Transcript Adoption of industrial biotechnology: The impact of regulation

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.