Confined field t Confined field trials ials Most lines in confined field trials do Most lines in confined field trials do NOT end up as products end up as products 100’s – 1000’s 10 - 100 1 – 4 Lines New trait moved into Potential Lines Potential Lines Submitted for 10 – 100 varieties using Unconfined Traditional breeding Approval Contained Confined Post-approval Laboratory Field Trial Use of new line Experimentation Experimentation In breeding programs Application for Application for Unconfined (commercial) Confined Field Release Trial
Recommend
More recommend
