An empirical approach is given for specifying coexistence requirements for genetically modified (GM) maize (Zea mays L.) production, to ensure compliance with the 0.9% labeling threshold for food and feed in the European Union. Field data were considered in which pollen-mediated gene flow (PMGF) was measured within maize receptor fields at a series of distances from source fields having a marker. An empirical model is presented that fits the observed decrease of gene flow with distance. The model was parameterized to provide both reasonable worst case and expected case predictions of gene flow for various combinations of isolation distance, use of non-GM border rows in the GM field and/or separately harvested border rows in the receptor field. Based on the data assessed, the model is used to show that the effect of scale is minimal for source fields of surface area 4 ha and greater. Combinations of isolation distance and border rows of 20 m or more are predicted to result in gene flow of less than 0.9%, as a blended average for receptor fields 1 ha or larger. Lesser requirements are necessary when the source field is much smaller than the receptor, and an extension to the model is provided to estimate such effects.

During the development of a genetically modified (GM) crop product, extensive phenotypic and agronomic data are collected to characterize the plant in comparison to a conventional control with a similar genetic background. The data are evaluated for potential differences resulting from the genetic modification process or the GM trait, and the differences--if any--are subsequently considered in the context of contributing to the pest potential of the GM crop. Ultimately, these study results and those of other studies are used in an ecological risk assessment of the GM crop. In the studies reported here, seed germination, vegetative and reproductive growth, and pollen morphology of Roundup Ready 2 Yield(®) soybean, MON 89788, were compared to those of A3244, a conventional control soybean variety with the same genetic background. Any statistically significant differences were considered in the context of the genetic variation known to occur in soybean and were evaluated as indicators of an effect of the genetic modification process and assessed for impact on plant pest (weed) characteristics and adverse ecological impact (ecological risk). The results of these studies revealed no effects attributable to the genetic modification process or to the GM trait in the plant that would result in increased pest potential or adverse ecological impact of MON 89788 compared with A3244. These results and the associated risk assessments obtained from diverse geographic and environmental conditions in the United States and Argentina can be used by regulators in other countries to inform various assessments of ecological risk.

Biological and ecological data collected on a genetically modified crop and an appropriate control are useful for assessing potential ecological risk. Specific characteristics studied are selected on the basis of relevance to potential ecological effects, are well known, and are accepted by plant breeders. In these studies, germination, vegetative and reproductive growth, or ecological characteristics of Roundup Ready Flex cotton, MON 88913 were compared with a negative control, MON 88913(‐). Statistically significant differences, when detected, were considered in the context of the genetic variation known to occur in cotton and their potential impact on plant pest (weed) potential (ecological risk). Experimental results revealed no effects of the genetic modification that would result in increased pest potential or ecological risk of MON 88913 compared with MON 88913(‐).

As part of an ecological risk assessment, Roundup Ready 2 Yield® soybean (MON 89788) was compared to a conventional control soybean variety, A3244, for disease and arthropod damage, plant response to abiotic stress and cold, effects on succeeding plant growth (allelopathic effects), plant response to a bacterial symbiont, and effects on the ability of seed to survive and volunteer in a subsequent growing season. Statistically significant differences between MON 89788 and A3244 were considered in the context of the genetic variation known to occur in soybean and were assessed for their potential impact on plant pest (weed) potential and adverse environmental impact. The results of these studies revealed no effects of the genetic modification that would result in increased pest potential or adverse environmental impact of MON 89788 compared with A3244. This paper illustrates how such characterization studies conducted in a range of environments where the crop is grown are used in an ecological risk assessment of the genetically modified (GM) crop. Furthermore, risk assessors and decision makers use this information when deciding whether to approve a GM crop for cultivation in-or grain import into-their country.