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Informing the public about modern biotechnology and biosafety

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Title: Informing the public about modern biotechnology and biosafety


1
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

HORIZONS sprl
2
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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3
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

HORIZONS sprl
4
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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5
Conventional breeding
  • Teosinthe
  • Todays sugar maize

6
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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7
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

8
Genetic Modification of Plants
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9
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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10
Genetic Modification
  • New technology
  • Is it useful?
  • Is it safe?

HORIZONS sprl
11
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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12
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

HORIZONS sprl
13
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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14
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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15
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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16
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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17
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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18
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19
Genetic Modification
  • New technology
  • Is it useful?
  • Is it safe? - for the environment- as food and
    feed

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20
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
HORIZONS sprl
21
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
HORIZONS sprl
22
  • 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

HORIZONS sprl
23
National biosafety systems
  • Different systems
  • Guidelines and standards, e.g Good Laboratory
    Practices
  • Regulations
  • Pre-market regulations
  • Post-market regulations

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24
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
25
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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26
  • Environmental Risk Assessment - Methodology
  • Methodology
  • Procedure Follow a number of steps
  • Substance Take into account a number of
    parameters

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27
  • 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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28
  • 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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29
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
HORIZONS sprl
30
Food Safety Assessment
Codex Alimentarius Foods derived from
biotechnology
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31
Guidance European Food Safety Authority (EFSA)
HORIZONS sprl
32
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

HORIZONS sprl
33
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

HORIZONS sprl
34
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"
HORIZONS sprl
35
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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36
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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37
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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38
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

HORIZONS sprl
39
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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40
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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41
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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42
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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43
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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44
  • Thank you

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