Risk assessment data for GM crops.

Abstract

The potential environmental risks and benefits of genetically modified (GM) crops “vary spatially, temporally, and according to the trait and cultivar modified,” L. L. Wolfenbarger and P. R. Phifer emphasize in their Review ( Science 's Compass, 15 Dec., p. [2088][1]). The same is true for conventionally derived cultivars. Biotechnology crops are not inherently less safe than their conventional counterparts. Formal scrutiny and regulation before and after commercialization should ensure that these crops maintain their status of “as safe as” or safer than conventional crops. With the vast array of potential risks of all new cultivars, priorities must be set to identify those cultivar-trait combinations that require supplemental data to facilitate the decision-making process. The authors focus exclusively on peer-reviewed data in the scientific literature and ignore the majority of data—that data reviewed by regulatory agencies and their independent advisors. Wolfenbarger and Phifer's suggestion as to the quantity and quality of information that should be generated not only ignores the need to set priorities but also does not acknowledge a successful history of reliance on risk assessments that use representative populations and added conservative assumptions to address uncertainties. Cooperation among a range of public and private institutions in agricultural biotechnology will be needed to fill gaps in data that are necessary to the decision-making process. Such a pact would alleviate two major constraints to progress: inadequate resources to support research, and a public lack of trust in agricultural biotechnology and those who develop and regulate it. To better deal with these issues in the public arena, an independent, multi-stakeholder, peer-review process should be created in countries where it is not already in place; where it does exist, such as in the United States and Canada, additional mechanisms to increase public understanding and awareness are needed. Our most important lesson from global discussions on new technologies is that while data alone cannot address cultural, economic, and ideological differences, we can ill afford to ignore valid data when assessing the impact of such technologies. # Response {#article-title-2} We conducted a thorough review of published literature and unpublished reports on transgenic organisms in the public domain during our research, compiling between 300 to 400 freely available papers and reports. The small number of unpublished studies included in our review were chosen because they both augmented areas of research lacking extensive published data and described their methods in sufficient detail as to make them repeatable. Most of the unpublished studies we reviewed did not contain significant data or did not describe their methods in detail. However, we did not request unpublished data submitted to regulatory agencies; thus, we are unable to comment on the quality or quantity of these data. Publication of any applicable data in the scientific, peer-reviewed literature would facilitate their entrance into the public dialogue concerning the benefits and risks of GM plants. We did identify in our Science Review gaps in research that will require a large quantity of high-quality data, and, admittedly, significant resources to address. Furthermore, we do not disagree that representative populations and conservative assumptions are an important component of risk assessments; however, we might differ in what we would define as an appropriate representative population. We would stress ecologically relevant populations because ecological comparisons between a GM crop and its alternatives will provide the key evidence for understanding relative environmental risks and benefits. Given the differences among ecosystems, not all ecological risk assessment data can be applied to all countries, yet we can provide a model of what data will best address these issues. We support Gregory et al. 's advocacy for science-based assessments of the potential benefits and risks of GM products and agree that scientific data alone cannot address a public's concern over biotechnology. We also believe that it is important the public is given valid, comprehensive, and understandable summaries or analyses of complex scientific issues, which is what we have attempted to provide. [1]: /lookup/doi/10.1126/science.290.5499.2088