Informing the public about modern biotechnology and biosafety

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Informing the public about modern biotechnology
and biosafety

• Sixth Dubai international Food safety Conference
  Session
• Moving with the trends and developments in food
  safety."
• Dubai, 28 February 2011
• Piet van der Meer,
• Horizons sprl, Belgium

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Topics

• Frequently asked questions
• What is genetic modification/engineering? How is
  it different from conventional breeding?
• What are the potential benefits of GM crops?
• How is safety of GM crops addressed ?
• What are the experiences with GM crops to date?

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Conventional breeding

• Since humans started farming about 10,000 years
  ago, farmers have used crossing and selection to
  improve crops so that they
• - produce more
• - taste better
• - are stronger in the field
• - have a longer shelf life
• - etc

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Conventional breeding

• For 1000s of years, breeding was largely trial
  and error
• 19th century Gregor Mendeldiscovered the rules
  of cross breeding.
• Early 20th century discovery of inducing
  mutations by radiation and chemicals.
• Early 20th century discovery of hybrids
• Crop breeding has made major achievements and is
• crucially important for food security

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Conventional breeding

• Teosinthe
• Todays sugar maize

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Conventional breeding

• Breeding and induced mutation also have some
  limitations
•  
• Cross breeding only works between related
  plants.
• For some species breeding is extremely difficult.
  
• Breeding can take very long, e.g. apples.
• Linkage drag not only the desired genes go
  across.
• Induced mutation is undirected and unpredictable.

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Genetic Modification of Plants

• Scientific discoveries in the 20th century to
  overcome
• these limitations
• Discovery of DNA and genes located on
  chromosomes
• Discovery of special enzymes to cut and paste
  genes,restriction enzymes, ligases, etc.
• Discovery of transfer of genes into plant cells
  

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Genetic Modification of Plants
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Genetic Modification of Plants

• Technical characteristics of GM compared with
  breeding
• Highly specific
• Faster
• Possible with plants that do not cross sexually
  
• Much greater reservoir of genes

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Genetic Modification

• New technology
• Is it useful?
• Is it safe?

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Biotechnology - the broader context

• Escalating global challenges
• Growing world population (9 billion in 2050)
• Increased consumption of food, feed, and fiber
• Increasing demand for renewable fuels
• Loss of agricultural land
• Shortage of water for irrigation.
• Climate change
• Reduced agrobiodiversity
• Environmental degradation
• Loss of natural habitats and biodiversity

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Biotechnology - the broader context

• Escalating global challenges
• Growing world population (9 billion in 2050)
• Increased consumption of food, feed, and fiber
• Increasing demand for renewable fuels
• Loss of agricultural land
• Shortage of water for irrigation.
• Climate change
• Reduced agrobiodiversity
• Environmental degradation
• Loss of natural habitats and biodiversity

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Genetic engineering - the broader context

• The world will not be able to feed itself without
  destroying the planet unless a fundamental
  transformation of agricultural production takes
  place.
• Farmers have to produce more while having less
  impact on the environment.
• Need for Sustainable intensification (FAO)

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Genetic engineering - the broader context

• Farmers need the availability of crop plants
  that
• -  produce more per hectare,
• -  produce more per litre of water,
• -  are less dependent on pesticides and
  fertilisers,  
• - can grow on marginal land,
• -  have enhanced nutritional value
• -  have reduced post harvest losses,
• -  reduce soil erosion,
• - etc.

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Genetic engineering - the broader context

• These immense challenges cannot be solved by
  conventional
• techniques alone.
• Modern biotechnology can contribute significantly
  to
• finding solutions for these challenges (Earth
  Summit
• Agenda 21, 1992 World Summit 2005)
• The future of the agriculture is not a matter of
  either this or
• that technology but rather of combining the most
  suitable
• approaches of each available technology.

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Situation with GM crops to date

• Since the early 80s, a massive biotechnology
  research effort is conducted in many research
  institutions all over the world to improve crop
  plants.
• In Agenda 21 (1992) a detailed blueprint was
  agreed for international collaboration in
  biotechnology research
• Many thousands of research trials with GM plants,
  trees, and micro-organisms have been conducted
  over the last decades.

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Situation with GM crops to date

• Since 1996, GM crops  have been grown
  commercially by farmers over more than 1 billion
  hectares world wide.
• In 2010, 15.4 million farmers planted 148 million
  hectares of biotech crops in 29 countries
• The GM crops grown commercially today are mainly
  soybean, cotton, maize and canola with insect
  resistance and/or herbicide tolerance.
• Source www.isaaa.org.  

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Genetic Modification

• New technology
• Is it useful?
• Is it safe? - for the environment- as food and
  feed

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Biosafety - History 1972 First publication
recombinant DNA 1974 Berg Letter hopes and
concerns - moratorium 1975 Asilomar end of
moratorium - safety case by case 1986 first
transgenic plants 1986 OECD rDNA safety
recommendations - Blue Book 1986 US
coordinated framework for regulation 1986
European Directives on GMOs
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Biosafety History 1992 UNCED, Rio De
Janeiro 1992 Agenda 21 - maximise benefits
- minimise risks 1992 Convention on
Biological Diversity - art 19 international
collaboration on biotechnology - art 8g
national biosafety systems
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• Biosafety - History
• 2000 The Cartagena Protocol on Biosafety.
• Procedures for transboundary movement of living
  modified organisms in absence of national
  regulations
• Agreed principles and methodology for risk
  assessment
• Mechanism for information sharing - Biosafety
  Clearing House

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National biosafety systems

• Different systems
• Guidelines and standards, e.g Good Laboratory
  Practices
• Regulations
• Pre-market regulations
• Post-market regulations

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National biosafety systems
Stage Topic Mechanism
Laboratory research Workers protection Environmental safety Laboratory requirements GLP
Field Trials Environmental safety Permit
Placing on the market Environmental safety Food/Feed safety Pre market approval/ deregulation Post market system
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Environmental Safety Food/feed Safety

• Often different bodies involved, e.g - US
  USDA, EPA, FDA
• - EU EFSA plus national authorities
• Internationally agreed principles and
  methodology
• Environmental safety Cartagena Protocol on
  Biosafety
• Food/Feed safety Codex Alimentarius

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• Environmental Risk Assessment - Methodology
• Methodology
• Procedure Follow a number of steps
• Substance Take into account a number of
  parameters

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• Environmental Risk Assessment - Methodology
• Identification of relevant phenotypic and
  genotypic changes that may have adverse effects
• Likelihood estimation
• Evaluation of the consequences
• Estimation of overall risk
• Are identified risks acceptable or manageable?

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• Environmental Risk Assessment - Methodology
• Take into account the relevant characteristics
  of
• The recipient (host) or parental organism(s).
• Inserted sequences.
• The resulting GMO
• The intended use (e.g field trial, commercial
  use)
• The receiving environment.

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Environmental risk assessment
Potential adv. effects / Likelihood Estimation / Evaluation of Consequences / Estimation of Risk / Manageable acceptable ?
scientifically plausible scenario Highly likely Likely Unlikely Highly unlikely Major Intermediate Minor Marginal High Moderate Low Negligible
Toxicity
Non target effects
Weediness
Et cetera
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Food Safety Assessment
Codex Alimentarius Foods derived from
biotechnology
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Guidance European Food Safety Authority (EFSA)
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Comparative GMO food/feed safety assessment

• Two main elements
• Intended changes
• The inserted genes and related traits
• Assess intrinsic properties and functions of the
  gene-product tiered approach
• Possible unintended changes in the GMO
• as result of insertion or expression
• Assess composition

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1. Intrinsic properties and functions of the gene
products

• Assessment of
• Possible changes in toxicity
• Possible changes in allergenicity
• Case-specific topics, such as nutritional changes
  

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Toxicity

• Step 1 For each newly expressed protein
• Molecular and biochemical characterisation
• Computer-aided comparison of homology with known
  toxins
• Digestibility in laboratory assay

Codex Standard "Weight of Evidence Approach"
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Toxicity

• Step 2 In cases indicated by step 1, and in
  specific cases whereby the composition of the GM
  plant is modified substantially.
• Animal toxicity tests with pure protein
• Whole food/feed testing
• Laboratory animal toxicity tests (e.g. 90 days
  test)
• Complex mixtures - More difficult to test than
  purified chemicals

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Allergenicity

• General
• Not an intrinsic, fully predictable property of a
  given protein
• Airway-, contact-, and food-allergies
• Food
• "Big eight food allergens (90)
• All food allergens are proteins

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Assessment of possible allergenicity

• Is the donor of the novel gene a known allergen?
• Comparison with known allergens - databases
• In vitro digestibility and processing stability
• When indicated by the above (weight of
  evidence) further testing, case by case
• Reaction with antisera from allergic patients
• Clinical tests, such as skin prick test
• Animal models

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Case-specific issue Nutritional assessment

• Food/feed contains nutrients, antinutrients which
  may be target of modification
• In those cases assessment of nutritional value
• Calculated from compositional data
• Domestic and laboratory animal feeding
  studies(NB these are not toxicity studies)
• Animal models
• Chicken (rapidly growing)
• Others, such as milk cows

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2. Unintended changes compositional analysis

• Macro/micronutrients, anti-nutrients, toxins, and
  compounds from relevant metabolic pathways
• Key parameters differ between organisms
• Parameters in OECD consensus documents
• Assessment
• Comparison with appropriate comparator(s)
• Multiple seasons and locations (crop)
• Identify differences that are relevant to
  food/feed safety

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Experiences with GM crops to date

• 87-fold increase in hectares since 1996.
• Aggregated data indicate
• Reduced production costs (50),
• Yield gains of 167 million tons equivalent with
   62.6 million additional hectares  
• pesticide reduction estimated at 356 million kg
  of active ingredient
• Reduction of fossil fuel use
• Source ISAAA

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Experiences with GM crops to date

• No verifiable reports of adverse effects of GM
  crops on human health or the environment
• NB Less mycotoxin contaminations in insect
  resistant crops due to reduced damage by pest
  insects

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Summary

• Genetic modification is tool that allows traits
  to be introduced in crop plants in a very
  targeted way and with a much greater reservoir of
  genes
• Although not a silver bullet, GM can help
  developing crops that produce more, that are less
  dependent on water, pesticides and fertilisers,
  that are more nutritious, and that have a longer
  shelf life

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Summary

• Internationally agreed methodologies are applied
  to assess the environmental and food safety of GM
  crops.
• The GM crops that are on the market to day are as
  safe as their non modified counterparts.
• Data show rapid global expansion of the adoption
  of GM crops by farmers, and substantial increases
  in yield, and reduction of use of pesticide and
  fossil fuels.

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• Thank you

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