The controversy regarding GM crops has less to do with their scientific safety assessment, which demonstrates that these crops are at least as safe as their conventional counterparts, than with the wider social, political, ethical and economic endpoints related to their commercialisation. As a result, national regulatory frameworks for the authorisation of GM crops often combine science-based risk assessments with public policy. The word ‘biosafety’ has come to denote the entire process of coming to a decision about the safe use of biotechnology products. Alternatively, Wolt and Peterson (2000) call the process of considering both scientific and social issues ‘risk analysis’ to distinguish it from risk assessment, which considers only technical risks. Applied to GM crops, this means that the consideration of potential export markets for these products would belong to the wider risk analysis, while the consideration of outcrossing with native species would belong to the technical risk assessment. Widening the risk discussion to include alternative framing of risk, such as the availability of export markets, invites public debate regarding the wider impacts of applied technology, such as political accountability, equity, ethics and economics. ‘Public debate is a way of isolating what is strictly scientific from what is socially or politically determined in the development of scientific activity’ (Touraine, 1997).National regulatory frameworks for GM crops are all alike, in that they seek to ensure an adequate level of protection for human and environmental health, based on the best available science. There is general agreement, for example, on the characterisation of donor and recipient organisms, environmental impact assessments and toxicity issues. On the other hand, national regulatory frameworks can also be diverse, depending on the basic assumptions about the novelty of using recombinant DNA techniques to modify plants. The margin separating natural from unnatural gene modification certainly exists but, because traditional plant breeding also involves the transfer of genes, on a scale that is magnitudes greater than during the genetic engineering of plants; it is less tangible than we would wish it to be. An important distinction must be made, in that there is both a need and a desire to know the kind of regulatory data requirements for risk assessment. Requesting unnecessary (nice to know) data will only add to the cost of technological development of transgenics, which in most cases is already becoming prohibitive.
Where gene modification is considered inherently safe, regulations tend to be product based, and only the final product is assessed, not the process that produced it, as in the United States. In almost all countries, the regulations governing transgenics are process based due to the fact that the organisms have been developed using modern genetic engineering techniques. Whenever gene modification is considered inherently dangerous, regulations are likely to be process based, and the trigger for regulation is the process itself. Adopted in February 2001, European Directive2001/18/EC, on the deliberate release of GM organisms, repealed Directive 90/220/EC as a comprehensive regulatory framework for environmental applications of GM organisms and their commercialisation. In both directives, regulations are process driven, since all ‘plants obtained through the techniques of genetic modification’ are subject to regulatory approval. Genetic modification in the Directive is understood as ‘the introduction of new combinations of genetic material by the insertion of nucleic acid molecules, the direct introduction of heritable material prepared outside the organism, cell fusion or hybridisation techniques’. In the US regulatory system, risk assessment for the environmental release of GM plants examines the likelihood of a GM plant to becoming a pest (7CRF340), based on the assumption that it has the potential to become one due to the presence of genetic elements from defined plant pests (CRF340.2). For example, the 35S promoter from cauliflower mosaic virus or regulatory elements from Agrobacterium used to transform plants. The Canadian approach, which is both product and process based, regulates both GM and conventional plants provided they ‘demonstrate neither familiarity nor substantial equivalence to those present in a distinct, stable population of a cultivated species of seed in Canada PNTs [plants with novel traits] include those derived from both recombinant DNA technology and plants derived through traditional plant breeding’ (Regulatory Directive Dir 94-08).
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