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Adoption of industrial biotechnology: The impact of regulation George T. Tzotzos, Ph.D United Nations Industrial Development Organization Adoption of Ag-biotech Present status & influencing factors Global GM crop plantings by crop 1996-2004 Source: Graham Brookes & Peter Barfoot PG Economics Ltd, UK, 2004 GM crops: the global socio-economic and environmental impact – the first nine years 1996-2004 2004’s share of GM crops in global plantings of key crops Source: Graham Brookes & Peter Barfoot PG Economics Ltd, UK, 2004 GM crops: the global socio-economic and environmental impact – the first nine years 1996-2004 Costs of new GM products Regulatory costs & IP acquisition drive industry consolidation Source: Inverzon International Inc. (St Louis, US), in Papanikolaw, 1999 Notes: AgrEvo and Rhone-Poulenc are merging into Aventis. AgrEvo figures include seed activities. Rank depends on average exchange rates used. Biotech & the developing world Pressing problems need urgent solutions The problem: land and & population World population Arable land per inhabitant (ha) Abiotic stress: extent of the problem Fact Drought 5000 lt H2O for 1kg of rice grain. 70% of world’s H2O used in agriculture Salinity 380 mil ha affected by high salinity Acidity 40% of world’s arrable land affected. In S. America only, 380 mil ha affected Temperature 70% of the total land in the Andes is devoted to potato production prone to cold stress Only some 10% of the world’s 13 billion ha is farmed. Alongside losses due to pests and diseases, a further 70% of yield potential has been calculated to be lost to abiotic stress Source: CGIAR/FAO, 2003. Interim Science Secretariat. Applications of Molecular Biology and Genomics to Genetic Enhancement of Crop Tolerance to Abiotic Stress Potential biotech solutions Genetic improvement of orphan crops Tolerance to abiotic stresses Vaccine producing crops Industrial crops for marginal lands Bio- & phytoremediation Rationalising biotech regulation Move focus away from the transgenic process Rationalise the basis of transgenic regulation Exempt selected transgenes from regulation Create regulatory classes in proportion to potential risk Revisit ‘event’ based regulation Reasons for focusing away from the transgenic process Focus on the phenotypes of transgenic plants and their safety & behaviour in the environment Environmental and toxicological issues are influenced by the expressed traits rather than the gene per se Although conventional breeding uses complex genomic manipulations (mutagenesis; somaclonal variation; protoplast fusion; embryo rescue; ploidy manipulations) its products are seldom characterised at the molecular level before variety release because regulation is based on long history of safe & beneficial use. For example mutation-derived herbicide resistance is deregulated Reasons for rationalising the basis of transgenic regulation Regulation triggered by constructs derived from pathogens (e.g. Agrobacterium, CmV promoter, etc.) •Agrobacterium transfers naturally to plant genomes and at times becomes stably integrated into the plant genome (e.g. A. rhizogenes in tobacco). • Viruses are ubiquitous in crop-derived foods. 14-25% of oilseed rape in the UK is infected by CmV and similar numbers have been estimated for cauliflower and cabbage. Historically humans have been consuming CmV and its 35S promoter in much larger quantities than in uninfected transgenic plants Exempting selected transgene & classes from regulation General gene suppression methods (e.g. antisense, sense suppression, RNAi) Non-toxic proteins that are commonly used to modify development Use of selected antibiotic resistance marker genes Selected marker genes that impart reporter phenotypes Creating regulatory classes in proportion to risk Low imparted traits are functionally equivalent to those manipulated in conventional breeding and where no novel protein or enzymic functions are imparted. ‘domesticating’ traits retarding spread into wild populations (e.g. sterility, ‘dwarfism’, seed retention, modified lignin) (bioconfinement) Medium Plant-made pharmaceutical/industrial proteins plants with novel products that have low human or environmental toxicity or that are grown in non-food crops and have low non-target ecological effects (e.g. plants used in remediation) High Where transgene products have a documented likelihood of causing harm to humans, animals or the environment (e.g. bioaccumulators of heavy metals are likely to have adverse effects on herbivores) Revisit ‘event’ based regulation The regulatory premise The actual “genomic” situation Transgenic event Event = successful transformation Events differ in the specific genetic components and in the place of insertion of the foreign DNA into the host chromosome Maize has 10 chromosomes any of which might incorporate the transgene ‘Event’ based regulation. The regulatory premise insertion sites of transgenes cannot be currently targeted (random insertion). Some insertions may alter the expression or inactivate endogenous genes resulting in unexpected consequences uncertainties significantly exceed those arising in conventional breeding (introgression or mutagenesis) ‘Event’ based regulation. Genomic science says otherwise Genome mapping and sequencing results indicate that site-specific characterisation has little value in the regulatory context. Total DNA content, the number of genes, gene order can vary among varieties of the same species Different varieties of maize, chilli pepper & soybean can differ by as much as 42%, 25% & 12% in DNA content respectively. For soybean this means varietal difference of 100 million base pairs or more. Closely related species such as maize, rice & sorghum have genomic regions with differing arrangements of essentially the same set of genes. Small insertions and deletions in maize occur every 85 base pairs in non-coding regions and the frequency of SN Polymorphisms is 1 in 5 to 200 base pairs. Transposons and retrotransposons continually insert themselves between gens and are likely to have resulted in improvements in plant adaptation.