GMO GMO safety ssafety research/regulation

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1 Three decades of GMO biosafety research hi in EU Ioannis Economidis

2 GMO safety research/regulation The Asilomar Conference: General agreement on need for regulations of GMOs : 80: Proposed Directive on notification and authorization of experimental releases and placing on the marked of GMOs. Turned down by industry and the UK (unanimity in Council). Ends up as a recommendation for notification only. notification and authorization of Bioengineering Programme 1987: The Single European Act provides the European Parliament with increased power by opening for qualified majority voting in Council. 1990: Directive on Deliberate e Release e of GMOs 90/220 (and Directive on Contained Use of GMMs 90/219) Biotechnology Action Programme BRIDGE

3 EC-Supported GMO Safety Research GMO safety research, regulation and practice: synergy and feedback

4 Overview of EU legislation on GMOs EU legislation on GMOs has been in place since the early 1990s. This specific legislation has two main objectives: to protect human health and the environment and to ensure the free movement of safe genetically modified d products in the European Union.

5 Overview of EU legislation on GMOs Directive 2001/18/EC on the deliberate release into the environment of GMOs applies to two types of activities: the experimental release of GMOs into the environment, i.e. the introduction of GMOs into the environment for experimental purposes (for example in connection with field tests); t the placing on the market of GMOs, for example the cultivation, importation or transformation of GMOs into industrial products.

6 Overview of EU legislation on GMOs 2003/1829/EC on the placing on the market of GMO food and feed or food and feed products containing or consisting of GMOs. 2003/1946/EC / on unintentional transboundary movements of GMOs as well as exports of GMOs to third countries. 2003/1829 & 1830/EC on Labelling and traceability requirements 90/219/EEC, as amended by Directive 98/81/EC, on the contained use of genetically modified microorganisms (GMMs).

7 EC-Supported GMO Safety Research GMO safety research, regulation and practice: synergy and feedback

8 2001 ( ) 2010 ( )

9 81 Projects, 400 teams Plants: : EC research puts impact of GM plants to the test Plant microbes: Microbes that help plants to grow Biocontrol: Micro-organisms organisms replace chemicals in crop pest and disease control Food: Tackling food safety concerns over GMOs Bioremediation: Cleaning up polluted environments: how microbes can help Tools: Novel tools and techniques to track GMOs Fish: Transgenic fish stay in the pond Vaccines: GM technology for better vaccines

10 50 projects, 400 teams Environmental impacts of GMOs GMO and food safety GMO for biomaterials and biofuels Emerging technologies Risk assesment and management Policy support and communication

11 Environmental impacts of GMO Crop improvement Nature and impact of GMOs on the environment Measures to avoid unwanted environmental impact

12 Crop improvement EURICE - European Rice: Transgenes for crop protection against fungal diseases TRANSVIR - Environmental impact assessment of transgenic grapevines and plums on the diversity and dynamics of virus populations NONEMA - Making plants resistant to plant parasitic nematodes: No access No feeding (Potato)

13 Crop improvement SUSTAIN Developing wheat with enhanced nitrogen use efficiency towards a sustainable system of production ECOSAFE - Biosafety research directed at more sustainable food production. GM Azospirilum with increased ability to promote plant growth RHIZOREMEDIATION - Testing integrated GM-rhizoremediation systems for soil bioremediation.

14 Nature and impact of GMOs on the environment POTATO TRAITS FOR AN - Evaluating new traits for potato in the Central Andes with an appropriate poverty focus CIMES Ciliates as monitors for envirnmental safety (HGT) of GMO. BT-BioNoTaBioNoTa Effects and mechanisms of Bt transgenes on biodiversity i of non-target insects: pollinators, herbivores and their natural enemies

15 Nature and impact of GMOs on the environment ECOGEN - Soil ecological and economic evaluation of fgm crops. POTATOCONTROL - Impact of three selected biotechnological strategies for potato pathogen control on the indigenous soil microbiota. transgenic potato lines that produce phage T4 lysozyme, transgenic potato lines that produce the lytic enzymes cecropin and/or attacin; and dth the use of avirulent mutants t of fth the pathogen which h compete with the wild-type pathogen in the rhizosphere and effectively interfere with its action.

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18 Measures to avoid unwanted environmental impact ECOTUB An ecologically safe selection system for transgenic crops based on modified plant- tubulin genes. (rice) CONFLOW Control of flowering time for sustainable and competitive agriculture and forestry (containment of transgenes) AENEAS Acquired environmental epigenetics advances: from Arabidopsis to maize SIGMEA - Sustainable introduction of GM crops to European agriculture

19 Food Safety Assessment the development of safety assessment approaches for GM foods/feed. to examine whether food/feed products derived from GMOs pose particular risks for humans, animals and the environment upon long term exposure and consumption.

20 the development of safety assessment approaches for GM foods/feed. ENTRANSFOOD - comparative determination in GM and non-gm products of levels of selected macro- and micro-nutrients, anti- nutrients, and known toxins GMOCARE - profiling - or omics - techniques to increase the probability of detecting unintended effects GM potato lines modified in their starch, amino acid, or glycoalkaloid metabolism, on GM tomato lines with elevated phytosterol or isoprenoid contents, and on various Arabidopsis GM-lines, down- regulated in their flavonoid pathway.

21 food/feed products derived from GMOs pose particular risks for humans, animals and the environment SAFOTEST In vivo & in vitro toxicological testing g( (GM rice lectins, Bt protein) GMOBILITY HGT from GM foods to humans

22 Detection of GMOs development of detection methods for GM food crop-derived foods with the challenge to design methods able to detect as many GMOs as possible in a single assay. GMO CHIPS - New technology in food science facing the multiplicity li i of new released GMOs. IMAGEMO - Development of a capacitance- based immunodetection analyser for the assay of GMOs in foods.

23 Post market monitoring of GMO derived foods is the product use as predicted, are known effects and side effects as predicted, does the product induce unexpected side effects. GMSAFOOD - Biomarkers for post-market monitoring i of short- and dl long-term effects of GMOs on animal and human health

24 GMO for biomaterials and biofuels Emerging technologies ICON - Industrial crops producing added-value oils for novel chemicals. ENERGYPOPLAR Enhancing poplar traits for energy applications

25 Risk assessment and management Policy support and communication biosafety research; risk analysis; coexistence and regulatory issues; consumer choice as well as risk/safety communication. VRTP IMPACT - two forms of gene flow, either from plant to virus by recombination or from plant to plant by outcrossing. Assessment of potential risks linked with GM virus resistance traits. SAFEFOODS - Risk Analysis Approach for foods that integrates assessment of human health aspects, consumer preferences and values, as well as impact analysis of socio-economical aspects.

26 Risk assessment and management Policy support and communication CO-EXTRA - coexistence and traceability of GM and non-gm supply chains. Practices of supply chains from seed production to retailers shelves with practical implementation (e.g. documentary and analytical) tools, addressing coexistence issues by multidisciplinary teams embracing supply chains as a whole.

27 Risk assessment and management Policy support and communication SCIENCE 4 BIOREG involve public sector scientists working in biotechnology research in international negotiations and policy discussions and extending the activities of the Public Research and Regulation Initiative (PRRI).

28 Risk assessment and management Policy support and communication GMO RES COM - A European initiative to enhance communication regarding GMO biosafety research. BIOSAFENET - Biosafety Research Communication Network BIOPOP - innovative approaches to public communication of life sciences and biotechnology by students and young researchers GMO-COMPASS - provided a GMO communication and safety evaluation platform

29 deliverables obtained some hundred peer-reviewed reviewed scientific publications, invaluable to researchers in public institutions, experts in risk assessment and risk management. not only in Europe but elsewhere, (especially the less developed countries). studies like these on the environmental impact of GMOs are the only way to decrease the regulatory burden, restore confidence in science and technology, and develop practical applications

30 deliverables obtained Only science, can demonstrate that GM crops are no more harmful for the environment than any other crop. On the contrary, there are clear ecological benefits when viewed within the framework of the role of agricultural systems in maintaining biodiversity. The current focus on assessing the environmental risks of GMOs in isolation from other agricultural practices defies logic.

31 deliverables obtained Only balanced risk-benefit analyses and pro- active strategies for risk mitigation, if required, can lead to constructive decision-making. input for the regulatory framework for coexistence rules.

32 EC-Supported GMO Safety Research GMO safety research, regulation and practice: synergy and feedback

33 EC-Supported GMO Conclusions (1) Safety Research GMOs (and non-gmos) neither inherently risky nor inherently safe No new risks beyond usual uncertainties of breeding Clarity on food safety Analysis of GM in agriculture has raised questions on conventional agriculture Concern remains over environment

34 EC-Supported GMO Safety Research Conclusions (2) Much new knowledge generated in molecular biology, ecology, etc Study of environmental impacts requires use of modern biotech tools and techniques Confirms utility yo of case-by by-case cse approach,,bu but need to get predictive EU approach well-suited to GM risk assessment research Communication challenge