Adoption of industrial biotechnology: The impact of regulation

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Adoption of industrial biotechnologyThe impact
of regulation

• George T. Tzotzos, Ph.D
• United Nations Industrial Development
  Organization

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(No Transcript)
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Adoption of Ag-biotech

• Present status influencing factors

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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
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2004s 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
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Costs of new GM products
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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.
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Biotech the developing world

• Pressing problems need urgent solutions

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The problemland and population
Arable land per inhabitant (ha)
World population
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Abiotic stress extent of the problem
Fact
Drought 5000 lt H2O for 1kg of rice grain. 70 of worlds H2O used in agriculture
Salinity 380 mil ha affected by high salinity
Acidity 40 of worlds 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 worlds 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 Only some 10 of the worlds 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
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Potential biotech solutions

• Genetic improvement of orphan crops
• Tolerance to abiotic stresses
• Vaccine producing crops
• Industrial crops for marginal lands
• Bio- phytoremediation

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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

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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

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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

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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

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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)

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Revisit event based regulation

• The regulatory premise
• The actual genomic situation

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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
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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)

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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.