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EC-sponsored Research on Safety of Genetically Modified Organisms - A Review of Results
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Tackling food safety
concerns over GMOs


H.P.J.M. Noteborn,
Department of Food Safety and Health,
State Institute for Quality Control of Agricultural Products (RIKILT) (NL)

Application of genetic transformation technology in agro-food has greatly increased the size of the gene pool and the opportunities for genetic changes that modern breeders and the food industry may draw upon. Initially, genetic modifications ranged from protection against pests and tolerance to herbicides to the production of source materials, such as starter cultures and enzymes for industrial food processes. More recently, food plants have been genetically modified (GM) or are being developed in order to enhance levels of essential amino acids, micronutrients and antioxidants like b-carotene (e.g. 'golden rice'). This means that the range and quality of genetic modifications in GM foods likely to be seeking regulatory approval in the future will be far greater than those that have already arrived in the market place. Moreover, the introduction of GM foods into the human diet has caused, and is continuing to cause, considerable public concern.

The focus of the debate on GM foods has been their safety as regards food use and the environment. Consequently, analysis of new evaluation techniques and protocols is an important part of the EC's current research strategy in this area. Hitherto, the projects that have been supported have tackled such challenges as how to detect quantitatively GM food materials, how to harmonise methodologies to assure food safety, how to detect gene transfer to the human microflora, and how to evaluate the usefulness of 'cell factory' technologies in risk assessment. However, relatively little attention has been paid to broader questions of GMO biosafety, such as communication of information, and consumer trust and acceptance (AIR3-CT94-2342).

It is apparent that the integration of GM foods into the community raises multiple societal, ethical and economic questions and demands strategies for informing European citizens about the technology and GMO biosafety. In this respect, earlier EC-supported research (FAIR-CT96-1667) has shown that consumer attitudes and purchase decisions are generally negative towards both the technology and its derived GM products. This poses a considerable problem since the demand for more information mainly activates existing 'negative' attitudes, regardless of the kind of information supplied or the information source. Current approaches to communication and information provision appear to be inadequate for future generations of GM foods. In particular, new strategies are needed that take into account the notion that perceptions of benefits are hindered by the perceptions of risks, and that consider how the important stakeholders need to interact to be able to move forward in partnership.

According to Article 8 of the Novel Foods and Novel Food Ingredients Regulation (258/97/EC), GM foods have to be labelled when either modified DNA or a novel protein can be detected. Previous research results (SMT4-CT96-2072) have highlighted the power and feasibility of polymerase chain reaction (PCR)-based systems to detect, in a qualitative manner, known GM material in foods. However, in terms of recently introduced GMO threshold values (Regulation 94/2000/EC), the development of quantitative methods for approved as well as for non-approved GMOs is an urgent regulatory need. Hence, the outcome of recently initiated research (QLK1-1999-01301) in this direction will be extremely important in providing the essential multiplex detection tools. Validation of these methods will be critical. But the growing need for EC standards and further development of databases for GMO detection should be addressed too. However, it is an open question whether it will be possible to keep all GM foods completely separated because of consumer demands or for other needs. The food industry is a global enterprise that depends on supplies from all over the world. In this scenario, the Scientific Committee on Plants has also argued that in the absence of any risk management strategy, traditional routes for the disposal of some novel crop by-products may have to be reconsidered.

For GM foods to become accepted, they must be shown to be safe. In contrast, many traditional foods have been introduced into Europe from other countries without the same testing as is now being applied to GM foods. In the EU, the assessment of risk to humans, animals and the environment and any hazard following 'accidental' consumption or exposure is based on Directive 90/220/EEC. In addition, the requirements of Regulation 258/97/EC must be satisfied before a GMO (or any product derived from it) can be used for food purposes. The principal issues considered in the EC-supported projects on GMO biosafety described in this chapter are those discussed by various scientific advisory bodies in relation to the release of GM foods. These issues concern traceability (detection) of genetically modified material(s), potential for transfer of the introduced gene(s) to other species, safety of the introduced gene product(s) including allergenicity, and the question of Substantial Equivalence.

Previous EC-supported projects in this area have extensively addressed the scientific principles for safety assessment using the concept of Substantial Equivalence. A huge amount of experience has been gained from assessing first prototypes of GMOs like modified lactic acid bacteria (BAP-0409/0420/0477, BAP-0474) and Bt-tomatoes (AGRF-CT90-0039, AIR3-CT94-2311). The results have been published and have served as case studies which have assisted scientific committees and advisory bodies in preparing guidelines for risk assessment, and have also provoked comments and observations from interested stakeholders. It has been demonstrated that the concept of Substantial Equivalence is a useful guiding tool for identifying similarities and differences between GM foods and conventional counterparts with a history of safe use. However, it should be stated that the risk assessment for potential allergenicity as carried out in the past is not yet 'foolproof'. In particular, structure-function studies of allergenic proteins should be encouraged, as well as the further development and validation of animal models.

The capacity of the human gut system to hydrolyse the modified DNA of plants is being re-evaluated in a new project (QLK1-1999-00527). The project will also examine whether this DNA can be taken up and incorporated into the genome of intestinal micro-organisms. If this is demonstrated, the implication of this DNA transfer will need to be assessed in terms of potential impact on intestinal flora/host interactions.

Many genes now being considered for introduction into food crops provide insect resistance and depend for their action on disrupting the digestive function of the pest. It is important to exclude the possibility that such pesticidal proteins may produce similar effects in mammals, including man. In Europe, there is no precise harmonisation of the design of methodologies to ensure the safety of GM foods, and it is difficult to use traditional animal models for feeding trials. Validation of the safety testing approach recommended by the Scientific Committee on Food is the objective of the recently launched research project QLK1-1999-00651; if the protocol investigated in this project fails to assess the fate and subsequent toxicological effects of the precursors (e.g. lectins), as well as the products of digestion, the proposed strategy for the safety evaluation of foods from GM crop plants will need to be revised.

A considerable body of data now exists on which to consider any possible hazard posed by the first generation of GM foods; since these contain new traits largely of interest to growers and food producers, changes in food composition are likely to be minor. However, refined strategies for managing the safety assessment of the next generation of GM foods is a major issue for the future which has been raised in the response of the OECD Task Force for the Safety of Novel Foods and Feeds to the G8. In particular, specific attention needs to be paid to issues related to nutrition, such as functionality of selected compounds and associated safety margins. Since these novel GM foods have been designed to be different from their conventional counterparts, the concept of Substantial Equivalence would be better served by the use of techniques which make no assumptions about compositional changes. This means attempting to measure the effects of the genetic transformation in as broad a manner as possible. This emerging issue is tackled in the project QLK1-1999-00765, where several new technical approaches, such as micro-array technology and proteomics, are being explored to allow a discerning analysis of future GMOs, in particular, the existence or otherwise of unintended effects. It should be noted, however, that despite the promise of the new techniques, there is still a long way to go in standardising sampling and extraction procedures, validation of profiling methods and in bioinformatics.

It is apparent that legislative bodies, the food industry and EU citizens expect that the new and powerful tools becoming available will be used to ensure full risk evaluation of the emerging complexities in GMO biosafety. In this, a key role will be played by the Thematic Network ENTRANSFOOD (QLK1-1999-01182), which clusters research activities of previous and ongoing EC-supported projects in this area. Among other activities, this network will critically assess risk assessments made and published to date and will discuss emerging issues relating to GM foods that need new scientific research; in other words it will serve as an early-warning system. In order to ensure safety of lifetime consumption of GMOs with added values (e.g. b-carotene, iron, etc.) the network will also explore the feasibility of post-market surveillance of GM foods in addition to pre-market assessment. The design of research protocols and of integrated risk/benefit assessment strategies for the new GM foods with functional/health claims is also urgently needed and is a great challenge for future research.

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