Informing the public about modern biotechnology and biosafety

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

Topics Frequently asked questions: Ø What is genetic modification/engineering? How is it different from conventional breeding? Ø What are the potential benefits of GM crops? Ø How is safety of GM crops addressed ? Ø What are the experiences with GM crops to date? 2 HORIZONS sprl

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 3 HORIZONS sprl

Conventional breeding ü For 1000 s of years, breeding was largely ‘trial and error’ ü 19 th century: Gregor Mendel discovered the rules of cross breeding. ü Early 20 th century: discovery of inducing mutations by radiation and chemicals. ü Early 20 th century: discovery of hybrids Crop breeding has made major achievements and is HORIZONS sprl crucially important for food security

Conventional breeding Teosinthe Today’s sugar maize

Conventional breeding Breeding and induced mutation also have some limitations: 1. Cross breeding only works between related plants. 2. For some species breeding is extremely difficult. 3. Breeding can take very long, e. g. apples. 4. “Linkage drag” – not only the desired genes go across. 5. Induced mutation is undirected and unpredictable. 6 HORIZONS sprl

Genetic Modification of Plants Scientific discoveries in the 20 th century to overcome these limitations: Ø Discovery of DNA and ‘genes’ located on chromosomes Ø Discovery of special enzymes to ‘cut and paste’ genes, restriction enzymes, ligases, etc. Ø Discovery of transfer of genes into plant cells 7

Genetic Modification of Plants Traditional plant breeding x Related variety “elite” variety Genetic Modification 8 any gene source HORIZONS sprl

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 9 HORIZONS sprl

Genetic Modification New technology: • Is it useful? • Is it safe? 10 HORIZONS sprl

Biotechnology - the broader context Escalating global challenges: Ø Growing world population (9 billion in 2050) Ø Increased consumption of food, feed, and fiber Ø Increasing demand for renewable fuels Ø Loss of agricultural land Ø Shortage of water for irrigation. Ø Climate change Ø Reduced agrobiodiversity Ø Environmental degradation Ø Loss of natural habitats and biodiversity 11 HORIZONS sprl

Biotechnology - the broader context Escalating global challenges: Ø Growing world population (9 billion in 2050) Ø Increased consumption of food, feed, and fiber Ø Increasing demand for renewable fuels Ø Loss of agricultural land Ø Shortage of water for irrigation. Ø Climate change Ø Reduced agrobiodiversity Ø Environmental degradation Ø Loss of natural habitats and biodiversity 12 HORIZONS sprl

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) HORIZONS sprl

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. HORIZONS sprl

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. 15 HORIZONS sprl

Situation with GM crops to date • Since the early 80 s, 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. 16 HORIZONS sprl

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. 17 HORIZONS sprl

Genetic Modification New technology: • Is it useful? • Is it safe? - for the environment - as food and feed 19 HORIZONS sprl

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 r. DNA safety recommendations - “Blue Book” 1986: US coordinated framework for regulation 1986: European Directives on GMOs HORIZONS sprl

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 8 g: national biosafety systems 21 HORIZONS sprl

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 22 HORIZONS sprl

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

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

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 25 HORIZONS sprl

Environmental Risk Assessment - Methodology Procedure: Follow a number of steps Substance: Take into account a number of parameters 26 HORIZONS sprl

Environmental Risk Assessment - Methodology 1. Identification of relevant phenotypic and genotypic changes that may have adverse effects 2. Likelihood estimation 3. Evaluation of the consequences 4. Estimation of overall risk 5. Are identified risks acceptable or manageable? 27 HORIZONS sp

Environmental Risk Assessment - Methodology Take into account the relevant characteristics of: a. The recipient (host) or parental organism(s). b. Inserted sequences. c. The resulting GMO d. The intended use (e. g field trial, commercial use) e. The receiving environment. 28 HORIZONS sprl

Environmental risk assessment Potential adv. effects / Likelihood Estimation / Evaluation of Consequences / Estimation of Risk / scientifically plausible scenario Highly likely Likely Unlikely Highly unlikely Major Intermediate Minor Marginal High Moderate Low Negligible Manageable acceptable ? Toxicity Non target effects Weediness Et cetera 29 HORIZONS sprl

Food Safety Assessment Codex Alimentarius Foods derived from biotechnology 30 HORIZONS sprl

Guidance: European Food Safety Authority (EFSA) 31 HORIZONS sprl

Comparative GMO food/feed safety assessment Two main elements: 1. Intended changes: • The inserted genes and related traits • Assess intrinsic properties and functions of the gene-product – tiered approach 2. Possible unintended changes in the GMO • as result of insertion or expression • Assess composition 32 HORIZONS sprl

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 33 HORIZONS sprl

Toxicity Step 1: For each newly expressed protein: 1. Molecular and biochemical characterisation 2. Computer-aided comparison of homology with known toxins 3. Digestibility in laboratory assay 34 HORIZONS sprl

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 35 HORIZONS sprl

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 36 HORIZONS sprl

Assessment of possible allergenicity 1. Is the donor of the novel gene a known allergen? 2. Comparison with known allergens - databases 3. In vitro digestibility and processing stability • 37 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 HORIZONS sprl

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 38 HORIZONS sprl

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 39 HORIZONS sprl

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 HORIZONS sprl

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 41 HORIZONS sprl

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 42 HORIZONS sprl

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. 43 HORIZONS sprl

Thank you HORIZONS sprl