European Network Safety Assessment of Genetically Modified Food Crops

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1 European Network Safety Assessment of Genetically Modified Food Crops European Commission Directorate General Research Co-ordinator ENTRANSFOOD: RIKILT - Institute of Food Safety Wageningen UR Wageningen The Netherlands AC AATTC G ATTC TC TAG C AC G C G C TAG TTAG TTTAC TAC C TAC G AC TG AG ATC G AAC AATTC G ATTC TC TAG C AC G C G C TAG TTAG TTTAC TAC C TAC G AC TG AG ATC G AAC AATTC G ATTC TC TAG C AC G C G C TAG TTAG TTTAC TAC C TAC G AC TG AG ATC G AAC AATTC G ATTC TC TAG C AC C G C TAG TTAG TTTAC TAC C TAC G AC TG AG ATC G AAC AATTC G ATTC TC TAG C AC G C G C TAG TAG TTTAC TAC C TAC G AC TG AG ATC G AAC AATTC G ATTC TC TAG C AC G C G C TAG TTAG TTTA C TAC C TAC G AC TG AG ATC G AAC AATTC G ATTC TC TAG C AC G C G C TAG TTAG TTTAC TAC C TA C G AC TG AG ATC G AAC AATTC G ATTC TC TAG C AC G C G C TAG TTAG TTTAC TAC C TAC G AC TG G ATC G AAC AATTC G ATTC TC TAG C AC G C G C TAG TTAG TTTAC TAC C TAC G AC TG AG ATC G A C AATTC G ATTC TC TAG C AC G C G C TAG TTAG TTTAC TAC C TAC G AC TG AG ATC G AAC AATTC G ATTC TC TAG C AC G C G C TAG TTAG TTTAC TAC C TAC G AC TG AG ATC G AAC AATTC G ATTC TC T AG C AC G C G C TAG TTAG TTTAC TAC C TAC G AC TG AG ATC G AAC AATTC G ATTC TC TAG C AC G C G C TAG TTAG TTTAC TAC C TAC G AC TG AG ATC G AAC AATTC G ATTC TC TAG C AC G C G C TAG TAG Main TTTAC TAC C TAC s G AC TG AG ATC G AAC AATTC G & ATTC TC TAG C AC G C G C TAG TTAG TTTA C TAC C TAC G AC TG AG ATC G AAC AATTC G ATTC TC TAG C AC G C G C TAG TTAG TTTAC TAC C TA C G AC TG AG ATC G AAC AATTC G ATTC TC TAG C AC G C G C TAG TTAG TTTAC TAC C TAC G AC TG G ATC G AAC AATTC G ATTC TC TAG C AC G C G C TAG TTAG TTTAC TAC C TAC G AC TG AG ATC G A C AATTC G ATTC TC TAG C AC G C G C TAG TTAG TTTAC TAC C TAC G AC TG AG ATC G AAC AATTC G ATTC TC TAG C AC G C G C TAG TTAG TTTAC TAC C TAC G AC TG AG ATC G AAC AATTC G ATTC TC T AG C AC G C G C TAG TTAG TTTAC TAC C TAC G AC TG AG ATC G AAC AATTC G ATTC TC TAG C AC G C G C TAG TTAG TTTAC TAC C TAC G AC TG AG ATC G AAC AATTC G ATTC TC TAG C AC G C G C TAG TAG TTTAC TAC C TAC G AC TG AG ATC G AAC AATTC G ATTC TC TAG C AC G C G C TAG TTAG TTTA C TAC C TAC G AC TG AG ATC G AAC AATTC G ATTC TC TAG C AC G C G C TAG TTAG TTTAC TAC C TA C G AC TG AG ATC G AAC AATTC G ATTC TC TAG C AC G C G C TAG TTAG TTTAC TAC C TAC G AC TG G ATC G AAC AATTC G ATTC TC TAG C AC G C G C TAG TTAG TTTAC TAC C TAC G AC TG AG ATC G A C AATTC G ATTC TC TAG C AC G C G C TAG TTAG TTTAC TAC C TAC G AC TG AG ATC G AAC AATTC G ATTC TC TAG C AC G C G C TAG TTAG TTTAC TAC C TAC G AC TG AG ATC G AAC AATTC G ATTC TC T AG C AC G C G C TAG TTAG TTTAC TAC C TAC G AC TG AG ATC G AAC AATTC G ATTC TC TAG C AC G AC AATTC G ATTC TC TAG C AC G C G C TAG TTAG TTTAC TAC C TAC G AC TG AG ATC G AAC AATTC G ATTC TC TAG C AC G C G C TAG TTAG TTTAC TAC C TAC G AC TG AG ATC G AAC AATTC G ATTC TC TAG Duration: C AC G C G C 01TAG 2000 TTAG 01 TTTAC TAC C TAC G AC TG AG ATC G AAC AATTC G ATTC TC TAG C AC C G Contract C TAG TTAG no: QLK TTTAC TAC C TAC G AC TG AG ATC G AAC AATTC G ATTC TC TAG C AC G C G C TAG TAG TTTAC TAC C TAC G AC TG AG ATC G AAC AATTC G ATTC TC TAG C AC G C G C TAG TTAG TTTA C TAC C TAC G AC TG AG ATC G AAC AATTC G ATTC TC TAG C AC G C G C TAG TTAG TTTAC TAC C TA This project was subsidised by the European Commission C G AC TG AG ATC G AAC AATTC G ATTC TC TAG C AC G C G C TAG TTAG TTTAC TAC C TAC G AC TG through the 5 th framework programme. G ATC G AAC AATTC G ATTC TC TAG C AC G C G C TAG TTAG TTTAC TAC C TAC G AC TG AG ATC G A Quality of Life Management of Living Resources, Key Action 1 C AATTC G ATTC TC TAG C AC G C G C TAG TTAG TTTAC TAC C TAC G AC TG AG ATC G AAC AATTC G ATTC TC TAG C AC G C G C TAG TTAG TTTAC TAC C TAC G AC TG AG ATC G AAC AATTC G ATTC TC T

2 Major Topics in the Debate on the Safety of Foods derived from Genetically Modified Crops 1 Introduction The characteristics of food crops can nowadays be altered by the application of modern recombinant DNA technology. Genetically modified (GM) crops, like soya, corn and cotton, currently cultivated, have improved pest resistance and/or herbicide tolerance. New GM crops are being developed with altered nutritional characteristics. While in the US, Canada and Argentina over 60 millions of hectares have been planted with these crops, the cultivation area in Europe is very small. Consumer and environmental groups have expressed concerns about the safety of these crops for humans and the environment, and have also raised more general doubts on the impact of the technology on sustainable agriculture and on socio-economical aspects.

3 It was against this background that ENTRANSFOOD, the EU funded Thematic Network on the Safety Assessment of Genetically Modified Food Crops, has started its activity. ENTRANSFOOD has in particular evaluated issues of the safety of GM crop derived foods and has also paid attention to issues like detection and traceability and public attitudes towards GM food crops. 2 Five Research Projects and Working Groups were set up with more than 65 participants recruited from academia, food industry, regulatory agencies and consumer groups of 13 European countries.

4 ENTRANSFOOD Structure: Safety Testing of Transgenic Foods Detection of Unintended Effects Gene Transfer Traceability and Quality Assurance Societal Aspects Integrated Discussion Platform Contributors from: Academia, Food Industry, Regulatory Agencies, Consumer Groups 3 Outcomes: Review and Position Papers Integrated Evaluation Document Press releases, Information on Web Site The outcomes of ENTRANSFOOD will be published as scientific papers (Special issue of Food and Chemical Toxicology), an Overarching Paper and an Executive Summary. These documents will be published on the ENTRANSFOOD Internet site: This flyer presents the main conclusions and recommendations of the topics investigated by ENTRANSFOOD. The five research projects are: 1. SAFOTEST: New methods for the safety testing of transgenic food. QLK GMOCARE: New methodologies for assessing the potential of unintended effects in genetically modified food crops. QLK GMOBILITY: Safety evaluation of horizontal gene transfer from genetically modified organisms to the microflora of the food chain and human gut. QLK QPCRgmofood: Reliable, standardised, specific, quantitative detection of genetically modified foods. QLK GMOCHIPS: New technology in food sciences facing the multiplicity of new released GMO. Measurement & Testing, G6RD-CT

5 Main s: Topic: Safety Testing of Transgenic Foods Are current safety evaluation strategies for foods derived from GM crops adequate to establish their safety? The safety evaluation of foods derived from GM crops is carried out in a comparative manner: i.e. differences between the GM crop and the conventionally grown crop are identified and investigated with respect to their impact on human or animal health (Concept of Substantial Equivalence, see figure 1). The basic idea behind this approach is that conventional foods have a long history of safe use. ENTRANSFOOD has designed a detailed stepwise procedure to carry out the safety assessment of GM crop derived foods on a case-by-case basis. The approach comprises four steps: Characterisation of the parent crop, which is genetically modified; characterisation of the genetic modification process; toxicological and allergenicity assessment of new gene products (proteins and metabolites); and safety evaluation of the whole GM food crop. A combination of existing test methods provides a robust test regime and ensures that GM foods that have passed the test procedure are as safe and nutritious as currently consumed plantderived foods. The designed approach is also applicable to new generations of GM food crops with extensive compositional changes. Comparative Safety Assessment of GM Crop Plants Gene transfer GM crop Comparison of the GM crop and its conventional counterpart (establishment of substantial equivalence) Introduced genes Allergenicity Novel or differently expressed proteins Degradability, digestibility Bio - availability Novel or differently formed chemical substances Testing for toxicological and nutritional significance of the identified differences Additional testing of whole foods, if necessary Conventional crop Toxicity Evaluation of safety and nutritional data Dietary intake 4 In the future, based on our improved understanding of molecular biology, toxicology and nutrition, further improvement of test methods may be considered that will render the safety assessment of foods even more effective and informative. Strategies for assessing the potential allergenicity of new proteins in current GM crops and of a possible alteration of the allergenic properties of the GM crop are adequate and are based on evaluation of various aspects. Further development of new in vitro methods and animal models to predict the allergenicity of food components is recommended. Post market monitoring of GM foods might be considered useful for those foods with specifically changed nutritional properties and whose intake can be followed through labelling. Post-market monitoring is not recommended as routine practice for commodity GM foods. Safety assessment of the GM crop Figure 1

6 5 Topic: Detection of Unintended Effects Is there a chance that the genetic modification used to develop GM crops may result in unexpected effects on the composition of GM food crops and that these changes pose health risks? Are the current analytical test methods robust and reliable enough to identify such changes? Unintended alteration in the composition of plants is a common phenomenon that occurs when changing the genetic information of a plant either by classical breeding methods or by GM technology. There is no indication that unintended effects are more likely to occur in GM crops. Detection of unexpected effects in plants, which are developed by GM technology, relies primarily on the comparative analysis of levels of selected key nutrients and toxic compounds present in the GM crop and its traditional non-modified counterpart. Identified alterations in composition may fall within the natural range of variations and thus not be of toxicological concern, or fall outside these ranges and then need further toxicological or nutritional investigations. This targeted approach has shown to be effective in conventional plant breeding to identify alterations in composition. In order to increase the probability of detecting unexpected effects, profiling techniques are under development. These methods, based on modern genomic, protein and metabolite detection techniques, are able to provide a global overview of gene expression and chemical composition of the GM and non-gm crop (non-targeted approach). Profiling methods are primarily informative for elucidating metabolic pathways in plants, but need further development and validation before they can be used in routine risk assessment. The establishment and coupling of databases containing gene expression, protein and metabolite profiles of food crops and their natural variation patterns are recommended. A combination of targeted and non-targeted methods of analysis, to be decided for on a case-by-case basis, is the best way forward to evaluate the safety of GM and conventionally bred crops. Topic: Gene Transfer Is there a risk of transfer of genetic material from foods derived from GM crops to a living cell or organism (horizontal gene transfer) and would this have negative consequences? Could foreign DNA from GM crops be transferred to human germ cells, or could transfer of antibiotic resistance marker genes from GM plants to the microbial population in the human gut occur and compromise the effectiveness of the antibiotic treatment of infections? Horizontal gene transfer is at the origin of the variety of life itself. The impact of horizontal gene transfer will depend among others on the selective advantage for the bacterial population. There is little reason to assume that the consumption of foods derived from GM crops constitutes a specific risk. Whereas uptake of ingested recombinant (foreign) DNA by mammalian somatic cells has been demonstrated, there is no evidence that consumed DNA will end up in germline cells. Transfer of antibiotic resistance marker genes from GM plant varieties to the gut microflora of humans and their expression is most probably a rare event, given the low amounts ingested and degradative conditions in the gastro-intestinal tract. However since gene transfer cannot completely be excluded, ENTRANSFOOD has classified antibiotic resistance marker genes based on their distribution and therapeutic importance. To reduce the risk of gene transfer to the microbial population in the gut the use of bacterial DNA in constructing GM plants should be kept to a minimum. Marker genes, which code for resistance against clinically important antibiotics, should not be used. Some antibiotic resistance marker genes such as the nptii gene and the hygromycin resistance gene can be used without the risk of compromising the use of important clinically used antibiotics. The use of alternative markers should also undergo a thorough safety evaluation.

7 Topic: Traceability and Quality Assurance The consumer wants to be informed whether a food product contains ingredients that are derived from genetic modified food crops or not. Are all systems such as traceability and detection methods adequate to ensure this freedom of choice of the consumer? Topic: Societal Aspects How can transparency in risk assessment, risk management and risk communication be improved in order to take account of consumer concerns (and risk perception) and to meet the broader consumers concern about the introduction of the new technology? The new EU regulations impose requirements of labelling of foods or feed containing ingredients derived from GM food/feed crops or containing traces of GM crops above a certain threshold (>0.9 %). To facilitate control and to verify labelling claims or to facilitate product recall when necessary, reliable documentation systems to trace back the origin of the ingredients (traceability system) and analytical methods to detect and quantify the amount of GM derived ingredients have been developed. Sequence information on the genetic modification as well as relevant reference material is crucial for the development of any GMO detection and / or identification method and should therefore be available to regulatory authorities and food control laboratories. With more GMOs being developed worldwide more efficient GMO detection and identification methods will need to be developed, based on the latest developments in molecular biology, in order to be able to adequately maintain GMO regulations within the European Union. The use of traceability systems for post-marketing applications requires new labelling systems that convey all necessary information on the presence of individual GMO varieties to the reader. Research is needed to determine the most effective form of food labels, which take due account of cross-cultural differences in information preferences where they exist. Risk assessment of GM foods has focused on adverse health effects for humans and the environment, but public concern is much broader, focusing not only on risks, but also on who benefits, what are the needs and how does it contribute to a sustainable agriculture. It is important to explicitly address public concerns, and to develop new methods for stakeholders involvement and public consultation. The optimal ways to formalise public engagement and consultation into new working procedures should be addressed in future research projects, as well as impact on the risk analysis process, on regulatory procedures and institutions involved. ENTRANSFOOD recommends the establishment of a Permanent Evaluation and Discussion Platform on the assessment and introduction of new foods in Europe produced by different breeding practices and production systems. There is a need for a general framework for risk analysis of all types of new foods produced by different breeding and production methods, taking scientific, economic and societal aspects into account. 6

8 Participants: 1. RIKILT - Institute of Food Safety, Wageningen University & Research Center, Wageningen, The Netherlands (Dr. H.A. Kuiper, Dr. G.A. Kleter, Dr. H.P.J.M. Noteborn, Dr. H.J.P. Marvin, Dr. A.A.C.M. Peijnenburg, Ir. E.J. Kok, Dr. H.J.M. Aarts, Ir. J.P.P.F. van Rie) 2. Institute of Food Safety and Toxicology, Danish Veterinary and Food Administration, Søborg, Denmark (Dr. I. Knudsen, Dr. M. Poulsen, Dr. B.L. Jacobsen, Dr. B. Holst, Dr. A. Wilcks, Dr. J. Pedersen) 3. Department of Agricultural and Environmental Sciences, University of Newcastle, Newcastle, United Kingdom (Dr. A.M.R. Gatehouse) 4. Département d Ecophysiologie Végétale et de Microbiologie CEA Cadarache, Saint Paul Lez Durance, France (Dr. J.J. Leguay) 5. European Commission - Joint Research Centre, Institute for Health and Consumer Protection, Food Products and Consumer Goods Unit, Ispra, Italy (Dr. G. van den Eede) 6. Umweltbundesamt, Vienna, Austria (Dr. A. Heissenberger) 7. Institute of Food Research, Food Quality and Materials Science Division, Diet Health & Consumer Science, Norwich, United Kingdom (Dr. I. Colquhoun, Dr. L. Frewer) 8. Rowett Research Institute, Aberdeen, United Kingdom (Dr. A. Chesson, Dr. H. Flint) 9. Unilever Research Colworth, SEAC Toxicology Department, Colworth, United Kingdom (Dr. R. Crevel) 10. Istituto Superiore di Sanitá, Section of Cereal Chemistry, Laboratory of Food, Rome, Italy (Dr. M. Miraglia) 11. Laboratoire Associe INRA-CEA d lmmuno-allergie Alimentaire, Service de Pharmacologie et Immunologie, Gif-sur-Yvette, France (Dr. J. M. Wal, Dr. C. Créminon) 12. Institut National de la Recherche Agronomique, UEPSD - Fonctions des Bacteries Intestinales, Jouy-en- Josas Cedex, France (Dr. G. Corthier) 13. Institute of Environmental Medicine, Karolinska Institute, Stockholm, Sweden (Dr. R. Grafström, Dr. T. Midtvedt) 14. Lehrstuhl für Allgemeine Lebensmitteltechnologie, Technische Universität München, München, Germany (Dr. K.H. Engel) 15. Metapontum Agrobios, Plant Biotechnology Department, Metaponto, Italy (Dr. F. Cellini) 16. Agricultural Economics Research Institute (LEI), Wageningen University & Research Center, The Hague, The Netherlands (Dr. V. Beekman) 17. TNO Nutrition and Food Research Institute, Zeist, The Netherlands (Drs. J.W. van der Kamp, Dr. A. Penninks, Dr. J. van der Vossen) 18. Cellular & Environmental Physiology Department, The Scottish Crop Research Institute, Dundee, United Kingdom (Dr. H. Davies) 19. Robert Koch Institut, Zentrum Gentechnologie, Berlin, Germany (Dr. H.J. Buhk) 20. International Life Sciences Institute, ILSI Europe, Brussels, Belgium (Dr. J. Kleiner) 21. Bundesinstitut für Gesundheitlichen Verbraucherschutz und Veterinärmedizin (BgVV), Center for Novel Foods and Genetic Engeneering, Berlin, Germany (Dr. J. Zagon, Dr. M. Schauzu) 22. Regulatory Toxicology, Herbicides en Biotechnology, Aventis CropScience, Sophia Antipolis Cedex, France (Dr. E. Debruyne) 23. Institute of Food Technology, General Food Technology and Food Microbiology, Hohenheim University, Stuttgart, Germany (Dr. W.P. Hammes) 24. European Commission - Joint Research Centre, Institute for Reference Materials and Measurements, Reference Materials Unit, Geel, Belgium (Dr. H. Schimmel) 25. Bureau Européen des Unions de Consommateurs (BEUC), Brussels, Belgium (Dr. B. Kettlitz) 26. Department of Biochemistry, University of Kuopio, Kuopio, Finland (Dr. S. Kärenlampi) 27. Institute of Applied Biotechnology, University of Kuopio, Kuopio, Finland (Dr. A. von Wright) 28. Scientific Affairs, Agricultural Sector, Monsanto Service International, Brussels, Belgium (Dr. A. Cockburn) 29. Quality and Safety Assurance, Nestlé Research Centre, Lausanne, Switzerland (Dr. A. Constable, Dr. D. Toet (now Unilever Rotterdam, NL)) 30. National Veterinary Institute, Section of Food and Feed Microbiology, Oslo, Norway (Dr. A. Holst-Jensen, Dr. K.G. Berdal) 31. Central Toxicology Laboratory, Syngenta, Cheshire, United Kingdom (Dr. I. Kimber) 32. Unilever Health Institute, Unilever Research, Vlaardingen, The Netherlands (Dr. M. Smith) 33. Swiss Quality Testing Services, Food Testing Laboratory, Migros Cooperatives, Courtepin, Switzerland (Dr. J. Rentsch) 34. Swedish National Food Administration, Uppsala, Sweden (Dr. U. Hammerling) 35. Centre for Bioethics and Risk Assessment, Research Department of Human Nutrition, Royal Veterinary and Agricultural University, Frederiksberg, Denmark (Dr. J. Lassen) 36. Centre for Market Surveillance, Research and Strategy for the Food Sector (MAPP), The Aarhus School of Business, Aarhus, Denmark (Dr. J. Scholderer) 37. Laboratoire de Biochimie Cellulaire, Facultés Universitaires Notre-Dame de la Paix, Namur, Belgium (Dr. J. Remacle, Mr. S. Leimanis) 38. Harvard University, Kennedy School of Government, Belfer Centre for Science & International Affairs, Cambridge, United States of America (Dr. A. König) 39. Department of Genetics, Carl von Ossietzky University, Oldenburg, Germany (Dr. W. Wackernagel) Further information: RIKILT - Institute of Food Safety Wageningen UR Dr. H.A. Kuiper/Dr. H.J.P. Marvin P.O. Box AE Wageningen, the Netherlands Telephone: Fax: entransfood.rikilt@wur.nl European Commission Ms Dyanne Bennink Directorate General Research SDME 8/9 B-1049 Brussels, Belgium Telephone: Fax: dyanne.bennink@cec.eu.int graphic design by Daniël Loos technical realisation by Propress BV, Wageningen Visit our internet site: