Characterization of the ecological interactions of Roundup Ready 2 Yield® soybean, MON 89788, for use in ecological risk assessment.

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.

Plant characterization of Roundup Ready 2 Yield ® soybean, MON 89788, for use in ecological risk assessment.

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.

Response to Bagavathiannan and Van Acker's "Transgenes and national boundaries - The need for international regulations": Biotechnology developers and regulators already consider transgene movement across national boundaries and the environmental risks posed by adventitious presence of unapproved events are overstated.

Bagavathiannan and Van Acker propose greater international cooperation and information sharing in risk assessment for biotechnology-derived crops because pollen- and seed-mediated gene flow across political boundaries may lead to the adventitious presence of unapproved transgenes at sites along the borders of neighboring countries. However, they fail to convince us that something is wrong with the current situation and provide no details of how it could be improved.

A tiered system for assessing the risk of genetically modified plants to non-target organisms.

Representatives of the developers of modern agricultural biotechnology are proposing a tiered approach for conducting non-target organism risk assessment for genetically modified (GM) plants in Europe. The approach was developed by the Technical Advisory Group of the EuropaBio Plant Biotechnology Unit (http://www.europabio.org/TAG.htm) and complements other international activities to harmonize risk assessment. In the European Union (EU), the principles and methods to be followed in an environmental risk assessment for the placing on the market of GM plants are laid out in Annex II of Directive 2001/18/EC on the deliberate release into the environment of GMOs, Commission Decision 2002/623/EC and Regulation (EC) No. 1829/2003. Additional information is provided in the European Food Safety Authority guidance document of 2004. However, risk assessment for effects to non-target organisms could benefit from further clarification and remains the subject of much discussion in Europe. The industry-wide approach developed by EuropaBio is based on the fundamental steps of risk evaluation, namely hazard and exposure assessment. It follows a structured scheme including assessment planning, product characterization and assessment of hazard/exposure (Tier 0), single high dose and dose response testing (Tier 1), refined hazard characterization and exposure assessment (Tier 2) and further refined risk assessment experiments (Tier 3). An additional tier (Tier 4) was included to reflect the fact that post-market activities such as monitoring are required under Directive 2001/18/EC. The approach is compatible with conditions of commercial release in the EU and around the world.

Glyphosate tolerant canola meal is equivalent to the parental line in diets fed to rainbow trout.

Two separate studies were conducted to evaluate the utility of glyphosate tolerant canola (GTC) as a feed ingredient in diets fed to rainbow trout. In the first study, two forms of GTC were compared to a parental line, Westar. In the second study, one line of GTC was reevaluated to Westar. In each study, processed canola meals were incorporated at 5, 10, 15, or 20% of the dry diet and a diet containing no canola was fed for comparison. All diets were fed to triplicate groups of fish in each study. In the first study, weight gain, feed efficiency (FE), protein efficiency ratio (PER), and protein retention (PR) were not significantly different in fish fed either Westar or GT200 at any level of substitution. Fish fed GT73 exhibited a gradual reduction in weight gain, FE, and PER as the level of GTC increased. However, the only significant reduction was in weight gain of fish fed 20% GT73 as compared to fish fed 5% GT73. Because of an error in preparing samples prior to the experiment, samples GT200 and GT73 were essentially equivalent in composition. The differences were explained by differences in processing temperatures that occurred after the sample mixing error occurred. In the second study, mean weight gain, PR, and survival were not significantly different among forms of canola. FE and PER values were significantly lower in fish fed 15% Westar as compared to fish fed 10% Westar; other FE and PER values were not significantly different. On the basis of these results, GTC processed into a toasted meal and incorporated into diets for rainbow trout is equivalent to a parental line of canola.