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Cumulative Long-Term Effects of Genetically Modified (GM)

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Cumulative Long-Term Effects of Genetically Modified (GM) Cumulative long-term effects of genetically modified (GM) crops on human/animal health and the environment: risk assessment methodologies Reference: No 07-0402/2005/414455/MAR/B4 CUMULATIVE LONG-TERM EFFECTS OF GENETICALLY MODIFIED (GM) CROPS ON HUMAN/ANIMAL HEALTH AND THE ENVIRONMENT: RISK ASSESSMENT METHODOLOGIES REFERENCE: NO 07-0402/2005/414455/MAR/B4 Final Report 31/03/06 Christine Henry Central Science Laboratory Sand Hutton York YO41 1LZ. UK Main Project Contractors Christine Henry, Sarah Hugo, James Blackburn, Central Science Laboratory (CSL) David Nicholls, RM Consultants Ltd 1 Cumulative long-term effects of genetically modified (GM) crops on human/animal health and the environment: risk assessment methodologies Reference: No 07-0402/2005/414455/MAR/B4 EXECUTIVE SUMMARY 1. The scientific evidence for long-term and cumulative effects of GM plant cultivation was reviewed. Currently available risk assessment methodologies were also reviewed and gaps in knowledge identified. Tools and techniques to fill these gaps have been identified, drawing on experience of risk assessment in other domains. Case studies were used to test and develop the risk assessment approaches, and to develop examples of monitoring and management measures. 2. Some areas of potential long-term risks and benefits were identified from the scientific literature but in fact there have been few comprehensive studies carried out in the field over the long-term that directly address long-term and cumulative effects. 3. Risk assessment methodologies for release of GMOs generally follow a case-by-case approach based on a scientific framework of assessment of hazards, potential for exposure, consequences of exposure and options for risk management. Many of these risk assessment frameworks do require that cumulative long-term effects are considered, however these assessments naturally tend to focus on identifying and monitoring effects of the GMO that can be anticipated, based on scientific evidence. Risk assessment methodologies currently in use probably do not easily lend themselves to the much broader, conceptual requirements of assessing unanticipated, long-term cumulative effects of the release of GM crops. 4. A workshop was held at CSL on 31 October 2005. A group of specialists attended the workshop and scoped different potential scenarios for long-term and cumulative risks from GM crops. Not all the risks identified in the workshop will necessarily be significant in practice, neither will they all be relevant to any particular release. Rather, together with the findings of the literature review, they show the range of possible risk types that assessment methodologies will need to be able to identify and evaluate. 5. Current approaches to risk assessment were identified and reviewed by contact with those involved in assessment of GM releases in the EU. A questionnaire was circulated to the competent authorities (CAs) of the Member States and other contacts supplied by DG Environment. A summary of their responses is given in the report, illustrating the diversity of approaches across the EU. 6. A risk assessment framework was developed and tested using case studies taken from GM plants in the pipeline for EU approval. The case studies were also used to develop examples of risk management strategies for monitoring and mitigation. 7. The risk assessment framework has been designed to be used by the CAs and to be made available to applicants. Consideration will need to be given to ensuring that the effort that it requires is proportionate to the effort required for the current environmental risk assessment (e.r.a), and to the level of risk identified. GM plants present inherently lower risk scenarios than, for example, medical products. GM crops, their products and derived products are traded commodities therefore, acceptability to the European Commission, WTO etc, will also need to be considered. If companies are asked to undertake a very lengthy risk assessment process for cumulative long-term risks, it may 2 Cumulative long-term effects of genetically modified (GM) crops on human/animal health and the environment: risk assessment methodologies Reference: No 07-0402/2005/414455/MAR/B4 not gain acceptance by them or by CAs and run the risk of not being addressed at all. If the long-term risk assessments were to be undertaken at a higher EU level on a more generic basis, then consideration of balancing these costs may become less important. Also, some thought will be needed as to how the framework will fit with current ‘short- term’ e.r.a.s, and any implications for these as the framework proposed in this report is more detailed than the guidance currently given. More work will therefore be required on the framework and its application before it can be used within the current EU regulatory system. 8. Areas where further work will be needed to improve the framework or fill gaps in our knowledge are as follows: • Obtaining Baseline Data. There is a need for good baseline data if monitoring is to be able to detect changes. A study is required to advise on the best indicators of long-term/ cumulative changes. There are also institutional and other practical aspects of implementation to be considered. For example, who should carry out the baselining, and how would it relate to ecological baselining for other purposes? • Ranking the Risks of Generic Crop-Trait combinations. It could be more cost- effective, for society as a whole, if some risk assessment work were to be done at a higher level than the release-specific ERAs. If certain crop-trait combinations (or other types of scenario) could be ranked in broad order of inherent risk, this would help both regulator and industry to ensure proportionate levels of depth and detail in risk assessments. It might also lead regulators to issue guidance indicating any broad classes of combinations that would be unlikely to be authorised, preventing wasted effort by all parties. The assessment framework could be applied in order to establish whether certain crop-trait combinations are inherently riskier than others. • Introgression into and Ecology of wild relatives. Currently, the mechanisms of introgression into wild relatives are not understood in sufficient detail to enable the likelihood of introgression to be determined with confidence. Neither is there, in general, a good enough understanding of the ecology of wild relatives, and hence of how undesirable traits might spread in the environment. Research is required to improve the understanding of introgression and of the ecology of wild relatives, in sufficient detail for risk assessment. • Improved hazard identification for long-term and cumulative effects. It is difficult to identify hazards that are fundamentally different from those that can occur in the short-term. In most cases, the long-term and cumulative hazards identified in this study were the same as the short-term ones, although the degree of risk associated with the hazard could be greater - given a longer time or more widespread planting, the likelihood and extent of undesirable effects may increase. Nevertheless, some genuinely different hazards can be identified. These tend to arise from rather subtle and complex combinations of factors, which would only be manifested in the long- term or as a result of widespread releases and plantings. The process of identifying long-term and cumulative risks could be made more efficient and effective if standard hazard-identification techniques (brainstorming, failure analyses, HHA etc) could be enhanced to focus more quickly on such genuinely long-term and cumulative effects. 3 Cumulative long-term effects of genetically modified (GM) crops on human/animal health and the environment: risk assessment methodologies Reference: No 07-0402/2005/414455/MAR/B4 • Tolerability Criteria. The absence of explicit criteria in the Directive for judging whether a risk is tolerable, and the apparent variations in practice between Competent Authorities, point to a need to develop some more explicit guidance on criteria that will encourage well-founded, consistent and fair decisions. There is a need to develop justifiable criteria for tolerable risk, and guidance on their application. • Tracking, Combining and Monitoring Cumulative Risks. In considering cumulative risks, the EC will need mechanisms to track and combine the risk assessments from multiple, and in some cases apparently unrelated, releases. There is a need to explore the scientific and institutional issues involved in tracking multiple release assessments and consents and to develop guidance for regulators. The study could consider both scientific aspects (how to identify any potential for cumulative risk) and institutional aspects (processes and procedures, IT issues). • Stakeholder Engagement in Risk Assessment. In other controversial debates about risk and the environment, there has been a growing realisation of the importance of considering social and ethical aspects. Stakeholder participation in framing the question and defining assessment methods is being given serious consideration and has occurred in some cases, in addition to the more traditional model, in which stakeholders review and challenge assessment results and assertions. Risk assessment should be used to provide a structured framework for discourse and decision-making under irreducible uncertainty, rather than as a technical and scientific exercise alone. Deliberative processes have been used in other domains, and this experience could be adapted
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