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.
Herbicides entering the aquatic environment by spray drift, run-off and leaching to field drains may cause adverse effects on non-target aquatic vegetation. The potential for such effects has typically been evaluated from tests with floating, monocotyledonous Lemna sp. However, concern has been expressed as to whether this species could be used to indicate potential effects on other vegetation types, particularly rooted, submerged, emergent or dicotyledonous species. In 1997, the Centre for Aquatic Plant Management undertook development of new tests based on the additional species, Glyceria maxima (Hartm) Holmb, Lagarosiphon major (Ridl) Moss and Myriophyllum spicatum L. The resulting methodology was used to assess the effects of the sulfonylurea herbicide, sulfosulfuron on these species. Data presented here demonstrate that exposure to initial sulfosulfuron concentrations of 3.33 microg litre(-1) for up to 21 days was tolerated by these species and that adverse effects were observed only when plants were exposed to initial concentrations of 3.33 and 10 microg litre(-1) for 70 days. As the occurrence of such high initial concentrations for long periods is unlikely in the aquatic environment, sulfosulfuron is not expected to have adverse effects on the growth of these species. This study has also demonstrated that G maxima, L major and M spicatum grown in small outdoor tanks can be used successfully to assess the effects of crop-protection products on non-target aquatic flora.
In many world regions, regulatory frameworks are in place to ensure that all precommercial genetically modified (GM) crops are evaluated for potential impacts on human health, animal health and the environment according to established standards of risk assessment and current scientific knowledge before authorizations for import or planting are granted. The environmental risk assessment for GM crops follows the same fundamental principles as other risk assessment schemes, i.e. risk is a function of hazard and exposure. However, one of the main differences that sets GM crop risk assessment apart is that it is highly dependent on the crop and the introduced trait; hence, a case-by-case approach is required. For many crop/trait combinations, the assessment is based on a comparison with an appropriate conventional non-GM crop. If agronomic/phenotypic and compositional/nutritional equivalence between the GM crop and its non-GM counterpart is demonstrated, the environmental risk assessment can focus on what is different. For products with no appropriate comparator, further testing or a non-comparative-based evaluation may be required. The goal of the environmental risk assessment is to systematically collect information to support decision making. This is achieved by focusing on end points that are clearly defined and aligned with environmental management goals defined by public policy. A well-constructed risk assessment should follow a logical progression or 'tiered approach', where all information available at a given time is gathered and assessed to determine what, if any, additional data must be collected to reach satisfactory risk conclusions. The risk assessment provides regulators with information that allows them to make knowledge based decisions about the GM crop. Final authorizations for commercialization, whether for import or cultivation, take into account the outcome of the environmental risk assessment, a formal assessment of food and feed safety, and in certain cases also consider political, economic and societal factors. Although the details of the risk assessment frameworks for GM crops vary from country to country, the general principles upon which they are based are comparable. Since 1996, over 100 GM crop/trait combinations have been placed on the market without negative environmental impacts, demonstrating the robustness of existing frameworks. This chapter reviews the main principles and regulatory aspects of the environmental risk assessment of GM crops.
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