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

Abstract

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.

Planning Environmental Risk Assessment for Genetically Modified Crops: Problem Formulation for Stress-Tolerant Crops

“…4). Tiered testing is a proven and accepted approach to refine the environmental risk assessment (Touart and Maciorowski, 1997;Garcia-Alonzo et al, 2006). Importantly, hypothesis 2 helps define the anticipated difference between the test and control, and higher tiered testing addresses the risk hypotheses that the droughttolerant maize has no greater persistence or invasiveness in the environment compared to conventional maize.…”

Problem formulation and hypothesis testing for environmental risk assessments of genetically modified crops

“…If the phenomenon is detected in the laboratory, then its relevance in the field can be tested with laboratory experiments that more closely mimic field conditions, or with semi-field or field studies. These are the principles behind tiered testing and risk assessment (Garcia-Alonso et al, 2006;Touart and Maciorowski, 1997). …”

Environmental risk assessment of genetically modified plants - concepts and controversies

“…Bt-toxins, see below) expressed therein ( Table 1). This interpretation was precedented by the US regulations [7] and found support by corporate developers of GM plants and some governmental regulators of GM organisms in the US and Europe [8,9]. This current implementation of the regulations of GM plants is grounded in the concept of 'substantial equivalence' of GM plants and its non-transformed counterparts [10][11][12].…”